EPI test

Field Guide for Health Workers

Family Health Unit

Ministry of Health Jamaica November 2017

4 3 2 1 Revision Issued

23/07/2018 07/10 05/5 04/5 Date

Draft Issue for use Draft Draft Issue Description

JRP RR RR RR Prepared by

ME KLB KLB KLB Checked by

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Table of Contents Table of Contents .......................................................................................................................... ii Foreword ........................................................................................................................................ x Abbreviations & Acronyms ....................................................................................................... xii List of Figures ............................................................................................................................. xiv List of Tables ............................................................................................................................. xvii Chapter 1: Introduction ............................................................................................................... 1 1.1

Policy................................................................................................................................ 1

1.2

Goal .................................................................................................................................. 2

1.3

Objectives ......................................................................................................................... 2

1.4

Strategies .......................................................................................................................... 2

1.5

Family Immunization ....................................................................................................... 3

1.6

Laws Governing Immunization in Jamaica...................................................................... 4

Chapter 2: Overview of the Expanded Programme on Immunization .................................... 5 2.1

Principles of Immunity ..................................................................................................... 5

2.2

The Purpose of Vaccination ............................................................................................. 5

2.3

Types of Vaccine .............................................................................................................. 6

2.4

Differences Between Live and Inactivated Vaccines ....................................................... 6

2.5

More Information About the Immune Response.............................................................. 9

2.6

General Guidelines for All Immunizations .................................................................... 10

2.7

The Immunization Schedule........................................................................................... 11

2.7.1

Children............................................................................................................................... 13

2.7.2

Adults and Older Children, Including Pregnant Women .................................................... 14

2.8

Accelerated or ‘Catch-up’ Vaccination for Children ..................................................... 16

2.9

HPV Vaccination in Adolescents ................................................................................... 17

2.10

Vaccines Not Given to Adults........................................................................................ 17

2.11

Immunization of Healthcare Workers ............................................................................ 17

2.12

Vaccines for Special Populations of Adults and Children ............................................. 18

2.13

What is a Contraindication? ........................................................................................... 18 ii

2.14 False Contraindications to Vaccination.......................................................................... 19 2.15

Special Populations ........................................................................................................ 19

2.15.1

Preterm infants .................................................................................................................... 19

2.15.2

Bleeding Disorders.............................................................................................................. 20

2.15.3 Immunosuppression / Immunodeficiency ................................................................................ 21 2.15.4 HIV-Exposed Infants ............................................................................................................... 23 2.15.5 Splenic Disorders ..................................................................................................................... 24 2.15.6 Pregnant and Breastfeeding Women ........................................................................................ 25 2.15.7 Haematopoietic Stem Cell Transplant (HSCT)........................................................................ 25

Chapter 3: Vaccine-Preventable Diseases ................................................................................ 27 3.1

Tuberculosis ................................................................................................................... 27

3.2

Diphtheria ....................................................................................................................... 29

3.3

Pertussis.......................................................................................................................... 30

3.4

Tetanus ........................................................................................................................... 32

3.5

Hepatitis B ...................................................................................................................... 33

3.6

Haemophilus Influenzae Type B (Hib) .......................................................................... 36

3.7

Poliomyelitis................................................................................................................... 37

3.8

Measles ........................................................................................................................... 39

3.9

Mumps............................................................................................................................ 40

3.10

Rubella ........................................................................................................................... 42

3.11

Yellow Fever .................................................................................................................. 43

3.12

Varicella ......................................................................................................................... 45

3.13

Pneumococcal Disease ................................................................................................... 46

3.14

Influenza ......................................................................................................................... 48

3.15

Human Papilloma Virus ................................................................................................. 49

3.16

Meningococcal Disease .................................................................................................. 50

3.17

Rotavirus Enteritis .......................................................................................................... 52

3.18

Other Vaccine-Preventable Diseases ............................................................................. 54

Chapter 4: Vaccines .................................................................................................................... 55 4.1

Definition of Vaccine ..................................................................................................... 55

4.2

Objectives of this Chapter .............................................................................................. 55 iii

4.3

List of Vaccines .............................................................................................................. 55

4.4

Bacillus of Calmette and GuĂŠrin Vaccine: BCG ............................................................ 56

4.5

DT Paediatric Vaccine: DT(P) ....................................................................................... 58

4.6

DT Adult Vaccine: DT (A) or DT or Td ........................................................................ 59

4.7

Diphtheria-Tetanus-Whole Cell Pertussis Vaccine: DTwP ........................................... 63

4.8

Hepatitis B Vaccine: HBV ............................................................................................. 65

4.9

Haemophilius Influenzae Type b Vaccine: Hib ............................................................. 69

4.10

Pentavalent Vaccine: DTwP/HepB/Hib ......................................................................... 71

4.11

Oral Polio Vaccine: OPV ............................................................................................... 73

4.11.1 Bivalent Oral Polio Vaccine: bOPV ........................................................................................ 73

4.12

Inactivated Poliomyelitis Vaccine (IPV)........................................................................ 75

4.13

Measles-Mumps-Rubella Vaccine: MMR ..................................................................... 77

4.13.1 Measles Vaccine; Rubella Vaccine; Mumps Vaccine.............................................................. 78

4.14

Human Papilloma Virus Vaccine: HPV ......................................................................... 79

4.15

Other Available Vaccines............................................................................................... 80

4.15.1

Yellow Fever Vaccine: YF ................................................................................................. 81

4.15.2

Meningococcal Vaccine ...................................................................................................... 83

4.15.3

Varicella Vaccine ................................................................................................................ 85

4.15.4

Pneumococcal Vaccines ...................................................................................................... 87

4.15.5

Influenza Vaccine ............................................................................................................... 89

4.15.6

Rotavirus Vaccine .............................................................................................................. 91

4.16 Summary of Vaccines ....................................................................................................... 93 Chapter 5: Care of Vaccines & Cold Chain ............................................................................. 99 5.1

What is the Cold Chain?................................................................................................. 99

5.2

Conditions for Storing EPI Vaccines ........................................................................... 100

5.4

Recommended Storage Temperatures for Vaccines .................................................... 103

5.5

Condition for Storing Diluents for EPI Vaccines......................................................... 103

5.6

Cold Chain Equipment Used in Health Centres and Health Departments ................... 105

5.6.1 Vaccine Refrigerators .............................................................................................................. 105 5.6.2 Cold Boxes ............................................................................................................................... 107 5.6.3 Vaccine Carriers....................................................................................................................... 107

iv

5.6.4 Ice Packs .................................................................................................................................. 108

5.7

Revised Multi-Dose Vial Policy .................................................................................. 109

5.8

How to Load Cold Chain Equipment ........................................................................... 111

5.9

Maintaining the Correct Temperature in Vaccine Carriers .......................................... 114

5.10

Cold Chain Monitoring Equipment .............................................................................. 115

5.10.1 Vaccine Vial Monitors ........................................................................................................... 115 5.10.2 Thermometers ........................................................................................................................ 116

5.12

Adjusting the Temperature in a Refrigerator or Freezer .............................................. 118

5.13

Maintaining Cold Chain Equipment ............................................................................ 120

5.14

Guidelines for Storing Vaccine during Power Cuts ..................................................... 121

5.15

Maintaining Vaccine Carriers ...................................................................................... 121

5.16

Management of the Cold Chain ................................................................................... 122

Chapter 6: Vaccination Supplies Stock Management ........................................................... 123 6.1

Introduction .................................................................................................................. 123

6.2

Principles of Vaccine Inventory and Stock Management ............................................ 124

6.3

Interpreting Expiration Dates ....................................................................................... 126

6.4

General Guidelines ....................................................................................................... 126

6.5

Exceptions to Expiration Dates of Labels .................................................................... 127

6.6

Stock Rotation .............................................................................................................. 127

6.7

Vaccine Inventory Accounting..................................................................................... 127

6.8

Counting Stock ............................................................................................................. 129

6.9

Vaccine Deliveries ....................................................................................................... 129

6.10

General Considerations ................................................................................................ 131

Chapter 7: Vaccine Administration ........................................................................................ 133 7.1

Preparing for a Session................................................................................................. 133

7.2

Registering, Assessing and Preparing the Client ......................................................... 133

7.2.1

Registering the Client........................................................................................................ 133

7.2.2

Assessing the Client .......................................................................................................... 138

7.2.3

Preparing the Client .......................................................................................................... 140

7.3

Tips for Effective Communication............................................................................... 140

7.4

Injection Equipment ..................................................................................................... 141 v

7.5

Handling Syringes and Needles Safely ........................................................................ 141

7.6

Sizes of Syringes and Needles ..................................................................................... 142

7.7

Mixing Vaccines .......................................................................................................... 142

7.8

Steps to Follow When Mixing Vaccines ...................................................................... 143

7.9

Giving Immunizations .................................................................................................. 145

7.10

Multiple Immunizations ............................................................................................... 147

7.11

How to Give an Intradermal Immunization: BCG ....................................................... 150

7.12

How to Give a Subcutaneous Immunization (such as MMR or Yellow Fever) .......... 151

7.13 How to Give an Intramuscular Immunization (such as DPT, DT, Pentavalent (DPT/HEPB/Hib), Hepatitis B, Hib) ....................................................................................... 153 7.14

How to Give an Oral Polio Vaccine ............................................................................. 156

7.15

Disposal of Syringes and Needles After Immunization ............................................... 157

7.16

Preventing Injuries & Infections When Administering Vaccines ................................ 159

7.17

Accidental Sharps Injury or Exposure to Blood, Blood Products or Bodily Fluids..... 161

Chapter 8: Safe Vaccination .................................................................................................... 163 8.1

Introduction .................................................................................................................. 163

8.2

Safe Vaccines ............................................................................................................... 164

8.3

The Regulatory Process ................................................................................................ 165

8.4

EPI Revolving Fund of the Pan-American Health Organization (PAHO)................... 167

8.5

Safe Injection Practices ................................................................................................ 167

8.6

Safety of the Injection Recipient .................................................................................. 167

8.7

Universal Precautions ................................................................................................... 172

8.7.1

Safety of the health worker ............................................................................................... 172

8.7.2

Safety of the Community and the Environment ................................................................ 172

8.8

Events Supposedly Attributable to Vaccination or Immunization (ESAVI) ............... 172

8.8.1

Classification and Rates of ESAVIs ................................................................................. 173

8.8.2

Management of ESAVIs ................................................................................................... 176

8.8.3

Management of Serious Vaccine-related Adverse Events ................................................ 177

8.9

Jamaica’s Process for ESAVI Management................................................................. 185

8.10

Communicating with the Media ................................................................................... 188

vi

Chapter 9: Surveillance ............................................................................................................ 191 9.1

Surveillance Definition ................................................................................................ 191

9.2

Importance of Surveillance to the EPI ......................................................................... 191

9.3

Surveillance Systems in Jamaica.................................................................................. 192

9.3.1

Purpose of VPD Surveillance ........................................................................................... 192

9.3.2

Sources of Surveillance Data ............................................................................................ 192

9.3.3

Structure of the Surveillance System in Jamaica .............................................................. 193

9.3.4

Approaches to Surveillance .............................................................................................. 193

9.4

Classes of Notifiable Diseases/Health Events .............................................................. 194

9.4.1 Class I Disease/Health Events.................................................................................................. 194 9.4.2 Class II Diseases/Health Events ............................................................................................... 196 9.4.3 Class III Diseases/Health Events ............................................................................................. 196

9.5

Roles and Responsibilities of Each Level .................................................................... 196

9.6

Surveillance of VPDs ................................................................................................... 197

9.6.1 Acute Flaccid Paralysis (AFP)/Poliomyelitis........................................................................... 197 9.6.2 Congenital Rubella Syndrome (CRS) ...................................................................................... 200 9.6.3 Diphtheria ................................................................................................................................ 203 9.6.4 Fever with Rash ....................................................................................................................... 206 9.6.5 Hepatitis B ............................................................................................................................... 211 9.6.6 Pertussis ................................................................................................................................... 214 9.6.7 Tetanus ..................................................................................................................................... 217 9.6.8 Tuberculosis ............................................................................................................................. 221 9.6.9 Other Vaccine Preventable Diseases........................................................................................ 223

Chapter 10: Adult & Older Child Immunization .................................................................. 225 10.1

Introduction .................................................................................................................. 225

10.2

Special Groups ............................................................................................................. 227

10.3

Vaccination with DT (Adult) and Prevention of Tetanus Following Injury ................ 228

10.4

Maternal and Neonatal Immunization .......................................................................... 228

10.5 Immunization Recommendations for All Healthcare Workers ....................................... 233 10.6

Influenza Vaccination .................................................................................................. 233

10.7

HPV Vaccination.......................................................................................................... 234 vii

Chapter 11: Monitoring & Evaluation ................................................................................... 237 11.1

Introduction .................................................................................................................. 237

11.2

Definitions .................................................................................................................... 237

11.3

Tools Used to Monitor and Evaluate the EPI............................................................... 238

11.4

Monitoring Vaccination Coverage and Dropout Rates ................................................ 240

11.4.1 Calculating Immunization Coverage...................................................................................... 240 11.4.2 Target populations.................................................................................................................. 240 11.4.3 Calculating Dropout Rates ..................................................................................................... 241 11.4.4 Analysis of Situations Related to the EPI .............................................................................. 242

11.5

Reporting Antenatal Tetanus Coverage ....................................................................... 244

11.6

Steps in Monitoring the EPI ......................................................................................... 246

Chapter 12: Programme Management & Community Outreach ........................................ 249 12.1

Programme Management ............................................................................................. 249

12.1.1

Ministry of Health ............................................................................................................ 249

12.1.2

Regional Health Authorities............................................................................................. 251

12.1.3

Parish Health Departments............................................................................................... 252

12.1.4

Health Centres .................................................................................................................. 253

12.1.5

Community Outreach ....................................................................................................... 254

12.2 Execution of Outreach Sessions ...................................................................................... 254 12.3 Completing an Outreach Session .................................................................................... 255 12.4 Managing Dropout Clients .............................................................................................. 256 12.5

Management of Vaccine Refusals or Hesitancy .......................................................... 256

12.6

Prosecution Procedures ................................................................................................ 257

References/Bibliography/Works Cited ................................................................................... 259 Appendices ................................................................................................................................. 261 Appendix A: Public Health (Immunization) Regulations, 1986 ............................................. 263 Regulations (Under section 14)......................................................................................................... 263 Jamaica Gazette Supplement: Public Health (Immunization) (Amendment) Regulations, 2013 ..... 266 Schedule, Form A: Certificate of Medical Contra-Indications, Unfitness for Immunization ........... 267 Excerpt from Immunization Regulation (1986) (Amended 2013) .................................................... 268

Appendix B: Jamaica’s Immunization Schedule .................................................................... 269 Immunization Schedule for Children ................................................................................................ 269

viii

Appendix C: EPI Monitoring Tools ........................................................................................ 270 Coverage Monitoring Tools .............................................................................................................. 270 Immunization Cards/Records ............................................................................................................ 282 Inventory Monitoring Tools .............................................................................................................. 286 ESAVI Monitoring Tools.................................................................................................................. 288 Audit Tools ....................................................................................................................................... 293

Appendix D: Checklist for Outreach Immunization Sessions ................................................ 300 Appendix E: Sample Immunization Notice ............................................................................ 302 Appendix F: Key Messages for Immunization Education and Promotion.............................. 303 Appendix G: Crisis Plan for the Management of Events Supposedly Attributable to Vaccination and Immunization (ESAVIs) .............................................................................. 304 Appendix H: Surveillance Tools and Forms ........................................................................... 316 Class I Notification Form – Individual Notification ......................................................................... 316 CARPHA Lab Investigation Form.................................................................................................... 317 Acute Flaccid Paralysis Investigation Form ..................................................................................... 318 Acute Flaccid Paralysis Surveillance: Neurological Examination: 60 Day Follow-Up ................... 320 Fever and Rash Case Investigation Form.......................................................................................... 321 Congenital Rubella Syndrome Case Investigation Form .................................................................. 322 Pertussis Case Investigation Form .................................................................................................... 323 Diphtheria Case Investigation Form ................................................................................................. 324 Tetanus and Neonatal Tetanus Case Investigation Form .................................................................. 325 Viral Hepatitis Case Investigation Form ........................................................................................... 326

Appendix I: Needle Stick, Sharp Object Injury and Fluid Exposure Report .......................... 327

ix

Foreword Dear Colleagues, The Expanded Programme on Immunization (EPI) was established by the World Health Organization (WHO) in 1974 to reduce illness and death due to vaccine-preventable diseases. In 1977, The Pan-American Health Organization (PAHO) launched the EPI in Jamaica and throughout the Americas.

The English-speaking Caribbean, has led the way in the elimination and eradication of vaccinepreventable diseases in the Region of the Americas. The last case of polio in Jamaica and the Caribbean was in 1982. The Region of the Americas was the first region to be certified poliofree in 1994. In 1988, the health ministers of the Caribbean countries resolved to eliminate indigenous cases of measles. They joined forces with PAHO and became the example for measles-elimination strategies throughout the Americas. The last case of indigenous measles in the Caribbean occurred in Jamaica in 1991. In 1998, at the Council for Human and Social Development of the Caribbean Community, the health ministers committed to the goal of eliminating rubella and congenital rubella syndrome in the Caribbean by the year 2000. Jamaica saw its last case of congenital rubella syndrome in 1998 and its last case of rubella in 2001.

These achievements, together with the introduction of vaccines such as pentavalent, pneumococcal, rotavirus, seasonal influenza and Human Papilloma Virus are preventing disease and saving lives throughout the Americas.

The EPI continues to be a flagship programme of the Government of Jamaica. Jamaica remains committed to the global goals for the Decade of Vaccines 2010 to 2020 to: o o o o o

achieve a world free of poliomyelitis meet global and regional elimination goals meet vaccination coverage targets in every region, country and community develop and introduce new and improved vaccines and technologies exceed the Millennium Development Goal 4 target for reducing child mortality

Since the beginning of the Decade of Vaccines, Jamaica’s coverage for each antigen in the primary schedule has been in excess of 90%, ranging between 91-100%.

The country has also embraced the 2016-2020 Regional Immunization Action Plan (RIAP) which provides Member States of the PAHO with the rationale, guiding principles, strategic lines of action, objectives, and indicators to “to extend, by 2020 and beyond, the full benefit of immunization to all people, regardless of where they are born, who they are or where they live.” x

This field guide is intended to improve the knowledge of health workers, especially those already in the field, and to assist in the training of new health workers. It contains information on the vaccines being administered and the diseases they prevent. It also establishes programme standards, and provides methods to monitor and evaluate the programme.

Thanks to the immunization unit of PAHO, the staff of the PAHO/WHO country office for their support to the preparation and production of this manual and special thanks to the core technical working group and co-opted members in the MOH and Regional Health Authorities that participated in the 2017 revision of this document.

Congratulations to health workers in the public and private sectors that have worked acidulously in ensuring that Jamaica continues to extend the benefits of vaccination to increasing numbers of children across the island. International agencies, such as the PAHO and United Nations Children’s Fund (UNICEF), should also be congratulated for the continuous technical and financial support, which has contributed to the success of the programme. Together we have made great strides towards the reduction, elimination and eradication of vaccine-preventable diseases in the Caribbean. With continued commitment, we will be able to achieve our goal of at least 95% immunization of infants and children in the target population.

Dr. Melody Ennis Director, Family Health Services (Acting)

xi

Abbreviations & Acronyms AFP AIDS Anti-HBs ARV BCG bOPV CDC CHA CHDP Cm CRS DPT/Hep B/Hib DT DTaP DTwP DT(A) DT(P) EPI ESAVI FHU GBS GE HBIg HBsAg HBV HCW HepA HepB Hib HIV HPV HSCT ID IgG, IgM, IgA IM IPV IU IV

Acute flaccid paralysis Acquired Immune Deficiency Syndrome Hepatitis B surface antibody antiretroviral Bacillus Calmette–Guérin Bivalent Oral Polio Vaccine Centre for Diseases Control community health aide Child Health Development Passport centimetre Congenital Rubella Syndrome Diphtheria Pertussis Tetanus/Hepatitis B/Haemophilus Influenza type b Diphtheria Tetanus Diphtheria Tetanus and Acellular Pertussis Diphtheria Tetanus and Whole Cell Pertussis Diphtheria Tetanus (adult) Diphtheria Tetanus (paediatric) Expanded Programme on Immunization Events Supposedly Attributable to Vaccination and Immunizations Family Health Unit Guillain-Barré Syndrome gastroenteritis Hepatitis B immunoglobulin Hepatitis B surface antigen Hepatitis B Vaccine healthcare workers Hepatitis A Hepatitis B Haemophilus Influenzae type b vaccine Human immunodeficiency virus Human papillomavirus Haematopoietic stem cell transplant intradermal immunoglobin G/M/A intramuscular inactivated poliomyelitis vaccine international units intravenous xii

IVIg Kg MDVP Mg mL MO(H) MOH MMR MPV NEJM NHF NSAIDS NSU OPV ORT PAHO PCV13 PEP PCV PHN p.o.

PPV RN Sc STI TB TIg tOPV UNICEF VAPP VPD VVM VZV WHO YF °C µg < >

intravenous immunoglobulin kilogram Multi-Dose Vial Policy milligram millilitre Medical Officer (Health) Ministry of Health Measles-mumps-rubella vaccine Meningococcal polysaccharide vaccine New England Journal of Medicine National Health Fund non-steroidal anti-inflammatory drugs National Surveillance Unit Oral polio vaccine Oral rehydration therapy Pan-American Health Organization 13-valent pneumococcal conjugate vaccine post-exposure prophylaxis Pneumococcal conjugate vaccine Public Health Nurse per ounce (by mouth) Pneumococcal polysaccharide vaccine Registered Nurse subcutaneous sexually transmitted infection tuberculosis Tetanus immunoglobulin trivalent oral polio vaccine United Nations Children’s Fund vaccine-associated paralytic polio vaccine-preventable disease vaccine vial monitor varicella zoster virus World Health Organization yellow fever degrees Celsius microgram less than greater than xiii

List of Figures Figure 2.5.1: The Immune Response …………………………………………………

8

Figure 4.4.1: Minimum time interval between administration of live vaccines ……..

60

Figure 4.4.2: Ancillary Lymphadenopathy…………………………………………...

62

Figure 5.1.1: Storage and Transport Links in Jamaica’s Cold Chain System ……......

108

Figure 5.2.1: Vaccines sensitive to heat ……………………………………………...

109

Figure 5.5.1: WHO Recommended Vaccine Storage Conditions ………………........

115

Figure 5.6.1.1: Warning sign to be placed on immunization refrigerators …………..

116

Figure 5.6.2.1: Vaccine Cold Box …………………………………………………....

118

Figure 5.6.3.1: Vaccine Carrier ………………………………………………………

119

Figure 5.6.4.1: Ice Packs (Water Packs) ……………………………………………...

120

Figure 5.7.1: Revised Multi-Dose Open Vial Policy for WHO prequalified vaccine ..

122

Figure 5.8.1: Correct Loading of the Vaccine Refrigerator …………………………..

124

Figure 5.8.2: Arranging ice packs in a vaccine carrier ………………………………..

125

Figure 5.9.1: Checking an icepack …………………………………………………….

127

Figure 5.10.1.1: Locations of VVMs on ampules or vials …………………………….

128

Figure 5.10.2: VVM showing colour change sequence and interpretation ……………

129

Figure 5.10.2.1: The dial thermometer (left) – no longer recommended; and the stem thermometer (right) …………………………………………………………………….

130

Figure 5.11.1: Refrigerator Temperature Record ………………………………………

132

Figure 6.2.1: Stock movement and relations between minimum, maximum and order Levels……………………………………………………………………………………

140

Figure 6.9.1: Vaccine Supply Chain in Jamaica ………………………………………..

146

Figure 7.2.1.1(a): Sample Immunization Register (Page 1) …………………………….

Figure 7.2.1.1(b): Sample Immunization Register (Page 2) …………………………….

151 151

xiv

Figure 7.2.1.2: Infant and Child Immunization Card …………………………………...

152

Figure 7.2.1.3: Child Health Development Passport ……………………………………

153

Figure 7.2.1.4: Adult Immunization Card ………………………………………………

154

Figure 7.4.1: Parts of a needle and syringe ……………………………………………..

158

Figure 7.7.1: Ampoules and Metal file ………………………………………………...

160

Figure 7.7.2: Breaking off the Neck of an Ampoule …………………………………...

160

Figure 7.8.1: Taking fluid from an ampoule ……………………………………………

161

Figure 7.8.2: Flicking a Vaccine Ampoule ……………………………………………...

162

Figure 7.8.3: Vials ……………………………………………………………………….

162

Figure 7.9.1: Parenteral Routes of Vaccination …………………………………………. 165 Figure 7.11.1: Position of syringe and needle ……………………………………….......

168

Figure 7.11.2: BCG needle position (intradermal) ……………………………………… 169 Figure 7.12.1: Holding child for subcutaneous immunization ………………………….

170

Figure 7.12.2: Needle position for subcutaneous immunization ………………………... 171 Figure 7.12.3: Giving Vaccine Subcutaneously ……………………………………….... 171 Figure 7.13.1: IM injection Site in Antero-lateral Thigh (Vastus Lateralis) ……………. 173 Figure 7.13.2: IM Injection Site in Upper Arm (Deltoid Muscle) ………………………. 173 Figure 7.13.3: Holding child for IM injection …………………………………………... 175 Figure 7.13.4: Needle position for IM injection ………………………………………… 175 Figure 7.14.1: Opening a glass vial ……………………………………………………... 176 Figure 7.14.2: Giving OPV, showing the dropper at an angle ………………………......

177

Figure 7.15.1: Puncture-proof safety box assembly and use …………………………....

178

Figure 7.15.2: Handmade disposal box …………………………………………………

178

Figure 8.1.1: Evolution of immunization programmers and importance of safe Vaccination………………………………………………………………………………. 185 Figure 8.3.1: Regulatory Process Vaccines Undergo ………………………………….... 187 xv

Figure 9.3.3.1: Levels of flow of surveillance information …………………………..

218

Figure 9.6.4.1: Scheme used in the PAHO region for case classification ……………

233

Figure 9.6.7.1: Neonatal Tetanus ……………………………………………………..

245

Figure 9.6.7.2: Risus sardonicus ……………………………………………………...

246

Figure 10.4.1: Integration of maternal immunization with other health services …….

256

Figure 11.4.4.1: Algorithm for interpretation of drop-out rates ………………………

271

Figure 11.5.1: Combined Monthly Immunization Report Form: section for antenatal immunization…………………………………………………………………………..

273

Figure 11.5.2: Calculation of Antenatal Tetanus Coverage …………………………...

274

Figure 12.1.1: The EPI Implementation Team ………………………………………...

277

xvi

List of Tables Table 2.4.1:

List of live attenuated vaccines ……………………………………..

6

Table 2.4.2:

List of inactivated vaccines …………………………………………

7

Table 2.7.1:

Summary of routine immunization in Jamaica ……………………..

12

Table 2.7.1.1: Recommended Childhood Vaccination Schedule …………………..

14

Table 2.7.2.1: Immunization Schedule for Adults and Children over 6 years: DT(A), Hepatitis B and MMR …………………………………………………………….....

15

Table 2.7.2.2: Immunization Schedule for Adults and Children over 6 years: Polio .

15

Table 2.7.2.3: Summary of adult and adolescent vaccines………..............................

17

Table 2.8.1: Accelerated or ‘Catch-up’ Vaccination of Children 1-6 years of age: BCG, DPT and Polio …………………………………………………………………

18

Table 2.8.2: Accelerated or ‘Catch-up’ Vaccination of Children 1-6 years of age: MMR and Hepatitis B ………………………………………………………………..

18

Table 2.13.1: Contraindications for Vaccines ………………………………………

21

Table 2.15.3.1:Vaccination of Persons with Symptomatic and Asymptomatic HIV Infection ……………………………………………………………………………...

26

Table 2.15.4.1: Recommended Childhood Vaccination Schedule for HIV-exposed Infants ………………………………………………………………………………...

27

Table 2.15.4.2: Vaccine schedule for symptomatic and asymptomatic HIV exposed infants…………………………………………………………………………………

28

Table 3.1: List of some Vaccine-Preventable Diseases ………………………………

31

Table 4.6.1: Requirements for DT immunization and TIG following injury to a person with normal immune system ……………………………………………………………….

65 Table 4.8.1: Recommended Dose and Route of Administration for Single Preparation Hepatitis B vaccines ……………………………………………………………………………..

72 Table 4.8.1: Immunization Schedule for infants who require Hepatitis B vaccination at birth …………………………………………………………………………………….

74 xvii

Table 4.16.1: Vaccines in schedule with temperature for storage, method of administration, adverse events and contraindications associated with immunization …

102

Table 5.2.1:

Vaccine Sensitivity to Extreme Cold …………………………………..

110

Table 5.14.1: Guidelines for storing vaccines during power cuts …………………….

135

Table 7.2.2.1: Screening questions for contraindications to vaccination ……………...

156

Table 7.6.1:

Sizes of syringes and needles for various vaccines …………………….

159

Table 7.10.1: Summary of Injection Sites and Routes ………………………………...

166

Table 7.10.2: Summary of vaccine dosing, administration route and syringe size ……

167

Table 7.17.1: Recommended Prophylaxis following Occupational Exposure to Known HIV Positive Source ……………………………………………………………

182

Table 8.6.1:

Programmatic Errors and Their Consequences …………………………

191

Table 8.6.2:

Allowable preservation time for opened vials …………………………..

193

Table 8.8.1:

Classification of adverse events following immunization ………………

195

Table 8.8.1.1: Minor adverse events due to vaccination ………………………………..

197

Table 8.8.1.2: Minor adverse events due to vaccination ………………………………..

198

Table 8.8.2.1: Clinical Management of Minor Vaccine-Related Adverse Events ……...

199

Table 8.8.3.1: Adrenaline dosage (1:1000) according to age …………………………... 205 Table 8.8.3.2: Adrenaline dosage (one in ten thousand) according to age ……………... 205 Table 8.9.1:

List of reportable ESAVIs ………………………………………………. 210

Table 8.9.2:

Steps in an ESAVI investigation ………………………………………... 211

Table 8.10.1: Summary of the frequency rates of minor events, attributed to vaccination or immunization and the times they take to appear ………………………………………... 213 Table 8.10.2: Summary of severe events attributed to vaccination or immunization, onset interval and rates ………………………………………………………………………... 214 Table 9.4.1:

Summary of Local Reporting Requirements for Class I Conditions ……

221

Table 10.1.1: Vaccines provided by MOH for adults and older children in specified target groups …………………………………………………………………………………… 253 xviii

Table 10.2.1: Recommended vaccines for special groups …………………………….

254

Table 10.4.1: Recommended maternal immunization schedule ………………………

257

Table 10.4.2: ‘Catch-up’ immunization schedule for women who have received one or more doses of DPT/DT prior to current pregnancy ………………………………………….. 259 Table 10.4.3: Recommended DT immunization schedule for previously unvaccinated pregnant women and women of childbearing age, and efficacy of vaccination …………………. 260 Table 10.4.4: MMR Schedule for Women of Childbearing Age (15-44 years) ……….

260

Table 10.5.1: Immunization Recommendation for All Healthcare Workers …………..

261

Table 11.3.1: EPI Goals and Tools …………………………………………………….

266

Table 11.4.2.1: Vaccines administered to target populations …………………………...

269

Table 11.4.3.1: Estimating dropout rates ………………………………………………..

270

Table 11.4.4.1: The four (4) situations/scenarios that can be interpreted from dropout rates and DPT1 coverage …………………………………………………………………………. 272 Table 11.6.1: Five Key Steps to Monitor the EPI ……………………………………..

274

Table 11.6.2: Work plan template to address increased drop-out rates ………………..

276

xix

xx

Chapter 1: Introduction The EPI is an essential programme in the prevention and control of diseases. It is responsible for the reduction of childhood mortality and morbidity in the last forty years. The successes of the immunization programme are also protected by the Immunization Regulation 1986 (amended 2013) which mandates that all children entering school must be adequately immunized. All vaccines provided to Jamaica’s population for routine immunization through the MOH are purchased with funding from the national budget through the PAHO EPI Revolving Fund and offered free of cost.

Significant investments in technological solutions have been made in recent years which are expected to enhance information systems for coverage monitoring and vaccination supplies stock management.

Outlined below are the policy, goal, objectives and strategies of the EPI programme. All members of health team must familiarise themselves with the contents of this manual.

1.1 Policy In keeping with The Immunization Regulations of 1986 (amended 2013) and the adolescent and adult vaccination policies, the following are essential: •

• • •

All children under 7 years of age must be adequately immunized prior to school entry (daycare, nursery, preschool, basic schools and primary schools, whether the institutions are publicly or privately operated). Additionally, all adolescents, adults and special groups must be appropriately vaccinated.

The primary vaccination schedule should be completed within 1 year of birth or soon thereafter. Re-immunization or boosters may be needed from time to time.

Exemptions may only be granted for medical contraindications.

Immunizations will be provided free of charge to children, adolescents and other special groups in the public-health service in accordance with the Ministry of Health's schedule of vaccines.

1

1.2 Goal •

To prevent death and illness from vaccine-preventable diseases by protecting at least 95% of susceptible persons through vaccination achieved through an effective immunization programme.

1.3 Objectives • • • • • • • • • • •

to immunize at least 95% of children by 0 – 11 months against tuberculosis, diphtheria, pertussis, tetanus, poliomyelitis, hepatitis B and haemophilus influenza type b; to immunize at least 95% of children 12 – 23 months against measles, mumps, and rubella; to immunize at least 80% of adolescent girls in the target cohort for HPV; to immunize at least 95% of women of child-bearing age and pregnant women against tetanus and rubella to prevent neonatal tetanus and congenital rubella syndrome; to provide, correctly utilise and monitor cold-chain equipment to ensure vaccine safety and efficacy; to conduct ongoing (daily) surveillance for vaccine-preventable diseases with special emphasis on poliomyelitis, measles and rubella; to document and investigate all ‘Events Supposedly Attributable to Vaccination and Immunizations’ (ESAVIs) to ensure vaccine safety; to collect and analyse coverage data on a monthly basis to monitor the progress of the EPI; to conduct periodic evaluations of the EPI on immunization; to prevent the reintroduction of yellow fever into Jamaica through the vaccination of travellers to endemic areas; and to facilitate the smooth transition from child to family immunization.

1.4 Strategies o Administer BCG vaccination in hospitals and in postnatal clinics o Conduct daily immunization in district, parish and comprehensive health centres and clinics o Provide weekly or monthly immunization in community and satellite health centres o Provide immunization in school health programmes o Provide vaccination services at no cost to children and special groups o Use tracking registers to identify defaulters 2

o o o o o o o o o o o o o

Conduct outreach sessions to include home visits in hard-to-reach areas Organize periodic vaccination campaigns Provide public education and social mobilization using all forms of media Partner with the private sector (training, supply of vaccines and collection of coverage data) Facilitate inter-sectoral collaboration (Ministry of Education, Youth and Culture; Ministry of Social Security) Conduct monthly monitoring of vaccination coverage by facility, health district, parish, region and national levels Introduce new vaccines Procure and maintain cold-chain equipment Monitor the cold chain to ensure efficacy of vaccines Conduct surveillance for vaccine-preventable diseases and ESAVIs Ensure regular and consistent supply of quality vaccines and syringes/needles Organize capacity building of healthcare providers, both in the public and private sectors Facilitate family immunization

1.5 Family Immunization Since the inception of the EPI programme, infants and young children have been the main target group because they are the ones most at risk of contracting and succumbing to vaccinepreventable diseases. The immunization programme has evolved over the years to include vaccination throughout the life cycle to ensure protection of the family. This requires all members of the family to be adequately protected from vaccine-preventable diseases. All individuals should be assessed for their immunity to disease and advised accordingly. Special attention should be paid to adolescents, the elderly, persons living with disabilities and chronic illnesses, healthcare workers and other at-risk groups, such as frontline workers and those working in farming or animal husbandry.

At every contact with the health system, the patient should be questioned about vaccination.

Efforts made to educate all clients on the importance of protection against the vaccine preventable diseases and to ensure that their immunizations are up to date.

Health staff should include screening for vaccination at Casualty or Accident and Emergency departments of hospitals, as well as at clinics such as:

3

• • • • • •

• • • • • •

Antenatal clinics Family Planning clinics Postnatal clinics STI/HIV clinics Chronic Diseases clinics Food Handlers’ clinics

Oral Health clinics School Medical clinics Curative clinics Mental Health clinics Adolescent Health clinics Adult Wellness clinics

1.6 Laws Governing Immunization in Jamaica The Public Health Immunization Regulations 1986 (amended 2013) are part of the Public Health Act of Jamaica. According to the regulations: o The Chief Medical Officer has the authority to approve the immunization schedule. o Immunization may be performed by a public immunization officer or by a medical practitioner. o Persons authorized to admit pupils to school must require proof of immunization prior to admitting pupils to school or allowing their continued attendance.

N.B. Principals or administrators who fail to comply with these provisions are guilty of an offence and may be fined or imprisoned. o Healthcare workers are legally responsible if they fail to seek out and immunize children, in accordance with the Immunization Regulations. o Parents are also liable if they wilfully prevent their children from being vaccinated. o Immunization performed by a public immunization officer, and any examination or certificate issued in connection therewith, shall be free of charge.

See Appendix A for details of the Immunization Regulations 1986 (Amended 2013).

4

Chapter 2: Overview of the Expanded Programme on Immunization 2.1 Principles of Immunity The Immune System The immune system is the bodyâ&#x20AC;&#x2122;s way of protecting itself from germs. It consists of specialized cells that fight bacteria, viruses and other substances foreign to the body, called antigens.

These specialized cells produce antibodies (protein molecules called immunoglobulins â&#x20AC;&#x201C; IgG, IgM, IgA) to fight off invading organisms or foreign substances. A person who has been exposed to a disease or vaccine and who has developed immunity usually has antibodies specific to the disease detectable in his or her blood.

Types of Immunity â&#x20AC;&#x201C; Active and Passive Immunity to disease usually occurs when the body produces an immune response to a germ or foreign substance. This is active immunity. Vaccines usually produce active immunity.

Immunity to disease can also be given passively when an individual receives antibodies from another human or animal. Passive immunity lasts only a few weeks or months. Here are a few examples of passive immunity: o o o o

A pregnant woman transfers her own antibodies to her foetus through the placenta A breastfeeding woman transfers her own antibodies to her infant through breast milk A person receives a blood transfusion which always contains some antibodies A person receives an injection of immune globulin

2.2 The Purpose of Vaccination The purpose of vaccination is to give the body protection from a disease BEFORE the disease has a chance to cause sickness. Vaccines contain weakened or killed germs. Vaccination induces an immune response similar to that of a natural infection, but without the development of signs and symptoms of the disease.

5

2.3 Types of Vaccine Vaccines may consist of living or dead organisms, or components of dead organisms (such as their proteins). The contents of the vaccine influence how it should be handled and stored, as well as who should and should not receive the vaccine.

Some people have poorly functioning immune systems, a condition known as immunosuppression or immunodeficiency. These persons require certain vaccines to protect against worsening of their condition and death. For example, persons with HIV, AIDS or cancer (e.g. leukaemia, lymphoma) may have difficulty fighting off various infections.

Some live vaccines can cause illness in persons who are immunosuppressed. It is important to know which live vaccines should and should not be given to immunosuppressed persons and their contacts. All other vaccines help people with immunosuppression to be protected against deadly diseases.

2.4 Differences Between Live and Inactivated Vaccines Live Attenuated Vaccines These vaccines: • • • •

• • •

are living bacteria and viruses that have been modified (weakened or attenuated) to reduce their ability to cause disease multiply in the body to produce an immune response will not work if they are damaged by light or heat. Handle carefully to avoid vaccine failure will not work if a person has circulating antibodies to the vaccine (e.g. due to injection of immunoglobulin or blood transfusion). The antibodies prevent the vaccine virus from multiplying and producing immunity should NOT be given to some immunosuppressed persons because severe and fatal reactions can occur in general, should NOT be given to pregnant women because of the theoretical risk of foetal infection Vaccine virus from the oral polio vaccine can be transmitted from vaccinated persons to unvaccinated persons (horizontal transmission) through the faeco-oral route. This is of benefit in producing herd immunity

6

Table 2.4.1:

List of live attenuated vaccines

Live Attenuated Vaccines Live Attenuated Viral Vaccines Measles Mumps Rubella Oral Polio Yellow Fever Varicella (chickenpox) Vaccinia (smallpox) Influenza (intranasal)

Live Attenuated Bacterial Vaccines Bacillus Calmette-Guérin Oral Typhoid

Inactivated vaccines These vaccines: • • • • •

consist of inactivated (dead) organisms, or parts of inactivated organisms are not alive and are, therefore, safe for people who have an immunodeficiency are unaffected by circulating antibodies need more than one dose to provide immunity against disease often require booster doses

The vaccine virus or bacteria is grown in a culture and then killed with heat or chemicals.

Adjuvants (aluminum phosphate or aluminum hydroxide) are added to some inactivated vaccines to enhance immune response. They can be irritants to the skin. Therefore, they can cause local reactions at the injection site, especially if given superficially into the subcutaneous tissue. There is no evidence, however, that aluminum given in this way either exceeds the safety levels approved by the WHO or has any other untoward effects.

“Recent advances in immunology, biochemistry and areas related vaccine technology have given birth to the use of recombinant proteins in vaccines which allows the targeting of immune response focused against a few protective antigens in pathogens of selected vaccine-preventable diseases. Recombinant vaccine technology permits the avoidance of several potential concerns raised in the development of vaccines, such as the copurification of undesired contaminants, reversal of toxoids to their toxigenic form, and

7

obtaining sufficient quantities of purified antigenic components to optimize the immune response.â&#x20AC;? 1

Table 2.4.2:

List of inactivated vaccines Inactivated Vaccines

Whole Virus Vaccines IPV Influenza (injectable) Rabies Hepatitis A

Whole Bacterial Vaccines Pertussis (whole cell) Typhoid (injectable) Cholera Plague Anthrax

Fractional Vaccines (consist of parts of inactivated organisms) Subunit Vaccines Hepatitis B (surface antigen) Influenza Pertussis (acellular) Haemophilus olysacch type b Meningococcal Pneumococcal (conjugate & olysaccharide) Human Papillomavirus (recombinant) Toxoids Diphtheria Tetanus

1

Source: Nascimiento IP, Leite LCC. Recombinant vaccines and the development of new vaccine strategies.

Braz J Med Biol Res, December 2012, Vol 45(12) 1102-1111

8

2.5 More Information About the Immune Response Most vaccines exert their protective effect by stimulating the production of antibodies (usually immunoglobulins (Ig) G and M). Some, including poliomyelitis and rubella, also induce surface acting IgA antibodies. BCG promotes a cell-mediated reaction detectable by the tuberculin skin test.

In an individual without prior exposure to natural infection, a first injection of an inactivated vaccine usually produces a low antibody response, predominantly involving IgM. After the initial injection, further vaccination at suitable intervals will result in an accelerated response, with the IgG antibody rising to a higher level. This is the secondary response. Thus, further injections can be expected to lead to prolonged high levels of antibody, usually sustained over many years. Following vaccination, exposure to the natural organism will lead to a similar immune response without (or with a modified) clinical illness.

If too little time has passed between doses of the same vaccine, antibodies persisting from the primary response will eliminate the vaccine (antigen), making the second dose ineffective.

Hence, a 4-week interval is recommended between doses of the same vaccine.

Figure 2.5.1:

2

The Immune Response 2

Source: Mackett M, Williamson J.D., Human Vaccines and Vaccination. Oxford: Bios; 1995

9

2.6 General Guidelines for All Immunizations •

All EPI vaccines are safe and effective when given at the same time Individuals can be vaccinated against several diseases in a single visit to increase efficiency and reduce the risk of delinquency. Scientific studies have shown that when different vaccines are given at the same time, they are as effective as when given separately, and there is no increased risk of reactions or complications.

•

If two injections of vaccine occur on the same day, they should be given on different sites of the body. For example, one injection in the right arm or thigh and the other injection in the left arm or thigh.

•

Vaccines should not be mixed in the same syringe unless they are designed for this purpose.

•

The recommended timing and spacing of vaccinations are shown in the Immunization Schedule (Table 2.7.1.1; Appendix B). The following general rules apply:

10

GENERAL GUIDELINES FOR ALL IMMUNIZATIONS 1. Health workers should strive to immunize according to the schedule.

2. An appropriate interval must pass between doses of the same vaccine. If the second, third, or fourth dose in a series is given too early, it may not be protective.

3. Similarly, do not give a vaccine earlier than the recommended age. It may not protect the child.

4. If the interval between vaccinations exceeds the scheduled interval, do not restart the schedule or add doses. Continue from where the schedule left off.

5. OPV and inactivated vaccines can be given at any time before or after each other as long as the immunization schedule is followed.

6. If doses of BCG, MMR, yellow fever and varicella vaccines are not given simultaneously, the vaccines should be separated by at least four weeks.

7. OPV and the inactivated vaccines can be given any time before or after the above vaccines (BCG, MMR, yellow fever, varicella) in keeping with the immunization schedule.

8. Immunoglobulins (antibodies) may interfere with the response to live viral vaccines. If an individual has received immune globulin or a transfusion before or after vaccination with a live attenuated vaccine, consult a paediatrician or the Family Health Unit to revise the patientâ&#x20AC;&#x2122;s immunization schedule. This rule does not apply to post-partum immunization with MMR. Immediate post-partum immunization with MMR should continue despite blood transfusion or immune globulin given during pregnancy or the postpartum period.

9. Inactivated vaccines are NOT affected by immune globulin or transfusion.

2.7 The Immunization Schedule Immunization is an integral part of Family Health Services. Jamaicaâ&#x20AC;&#x2122;s goal is to completely immunize all children under 7 years of age, adolescents against HPV, special groups and all women of childbearing age as early as possible in accordance with the National Immunization Schedule. The schedule is designed to minimize the number of clinic visits the client has to make for the purpose of immunization.

11

Vaccines can be given at any age. It is never too late for someone to be vaccinated. They are given throughout the life cycle. Adults and children over 7 years of age receive DT instead of DPT. Women of childbearing age should be up to date with their rubella and DT immunizations.

Immunization schedules vary from country to country and may be modified from time to time as new scientific evidence and vaccines emerge. The immunization schedule is, therefore, a guideline and is flexible.

Table 2.7.1

Summary of routine immunization in Jamaica3

Antigen BCG

Polio

Children 1 dose 3 doses 2 boosters (NB at least 1 dose with IPV)

Adolescents

Adults

3 doses 2 boosters

Booster (with DT) as necessary

Hepatitis B

3 doses (with DPT)

3 doses in high risk groups if not previously vaccinated

Haemophilus Influenzae type b

3 doses (with DPT)

Measles, mumps and rubella

2 doses

DPT

HPV

Considerations Exception: HIV Type of vaccine (OPV, IPV)

Maternal immunization; Combination vaccines Birth dose; Combination vaccines

1 dose (if not previously vaccinated with 2 doses in childhood)

2 doses (females)

Target: 9-14 yo girls; Females â&#x2030;Ľ15yo + immunecompromised get 3 doses

Vaccines for consideration outside of the routine schedule include influenza, meningococcus, yellow fever, pneumococcus, DTaP and others, as deemed necessary.

3

Adapted from Summary of WHO Position Papers (updated March 2013). http://www.who.int/immunization/policy/Immunization_routine_table1.pdf

12

2.7.1 Children Children under one year old are the main target group because they are at highest risk of illness due to vaccine-preventable diseases. The Immunization Schedule is designed to ensure all infants are comprehensively immunized against the ten targeted diseases: H. Influenzae type b, hepatitis B, tuberculosis, diphtheria, pertussis, tetanus, poliomyelitis, measles, rubella, and mumps) by their first birthday. This primary series is followed by booster doses of MMR, DPT and OPV vaccines prior to school entry.

Modifications to the recommended schedule may be needed because of missed appointments or illnesses. Interruption of a recommended series does not require restarting the series, regardless of the interval that has elapsed. Children who do not receive all their immunizations during the first year of life can be given vaccines according to the catch-up schedule (Table 2.8.1).

See Table 2.7.1.1 for the immunization schedule for children in Jamaica. Note also that additional vaccines may be available and given in the private sector.

Table 2.7.1.1: Recommended Childhood Vaccination Schedule

AGE Birth to six weeks 6 weeks

3 months

6 months

VACCINE BCG 1st Polio (IPV)* 1st DPT/Hepatitis B/Hib (Pentavalent 2nd Polio (OPV/IPV)* 2nd DPT/Hepatitis B/Hib (Pentavalent) 3rd Polio (OPV/IPV)* 3rd DPT/Hepatitis B/Hib (Pentavalent)

12 months

1st MMR

18 months

1st Booster DPT 1st Booster Polio (OPV/IPV)* 1st Booster MMR

4 â&#x20AC;&#x201C; 6 years

2nd Booster DPT 2nd Booster Polio (OPV/IPV)*

*IPV is also given to immunosuppressed or immunodeficient children and their close contacts.

13

2.7.2 Adults and Older Children, Including Pregnant Women The MOH provides certain vaccines for special populations in addition to traditional routine vaccination for children: • • • • • •

women of childbearing age adolescents and adults during special campaigns grade 7 girls for cervical cancer prevention people with wounds that require administration of DT contacts of persons infected with Hepatitis B healthcare workers

Adolescents and adults should seek care in the private sector according to the schedule in Table 2.7.2.1. When a vaccine is given to an adult or adolescent FOR ANY REASON, it must be recorded in the older child and adult immunization register, the client docket and the client immunization card.

Table 2.7.2.1: Immunization Schedule for Adults and Children over 6 years: DT(A), Hepatitis B and MMR

Vaccine

First Contact

Second Contact (At least 4 weeks after first contact)

Third Contact (At least 6 months after second contact)

Fourth Contact (At least 1 year after third contact)

Fifth contact (At least 1 year after last contact)

DT(A)* 1st

2nd

3rd

4th

5th

Hep B

1st

2nd

3rd

---

---

MMR

1st

2nd

* If the person has a vaccination history of receiving DPT refer to Table 10.4.2

14

Table 2.7.2.2: Immunization Schedule for Adults and Children over 6 years: Polio

Vaccine

First Contact

Second Contact (At least 4 weeks after first contact)

Third Contact (At least 4 weeks after second contact)

Fourth Contact (At least 4 weeks after third contact)

Fifth Contact (At least 4 weeks after fourth contact)

IPV/ OPV*

1st

2nd

3rd

4th

5th

*If at least one dose of OPV was administered prior to the national tOPV to bOPV switch in April 2016, then continue the schedule with OPV (that is, bOPV). If there in no history of polio vaccination prior to the national tOPV to bOPV switch in April 2016, then administer IPV on first contact to protect against poliovirus type 2 and continue the schedule with OPV (that is bOPV) as long as there is no contraindication to the use of OPV.

In summary, adults and adolescents should have received in total the following: Table 2.7.2.3: Summary of adult and adolescent vaccines

Vaccine Tetanus Diphtheria Hepatitis B Polio Measles Mumps Rubella Human Papillomavirus

Number of Doses 5 or 6 doses (in accordance with above schedules) 5 or 6 doses (in accordance with above schedules) 3 doses 5 doses 2 doses 1 or 2 doses 1 or 2 doses 2 or 3 doses

If the requisite numbers of doses have not been received, immunization should be updated.

Additionally, adults should be reminded of the necessity to update immunization and to consider immunization requirements well in advance of overseas travel, tertiary education, employment in the police or military service, or healthcare sector.

See Chapter 10 for further details.

15

2.8 Accelerated or ‘Catch-up’ Vaccination for Children For children one to six years of age, with no history of vaccination, the health worker should immunize according to the following schedules (Table 2.8.1). This schedule is specific to older children and does not apply to those under the age of one.

Accelerated or ‘Catch-up’ Vaccination of Children 1-6 years of age 4: BCG, DPT and

Table 2.8.1: Polio

Vaccine

First Second Contact Contact (At least 4 weeks after 1st immunization)

Third Contact (At least 4 weeks after 2nd immunization)

Fourth Contact (At least 6 months after 3rd immunization)

Age 4-6 years AND At least 6 months after last immunization

BCG DPT IPV/ OPV*

1st 1st 1st

--3rd 3rd

--4th 4th

--5th 5th

--2nd 2nd

*If at least one dose of OPV was administered prior to the national tOPV to bOPV switch in April 2016, then continue the schedule with OPV (that is, bOPV). If there in no history of polio vaccination prior to the national tOPV to bOPV switch in April 2016, then administer IPV on first contact to protect against poliovirus type 2 and continue the schedule with OPV (that is bOPV) as long as there is no contraindication to the use of OPV. Table 2.8.2: Hepatitis B

Accelerated or ‘Catch-up’ Vaccination of Children 1-6 years of age: MMR and

Vaccine

First Contact

Second Contact (At least 4 weeks after 1st immunization)

Third Contact (At least 4 months after 1st immunization)

MMR Hep B

1st 1st

2nd 2nd

3rd

If a one-to-six-year-old child has received NO vaccine, priority should be given to MMR, polio and DPT. Unless there are contraindications, all these vaccines should be given to the child at one time.

4

Note that this schedule for DPT is in line with current CDC catch-up schedule for children 4 months to 6 years of age.

16

2.9 HPV Vaccination in Adolescents The World Health Organization (WHO) recommends that HPV vaccines be included in national immunization programmes as a core strategy for primary prevention against cervical cancer. WHO states that HPV vaccination for 9 to 14 year old girls is the most cost-effective public health measure against cervical cancer.

HPV vaccination in Jamaica is part of a coordinated and comprehensive approach to cervical cancer control that also includes secondary prevention through screening and treatment of adult women for pre-cancerous lesions, and tertiary and palliative care for women affected by cervical cancer.

2.10 Vaccines Not Given to Adults BCG, Hib, and Pertussis are NOT GIVEN to older children and adults. The specific age limit for children varies according to the vaccine (refer to Chapter 4 on Vaccines).

2.11 Immunization of Healthcare Workers For the purposes of this field guide, healthcare workers (HCWs) is defined as physicians, nurses, emergency medical personnel, dental professionals, medical and nursing students, laboratory and other technicians, community health aides, hospital volunteers, housekeeping staff, and other administrative staff who come in direct contact with patients or infective materials from patients. HCWs adhere to universal precautions for infection control to prevent the acquisition and transmission of infectious diseases in the workplace. However, maintenance of immunity is also an essential part of infection-control programmes for HCWs. Immunizing agents safeguard the health of workers by: 1. Reducing the number of susceptibles in hospitals and health departments.

2. Decreasing the risk of transmission of vaccine preventable diseases to patients and other co-workers.

Like other adults, HCWs are strongly advised to be immunized against hepatitis B, tetanus, diphtheria, influenza, measles, mumps and rubella.

If a HCW has not previously had chicken pox or shingles (i.e. varicella zoster virus), immunization with varicella zoster vaccine is suggested.

For more details on immunizing HCWs, consult the EPI managers.

17

2.12 Vaccines for Special Populations of Adults and Children Pneumococcal, meningococcal, varicella zoster, hepatitis A, influenza, and yellow fever vaccines should also be considered for those at risk.

2.13 What is a Contraindication?

A contraindication is a circumstance that greatly increases the risk of a serious adverse reaction from vaccination. If there is a contraindication, the client should not be vaccinated. There are few true contraindications to vaccination. Table 2.13.1 shows the contraindications that apply to ALL vaccines, as well as additional contraindications for specific vaccines.

Table 2.13.1:

Contraindications for Vaccines

Vaccine

Contraindication

All Vaccines

-

Severe allergic reaction to the vaccine or any of its constituents Moderate to severe acute illness, including fever >38ºC • This is a temporary contraindication; once illness or fever has resolved, the vaccine may be given.

• This does not apply to mild illnesses.

BCG

-

-

Immunosuppression/ Immunodeficiency† Positive tuberculin skin test Extensive skin disease or burns Pregnancy Encephalopathy within 7 days of a previous dose The following reactions within 48 hours of a previous dose: • Temperature > 40.5ºC (105ºF) • Collapse or shock-like state (hypotonic-hypotensive episode) • Persistent, inconsolable crying for > 3 hours Convulsions with or without fever within 3 days of a previous dose

Hepatitis B

-

Severe allergy to baker’s yeast

Hib

-

Age < 6 weeks

OPV

-

Immunosuppression / Immunodeficiency Contact with immunosuppressed/immunodeficient person Pregnancy Anaphylaxis to prior dose of IPV, streptomycin, polymyxin B, or neomycin

MMR

-

Severe allergic reaction to prior dose of MMR, gelatin, neomycin‡ Pregnancy Severe immunodeficiency/immunosuppression Receipt of transfusion or immune globulin within past 7 months or subsequent 14 days (consult physician to revise immunization schedule).

Influenza

-

Allergy to eggs

DPT

IPV

‡ Egg allergy is no longer considered a contraindication to MMR vaccination. Measles and mumps containing vaccines are produced in chick embryo fibroblasts; however, reactions to the vaccine have been shown to be related to other vaccine components (e.g. gelatin) and not to egg. Therefore, MMR may be given to children allergic to egg, with little associated risk.

18

2.14 False Contraindications to Vaccination The following are NOT contraindications to vaccination: • • • • • • • • • • • • • • • •

Mild illness such as (fever <38°C), cold or upper respiratory tract infection, mild diarrhoea (< 2 episodes per day), otitis media, asthma Premature birth or low birth weight Breastfeeding mothers and their infants Meningitis which has been treated Disease exposure or recent hospitalization Pregnancy in the household Allergies to products not in vaccine Family history unrelated to immunosuppression Need for TB skin testing Need for multiple vaccines Family history of convulsions Treatment with antibiotics, topical or inhaled steroids Local skin infections, eczema Children with Down’s syndrome or cerebral palsy History of jaundice (yellow skin) at birth Infant of an HIV infected mother (follow schedule in Tables 2.15.4.1 and 2.15.4.2)

In these circumstances, persons should be immunized according to the routine immunization schedule.

2.15 Special Populations Certain health conditions increase the risks associated with infectious disease. Children and adults with such conditions should be immunized as a matter of priority.

2.15.1 Preterm infants The risk of infectious disease is higher for preterm and infants with low birth weight than for other infants. Preterm infants should be immunized according to their chronological age (based on the usual immunization schedule), provided they have no medical contraindications.

Further protection of the preterm infant should be ensured by immunization of the family and caregivers, including hospital personnel.

19

•

Infants of mothers who have Hepatitis B (acute or chronic), whether preterm or not, should receive a dose of Hepatitis B vaccine and a dose of Hepatitis B immunoglobulin at birth. The three other Hepatitis B doses should be given according to the regular schedule as part of the combination Pentavalent vaccine.

If an infant is still in hospital when other immunizations are due: • •

•

Pentavalent (DPT/HepB/Hib) vaccine should be given at the scheduled time.

OPV should be given upon discharge from the hospital (at the appropriate age) to avoid circulation of vaccine virus in hospital to patients who may be immunosuppressed.

Preterm infants who develop chronic respiratory diseases can be given the influenza vaccine from age six months. This is dependent on the advice of the paediatrician.

2.15.2 Bleeding Disorders For persons with thrombocytopenia, haemophilia, or other bleeding disorders, consider the use of alternate vaccines that may be administered by the non-intramuscular route.

Additionally, some vaccines that are usually administered IM may be given subcutaneously.

Ensure that you check the product instructions.

If an IM injection is necessary: • Consult the patient’s physician regarding the need for specific clotting factors or observation in hospital following vaccination.

• A fine needle (23 gauge or smaller) should be used for the injection.

• Apply direct pressure (without rubbing) to the injection site for at least five minutes following injection.

• The patient or family should receive instructions regarding the risk of haematoma formation from the injection and what to do in case of an emergency.

• The patients should be warned against the use of NSAIDS Patients who receive plasma-derived products, are at higher risk of contracting Hepatitis A and B, and should, therefore, be offered vaccination for these diseases.

20

2.15.3 Immunosuppression / Immunodeficiency A poorly functioning immune system can be due to diseases or treatments (e.g. drugs, radiation.) People with immune responses which are inadequate or lower than usual are referred to as having immunosuppression or immunodeficiency.

Conditions characterized by immunosuppression or immunodeficiency are: • • • •

• •

Congenital immunodeficiency Chronic renal disease Leukemia, Lymphoma or Generalized malignancy (cancer) Receipt of > 20 mg of prednisone or > 2 mg/kg/day prednisone (or corticosteroid equivalent) for over two weeks, or widespread use of potent topical corticosteroids; MMR and varicella vaccines should not be given until 1 month after discontinuation of high dose corticosteroid therapy.

Treatment with alkylating agents, antimetabolites, or radiation (e.g. for cancer); live vaccines should not be given until 3 months after therapy has been discontinued.

HIV Remember that some people who are infected with HIV have no symptoms and are only mildly immunosuppressed, while others with HIV are severely immunosuppressed. Certain live vaccines may be given to HIV+ individuals. Table 2.15.3.1, 2.15.4.1 and 2.15.4.2 show which vaccines may be given to HIV+ individuals and infants exposed to HIV

General recommendations for immunosuppression/immunodeficiency are as follows: • • •

•

•

In general, live vaccines are contraindicated for immunosuppressed individuals.

Remember that the live vaccines are MMR, OPV, Yellow Fever, Varicella, Vaccinia (smallpox), Influenza (intranasal), BCG, and Oral Typhoid.

OPV should not be given if there is an immunosuppressed person in the household.

All other live vaccines can be given to close contacts of immunosuppressed persons because they are not transmitted from person to person.

Inactivated vaccines are safe and necessary for immunosuppressed or immunodeficient people. However, immune response to inactivated vaccines may be sub-optimal.

In addition to the routine immunization schedule, other vaccines (pneumococcal conjugate vaccine, pneumococcal polysaccharide vaccine, meningococcal polysaccharide vaccine, hepatitis A vaccine, influenza vaccine, IPV, and varicella vaccine) may be indicated for specific immune conditions.

21

Immunosuppressed/immunodeficient persons and their family members should be given these vaccines on the advice of a physician.

Live vaccines may be used in the following circumstances: • • •

•

Patient regularly or intermittently uses inhaled corticosteroids Previously healthy child receiving less than two weeks of corticosteroids Previously healthy child receiving low to moderate dose (0.5-1 mg/kg/day) prednisone (or corticosteroid equivalent) long-term for a condition which is not of itself immunosuppressive Use of corticosteroids in the skin or eyes, or in the form of intra-articular, bursal or tendon injections

Table 2.15.3.1: Vaccination of Persons with Symptomatic and Asymptomatic HIV Infection

Vaccine BCG DPT OPV

Give to Asymptomatic HIV+ Yes

Give to Symptomatic HIV+ No Yes No (recommend IPV)

IPV

Yes Yes (2nd choice; recommend IPV) Yes (1st choice)

MMR

Yes

Hepatitis B

Yes

Depends on severity of immunosuppression (e.g. CD4 count, symptoms); check with paediatrician before immunizing Yes

Yellow Fever

No (a travel waiver may be needed) No (recommend Inactivated Influenza vaccine)

No (a travel waiver may be needed) No (recommend Inactivated Influenza vaccine)

Yes

Yes

Yes (consult paediatrician prior to vaccination) Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Live Attenuated Influenza Vaccine (intranasal) Inactivated Influenza Vaccine Varicella Hepatitis A Meningococcal Polysaccharide Vaccine Pneumococcal Conjugate & Polysaccharide Vaccines HPV

22

Yes

Yes

2.15.4 HIV-Exposed Infants All infants of HIV+ mothers may be exposed to the virus during delivery. Therefore, HIVinfected women are given antiretroviral prophylaxis.

Routine childhood immunizations are not hazardous to children born to HIV positive mother.

These infants should follow the special immunization schedule in Table 2.11 (below) until their HIV status can be confirmed.

Table 2.15.4.1: Recommended Childhood Vaccination Schedule for HIV-exposed Infants

Age

Vaccine

Birth to 6 weeks

BCG if asymptomatic (pediatrician or physician should assess)

6 weeks

1st IPV 1st DPT/Hepatitis B/Hib (Pentavalent) 2nd IPV 2nd DPT/Hepatitis B/Hib (Pentavalent)

3 months 6 months 12 months 18 months

4-6 years

3rd IPV 3rd DPT/Hepatitis B/Hib (Pentavalent) 1st MMR if the child is well 1st Booster DPT/DT(P) 1st Booster IPV 1st Booster MMR if the child is well 2nd Booster DPT/DT(P) 2nd Booster IPV

Asymptomatic children should receive the same immunization as other children. However: â&#x20AC;˘ â&#x20AC;˘

Infants with HIV infection should be vaccinated with IPV rather than OPV. BCG is not recommended for symptomatic HIV infected individuals IPV should also be used to immunize household contacts of a child with HIV

23

Table 2.15.4.2: Vaccine schedule for symptomatic and asymptomatic HIV exposed infants 5

Give to asymptomatic HIV exposed Yes Yes Yes

Give to symptomatic HIV exposed Yes Yes No

Yes

Yes

Hep B Hib MMR

Yes Yes

Yes Yes

Yes

Yes

Influenza PCV Varicella Rotavirus

Yes Yes Yes Yes

Yes Yes Yes Yes

Vaccine BCG DPT or paed DT OPV IPV

Optimal timing of immunization Birth to 6 weeks 6 weeks, 3 months, 6 months; boosters at 18 months and 46 years 6 weeks, 3 months, 6 months 12 months; boosters at 18 months As for uninfected individuals

2.15.5 Splenic Disorders Individuals may lack a spleen or may have a poorly functioning spleen due to: • • •

surgical removal (e.g. post-trauma) diseases such as sickle cell anaemia, thalassemia major, essential thrombocytopenia, celiac disease or inflammatory bowel disease congenital asplenia

These conditions increase the risk of fulminant bacteraemia (bacteria in the blood), which is associated with high mortality rate, particularly among infants. The organisms that most commonly cause fulminant sepsis in these individuals are Streptococcus pneumoniae (most frequent), Neisseiria meningitidis, Haemophilus influenzae type b, and Escherichia coli. As such, the following additional vaccines are recommended: • • • •

5

Pneumoccocal conjugate vaccine (PCV) up to the age of 5 years.

Pneumococcal polysaccharide vaccine (PPV) for children over 5 years old and adults.

Meningococcal polysaccharide vaccine for children and adults over 2 years of age.

Influenza vaccine annually for adults and children over 6 months of age.

Adapted from MOH pMTCT manual, Chapter 9.

24

Detailed information on scheduling and boosters is found in Chapter 4.

2.15.6 Pregnant and Breastfeeding Women •

•

•

• • •

Inactivated vaccines may be given during pregnancy and are recommended when the risks of maternal or foetal infection and associated disease are high (e.g. tetanus, woman at high risk of complications from influenza). However, a precautionary position is taken in pregnancy. That is, if the risk of infection from a particular disease is not immediate and significant, then the relevant vaccine should be postponed until after the pregnancy. In some cases, the risk of exposure (and the need for vaccination) can be eliminated by changing travel plans.

Live vaccines are usually not given during pregnancy because of the theoretical risk of foetal infection. However, no adverse effects have ever been demonstrated from licensed vaccines (with the historical exception of smallpox vaccine). o For example, even though the rubella vaccine virus can cause viremia, there is no evidence that rubella vaccine causes congenital rubella syndrome in infants born to susceptible mothers vaccinated during pregnancy. For women who are vaccinated and then subsequently found to be pregnant, abortions are not recommended. It is not necessary to counsel women to avoid pregnancy following rubella vaccination because there is no known risk of adverse foetal outcome.

Pregnant women travelling to areas where the risk of yellow fever is high (e.g. ongoing epidemic) should receive live attenuated yellow fever vaccine. This is the only circumstance when yellow fever vaccine may be given during pregnancy.

Similarly, if a woman is at substantial risk of exposure to poliovirus and cannot complete the IPV series prior to the expected exposure, she should be given OPV. Therefore, pregnancy does not constitute an absolute contraindication to the use of standard vaccines.

There is no evidence of risk to the breastfeeding baby if the mother is vaccinated with any of the live or inactivated vaccines in the immunization schedule. Breast-feeding does not adversely affect immunization and is not a contraindication for the administration of any vaccine to the baby.

2.15.7 Haematopoietic Stem Cell Transplant (HSCT) •

HSCT is given to patients who have received chemotherapy or radiation because of cancer, blood or immune disorders.

25

•

• • • •

After HSCT, antibody titres to vaccine-preventable diseases decline. Therefore, patients must be re-vaccinated according to the recommendations of the treating physician.

Revaccination usually begins 1 year following HSCT (with the exception of influenza vaccination, which can begin 6 months after HSCT).

In general, live vaccines should not be given until 2 years post-transplant.

Consultation with the treating physician is recommended.

They are usually not vaccinated with varicella, pneumococcal and meningococcal conjugate vaccines.

26

Chapter 3: Vaccine-Preventable Diseases Vaccine-preventable diseases (VPDs) are infectious diseases for which an effective preventative vaccine exists. Some VPDs are listed in the table below.

Table 3.1:

List of some Vaccine-Preventable Diseases

Tuberculosis Diphtheria Pertussis Tetanus Hepatitis B Haemaphilus Influenza type b Poliomyelitis Measles Mumps Rota Virus

Rubella Yellow Fever Varicella Pneumococcal Disease Influenza Human Papillomavirus Infection Meningococcal Rabies Japanese Encephalitis

3.1 Tuberculosis What is tuberculosis (TB)?

• • • • •

Tuberculosis is caused by a bacterium (Mycobacterium tuberculosis).

It is usually a disease of the lungs and respiratory tract.

It can affect almost any organ in the body, e.g. brain, kidney and spine.

It can cause an asymptomatic (latent) infection or active disease.

Only people who have active disease can spread the infection to others.

How is it spread?

• • • •

It is spread through the air when a person with TB disease of the lung or throat coughs or sneezes. Another person inhaling that air may then become infected.

Spread is facilitated by crowded living conditions, malnutrition and poor access to care.

People of any age can contract TB, but children under five years of age, older adults, diabetics and people with HIV or AIDS are at higher risk of developing the disease.

A person with the disease can infect others for several weeks after beginning treatment.

27

Incubation Period •

Usual incubation period (time from exposure to onset of symptoms) is 4 – 12 weeks, but infection may last for months or years before the disease develops. Some people who are infected may never develop the disease.

What are the signs and symptoms?

• •

•

Generalized weakness, fever, weight loss, decreased or lost appetite and night sweats.

In the lungs, TB causes persistent cough, the coughing up of blood, and chest pain; however, young children may not have these symptoms. The only sign of pulmonary TB may be stunted growth or failure to thrive.

Other signs and symptoms depend on the part of the body that is affected.

What are the complications?

•

The complications include weakening of the body, increased susceptibility to other diseases, and death.

How is TB treated?

• •

With two or more anti-TB drugs for at least 6 – 9 months.

If the drugs are not taken properly or if they are stopped too early, they will not work.

Ineffective treatment can also lead to multidrug-resistant TB, which is very difficult to treat.

How is TB prevented?

• •

Immunization of infants with Bacillus Calmette–Guérin (BCG) vaccine, a vaccine primarily used against TB. Control of spread centres upon early diagnosis and adequate treatment of cases, as well as the investigation and treatment of contact(s). o TB is a Class I notifiable disease. Suspected cases should be reported to the parish health department within 24 hours so that a case investigation may be done and disease prevention and control measures put in place. o Health departments should notify the regional epidemiologist/surveillance officers and the National Surveillance Unit immediately by phone or fax.

28

3.2 Diphtheria What is diphtheria?

• • •

An acute bacterial disease of the mouth, throat, nose or skin caused by Corynebacterium diphtheria.

Diphtheria produces a toxin (poison) that destroys nearby tissues and can spread through the body, causing severe illness.

It affects people of all ages, but mostly non-immunized children less than 15 years of age.

How is diphtheria spread?

• •

Contact with infected secretions produced by coughing, sneezing or skin ulcers.

Many can carry the disease without symptoms and can pass it on to others for two to four weeks.

Incubation Period •

Usually 1 – 5 days with a range of 1 – 10 days.

What are the signs and symptoms?

•

•

People with diphtheria of the throat and tonsils develop fever, sore throat, loss of appetite, and malaise two to five days following exposure. A few days later, an adherent coating, bluish-white, grey or black in colour, forms on the throat and tonsils. This coating can obstruct the airway and can cause death. The throat may bleed if one tries to remove this coating.

Diphtheria of the skin causes painful red sores.

What are the complications?

• •

Airway obstruction, inflammation of the heart muscle or arrhythmia, (myocarditis, neuritis, thrombocytopenia, proteinuria); Paralysis and death.

How is diphtheria treated?

• • •

With antibiotics (erythromycin or penicillin) and diphtheria antitoxin About two days after starting antibiotic treatment, patients are no longer infectious.

Isolation to avoid exposing others to the germs.

29

How is diphtheria prevented?

•

•

Immunization with diphtheria toxoid, which is a part of the following vaccines: o Pentavalent (DPT/Hib/Hepatitis B), DPT, DT(P), DT(A) and DTaP (which is only given in the private sector). o Immunity wanes over time and a booster dose should be administered every 10 years.

Early diagnosis and adequate treatment of cases, and the investigation, prophylactic treatment, and immunization of contact(s). o Diphtheria is a Class I notifiable disease. Suspected cases should be reported to the parish health department within 24 hours to initiate a case investigation. o Health departments should notify the regional epidemiologist/surveillance officers and the NSU immediately by phone or fax.

3.3 Pertussis What is pertussis (whooping cough)?

• •

Pertussis is a very contagious respiratory disease caused by Bordetella pertussis, a germ (bacterium) that lives in the mouth, nose and throat.

It is common in non-immunized children everywhere, but young infants are at highest risk.

How is it spread?

• •

It is spread through contact with, or inhalation of, infected droplets produced by coughing or sneezing.

Transmission occurs from seven days after exposure until three weeks after coughing begins.

Incubation Period •

Usually 7 – 10 days with a range of 4 – 21 days.

What are the signs and symptoms?

There are usually three stages of the illness (See below). High fever is uncommon at any stage.

30

Stage 1: The child appears to have a common cold. This is accompanied by runny nose, watery eyes, sneezing, fever and a mild cough. The cough worsens gradually for one to two weeks.

Stage 2: Coughing spells begin. Bursts of rapid coughing are followed by the child taking in air with a high-pitched “whoop”. (Infants younger than six months may have apnoeic spells instead of a whoop). Because of these coughing spells, the child may turn blue (because he or she cannot breathe), vomit after coughing, and may become very tired. This stage usually lasts from one week to six weeks, but can last up to 10 weeks. The attacks become milder with the passage of time.

Stage 3: Coughing slows down and usually stops in two to three weeks.

What are the complications?

• • •

Pneumonia, seizures (convulsions), encephalopathy, apnoea or death.

Less serious complications include loss of appetite, dehydration, and ear infections.

Complications are most frequent and harmful in children under one year old.

How is pertussis treated?

• • •

Antibiotics (usually erythromycin) reduce severity and prevent infection of others.

Plenty of fluids should be given to prevent dehydration.

Isolation to avoid exposing others to the germ

How is pertussis prevented?

•

•

Immunization with pertussis vaccine, which is a part of the following vaccines: o Pentavalent (DTwP/Hib/HepB), DTwP o DTaP; DTP/Hib; DTaP/Hib/HepB/IPV; DTaP/Hib/IPV (these vaccines are only given in the private sector) Early diagnosis and adequate treatment of cases, and the investigation, prophylactic treatment, and immunization of contact(s). o Pertussis is a Class I notifiable disease o Report suspected cases to the parish health department within 24 hours to initiate a case investigation o Health departments should notify the Regional Epidemiologist/Surveillance Officers and the NSU immediately by phone or fax

31

3.4 Tetanus What is tetanus (lockjaw)?

• • • •

Tetanus is an acute disease caused by a neurotoxin (nerve poison) released by the bacterium Clostridium tetani.

It causes a person’s muscles to contract, making the body stiff.

Clostridium tetani bacteria can be found throughout the environment (e.g. in soil and manure).

People of all ages can get tetanus, and almost all babies who get the disease die.

How is tetanus spread?

• • •

Tetanus is spread through infected soil or dung entering a wound by way of a contaminated object (e.g. knife, nail, thorn).

It cannot be spread from person to person.

Newborn babies can get neonatal tetanus when: o the umbilical cord is cut with a dirty instrument. o the umbilical cord is dressed with contaminated cow dung or ash. o contaminated hands or instruments are used to deliver or circumcise an infant. o dirt, charcoal or other unclean substances are rubbed into a wound. o the skin is pierced with an unclean object.

Incubation Period •

The incubation period is 3 – 21 days for adults and 4 – 14 days for newborns.

What are the signs and symptoms?

•

•

In the most common type of tetanus (generalized tetanus), stiffness begins in the jaw and neck and then descends. Difficulty in swallowing follows, as well as stiffening of the stomach muscles, muscle spasms lasting several minutes, sweating and fever.

Newborn babies with tetanus look normal at birth but stop sucking 3 – 10 days later.

They develop a progressive inability to feed because of stiffness in their jaw. Their entire body becomes stiff, fits develop, and they will usually die if not treated.

What are the complications?

• • •

Fractures of the spine or other bones as a result of muscle spasms and convulsions; Abnormal heartbeat, high blood pressure, difficulty breathing, pneumonia, coma; Death, particularly in the very young and older (over 60 years) age groups.

32

What is the treatment for tetanus?

• • • •

Admission to hospital for supportive therapy (e.g. antibiotics, airway maintenance, etc.)

All wounds must be cleaned and dead tissues removed.

Tetanus immunoglobulin (TIG) should be given as soon as possible (see Chapter 4 for dosing).

Once the patient is stable, vaccination should begin or continue with tetanus toxoid.

How is tetanus prevented?

•

• •

• • •

Immunization with tetanus toxoid, which is a part of the following vaccines: o Pentavalent (DTwP/Hib/Hepatitis B); DTwP, DT(P), DT(A) o DTaP, DPT/HepB, TT, DTaP/Hib/Hepatitis B/IPV (private sector only) Proper wound care Immunization of women of childbearing age with tetanus toxoid-containing vaccine, either during pregnancy or outside of pregnancy. This protects women and their newborns against tetanus.

Hygienic practices are especially important when a mother is delivering a child, even if she has been immunized.

Passive immunization with TIG may be required when an injury occurs (Follow guidelines in Chapter 4).

Tetanus is a Class I notifiable disease. Report suspected cases to the parish health department, regional epidemiologist or surveillance officers and NSU within 24 hours.

3.5 Hepatitis B What is hepatitis B? • It is a viral disease affecting the liver caused by infection with the Hepatitis B virus.

• It occurs worldwide and affects all age groups • Infants and children are more likely to become chronic carriers (chronic infection with Hepatitis B) than are adults.

33

How is hepatitis B spread?

• • •

The hepatitis B virus is found in blood and other bodily fluids, such as the saliva, semen, and vaginal fluids of acutely infected individuals and chronic carriers.

The virus can survive outside of the body for seven days and still be able to infect people.

It is usually spread by mucosal or percutaneous exposure to blood and bodily fluids from these persons. For example: o during sexual intercourse with an infected partner; o from an infected mother to baby during delivery; o from person to person through contact with cuts, scrapes or scratches; o to others in a household by sharing toothbrushes or razors with an infected person; o by injection with unclean needles or syringes (e.g. IV drug use); o contact with blood or open wounds of an infected person; o needle sticks or sharp instruments exposure. (e.g. HCW).

Incubation Period •

The incubation period is from 6 weeks to 6 months; an average of 60 – 90 days.

What are the signs and symptoms?

•

•

•

Infants, children and 50% of adults generally do not show acute signs or symptoms.

Chronic carriers may also be asymptomatic. As such, infected persons may pass the disease to others without knowing.

In persons with symptoms, the immediate presentation is that of acute viral hepatitis: o The prodrome consists of malaise, anorexia, nausea, vomiting, arthritis or arthralgia, skin rashes, fever, headache, dark urine lasting 3 – 10 days. o It is followed by yellowing of the skin or eyes (jaundice), pale stool, enlargement and tenderness of the liver (all lasting 1 – 3 weeks). o Fatigue and malaise may persist for weeks to months following the jaundice, but in most adults, full recovery can be expected. o Fulminant hepatitis can occur in a small percentage and lead to death.

Children are far more likely to become chronic carriers and develop the serious complications associated with hepatitis B than adults.

What are the complications?

•

Chronic hepatitis (liver inflammation), cirrhosis (permanent liver damage), liver failure, liver cancer, and death.

34

What is the treatment for hepatitis B? • •

There is no treatment for the acute condition.

In chronic infection, the disease process can sometimes be stopped by antiviral medications such as Interferon and Lamivudine.

How is hepatitis B prevented?

•

•

•

Immunization with hepatitis B vaccine, which may be given on its own or as part of the Pentavalent (DPT/Hib/hepatitis B) vaccine. o In the private sector, other combination vaccines containing hepatitis B, such as DPT/HepB and HepA/HepB, are available.

Persons with hepatitis B virus should not donate blood and should not allow other persons to come in contact with their blood or other body fluids. They should use barrier methods (e.g. condoms) when engaging in sexual intercourse and should not share toothbrushes, needles or razors with other people. During a meal, they should avoid sharing eating utensils with others.

To prevent the spread of hepatitis B, acutely infected persons and carriers must be identified. Passive and active immunization of contacts depends on the type of exposure: o To prevent transmission from mothers to infants, pregnant women may be tested to determine whether they carry the hepatitis B virus in their blood. o Babies of mothers who are carriers should receive an injection of hepatitis B immunoglobulin if available and a dose of hepatitis B vaccine at birth at separate anatomic sites. (See Chapter 4 for more information on postexposure prophylaxis). o Healthcare workers should be vaccinated against the disease and use universal infection-control precautions with all patients. A healthcare worker who is not hepatitis B immune and is accidentally exposed to the virus (e.g., needle-stick injury or “contact of mucous membrane or non-intact skin with blood, tissue, or other body fluids that are potentially infectious”) should receive hepatitis B immunoglobulin and hepatitis B vaccine at separate anatomic sites as soon as possible. This should be followed with completion of the hepatitis B series.

(See Chapter 4 for more information on post-exposure prophylaxis). o Household contacts and sexual partners of hepatitis B infected persons should be vaccinated and will require HBIG under certain circumstances. (See Chapter 4 for more information on post-exposure prophylaxis). o Hepatitis B is a Class I notifiable disease. Suspected cases should be reported to the parish health department within 24 hours to initiate a case investigation. o Health departments should notify the regional epidemiologist or surveillance officers and the NSU immediately by phone or fax.

35

3.6 Haemophilus Influenzae Type B (Hib) What is Haemophilus influenzae type b (Hib)?

• • •

A bacterium that can cause inflammation or infection of many different organ systems (e.g. brain, skin and lung) It should not be confused with the influenza virus, which causes the flu.

It causes serious diseases in children less than five years of age. Children who are less than 18 months of age, live in crowded conditions, attend daycare, and have low socio-economic status are particularly at risk.

How is Hib spread?

•

Through contact with discharges from the eyes, nose and mouth of infected people

Incubation period •

Unknown but may last 2 – 4 days.

What are the signs and symptoms?

Symptoms may appear as early as 27 – 72 hours after exposure. In children less than 5 years old, Hib most commonly causes: •

•

• •

Meningitis (inflammation of the coverings of the brain), which presents with drowsiness, poor feeding, high fever, and neck stiffness. Older children may present with headaches and vomiting.

Epiglottitis (inflammation of the epiglottis), which presents with stridor (inspiratory wheeze), drooling and respiratory obstruction. The child will lean forward to keep the airway open.

Pneumonia (infection of the lungs), which causes respiratory distress and fever.

Skin, ear, and joint infections

What are the complications of Hib infections?

• • •

The complications of Hib infection are the complications of the diseases it causes (meningitis, epiglottitis, pneumonia and other infections).

Before the introduction of the vaccine, Hib was the leading cause of bacterial meningitis among children less than 5 years old.

Both meningitis and epiglottitis will lead to death if not treated.

36

What is the treatment for Hib infections?

•

Immediate antimicrobial therapy (usually a 3rd generation cephalosporin, such as cefotaxime or ceftriaxone or chloramphenicol in combination with ampicillin.).

However, the type of antimicrobial is dependent on the sensitivity pattern of the organism.

How are Hib infections prevented?

• •

•

Immunization with Hib vaccine, which may be given on its own or as part of the Pentavalent (DPT/Hib/HepB) vaccine.

Meningitis and sepsis, which are often caused by Hib, are Class I notifiable diseases.

Suspected cases should be reported to the parish health department within 24 hours to initiate a case investigation.

Health departments should notify the regional epidemiologist or surveillance officers and the NSU immediately by phone or fax.

3.7 Poliomyelitis What is polio?

• It is a paralyzing disease caused by poliovirus.

• Polio mostly affects children, but also can affect adults.

• The last poliomyelitis cases in the English-speaking Caribbean were in Jamaica in 1982.

How is polio spread?

• •

Faecal-oral transmission (i.e. from person to person, when people eat food or water that has been contaminated with infected faeces.)

The disease is more likely to spread in areas where there is poor sanitation.

Incubation Period •

7 – 10 days with a range of 4 – 40 days.

37

What are the signs and symptoms?

Many infected people may not feel ill at all. If they do develop symptoms, they may have: • • • •

•

Fever and sore throat Loose stools, upset stomach, headache Stiffness in neck, back or legs Paralysis o Paralytic polio is the severe form of the disease, which affects less than 1% of infected children. It occurs because the virus gets into certain types of nerve cells and damages or destroys them. Patients who develop paralysis may not be able to walk or even breathe by themselves. The degree of recovery varies from person to person. An increased rate of paralysis is found among pregnant women.

Laboratory testing of the stools or throat secretions is used to confirm cases of polio, but stool is the preferred specimen for testing.

What are the complications of polio?

•

Permanent paralysis is the major complication of polio. Death can also occur if respiratory muscles are affected and no respirator is available to support breathing.

How is polio treated?

•

There is no treatment for polio, but supportive therapy can be given (e.g. respirator, symptomatic treatment of fever and muscle pain, physical therapy for paralysis).

How is polio prevented?

•

• •

•

Immunization with oral poliovirus vaccine (OPV) and/or inactivated poliovirus vaccine (IPV) o IPV only is given to immunodeficient or immunosuppressed persons and their close contacts instead of OPV. o IPV may be given on its own or (in the private sector) as part of DTaP/Hib/Hepatitis B/IPV vaccine. o OPV is given in combination with IPV; Jamaica has been certified polio free, however, surveillance is still required.

Acute flaccid paralysis (AFP)/poliomyelitis is a Class I notifiable disease. Suspected cases should be reported to the parish health department within 24 hours to initiate a case investigation and appropriate containment activities.

Health departments should notify the Regional Epidemiologist/Surveillance Officers and the NSU immediately by phone or fax.

38

3.8 Measles What is measles?

• A systemic illness caused by the highly contagious measles virus (rubella).

• It kills more children than any other vaccine-preventable disease.

• The measles virus circulates worldwide (where there are unimmunized people) and the risk of importation exists.

The last case of indigenous measles in the Caribbean occurred in 1991. However, cases have been imported to the Caribbean sub-region, including Jamaica, since that time.

How is it spread?

• •

By contact with the nose and throat secretions of an infected person, and in airborne droplets released when an infected person sneezes or coughs.

An infected person can infect other people before and after developing symptoms.

Incubation Period •

7 – 21 days

What are the signs and symptoms?

Symptoms begin 7 – 18 days after exposure to the virus and occur in two stages.

Stage 1: High fever (greater than 100°C) lasts from 1 – 7 days and may be accompanied by cough, runny nose (coryza) and red watery eyes (conjunctivitis) sensitive to light.

Small white spots (Koplik spots) may develop on the inside of the cheeks but will usually disappear before the second stage.

Stage 2: A slightly raised, red maculopapular rash appears on the hairline and face and spreads down the body to the hands and feet. It lasts from 3 – 7 days. Loss of appetite and loose stools may also occur.

What are the complications?

• • •

Pneumonia, ear infections, severe diarrhoea, encephalitis (swelling of the brain), seizures, blindness, and death; Complications are most likely in adults and children less than five years old.

Children who are immunocompromised or malnourished, particularly those depleted in Vitamin A, are at greatest risk.

39

•

Complications of infection during pregnancy: premature labour, spontaneous abortion, and low-birth-weight infants

What is the treatment?

• • •

Give fluids and feed the child properly.

Give antibiotics for complicating infections such as pneumonia and ear infections.

All infected children should receive two doses of Vitamin A 24 hours apart. Giving Vitamin A can help prevent eye damage and blindness. Vitamin A supplementation reduces the number of deaths from measles by 50 %.

How is it prevented?

• • •

Immunization with the MMR (measles-mumps-rubella) vaccine.

Isolation of cases, and the investigation, prophylactic treatment, and immunization of contact(s).

Fever with generalized rash or suspected measles is a Class I notifiable condition.

Suspected cases should be reported to the parish health department within 24 hours to initiate a case investigation and appropriate containment activities.

Health departments should notify the Regional Epidemiologist/Surveillance Officers and the NSU immediately by phone or fax.

3.9 Mumps What is mumps?

• • • •

An acute viral illness caused by the mumps virus It causes inflammation of different glands in the body (salivary, testes, ovaries and pancreas) and of the coverings of the brain (meninges).

Usually, it is a mild childhood disease affecting children 5-9 years old. In adults, complications of mumps are more likely to be serious.

Mumps virus is present throughout the world.

How is it spread?

• •

By airborne droplets released when an infected person sneezes or coughs, or by direct contact with infected nose and throat secretions.

It then multiplies in the nose, throat and lymph nodes. After 2 – 3 weeks, the virus enters the blood and spreads to organs like the salivary glands, the ovaries and the testes. Inflammation in infected tissues leads to the symptoms of parotitis, orchitis or oophoritis, and aseptic meningitis.

40

Incubation Period •

12 – 13 days

What are the signs and symptoms?

Symptoms usually begin 2 to 3 weeks after a person is infected.

• The first symptoms include muscle pains, loss of appetite, headache, fever and fatigue • After this, the salivary glands become swollen (parotitis), causing pain behind the ears when chewing and swallowing. The gland (located near the jawbone) will be painful to touch. One or both glands can be affected.

• About a third of children infected with the mumps virus have no symptoms.

What are the complications?

• •

The most common complication is meningitis. The symptoms of meningitis include headache, vomiting, stiff neck, back pain, and high fever.

Other complications include swelling and tenderness of the testes or ovaries (orchitis or oophoritis); pancreatitis; and hearing loss.

How is mumps treated?

•

There is no specific treatment for the disease. Symptoms are treated as they occur.

How is mumps prevented?

• •

Immunization with the MMR (measles-mumps-rubella) vaccine.

Investigation of cases, identification and protection of contacts. o Mumps is a Class III notifiable disease. Health care providers should report suspected cases to the parish health department as soon as possible Class III diseases are reported by the parish health department to the NSU and regional epidemiologists or surveillance officers as monthly case totals.

41

3.10 Rubella What is rubella?

• A viral infection that causes a rash and lasts only a few days • Affects people of all ages, but most seriously affects the developing foetus of a pregnant woman.

How is it spread?

• •

By direct contact with secretions from the nose and mouth of an infected person.

If a woman is pregnant, it can spread from the mother’s blood to the unborn child through the placenta causing Congenital Rubella Syndrome.

Incubation Period •

12 – 23 days

What are the signs and symptoms?

•

• •

Rash is usually the first sign of infection in children. It starts on the face, spreads quickly to the rest of the body, and usually disappears by the third day. The rash may be hard to see and is sometimes itchy.

Older children and adults will usually have fever, swollen glands and symptoms of a cold about a week before the rash appears. The rash may last only a few days.

The disease can be very mild; many people will not come in to see a health worker.

What are the complications?

• •

Joint aches and pains, brain inflammation and bleeding problems Congenital Rubella Syndrome (CRS): babies born to mothers who had rubella in their first trimester (0 – 12 weeks) of pregnancy have a very high chance (up to 85%) of developing CRS. Maternal rubella infection in the second and third trimesters poses a lesser risk of CRS. CRS babies can have the following: o o o o o o o

A small head, mental retardation, meningitis Low birth weight Cataracts, glaucoma or eye inflammation Blood thinning Deafness in one or both ears Lung problems Heart conditions 42

o Thyroid disease o Hepatitis or a large liver or spleen How is rubella treated?

There is no treatment for the disease. Supportive therapy is given to relieve symptoms.

How is rubella prevented?

• •

Immunization with the MMR (measles-mumps-rubella) vaccine Investigation of cases of suspected rubella or CRS, with isolation of cases and immunization of contacts as needed. Infants with CRS shed large quantities of virus in their pharyngeal secretions and urine for up to 1 year and therefore may infect their contacts. Babies suspected of having rubella should be managed under contact isolation precautions and placed in a private room or isolation area.

CRS and Rubella are Class I notifiable diseases. Suspected cases should be reported to the parish health department within 24 hours. Health departments should notify the regional epidemiologist or surveillance officers and the NSU immediately by phone or fax.

3.11 Yellow Fever What is yellow fever?

•

•

An acute illness caused by the yellow fever virus, which is found in the tropics of South America and Africa. It is not endemic to the Caribbean (except for Trinidad and Tobago, Guyana and Suriname).

Affects people of all ages

How is yellow fever spread?

• • •

Through the bite of an infective Aedes aegypti mosquito.

Mosquitoes may acquire the virus for life by biting either infected monkeys or infected humans.

It is not spread from person to person.

43

Incubation Period •

Usually 3 – 6 days

What are the signs and symptoms?

• • • • • •

Symptoms may be mild and go unnoticed, or severe, affecting many organ systems.

Symptomatic illness begins with fever, chills, headache, backache, general muscle pain, upset stomach, and vomiting.

If the disease progresses, weakness, jaundice, bleeding of the gums, hematemesis (vomiting of blood) and blood and protein in the urine may occur.

Bleeding occurs because of problems with clotting of blood. This is why yellow fever is referred to as a ‘haemorrhagic fever’.

Illness usually lasts two weeks, after which the patient either recovers or dies.

Persons who recover from yellow fever have lifelong immunity.

Diagnosis of yellow fever is difficult because its signs and symptoms are similar to those of other diseases, such as hepatitis, malaria, dengue, and typhoid fever. Any person who develops jaundice within 2 weeks of a fever, and has recently returned from travel in a yellow fever endemic area, or has been in contact with a return traveler, should be tested for yellow fever. To confirm the diagnosis of yellow fever, a 3cc blood sample should be drawn into a plain tube and allowed to clot. Serum should be extracted, placed in a labelled tube and sent to the laboratory for testing.

What are the complications?

•

Liver and renal failure; death

How is yellow fever treated?

• •

There is no specific treatment for yellow fever.

Dehydration and fever can be corrected with oral rehydration solution and acetaminophen (e.g. paracetamol, Tylenol). Any superimposed bacterial infection should be treated with an appropriate antibiotic.

How is yellow fever prevented?

• • •

Immunization with yellow fever vaccine Control of Aedes aegypti mosquitos Vigilant surveillance is critical for prompt recognition and rapid control of outbreaks. o Yellow Fever is a Class I notifiable disease. Suspected cases should be reported to the parish health department within 24 hours, so that a case investigation and disease prevention and control measures may be put in place.

44

o Health departments should notify the regional epidemiologist or surveillance officers and the NSU immediately by phone or fax.

3.12 Varicella What is Varicella?

• •

Infection with varicella zoster virus (VZV) Primary varicella infection causes chickenpox. VZV may lie dormant in the nervous system following initial infection and reactivate as shingles later in life.

How is varicella spread?

• • • • •

By contact with, or inhalation of, infected respiratory secretions or vesicular fluid from skin lesions.

Chickenpox is highly communicable. It is contagious from 1 – 2 days before the rash appears until 5 days after the appearance of the first crop of vesicles.

Nine out of ten susceptible household contacts will develop chickenpox.

Contagiousness may be prolonged in patients with altered immunity.

Shingles is transmissible for a week after the appearance of lesions. Susceptible individuals should be considered infectious for 10 – 21 days following exposure.

Incubation Period •

Usually 14 to 16 days

What are the signs and symptoms?

•

• •

Generalized, pruritic rash, which starts as macules. Lesions progress to papules and then vesicles before crusting over. You will see lesions at different stages. It usually appears on the scalp then descends to the trunk and the extremities.

Lesions may also occur on mucous membranes (e.g. oropharynx, vagina and cornea).

Fever and malaise may occur 1 – 2 days before the rash and continue for a few days.

45

What are the complications?

•

•

• •

Bacterial infection of skin lesions, pneumonia, dehydration, meningitis, encephalitis, hospitalization, and death are more common in infants, persons older than 15 years, and the immunosuppressed.

Congenital varicella syndrome (low birth weight, limb hypoplasia, scarring, muscular atrophy, brain abnormalities) occurs occasionally when a woman has chickenpox in the first 20 weeks of pregnancy.

Neonatal varicella, which has a 30% fatality rate, can result when a woman has chickenpox 5 days before or 2 days after delivery.

Reye’s syndrome has occurred when aspirin is given during the illness

How is varicella treated?

•

Supportive therapy; antiviral medications are sometimes given to reduce severity and length of illness.

How is varicella prevented?

• •

Immunization with varicella vaccine Varicella is a Class III notifiable disease. Health care providers should report suspected cases to the parish health department as soon as possible. Class III diseases are reported by the parish health department to the NSU and regional epidemiologists or surveillance officers as monthly case totals.

3.13 Pneumococcal Disease What is Pneumococcal Disease?

• •

A group of illnesses (pneumonia, bacteraemia, meningitis, otitis media) caused by the bacterium, streptococcus pneumoniae.

Streptococcus pneumoniae is also known as pneumococcus.

How is pneumococcal disease spread?

•

•

Humans are the natural reservoir for streptococcus pneumoniae and may asymptomatically carry the organism in their nasopharynx. Carriers may develop disease by autoinoculation.

It is spread from person to person by direct contact with infected droplets.

46

•

Crowded living conditions and the presence of upper respiratory tract infections facilitate spread.

Incubation Period •

Incubation period of pneumococcal pneumonia is very short, about 1 – 3 days.

What are the signs and symptoms?

Signs and symptoms of pneumococcal disease depend on the organ system(s) infected: • •

•

• •

Pneumococcus causes pneumonia, bacteremia (bacteria in the blood), meningitis and otitis media. These conditions may occur at the same time or on their own.

The pneumonia comes on quickly, 1 – 3 days following exposure, and is characterized by fever, chills, pleuritic chest pain, productive cough, shortness of breath, poor oxygenation, increased heart rate, weakness and malaise.

Bacteremia leads to fever, increased heart and respiratory rates, and an abnormal white blood cell count. In severe cases, blood oxygenation and urine output decline because of poor organ perfusion. Death may follow.

Pneumococcal meningitis causes fever, photophobia, drowsiness, neck stiffness, headache, vomiting, and irritability and can lead to seizures, coma and death.

Otitis media (inflammation of the middle ear) causes fluid to accumulate in the middle ear and results in ear pain, drainage of fluid from the ear, hearing loss, and generalized symptoms of infection (fever, lethargy and irritability).

What are the complications?

•

Empyema, pericarditis, endobronchial obstruction (with atelectasis and lung abscess) formation, mastoiditis, hearing loss, death.

How is pneumococcal disease treated?

• •

Penicillin is the drug of choice.

Cephalosporins, erythromycin, chloramphenicol are alternatives in case of allergy

How is pneumococcal disease prevented?

• • •

Immunization with pneumococcal polysaccharide or pneumococcal conjugate vaccines.

Penicillin prophylaxis is another method of preventing pneumococcal infection.

Pneumococcal meningitis is a Class I notifiable disease. Suspected cases should be reported to the parish health department within 24 hours. Health departments should 47

notify the regional epidemiologist or surveillance officers and the NSU immediately by phone or fax.

3.14 Influenza What is influenza disease?

• • • • •

Influenza is a highly contagious acute viral infection of the respiratory tract.

It affects all age groups, but the very young and very old are more susceptible.

There are three types of influenza virus – Types A, B and C. Influenza A and B mainly cause disease in humans, including epidemics and pandemics.

Influenza A is most often the cause of pandemics and epidemics.

How is influenza spread?

•

By contact with, or inhalation of, infected respiratory secretions (aerosolized or droplet transmission)

Incubation Period •

1 – 5 days

What are the signs and symptoms?

• • • • •

Symptoms may be mild and go unnoticed, or severe.

Symptoms include sudden onset of fever, chills, headache, myalgia, malaise.

Sore throat and a dry cough may also occur.

GI symptoms such as nausea, vomiting or diarrhoea may accompany respiratory symptoms.

The illness usually lasts 3 – 7 days.

48

What are the complications?

• • • • • • •

Persons with chronic conditions (e.g. diabetes, heart, kidney and lung disease) pregnant women and the elderly are more at risk of complications Bronchitis Secondary Bacterial pneumonia Otitis Media Worsening chronic conditions (e.g. heart conditions and diabetes) Reye’s syndrome in children who have ingested salicylates Death

How is influenza treated?

•

Supportive therapy; antiviral medications are sometimes given to reduce severity and length of illness.

How is influenza disease prevented?

• • • •

Immunization with influenza vaccine yearly.

Handwashing Covering cough and sneezes.

Influenza is a Class II notifiable disease. Health care providers should report suspected cases to the parish health department as soon as possible. Class II diseases are reported by the parish health department to the NSU and regional epidemiologists or surveillance officers as weekly line listings.

3.15 Human Papilloma Virus What is HPV? • • •

The persistent infection of epithelial cells with the human papillomavirus leading to warts and cancers of the ano-genital region, e.g., cervix, vulva, penis and anus.

Although there are over 40 types of human papillomaviruses that affect the genitalia, only a few (such as Types 16 & 18) are known to cause cancer.

HPV Types 6 & 11, among others, cause warts.

49

How is HPV spread?

•

HPV infection is spread through sexual contact.

What are the signs and symptoms?

• • •

HPV infection is often asymptomatic but may present as genital warts.

Bleeding from the vagina, including bleeding after sexual intercourse, may be signs of cervical cancer.

HPV can only be diagnosed by specific laboratory tests.

What are the complications?

• • •

Obstruction of the genital tract by warts Persistent HPV infection may lead to cancer of the cervix or penis.

Death from cancer

How is HPV treated?

•

HPV infection may be treated through cauterization once diagnosed.

How is HPV prevented?

• • •

Safe sexual practices, such as having one faithful sexual partner and condom use Early identification (through Pap smears) and treatment to prevent persistent infection Immunization against specific cancer-causing virus types with the HPV vaccine

3.16 Meningococcal Disease What is meningococcal disease?

• • • •

Refers to infections caused by the bacterium Neisseria meningitides (also known as meningococcus) Neisseria meningitides causes meningitis, sepsis (bloodstream infection), pneumonia, arthritis, otitis media, and epiglottitis.

Five strains of Neisseria meningitides cause serious disease: serogroups A, B, C, Y and W-135.

The disease occurs globally and is most common in infants and children.

50

•

Persons with acute and chronic health conditions (e.g., hyposplenism) and immune deficiencies are also at greater risk of the disease. (See ‘Special Populations’ in Chapter 2 for recommendations).

How is meningococcal disease spread?

• •

From person to person By direct contact with infected nose and throat secretions or by contact with respiratory droplets released when an infected person sneezes or coughs. Persons who carry the bacteria in their nose and throat without developing serious illness are called carriers. They may transmit the infection while being asymptomatic.

What are the signs and symptoms?

The incubation period ranges from 2 – 10 days (average 3 – 4 days). The symptoms depend on the site(s) of meningococcal infection.

• Meningitis causes fever, headache, stiff neck, photophobia, nausea, vomiting, and an altered mental state (e.g. lethargy, delirium and coma).

• Infants may not have these classic symptoms, presenting instead with irritability, reduced activity, vomiting, fever, and poor feeding.

• Sepsis causes fever, petechial or purpuric rash (small spots of bleeding into the skin), hypotension, shock, and organ failure • Pneumonia, arthritis, otitis media and epiglottitis are not as common What are the complications?

• •

Deafness, limb loss, neurologic sequelae (e.g. seizures, mental retardation) Death

How is meningococcal meningitis treated?

• •

As a medical emergency; urgent admission to hospital is indicated Initially, obtain cultures and treat with broad-spectrum antibiotics. Once the causative organism is confirmed to be Neisseria meningitidis, penicillin alone may be used.

How is meningococcal meningitis prevented?

•

Immunization with meningococcal vaccine o Currently, a meningococcal polysaccharide vaccine (MPV) is licensed for use in Jamaica. It protects against serogroups A, C, Y, and W-135. o It is not effective in children < 2 years of age and, therefore, is not part of the routine childhood immunization schedule.

51

o Conjugate (protein-polysaccharide) meningococcal vaccines that protect against serogroup C can protect infants and have been introduced into the routine infant immunization schedule in the United Kingdom and Canada. o There are no vaccines against serotype B. •

Investigation of cases and identification and protection of contacts o Meningococcal meningitis and septicemia are Class I notifiable diseases.

Suspected cases should be reported to the parish health department within 24 hours. Health departments should notify the regional epidemiologist or surveillance officers and the NSU immediately by phone or fax. o Close contacts of the case should receive antimicrobial prophylaxis within 24 hours of case identification; Rifampicin, ciprofloxacin, and ceftriaxone are effective.

Remember: The MPV vaccine is not effective in infants and young children and, therefore, is not part of the routine childhood immunization schedule.

3.17 Rotavirus Enteritis What is Rotavirus Enteritis?

• • • •

This is caused by the rotavirus.

It is the most important cause of severe/fatal diarrhoea especially in children.

The peak incidence is at 6 – 24 months of age. ~100% of children are infected by 24 months of age.

52

How is Rotavirus spread?

• •

Transmission primarily faeco-oral, that is, contact with food or water contaminated with stool/faeces.

Transmission may also be through the respiratory tract by droplet infection.

Incubation Period •

1 – 3 days

What are the signs and symptoms?

• • •

Most first infections are symptomatic; later infections may be milder or asymptomatic.

Abrupt onset of fever, vomiting, explosive watery diarrhoea The illness usually lasts 3–9 days and is often self-limiting.

What are the complications?

• •

Severe dehydration with electrolyte imbalance and metabolic acidosis Death

How is rotavirus treated?

• • •

Supportive therapy can reduce diarrhoeal mortality, if timely, through replacement of fluid and electrolyte losses Oral rehydration therapy (ORT) is > 90% effective for all cases of diarrhoea IV fluids are administered to children with intractable vomiting

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How is rotavirus disease prevented?

• •

Immunization with the rotavirus vaccine Gastroenteritis is a Class II notifiable disease. Health care providers should report suspected cases to the parish health department as soon as possible. Class II diseases are reported by the parish health department to the NSU and regional epidemiologists or surveillance officers as weekly line listings.

3.18 Other Vaccine-Preventable Diseases Vaccines have been developed to protect against other diseases such as 6: • Hepatitis A • Hepatitis E • Japanese encephalitis • Tick-borne encephalitis • Rabies • Cholera • Dengue • Typhoid • Malaria

6

http://www.who.int/immunization/diseases/en/

54

Chapter 4: Vaccines 4.1 Definition of Vaccine A vaccine is a product that induces immunity to a disease and can be administered by way of injections, by mouth, or by aerosol.

4.2 Objectives of this Chapter 1. To describe the purpose, schedule, method of administration and storage of each vaccine 2. To outline the contraindications and common adverse reactions to each vaccine in the immunization schedule

4.3 List of Vaccines • • • • • • • • • • • • • • • • •

Bacillus of Calmette and Guerin Diphtheria Toxoid (Paediatric) Diphtheria Toxoid (Adult) Diphtheria, Pertussis and Tetanus Hepatitis B Haemophilus Influenza type b Pentavalent Oral Poliovirus Inactivated Poliovirus Measles, Mumps and Rubella Human Papilloma Virus Yellow Fever Meningococcal Varicella Pneumococcal Influenza Rotavirus

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4.4 Bacillus of Calmette and Guérin Vaccine: BCG The vaccine contains live attenuated (weakened) Mycobacterium bovis, which protects against TB in children. It comes as a freeze-dried preparation (powder) that must be mixed with diluent for reconstitution.

Schedule • • •

Should be administered at birth, or as soon as possible thereafter It is not given to children over age 6 years or to adults Should not be given within 4 weeks of administration of any other live vaccine as this can suppress the tuberculin reaction.

Figure 4.4.1:

Minimum time interval between administration of live vaccines

Storage • • •

Store between +2°C and +8°C in a refrigerator or vaccine carrier BCG vaccine and diluent should be stored side-by-side The vaccine must be used within 6 hours of mixing

Method of administration • • •

Read pamphlet accompanying the vaccine in order to determine the dose. The usual dose is EITHER 0.05 ml or 0.1 ml.

To measure and inject such a small dose accurately use a special syringe (0.1 ml), and needle (26 or 27 gauge x 3/8 inch length) Inject vaccine intradermally (top layer of the skin) in the upper right arm. The same site is used for every child for ease of identification of the scar.

56

Contraindications • •

• • •

Moderate to severe acute illness, including fever > 38°C Immunosuppression due to drugs, radiation, cancer or other impairment of the immune system (e.g. hypogammaglobinaemia, impaired cell-mediated immune response, symptomatic HIV/AIDS) Extensive active skin disease or burns A positive tuberculin skin test Pregnancy

What to Expect Following Administration of BCG • •

Once injected correctly a small raised lump will appear on the skin. This has an orange peel appearance and usually disappears within 30 minutes.

After approximately two weeks, a red sore or ulceration develops which is about the size of the end of an unsharpened pencil (10 mm). The sore heals after another one to three months. A small scar, about 5mm across, usually remains at the site of immunization.

Adverse Reactions • • • • •

Swelling of one or more lymph nodes in the child’s armpit on the same side as the inoculation (Figure 4.4.2).

A draining sinus over a lymph node Abscess or ulcer at the injection site Keloid formation (which can be avoided by injecting below the insertion of the deltoid muscle near the middle of the upper arm) Rare complications include lupus vulgaris, erythema nodosum, iritis, osteomyelitis, anaphylaxis and disseminated BCG

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

57

Figure 4.4.2:

Ancillary Lymphadenopathy 7

4.5 DT Paediatric Vaccine: DT(P) The paediatric DT vaccine is a liquid that contains diphtheria and tetanus toxoids (DT). The vaccine is administered to infants and children in whom pertussis vaccine is contraindicated due to history of a febrile or afebrile convulsion according to the same schedule as the Pentavalent (DTwP/HepB/Hib).

Schedule • • •

Administered at 6 weeks, 3 months and 6 months of life Administered to children between 7 and 10 years (DTwP should NOT be given over age 7) The interval between doses should be at least 4 weeks

Storage • • •

Store between +2°C and +8°C in a refrigerator or vaccine carrier Freezing damages the diphtheria and tetanus toxoids To check if DT Paediatric vaccine has been frozen, perform the shake test described in Chapter 5.

Method of administration • • 7

The dose is 0.5 ml Intramuscular

Source: Safe Vaccination Presentation, Technical Aspects, PAHO/WHO 2003

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• •

Infant <18 months of age: inject vaccine into the anterolateral aspect of the thigh muscle (vastus lateralis); at the junction of the middle and upper third Older child > 18 months of age (i.e. for all booster doses): inject vaccine into the deltoid muscle of the upper arm

Contraindications • •

Moderate to severe acute illness, including fever > 38°C. DT immunization should be postponed until the child is well.

History of a severe allergic reaction to a previous dose of DT vaccine

Adverse Reactions • • • • •

Swelling, pain, and redness at the injection site A small painless nodule may form at the injection site but usually disappears after a few weeks Malaise, fever and headache may occur Abscess at the inoculation site Rare reactions include o Anaphylaxis, o Generalized urticaria, o Neurological reactions (brachial neuritis and Guillain-Barré Syndrome) o Exaggerated local reaction involving extensive painful swelling between the shoulder and elbow. This local reaction is thought to occur in persons who have received frequent doses of diphtheria and tetanus toxoids. o

4.6 DT Adult Vaccine: DT (A) or DT or Td The adult DT vaccine is a liquid that contains tetanus toxoid and a lower dose of diphtheria toxoid than is present in the paediatric DT vaccine. In Jamaica, adult DT vaccine is administered to persons beginning at age 10 years and can be administered to a child as young as 7 years if the paediatric DT is unavailable.

Schedule • •

Persons 10 years and older for primary immunization or boosters Pregnant women to prevent the occurrence of maternal and neonatal tetanus.

Pregnant women who are partially immunized or have never been immunized should complete the series in accordance with Tables 10.4.2 and 10.4.3, respectively.

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•

•

• •

Adults who have received a total of 5 or 6 doses of tetanus toxoid (as part of DT, DPT, or Pentavalent (DTP/HepB/Hib)), either in childhood or adulthood, should not routinely be given booster doses, other than at the time of tetanus prone injury. The practice of routine booster doses for adults beyond the recommended regime can be associated with severe local reactions.

Special high-risk populations such as farmers, diabetics, elderly, carpenters, and those of similar occupational hazards as well as those who received a wound may require a booster or Tetanus immunoglobulin at 10-year intervals (Table 3-1) Other adults who have never been immunized should follow the adult and adolescent schedule in Chapter 2 (Table 2.7.2.1) to receive 5 doses of DT vaccine.

The minimum interval between doses is 4 weeks.

Table 4.6.1: Requirements for DT immunization and TIG following injury to a person with normal immune system 8

Clean, Open, Minor Wound (Not deep, not due to puncture, <6hrs old)

All Other Wounds (contaminated with saliva, stool, soil or other foreign matter, major tissue damage, more than 6 hrs old, due to puncture, or very deep)

Vaccination received DT

TIG

DT

TIG

Primary series & DT within 5 years

No

No

No

No

Primary series & DT within 5-10 years

No

No

Booster DT

No

NO DT in past 10 years, but received > 3 doses in lifetime

Booster DT

No

Booster DT

No

< 3 DT in lifetime or status unknown

Complete adult DT series (5 doses)

No

Complete adult DT series (5 doses)

Yes

Note: DT vaccine and TIG may be given at the same time as long as they are injected into different limbs, using separate syringes.

8

Adapted from: Center for Disease Control and Prevention. Epidemiology and Prevention of VaccinePreventable Diseases. Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington D.C. Public Health Foundation, 2015.

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Storage • • •

Store between +2°C and +8°C in a refrigerator or vaccine carrier.

Freezing damages the diphtheria and tetanus toxoids.

To check if DT Paediatric vaccine has been frozen, perform the shake test described in Chapter 5.

Method of administration • • •

The dose is 0.5 ml.

Intramuscular injection Inject vaccine into the deltoid muscle of the upper arm

Contraindications • •

Moderate to severe acute illness, including fever > 38°C. DT immunization should be postponed until the client is well.

History of a severe allergic reaction to a previous dose of DT vaccine

Adverse Reactions • • • • •

Swelling, pain, and redness at the injection site are common Malaise, fever and headache may also occur A small painless nodule may form at the injection site but usually disappears after a few weeks Abscess at inoculation site Rare reactions: o Anaphylaxis, generalized urticaria o Neurological reactions (peripheral neuropathy and GBS) o Exaggerated local reaction (extensive painful swelling between shoulder and elbow) thought to be due to an immune reaction in persons who have received frequent doses of diphtheria and tetanus toxoids.

Any adverse reaction to vaccination with DT(P) or DT(A) should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

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Prevention of Tetanus following injury a) Clean minor wound (e.g. open, not contaminated, not deep, not due to puncture, less than 6 hours old, negligible tissue damage): • TIG is not necessary • A DT booster should be given as soon as possible if someone received a primary series (3 doses of tetanus toxoid as DT, TT, DTwP or Pentavalent (DTwP/Hib/HepB)), but more than 10 years have passed since the last dose • A complete adult series should be started as soon as possible if the immunization history is unknown or 0 doses were received in the person’s life b) Any other type of wound (e.g. contaminated with saliva, stool, soil or other foreign matter, major tissue damage, more than 6 hours old, due to puncture, or very deep): • TIG may be indicated if the immunization history is unknown or the person has received fewer than three doses of DT in their lifetime, because early doses of toxoid do not induce immunity. TIG serves as an anti-toxin, thereby providing temporary passive immunity • A DT booster should be given if the person received a primary series (three doses of tetanus toxoid as DT, TT, DTwP or Pentavalent (DTwP/Hib/HepB)), but more than five years has passed since the last dose • A complete adult series of DT (five doses) should be given if the immunization history is unknown or zero to two doses were received in the person’s lifetime • Antibiotics are needed, and the decision should be considered on a case by case basis for the prophylaxis of wound infection c) Unclean wound in a person with impaired immunity (e.g. HIV infection): • Such a person should ideally be hospitalized.

TIG may be needed, depending on the immune problem, age of the patient and vaccination history; a physician should be consulted Tetanus Immune Globulin (TIG) Dose for Prevention of Tetanus: If a patient requires TIG for prevention of tetanus: • Patient under age 7 years: Administer 4 units TIG/ kg intramuscularly (Hospital for Sick Children Toronto dose) • Patient over age 7 years: Administer 250 IU of TIG intramuscularly • Highly tetanus-prone wound (more than 24 hours have elapsed since injury, it is a burn related injury, or there is a risk of heavy contamination): >250 IU TIG may be needed (consult specialist).

The optimal dose of TIG for treatment of Tetanus disease has yet to be established. Doses as high as 3,000-6,000 IU have been recommended, however, 500 IU is enough to neutralize systemic antibodies.

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Note: Human intravenous immunoglobulin (IVIG) contains some tetanus immune globulin and has been given in cases where tetanus immune globulin is unavailable.

Availability and Storage • • •

4.7

TIG is issued in ampoules, each containing 250 IU. Ampoules should be protected from light and stored in a refrigerator at +2° to +8°C. TIG must never be frozen.

Diphtheria-Tetanus-Whole Cell Pertussis Vaccine: DTwP

The vaccine is a liquid that contains Diphtheria toxoid, Tetanus toxoid and killed whole cell Bordetella pertussis.

Schedule • • •

At 6 weeks, 3 months and 6 months of age as part of the Pentavalent (DTwP/Hib/HepB) vaccine or on its own as DTwP vaccine At 18 months, 4-6 years on its own as booster doses The minimum interval between doses of DTwP is 4 weeks, if given separately from the Pentavalent (DTwP/Hib/HepB)

Storage • • • •

•

Store between +2°C and +8°C in a refrigerator or vaccine carrier Freezing damages the diphtheria and tetanus toxoid components of the DTwP Whole cell B. pertussis is damaged by heat If DTwP vaccine stands for a long time, granules separate from the liquid and look like fine sand at the bottom of the vial. Shaking the vial mixes the vaccine and gives a homogenous suspension To check if DTwP vaccine has been frozen, perform the shake test described in Chapter 5

Method of Administration • • •

The dose is 0.5 ml Infant <18 months of age: inject vaccine into the antero-lateral aspect of the thigh muscle (vastus lateralis); at the junction of the middle and the upper third Older child > 18 months of age (i.e. for all booster doses): inject vaccine into the deltoid muscle of the upper arm (See diagram 1)

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Contraindications • • •

DTwP vaccine should NOT be given to children over 7 years of age as adverse reactions to the pertussis component are more likely in older children and adults Moderate to severe acute illness, including fever > 38°C. DTwP immunization should be postponed until the client is well.

History of a severe allergic reaction to a previous dose of DTwP vaccine

Adverse Reactions •

Fever or a local reaction (swelling, redness, and tenderness). Fever usually appears within 3-6 hours, but can be seen up to 48 hours post-vaccination. Local reactions usually resolve by themselves and require no therapy.

Acetaminophen (Paracetamol) may help to reduce adverse effects of the vaccine and may be given before the immunization and every 4-6 hours thereafter, as needed.

• •

•

•

A painless lump may form at the injection site; it usually disappears and should not cause worry.

Up to 55% of children experience irritability, malaise and other non-specific symptoms (e.g. drowsiness, decreased appetite). They usually resolve on their own, but symptomatic treatment, including an aspirin-free antipyretic (e.g. paracetamol), may be given.

An abscess may develop at the site of injection a week or more following vaccination.

This can happen for several reasons including the vaccine not being injected deep into the muscle.

Rare and severe reactions which may prevent further vaccination with DTwPcontaining vaccines: o Encephalopathy, a disorder of the brain, which presents with major changes in consciousness or behavior, and/or seizures, within 3 days of immunization.

Occurs in children who were previously healthy and usually does not cause chronic harm. o Convulsions (i.e. seizures) within 3 days of immunization o Inconsolable crying lasting > 3 hours within 48 hours of immunization o Collapse or shock-like state (hypotonic hypotensive episode) within 48 hours of immunization o High fever > 105°F (>40.5°C) not due to another identifiable cause within 48 hours of immunization o Exaggerated local reaction (extensive painful swelling between shoulder and elbow) 64

o Anaphylaxis; generalized urticaria (hives) o Peripheral neuropathy (e.g. brachial neuritis, GBS) If any of the severe reactions occurs, a doctor’s advice should be sought before giving a future dose of DTwP-containing vaccine.

The physician may recommend giving DT instead of DTwP, or using an aspirin-free antipyretic to reduce the risk of future febrile convulsions. Any adverse reaction should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

If a third dose of DPT has been administered, and at least 6 months have elapsed since the last convulsion, DPT can be continued.

In the case of history of a seizure a thorough physical exam and history, with lab tests must be done to evaluate whether an evolving neurological disorder is present: if not, DPT can be continued.

4.8 Hepatitis B Vaccine: HBV The vaccine contains Hepatitis B surface antigen (HBsAg) adsorbed to aluminum hydroxide and is available in 2 preparations: 1. Part of the combination Pentavalent (DTwP/HepB/Hib) vaccine, or 2. A single vaccine preparation that does not need to be mixed The preparations come as single dose vials for pediatrics and adults and 10 dose vials for adults.

Schedule • Infants at 6 weeks, 3 months and 6 months of age as part of the Pentavalent (DTwP/HepB/Hib) vaccine or as Hep B single vaccine preparation when Pentavalent is contraindicated • The minimum interval between the first and second doses is 4 weeks. The third dose should be given at least 2 months after the second dose and at least 4 months after the first dose.

• Those at high risk of infection such as health workers and other emergency care staff according to the schedule in Table 2.7.2.1 • To adults, adolescents and older children at risk of Hepatitis B infection (e.g. contacts of cases). For adults and adolescents, the first two doses are given 4 weeks apart and the third dose is given six months after the first dose.

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•

Persons with normal immune systems currently require no boosters Persons with poor antibody response to the vaccine (e.g. hemodialysis patients) may require booster doses and should have their antibody levels tested per physician instructions.

Storage • • • •

Store between +2°C and +8°C in a refrigerator or vaccine carrier If hepatitis B vaccine stands for a long time the granules separate from the liquid and look like fine sand at the bottom of the vial. It must be mixed by shaking.

Freezing and heat destroy the potency of the vaccine.

To check if Hep B vaccine has been frozen, perform the shake test described in Chapter 5.

Method of Administration • •

Dose and route of administration vary according to client characteristics and are shown in Table 3-2.

If not being administered as Pentavalent do not inject Hep B and DTwP in the same site.

Table 4.8.1: B vaccines

Recommended Dose and Route of Administration for Single Preparation Hepatitis Population

Dose

Route

Infants up to 18 months

0.5 ml (10µg)

Inject into the muscle of the antero-lateral thigh (IM)

Children > 18 months and adolescents (up to 19 years of age)

0.5 ml (10µg)

Inject into the deltoid muscle of the upper arm (IM)

Adults > 20 years of age

1 ml (20µg)

Inject into the deltoid muscle of the upper arm (IM)

Adults who may have lower than normal antibody response (hyporesponsive)

To be advised by physician.

2 ml (40µg)

Inject into the deltoid muscle of the upper arm (IM)

e.g. haemodialysis patients

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Contraindications • • •

Moderate to severe acute illness, including fever > 38°C. Immunization should be postponed until the client is well.

History of anaphylaxis after a previous dose of Hepatitis B vaccine Allergy to yeast (Hepatitis B vaccine is developed in baker’s yeast)

Adverse Reactions • • • •

Mild fever for 1 to 2 days after vaccination in < 6% of patients Soreness and redness at the injection site occurs in 3-9% of children and 13-29% of adults Mild systemic symptoms: fatigue, headache, irritability (0-20% of children; 11-17% of adults) Rare: o A combination of fever, rash and malaise; or o Flu-like syndrome, with joint/muscle pains and abnormal liver function

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the FAMILY HEALTH UNIT, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

Post-Exposure Prophylaxis • •

Persons exposed to Hepatitis B require vaccination to prevent infection. They may also require Hepatitis B immune globulin (HBIG).

HBIG can be given at the same time as Hepatitis B vaccine but should be given at a different anatomic site.

Exposures that may require Hepatitis B vaccine and HBIG include: • • • •

Infant born to a woman who is HBsAg-positive Infant living with a caregiver who is HBsAg-positive Exposure to blood, blood products or bodily fluids (e.g. needle stick injury) Household contact or sexual partner of person with acute or chronic Hepatitis B infection

1. Infant born to a woman who is HBsAg-positive (acute or chronic HBV infection) •

Give Hepatitis B single preparation vaccine within 12 hours of birth

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•

•

• •

Continue with the routine vaccination schedule at six weeks, three months and six months, so that the child receives four doses of Hepatitis B vaccine (one single vaccine preparation at birth and three Pentavalent) Give 0.5 ml HBIG intramuscularly immediately after birth and within 48 hours; efficacy of HBIG declines significantly after 48 hours (It may be given at the same time as HBV in the contra-lateral site) If the nurse is unable to give Hepatitis B vaccine and HBIG within the above time frames because of extenuating circumstances, she should do so at the first opportunity Premature infants should be given HBV and HBIG at birth as described here.

However, the pediatrician may wish to alter the timing of the second dose of HBV In the absence of post-exposure prophylaxis, vertical transmission of Hepatitis B is highly efficient; 70-90% of infants of HBsAg and HBeAg positive mothers will contract the virus.

Table 4.8.1:

Immunization Schedule for infants who require Hepatitis B vaccination at birth

Birth

6 Weeks 3 Months 6 Months

1) BCG* 2) Hepatitis B Vaccine 3) HBIG 1) Pentavalent (DTwP/Hib/Hep B) 2) Polio 1) Pentavalent (DTwP/Hib/Hep B) 2) Polio 1) Pentavalent (DTwP/Hib/Hep B) 2) Polio

*If mother is HIV positive and HBsAg-positive, no BCG is given until review of the infant’s health by a physician. Hepatitis B and BCG vaccines can be given to asymptomatic infants.

Note: For babies born to Hepatitis B positive mothers, serum antibody levels should be done at about nine months old to confirm seroconversion.

2. Infant (< 12 months) whose primary caregiver (e.g. mother or father) has acute or chronic HBV infection •

•

If infant has received first and second doses of Hepatitis B vaccine (as a single vaccine preparation or as part of the Pentavalent vaccine), continue with third dose as per routine schedule.

If infant has never been vaccinated against Hepatitis B, give 0.5 ml HBIG IM and first dose of HBV in separate sites. Continue with the routine HBV vaccination schedule.

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3. Percutaneous or mucosal exposure to HBV infected blood, blood products or bodily fluids (e.g. needlestick injury, household contact such as razor or toothbrush, sexual contact with acutely infected person) •

•

•

If the exposed person has never been immunized against Hepatitis B, give a dose of HBIG (0.06 ml/kg for older children, adolescents and adults or 0.5 ml for infants) and a dose of HBV in contra-lateral anatomic sites as soon as possible following exposure. o These injections should be followed by additional doses of Hepatitis B vaccine according to the routine schedule, unless the person has been infected with Hepatitis B from the exposure. o Antibodies to Hepatitis B should be determined at the time of exposure to guide future decision-making. o If HBIG and HBV are given within 7 days of needle-stick exposure and within 14 days of sexual exposure, and followed up with the full series for HBV, 75% of Hepatitis B infections will be prevented. (NEJM 2004) If the exposed person has been previously immunized, give a booster dose of vaccine as soon as possible following exposure, unless they are known to have protective levels of antibody. o They should be tested to determine their anti-HBs antibody level, and given HBIG if it is less than 10 IU/L. o The need for follow-up vaccination with HBV should be determined by a physician on the basis of testing the anti-HBs titer 6 months following HBIG. Note that sexual contacts of persons with chronic Hepatitis B do not require HBIG, but should be fully vaccinated against Hepatitis B.

4. Household contacts and sexual partners of person with acute or chronic Hepatitis B infection • Require routine HBV series • HBIG would be given in case of exposures listed above Note: The exact dose of HBIG to be given must be determined by the clinician managing the patient.

4.9 Haemophilius Influenzae Type b Vaccine: Hib The Hib vaccine is an inactivated vaccine that contains parts of the H. influenzae type b bacteria and protects against various diseases caused by the organism. It is available in 3 preparations: 69

1. A single vaccine preparation which must be reconstituted with a diluent (reconstituted) 2. A single liquid vaccine preparation that does not need to be reconstituted 3. Part of a combination vaccine such as Pentavalent (DTwP/HepB/Hib) Children who start a course of Hib vaccine on one manufacturer’s product can have the course completed with another product, should the need arise.

Schedule •

• • •

Infants at 6 weeks, 3 months and 6 months as part of the Pentavalent (DTwP/HepB/Hib) vaccine or a single vaccine preparation when Pentavalent is contraindicated Booster doses are not routinely given in the public sector after the primary series although I may be given privately The minimal interval between doses is 4 weeks.

Jamaica does not routinely immunize children over 1 year of age with Hib vaccine.

However, children 1 to 4 years of age who have never been immunized against Hib may be given a single dose of Hib vaccine.

Children aged 1-4 years are at a lower risk of disease and therefore only one dose is needed. The incidence of invasive disease from Hib falls sharply after four years of age.

•

Though routine immunization of older children and adults is not recommended, in some rare instances a doctor may recommend that certain categories of clients such as persons with functional or anatomic asplenia, or immunocompromised persons be vaccinated.

Storage • •

Stored between +2°C and +8°C in a refrigerator or vaccine carrier Freezing damages the Hib vaccine

Method of administration • • • •

The dose is 0.5 ml Intramuscular or deep subcutaneous injection For infants < 12 months old, inject vaccine into the anterolateral aspect of the thigh muscle (vastus lateralis); at the junction of the middle and upper third For children > 12 months up 48 months who were never previously immunized, inject the vaccine into the deltoid muscle 70

• •

For adults (in high risk groups as described above), Hib is injected into the deltoid muscle.

Should be given in a different limb from other vaccines given at the same time.

Contraindications • • •

Moderate to severe acute illness, including fever > 38°C. Immunization should be postponed until the client is well.

History of anaphylaxis to a previous dose of Hib vaccine Age < 6 weeks

Adverse Reactions •

•

Swelling, redness, and pain at the injection site occur in 5-30% of vaccinees, but usually resolve within 24 hours. Local reaction does not preclude further immunization against Hib. Systemic reactions (fever, irritability) and severe reactions are rare

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the FAMILY HEALTH UNIT, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

4.10 Pentavalent Vaccine: DTwP/HepB/Hib The pentavalent vaccine used in Jamaica is a combination of five (5) antigens: 1. Diphtheria toxoid 2. Tetanus toxoid 3. Killed whole cell Bordetella pertussis 4. Hepatitis B 5. Haemophilus influenzae Type b

The Pentavalent Vaccine is a combination of five (5) antigens. It is freeze-sensitive and comes in a liquid form as a single dose vial. It is sometimes presented as two separate forms in single dose vials. The Hib component comes in a freeze-dried solid form. The diphtheria, pertussis, tetanus and hepatitis B are premixed in a liquid form and is used to reconstitute the freeze-dried Hib.

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Schedule • • •

To infants at 6 weeks, 3 months, and 6 months of age.

Only infants under 1 year of age receive Pentavalent.

The minimum interval between the first and second doses is 4 weeks. The minimum interval between the first and third doses is 4 MONTHS (because of the Hepatitis B component).

Storage • •

In the refrigerator or vaccine carrier between +2°C and +8°C The Pentavalent vaccine is damaged by freezing. To check if the vaccine has been frozen, do the shake test, as described in Chapter 5.

Method of administration • • • •

The dose is 0.5 ml Intramuscular or deep cutaneous injection Inject into the muscle in the outer part (anterior lateral aspect) of the thigh.

The vaccine can be administered subcutaneously to patients with thrombocytopenia or bleeding disorders, but this should be done under supervision of a physician

Contraindications • • •

Moderate to severe acute illness, including fever > 38°C. Immunization should be postponed until the client is well.

History of anaphylaxis or severe reaction to a previous dose of Pentavalent or any of its components Presence of a contraindication to any vaccine or other component of the vaccine (See all sections above which pertain to the individual vaccines and components of this vaccine).

Adverse Reactions • •

Similar to those observed for other DTwP vaccines currently in use and usually last only a few days Refer to the preceding sections for adverse reactions which may occur due to individual vaccine components 72

• •

Common reactions include: redness (>2 cm), swelling (>2 cm), and pain at the injection site within 48 hours Fever, unusual crying, irritability

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

4.11 Oral Polio Vaccine: OPV OPV is a liquid that comes in a small bottle that works with a dropper. There are 3 types of OPV: • Trivalent OPV (tOPV)is no longer manufactured. It contained weakened live strains of poliovirus types 1, 2 and 3 and therefore protected against the three types of viruses that cause polio.

• Bivalent OPV (bOPV) protects against two types of poliovirus. It contains weakened live strains of poliovirus types 1and 3.

• Monovalent OPV (mOPV) protects against 1 type of poliovirus. It contains a weakened live strain of poliovirus type 1, 2 or 3.

In keeping with the Global Polio Eradication Initiative’s Polio Eradication and Endgame Strategic Plan 2013-2018, Jamaica switched from using trivalent OPV to bivalent OPV in the routine immunization programme in April 2016. This was a globally coordinated event where all manufacturers of tOPV ceased production prior to the switch and all tOPV was recalled after the switch and destroyed. Any use of tOPV after the switch will jeopardize polio eradication by generating circulating vaccine-derived polioviruses (cVDPV) from the type 2 component of the vaccine.

4.11.1 Bivalent Oral Polio Vaccine: bOPV Schedule •

The primary series for polio is given at 6 weeks, 3 months and 6 months. Both IPV and bOPV are given in the polio series as per the national immunization.

• Booster doses are given at 18 months and at 4 to 6 years of age • The minimum interval between doses is 4 weeks Storage • •

OPV is easily damaged by heat Unopened OPV vials should be stored in the refrigerator between +2°C and +8°C They are not damaged by freezing and may also be placed in the freezer.

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•

Opened multi-dose OPV vials should be placed on the top shelf of the main compartment of the refrigerator after use. They may be used up to 4 weeks after they have been opened as long as certain conditions are met (see multi-dose open vial policy in Chapter 5).

Method of administration • •

The dose is two drops in the mouth with the dropper that comes with the vaccine If the child spits the vaccine out, give another dose (two drops).

Contraindications • • •

Moderate to severe acute illness, including > 3 episodes of diarrhea per day, vomiting, or fever > 38°C.Immunization should be postponed until the client is well.

History of anaphylaxis to a previous dose of OPV Immunosuppression or close contact with an immuno-suppressed person Inactivated polio vaccine (IPV) should be used for immunosuppressed persons, including HIV positive individuals and their contacts, because of an increased risk of vaccineassociated paralytic polio (VAPP).

Note: OPV may be given to contacts of pregnant women.

Adverse Reactions • •

OPV has minimal side effects.

Rare cases of vaccine-associated paralytic poliomyelitis (VAPP) have been reported in recipients of OPV and in the contacts of recipients who are not fully immunized. o The possibility of a very small risk of VAPP induced by OPV cannot be ignored but is insufficient to warrant a change in immunization policy. o Persons who care for children recently vaccinated with OPV must wash hands thoroughly with soap and water, especially after handling stool, because the polio vaccine viruses are passed out in the stool for up to 6 weeks following vaccination.

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

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4.12 Inactivated Poliomyelitis Vaccine (IPV) This vaccine contains polioviruses of all three types (types 1, 2 and 3) which have been inactivated by formaldehyde. Traces of formaldehyde, neomycin, streptomycin and polymyxin B may be present in the vaccine Schedule An IPV only schedule is given: • • • • •

• • • •

When OPV is contraindicated The primary series is given at 6 weeks, 3 months and 6 months Booster doses are given at 18 months and at 4 to 6 years of age The minimum interval between doses is 4 weeks If a child has started on an OPV series, the series may be continued with IPV (if indicated). Similarly, if a child has started an IPV series, the series may be completed with OPV. As long as a child has received five doses of either OPV or IPV, he or she is considered fully immunized against polio.

Remember: IPV must be used for HIV-positive babies or babies born to HIV-positive mothers.

IPV/OPV combined schedule: At least 1 dose of IPV is given as a part of the primary series, starting at 6 weeks.

OPV is given after IPV to complete the primary series and as booster doses at 18 months and 4-6 years

Storage • • • •

In the refrigerator at a temperature between +2° and +8°C. It is easily damaged by heat and should not be frozen.

IPV should appear clear and colourless; return to your supervisor any vaccine with particles, a cloudy appearance, or a change in colour.

Multi-dose vials should be used within the time specified by the manufacturer

Method of administration • • • •

The dose is 0.5 ml For infants less than 18 months old, IPV is given as a subcutaneous (or intramuscularcheck the brand) injection in the anterior lateral aspect of the thigh.

For children >18 months and adults, IPV is given as a subcutaneous (or intramuscular-check the brand) injection in the deltoid region.

IPV may be given intradermally as a fractionated dose if the need arises 75

Contraindications • •

•

Moderate to severe acute illness, including diarrhea, vomiting or fever > 38°C. Immunization should be postponed until the client is well.

History of anaphylaxis to a previous dose of IPV or any vaccine constituent. Persons with a history of anaphylactic reaction to neomycin, polymyxin B or streptomycin should not receive IPV. Pregnancy is not a contraindication to IPV. However, vaccination is usually delayed until after pregnancy, unless the risk of polio infection is imminent, because of theoretical risks. No actual evidence of adverse effects on the fetus has been found.

Adverse Reactions • • •

Minor local reactions such as pain and redness at site of injection may occur.

No serious adverse reactions have been documented.

Allergic reactions to the vaccine are very rare.

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

Use of IPV instead of OPV •

The most important advantage of IPV is that it is inactivated. It does not replicate inside the vaccine recipient and is not shed in his/her stool.

• IPV does not cause vaccine-associated paralysis or circulating vaccine derived poliovirus.

• Safe to use in HIV-positive and other immuno-deficient persons or in household contacts of those persons.

IPV produces less local gastrointestinal immunity than does OPV, so persons who receive IPV are more readily infected with wild polio virus than OPV recipients. A person who receives IPV could become infected with wild polio virus in an endemic area. The infected person would be protected from paralytic polio but the wild virus being shed in the stool could spread and result in transmission to a contact

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4.13 Measles-Mumps-Rubella Vaccine: MMR • • •

•

Contains weakened forms of the live measles, mumps, and rubella viruses Comes in powder form Before it can be used it must be mixed with the diluent supplied by the manufacturer.

The diluent should be at the same temperature as the vaccine when mixing (+2° and +8°C).

MMR vaccine should be used within six hours of reconstitution.

Schedule • • • • •

At 12 months of age or as soon as possible thereafter A booster dose is given at 18 months of age The minimum interval between two doses is 4 weeks If doses of BCG, MMR, yellow fever and varicella vaccines are not given simultaneously, the vaccines should be separated by four weeks.

A waiting period is required between antibody containing blood products and administration of MMR; consult the Family Health Unit or a physician to modify the child’s schedule.

Storage • • •

In the refrigerator at a temperature between +2° and +8°C, but it may be stored in the freezer (-25°C to -15°C).

The diluent is stored in the refrigerator at a temperature between +2° and +8°C, and must not be frozen.

The vaccine must be discarded within 6 hours of reconstitution or at the end of the session, whichever comes first.

Method of administration • • •

The dose is 0.5 ml Administered into the deep subcutaneous layer of the upper arm If alcohol is used to cleanse the skin, ensure it evaporates from the skin before injection since it may inactivate the vaccine.

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Contraindications • • • • •

Moderate to severe acute illness, including fever > 38°C. Immunization should be postponed until the client is well.

History of anaphylaxis to a previous dose of MMR History of anaphylaxis to any vaccine constituent. Persons with a history of anaphylactic reaction to neomycin, kanamycin, or gelatin should not receive MMR. Pregnancy Immunosuppression a) Asymptomatic HIV positive individuals, who are not severely immunosuppressed, may receive MMR

Note: Allergy to egg is no longer a contraindication to MMR Adverse Reactions • •

•

Anaphylaxis and other allergic reactions are rare The following reactions tend to occur 5-12 days post-vaccination: o Fever with or without rash o Arthritis (most common in adult women) Rare: o Febrile convulsions o Parotid (cheek) swelling o The rubella component is sometimes associated with decreased platelets (thrombocytopenia). o Mumps meningo-encephalitis

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

4.13.1 Measles Vaccine; Rubella Vaccine; Mumps Vaccine • • •

Measles, mumps and rubella vaccines may also be available on their own as monovalent vaccines in the private sector.

Measles and Rubella vaccines are available in a combination (MR) vaccine.

Storage, administration, indications for use, contraindications, and adverse events are similar for these vaccines as for the combination MMR vaccine.

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4.14 Human Papilloma Virus Vaccine: HPV HPV vaccines are recombinant vaccines in liquid form. HPV vaccination prevents persistent HPV infection and related cervical lesions in HPV naïve women. Three vaccines have been licensed for use: • • •

the bivalent vaccine protects against 2 genotypes: HPV types 16 and 18 the quadrivalent vaccine protects against 4 genotypes: HPV type 16, 18, 6 and 11 the nonavalent vaccine protects against 9 genotypes: HPV type 16, 18, 31, 33, 45, 52, 58, 6 and 11.

The 3 vaccines give excellent protection for cervical cancer caused by HPV 16 and 18, which cause at least 70% of cervical cancer cases. The WHO recommends that HPV vaccination be included in national immunization programmes as a core strategy for primary prevention against cervical cancer.

Cervical cancer screening (Pap smear) is recommended for women whether or not they have been vaccinated as the vaccines do not necessarily protect against all the cancer-causing genotypes

Schedule • • • • • • • • •

The WHO recommends vaccination of girls ages 9-14 years with 2 doses of HPV for best protection.

The bivalent vaccine is licensed for use in females only The quadrivalent and nonavalent vaccines may be given to both males and females For adolescents ages 9 to 14 years: 2 doses are given 6 months apart For persons 15 years and older: 3 doses are given, with the 2nd dose given at least 4 weeks after the 1st dose, and the 3rd dose given at least 6 months after the 1st dose For persons who are immunocompromised (e.g. HIV): the 3-dose schedule should be used regardless of age.

There is no maximum recommended interval between doses. However, an interval no greater than 12-15 doses is suggested to complete the schedule promptly Ideally given before sexual debut i.e. before risk of exposure to HPV, and when the immune response to the vaccine is strongest (ages 9 to 14 years) May be given at the same time as other vaccines

Storage • • •

In the refrigerator or vaccine carrier between +2°C and +8°C Do not freeze or expose to freezing temperatures Protect it from light 79

Method of administration • •

Given by intramuscular injection in the deltoid area of the arm The volume per dose is 0.5mL

Contraindications • • • • •

Persons with life threatening allergies to yeast or any other component of the HPV vaccine Severe adverse reaction to a previous dose of HPV vaccine Pregnancy (precautionary). If the person got pregnant after starting the series, withhold subsequent doses until after pregnancy Severe febrile illness HIV infection and minor infections such as a cold are not contraindications.

Adverse Reactions Serious side effects are very rare.

Mild • • • •

Pain, redness, itching or swelling at the injection site Mild to moderate fever Headache Nausea

Severe (occurs within minutes to a few hours after vaccination) • Severe allergic reaction • High fever

4.15 Other Available Vaccines Vaccines have been developed to protect against yellow fever, meningococcal diseases, chicken pox (varicella), the flu (influenza), pneumococcal diseases, hepatitis A, and rotavirus. While these vaccines are not yet a formal part of the MOH’s routine immunization schedule, yellow fever, influenza, and pneumococcal vaccines are provided by the MOH for special populations. Persons with specific health problems or circumstances (e.g. health workers, travelers) may be eligible to receive these vaccines. Persons may also choose to be vaccinated against these diseases in the private sector.

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4.15.1 • • •

• • •

Yellow Fever Vaccine: YF Contains a weakened form of the live yellow fever virus. This vaccine virus is made in chick embryos.

Also contains neomycin and polymyxin (two different antibiotics) Comes in powder form and must be mixed with the diluent supplied by the manufacturer before use. The diluent should be at the same temperature as the vaccine (+2°C to +8°C) when mixing.

Once reconstituted, the vaccine should be kept at a temperature of +2°C to +8°C and used within six hours.

Recommended as part of the routine infant immunization schedule only in countries where the disease is endemic or there is a high risk of outbreaks.

Given to Jamaicans traveling to high risk or endemic countries. The vaccines can be obtained through designated clinics in each region. These clinics provide the International Certificate of Vaccination required for travel to yellow-fever endemic countries. Other sites requesting the vaccine must contact the Family Health Unit, MOH.

Schedule • • • • •

Only one dose is required for full immunization.

Given to travelers requiring an International Certificate of Vaccination for entry into an endemic or high-risk country.

It should be given at least 10 days prior to travel Persons 12 months of age and older may receive it Should NOT be given to children under 6 months of age

Storage • •

Vaccine and diluent are both stored in the refrigerator at a temperature between +2°C and +8°C The vaccine is easily damaged by light and heat but not by freezing. The diluent should not be allowed to freeze.

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Method of administration •

• • • •

After reconstituting the vaccine, mix the vaccine and diluent together by gently swirling the vial before removing each dose; vigorous shaking is to be avoided as it causes the suspension to foam.

Discard vaccine if particles or discolouration are present The dose is 0.5 ml Given by subcutaneous injection in the upper outer arm, in the deltoid muscle YF vaccine must be used within 6 hours of reconstitution.

Contraindications • • • • • • •

Age <12 months (because of the risk of encephalitis) Pregnant or nursing woman (If travel to a high-risk zone cannot be postponed, or there is an epidemic, it may be given).

Moderate to severe acute illness, including fever > 38°C. Immunization should be postponed until the client is well.

Immunosuppression HIV/AIDS History of anaphylaxis to a previous dose of yellow fever vaccine History of anaphylaxis to any vaccine constituent including neomycin, polymyxin, gelatin, egg, or chicken

Note: When yellow fever vaccine is contraindicated, a traveler to an endemic area may require an official exemption letter from a Yellow Fever vaccination centre.

Precautions •

Systemic adverse reactions are more likely in persons aged >65 years compared with younger persons, therefore: o the physician should conduct a risk assessment involving an examination of the patient’s health status and need for the vaccine prior to immunization. o the geriatric patient should be monitored for adverse effects for 10 days postvaccination

82

Adverse Reactions • • •

Usually mild and occur 5-10 days post-vaccination, including headaches, muscle aches, low-grade fever Anaphylaxis and other allergic reactions are uncommon Encephalitis and multiple organ failure (sepsis-like syndrome) are very rare

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

4.15.2

Meningococcal Vaccine

Two types of inactivated vaccines protect against meningococcal meningitis: 1) Capsular polysaccharide vaccines (e.g. MPV) •

Capsular polysaccharide vaccines against meningococcal diseases were developed first (more than 30 years ago), but produce poor immune responses (immunogenicity) in children under 2 years of age. The meningococcal polysacharride vaccine (MPV) currently available in Jamaica protects against serogroups A, C, Y, and W-135.

2) Conjugate protein-polysaccharide vaccines •

•

Technology of linking (conjugating) polysaccharide antigen to a protein carrier was shown to improve immunogenicity of pneumococcal and Hib vaccines, and was therefore tried for meningococcal vaccine as well.

Compared to polysaccharide vaccine, conjugate protein-polysaccharide meningococcal vaccine is more immunogenic in infants and induces an immunological memory which gives longer-lasting protection. It has been introduced in the UK and Canada and may be available in the future in Jamaica; it protects against serogroup C disease and may be given to infants.

83

Meningococcal Polysacharride Vaccine (MPV): • • • • • •

•

Contains the inactivated capsular polysaccharides of meningococcal bacteria Protects against serogroups A, C, Y, and W-135 Not effective in children < 2 years of age and therefore it is not part of the routine childhood immunization schedule.

Currently licensed for use in Jamaica Comes in freeze-dried powder form Before it can be used it must be mixed with the diluent supplied by the manufacturer.

The diluent should be at the same temperature as the vaccine when mixing (+2° and +8°C). The vaccine should have a clear, colourless appearance once reconstituted.

Vials of reconstituted vaccine must be discarded at the end of each immunization session or at the end of six hours, whichever comes first.

Schedule •

• •

A dose is given to persons in high-risk groups, who are over age 2, including, o Persons with terminal complement component deficiencies, functional or anatomic asplenia; laboratory workers, travelers to endemic or epidemic areas; persons experiencing an outbreak in their community.

A booster dose may be required in persons at high risk every 2-5 years (upon the advice of their physician) Not given routinely to children under 2 years of age because of poor immunogenicity

Storage • •

Vaccine and diluent are stored in the refrigerator at a temperature between +2° and +8°C, and must not be frozen.

Single dose vials of the vaccine must be used or discarded within 6 hours of reconstitution; Multi-dose vials of vaccine must be used or discarded within 10 days of reconstitution.

Method of administration • • •

The dose is 0.5 ml Given by subcutaneous injection in the upper outer arm Inspect the vaccine prior to immunization; do not administer if particulate matter or discolouration are present

84

Contraindications • • •

Moderate to severe acute illness, including fever > 38°C. immunization should be postponed until the client is well.

History of anaphylaxis to a previous dose of MPV History of anaphylaxis to a component of MPV vaccine constituent

Physicians may consider MPV in pregnancy or while breastfeeding if it is indicated.

Adverse Reactions • • •

Generally mild: headache, malaise, or fever (in 2-5% of recipients) Soreness and redness at the injection site occur in 5-10% of patients and last 1-2 days Severe reactions, including anaphylaxis and other allergies, are rare

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

4.15.3 • • •

•

Varicella Vaccine Contains live attenuated varicella zoster virus, Oka strain Comes in powder form Before it can be used it must be mixed with the diluent supplied by the manufacturer.

The diluent should be at the same temperature as the vaccine when mixing (between +2°C and +8°C).

Duration of the vaccine-induced immunity is unknown, so studies are currently being conducted to determine the need for booster doses.

Schedule • •

Not routinely given to children or adults in Jamaica It may be given as follows [in the private sector]: o Children 12-18 months of age receive one dose and no boosters; vaccination of a child who has had chicken pox is not harmful, but it is unnecessary. o It is not recommended for use in children less than one year of age o Susceptible adolescents (>13 years) and adults receive two doses, separated by 4 to 8 weeks 85

• •

o Non-pregnant women of childbearing age, persons living or working in institutional settings (military, college, jail) or with children (teachers, daycare personnel), health care workers, and close contacts of immunosuppressed persons should consider getting the vaccine.

If doses of BCG, MMR, yellow fever and varicella vaccines are not given simultaneously, the vaccines should be separated by four weeks.

A waiting period is required between antibody containing blood products and administration of varicella vaccine (consult the Family Health Unit or a physician to modify the child’s schedule)

Storage •

• •

Requirements vary according to the manufacturer. Some brands are very sensitive to heat and require storage at -15°C or colder. Newer brands, such as Varilrix, may be stored at +2°C to +8°C. The diluent is stored in the refrigerator at a temperature between +2° and +8°C, and must not be frozen.

Should be administered immediately after reconstitution to minimize loss of potency.

Refer to manufacturer’s insert for the required time for discarding reconstituted vaccine.

Method of administration • •

The dose is 0.5 ml Administered into the subcutaneous layer of the upper outer arm, in the deltoid muscle

Contraindications • • • •

•

Moderate to severe acute illness, including fever > 38°C. Immunization should be postponed until the client is well.

History of anaphylaxis to a previous dose of varicella vaccine History of anaphylaxis to any vaccine constituent. Persons with a history of anaphylactic reaction to neomycin or gelatin should not receive the vaccine.

Immunosuppression a) Exception: Asymptomatic HIV positive individuals, who are not severely immunosuppressed, may receive varicella vaccine. Consult a physician for the correct immunization schedule for these persons.

Pregnancy; also women should avoid getting pregnant for 4 weeks after receiving varicella vaccine 86

Adverse Reactions • • • •

Local reaction in 19% of children: redness, swelling and pain at the injection site Fever In 3% of children, varicella-like rash localized to the injection site occurs within 2 weeks of vaccination; generalized rash may occur 2-3 weeks after vaccination Herpes zoster following varicella vaccination in healthy children is a rare occurrence (18 per 100,000 person-years of follow-up) and has been mild and without complication.

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

4.15.4

Pneumococcal Vaccines

Two types of inactivated vaccines protect against pneumococcal disease: 1.

2.

• •

Pneumococcal polysaccharide vaccines (PPV) Pneumococcal conjugate vaccines (PCV) Both vaccines come in a liquid form PPV is not given to children under 2 years of age because it does not produce a good immune response, including protective antibody levels, in them • One of the advantages of PCV over PPV is that it is immunogenic (i.e. produces an adequate immune response) in infants and children, even when they have HIV or sickle cell disease.

Schedule PPV: • • • •

Not routinely given to children or adults in Jamaica Should be given two weeks prior to elective splenectomy, planned chemotherapy or immunosuppressive therapy May also be considered for adults 65 years of age or older.

Should be considered for persons over age 2 with a high risk of infection or complication from pneumococcus including persons with: o Functional or anatomic asplenia o Sickle cell disease o Nephrotic syndrome or chronic renal failure o Immunosuppression o Chronic diseases (cardiovascular or pulmonary disease, diabetes, alcoholism, cirrhosis, or cerebrospinal fluid leaks)

87

PCV: •

•

• •

May be given to children under 2 years of age o Usually, doses are given at 2,4 and 6 months of age; a booster is given between 12 and 15 months of age o Consult the product pamphlet if not following this schedule, as fewer than 4 doses are required for infants and children beginning their series at a later age. o Minimum interval between doses is 4 weeks in children <1 year and 8 weeks in children >1 year May be given to children 2-5 years of age: o Children with high risk medical conditions such as sickle cell disease, functional or anatomic asplenia, HIV infection, chronic illness or immunosuppression o Two doses are given at least 8 weeks apart Not recommended for persons over age six Booster doses are given on the basis of the patient’s medical condition according to a physician’s advice.

Storage Both types of vaccines • Are stored in the refrigerator or vaccine carrier between +2°C and +8°C • Are damaged by freezing

Method of administration • • •

The dose for both PPV and PCV is 0.5 ml PPV: inject into the deltoid muscle (IM) or subcutaneous tissue of the upper outer arm of persons over age 2 years.

PCV o Infant <18 months of age: inject vaccine into the muscle (vastus lateralis) of the antero-lateral thigh o Child > 18 months-59 months: inject vaccine into the deltoid muscle of the upper arm

Contraindications •

Moderate to severe acute illness, including fever > 38°C. Immunization should be postponed until the client is well.

88

•

History of anaphylaxis or severe allergic reaction to a previous dose of PPV or PCV or any of its components

Precautions • •

Avoid giving PPV during pregnancy as its safety has not been adequately studied.

PCV is not recommended for persons over age six

Adverse Reactions PPV: • • •

Swelling, redness, or pain at the injection site occur in 30-50% of vaccinees, but usually resolve within 48 hours.

Systemic reactions (fever, muscle soreness) are uncommon Severe systemic reactions are rare

PCV: • • •

Local reaction at the injection site (pain, swelling, redness) occurs in 10-20% of vaccinees Fever No severe adverse events are known

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

4.15.5 •

Influenza Vaccine The flu vaccine is a very safe and effective vaccine that provides protection against influenza infections caused by specific vaccine strains.

• Influenza vaccines can be: a) Quadrivalent or trivalent. The trivalent vaccine is used in Jamaica and protects against 3 different strains of the influenza virus: 2 types of Influenza A virus (H1N1 and H3N2); and 1 type of Influenza B virus 89

b) Live attenuated (weakened) or inactivated. Live attenuated (weakened) virus vaccine given by intranasal spray. Inactivated virus vaccines are used in Jamaica and a may contain whole virus, subvirion/ split virus or purified surface antigens. c) Southern Hemisphere or Northern Hemisphere. The Northern Hemisphere formulation is usually given in Jamaica.

•

Vaccine virus composition is changed annually in anticipation of expected circulating strains of influenza virus.

•

Vaccine virus is produced in live fertilized chicken eggs

Schedule •

• •

The vaccine is usually given annually prior to the ‘flu season’in the cooler months of the year. Optimally, vaccination should occur before the start of the flu season, if possible, namely September to November.

Given to persons 6 months and over In Jamaica, priority groups for vaccination have been identified with the view to: protecting at-risk individuals from infection and/or serious illness; maintaining the health of the workers in essential services; and preventing or minimizing the spread of infection. These priority groups are: 1. Health care workers 2. Pregnant women 3. Children over 6 months of age with chronic illnesses 4. Non-health frontline workers such as the police, army, correctional services, customs and immigration officers 5. Parliamentarians 6. Institutionalized persons 7. The elderly (adults over 65 years) with chronic illnesses

Storage • •

In the refrigerator or vaccine carrier between +2°C and +8°C The vaccine should not be frozen or exposed to light or heat

Method of administration • •

The inactivated vaccine is given by intramuscular injection in the deltoid area of the arm for persons aged > 1 year The usual dose for persons 3 years and over is 0.5 mL 90

• • • •

The dose for children ages 6 to 12 months is 0.25 mL given IM in the anterolateral aspect of the thigh One dose is required for persons 9 years and over For children < 8 years, if they have never received a previous dose of Influenza vaccine, the recommendation is 2 doses of vaccine given 4 weeks apart The live attenuated virus vaccine is divided into two portions per dose in the syringe.

Half of the dose is sprayed into one nostril and the other half in the other nostril

Contraindications • • • • •

Anaphylactic reaction to egg Anaphylaxis to a previous dose of Influenza vaccine History of Guillain-Barre Syndrome following previous vaccination with Influenza Known sensitivity/allergy to Thimerosol (mercury) The live vaccine should not be given to pregnant women, immunocompromised persons or persons less than 5 years or over 49 years.

Adverse Reactions Most are mild lasting 1-2 days usually and include: • • • •

Pain, redness and swelling at vaccination site Low-grade fever Muscle or joint pains The live vaccine may cause a mild flu-like illness or worsen respiratory disease such as asthma

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

4.15.6

Rotavirus Vaccine

There are currently two presentations of the Rotavirus vaccine produced by two different manufacturers. One trademarked RotaTeq from Merck and the other trade marked Rotarix from GlaxoSmithKline.

RotaTeq: • • •

Live, oral, pentavalent vaccine using bovine strains Liquid formulation Prevents severe serotype specific Rotavirus GE and hospitalization in infants children 91

Rotarix: • • •

Live, oral, monovalent vaccine using human strain Lyophilized formulation. Reconstituted with a diluent.

Prevents severe serotype specific Rotavirus GE and hospitalization in infants children

Schedule • • •

Given to infants within the first 6 months of life RotaTeq given as a three dose schedule at 2, 4 and 6 months Rotarix given as a two dose schedule at 2 and 4 months

Storage • • • •

In the refrigerator or vaccine carrier between +2°C and +8°C Diluent and vaccine must be stored together for Rotarix Do not freeze or expose to freezing temperatures Protect it from light

Method of administration • • • •

Given by mouth (orally) The volume per dose is 1 mL for Rotarix and 2 mL for RotaTeq Rotarix is given by a syringe RotaTeq is given by a squeeze tube

Contraindications • •

Hypersensitivity to any vaccine component Immunocompromised persons (cautioned use)

Adverse Reactions • • • • • •

Diarrhoea Vomiting Otitis media Nasopharyngitis Bronchospasm Hematochezia (bloody stools)

Any adverse reaction to vaccination should prompt the health worker to complete an adverse event reporting form and forward it to the Family Health Unit, MOH. Details of all adverse events should also be recorded in the adverse events register and the patient docket.

92

4.16 Summary of Vaccines Table 4.16.1: Vaccines in schedule with temperature for storage, method of administration, adverse events and contraindications associated with immunization

Vaccine

Storage temperature

Dose

Route

Common adverse reactions

Site

Contraindications

Bacillus of Calmette and Guerin- BCG

+2°C to +8°C

0.05 or 0.1 ml

Intradermally (ID)

Upper arm

right

-Swelling of lymph nodes in armpit -Draining sinus over lymph node -Abscess or ulcer over injection site -Keloid formation

-Acute illness including fever of> 38°C -Immunosuppression -Extensive skin burns -Active skin disease -Pregnancy -A positive tuberculin test

Pediatric Diptheria and Tetanus ToxoidDT(P)

+2°C to +8°C

0.5 ml

Intramuscular (IM)

Infants < 18 mnthsanterolateral thigh

-Swelling, pain and redness at the injection site -A small painless nodule at the inoculation site -Malaise, fever and headache -Abscess at the injection site -Swelling, pain and redness at the injection site -A small painless nodule at the inoculation site -Malaise, fever and headache -Abscess at the injection site

-Acute illness including fever of> 38°C -History of a severe allergic reaction to a previous dose of DT vaccine

Children > 18 monthsUpper arm

Adult Diptheria and Tetanus Toxoid- DT(A), DT or Td

+2°C to +8°C

0.5 ml

Intramuscular (IM)

93

Upper arm

-Acute illness including fever of> 38°C -History of a severe allergic reaction to a previous dose of DT vaccine

Table 4.16.1 (Continued) Vaccine DiphtheriaTetanus-Whole cell Pertussis DTwP

Storage temperature

Dose

Route

Site

+2°C to +8°C

0.5 ml

Intramuscular (IM)

Infants < 18 mnthsanterolateral thigh Children > 18 mnths- Upper arm

Hepatitis B- Hep B

+2°C to +8°C

0.5 (10µg)

ml

Infants < 18 mnthsanterolateral thigh

0.5ml (10µg) Intramuscular (IM)

0.5 ml

-Fever -Swelling, pain and redness at the injection site -A small painless nodule at the inoculation site -Malaise, fever and headache -Abscess at the injection site

-History of febrile or afebrile convulsions without neurological clearance -Children over 7 years of age and adults (because of the wPertussis component)

-Mild fever for 1 to 2 days -Soreness and redness at the injection site -Fatigue, headache, irritability

-Moderate to severe acute illness, including fever > 38°C -History of anaphylaxis after a previous dose of Hepatitis B vaccine -Allergy to yeast (Hepatitis B vaccine is developed in baker’s yeast)

-Swelling, redness, and pain at the injection site -Fever, irritability

-Acute illness including fever of> 38°C -History of a severe allergic reaction to a previous dose of Hib vaccine

-Redness (>2 cm), swelling(>2 cm), and pain at the injection site within 48 hours -Fever -A small painless nodule at the inoculation site -Malaise, fever and headache -Abscess at the injection site

-Moderate to severe acute illness, including fever > 38°C -History of anaphylaxis or severe reaction to a previous dose of Pentavalent or any of its components -Presence of a contraindication to any component of the vaccine

Immunosuppressed adults- upper arm

2 ml (40µg)

+2°C to +8°C

Intramuscular (IM) or deep subcutaneous (SC)

Infants < 18 mnthsanterolateral thigh Children > 18 months and adults - upper arm

Pentavalent DTwP/HepB/Hib

+2°C to +8°C

0.5 ml

Contraindications

Adults > 20 years of age – upper arm

1 ml (20µg)

Hemophilus Influenza Type B- Hib

Children > 18 months and adolescents (up to 19 years of age)upper arm

Common adverse reactions

Intramuscular (IM)

94

Anterolateral thigh

Table 4.16.1 (Continued) Storage temperature

Dose

Route

Site

Common adverse reactions

Bivalent Oral Polio- bOPV

+2°C to +8°C

2 drops

Oral

Mouth

Side effects are rare

-Moderate to severe acute illness, including > 3 episodes of diarrhea per day, vomiting, or fever > 38°C -History of anaphylaxis to a previous dose of OPV -Immunosuppression or close contact with an immuno-suppressed person -HIV/AIDS

Inactivated Polio virus - IPV

+2°C to +8°C

0.5ml

Intramuscular (IM) or deep subcutaneous (SC)dependent on brand

Infants < 18 mnthsanterolateral thigh

- Pain and redness at the site of the injection

-Moderate

-Moderate to severe acute illness, including fever > 38°C -History of anaphylaxis to a previous dose of MMR -History of anaphylaxis to any vaccine constituent (Neomycin, kanamycin, or gelatin) -Pregnancy -Symptomatic HIV infection and Asymptommatic infection with severe immune-suppression (CD4 percentage of <15%) -Persons with life threatening allergies to yeast or any other component of the HPV vaccine -Severe adverse reaction to a previous dose of HPV vaccine -Pregnancy

Vaccine

Children > 18 months and adults - upper arm

Measles, Mumps and Rubella MMR

+2° to +8°C OR -25°C to -15°C

0.5ml

Deep subcutaneous (SC)

Upper arm

-Feverwith without rash -Arthritis

Human Papilloma VirusHPV

+2°C to+8°C

0.5ml

Intramuscular (IM)

Upper arm

-Pain, redness, itching or swelling at the injection site -Mild to moderate fever -Syncope (fainting)

95

outer

or

Contraindications

to severe acute illness, including diarrhea, vomiting or fever > 38°C -History of anaphylaxis to a previous dose of IPV or any vaccine constituent.

-History of anaphylactic reaction to neomycin, polymyxin B or streptomycin

Table 4.16.1 (Continued) Storage temperature

Dose

Route

Site

+2°C to+8°C

0.5ml

Subcutaneous (SC)

Upper arm

outer

-Headaches -Muscle aches -Low-grade fever

-Age <12 months (because of the risk of encephalitis) -Pregnant or nursing woman (If travel to a high-risk zone cannot be postponed, or there is an epidemic, it may be given).

-Moderate to severe acute illness, including fever > 38°C -Immunosuppression -HIV/AIDS -History of anaphylaxis to a previous dose of yellow fever vaccine -History of anaphylaxis to any vaccine constituent including neomycin, polymyxin, gelatin, egg, or chicken

Meningococcal PolysaccharideMPV

+2°C to+8°C

0.5ml

Subcutaneous (SC)

Upper arm

outer

-Headache -Malaise -Fever -Soreness and redness at the injection site occur

-Moderate

Varicella

+2°C to +8°C OR -15°C or colder (Dependent on brand)

0.5ml

Subcutaneous (SC)

Upper arm

outer

-Redness,

-Moderate to severe acute illness, including fever > 38°C -History of anaphylaxis to a previous dose of varicella vaccine -History of anaphylaxis to any vaccine constituent such as neomycin or gelatin - Symptomatic HIV infection and Asymptommatic infection with severe immune-suppression (CD4 percentage of <15%) -Pregnancy

Vaccine Yellow (YF)

Fever

96

Common adverse reactions

and pain injection site -Fever

swelling at the

Contraindications

to severe acute illness, including fever > 38°C -History of anaphylaxis to a previous dose of MPV -History of anaphylaxis to a component of MPV vaccine constituent

Table 4.16.1 (Continued) Vaccine Pneumococcal Polysaccharide (PPV) or Pneumococcal Conjugate (PCV)

Storage temperature

Dose

Route

Site

Common adverse reactions

+2°C to+8°C

0.5ml

PPVSubcutaneous (SC) or Intramuscular (IM)

Upper arm

PCVIntramuscular (IM)

Infants < 18 mnthsanterolateral thigh

outer

-Fever (more likely for PCV) - Swelling, redness, or pain at the injection site

-Moderate to severe acute illness, including fever > 38°C -History of anaphylaxis or severe allergic reaction to a previous dose of PPV or PCV or any of its components

-Pain,

redness and swelling at vaccination site -Low grade fever -Muscle or joint pains -Mild flu-like illness or worsen respiratory disease such as Asthma (Live vaccine)

-Anaphylactic reaction to egg -Anaphylaxis to a previous dose of Influenza vaccine -History of GuillainBarre Syndrome following previous vaccination with Influenza -Known sensitivity/allergy to Thimerosol (mercury) Pregnant women, immunocompromised persons or persons less than 5 years or over 49 years (Live attenuated form).

-Diarrhoea -Vomiting -Otitis media -Nasopharyngitis -Bronchospasm -Hematochezia (bloody stools)

-Hypersensitivity to any vaccine component

Children > 18 to 59 monthsupper arm Influenza

Rotavirus

+2°C to+8°C

+2°C to+8°C

0.5ml- ≥3 years 0.25ml - <3 years

1mLRotarix 2mL RotaTeq

Intramuscular (IM)Inactivated Form

-Antero-lateral thigh

Live attenuated

Intranasal

Oral

Mouth

-

97

-Upper arm

Contraindications

outer

98

Chapter 5: Care of Vaccines & Cold Chain 5.1 What is the Cold Chain?

The cold chain is the equipment, people and procedures that keep vaccines cold during their journey from the manufacturer to the patient. Vaccines are destroyed by heat and excessive cold. As such, they must be kept at the required temperature of +2ºC to +8ºC from the time they are manufactured until they are used. A cold chain, therefore, includes three main elements: 1. equipment for safe storage and transport of vaccines 2. personnel who use and maintain the cold chain equipment and provide the health service 3. procedures to manage the programme and control the distribution and use of vaccines

The storage and transport links in Jamaica’s cold chain system are shown in the figure below: Vaccine Manufacturers International transport by air VACCINES Same-day clearance or transit storage facilities if needed (+2°C to +8°C)

Norman Manley Airport Transported with refrigerated trucks or vaccine carriers with Temptail /cold tag

Cold room (+2°C to +8°C) and Freezers (-15°C to -25°C), automatic standby generator

NHF Pharmaceuticals Central Vaccine Store

Refrigerator (+2°C to +8°C) with freezer compartment; standby generator should be present

Parish Store

Transport of Vaccine in Carrier

Refrigerator (+2°C to +8°C) with freezer compartment. Vaccine carriers used during immunization session.

Health Centre

Vaccine Administration Figure 5.1.1:

Storage and Transport Links in Jamaica’s Cold Chain System

99

Maintenance of the cold chain requires vaccine and diluent to be: • collected from the airport as soon as they arrive • transported at the correct temperature from one storage site to another – A thermometer must be in the transport vessel • stored at the correct temperature at the central, parish, and health centre levels • transported at the correct temperature to outreach sites • kept cold during immunization sessions with conditioned ice packs You are responsible for maintaining the cold chain while vaccine is stored in your health centre, while it is being transported to outreach sites, and during immunization sessions.

Any break in the cold chain could result in the administration of ineffective vaccine, thereby defeating the purpose of the vaccination programme (i.e. reduced immunity of the community).

5.2 Conditions for Storing EPI Vaccines • •

Vaccines differ in their sensitivity to heat, cold and light. Therefore, different vaccines require different storage conditions.

All vaccines are sensitive to damage by heat, but some are more sensitive than others.

Tools used to monitor heat exposure include Vaccine Vial Monitor and the shake test.

If a vaccine is damaged by heat, it loses some of its potency (i.e. its ability to give protection against disease). EPI vaccines may be ranked according to their sensitivity to heat as follows:

Figure 5.2.1

•

9

Vaccines sensitive to heat 9

Freeze-dried vaccines (BCG, MMR, Yellow Fever, Hib) become much more heatsensitive after they have been reconstituted (i.e. diluent has been added).

Source: Immunization in Practice: A Practical Guide for Health Staff, updated 2015

100

•

It is very important that they are not exposed to heat. Vials of reconstituted vaccine must be discarded at the end of each immunization session or at the end of six hours, whichever comes first.

Remember that vaccines can be damaged by heat in a short period (e.g., as a result of keeping vaccine in a closed vehicle in the sun or a small amount of heat over a long period (e.g., as a result of the frequent opening of a refrigerator door).

Some vaccines, particularly toxoids, are sensitive to being too cold. For these vaccines, freezing or exposure to temperatures below zero degrees centigrade (0°C) can cause loss of potency, and again, the vaccine will become useless. It is, therefore, essential to protect these vaccines not only from heat, but also from freezing.

•

•

Table 5.2.1:

Vaccine Sensitivity to Extreme Cold

Vaccines Damaged by Freezing • • • • • • • • • • • • • •

Vaccines Not Affected by Freezing • • • • • • • •

DPT, DT/Td, TT Hepatitis A & Hepatitis B Haemophilus influenzae Type b (Hib) IPV HPV Rabies Cholera Influenza Pneumococcal Meningococcal Rotavirus (liquid and freeze-dried) All combinations of the above vaccines Vaccine diluents

OPV Measles Mumps Rubella Yellow Fever MMR Varicella BCG

Vaccines containing live virus, such as BCG, MMR and OPV, varicella, yellow fever and intranasal influenza, are very sensitive to light. For these vaccines, exposure to sunlight or fluorescent (neon) light will cause loss of potency. Normally, these vaccines are supplied in vials made from dark brown glass, which gives them some protection against light damage, but care must still be taken to keep them covered and protected from strong light at all times. They should be kept in their secondary packaging for as long as possible to protect them during storage and transportation.

101

5.3 The Shake Test The shake test is used to determine whether vaccine has been frozen: 1. Take two vials, one that you think might have been frozen and another from the same manufacturer, which you KNOW has never been frozen.

2. Shake both vials.

3. Look at the vaccine inside the two vials (see Figure 5.4 below) 4. Let the sediment settle for 15-30 minutes.

5. Again, look at the vaccine inside the two vials. If a thick sediment forms in the bottom of the vial, the vaccine has failed the shake test and should be returned to your supervisor for disposal.

6. Complete the vaccine wastage form for weekly tally.

Figure 5.3.1: The Shake Test 10

10

Source: How to perform the â&#x20AC;&#x153;Shake Testâ&#x20AC;?. PAHO. Immunization Newsletter. Volume XXXII, Number 2.

April 2010

102

5.4 Recommended Storage Temperatures for Vaccines •

• • •

• •

The maximum times and temperatures for storing EPI vaccines are shown in the figure below. At the central vaccine store, OPV must be kept frozen between minus 15 and minus 25 degrees centigrade (-15oC to -25oC).

All other EPI vaccines should be stored at between +2°C and +8°C at all levels of the cold chain.

If the OPV is received thawed, it should not be refrozen. Instead, store it on the top shelf of the refrigerator to be used first.

Even when stored at the correct temperature, vaccines do not retain their potency forever. All vaccines (and diluents) have an expiry date. They must be used by this date or returned to your supervisor for disposal. Check the expiry dates of vaccine stocks at your clinic on a monthly basis. Never use expired vaccine! Always use vaccines with earlier expiration dates first.

If a vaccine has been damaged by heat or other causes, its potency will be reduced even before the expiry date shown on the vial or packet is reached.

Only vaccine stocks that are fit for use should be kept in the cold chain. Any expired vials, heat damaged vials or vials with vaccine vial monitors beyond the discard point should not be kept in the refrigerator or freezer, as they may be confused with good quality vaccines. These should be clearly labelled, logged, and returned to the central store to be discarded.

5.5 Condition for Storing Diluents for EPI Vaccines A vaccine diluent is the liquid mixed with a lyophilized (freeze-dried) vaccine in order to reconstitute the lyophilized vaccine and provide the final vaccine for administration. A vaccine diluent may be sensitive to heat or freezing and may require transportation and storage in the cold chain. Diluents vary widely in composition and therefore only the diluent assigned by the manufacturer for the specific vaccine and presentation should be used.

1. Freeze-dried vaccines and their diluents should always travel together in matching quantities. Diluents may appear to be simple water, but in fact contain a variety of salts, chemicals and additives required to stabilize a specific vaccine after reconstitution.

2. Each vaccine requires a specific diluent and therefore, diluents are not interchangeable. For example, o Diluent made for MMR vaccine, must not be used for reconstituting BCG, yellow fever or any other type of vaccine. Likewise, 103

o Diluent made by one manufacturer for use with a certain vaccine cannot be used for reconstituting the same type of vaccine produced by another manufacturer. This means that diluent for MMR vaccine made by company 'A' cannot be used for reconstituting MMR vaccine made by company 'B'.

3. Diluent must always be of the correct type for the vaccine being used, and from the same manufacturer as the vaccine which it is accompanying. o Store diluent in the same tray as the vaccine it belongs with, to avoid errors in reconstitution. Ensure that both diluent and vaccine are adequately labeled. o Diluent vials must NEVER be frozen or allowed to be in contact with any frozen surface. Freezing can cause the glass to crack allowing contamination of the diluent. Diluents can be kept outside of the refrigerator but should ALWAYS be stored between +2°C and +8°C (preferably overnight) prior to reconstitution. o When vaccines are being reconstituted, the diluent should be at the same temperature as the vaccine. Some combination vaccines comprise a freezedried component (such as Hib) which is designed to be reconstituted by a liquid vaccine (DTP-HepB liquid vaccine) instead of a normal diluent. For such combination vaccines, it is again vital that ONLY vaccines manufactured and licensed for this purpose are combined. Keep all components in the cold chain at +2°C to +8°C at all times.

4. Unless otherwise specified by the manufacturer, the correct temperature for long-term storage of diluents is +2oC to +8oC. o Diluent packages with or attached to the vaccine should always be stored with the corresponding vaccine at +2oC to +8oC. o Diluents not packaged with the vaccine can be stored at room temperature ONLY if the manufacturer’s instructions allow it. In this case, the manufacturer’s instructions regarding cooling prior to reconstitution should be followed.

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Figure 5.5.1

WHO Recommended Vaccine Storage Conditions 11

5.6 Cold Chain Equipment Used in Health Centres and Health Departments 5.6.1 Vaccine Refrigerators Refrigerators are indispensable to the EPI. They must be in good operating condition and well maintained. Vaccine refrigerators have two sections: 1. A main section for storing vaccines and diluents, in which the temperature should be kept between +2°C and +8°C. 2. A freezer for freezing ice packs and storing vaccines (that can be frozen). This section should be kept below 0°C. Vaccines, diluents and ice packs should have their own refrigerator. Storing other supplies in a vaccine refrigerator raises the temperature because of the frequent opening of the refrigerator.

11

Adapted from: WHO Guidance Note: Vaccine Diluents. Revision 2015. The Proper Handling and Use of Vaccines Diluents

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A refrigerator in a health centre should be able to hold: • One month’s supply of vaccines and diluent; and • One- to two- week’s reserve stock of vaccines and diluent (buffer stock) and • Frozen ice packs or bottles of water in the bottom of the refrigerator to keep it cool if the power fails; and • Half the total space must be empty to allow air to circulate around the vaccines and diluents, keeping them cool.

In Jamaica, most, if not all, health centre refrigerators are powered by electricity. Each refrigerator should have a surge protector to protect it from fluctuations in power. Guard the power supply of the refrigerator by writing a notice against turning off the power or unplugging the refrigerator.

Figure 5.6.1.1:

Warning sign to be placed on immunization refrigerators 12

Vaccine refrigerators must have a reliable electrical supply. Each health department should connect the vaccine refrigerator to a backup generator, so an alternate power source is available if a power outage occurs.

Note: Opening the refrigerator door raises the temperature. Before you open the door, plan what you are going to do. When you open the door, do what you have to do quickly and close the door as soon as possible. Try not to open the refrigerator door more than three (3) times a day.

12

Source: Centre for Disease Control. Vaccine Storage and Handling Tool Kit. January 2018

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5.6.2 Cold Boxes A cold box is an insulated container that can be lines with water packs to keep vaccines and diluents in the required temperature range during transport or short-term storage. Some models can store vaccines for 2 to 7 days (i.e. the “cold life” of the cold box) • when there is no electricity available • when the facility refrigerator is out of order • when a passive container is needed while facility refrigerator is being defrosted Cold boxed can be used to transport monthly vaccine supplies from district stores to the health facility, and from the health facility to outreach sessions if vaccine carriers are too small.

Figure 5.6.2.1:

Vaccine Cold Box 13

5.6.3 Vaccine Carriers Vaccine carriers are insulated containers that can be lined with frozen ice packs to keep vaccines and diluent cold for 24 – 72 hours. They are used by health centre staff: • to collect and transport vaccine supplies from parish and central stores • to store vaccines and diluent during immunization sessions at the health centre, on outreach visits, and when the refrigerator is out of order or being defrosted Different sizes and types of vaccine carriers are available. To choose the right one for your health centre, consider the amount of vaccine and diluent to be stored, the cold life needed, and your means of transportation.

13

Sources:

WHO PQS devices catalogue. Version date 24 August 2017 Immunization in Practice: A Practical Guide for Health Staff, updated 2015

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Some vaccine carriers come with a soft foam pad that fits on top of the ice packs inside the carrier. When the carrier lid is open, the foam pad keeps the vaccines underneath it in a cool state. It also holds and protects vaccine vials during immunization sessions

Figure 5.6.3.1:

Vaccine Carrier 14

5.6.4 Ice Packs Ice packs are square, flat, plastic bottles of various sizes that can be filled with water and frozen. The required number of ice packs varies according to the type of vaccine carrier, but all four sides of the carrier should always be lined with packs. Every health centre should have at least two sets of ice packs; one set should be in the freezer while the other set is in use.

Make ice packs as follows: • Fill bottle with clean cold water and put the cap on tightly.

• Hold each ice pack upside down and squeeze it to make sure that there is no leak.

• Put the ice packs upright or on their sides in the freezer and close the door.

• Leave them in the freezer for at least 48 hours to freeze solid.

• You do not have to refill ice packs every time you use them. Use the same water repeatedly.

14

Sources:

WHO PQS devices catalogue. Version date 24 August 2017 Immunization in Practice: A Practical Guide for Health Staff, updated 2015

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The use of wet ice in plastic water bags is strongly discouraged as this may expose vaccines to freezing temperatures.

Note: It takes 48 hours to freeze an ice pack. An ice pack melts quickly if not completely frozen. Make sure that the centre is frozen, as well as the outside.

Figure 5.6.4.1:

Ice Packs (Water Packs) 15

5.7 Revised Multi-Dose Vial Policy Recent research has shown that this it is not necessary to discard all vials of vaccine that have been opened for an immunization session. PAHO/WHO issued a revised statement in 2014 on the Multi-dose Vial Policy (MDVP).

All opened WHO-pre-qualified multi-dose vials of vaccines should be discarded at the end of the immunization session, or within 6 hours of opening, whichever comes first, unless the vaccine meets all 4 criteria listed below. If the vaccine meets the 4 criteria, the opened vial can be kept and used for up to 28 days after opening. The criteria are as follows: 1. The vaccine is currently pre-qualified by WHO 2. The vaccine is approved for use for up to 28 days after opening the vial, as determined by WHO 3. The expiry date of the vaccine has not passed 4. The vaccines have been, and will continue to be, stored at WHO- or manufacturerrecommended temperatures; furthermore, the vaccine vial monitor, if one is attached, is visible on the vaccine label and is not past the discard point, and the vaccine has not been damaged by freezing.

15

Sources:

WHO PQS devices catalogue. Version date 24 August 2017 Immunization in Practice: A Practical Guide for Health Staff, updated 2015

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If ALL of the criteria cited above are present, the vaccine vial may be kept and used up to 28 days after opening, or until all the doses are administered.

The revised policy does not change recommended procedures for handling vaccines that must be reconstituted, that is: BCG, MMR, Pentavalent (DPT/HepB/Hib), Hib and yellow fever vaccines. Once they are reconstituted, vials of these vaccines must be discarded at the end of each immunization session or at the end of six hours, whichever comes first.

Death due to toxic shock syndrome has resulted, when reconstituted live virus vaccines kept longer than the recommended period, was administered to the vaccinee.

An opened vial of ANY vaccine MUST BE DISCARDED immediately if: • sterile procedures have not been followed; or • the presence of floating particles or a change in the appearance of the vaccine shows that it has been contaminated; or • if it is suspected that the vaccine has been contaminated.

Any opened vial that you decide to keep should be put in a box marked ‘RETURNED’ in the refrigerator and used before any others during the next session. The date on which the vials were opened should be recorded on the vial with a pen.

If vaccines or diluents have been exposed to unacceptably high temperatures or have been frozen, please call the Family Health Unit (FHU) immediately upon discovery. The decision on use of the vaccines will be taken by the FHU. Do not discard or remove the vaccines from the cold chain before notifying the FHU.

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Figure 5.7.1: Revised Multi-Dose Open Vial Policy for WHO prequalified vaccine

5.8 How to Load Cold Chain Equipment

Cold-chain equipment, including refrigerators and vaccine carriers, must be loaded correctly to maintain the temperature of the vaccine and diluent inside.

Arrange the vaccine refrigerator as follows: • Store ice packs in the freezer. This keeps the temperature low in the event of a malfunction or power failure.

• Keep plastic bottles or ice packs filled with water on the bottom shelf. They help to keep the temperature constant.

• The ice packs and water bottles must be kept 2 – 5 centimeters apart and the same distance away from the walls of the refrigerator. This is to allow cool air to circulate.

• Put vaccines and diluents on the top and middle shelves of the main section.

- OPV and MMR vaccine on the top shelf or in the freezer compartment 111

-

•

• • • • • •

BCG, DPT, DT, Hepatitis B, Hib and Pentavalent vaccines on the middle shelves - Diluents next to the vaccines with which they were supplied Arrange boxes or vials of vaccine in lines (rows) between which the cold air can circulate freely. Ideally, vaccines should take up only about half of the storage area in order to allow air movement.

Those with the earliest expiration dates should be placed near the front so they will be used first.

Vaccines must be stored in perforated trays/containers so that they do not stand in water and lose their labels.

DO NOT put vaccines in door shelves. The temperature is not low enough.

DO NOT keep any food, drink, or drugs in a vaccine refrigerator.

It is important to open the door only when needed. During power failures, the refrigerator should not be opened except to remove vaccines for storage elsewhere.

DO NOT keep expired vaccines in the refrigerator. Return them to NHF Pharmaceuticals through your health department.

Figure 5.8.1: 16

Correct Loading of the Vaccine Refrigerator 16

Source: Immunization in Practice: A Practical Guide for Health Staff, updated 2015

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Load vaccine carriers as follows: 1. Quickly take all the frozen ice packs you need from the freezer and close the door.

2. Remove extra ice from the surface of the ice packs and allow icepack to â&#x20AC;&#x153;sweat.â&#x20AC;?

3. Put ice packs against each of the four sides of the vaccine carrier.

Figure 5.8.2:

Arranging ice packs in a vaccine carrier 17

4. Quickly take all the vaccines and diluents you need from the main section of the refrigerator and close the door.

5. Put the vaccines and diluents in the middle of carrier. Vials may be kept in their boxes or packed without them, depending on how many vials you need. Do not let vials of vaccine or diluent touch the ice packs directly. Put newspaper or cardboard around the vaccines, or place them in a plastic cup or gallipot, to protect them from freezing. This also means that you should not put opened vials in the holes that are made in some ice packs. Use a cup, gallipot or foam pad.

6. Put a thermometer and ice packs on top of the vaccines.

7. If you have one, place a foam pad on top of the ice packs.

8. Close the carrier lid tightly, and do not expose the carrier to direct sunlight where possible.

Remember that in order to maintain the temperature in vaccine carriers, keep them in the shade and keep their lids on.

17

Source: Immunization in Practice: A Practical Guide for Health Staff, updated 2015

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5.9 Maintaining the Correct Temperature in Vaccine Carriers The temperature in vaccine carriers cannot be adjusted, but you can maintain it below +8° C if you keep heat out as follows: • Keep the lid tightly on the vaccine carrier when travelling.

• If your carrier comes with a foam pad, keep opened vials on the pad during immunization sessions. The foam pad keeps vaccines inside the carrier cool while providing a place to hold and protect vaccine vials in use.

• Keep vaccine carriers in the shade. Do not leave a cold box or vaccine carrier in a vehicle that is standing in the sun. Take it out of the vehicle and put it in the shade where possible.

• To check if the ice packs in the vaccine carrier have melted, shake them. If you hear only water and no ice splashing around in ALL the packs, they have melted and the vaccines are too warm to be used. They must be discarded.

Figure 5.9.1:

18

Checking an icepack 18

Source: Immunization in Practice: A Practical Guide for Health Staff, updated 2015

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5.10 Cold Chain Monitoring Equipment The purpose of cold chain monitoring equipment is to keep track of the temperature that vaccines and diluent are exposed to during transportation and storage.

5.10.1 Vaccine Vial Monitors A vaccine vial monitor (VVM) is a label that changes colour when the vaccine vial has been exposed to heat over a period of time. Before opening a vial, the status of the VVM must be checked to see whether the vaccine has been damaged by heat.

Figure 5.10.1.1: Locations of VVMs on ampules or vials 19

Manufacturers attach VVMs to vials of most vaccines. The VVM is printed on the vial label or cap. It looks like a square inside a circle. As the vaccine vial is exposed to more heat, the square becomes darker. â&#x20AC;˘ Use only vials with inner squares that are lighter in colour than the outer circle â&#x20AC;˘ Vials with VVMs in which the inner square has begun to darken but is still lighter than the outer circle should be used before the vials with a lighter inner square

19

Source: Immunization in practice: a practical guide for health staff. Updated 2015

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Figure 5.10.2:

VVM showing colour change sequence and interpretation 20

Important note: VVMs do not measure exposure to freezing temperatures (for freeze-sensitize vaccines).

A VVM not at ‘discard point’ does not exclude the possibility that the vaccine was frozen.

Before use, make sure the freeze-sensitive vaccine with good VVM has not been frozen.

5.10.2 Thermometers • •

•

Health centre staff use thermometers to monitor the temperature of refrigerators and vaccine carriers.

A thermometer must be kept in the middle shelf of the main section (not the freezer) of the vaccine refrigerator so that the temperature can be read, monitored and recorded in the morning and afternoon of each working day.

There is no need for a thermometer to be kept in the freezer compartment of the refrigerator. As long as the freezer is freezing (making ice) it should be adequate.

Note: Dial thermometers are no longer recommended for use by WHO

20

Source: Immunization in practice: a practical guide for health staff. Updated 2015

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Figure 5.10.2.1: The dial thermometer (left) â&#x20AC;&#x201C; no longer recommended; and the stem thermometer (right)

To monitor the temperature of the main section of a refrigerator you need a thermometer and a temperature chart, which you should tape to the outside of the fridge door.

5.11 How to Monitor the Temperature in a Refrigerator or Freezer 1. Read the temperature on the thermometer in the main section first thing every morning and last thing in the afternoon, at the same hour each day (This will allow for early detection of defects). The first person to open the fridge in the morning should be the one to do the reading.

2. On the chart, record the temperature for the day and time, as shown below.

3. After the temperature has been read in the afternoon, record the temperature in the slot provided for the afternoon. Plot the higher of the two readings for the day in the middle column between which you recorded the readings.

4. If the temperature is not within the normal range, take corrective measures immediately. Adjust the thermostat as described in the next section. Also, check the door seal and power supply. Notify your supervisor if needed.

5. If there is a power outage on a holiday or weekend, it must be indicated in the appropriate space on the chart (in the section for remarks).

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6. Keep the temperature chart on the outside of the refrigerator and chart daily except weekends and public holidays.

7. At the end of the month when the chart has been completed, replace it with a new one.

8. Keep the temperature charts for one year.

9. If the thermometer is taken out of the refrigerator, the temperature should be recorded after it has been back in the refrigerator for at least an hour. Otherwise the room temperature will affect the reading at the end of the day.

Figure 5.11.1:

Refrigerator Temperature Record 21

5.12 Adjusting the Temperature in a Refrigerator or Freezer •

• •

21

Thermostats in the main section of the refrigerator are used to adjust the temperature.

The Public Health Nurse or Midwife should be the only person to alter the refrigerator’s thermostat.

Ensure that the refrigerator is empty before adjusting the temperature In an electric refrigerator:

Source: Immunization in practice: a practical guide for health staff. Updated 2015

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o Find the temperature control knob, which usually has numbers from “1” to “7” and sometimes the word “colder” with an arrow indicating how to turn to the colder temperature. o Turn the knob to a higher number to make the fridge colder and to a lower number to make the fridge warmer. o Wait at least an hour before checking the temperature again. o Continue adjustment until the internal temperature is within the required ranges.

If the temperature of the refrigerator is too LOW (below +2℃): • Turn the thermostat knob so that the arrow points to lower number to make the fridge warmer • Check whether the door of the freezer closes properly. The seal may be broken.

• Check freeze-sensitize vaccines (DPT, DT, dT, HepB, DPT/HepB, liquid Hib, DPT/HepB/Hib, and HPV) to see whether these have been damaged by freezing by using the shake test If the temperature of the refrigerator in too HIGH (above +8℃): • Make sure that the refrigerator is working. If not, check if power supply is present • Check whether the door of the fridge or freezing compartment closes properly. The seal may be broken • Check whether frost is preventing cold air in the freezing compartment from entering the refrigerator compartment. Defrost if necessary • Turn the thermostat knob so that the arrow points to a higher number to make the refrigerator cooler If the temperature cannot be maintained between +2℃ and +8℃, store the vacines in another place until the refrigerator is repaired.

Warning!

Don not adjust thermostat to a higher (cooler) setting after a power cut. This could freeze the vaccines.

Do not adjust the thermostat to a higher setting when vaccines arrive. This could freeze the vaccines.

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5.13 Maintaining Cold Chain Equipment A number of routine procedures will ensure proper functioning of your refrigerator: o Place the refrigerator in the shade, away from any heat source, perfectly level, and at least 15 cm (six inches) away from any wall. o Write a notice against turning off the power or unplugging the refrigerator. The cord should not dangle or obstruct movement of staff. o The door should close such that the seal is airtight with no gaps. Perform a “paper test” to check the seal of the refrigerator door. Place a piece of paper in the door and close the door. Gently tug on the paper. If the seal is intact, you should encounter some resistance in removing the paper. If there is little or no resistance, have the seal checked. o A refrigerator works well only if it is cleaned and defrosted regularly. Thick ice does NOT keep a refrigerator cooler but makes it work harder and use more power. You should therefore defrost each refrigerator once a month, or when 0.5 cm (¼ inch) of ice has formed on the internal sides of the freezer compartment. Frost-free refrigerators do not need to be defrosted. o To defrost and clean a refrigerator, proceed as follows: 1. Take out all the vaccines, diluents and frozen ice packs and transfer them to a cold box lined with frozen ice packs.

2. Turn off the power supply to the refrigerator.

3. Leave the door open and wait for the ice to melt. Do not try to remove the ice with a knife or ice pick, since doing so can permanently damage the refrigerator.

4. Clean the inside of the refrigerator with a cloth.

5. Turn the refrigerator on again.

6. When the temperature in the main section falls to +8° C or lower, return the vaccines, diluents and ice packs to their appropriate places. Do not do defrosting on a Friday. o If your vaccine refrigerator stops working, first protect the vaccines and then deal with the refrigerator.

If you need to defrost your refrigerator more than once a month: You may be opening it too often (more than three times daily); or The door may not be closing properly.

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5.14 Guidelines for Storing Vaccine during Power Cuts If you experience a power cut in your health facilities do the following: Table 5.14.1:

Guidelines for storing vaccines during power cuts

Duration of Power Cut

Action

< 4 hours

Keep the vaccine in the refrigerator (DON’T OPEN THE FRIDGE)

4-8 hours

∗Transfer the vaccines to vaccine carriers (IGLOOS) with ice-packs

> 8 hours

∗Transfer the vaccines to another health facility or health department with electricity

∗Note: When electricity returns to your facility transfer the vaccines back to the refrigerator.

If the refrigerator stops working and a lack of power is not the problem, arrange for immediate transfer of the vaccines to another health facility. Keep the refrigerator closed until arrangements are made to remove the vaccines inside. Repair the refrigerator or report to your repair technician or supervisor.

5.15 Maintaining Vaccine Carriers • • • • •

Knocks and sunlight can cause cracks in the walls and lids of cold boxes and vaccine carriers. If this happens, the vaccines inside will be exposed to heat.

Each time you pack a vaccine carrier, make sure that it is outside walls, inside walls, all eight corners and hinges are intact.

Ensure that the carrier is airtight and protects the vaccines from direct sunlight. The lid should be intact and form a hermetic seal.

If a cold box or carrier wall has a small crack you may be able use it during vaccination session, but not for outreach activities.

Ensure that each vaccine carrier has two full sets of ice packs.

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5.16 Management of the Cold Chain Roles and Responsibilities The public health nurse (PHN) or midwife in each health centre has the main responsibility for the refrigerator. His or her responsibilities include ordering, transporting and storing vaccines, and diluents, checking and recording the temperature daily, and maintaining the centre's cold-chain equipment. However, all health workers in a health centre must know how to monitor the cold chain and that they need to notify the supervisor if the temperature is too high or too low.

If there is a power outage for over 4 hours on the week-end or public holiday, a health worker who lives in the same district must be given the responsibility for ensuring the maintenance of the cold chain by removing the vaccines to an igloo or to another facility with electricity The Senior PHN or EPI Co-ordinator in each parish should complete the Cold Chain Monitoring and Evaluation Checklist during supervisory visits, and provide feedback to the field on areas for improvement. The Senior PHN or EPI Co-ordinator is also responsible for updating the cold chain inventory each year.

Stock Management Stock levels should be regularly monitored. At the health centre level (type 3 â&#x20AC;&#x201C; 5), not more than six weeksâ&#x20AC;&#x2122; supply of vaccines should be available at any given time times. Types one and two health centres should not have more than four weeksâ&#x20AC;&#x2122; supply of vaccines at any given time. Ordering should be done at least monthly and, therefore, limit the quantity of vaccine in storage. This is very important where there is no standby generating capacity at the health centre level. Vaccine stock in the refrigerator should be arranged for use according to expiry date, that is, put new stock at the back so that old stock is used up first.

Monitoring and Evaluation The MOH recommends at least monthly performance reviews of the refrigerator (using the temperature records) and other cold chain equipment. The EPI coordinator or the MO(H) should be available to advise field staff on refrigerator performance and if vaccine damage is suspected.

The Cold Chain Monitoring and Evaluation Checklist should be filled out during supervisory visits by parish staff. It may also be used by health centre staff as a self-assessment tool.

Before field staff discards any vaccine, consultation should occur with the parish EPI coordinator or the MOH or the director of the Family Health Unit. Vaccines should be discarded by returning them to the central store (NHF Pharmaceuticals).

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Chapter 6: Vaccination Supplies Stock Management 6.1 Introduction Effective Vaccine Stock Management (EVSM) is based upon quality assurance principles.

Vaccine quality can only be assured if the product is correctly stored and handled from the point of manufacture to the point of use. Programme managers can only establish with certainty that quality has been maintained when detailed records are kept, and these records are reliable. If records are incomplete or inaccurate, the system cannot be properly assessed.

A system that cannot be assessed is not ‘quality assured’ and cannot be accepted as satisfactory.

It is essential to keep complete and accurate records of all stock transactions in order to maintain the quality of vaccines throughout the cold chain. A stock control system comprises three steps, each of which must be performed regularly, accurately and completely.

1. Checking and recording details of vaccine consignments when they arrive at a storage point; 2. Checking details and conditions of vaccine stocks during the time they are kept in storage; 3. Checking and recording details of vaccines consignments when they leave the storage point for distribution to regions, parishes, districts, facilities, and eventually, the user.

In addition, good warehousing practices should be adopted, and physical stock counts should be carried out on a regular basis to verify stock records.

Step 1: Standardized recording and reporting of all stock transactions is carried out •

• •

• •

Arrival: accurately record incoming vaccines, diluents and droppers, and other consumables. When vaccines and consumables arrive, check the delivery/arrival form or voucher, report any discrepancies and report all indicator changes.

Requisitions: operate an effective system for receiving and checking requisitions.

Dispatch: establish a pre-delivery or pre-collection notification system. Issue vaccines, diluents and other date-limited products in earliest-expiry first-out (EEFO) order. When vaccines and consumables leave the store, verify the information in the stock record system for all items that are issued.

Disposal: safely dispose of damaged or expired stock in accordance with standing orders.

Back up: back up all computer records at least once a week.

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Step 2: Stocks have been maintained between the safety stock level and the maximum stock level for each vaccine and for other consumables Establish a maximum stock level and a safety (reserve) stock level for each vaccine and for each consumable. When orders for new vaccine stocks and consumables are placed, allow sufficient lead-time so as to ensure that each item arrives before the safety stock level for that item is breached.

Step 3: Periodic physical inventories have been conducted Carry out a physical inventory of vaccine, diluent and dropper stocks at least once every month, and of other consumables (syringes, safety boxes, consumables, spare parts, etc.) at least once every three months.

Step 4: Good warehousing practices are in place • • • • •

Stock security: keep all vaccines and consumables under secure conditions.

Data security: keep all records secure.

Storage: store all vaccines, diluents and droppers and other consumables in an orderly fashion.

Cleanliness: keep the vaccine store clean and free of pests.

Supervision: ensure that all staff members are effectively supervised.

6.2 Principles of Vaccine Inventory and Stock Management A stock management system must be simple. Its purpose is to move supplies, not create paperwork. Using a minimum/maximum inventory control system will help managers prevent both over-stocking (which leads to higher wastage) and shortages or stock-outs.

Reordering the same amount as used last month often is not an adequate strategy.

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Figure 6.2.1

Stock movement and relations between minimum, maximum and order levels 22

Carry out systematic physical stock counts and reconcile any discrepancies in the stock records. Recommended reports include monthly, quarterly and annual stock summaries. In cases of vaccine wastage, stock records must be adjusted, and loss/wastage reports prepared.

Recording and processing of inventory information is not a goal in and of itself, but a way to improve decision making within a supply chain. The main task is to turn numbers into information that can be used to determine whether there is enough stock to last until the next planned arrival/shipment.

Average monthly consumption should be calculated based on at least the most recent 6 months data. Consumption rates may vary from month to month (e.g. new vaccine introduction, outreach activities, other activities to increase coverage rates).

22

Adapted from: WHO Vaccine stock management: Guidelines on stock records for immunization and vaccines store managers. 2006

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While assessing the supply status, key attention must be paid to expiry dates. It is easier to make stock assessments by expiry dates with a computerized management information system. This analysis takes more time if done manually.

Stock status should be assessed on a regular basis, preferably monthly. This ensures that there is no risk of being out of stock.

Vaccine Access Only authorized staff should have access to vaccine supplies.

6.3 Interpreting Expiration Dates • • • • •

All vaccines and diluents have expiration dates.

These dates vary by type of vaccine or diluent and lot number and are printed on vials, manufacturer-filled syringes and packages.

They indicate the date by which a product should be used (package insert).

When the expiration date is marked with only month and year, the vaccine or diluent may be used up to and including the last day of the month indicated.

If a day is included with month and year, the vaccine may only be used through that day.

6.4 General Guidelines • • • • • • •

Document every dose removed from storage unit whether compromised, expired, or transferred.

Expiration dates should be checked a minimum of once per week and stock should be rotated to ensure that those soonest to expire is in front.

Document each time vaccine or diluent doses expire and immediately remove from unit.

These records will help you decide how much vaccine to order to minimise future waste.

Note each time vaccine doses cannot be used because they have been exposed to inappropriate storage conditions or because vials have been damaged.

Once confirmed unusable by the national EPI manager, immediately remove these vaccines from the unit.

Subtract these unusable doses from the running balance on the stock record to calculate the new balance of doses.

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6.5 Exceptions to Expiration Dates of Labels Reconstitution Once a lyophilized (freeze-dried) vaccine is mixed with a diluent (liquid) and reconstituted into a liquid form, there is a limited time frame in which the vaccine can be used. This time frame is indicated in the manufacturer’s package insert.

Multi-dose vials Most multi-dose vials may be used until the expiration date printed on the vial unless contaminated or compromised in some way. However, some multi-dose vials have a specified time frame for use once the vial is entered with a needle (package insert).

Manufacturer shortened expiration date If the vaccine has been exposed to inappropriate storage conditions, its potency may be reduced before the expiration date printed on the label. A manufacturer may determine that the vaccine can be used, but with a shortened expiration date. Contact the Family Health Unit, Ministry of Health, for further guidance in determining if the vaccine can be used with a shortened expiration date or if it should be discarded.

When vaccines must be used prior to the expiration date on the label, this is referred to as the “beyond use date” or “BUD”, noted in the package insert. For reconstituted vaccines, this may be a date and/or time after which the vaccine cannot be used. The “BUD” (date and/ or time) should be noted on the label along with the initials of the person changing the date/time.

6.6 Stock Rotation Immediately unpack vaccine deliveries. At least once per week and each time vaccines are delivered, the vaccine coordinator should ensure that someone checks and rearranges placement of vaccines and diluents in the storage unit according to expiration dates.

Vaccines with soonest expiration dates should be placed in front of other vaccines of same type that have later expiration dates. Immediately remove expired vaccines and diluents from storage units to avoid risk of inadvertent administration or dispatch.

6.7 Vaccine Inventory Accounting Proper vaccine and diluent inventory management includes recording quantities: • • • • •

received spoiled, expired, transferred currently in stock to be used first that need to be ordered 127

All vaccine doses removed from unit should be totaled by vaccine type and recorded on a stock record. Stock records should be completed weekly. The balance of doses remaining in stock is indicated on stock record using tally of doses spoiled, expired, or transferred during that week.

For lyophilized (freeze-dried) vaccines that require reconstitution, document this information for diluents on a separate vaccine stock record. Quantities of these vaccines and diluents should be equal at all times.

Stock records should contain the following: • • •

the date each vaccine and diluent delivered the initials of the person who unpacked delivery (This person should document delivery on stock record.) the condition of each vaccine and diluent upon arrival (i.e., Did the vaccine arrive in good condition at proper temperature?)

The following information should be recorded: • • • • • • • •

Name of each vaccine and diluent Manufacturers’ name Vaccine presentation (i.e., single-dose vial, multi-dose vial, or manufacturer-filled syringe) Lot number(s) (each lot should be documented separately) Expiration date(s) for each lot Number of doses received (or balance of doses carried forward) Number of doses used (i.e., compromised, expired, or transferred – if vaccine is transferred, note destination beside number of doses) Balance remaining (in DOSES) after subtracting amount used (i.e., compromised, expired, or transferred)

Tally sheets should be placed in easily accessible locations (e.g., outside unit door) and used to document each time doses are removed from unit, including compromised, expired, or transferred. This can be documented with tick marks. Tally sheets can be used to keep stock records updated. For example, at the end of the week, the vaccine coordinator or designated person should add up number of doses on tally sheet of each vaccine used and update stock record accordingly. The old tally sheet should then be removed and replaced with a new one for the following week. Store and maintain used tally sheets in a file for future reference.

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6.8 Counting Stock • • • • •

• • • •

At least once per month and before ordering, vaccine and diluent doses should be counted.

This will ensure there are enough vaccine doses to meet the needs of the facility, and is useful for checking the accuracy of running balance of doses in the stock record.

The number of vaccine doses in the unit and the number of doses reflected on stock records should match.

When counting vaccine doses, always review expiration dates and immediately remove expired vaccines and diluents.

If there is a difference between count of doses in unit and stock record balance, enter correct balance from your count on a separate line in the stock record below the old balance.

Write a note with your signature beside it to indicate that your count has confirmed the new balance.

Use new corrected balance for all future stock.

At end of every month, make a summary of amount of each vaccine and diluent used during that month and the amount of stock still available at end of that month.

At end of every year, total amount of each vaccine and diluent received and amount used. This information is useful for determining annual vaccine needs of facility.

6.9 Vaccine Deliveries Receiving Deliveries Arrange for vaccine and diluent deliveries to be made only when the vaccine coordinator or alternate (back-up) coordinator is on duty. Consider holidays, vacations, staff schedules, and changes in hours of operation. All staff members who may be involved in deliveries must be aware of the importance of maintaining cold chain.

Unpacking Deliveries Immediately unpack and examine deliveries upon arrival. Cross-check contents with packing slip to be sure they match. Check expiration dates to ensure that you have not received any vaccines or diluents that have already expired or will expire soon. Check that lyophilized (freeze-dried) vaccines have been shipped with the correct type and quantity of diluents.

Check that vaccines were properly packed. There should be an insulating barrier (such as bubble wrap, Styrofoam pellets, or some other barrier) between vaccines and the refrigerated or frozen coolant packs. If there are any discrepancies with the packing slip or concerns about contents, immediately notify the EPI manager for guidance.

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Storing and Documenting Deliveries After contents have been checked according to procedures, immediately store vaccines and diluents at recommended temperatures and record each vaccine and diluent, noting all details on the stock record. Do NOT leave the shipping container unpacked and unattended as vaccines and diluents inside might warm to inappropriate temperatures and become unusable.

Staff members who accept deliveries for the facility must be aware that vaccine deliveries require immediate attention. They must know their responsibilities in assuring that the cold chain is maintained.

Vaccine Transport Transport involves the movement of vaccine over a short time and distance between providers. Each transport increases the risk of exposing vaccines to inappropriate storage conditions.

Figure 6.9.1:

Vaccine Supply Chain in Jamaica

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There are many variables to consider when transporting vaccines. These include the type and amount of vaccines; the container, packing materials, and pack out method; and the number of times container is opened and closed. If vaccines must be transported to an off-site/satellite facility, the amount transported should be limited to only what is needed for that workday.

Ensure that vaccines are: • • •

Not placed in the vehicle trunk Delivered directly to the facility Promptly unpacked and placed into appropriate storage units upon arrival

6.10 General Considerations For refrigerated vaccines: • • •

• • • • • •

Pack refrigerated vaccines before packing frozen vaccines A hard-sided insulated cooler with at least 2-inch walls may be used if it can maintain recommended temperature range (between 2°C and 8°C) Place a layer (at least 2 inches) of “conditioned” ice packs in transport container first.

Ice packs that are frozen must be “conditioned” by leaving them at room temperature for 1 to 2 hours until edges have defrosted and packs look like they’ve been “sweating.” Frozen ice packs that are not “conditioned” can freeze vaccines.

Place an insulating barrier layer on top of ice packs (e.g., bubble wrap or Styrofoam pellets).

Stack vaccines with a thermometer on top of the barrier Place another insulating barrier layer on top of vaccines Place another layer of “conditioned” ice packs on top of barrier Always ensure there is no direct contact between the ice packs and vaccines Place a final insulating barrier layer (at least 2 inches) on top of coolant packs along with a list of vaccines in the container.

For diluents: • • •

•

Diluents should be transported with their corresponding vaccines to ensure there are always equal amounts of vaccine and diluent for reconstitution Follow manufacturer guidance for specific temperature requirements Diluents that contain antigen (e.g., DTaP-IPV diluent used with Hib lyophilized vaccine) should be transported with corresponding vaccines at refrigerator temperature.

Place an insulating barrier between diluents and ice packs.

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•

•

Refrigerate, in advance, diluents stored at room temperature before transporting in same container with refrigerated vaccines, so they will not increase temperature in container.

NEVER freeze diluents, even in transport.

Keeping vaccines in a transport container(s) is not recommended. If vaccines must be kept in a transport container(s) during an off-site clinic, temperature(s) should be read and recorded at least hourly. In addition, container(s) should remain closed as much as possible. Only the amount of vaccine needed at a given time (no more than one multi-dose vial or 10 doses) should be removed for preparation and administration by each vaccinator.

If you have concerns about vaccines or diluents that may have been compromised (exposed to inappropriate conditions/ temperatures or handled improperly), label them ‘Do NOT USE’ and store them under appropriate conditions (set apart from other vaccines). Immediately contact your EPI manager for guidance. DO NOT discard the vaccines or diluents unless directed to by the National EPI manager.

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Chapter 7: Vaccine Administration 7.1 Preparing for a Session Prior to the immunization session, ALL vaccines and diluents that you will need during the session should be removed from the refrigerator at the same time and loaded into the vaccine carrier. If the diluents are not kept in the refrigerator, they should be placed in the body of the refrigerator prior to the vaccination session. Appropriate loading of the vaccine carrier is discussed in Chapter 5 (Care of the Vaccine and the Cold Chain).

7.2 Registering, Assessing and Preparing the Client 7.2.1 Registering the Client The immunization register, patient chart and Child Health Development Passport (CHDP)/immunization card provide a record of health services delivered at the clinic. They also help to identify missed opportunities for vaccination.

1. When a client arrives at a health centre or outreach site, the first thing you should do is register him or her. Ensure that you have all the information necessary to fill out the immunization register and to locate the client in the future if necessary. You must have: • the child’s name • the child’s date and place of birth • the mother’s name, locating address, and telephone number

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Month of Birth: July Child’s Name

Sex

Joseph Williams

M

Mother’s Name

Montego Bay

Claudine Williams

222 Spring Street, Apt. 207 (blue house behind Baptist Church) Cell: 876-555-1331

2nd

3rd

Feb. 1 2003

Sep. 15 2003

Oct. 30 2003

Feb. 1 2003

DPT/ DT

1st

2nd

3rd

1st

18 mths

18 mths

18 mths

4-6 yrs

4-6 yrs Aug. 1 2007

1st

OPV/ IPV

Aug.1 2007

3rd

MMR

Feb.1 2004

2nd

OPV/ IPV

Feb. 1 2004

1st

DPT /DT

Feb.1 2004

3rd

Boosters

July 28 2004

2nd

M M R

Feb. 1 2003

1st

Oct. 30 2003

Hib

Sep.15 2003

Hep B

Feb.1 2003

Polio

Oct. 30 2003

DPT/DT

Figure 7.2.1.1(b):

Mother’s Name Locating Address

Sample Immunization Register (Page 1)

Sep.15 2003

July 28 2003

B C G

July 27, 2003

Place of Birth

Oct. 30 2003

Figure 7.2.1.1(a):

Date of Birth

Sep. 15 2003

Medical Record Number 2100

Year of Birth 2003

Sample Immunization Register (Page 2)

Request to see the patient’s immunization card. If a client does not have an immunization card, you should provide one and enter on it the person's name, address and birth date.

More information is added when the client is screened. Do not write the date of an immunization until it has been given.

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The child and adult immunization cards are shown in the figures below.

Figure 7.2.1.2:

Infant and Child Immunization Card

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Figure 7.2.1.3:

Child Health Development Passport

136

Figure 7.2.1.4:

Adult Immunization Card

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7.2.2 Assessing the Client Each client’s health and immunization status should be assessed prior to immunization.

Assessment of health status is discussed in the EPI, and usually consists of a routine history and physical examination at well-baby, family planning, or curative visits (refer to Family Health Manual).

The following questions should be part of the assessment of immunization status. They help determine the need for immunization and the presence of any contraindications.

•

Is this the right time for an immunization?

Look at the client’s immunization card and compare it to the routine immunization schedule. Has the correct number of doses of each vaccine been given?

If he or she does not have an immunization card/Child Health Development Passport, find out the client’s age, what immunizations he or she has had, and where they were given. Verify this information with the health centre where the vaccine was given.

•

Has sufficient time passed since the last dose?

Doses of the same vaccine must be given at least four weeks apart.

Hepatitis B is an exception. At least four months must pass between the first and third doses of Hepatitis B. This rule applies whether Hepatitis B vaccine is given as part of the pentavalent vaccine or on its own.

•

Is this the right time to give a woman (15-44 years old) DT vaccine? How much time has passed since the last dose?

Refer to Tables 10.4.2 and 10.4.3, which outline the schedule for DT immunization of women in their child-bearing years.

•

Can I give different vaccines at the same time?

All the EPI vaccines are safe and effective when given at the same time, but they should be given in different anatomic sites when this happens.

Remember: DO NOT give more than one dose of the same vaccine at one time.

DO NOT mix different vaccines in one syringe before injection (unless directed).

Use a different syringe and needle for each vaccine and for each injection

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â&#x20AC;˘

Should I give a booster dose?

Always check the immunization schedule to know when booster doses are to be given. Boosters are a required part of the immunization schedule and may be needed by adults and children alike who have not completed their full series of immunizations.

â&#x20AC;˘

Is there a contraindication to immunization?

There are few contraindications to immunization. They are listed in Table 2.13.1. It is safe to immunize children and women even if they have minor illnesses, including colds, diarrhoea, fever, allergy, and asthma.

Ask the following questions to screen for a contra-indication: Table 7.2.2.1: Screening questions for contraindications to vaccination Question

Screens for:

How is your child feeling today?

Moderate or acute illness

Is your child allergic to any food or medication?

Severe allergy to a vaccine component

Was there any problem the last time your child was immunized?

Severe adverse reaction to vaccination Allergy to a vaccine or vaccine component

Does your child have a problem with their immune system?

Contraindication to live attenuated vaccines

Does anyone in your house have a problem with their immune system?

Contraindication to OPV

Did the child receive blood products (transfusion immunoglobulin) in the past year?

Contraindication to live attenuated vaccines

Are you trying to become pregnant or are you pregnant now?

Contraindication to MMR, Varicella, Influenza, BCG

Remember: If a client comes to the health centre for reasons other than immunization, such as a dental visit, ensure that you ask to see his or her immunization card. Assess the clientâ&#x20AC;&#x2122;s need for immunization and vaccinate accordingly before he or she leaves the health centre. If assessment is not performed carefully, you may miss an opportunity to immunize.

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7.2.3 Preparing the Client When you finish the assessment, discuss with the patient or parent the 5 essential messages about immunization: 1. What vaccines are required today?

2. What side effects may occur? o If you are giving several vaccines at once, explain the side effects of each. o Explain how important it is to remain at the clinic for at least 30 minutes following vaccination.

3. What to do if a side effect occurs? o Describe how side effects can be treated and when to seek help from a health professional 4. Future immunizations that are needed, and when they should return to the clinic.

5. The date, time and place of the next appointment

7.3 Tips for Effective Communication Communication means delivering messages that can be understood. Health workers not only give messages to parents, but also receive messages from them. In both cases, communication takes place only when the messages are understood.

To make sure that your communication is effective: • • • • •

•

Find out what the client already knows, and use phrases that he or she understands.

Do not rush.

Show that you are listening to what the person says or indicates through body language.

Find out whether people have any particular concerns about immunizations and answer these questions straight away.

Provide positive reinforcement. o When people make return visits praise them for the immunizations they have already received.

Make sure that the person understands you by asking open-ended questions that require answers other than “yes” or “no.” For example: o How long will you wait at the clinic after the immunization before leaving? o What will you do if your baby gets a fever or is irritable? o What will you do if your baby looks very sick? o When will you bring your child in for the next immunization?

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7.4 Injection Equipment Disposable syringes and auto-disable (AD) needles are used to give injectable vaccines. AD needles with syringes for fixed dose immunization have the following features: • a self-locking mechanism that allows only one use; this is called a reuse prevention feature (RUP) • a fixed needle (usually 23G x 25 mm, but various sizes are manufactured) • a specific scale mark showing only the quantity to be administered.

A sterile packed needle and syringe must be used for each injection and disposed of immediately after use. DO NOT reuse needles and syringes because that places the general public at high risk of disease. It is important to know the parts of a needle and syringe in order to handle them safely and avoid contamination.

Figure 7.4.1:

Parts of a needle and syringe 23

7.5 Handling Syringes and Needles Safely You have to hold a syringe to give an injection. However, in order to avoid contamination, you should not touch parts that come into contact with the vaccine or the patient.

Do not touch: • the shaft, bevel or adaptor of the needle.

• the adaptor, plunger seal or plunger shaft of the syringe.

If you touch any of these parts by accident, discard the syringe and needle and get new sterile ones.

You may touch the barrel and the plunger top.

23

Sources: Immunization in Practice: A Practical Guide for Health Staff, updated 2015

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7.6 Sizes of Syringes and Needles Different sizes of syringes and needles are needed for different uses: Table 7.6.1: Sizes of syringes and needles for various vaccines

Use

BCG (for intradermal injection)

Syringe Size 0.1 ml

Needle Size

26 or 27 gauge, 3/8 inch (10 mm)

Intramuscular Injection Child < 18 months

1 ml

23 gauge, 1 inch (25 mm)

Intramuscular Injection Child > 18 months

1 ml

25 or 26 gauge, 5/8 inch (16 mm)

Subcutaneous Injection (e.g. MMR)

1 ml

25 or 26 gauge, 5/8 inch (16 mm)

Mixing Needle (for reconstitution)

3-5 ml

20-22 gauge, 1 inch (25 mm)

7.7 Mixing Vaccines BCG, MMR, and Hib vaccines are dry-powder preparations that must be mixed with a fluid (diluent) before they can be used. This process is known as â&#x20AC;&#x2DC;reconstitutionâ&#x20AC;&#x2122;. Yellow Fever vaccine is mixed in a similar manner as the MMR vaccine.

Important: Once BCG and MMR have been mixed with diluent, they can only be used for six hours.

Do NOT mix the vaccine until clients have arrived and you are ready to vaccinate them. For other reconstituted vaccines, consult Chapter 4.

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Figure 7.7.1:

Ampoules and Metal file

Figure 7.7.2

Breaking off the Neck of an Ampoule

7.8 Steps to Follow When Mixing Vaccines 1. Wash your hands with clean water and soap.

2. Read the label on the ampoule (glass bottle) or vial to be sure that − it is the diluent the manufacturer sent with the vaccine you are mixing − the expiry date has not passed 3. Inspect the ampoule or vial for cracks.

4. To open the ampoule, break off the pointed glass top. (For a vial, remove cover).

5. You may hold the ampoule in a piece of gauze or clean cloth when breaking the top off to guard against glass splinters.

Remember: Use ONLY the diluent that is supposed to be mixed with the vaccine, based on the manufacturer’s instructions.

NEVER substitute sterile water or saline for diluent.

6. Draw up ALL the diluent in the ampoule into a sterile mixing (3-5 ml) syringe with a sterile mixing (20-22 gauge) needle.

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Figure 7.8.1:

Figure 7.8.2:

Taking fluid from an ampoule

Flicking a Vaccine Ampoule

7. Before opening a vaccine vial, check the label to make sure that: o It is the correct vaccine o The expiry date of the vaccine has not passed o The vaccine vial monitor (if present) has not changed colour â&#x20AC;˘ If any of these conditions are not met, do not use the vaccine.

8. Flick the vial or ampoule to make sure all the vaccine powder is at the bottom. Open the vaccine vial by lifting the centre of the metal cap and bending it back. â&#x20AC;˘

Most vaccines come in vials, however, there are instances where they are packaged in ampoules. A vial is a glass bottle with a rubber stopper held in place by a metal cap.

The centre of the metal cap is pre-cut so that it can easily be removed.

Figure 7.8.3:

Vials

144

9. Insert the mixing needle into the vaccine vial or ampoule. Hold the plunger end of the mixing syringe between your index and middle fingers and push the plunger in with your thumb. This empties the diluent into the vaccine.

10. To mix the diluent and vaccine, draw them slowly up into the syringe and inject them slowly back into the ampoule or vial. Repeat this several times. They may also be mixed by gently swirling the vial.

11. Wrap the mixed vaccine in gauze or paper to protect it from dirt and sunlight.

12. Place the mixed vaccine in a cup or gallipot in the vaccine carrier, so it does not come in direct contact with ice packs 13. Dispose of the empty diluent ampoule in a sharps container (biohazard container).

Remember: Dispose of all mixed vaccine within the appropriate time interval.

7.9 Giving Immunizations 1. Wash your hands before and after immunizing each child.

• By washing your hands with soap and water, you remove germs and bacteria and help to prevent contamination. However, even after thorough washing, some germs and bacteria remain on your hands. As such, you should touch syringes and needles as little as possible.

2. Check vial labels before you use any vaccine or diluent.

• Be sure you are using the correct vaccine and diluent • If the label has come off or the expiry date has passed, record the batch and lot numbers and return them to your supervisor for disposal.

3. Before an injection, clean the patient’s skin with a cotton swab and water. A small amount of soap may be used (if needed), but make sure that all soap is washed off the skin prior to injecting vaccine.

• In the past, alcohol and a cotton swab were used to clean the skin before administration of vaccine. Because of the potential for interaction between alcohol and vaccines, this practice is no longer recommended. For example, alcohol destroys MMR vaccine. [If alcohol is used, ensure that the skin is completely dry prior to injection of vaccine and do not apply an alcohol-soaked swab to the vaccination site following injection.]

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4. When you are ready to give an injection, locate the appropriate sterile syringe and needle (as shown in table 5-1) and draw up vaccine as follows: • [Gently swirl the vial to ensure a homogeneous consistency.]

• Push the needle through the rubber stopper into the vaccine vial.

• Inject air into the vial by pushing in the plunger.

• Draw the vaccine out of the vial by pulling back the plunger. The vaccine comes out easily because the air you have injected takes its place.

Note: It is inappropriate to pre-fill multiple syringes and store them in the vaccine carrier.

Too many errors can occur when vaccines are pulled up in advance and left in the vaccine carrier. Therefore, you should always pull-up vaccine just prior to injecting.

5. Point the needle upwards and press in the plunger to get rid of air bubbles and excess vaccine. Read the scale on the barrel of the syringe to make sure that you have the correct amount of vaccine. You are now ready to inject the vaccine.

6. Position the child as appropriate for the specific vaccine • Appropriate restraint limits strain on the child’s limbs and prevents tissue damage.

Also, it protects the caregiver and vaccinator from accidental needle sticks.

7. Inject vaccine For vaccines to work, they have to be administered at the preferred site and with the most effective technique. Choosing a needle of the appropriate length and gauge ensures that vaccine is deposited in the correct tissue layer. Vaccine can enter the body through different routes: • Intradermal- between the layers of the skin (dermis) • Intramuscular- into the muscle • Subcutaneous – under the skin • Oral – into the mouth

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Figure 7.9.1:

Parenteral Routes of Vaccination

Giving Immunizations…

• Right patient • Right vaccine and diluent (when applicable) • Right time (including correct age and interval, as well as before the product expiration date/time) • Right dosage • Right route (including correct needle gauge and length and technique) • Right site • Right documentation

7.10 Multiple Immunizations If multiple vaccines are administered at a single visit, administration of each preparation at a different anatomic site is desirable. For infants and younger children, if more than two vaccines are injected in a single limb, the thigh is the preferred site because of the greater muscle mass. For older children and adults, the Deltoid muscle can be used for more than one IM injection. The injection sites should be separated by one inch or more, if possible, so that any local reaction can be differentiated.

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Use a separate limb for most reactive vaccines (e.g. TT containing and PCV 13 vaccines) Table 7.10.1:

Summary of Injection Sites and Routes

Type of Vaccine BCG

Kind of Injection Intradermal

Upper right arm

Pentavalent (DPT/HepB/Hib) DPT

Intramuscular (IM)

Antero-lateral thigh (outer part of thigh)

Intramuscular (IM)

IPV

Intramuscular (IM)

OPV

Oral

Children under 18 months old: Outer part of thigh Children 18 months and older: Deltoid muscle Children under 18 months old: Outer part of thigh Children 18 months and older & adults: Deltoid muscle Mouth

MMR

Deep Subcutaneous (SC) or IM Intramuscular (IM)

Upper arm

Hib

Deep subcutaneous or Intramuscular

Hepatitis B

Intramuscular (IM)

Human Papilloma Virus Vaccine

Intramuscular (IM)

Pneumococcal vaccine conjugate

Intramuscular (IM)

Pneumococcal vaccine Polysaccharide

Deep subcutaneous (SC) or Intramuscular

Children under 18 months old: Outer part of thigh Children 18 months and older: Deltoid muscle Children under 18 months old: Outer part of thigh Children 18 months and older & adults: Deltoid muscle Children under 18 months old: Outer part of thigh Children 18 months and older & adults: Deltoid muscle Children under 18 months old: vastus lateralis muscle in the anterolateral thigh Children 18 months and older: Deltoid muscle Children under 18 months old: vastus lateralis muscle in the anterolateral thigh Children 18 months and older: Deltoid muscle

DT

Injection Site

Deltoid muscle

The route and site of administration for each of the EPI vaccines is shown in Table 7.10.2.

Administration techniques are discussed in detail in the following pages.

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Table 7.10.2:

Summary of vaccine dosing, administration route and syringe size

Type of immunobiological BCG

OPV

Hep B

Dose number

2 drops orally

5

3

0.5 ml deep intramuscular in the 1cc – 23 G x 1 thigh’s external anterolateral inch middle third.

3

0.5 ml deep intramuscular in the 1cc- 23G x 1 thigh’s external anterolateral inch middle third.

5

0.5 ml deep intramuscular in the 1cc- 23G x 1 thigh’s external anterolateral inch middle third.

(DPT + HepB + Hib)

Yellow Fever

MMR

Adult DT

DPT

Paediatric DT

Syringe

0.1 ml intradermal in the right 1cc- 26G x3/8 arm’s upper third deltoid region inch

Single dose

PENTAVALENT

IPV

Dose/Administration Route and Area

Single dose (if required)

2

0.5 ml subcutaneous in the deltoid 1cc- 25G x 5/8 muscle area of the right or left arm. inch

0.5 ml subcutaneous in the deltoid 1cc- 25G x 5/8 muscle area of the right or left arm. inch

0.5 ml intramuscular in the deltoid 1cc-22G x 1 ½ At least 3 doses muscle area of the right or left arm. inch

2

2

0.5 ml deep intramuscular in the 1cc- 23G x 1 thigh’s external anterolateral inch middle third or in the deltoid area of the arm 0.5 ml intramuscular in the deltoid muscle area of the right or left arm. 1cc c/a 23 x 1

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7.11 How to Give an Intradermal Immunization: BCG • • • •

• •

• •

BCG vaccine is the only vaccine routinely given by intradermal injection only.

The site of injection is the right upper arm, preferably below the deltoid insertion.

Injecting the vaccine in the same place for each child makes it easy to find the BCG scar later.

To measure and inject either 0.05 ml or 0.1 ml of BCG accurately, you must use a special BCG syringe (0.1 ml), and a special BCG needle (26 or 27 gauge x 3/8 inch length).

Ask the caregiver to free the child’s right arm from its clothing, seat the child on her/his lap, and hold the child firmly. This is known as the ‘cuddle position’.

Hold the child’s arm with your left hand so that: - your left hand is under the arm.

- your thumb and fingers reach around the arm and stretch the skin tight.

Hold the syringe in your right hand, with the bevel of the needle facing up towards you. Hold the syringe by the barrel and do not touch the plunger.

Lay the syringe and needle almost flat along the child's arm with the needle in the direction of the child’s shoulder.

Figure 7.11.1:

Position of syringe and needle

Figure 7.11.2:

BCG needle position (intradermal)

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•

•

• •

Insert the tip of the needle just under the skin – insert only the bevel and a little bit more. Keep the needle FLAT along the arm, so that it goes into the top layer of skin only. Keep the bevel facing upward.

Do NOT push too far and do NOT point down or the needle will go under the skin.

To hold the needle in position, place your left thumb on the syringe near the needle, but DO NOT touch the needle.

Hold the plunger top between the index and middle fingers of your right hand. Press the plunger top in with your right thumb.

Inject the vaccine and remove the needle.

If you have injected BCG correctly, you will see a clear, flat-topped swelling on the skin, like a mosquito bite. The swollen skin may look pale with small pits (an orange peel appearance).

If BCG is injected under the skin, an abscess or enlarged glands may result.

When an intradermal injection is given correctly, the plunger is hard to push. If the vaccine goes in easily, you may be injecting too deeply. In this event, proceed as follows: • Stop injecting immediately, correct the position of the needle and give the remainder of the dose but no more.

• If the whole dose has already gone under the skin, count the child as being injected.

Do NOT repeat the dose.

• Ask the parent to return with the child if any side effects, such as abscesses or enlarged glands, appear.

7.12 How to Give a Subcutaneous Immunization (such as MMR or Yellow Fever) • •

• • •

MMR and yellow fever vaccines are administered subcutaneously.

The preferred site for subcutaneous injection is the upper outer arm based on its accessibility and good vaccine uptake. A subcutaneous injection should be given into healthy tissue that is away from bony prominences and free of large blood vessels or nerves.

Use a sterile 1.0 ml syringe and 255/8 gauge single-use needle.

Ask the caregiver to free the child’s right or left arm from its clothing, seat the child on her/his lap, and hold the child firmly. This is known as the ‘cuddle position’.

If the injection is to be made into the child's left arm, he or she should sit on the parent's lap as follows: 151

-

The parent's left arm should be around the child, supporting her or his head and holding the left shoulder.

The child's right arm should be tucked around the parent's body.

The parent's right arm should hold the child's legs out of the way, and the parent's right hand should hold the child's left hand.

Figure 7.12.1:

Holding child for subcutaneous immunization

Figure 7.12.2:

Needle position for subcutaneous immunization

• • • • •

Hold the child's arm from underneath. Your fingers reach around and PINCH the skin.

Push the needle into the pinched-up skin at a 45° angle so that it goes below the dermal layer of the skin, but not into the muscle.

To control the needle, support the end of the syringe with your thumb and finger while you push the needle in. Do NOT touch the needle itself.

Press the plunger with your thumb to inject the vaccine.

Withdraw the needle and press the site with a clean, dry cotton swab

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Figure 7.12.3:

Giving Vaccine Subcutaneously

7.13 How to Give an Intramuscular Immunization (such as DPT, DT, Pentavalent (DPT/HEPB/Hib), Hepatitis B, Hib) For children less than 18 months old, the preferred site for intramuscular injection is the antero-lateral aspect of the thigh between the middle and upper thirds (Figure 7.13.1). It provides the largest muscular mass, the vastus lateralis muscle. In thigh injections, the needle should be angled towards the patella (kneecap).

In children 18 months of age and older, and in adults, the deltoid has achieved sufficient size to offer a convenient site for intramuscular injection. The deltoid muscle is located in the lateral aspect of the upper arm (Figure 7.13.2). The injection area is a small triangle pointing downward from a line extending along the lower edge of the acromion process to the midpoint of the lateral aspect of the upper arm. The injection site is in the centre of the triangle. For deltoid injections the needle should be angled towards the acromion.

More superficial injections of toxoid vaccines result in greater rates of local reaction (e.g. sterile abscess) than deeper ones. Careful use of a longer needle will cause less damage than a short needle.

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Figure 7.13.1:

IM injection Site in Antero-lateral Thigh (Vastus Lateralis) 24

Figure 7.13.2:

IM Injection Site in Upper Arm (Deltoid Muscle) 25

24 25

Source: The Australian Immunization Handbook, 7th Edition Source: Immunization Handbook, Ministry of Health, New Zealand,1996

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Gluteal vaccinations are not recommended. Use of the buttock for vaccine administration is to be avoided because of risks of abscess formation, damage to the sciatic nerve, and effects on vaccine efficacy.

Pentavalent (DPT/HepB/Hib), DT, DPT, Hepatitis B and Hib vaccines are given by intramuscular injection. Follow these steps for IM administration of vaccine.

• •

Select the appropriate needle, syringe and administration site based on the patient’s age.

Position the child.

- ask the caregiver to free the child’s leg or arm from its clothing, seat the child on her/his lap, and hold the child firmly. This is known as the “cuddle position.”

- If the injection is to be made into the thigh, the child should sit on the parent's lap as follows: o The parent's arm should be around the child, supporting her or his head and shoulder. o The child's inside arm should be tucked around the parent's body. o The parent's other arm and hand should hold the child's legs firmly - If the injection is to be made into the child's deltoid he or she should sit on the parent's lap as follows: o The parent's arm should be around the child, supporting her or his head and shoulder. o The child's inside arm should be tucked around the parent's body. o The parent's other arm should hold the child's legs out of the way, while the parent's hand holds the child's hand.

Figure 7.13.3:

Holding child for IM injection

155

Figure 7.13.4:

• • • •

Needle position for IM injection 26

Stretch the skin of the thigh or upper arm flat between your finger and thumb.

Quickly push the needle straight down through the skin between your finger and thumb. Go deep into the muscle.

Press the plunger with your thumb to inject the vaccine.

Withdraw the needle and press the site with a piece of clean, dry cotton.

7.14 How to Give an Oral Polio Vaccine •

Open the Oral Polio Vaccine (OPV) container. o OPV comes in either a plastic dropper bottle or a glass vial with the dropper in a separate plastic bag. To open a dropper bottle, remove the cap and break off the plastic closure. To open a glass vial, remove the metal cap and rubber stopper. o Then, cut open the plastic bag containing the dropper and fit the dropper on the open vial.

Figure 7.14.1:

•

26

Opening a glass vial

Ask the parent to hold the child firmly, with the child lying on her or his back or in sitting position.

Source: Immunization Handbook, Ministry of Health, New Zealand,1996

156

• •

•

Open the child's mouth by squeezing the cheeks gently between your fingers. This makes the child's lips point outward.

Hold the dropper over the child's mouth at an angle of 45°. Let the correct dose of vaccine fall from the dropper on to the child's tongue. (Currently the dose is two drops, but this can change with the brand of vaccine).

If the child spits the vaccine out, give another dose.

Figure 7.14.2:

Giving OPV, showing the dropper at an angle

Remember: OPV is not usually given to HIV-exposed infants. Use IPV instead. OPV is the most heat sensitive of the EPI vaccines.

7.15 Disposal of Syringes and Needles After Immunization After immunization: • To avoid needle-stick injuries, do not recap the needle or separate the syringe and needle after vaccination.

• Safely dispose of all used needles, syringes, vials and ampoules.

• Immediately after use, syringes, needles and empty vaccine vials/ampoules must be placed in a puncture-proof container (disposal box, sharps container, biohazard container) o Keep containers as close as possible to where you give injections o Containers should be waterproof and tamper-proof, and needles should not be able to pierce them o If you don’t have a needle box, you may use containers made of thick plastic or metal cans and have narrow necks to prevent syringes and needles from being taken out 157

Figure 7.15.1:

Puncture-proof safety box assembly and use

Figure 7.15.2:

Handmade disposal box

â&#x20AC;˘ â&#x20AC;˘

Contaminated sharps should not be transferred from container to container. When a disposal box is three-quarters full, it should be sent for incineration (burning).

If only burning is done, the remains of the needles and disposal box should be buried after burning. Bury them deeply in a pit latrine, controlled landfill, or a similar location where people do not have access to them. o If used needles and syringes are collected from health centres by the parish supervisor, he/she is then responsible for disposing of them safely.

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• •

• • •

On the immunization card/CHDP, record the date of each vaccine given. Sign for each vaccine given.

In the patient docket, for each vaccine given, record: o type of vaccine o dose o injection site o lot or batch number o date vaccine given In the immunization tracking register, record the date of each vaccine given.

Ask the caregiver or patient to stay at the clinic for at least 30 minutes following vaccination.

While thanking the parent or client for coming, remind her or him about: o the date and time of the next immunization o where to attend for the next immunization o the number of immunization visits remaining o the side effects that may occur o how to deal with these side-effects

7.16 Preventing Injuries & Infections When Administering Vaccines To reduce the risk of injuries and infections health workers use universal precautions when handling injection equipment. Universal Precautions are simple practices of infection control which reduce the risk of transmission of blood borne infections. They should be applied throughout the immunization programme. Refer to the Guidelines for the Prevention of Accidental Exposure to Body Fluids issued by the National HIV-STI Programme of the Ministry of Health. The immunization programme advocates close adherence to these guidelines, which include the following precautions: 1. Careful handling and disposal of ‘sharps’ Transmission of blood-borne diseases such as Hepatitis B, C, and HIV can occur in health care settings when the skin is punctured with contaminated needles or ‘sharps’. Such needle-stick injuries frequently occur when needles are recapped, improperly handled, disposed of, or inappropriately discarded.  To prevent these injuries, avoid recapping needles whenever possible.  Puncture-resistant disposal containers must be available and readily accessible for the disposal of ‘sharps’. Other puncture-proof containers such as a thick plastic bottle can be used if the prescribed biohazard container is not available.  It is important to wear heavy-duty gloves when transporting ‘sharps’ containers.

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 Sharps containers should not be emptied. They should be burned in a closed incinerator, when they are ¾ full, at a high enough temperature to melt the needles.

Added precautions to prevent ‘sharp’ injuries include wearing gloves, having an adequate light source when treating patients, locating sharps containers directly at the point of use, never discarding ‘sharps’ in general waste, and keeping ‘sharps’ out of the reach of children.

Whenever possible, needle holders should be used when suturing.

2. Wash hands with soap and water before and after all procedures.

3. Use protective barriers such as gloves, gowns, aprons, masks, goggles for direct contact with blood and other body fluids. Health workers with recent grazes or skin defects should cover them with an impermeable dressing prior to contact with patient.

4. Safe disposal of waste contaminated with blood or body fluids.

5. Proper disinfection of instruments and other contaminated equipment; • Spills involving blood or other bodily secretions on work surfaces should be cleaned with bleach (diluted 1 to 9 parts water) and the area thoroughly washed with hot soap and water.

• Syringes and needles are “high risk equipment because they have penetrated the body. They should be disposed of immediately after use.

6. Proper handling of soiled linen.

• Contaminated linen is adequately treated by a routine hot wash cycle (60-70°C) using ordinary bleach concentration.

• All soiled linen should be handled as little as possible, bagged at the point of collection and not sorted or rinsed in patient care areas. If possible, linen with large amounts of body fluid should be transported in leak proof bags. If leak proof bags are not available, the linen should be folded with the soiled parts inside and handled carefully, with gloves.

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7.17 Accidental Sharps Injury or Exposure to Blood, Blood Products or Bodily Fluids Following a ‘sharps’ injury, immediate first aid should be given: • Flush the site of contamination thoroughly with large amounts of running water o Needle sticks and cuts should be washed with large amounts of water. o Splashes to the nose, mouth or skin should be flushed with water. o Eyes should be irrigated with clean water or saline.

• If the site is bleeding, allow it to bleed briefly.

• Antiseptic solutions (bleach, alcohol, Savlon) can have a caustic effect and have not been proven to be effective AND ARE NOT RECOMMENDED. • The type of exposure and the actions taken should be recorded and the appropriate authorities (especially the immediate supervisor) should be notified promptly. o In hospital, report to the infection control nurse or designate on each shift. o At the health centre to the nurse in charge, who should report to the parish Public Health Nurse and parish Medical Officer of Health. o At the lab to the Chief Medical Technologist or designated individual • An exposure report form (see Appendix I) should be completed including information about the type of injury, any witnesses to the injury and the name of the patient if known. They should be submitted to the parish Medical Officer of Health.

• Assess the risk of acquiring Hepatitis B, Hepatitis C and HIV. The risk of infection varies with the type of exposure (see Table 7.17.1) and factors such as: o the amount of blood involved in the exposure o the HIV, Hepatitis B and Hepatitis C status of the patient's blood at the time of exposure o the severity of the injury e.g. scalpel or large bore needle injury increases risk o the anatomical site at which sharp was used e.g. use in artery or vein poses greater risk than use in muscle or mucous membrane.

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Table 7.17.1: Recommended Prophylaxis following Occupational Exposure to Known HIV Positive Source 27 Type of Exposure Percutaneous

Risk

Source

Antiretroviral

High risk

Know HIV positive

Recommended

Low risk

Unknown serostatus

Should be offered (consider for unknow serostatus)

Suggested Regimen TDF/3TC + ATV/r TDF/3TC + ATV/r

(Duration 4 weeks) Mucous membranes; Non-intact skin

•

• • • • • •

•

•

27

Large volume

Know HIV positive

Should be offered (consider for unknow serostatus)

TDF/3TC + ATV/r

Small volume (few drops)

Unknown serostatus

Should be offered (not recommended for unknow serostatus)

TDF/3TC + ATV/r (Duration 4 weeks)

Initiation of PEP should be decided on a case-by-case basis and after full discussion with the exposed person. It should begin ideally within one to two hours of exposure, but no later than 72 hours. If PEP is given for suspected HIV exposure, it should be continued for four weeks unless the source patient is found to be HIV negative.

Begin prophylaxis if source patient is HIV positive or of unknown HIV status, or has refused testing.

Perform HIV serology on source patient and if result is negative, stop prophylaxis.

Recommended dose for TDF/3TC (Tenofovir + Lamivudine) is one tablet PO once per day for four weeks ATV/r (Atanavir + Rotonavir) 300/100mg once per day for four weeks For pregnant women, only TDF/3TC (Tenofovir + Lamivudine) is recommended.

Individuals who have not previously been immunized against Hepatitis B should commence the vaccine immediately and be given Hepatitis B Immunoglobulin if available.

Voluntary confidential counselling and testing should be made available immediately.

PEP with antiretroviral treatments (ARV) can reduce the risk of becoming infected with HIV. Similarly, PEP for Hepatitis B (e.g. Hepatitis B immunoglobulin and Hepatitis B vaccine) may be needed depending on the disease status of the person who was the source of the exposure and the immunization status of the person injured.

Refer to the Clinical Management of HIV Disease Guidelines for Medical Practitioners 2017 for more information.

Source: MOH Jamaica. Clinical Management of HIV Disease: Guidelines for Medical Practitioners. 2017

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Chapter 8: Safe Vaccination 8.1 Introduction Safe Vaccination is of paramount importance to the immunization programme. This chapter provides health workers with the necessary information that must be followed in providing vaccinations and attending to public concerns related to the risks of vaccination and possible Events Supposedly Attributable to Vaccination or Immunization (ESAVIs).

All vaccines are extensively tested by their manufacturers to ensure safety and efficacy.

However, vaccines are drugs and, as such, may be associated with side effects and adverse events.

As vaccine-preventable diseases become less visible because of effective vaccination programs, more attention is paid to adverse events associated with vaccination. When controversy over the safety of vaccination arises, it can reduce public confidence in immunization and interfere with established vaccination programmes. The world has seen the dangers and effects of interrupting vaccination (refer to case description in Figure 8.1) Therefore, the occasional occurrence of an adverse event or series of adverse events linked to vaccination can quickly become a serious threat to public health and to the immunization programme. Consequently, health workers need information on safe vaccination. It is also essential to have a national monitoring system for adverse events associated with vaccination.

Safe Vaccination requires: 1. Safe Vaccines 2. Safe Injection Practices 3. Monitoring and Investigation of Adverse EESAVI Each of these factors is addressed in this chapter.

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Case Description of Decreased Confidence in Vaccination and Increased Disease A well-known situation occurred in the 1970s in the United Kingdom: concern over the risks of whooping cough (pertussis) vaccination provoked a rapid fall in pertussis vaccination coverage. Coverage had been higher than 80% with only 2,000-8,000 cases of whooping cough per year. When coverage fell to 30%, the number of cases of whooping cough rose to more than 100,000 annually, causing deaths and hospitalizations that could have been avoided. After two large epidemics and some education campaigns on the disease and the vaccine, people slowly recovered their confidence in the vaccine. In the middle of the decade, coverage rose to 95% and as a result, the number of cases of whooping cough fell to its lowest recorded level in the history of the United Kingdom.

Evolution of Immunization Programs and Importance of Safe Vaccination 1

3

2

Pre-vaccination

Increase in coverage

Loss of confidence

4

5

Recovery of confidence

Vaccination stops

Disease

Incidence

Eradication

¿?

Vaccination coverage

Outbreak Adverse Events

Maturity

Eradication

C., R et. al., “Vaccine Safety: Future Challenges” Ped. Ann., July 1998; 27(7): 445-55

Figure 8.1.1:

Evolution of immunization programmes and importance of safe vaccination

8.2 Safe Vaccines In Jamaica, the safety and quality of drugs, especially vaccines, is organized and controlled, taking into account international guidelines.

164

The Ministry of Health guarantees safe, effective and high-quality vaccines for the population.

Jamaica purchases vaccines through the PAHO EPI Revolving Fund from manufacturers certified by the World Health Organization. These vaccines undergo a rigorous regulatory process in their countries of manufacture prior to release. The WHO evaluates vaccine quality, safety and effectiveness to ensure compliance with the requirements of United Nations agencies, including those relating to good manufacturing practices.

Quality control documents and information on the final laboratory testing of each lot of vaccine accompany all shipments. These documents and the ‘certificate for the release of vaccines acquired by United Nations agencies’ are vetted by the Standards and Regulations Division of the Ministry of Health. Systems are in place to ensure that all vaccines used in Jamaica are registered through the Standards and Regulations division of the Ministry of Health. Thus, the vaccines used in Jamaica’s EPI must be innocuous and effective and comply with operational specifications regarding packaging and presentation.

8.3 The Regulatory Process Figure 8.3.1 shows the regulatory process that vaccines undergo in their countries of manufacture. Each step in the process is explained thereafter.

SURVEILLANCE CLINICAL TESTS

National Regulatory

GMP INSPECTIONS

Agency

ACCESS TO LABORATORY LOT BY LOT RELEASE

Figure 8.3.1: 28

Regulatory Process Vaccines Undergo 28

Source: ESAVI training materials, PAHO/WHO

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REGISTRATION

• •

•

• • •

•

Regulation of vaccines is a continuous process.

In their countries of manufacture, vaccines are registered with the National Regulatory Authority (NRA), which has the responsibility for obtaining technical data on the vaccine and the manufacturer.

The NRA releases lots of vaccine, including the results of the quality-control tests carried out in its official laboratories. At a minimum, release is based on an examination of the manufacturing protocol summaries of the lot, which give a detailed description of the production process.

The function of the laboratory is to confirm the quality of the vaccines, by testing the finished product.

Manufacturers are inspected and granted licenses on the basis of their compliance with good manufacturing practices.

Distributors (importers, wholesalers and retailers/pharmacies) are also inspected and granted licenses to ensure that they comply with relevant regulations in order to acquire and retain their licenses.

Evaluation of the safety and effectiveness of vaccines are derived scientifically from controlled clinical tests. o After pre-clinical trials have been successfully completed, studies on human beings may begin. o Clinical Trial Phases 1. Phase I, or first time used on humans.

2. Phase II, in some cases, when research into a target population is allowed.

3. Phase III, the comparative study stage, decides the effectiveness of the product − It is usually the results of phase III that enable or prohibit a product’s submission for registration.

4. Phase IV, or the after-sales surveillance stage, is when the results of using the product on the general population are obtained.

Once a vaccine is placed on the market, the NRA continues to conduct after-sales surveillance, including: 1. Periodic inspections of manufacturers 2. Continual supervision of vaccine quality through lot release programmes and case-bycase evaluation of samples taken in the field.

3. Monitoring, checking and evaluation of the secondary effects associated with vaccination.

4. Collaboration in monitoring the effectiveness and efficiency of vaccines in preventing targeted diseases.

5. Evaluation of the use of the vaccine.

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8.4 EPI Revolving Fund of the Pan-American Health Organization (PAHO) The EPI Revolving Fund is a pool of money maintained by PAHO that enables countries to pay in advance for vaccine and syringe purchases. Within a given period, countries must reimburse the fund for the cost of each purchase. The main purpose of the fund is to ensure a uniformed and continuous supply of vaccines and supplies for country immunization programs.

8.5 Safe Injection Practices An injection is a traumatic procedure that consists of puncturing the skin with a syringe and needle in order to introduce a substance to heal or prevent disease. Approximately 12 to 16 billion injections are administered each year worldwide; one out of 20 (5%) injections is administered for vaccination purposes.

• Injections can be administered by intravenous, intramuscular, intradermal or subcutaneous routes. Vaccinations do not use the intravenous route.

• Hazardous injection practices may lead to transmission of blood-borne pathogens (HIV, Hepatitis C virus and Hepatitis B virus) from one patient to another, from patient to health care worker, and rarely from health care worker to patient. The community at large can also be exposed to serious infectious risks when injection equipment is not adequately discarded.

• Many epidemiologic studies in industrialized countries have documented spread of Hepatitis B due to accidental needle pricks or the shared use of syringes and needles.

• A safe injection does not endanger the recipient’s life, expose the health care worker to any avoidable risk, or produce any waste that may be harmful to other people.

Characteristics of a safe injection  Safe for the injection recipient  Safe for the health worker  Safe for the community and the environment

8.6 Safety of the Injection Recipient Five interrelated aspects are fundamental in guaranteeing the safety of vaccinees:

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Avoidance of Programmatic Errors (Operational Mistakes) Programmatic errors are caused by human negligence or error. To a great extent, they can be prevented. Nevertheless, they occur more frequently than those caused by vaccines or technology. Prevention of programmatic errors requires adequate staff training and equipment, and proper supervision.

Inadequate vaccination practices may give rise to abscesses or blood-transmitted infections.

The most serious case is toxic shock caused by the inappropriate manipulation of a reconstituted vaccine vial. In such a case, many infants vaccinated from the same vial may die soon after the injection has been administered.

These are the basic rules to avoid programmatic errors: • Use sterile needles and syringes for each injection.

• Use the correct injection administration procedures • Never leave a mixing needle in a vial.

• Never pre-fill syringes prior to vaccination sessions.

• Reconstitute vaccine only with the diluent provided by the manufacturer for the vaccine.

• Discard reconstituted vaccines (MMR, yellow fever and BCG vaccines) within six hours after reconstitution.

• Follow the WHO policy on the reuse of multiple-dose vials (Chapter 5).

• Do not store drugs, food, drinks, and other substances in a vaccine refrigerator.

• Train and supervise workers appropriately in order for them to learn about safe injection practices.

• Investigate any programmatic error so as to avoid its recurrence.

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Table 8.6.1:

Programmatic Errors and Their Consequences

Incorrect Practice Non-sterile injection: • Reuse of a disposable syringe or needle • Improperly sterilized syringe or needle (Jamaica does not use sterilized needles and syringes in the EPI programme) • Contaminated vaccine or diluent • Use of re-constituted vaccines for a period longer than indicated Reconstitution error: • Reconstitution with the wrong diluent • Drug substituted for vaccine or diluent • Inadequate mixing of vaccine

Injection at incorrect site: • BCG applied subcutaneously • Very superficial administration of the DPT/DT/TT vaccine • Injection in the buttock Incorrect transport/storage of vaccines • Cold chain not maintained • Freezing of vaccines which should be kept at +2°C to + 8°C Ignore vaccinee contraindications

Potential reaction or event • •

•

Infection such as abscess at the injection site, sepsis, toxic shock syndrome or death Transmission of blood-borne infection, such as hepatitis B/C or HIV

• •

Local abscess due to solid particles caused by improper mixing (agitation) Adverse effect of a drug; for example, insulin Death Ineffective vaccine

•

Local reaction or abscess

•

Potential damage to the sciatic nerve

• •

Local reaction from frozen vaccine Ineffective vaccine

• •

Severe preventable reactions Death

•

Adequate Vaccine Preservation Cold Chain Management is discussed in detail in Chapter 5. Vaccines and diluents must be stored within the required temperature ranges at all times to guarantee appropriate preservation. Consult Figure 5.5.2 for details.

Healthcare workers should verify that vaccines are being kept under appropriate cold chain conditions at all times by following the steps outlined in Chapter 5, including: • Protecting vaccines and diluents from coming into direct contact with ice packs or cold water • Verifying the temperature of the refrigerator • Verifying the positioning of vaccines in the refrigerator and vaccine carrier • Continuously verifying the operational capacity of the cold chain equipment 169

Appropriate Handling of Opened Multi-Dose Vials Vials containing multiple doses of OPV, DPT, DT, and Hepatitis B vaccines, which have been used to administer one or more doses during a vaccination session, may be used in subsequent immunizations, within a maximum period of four weeks, provided the following conditions are met: • Vaccines have not expired.

• Vaccines have been stored and preserved under appropriate cold chain conditions.

• The rubber stopper has not been submerged in water.

• Vaccine doses have been withdrawn using strict aseptic procedures (e.g. a minimal touch technique was used with hand washing between doses; the bung was not touched; no needle was left in the vial.)

• Vaccines were not transported and opened for field use (i.e. outreach sessions).

• The vaccine vial monitor (VVM), if attached, has not reached the discard point.

The revised policy does not modify the procedures recommended for vaccines that must be reconstituted, such as the BCG, MMR, Hib and yellow fever vaccines These vaccines must be discarded six hours after having been reconstituted, or at the end of each vaccination session –whichever occurs first. Refer to Table 8.6.2 for details regarding the allowable preservation time for opened vials.

Death due to toxic shock syndrome has resulted when reconstituted live virus vaccines kept longer than the recommended period have been injected.

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Table 8.6.2:

Allowable preservation time for opened vials

Biological

Preservation temperature

OPV IPV IPV BCG DPT Haemophilus Influenzae type b Hepatitis B Pentavalent Pediatric DT Adult DT

+2 ℃ to +8℃ +2 ℃ to +8℃ +2 ℃ to +8℃ +2 ℃ to +8℃ +2 ℃ to +8℃

Yellow Fever

+2 ℃ to +8℃

MMR Meningococcal Polysaccharide Vaccine (MPV) Meningococcal Polysaccharide Vaccine (MPV) Influenza (inactivated) Rotavirus HPV

Preservation time of the opened vials

Formulation Multiple-dose vial Multiple-dose vial Single- dose vial Multiple-dose vial Multiple-dose vial Multiple-dose vial Single-dose vial Multiple-dose vial Single-dose vial Multiple-dose vial Multiple-dose vial

+2 ℃ to +8℃

Four weeks maximum Four weeks maximum Use immediately Six hours Four weeks maximum 30-day maximum (M-d vial) Use immediately Four weeks maximum Immediate use Four weeks maximum Four weeks maximum 1 hour if diluent is not kept at temperature between 2-80C as the vaccine. But 6 hrs if diluent is kept at temperature between 2-80C as the vaccine.

Six hours

+2 ℃ to +8℃

30 minutes

Single-dose vial

+2 ℃ to +8℃

10 days maximum

Multiple-dose vial

+2 ℃ to +8℃

Four weeks maximum

Multiple-dose vial

+2 ℃ to +8℃ +2 ℃ to +8℃

Immediate use Immediate use

Single-dose vial Single-dose vial

+2 ℃ to +8℃ +2 ℃ to +8℃ +2 ℃ to +8℃ +2 ℃ to +8℃ +2 ℃ to +8℃

Multiple-dose vial

Multiple-dose vial

Administration Technique: Dose, Route, Injection Site and Syringe As outlined in the Chapter 7 on Vaccine Administration, one must: • Ensure injection of the correct vaccine and dose.

• Ensure administration of the vaccine with the correct syringe and needle.

• Ensure application of the vaccine at the right site.

• Ensure use of the correct route of administration.

Appropriate use of syringes See Chapter 7.

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8.7 Universal Precautions Universal precautions should be used throughout the immunization programme as described in Chapter 7.

8.7.1 Safety of the health worker The safety of the health worker depends on appropriate handling of disposable syringes and safety boxes.

• Do not recap the needle after administering the vaccine.

• Do not remove the needle from the syringe after administering the vaccine.

• Use a safety box (or other puncture-resistant container with a wide neck to allow insertion but not removal of the used needles and syringes) to dispose of syringes and needles immediately after use.

• Never use plastic or paper bags or common garbage containers for disposal of syringes and needles.

8.7.2 Safety of the Community and the Environment The safety of the community and the environment requires the appropriate disposal of needles and syringes. This prevents the generation of waste that is hazardous to the community or the environment.

Although health centres may collect needles and syringes in safety boxes, eventually they must be destroyed.

• Incineration is the most reliable and safest means to dispose of this hazardous waste.

• Incinerated waste should be buried at a site that is not accessible to the public.

• Should an incinerator not be available, this waste may be burnt in a pit. Burying or dumping waste in an open field or in public or municipal dumps is NOT a recommended practice.

8.8 Events Supposedly Attributable to Vaccination or Immunization (ESAVI) • •

An ESAVI is a set of symptoms that occurs after a vaccination has been given; the symptoms cause concern and are believed to be due to immunization.

Reported ESAVIs can either be: o True adverse events (due to the vaccine or immunization process)

OR o

Coincidental events that are not due to the vaccine or immunization process but are temporally associated with immunization (occurred at the same time).

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For the purpose of these guidelines ESAVIs are classified into three categories (see Table 8.8.1).

Table 8.8.1:

Classification of adverse events following immunization

Vaccine reaction:

Event caused or precipitated by the vaccine when given correctly. It is caused by the inherent properties of the vaccine.

Programme error:

Event caused by error in vaccine storage, preparation, handling or administration.

Coincidental:

Event that happens after immunization but is not caused by the vaccine - a chance association.

â&#x20AC;˘

No biological or pharmaceutical product is totally innocuous, and occasional adverse effects related to vaccines occur. Vaccinators must know what to expect (type of event and frequency) when EPI vaccines are administered. In addition, vaccinators must know how to manage and report such reactions.

8.8.1 Classification and Rates of ESAVIs ESAVIs are classified according to their severity in the following manner: A. Minor and more common B. Severe and less frequent Knowing the types of events to expect after vaccination can help health workers to: o Educate parents and other caregivers about side effects. o Prepare for treatment of patients. o Monitor the occurrence of ESAVIs at their health centre. o Prevent events that could arise in the immunization programme. o Detect events that are NOT linked to vaccines. o Compare the rates occurring with those expected.

Heath care personnel are obliged to inform parents of the more common events expected post-vaccination and how to manage them. It is also essential to inform them that in the event of any reaction appearing after vaccination, they must go to the nearest health center or doctor.

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A. Minor and More Common Adverse Events Most reactions to vaccination are normal and mild. Local reactions, fever and other symptoms may be part of the normal immune response to vaccination. Recovery does not require treatment and there are no long-term consequences. The frequency of minor adverse events attributable to vaccination or immunization is summarized in Table 8.8.1.1.

Table 8.8.1.1: Minor adverse events due to vaccination

Local reaction (pain, swelling, redness) 5-15%

2-10%

Measles/MMR Oral poliomyelitis (OPV)

Up to 30% in adults Up to 9% in children Up to 10% None

1-6% up to 5% less than 1%

IPV

Less than 0.1%

TT/DT

Up to 10% For Boosters: 50-85% Up to 50% 90-95% Up to 10%

Vaccine Haemophilus influenzae type b (Hib) Hepatitis B

DPT BCG HPV 29

Fever

Less than 0.1% up to 10% Up to 50% Less than 10%

Irritability, malaise and non-specific symptoms -

Up to 20% up to 5% less than 1% (includes diarrhea, headache, muscle pains)

up to 25% up to 60% Up to 10%

B. Severe and less frequent adverse events Serious reactions are much rarer and may require treatment as outlined below. They produce few long-term problems. Anaphylaxis, though it can be fatal, produces no long-term complications if treated in time. The frequency and timing of the uncommon and severe adverse events associated with vaccination are detailed in Table 8.8.1.2.

29

HPV Manufacturers leaflet accessed at https://www.medicines.org.uk/emcmobile/PIL.20207.latest.pdf

174

Table 8.8.1.2: Minor adverse events due to vaccination

Vaccine

Event

Onset interval

Rates per 1,000,000 (million) doses

BCG

Suppurative lymphadenitis BCG osteitis Disseminated BCG

2-6 months 1-12 months 1-12 months

100-1000 1-700 2

Hib

Nil known

-

-

Hepatitis B

Anaphylaxis Guillan-BarrĂŠ syndrome (vaccine obtained from plasma)*

time 0-6 weeks

1-2 5

MMR

Febrile seizures Thrombocytopenia (low platelet count) Anaphylaxis

5 -12 days 15-35 days 0-1 hour

333 33 1-50

Oral poliomyelitis (OPV)

Vaccine-associated paralytic poliomyelitis (VAPP)/circulating Vaccine-Derived Polio Virus (cVDPV)

4-30 days

Less than 1

Anaphylaxis 30 IPV

Less than 1

Poly neuropathy 31

0-1hr Less than 0.01%

Apnea in very premature infants ( less than 28 weeks gestation

TT/DT

Brachial neuritis Anaphylaxis Sterile abscess

2-28 days time 1-6 weeks 0-24 hours

DPT

Persistent screaming lasting for more than 3 hours.

Seizures Hypotonic hypotensive episode (HHE)

days 0-24 hours

Anaphylaxis Encephalopathy

Anytime 0-3 days (average)

Post vaccination encephalitis

7-21 days

Allergic reaction/anaphylaxis

0-1 hour

Allergic reaction/anaphylaxis

0-1 hour

Yellow fever HPV

30

5-10 1-6 6-10 1,000-60,000 570 570 20 0-1 500-4,000 in infants under 6 months 5-20 Less than 1

CDC Possible side effects of Vaccinations accessed at https://www.cdc.gov/vaccines/vac-gen/sideeffects.htm 31 IPV Manufacturers leaflet accessed at http://www.who.int/immunization_standards/vaccine_quality/pq_231_282_IPV_Bbio_PI_05_2015.pdf?ua=1

175

8.8.2 Management of ESAVIs Faced with a suspected case of an adverse event, the following steps should always be considered: A. Treatment of the patient.

B. Subsequent conduct: indicate or contraindicate subsequent doses of the vaccine.

C. Investigation and notification. a) Treatment of the Patient Table 8.8.2.1: Clinical Management of Minor Vaccine-Related Adverse Events

ESAVI

Abscess at the injection site

Severe local reaction

Symptoms

Treatment

Contraindication for subsequent doses None

Fluctuant lesion that contains liquid at the site of vaccine application; may or may not be accompanied by fever; pain at site of application or with movement of the affected limb.

Requires a medical examination to determine treatment

-Analgesia (Use non-aspirin containing pain reliever in children)

Redness, edema, or pain at the site of injection; pain may occur with movement of the affected limb.

Most cases get better on their own

Analgesia (Use non-aspirin containing pain reliever in children) -Cold or hot compress

None

Re-absorbs completely in a few weeks on its own

None

None

Usually benign and self-limited

Fluids; rest

None, unless occurs with a more serious ESAVI

Painless Nodule

Fever

Course/ Action needed

On average occurs 3-6 hours after vaccination.

May occur up to 48 hours after vaccination with the exception of MMR vaccine. In the case of MMR, fever can appear between 5 to 12 days after vaccination.

Children must be examined to rule out another cause of the fever (e.g. intercurrent infection)

176

-Cold or hot compress - May require incision and drainage -May require Antibiotics

Administer antipyretics: preferably Paracetamol, avoid the use of aspirin.

Do not apply ice or alcohol.

Examine child for infection and treat according to findings.

•

All vaccine-related adverse events, including the minor reactions above, must be recorded in the Adverse Events Register and reported to the MOH using the Adverse Events Reporting Form (See Appendix C). Large increases in certain local reactions may be associated with errors in technique or a given lot of vaccine, so it is important that they are reported and investigated.

8.8.3 Management of Serious Vaccine-related Adverse Events This section is designed to provide information on Serious Vaccine-Related Adverse Events in order to familiarize the EPI team. However, a physician should be consulted immediately to assist with the assessment and clinical management of all serious vaccinerelated adverse events. Health Care Workers should familiarize themselves with the management of anaphylaxis, so that they can stabilize patients prior to the arrival of a physician or transfer to hospital. All serious vaccine related adverse events must be reported to the Surveillance Unit/Family Health Unit immediately (see ESAVI Crisis Plan in Appendix G)

BCG Lymphadenitis Case definition: At least 1 lymph node > 1.5 cm in size OR a draining sinus over a lymph node Clinical features: − Usually occurs in the armpit within 2-6 months of BCG vaccination − Occurs on the same side of the body as the vaccination Management: − Heals spontaneously over months − Refer to pediatrician for observation and management − Fistula requires surgical opinion − Systemic treatment is ineffective Contraindications for subsequent doses: None

177

Persistent Crying/Screaming Clinical Features: Continuous inconsolable crying may last from >3 hours and sometimes up to 48 hours, postvaccination (usually with DPT) and is accompanied by screaming. It is thought to be associated with pain at the injection site. It stops spontaneously.

Management: − Observe and verify the intensity of the local reaction − If there is an intense local reaction give Paracetamol − The child should be taken to a hospital for evaluation and to rule out other causes of the crying Contraindications for subsequent doses: Generally, inconsolable crying which lasts >3 hours after DPT vaccination is a contraindication to further doses of DPT. DT should be given in the future. An alteration to this policy could be considered in the setting of an outbreak.

Seizures Clinical Features: − Involuntary movements associated with an effect on consciousness. − May be generalized (convulsions/fits) or local − May be tonic and/or clonic − Can occur up to 72 hours after application of DPT or 5 to 7 days after application of the MMR vaccine − Often accompanied by fever − Prognosis is good and no short or long-term complications have been shown Management: o Lay the patient on his/her side o DO NOT place anything in his/her mouth or between his/her teeth so that the airway remains clear o Transfer to hospital as soon as possible for assessment and observation. Seizures may recur. o Physicians can give Diazepam if the crisis does not stop spontaneously.

Phenobarbital can also be used as an alternative first line drug or as adjunctive treatment. Additional emergency measures should be applied in cases of status epilepticus (Maintain airway, breathing, circulation, including provision of 100% O2).

178

Contraindications for subsequent doses: o Generally, seizure is a contra-indication to further doses of DPT. DT should be given in the future. An alteration to this policy could be considered in the setting of an outbreak. o If the seizure is a febrile seizure, post-MMR for example, consideration may be given to further MMR immunization with fever control (anti-pyretics).

Shock type syndrome (hypotonic hypotensive episode: HHE) Clinical Features: Sudden loss of color, loss of muscular tone, loss of response to stimuli, occurring in the first 48 hours (usually less than 12 hours) after the vaccination. The episode is temporary and disappears spontaneously without sequels. May be accompanied by respiratory depression, cyanosis, prolonged sleep or loss of consciousness.

Some cases described as HHE can be confused with anaphylaxis-type reactions or seizures.

The presence of urticaria or angioedema, particularly in the larynx, indicates an anaphylactic reaction.

Prognosis is good; it is generally temporary and self-limiting. Studies of children who have had HHE do not show neurological sequelae in the short or long term.

Management: o Transfer to hospital o Keep under close observation until the signs and symptoms have disappeared completely o Take appropriate measures when hypotension, cyanosis or respiratory depression is present Contraindications for subsequent doses: Generally, HHE is a contra-indication to further doses of DPT. DT should be given in the future. An alteration to this policy could be considered in the setting of an outbreak.

Anaphylactic shock (anaphylaxis, anaphylactic reaction) Clinical features: These are reactions that occur less than 2 hours after application of the vaccine, generally in the first half hour; their association with vaccines is very rare. Symptoms may include: â&#x20AC;˘ Neurological: anxiety, limpness (change in muscle tone), syncope, convulsion, change in conscientious, paralysis 179

• • •

Cardio-circulatory: pallor, hypotension, arrhythmia, shock, cyanosis, cold extremities, weak or absent pulses Respiratory: oedema of the larynx, stridor, difficulty breathing, cough, dyspnea, respiratory distress Dermatological: pruritus, angioedema, generalized urticaria and/or erythema

Prevention and Preparation: Anaphylactic reactions are very rare, unexpected, and can be fatal. All health workers must, therefore, be able to distinguish anaphylaxis from convulsion and fainting. Fainting, while relatively common after immunization of adults and adolescents, is very rare in young children in whom sudden loss of consciousness should be presumed to be an anaphylactic reaction. There is no place for conservative management of anaphylaxis.

Early administration of adrenaline is essential. All health workers must be familiar with the practical steps necessary to save a life following an anaphylactic reaction.

Anaphylaxis may be avoidable if an allergy or prior vaccine reaction is known to be present.

To prevent anaphylaxis: ensure there are no contraindications to immunization; ask the recipient or caregiver about known hypersensitivities or previous adverse reactions to vaccines; if in doubt as to the advisability of administering the vaccine, consult the MO(H) or Director, Family Health, recipient’s general practitioner or refer to a paediatrician. If vaccine is given, keep the recipient under observation for at least 30 minutes after the injection.

All vaccination clinics must have an Emergency Tray with resuscitation equipment permanently available. Medical and nursing personnel must be trained to recognize and treat anaphylactic shock and rehearse the procedures periodically. Rapid treatment is vital.

Each vaccinator should have adrenaline available as adrenaline 1:1,000. The expiry date of the adrenaline and other drugs should be written on the outside of the kit and the whole kit should be checked monthly or at least three or four times a year. Adrenaline that has a brown tinge must be discarded. Hydrocortisone and an injectable antihistamine for intravenous administration should be included in the emergency kit.

The main treatment of anaphylactic reactions is adrenaline.

Corticosteroids and antihistamines have a delayed effect, and though they may help to reduce the overall duration of a reaction and may prevent relapse, they must not be used to the exclusion of adrenaline in the management of anaphylaxis. Adrenaline should be used early at the first suspicion of anaphylaxis. It is safe and effective.

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Management: The following four steps should be done rapidly or simultaneously, so that the administration of adrenaline is not delayed.

1. Call for assistance, including an ambulance.

2. Lay patient in left lateral position to keep the airway clear and with legs elevated.

3. Establish an oral airway if necessary and administer oxygen by facemask at a high flow rate (6L/min).

4. Promptly administer adrenaline 1:1000 intramuscularly. This may be repeated at 5-10 minute intervals up to a maximum of three doses (See Table 8.8.3.1), depending on the severity of the reaction. Avoid injecting adrenaline in the limb in which the vaccine was given. A tuberculin syringe can be used to improve the accuracy of measurement when drawing up small doses. If measurement of small volumes of adrenaline is a problem, use adrenaline 1; 10,000 in children up to 10 years of age (See Table 8.8.3.2 for dosing).

Additional steps include: 5. Establish intravenous line, if possible 6. Monitor vital signs every 15-30 minutes for at least 4 hours.

7. Administer either: o intravenous or oral corticosteroid, e.g., hydrocortisone or prednisone o intravenous or intramuscular antihistamine, e.g., diphenhydramine 8. If there is Bronchospasm administer either nebulised Ventolin via face mask or intravenous aminophylline.

9. Make arrangements to transport patient to hospital immediately, never leave patient alone. Keep patient rested, avoid heat, and provide reassurance.

10. All cases should be admitted to hospital for further observation and treatment.

Table 8.8.3.1: Adrenaline dosage (1:1000) according to age

Age (years)

Dose of adrenaline (1:1000)

Less than 1

0.05-0.1 mL

1-2 (approx. 10 kg)

0.1 mL

2-3 (approx. 15 kg)

0.15 mL

4-6 (approx. 20 kg)

0.2 mL

7-10 (approx. 30 kg)

0.3 mL

11-12 (approx. 40 kg)

0.4 mL

12 and over

0.5 mL 181

Table 8.8.3.2: Adrenaline dosage (one in ten thousand) according to age

Age (years)

Dose of adrenaline (1:10,000)

Less than 1

0.5-1 mL

1-2 (approx. 10 kg)

1 mL

2-3 (approx. 15 kg)

1.5 mL

4-6 (approx. 20 kg)

2 mL

7-10 (approx. 30 kg)

3 mL

Contraindications for subsequent doses: If anaphylaxis occurs, the same vaccine would be contra-indicated in the future.

Encephalopathy and encephalitis Clinical features: Encephalopathy is the acute appearance of one of the following conditions after vaccination: o Convulsive crisis o Severe alteration of consciousness lasting a day or longer o Behavioral disorder lasting a day or more May occur in the seven days following vaccination and must be notified in the first 24-48 hours after discovery.

Encephalitis is characterized by the signs and symptoms described for encephalopathy and is caused by cerebral inflammation; in addition, pleocytosis of the CSF may be observed. Any encephalitis occurring in the four weeks after immunization must be investigated and reported immediately. (Parents/guardians should be informed of this during the prevaccination educational session).

Encephalopathy or encephalitis may occur within the first 48 hours although they may also appear up to seven days after a DPT vaccine (encephalopathy), and seven to twelve days after a measles/MMR or yellow fever vaccination (encephalitis).

Management: Patient must be taken to hospital for admission, evaluation and neurological treatment.

Contraindications for subsequent doses: Yes, for all doses of the implicated vaccine. In the event of a DPT vaccine being applied continue with DT. 182

Exanthema Clinical features: A maculopapular type of erythematous skin eruption, usually generalized. 5% of vaccinees receiving the measles or rubella vaccine may present with exanthema 7 to 10 days after vaccination, lasting approximately two to four days.

Management: Determine whether post-vaccination event or case of measles, rubella, chicken pox or other skin condition and manage accordingly. Notify the event and investigate as for fever and rash.

Contraindications for subsequent doses None Thrombocytopenic purpura Clinical features: Hemorrhagic-type skin lesions (petechiae and ecchymoses) caused by a reduction in the number of platelets. Blood may also be found in mucous membranes and internal organs.

May occur in the first two months after vaccination, in 1 in 30,000 to 1 in 40,000 vaccinees with the measles vaccine; infrequent with the Hib vaccine.

Management: Specialist evaluation required.

Contraindications for subsequent doses: In the event of post-vaccine purpura, the severity of the symptoms must be evaluated by a physician to decide whether a subsequent dose is indicated or not.

Vaccine-associated paralytic poliomyelitis The risk of VAPP is higher for the first dose than for subsequent doses.

Clinical features: Paralytic poliomyelitis associated with the OPV vaccine is characterized by: â&#x20AC;˘ Appearance of acute flaccid paralysis (variable intensity, generally asymmetric, lower limbs usually) between 4 and 40 days after receiving the vaccine or between 4 and 85 days after contact with a vaccine, followed within 60 days of the motor deficit onset by neurological sequelae compatible with poliomyelitis.

183

Management: Refer to specialist; treatment is symptomatic, with aim of reducing sequelae. The isolation of polio vaccine virus in feces is necessary for the case to be confirmed as associated with the vaccine. Two faecal samples must therefore be obtained as early as possible, in the first 15 days after onset of the paralysis with a minimum interval of 24 hours, for cultivation and isolation of the virus.

The Surveillance Unit and Family Health Unit must be notified immediately.

Contraindication for subsequent doses of OPV: Contraindicated. Give IPV instead.

Toxic shock Clinical features: Sudden appearance of fever, vomiting and diarrhoea a few hours after vaccination; often leading to death in 24 to 48 hours.

Management: This is an emergency and the patient must be taken to hospital for adequate treatment (rehydration, antibiotics, oxygen therapy, use of vasopressors and other intensive care measures).

Contraindications for subsequent doses: None. However the findings of the investigation and the report of the physician must be taken into account.

Peripheral neuritis (brachial or sciatic) Clinical features: Pain in the affected area and limb (shoulder, arm, gluteus or thigh) followed by weakness and reduction in muscle mass; loss of feeling is not prominent. Occurs 2 to 28 days after vaccination and may be the manifestation of an infection by immunocomplexes or direct damage to a nerve at the time of injecting the vaccine.

Management: Treatment is symptomatic. Analgesics and evaluation by a specialist are indicated.

Contraindications for subsequent doses None. Special attention must be paid to vaccination technique.

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8.9 Jamaica’s Process for ESAVI Management Appropriate management of ESAVIs implies: • rapid and adequate detection, • evaluation, • management and • prevention of these events, as well as • a sound communication plan.

In the case of an ESAVI, the following steps should be taken: 1.

2.

3.

Treatment of the patient.

Subsequent conduct: indicate or contraindicate subsequent doses of the vaccine.

Investigation and notification.

Treatment (1) of the patient and subsequent conduct (2) were discussed above. Investigation and notification (3) are discussed below.

Investigation and notification An investigation follows standard epidemiological investigation principles. In addition, investigation of the vaccine(s), cold chain, immunization techniques and procedures needs to be conducted. The vaccination process by the field must also be observed. For every adverse event, the following steps should be taken: a. An “Adverse Reaction to Vaccination” report form must be filled out and directed to the parish Medical Officer of Health; The MO(H) will request further investigations as deemed necessary for the normal, expected reactions.

Remember that fever and rash needs to be completely investigated including blood sample collection. b. The event should be recorded in the adverse events register and patient docket c. Statistics on adverse events should be provided to the Family Health Unit on a monthly basis as part of the routine EPI coverage reporting system. d. All completed adverse events reporting forms must be submitted to the Surveillance Unit/Family Health Unit e. Severe complications should be reported immediately to the Family Health Unit, Ministry of Health through the Medical Officer of Health responsible for the EPI Programme.

185

Table 8.9.1:

List of reportable ESAVIs         • 

Anaphylactoid reaction (acute hypersensitivity reaction) Anaphylaxis Persistent (more than 3 hours) inconsolable screaming Hypotonic hyporesponsive episode (HHE) Toxic shock syndrome (TSS) Severe local reaction Occurring within 5 Sepsis days of immunization Injection site abscess (bacterial/sterile) Fever and rash Seizures, including febrile seizures (6-12 days for measles/MMR; 0-2 days for Occurring within 15 DTP) days of immunization  Encephalopathy (6-12 days for measles/MMR; 0-2 days for DTP) Occurring within 3  Acute flaccid paralysis (4-30 days for OPV recipient; 4-75 days for contact) months of  Brachial neuritis (2-28 days after tetanus containing vaccine)  Thrombocytopaenia (15-35 days after measles/MMR) immunization Occurring between 1  Lymphadenitis and 12 months after  Disseminated BCG infection  Osteitis/Osteomyelitis BCG immunization No time limit Any death, hospitalization, or other severe and unusual events that are thought by health workers or the public to be related to immunization Occurring within 24 hours of immunization

The investigation must proceed in an orderly fashion in order to establish the cause of the ESAVI: Table 8.9.2 outlines the steps to be completed in investigating ESAVIs. The Medical Officer of Health must ensure that the investigation is completed and the report submitted to the Surveillance Unit/Family Health Unit.

For serious ESAVIs, these must be reported to the Surveillance Unit/Family Health Unit within 24 hours of notification of the event and the MO(H) must lead this investigation and submit a preliminary report within 24 hours.

Decisions to suspend use of, or recall, a vaccine or specific lot is the responsibility of the Director, Family Health and needs to be made as swiftly as possible, but should be very carefully thought out.

186

Table 8.9.2:

Steps in an ESAVI investigation.

Step

Actions

1) Confirm information in report

 Obtain patient’s medical file (or other clinical record)  Check details about patient and event from medical file and document information.  Obtain any details missing from ESAVI Report Form (see Appendix)  Identify any other cases that need to be included in the investigation.  Immunization history  Previous medical history, including prior history of similar reaction or other allergies or contraindications  Family history of similar events.  History, clinical description, any relevant laboratory results about the ESAVI and diagnosis of the event  Treatment, whether hospitalized, and outcome.  Conditions under which the vaccine was shipped, its present storage condition, state of vaccine vial monitor, and temperature record of refrigerator  Storage of vaccine before it arrived at health facility, where it has come from higher up the cold chain, vaccine monitor card.  How it was mixed (if relevant); diluent used  Dose given  Whether others received the same vaccine and developed illness  Whether others had similar illness (may need case definition); if so exposure of cases to suspect vaccine(s)  Investigate the local immunization service  Vaccine storage (including open vials), distribution, and disposal  Diluent storage and distribution  Reconstitution (process and time kept)  Use and sterilization of syringes and needles  Details of training in immunization practice, supervision and vaccinator(s)  Number of immunizations- greater than normal? e.g. outreach, mass campaign  Refrigerator – what else is stored (note if similar containers stored next to vaccine vials which could be confused); which vaccines/diluents stored with other drugs; whether any vials have lost their label  Immunization procedures (reconstitution, drawing up vaccine, injection technique, safety of needles and syringes; disposal of opened vials)  Do any open vials look contaminated?  On the likely/possible cause(s) of the event.

2) Investigate and collect data: About the patient: About the event:

About the suspected vaccine(s):

About other vacinees/people:

3) Assess the service by: asking about:

Observing the service in action:

4) Formulate a working hypothesis: 5) Test working hypothesis 6) Conclude investigation

     

Does case distribution match working hypothesis?

Occasionally, laboratory tests may help Reach a conclusion on the cause.

Complete ESAVI Investigation Form (see Appendix) Take corrective action, and recommend further action Communicate with the patient and public as needed.

187

8.10 Communicating with the Media The media (newspaper, radio, and television) play an important role in public perception.

Understanding what the media want from a story will assist communication with them.

In certain situations, media coverage is likely to raise public concern about immunization. In these situations, it is important to communicate with the Family Health Unit, prior to the information being disseminated to the media. The communication should include preparation on how to deal with the public concern on this issue, to minimize the potential harm. It is also useful to have other groups and individuals that have public respect and authority e.g.

Medical Association of Jamaica, Paediatric Association of Jamaica make public comments to endorse and strengthen key messages.

Designating the spokesperson(s) to communicate with the media limits the possibility of conflicting messages coming from different sources. The spokesperson should have some training on media relations, and be designated and trained before any vaccine safety issues arise, so that the spokesperson can develop a relation with key reporters. In general, the CMO or the Director, Family Health Unit should communicate with the media on serious adverse events.

Decisions to suspend use of, or recall, a vaccine or specific lot is the responsibility of the Director, Family Health and needs to be made as swiftly as possible, but should be very carefully thought out. The impact on the immunization programme, alternate sources of vaccine, and the reliability of the evidence on which the decision is based, need careful scrutiny. In particular, there needs to be consideration concerning the possibility of biased reporting resulting from an alert about a possible problem with a vaccine or lot. Consultation with the vaccine manufacture and PAHO/WHO is advisable before making the decision.

188

Table 8.10.1: Summary of the frequency rates of minor events, attributed to vaccination or immunization and the times they take to appear.

Vaccine Haemophilus influenzae type b (Hib) Hepatitis B

Local reaction (pain, swelling, redness) 5-15%

Measles/MMR Oral poliomyelitis (OPV)

Up to 30% in adults Up to 9% in children Up to 10% None

IPV

Less than 0.1%

TT/DT

Up to 10% For Boosters: 50-85% Up to 50% 90-95% Up to 10%

DPT BCG HPV 32

Fever

Irritability, malaise and non-specific symptoms -

2-10%

1-6% up to 5% less than 1%

Up to 20% up to 5% less than 1% (includes diarrhea, headache, muscle pains)

Less than 0.1% up to 10%

up to 25%

Up to 50% Less than 10%

up to 60% Up to 10%

(N.B. the rates corresponding to the administration of vaccines will be lower, given that these symptoms appear normally in children, regardless of vaccination). a) b) c) d) e)

Diarrhoea, headache and muscular pains It is likely that the rates of local reaction increase with the booster from 50 to 85%.

Whole cell whooping cough vaccine. The rates for acellular whooping cough vaccine are lower.

Local reactogenicity varies from one vaccine to another as a function of the strain and number of viable bacilli.

The reaction consists of the appearance of a nodule and subsequent reaction.

Table 8.10.2: Summary of severe events attributed to vaccination or immunization, onset interval and rates Vaccine

Event

Onset interval

BCG

Suppurative lymphadenitis BCG osteitis Disseminated BCG Nil known Anaphylaxis Guillan-BarrĂŠ syndrome (vaccine obtained from plasma)* Febrile seizures Thrombocytopenia (low platelet count) Anaphylaxis Vaccine-associated paralytic poliomyelitis (VAPP)/circulating Vaccine-Derived Polio Virus (cVDPV) Anaphylaxis 33

2-6 months 1-12 months 1-12 months 0-1 hr 0-6 weeks

Rates per 1,000,000 (million) doses 100-1000 1-700 2 1-2 5

5 -12 days 15-35 days 0-1 hr 4-30 days

333 33 1-50 Less than 1

0-1hr

Less than 1\

Hib Hepatitis B

MMR

Oral poliomyelitis (OPV) IPV

32

HPV Manufacturers leaflet accessed at https://www.medicines.org.uk/emcmobile/PIL.20207.latest.pdf

189

Vaccine

TT/DT

Event

Poly neuropathy 34 Apnea in very premature infants ( less than 28 weeks gestation Brachial neuritis Anaphylaxis Sterile abscess Persistent screaming lasting for more than 3 hours.

Seizures Hypotonic hypotensive episode (HHE) Anaphylaxis Encephalopathy

Onset interval

Rates per 1,000,000 (million) doses Less than 0.01%

5-10 1-6 6-10 1,000-60,000 570 570 20 0-1

Yellow fever

Post vaccination encephalitis

2-28 days 0-1 hr 1-6 weeks 0-24 hours days 0-24 hours 0-1 hr 0-3 days (average) 7-21 days

HPV

Allergic reaction/anaphylaxis Allergic reaction/anaphylaxis

0-1 hour 0-1 hour

DPT

500-4,000 in infants under 6 months 5-20 Less than 1

a) No reaction (except anaphylaxis) when there is immunity (~90% of those who receive a second dose); febrile seizures are very unlikely in children over six. b) The risk of VAPP is higher for the first dose (1 in 1.400.000â&#x20AC;&#x201C;3.400.000 dosage) than for subsequent doses and contacts, one in 5.900.000 and one in 6.700.000 doses, respectively. c) Seizures are principally febrile and frequency depends on personal and family background and age, with the risk lower for children under four months. d) Isolated cases with no denominator make evaluation of frequency more difficult for children and adults, but are extremely rare (less than one case in 8.000.000 doses.

33

CDC Possible side effects of Vaccinations accessed at https://www.cdc.gov/vaccines/vac-gen/sideeffects.htm 34 IPV Manufacturers leaflet accessed at http://www.who.int/immunization_standards/vaccine_quality/pq_231_282_IPV_Bbio_PI_05_2015.pdf?ua=1

190

Chapter 9: Surveillance 9.1 Surveillance Definition Surveillance is the ongoing and systematic collection, interpretation and dissemination of health information essential to the planning, implementation and evaluation of public health activities. It can be described simply as information for action.

The three primary surveillance activities are: 1. collection of relevant health data for a specified population, time period geographic area; 2. meaningful analysis (interpretation) of data; and 3. routine dissemination of data with accompanying interpretation.

and/or

The overall goal of surveillance is to reduce morbidity and mortality through the prevention and control of diseases and other adverse health events.

Each of us is a surveillance officer!

We collect information on vaccination coverage and cases of vaccine-preventable disease, submit it to the parish, regional and national levels, where it is analyzed and plans for the future are made based on interpretations of the data.

9.2 Importance of Surveillance to the EPI â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘

To evaluate the effect of EPI on the occurrence of vaccine-preventable diseases To identify high-risk groups and/or geographic areas where intensified immunization activities may be needed To identify outbreaks so that control measures, including immunization, may be implemented

Surveillance data must therefore be timely and complete to accurately reflect the occurrence and distribution of disease.

191

9.3 Surveillance Systems in Jamaica 9.3.1 Purpose of VPD Surveillance The purpose of the National Surveillance System is to collect, collate, analyze and interpret data for action on a) reportable communicable diseases or health events as stipulated in the Public Health Act, Quarantine Act or gazette thereafter, and b) syndromes under surveillance at sentinel sites.

The surveillance system for VPDs is used to: • Monitor trends in VPDs o Define endemic levels and epidemic thresholds o Detect clusters of cases, outbreaks, epidemics and the potential for same o Document magnitude, distribution and spread of disease • Determine the need for public health action • Assist in planning of interventions to mitigate and control disease spread, and for disaster management • Assess effectiveness of public health programmes • Evaluate the effects of immunization services on the number of suspected cases and deaths from vaccine-preventable diseases.

• Identify health disparities • Define natural history of disease • Facilitate research • Monitor changes in disease agents • Forecast future trends and events in diseases Surveillance data must be timely and complete to accurately reflect the occurrence and distribution of disease (CDC 1990).

9.3.2 Sources of Surveillance Data • • • • • • •

• • •

Vital statistics Censuses Morbidity reports (hospital records), Mortality data Disease registries Sentinel Sites reports Case investigations

• • 192

Epidemic field reports Laboratory reports Special surveys (e.g. Jamaica Health and Lifestyle Survey) Biologics and drug distribution records Disease notifications

• • • •

• •

Hospital Active Surveillance Reports Laboratory surveillance Hotel surveillance Port health surveillance (air and sea ports)

Informal e.g. news, rumours, etc.

Events Supposedly Attributable to Vaccination or Immunization (ESAVI) monitoring

9.3.3 Structure of the Surveillance System in Jamaica Please see Figure 9.3.3.1 which outlines the levels of flow of surveillance information

Figure 9.3.3.1: Levels of flow of surveillance information

9.3.4 Approaches to Surveillance Surveillance in Jamaica is conducted using a mix of active and passive systems.

1. Passive surveillance is a provider-initiated method of data collection on health events.

• Health care providers send notifications and reports to a designated public health facility (e.g. the parish health department) in compliance with a known set of rules or regulations (e.g. the Public Health Act).

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• •

Passive surveillance requires timely and complete data.

Health care providers MUST be aware of notifiable diseases/conditions and take relevant actions.

2. Active surveillance is health-facility initiated.

• Public-health personnel (e.g. hospital active surveillance or HAS officers) visit healthcare facilities or community sites to find suspected or confirmed cases of notifiable diseases/events.

• Active surveillance is costly and time-consuming.

No single surveillance tool is perfect, and usually combinations of approaches work best.

9.4 Classes of Notifiable Diseases/Health Events Jamaica has three classes of notifiable diseases/health events. These are Class I, Class II and Class III.

9.4.1 Class I Disease/Health Events Class I diseases/health events are of highest priority because of 1. their potential to cause high morbidity and/or mortality 2. their significance as diseases/events of national/international interest 3. the establishment of special programmes for these diseases/events Class I diseases/health events are mainly infectious diseases, and include - those that are subject to international health regulations, such as cholera yellow fever, as well as - those under international surveillance e.g., HIV and AIDS, malaria, and VPDs such as measles, diphtheria, polio and tetanus.

Any exotic or unusual disease, or occurrence of an unusual disease in unusually high numbers may be upgraded to Class I status. If the number of cases exceeds its epidemic threshold, only the Chief Medical Officer can declare an outbreak or epidemic.

• Health care providers MUST report suspicion of Class I diseases within 24 hours to the parish health department or the NSU (see Class I Disease Order in the Appendix).

• The Class I Notifiable Diseases Reporting Form (see Appendix H) MUST be completed on suspicion, at first contact with the patient. This facilitates timely initiation of case investigations and control measures.

• Most VPDs are Class I. Note however that Mumps is a Class III notifiable disease and Influenza is a Class II notifiable disease.

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List of Class I VPDs (Public Health Act) • • • • • •

• • • • • •

AFP/Polio Congenital Rubella Syndrome Diphtheria Fever and Rash Hepatitis B and C Measles

Meningitis Pertussis-like Syndrome Rubella Tetanus Tuberculosis Yellow Fever

The list of other notifiable diseases/events can be found in the MOH National Surveillance Manual.

Table 9.4.1: Summary of Local Reporting Requirements for Class I Conditions Entity Health Provider

Parish Health Department

Reporting Content

To

Using

Timeline

Suspicious case of Class I condition or health event.

Indicate: - Demographic and contact information for the patient - Symptoms - Date of onset of symptoms - Travel history - Immunization history - Laboratory information (date of sample collection) - Other pertinent information to assist with case identification, investigation and data analysis Class I notifiable disease/ health event

Medical Officer (Health) at the parish health department

Class I Notifiable Disease Form (NB fill out form at first contact with the patient)

Report on suspicion within 24 hours of discovery

Regional Epidemiologist/ Surveillance Officer;

Telephone or faxed notification, followed by hard copies

Immediately on receiving Class I notification

National Surveillance Unit Parish Health Department in which patient resides, if it differs from the one in which he/she received healthcare

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9.4.2 Class II Diseases/Health Events Class II diseases are reported weekly in a line-listing format to the parish health department. Data captured on line lists should include: o Patientâ&#x20AC;&#x2122;s full name o Address and landmark or means of locating the individual if the address is not available o Next of kin o Age/date of birth o Sex o Occupation o Work/School address o Date of onset of symptoms o Date of first report o Lab results (if available) o Case classification

9.4.3 Class III Diseases/Health Events Class III diseases include sexually transmitted infections and are reported to the parish Health Department, Regional Health Authority and National Surveillance Unit as monthly case totals.

9.5

Roles and Responsibilities of Each Level

Parish For each reportable disease/health event, the parish: 1. verifies the diagnosis in order to confirm, discard the case, or request further investigation 2. searches for other cases (in the case of infectious diseases) 3. implements strategies to contain the spread of infectious diseases. This may include locating contacts Region The functions of the Regional Surveillance Unit include, but are not limited to, the following: 196

• • • • • •

collation, review and analysis of notification data transformation of notification data into information for action assist with investigation on exceptional cases development of prevention strategies and actions provision of support and resources for surveillance at the local level monitoring and evaluation of parish health departments

MOH Head Office At the NSU, all notifications and investigation reports received should be routed to the desk of the MO(H) responsible for surveillance. He/She is responsible for assigning a Surveillance Officer to follow up on the investigation. The surveillance officer is responsible for: • updating the notifiable diseases/health events electronic database; • ensuring that the relevant parish health department has initiated appropriate investigations; • ensuring that all relevant parish health departments have been notified, where more than one parish is involved, and that they are aware of their responsibilities in the investigation; • follow-up on the investigation periodically to ensure that investigation reports are completed and submitted to the NSU within the time frames specified.

9.6 Surveillance of VPDs 9.6.1 Acute Flaccid Paralysis (AFP)/Poliomyelitis Rationale for Surveillance Polio has been targeted for worldwide eradication by the World Health Organization. In order to verify eradication, a robust surveillance system that is capable of detecting possible cases of polio should be in place. The syndrome of acute flaccid paralysis is used to detect polio cases.

Surveillance Case Definition Acute onset of a flaccid paralysis in the absence of trauma. 35 35

MOH National Surveillance Manual 2009, page 24.

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Case Classification Suspected Case Any acute flaccid paralysis(AFP) in a person under 15 years of age, for which no cause can be immediately identified, or any case of suspected polio, regardless of age. (This includes cases diagnosed with Guillain–Barré syndrome or Transverse Myelitis.)

Probable Case A suspected case in which the paralysis is flaccid and no other cause for the paralysis can be immediately identified.

Confirmed Case A suspected or probable case, with or without residual paralysis, from which wild poliovirus is isolated from stool culture.

Note: Classification as ‘suspected’ is temporary. Cases should be reclassified by the Surveillance Unit as ‘probable’ or ‘discarded’ within 48 hours of initial notification.

Specimen Collection and Laboratory Investigation Confirmation of poliomyelitis is based on isolation of poliovirus from a clinical (stool) specimen.

Collection, storage, transportation • Collect a stool sample of approximately 12 grams (3 adult thumbnails) at first contact, and in any event, within 14 days after the onset of paralysis. Rectal swabs are not recommended because the amount of stool collected is inadequate for testing.

• Place stool in a clean, dry, screw-capped container without any preservative.

The container should be labelled with the patient’s name and date of collection.

• Place specimen(s) immediately in a cold box or refrigerator at 4oC pending transport. Transport on ice.

Laboratory Investigation • Specimens should be sent to the Enteric Section of the National Public Health Laboratory (NPHL), which forwards them to the WHO-accredited laboratory at the Caribbean Public Health Agency (CARPHA), formerly Caribbean Epidemiology Centre (CAREC), in Trinidad.

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•

The CARPHA Laboratory Form (see Appendix) must accompany the specimen and should have (in bold across the top): ‘For CARPHA’. The NPHL should be informed by phone that a specimen is en route.

Note: If the patient dies before stool samples can be collected, an autopsy should be performed within 24 hours of death to determine cause of death and collect appropriate samples. These should be sent to CARPHA and the University Hospital of the West Indies (UHWI) Virology Laboratory in accordance with the surveillance manual.

Reporting Procedure •

•

•

Healthcare providers should report suspected cases to the parish health department within 24 hours using the Class I Diseases Notification Form (see Appendix).

Health departments should notify the Regional Epidemiologist/Regional Surveillance Officer and the NSU immediately by phone or fax. Hard copies of the notification form must follow telephone/fax/email notifications. (Note: patient information should not be transmitted over the internet) NSU reports each case to the Family Health Unit and the EPI Regional Advisor at the CARPHA.

Case Investigation The Public Health Nurse assigned to the case should: 1.

Initiate a case investigation within 24 hours of case identification o Obtain clinical history and laboratory test results from physician o Obtain travel and immunization history o Ensure appropriate specimen is collected and transported to the appropriate laboratory o Visit the home, school, nursery or workplace as needed to search for other cases and obtain immunization history of close contacts o Initiate community and hospital surveillance for additional cases o Follow-up with attending physician/specialists for additional test results and clinical history, in preparation for completing the 60-day follow-up.

2. Complete and submit an Acute Flaccid Paralysis Investigation Form to the parish MO(H) within 7 days of notification (see Appendix H).

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3. Complete a 60-day Follow-up Form (see Appendix H) based on a review of residual paralysis; information on this form should be based on consultation with the patient, physician, or physiotherapist.

4.

Ensure that the patient is assessed by a physician at or after 60 days post the onset of paralysis.

Prevention and Control Measures Containment activities are required following the identification of a suspected case.

Intensified surveillance, immunization of close contacts, review of vaccination coverage and targeted immunization, and public education are all important parts of the outbreak response.

9.6.2 Congenital Rubella Syndrome (CRS) Rationale for Surveillance • • • •

Rubella and Congenital Rubella Syndrome are Class I notifiable diseases The most recent confirmed case of CRS occurred in 1998 This confirmed case indicates that transmission of the rubella virus was still occurring on the island up to that time period.

The Region of the Americas was certified to have eliminated rubella and congenital rubella syndrome in 2015.

Surveillance Case Definition and Classification Suspected Case • An infant less than one year of age clinically suspected of having CRS and presenting with one or more of the following: congenital cataracts, glaucoma, deafness, microphthalmia, microcephaly, congenital heart defects, meningoencephalitis OR • An infant born to a woman who had confirmed rubella infection during pregnancy or who received MMR vaccine during pregnancy.

OR • An infant less than one year of age with a positive result for Rubella IgM antibodies at a non-WHO accredited laboratory.

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Confirmed Case • A suspected case of CRS with supportive laboratory evidence from a WHO accredited laboratory.

Sampling Blood • At first contact, collect 5 to 10 mL of blood in a red-top tube.

• Additional convalescent blood specimens may be requested and should be collected in the same way.

• Keep blood specimens in an upright position for at least one hour to allow the blood to coagulate. The serum should be separated and stored at 4°C or less and transported to NPHL within 24 hours.

Urine • Urine specimens should only be taken from highly suspected cases and from confirmed cases to isolate the rubella virus and determine its source.

• Collect up to 100 mL of urine in an empty sterile specimen container.

• Keep cool at 4°C (ice packs or wet ice) until transported to the laboratory Transportation • •

Transport specimens to the Immunology Section of NPHL for shipment to the Caribbean Public Health Agency (CARPHA).

Notify the NSU and NPHL that the specimen is en route

Case Investigation The Public Health Nurse (PHN) assigned to the case should: 1. Initiate a case investigation within 48 hours of case identification o Obtain clinical history and laboratory test results from physician o Obtain mother’s immunization and travel history during pregnancy and history of illness/contact with rubella case during pregnancy o Ensure appropriate specimen is collected and transported to the appropriate laboratory o Visit the home to review immunization history of close contacts and search for other cases. All persons found to not be fully immunized or not have documentation of immunization should be vaccinated immediately o Initiate community and hospital surveillance for additional cases

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o Follow-up includes review of the case physician/specialists to obtain the final diagnosis.

with

the

attending

2. Complete and submit a CRS Investigation Form to the parish MO(H) within 4 to 6 weeks of notification.

Laboratory Investigation Diagnosis of CRS can be based on any one of the following: • Detection of rubella-specific IgM antibodies in infant serum specimen(s); • Maintenance or increase in IgG antibody titre between acute and convalescent samples • Isolation of rubella virus from nasopharyngeal swab, urine, CSF or blood • Detection of rubella virus in tissues by PCR. Reporting Procedure • • •

•

Class I notifiable disease Healthcare providers should report suspected cases to the parish health department within 24 hours using the Class I Diseases Notification Form Health departments should notify the Regional Epidemiologist/Surveillance Officer and the National Surveillance Unit (NSU) immediately by phone or fax.

Hard copies of the notification form must follow telephone/fax notifications.

NSU reports each case to the Family Health Unit and the EPI Regional Advisor at CARPHA.

Prevention and Control Measures • •

• •

Public education and routine immunization are key to CRS prevention.

Containment activities are required following the identification of a suspected case. Babies suspected of having rubella should be managed under contact isolation precautions and placed in a private room. [Only health care workers who are NOT PREGNANT should be involved in their medical care.] Medical providers should be notified immediately if the suspected case develops a rash.

Close contacts should be immunized if they are not already and should remain at home while they are still infectious.

Intensified surveillance, review of vaccination coverage and targeted immunization, and public education are all important parts of the response.

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9.6.3 Diphtheria Rationale for Surveillance Diphtheria is a severe infectious disease that has epidemic potential. Control of diphtheria is based on • Primary prevention of disease by ensuring high population immunity (target > 90% coverage) • Secondary prevention of spread by conducting rapid investigation of close contacts, as well as isolation/quarantine.

• Tertiary prevention of complications and death through early diagnosis and proper management Surveillance Case Definition and Classification Suspected Case • A person presenting with acute pharyngitis or laryngitis AND a tonsillar or laryngeal pseudomembrane Confirmed Case Cases may be confirmed in one of two ways: • A laboratory confirmed case is a suspected case from whom Corynebacterium diphtheriae was isolated from bacterial culture • An epidemiologically confirmed case is a suspected case that is epidemiologically linked to a laboratory confirmed case Case Reclassification Suspected cases are reclassified as confirmed or discarded based on laboratory investigations.

Reporting Procedure • • •

•

Class I notifiable disease Healthcare providers should report suspected cases to the parish health department within 24 hours using the Class I Diseases Notification Form Health departments should notify the Regional Epidemiologist/Surveillance Officer and the National Surveillance Unit (NSU) immediately by phone or fax.

Hard copies of the notification form must follow telephone/fax/email notifications.

NSU reports each case to the FHU and the EPI Regional Advisor at PAHO.

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Case Investigation The Public Health Nurse assigned to the case should: 1. Initiate a case investigation within 48 hours of case identification o Obtain clinical history and laboratory test results from physician o Obtain travel and immunization history o Ensure specimen collection and transportation to the appropriate laboratory o Visit the home, day care, nursery or workplace to review immunization history of close contacts and search for other cases. All persons found to not be fully immunized, or not have documentation of immunization, should be vaccinated immediately. o Initiate community and hospital surveillance for additional cases o Follow-up includes: review of the case to obtain the final diagnosis and outcome; home visit; check for additional cases; follow-up vaccinations 2. Complete and submit an investigation report to the parish MO(H) within 7 days of notification.

Specimen Collection and Laboratory Investigation Laboratory confirmation of Diphtheria is based on: • Culture of C. diphtheriae (throat, nose, nasopharyngeal, skin) • Gram stain may aid in diagnosis Caution: Ensure that personal protective equipment is used and that respiratory support is available Collection, storage, transportation Throat, nose, nasopharyngeal, skin swabs: • At first contact, swab the lesion with a cotton-tipped swab stick.

• Place swab in transport (Amies) medium and transport at room temperature.

• Parish Health Department should contact the Microbiologist at NPHL upon collection of the sample and verify the collection of the sample.

Laboratory Investigation • Transport specimens to the bacteriology section of NPHL accompanied by a copy of the completed CARPHA laboratory request form (see Appendix H). Age of the patient, clinical presentation, and site of the swab are mandatory fields 204

Prevention and Control Measures • •

•

Public education and routine immunization are key to diphtheria prevention.

Control measures are required following the identification of a suspected case. o Suspected cases should be placed in strict isolation and treated o All articles in contact with patient and all articles soiled by discharges of patient should be disinfected by terminal cleaning.

Close contacts should remain at home until they can no longer infect others, and should be vaccinated against diphtheria if they are not fully immunized.

Prophylactic treatment of carriers ♦ All close contacts should have cultures taken for testing and should be kept under surveillance for 7 days. ♦ A single dose of penicillin (IM) or a 7-10-day course of erythromycin (PO) is recommended for all persons exposed to diphtheria, regardless of their immunization status. A single dose of benzathine penicillin G (IM) (600,000 units for persons <6 years of age and 1.2 million units for persons 6 years of age) or a 7-10 day course of erythromycin (PO) (40 mg/kg/d for children and 1 g/d for adults) has been recommended. If cultures are positive, they should be treated with antibiotics. ♦ Contacts who handle food or work with school children should be excluded from work or school until bacteriologic examination proves them not to be carriers. ♦ Previously immunized contacts should receive a booster dose of diphtheria toxoid, and a primary series should be initiated in un-immunized contacts, using Td, DT, DTP vaccine depending on age. ♦ The search for carriers by use of nose and throat cultures is not ordinarily useful or indicated.

Epidemic measures ♦ Immunize the largest possible proportion of the population group involved, with emphasis on protection of infants and preschool children. ♦ In an epidemic involving adults, immunize groups that are most affected and at high risk. Repeat immunization procedures 1 month later to provide at least 2 doses to the recipients. ♦ Identify close contacts and define population groups at special risk. In areas with appropriate facilities, carry out a prompt field investigation of reported cases to verify diagnosis, determine biotype and toxigenicity of C. diphtheriae.

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9.6.4 Fever with Rash Measles was eliminated from Jamaica in 1995 (last case in 1991) after years of intense effort through immunizations and surveillance. In 1998, Jamaicaâ&#x20AC;&#x2122;s Ministry of Health embarked on a similar programme to eliminate rubella. At that time, surveillance for these two febrile rash diseases were integrated into fever with rash surveillance. Jamaica remains on high alert for imported cases and so surveillance is ongoing.

Surveillance Case Definition and Classification Suspected Case Any person presenting with, or giving a history of a body temperature > 38oC (101.0oF) rectally or >38.6oC (101.5oF) axillary AND a generalized rash. Cases with fever and rash, for whom there is no obvious diagnosis or focus of infection, should be reported.

Case Reclassification Suspected cases are re-classified as confirmed or discarded based on laboratory investigations for measles and rubella. For cases lost to follow up, a review of the medical records by a physician should be done to classify the case.

The following scheme is used in the PAHO region for case classification.

Fever with Rash

Adequate Specimen

Measles/Rubella IgM positive

Confirm*

Measles/Rubella IgM negative

Discard Clinically confirmed Measles

Inadequate Specimen

Case dead, or lost to follow-up.

Figure 9.6.4.1: Scheme used in the PAHO region for case classification.

Expert Review

Discard

* If a case has documentation of immunization with MMR 2 to 4 weeks prior to specimen collection, then discard as per advice from the CARPHA laboratory.

Reporting Procedure â&#x20AC;˘

Class I notifiable disease

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• •

•

Healthcare providers should report suspected cases to the parish health department within 24 hours using the Class I Diseases Notification Form Health departments should notify the Regional Epidemiologist/Surveillance Officer and the National Surveillance Unit (NSU) immediately by phone or fax.

Hard copies of the notification form must follow telephone/fax/email notifications. (Note: patient information should not to be transmitted via the internet) NSU reports each case to the Family Health Unit and the EPI Regional Advisor at PAHO.

Case Investigation Fever and rash requires the first contact strategy, i.e. the case investigation is conducted by the first healthcare worker to see the case: 1. Initiate and submit a case investigation immediately: o Obtain clinical history and laboratory test results from physician. o Obtain travel and immunization history. o Ensure specimen collection and referral to the appropriate laboratory. o The PHN assigned to the case should: visit the home, daycare, nursery, school or workplace to review immunization history of close contacts and search for other cases. All persons found to not be fully immunized, or not have documentation of immunization, should be vaccinated immediately with MMR. o Initiate community and hospital surveillance for additional cases. o Follow-up including review of the case with the attending physician/specialists to obtain the final diagnosis, and follow-up vaccinations at the home of the patient.

Specimen collection and laboratory investigation Laboratory testing for measles (and confirmation of rubella) must be done in a WHO accredited laboratory which uses standard methods and approved reagents, and which will have passed a recent proficiency test. At the writing of this document, the only WHO accredited laboratory within the Caribbean sub-region is located at the Caribbean Public Health Agency (CARPHA) in Trinidad.

The presence of IgM antibodies in serum indicates recent exposure to the virus, either through infection or immunization. Highly suspicious cases or confirmed cases should also have urine cultures processed for isolation of measles or rubella virus. This will assist in identification of the source of the virus.

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Specimen Blood – Acute: Approximately 5 to 10mL of blood should be collected in a red-top tube, i.e. one without any preservatives or anticoagulant. An acute specimen should be collected at first contact and A convalescent sample thereafter Blood – Convalescent: Depending on the type of test done, a convalescent specimen may be requested. This should be taken 4 to 6 weeks after the acute specimen.

Handling and Storage of Specimens Blood: Blood specimens should be kept in an upright position for at least one hour to allow the blood to coagulate. If possible, the serum should be separated from the clot and placed into a clean receptacle i.e. a different red-top tube, a cryovial, or other suitable vial for safe transport of serum. The serum should be stored at 4°C or less until transportation to the laboratory. Storage of separated serum at –20°C is optimal.

If serum separation is not possible at the collection site, the tube containing the clotted blood should be kept cool (but not frozen) and shipped to the laboratory within 24 hours after collection.

The specimen should be transported to the Immunology Section of the National Public Health Laboratories for shipment to CARPHA. The laboratory form should have (in bold across the top): ’For CARPHA’. The laboratory should be informed by phone that a specimen is en route.

At the Immunology Laboratory of the NPHL, the serum sample should be divided into two aliquots, each to be stored in cryovials approved by CARPHA. One aliquot is to be shipped to CARPHA and the second to be tested at the NPHL (also to serve as a backup in case of mishandling or loss of the sample sent to CARPHA).

Urine: Urine specimen should be taken from high-risk individuals. The purpose of collecting a urine specimen is for virus isolation. This allows the laboratory to study the virus and obtain epidemiological information necessary to determine the original source.

High-risk individuals are: • visitors to Jamaica (especially from a country where measles is circulating); • locals who have been in contact with a visitor or have visited another country where measles is endemic recently; or

208

•

persons that form a cluster of suspected measles cases (random urine samples should be taken).

Collection and Processing of Urine Specimen • Urine should be collected within 5 days of rash onset (1-3 days is best).

• First-morning voided urine is ideal, but any urine specimen is adequate.

• A volume of up to 100 mL of urine should be collected in an empty sterile specimen container.

• The urine specimen must be kept cool at 4°C (ice packs or wet ice) and transported to the immunology section of the NPHL immediately or, in any case, within 24 hours. The laboratory and the NSU must be notified that a specimen is en route as these specimens require special handling.

• At the NPHL, the following must be done: o 50 mL of urine specimen should be transferred to a sterile plastic centrifuge tube and centrifuged at 1500rpm for 5-10 minutes at 4°C to pellet the sediment. If no refrigerated centrifuge is available, an ordinary centrifuge will do. o The sediment should be re-suspended in 2 mL of viral transport media and stored at –70°C (if available) or –20°C pending shipment to CARPHA. It is very important that the samples arrive at CARPHA within 5 days from the date of collection. This ensures optimal virus recovery.

Prevention Measures Public education and routine immunization are key to measles and rubella prevention.

Control Measures • Timely investigation to include o Home visit within 48 hours of notification o Adequate specimen collection • Control measures are required following the identification of a suspected case. o Suspected cases should be removed from the presence of young children and infants, until they have been classified as discarded. o Highly suspicious (symptomatic high-risk cases) should be placed in respiratory isolation and treated until laboratory results are obtained. o Confirmed measles cases should be treated appropriately and placed in respiratory isolation until day 5 after the onset of rash.

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•

o Symptomatic close contacts of a confirmed or highly suspicious case should be placed in respiratory isolation and investigated as suspected cases. o Asymptomatic close contacts of a confirmed or highly suspicious case should be quarantined at home until they can no longer infect others (21 days after last exposure). They require vaccination against measles and rubella if not fully immunized or if evidence of immunization is not available.

Definition of a contact: A person that lives in the same household of the case or has close contact with the case 5 days before to 5 days after the onset of rash in the case.

Data Management & Analysis The following indicators must be monitored at both parish and national levels: • Percentage of sites (Sentinel and HAS) reporting every week (target is 90% or greater); • Percentage of sites reporting on time (target is 80% or greater); • Fever with Rash cases with investigations initiated in less than 48 hours after presentation to a health care facility (target is 80% or greater); • Cases with adequate blood specimens or epidemiological linkage to confirmed measles/rubella case (target is 80% or greater); • Specimens arriving at CARPHA within 5 days of collection; • Proportion of total laboratory confirmed cases with source of infection identified (target is 80% or greater).

• Number of cases with immunization history recorded and number with adequate immunization with MMR (i.e. 2 doses); • Number of cases confirmed and number discarded; • Proportion of total cases with adequately completed investigation forms, which must include the following data points. o unique identifier o address (community and parish) o name o date of birth o date of rash onset o date of notification o date of initiation of case investigation o date of specimen collection o date specimen sent to lab o number of doses of measles-containing vaccine received o date of last doses of measles-containing vaccine 210

9.6.5 Hepatitis B Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). It is a major global public health problem as it can cause chronic infection and puts people at high risk of death from cirrhosis and liver cancer. Hepatitis B is also an important occupational hazard for health workers.

Surveillance Case Definition and Classification Suspected case A person presenting with anorexia, abdominal pain, nausea, vomiting and jaundice; Or a person, with or without symptoms, who has been in close contact with a confirmed case. Close contact includes sexual contacts, household contacts and children in nurseries/day-care centers.

Confirmed case A suspected case with laboratory confirmation of Hepatitis B infection:   

Detection of serum antibodies to the hepatitis B surface antigen (HBsAg); OR Detection of serum antibodies to the core antigen (HBcAg); OR Detection of serum antibodies to the e antigen (HBeAg).

Case Reclassification: Reclassification of suspected or probable cases to ‘confirmed’ is based on laboratory evidence of infection.

Reporting Procedure • • •

•

Class I notifiable disease Healthcare providers should report suspected cases to the Parish Health Department within 24 hours using the Class I Diseases Notification Form Health departments should notify the Regional Epidemiologist/Surveillance Officer and the National Surveillance Unit (NSU) immediately by phone or fax.

Hard copies of the notification form must follow telephone/fax/email notifications.

NSU reports each case to the Family Health Unit and the EPI Regional Advisor at PAHO. 211

Case Investigation Cases should be investigated using the standard form provided by the Surveillance Unit.

The time frame for submission of case investigation reports to the parish MO(H) is 6 weeks from identification of the case. Case investigation is the responsibility of the public health nurse and the contact investigator as directed by the parish MO(H).

In general, investigation involves: • Taking of case history to attempt to discover the source of the infection e.g. history of sexual contacts, occupational risk, or other risk (history of obtaining a tattoo, injection drug use, recipient of donated blood or blood product, etc).

• Counselling of sexual and household contacts re risk of exposure, symptoms, sequelae and disease spread; • Testing of contacts to determine if they have also been infected.

For details on case investigation and counseling, refer to the Ministry of Health’s Contact Investigation Field Guide Manual.

Specimen Collection and Laboratory Investigation Three clinically useful antigen-antibody systems have been identified for hepatitis B: 1. hepatitis B surface antigen (HBsAg) and antibody to HBsAg (anti-HBs); 2. hepatitis B core antigen (HBcAg) and antibody to HBcAg (anti-HBc); and 3. hepatitis B e antigen (HBeAg) and antibody to HBeAg (anti-HBe).

HBsAg can be detected in the serum from several weeks before onset of symptoms to days, weeks or months after onset; it persists in chronic infections. HBsAg is present in serum during acute infections and persists in chronic infections. The presence of HBsAg indicates that the person is potentially infectious. Anti-HBc appears at the onset of illness and persists indefinitely. Demonstration of anti-HBc in serum indicates HBV infection, current or past; IgM anti-HBc is present in high titre during acute infection and usually disappears within 6 months, although it can persist in some cases of chronic hepatitis; thus, this test may reliably diagnose acute HBV infection. The presence of HBeAg is associated with relatively high infectivity.

Specimen Blood: Approximately 5 to 10 mL of blood should be collected in a red-top tube i.e. one without any preservatives or anticoagulant.

212

Retesting: Persons that test positive for HBsAg should be retested 6 months subsequently to differentiate persons who have cleared the virus from those with chronic infection.

Handling and Storage of Specimens Blood specimens should be kept in an upright position for at least one hour to allow the blood to coagulate. If possible, the serum should be separated from the clot and placed into a clean receptacle i.e. a different red-top tube, a cryovial or other suitable vial for safe transport of serum. The serum should be stored at 4°C or less until transportation to the laboratory. Storage of separated serum at –20°C is optimal.

If serum separation is not possible at the collection site, the tube containing the clotted blood should be kept cool (but not frozen) and shipped to the laboratory within 24 hours after collection. The specimen should be transported to the Immunology Section of the National Public Health Laboratory.

Prevention and Control There is no cure for Hepatitis B infection. The majority of cases will develop antibodies to the HBsAg antigen and clear their infection in a few weeks or months. Some persons, however, will become chronically infected. The infection is considered chronic when HBsAg persists for longer than 6 months after the resolution of symptoms.

Preventive measures Spread of this virus can be prevented using the following strategies: • The general public should be educated on the nature of the infection – risk factors for acquiring the virus, the symptoms, and the value of immunization against it.

• All health workers (e.g. surgeons, dentists, oral surgeons, pathologists, operating room and emergency room staff, and clinical laboratory workers who handle blood are at highest risk) should receive the hepatitis B vaccination series.

• Healthcare workers should always employ universal precautions when handling blood, blood products, organs, tissue, semen or other body fluids. They should also practice the recommended procedures for safe disposal of used needles.

• Health facilities should ensure that the proper containers are used for discarding of needles so as to decrease incidences of needle stick injuries; • Blood donors should be tested for Hepatitis B infection; • Infected persons should be educated on the nature of the disease and how it is spread.

They should be educated on strict condom use for every sex act.

• Infected persons should not donate blood, plasma, body organs or tissues, or semen until it can be demonstrated that the HBsAg test is negative.

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•

• •

• •

Women who are infected should be made aware that if they become pregnant during the period that they test positive for the HBsAg, there is a high likelihood that they will pass the virus to their unborn child.

Infants born to women who are actively infected should be given Hepatitis B immune globulin along with a hepatitis B vaccination series as soon as possible after birth.

Infected persons should be educated on methods of preventing spread to household contacts i.e. cuts or skin lesions should be covered; toothbrushes, utensils, razors etc. should not be shared with others.

Infected persons should be educated to always inform health care practitioners e.g. dentists and physicians of their infectious status.

All infants must be immunized with the hepatitis B vaccine as per government schedule.

Control measures The main methods of control are: • Vaccination to prevent infection; • Contact tracing of confirmed cases to identify new cases and prevent spread; • Treatment of recent contacts of confirmed cases with immune globulin (e.g. infants born to infected mothers).

9.6.6 Pertussis Pertussis, or whooping cough, is a disease of the respiratory tract caused by Bordetella pertussis bacteria that live in the mouth, nose and throat. Because it is highly communicable and affects unimmunized infants in particular, pertussis remains a public health concern globally, including in countries where vaccination coverage is high.

Surveillance Case Definition and Classification Suspected Case • 36A person with a cough lasting at least 2 weeks with at least one of the following: o paroxysms (i.e. fits) of coughing o inspiratory “whooping” o post-tussive vomiting (i.e. vomiting immediately after coughing) o without other apparent cause

36

WHO Recommended Surveillance Standards 2nd Edition (WHO/CDS/CSR/ISR/99.2) http://www.who.int/csr/resources/publications/surveillance/whocdscsrisr992.pdf

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Confirmed Case Cases may be confirmed in one of three ways: • A laboratory confirmed case is a suspected case with positive laboratory findings.

• An epidemiologically confirmed case is a suspected case that is epidemiologically linked to a laboratory confirmed case.

• A clinically confirmed case is a suspected case that has been evaluated by a competent medical professional and diagnosed with Pertussis. Pertussis is commonly diagnosed based on history and physical examination findings.

Case Reclassification Suspected cases are re-classified as confirmed or discarded based on laboratory investigations or evaluation by a competent medical professional.

Reporting Procedure • •

•

Health care providers should report suspected cases to the Parish Health Department within 24 hours using the Class I Diseases Notification Form.

Health departments should notify the Regional Epidemiologist/Surveillance Officer and the National Surveillance Unit (NSU) immediately by phone or fax.

Hard copies of the notification form must follow telephone/fax notifications.

NSU reports each case to the Family Health Unit and the EPI Regional Advisor at PAHO.

Case Investigation The Public Health Nurse (PHN) assigned to the case should: 1) Initiate a case investigation within 48 hours of case identification. o Obtain clinical history and laboratory test results from physician. o Obtain travel and immunization history. o Ensure specimen collection and referral to the appropriate laboratory. o Visit the home, day care, nursery, school or workplace to review immunization history of close contacts and search for other cases. All persons under age 7 years found to not be fully immunized, or not to have documentation of immunization, should be vaccinated immediately. o Initiate community and hospital surveillance for additional cases. o Follow-up includes review of the case with the attending physician/specialists to obtain the final diagnosis, and follow-up vaccinations at the home of the patient.

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2) Complete and submit an investigation report to the parish MO(H) within 6 weeks of notification.

Specimen Collection and Laboratory Investigation Collection, storage, transportation Nasopharyngeal Swab: • Prior to sample collection, contact National Surveillance Unit and Consultant Microbiologist at NPHL. • At first contact and as early in the cough as possible, swab the posterior nasopharynx with polyester (Dacron), rayon or nylon-tipped swab and place in Reagan-Lowe or Amies medium containing charcoal. Transport to the laboratory between 15oC to 30oC (room temperature).

• Contact the laboratory to ensure that blood agar plates are available and make alternative arrangements with NPHL or other laboratory if they are not.

• Rapidly transport the swab to NPHL (with correct media) at room temperature within 24 hours OR streak the swab onto Reagan-Lowe or Bordet-Gengou agar (with 15% defibrinated horse blood).

Blood: • In the event of a verified or suspected outbreak, collect blood in a red top tube and store upright for approximately 1 hour (or until blood has coagulated).

• Separate the serum and place it in a sterile tube for transport to the laboratory.

• Serum samples should be sent to the Immunology Section of NPHL for shipment to CARPHA. o NPHL should be informed by phone that the serum is en route. o The laboratory form should have (in bold across the top): “For CARPHA”.

Laboratory confirmation of pertussis is based on: • Isolation of Bordetella pertussis from culture of the posterior nasopharynx.

• Direct fluorescent antibody testing • Polymerase Chain Reaction (PCR) • Detection of pertussis-specific serum IgM may aid in diagnosis Prevention Measures Public education and routine immunization are key to pertussis prevention.

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Control Measures Control measures are required following the identification of a suspected case.

• Suspected cases should be removed from the presence of young children and infants, until they have received at least 5 days of a minimum 14-day course of antibiotics.

• Confirmed cases should be placed in respiratory isolation and treated.

• Symptomatic close contacts should remain at home until they can no longer infect others. They should also receive a 14-day course of Erythromycin regardless of age and immunization status.

• Asymptomatic contacts should be vaccinated against pertussis if they are below age 7 years and not fully immunized. Whole cell pertussis-containing vaccine is not given to persons older than 7 years of age. They should also receive a 14-day course of Erythromycin regardless of age and immunization status.

9.6.7 Tetanus Tetanus is a Class 1 notifiable disease and is targeted for elimination by the WHO. Surveillance Case Definition and Classification Suspected a) Neonatal Tetanus – An infant between the ages of 3 to 28 days who, having been able to suck normally for the first few days after birth, develops an inability to suck.

Death of a neonate between the ages of 3 and 28 days should be reviewed by a competent medical professional as to the possibility that death was caused by tetanus.

b) Non-neonatal Tetanus – Any person experiencing difficulty swallowing, contraction of the jaw and neck muscles, followed by muscle spasm and rigidity.

History of an injury is supporting evidence of possible exposure but is not necessary.

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Confirmed: a)   

Neonatal Tetanus – A suspected case with one or more of the following: Facial grimace; Stiffness of the body and arching of back; Generalized spasms or convulsions.

Figure 9.6.7.1: Neonatal Tetanus

b) Non-neonatal Tetanus – A suspected case exhibiting the typical facial expression (risus sardonicus).

Figure 9.6.7.2: Risus sardonicus

Case Reclassification: Suspected cases are confirmed or discarded based on case history and clinical presentation.

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Reporting Procedure • •

•

Health care providers should report suspected cases to the Parish Health Department within 24 hours using the Class I Diseases Notification Form Health departments should notify the Regional Epidemiologist/Surveillance Officer and the National Surveillance Unit (NSU) immediately by phone, secured email or fax. Hard copies of the notification form must follow telephone/fax notifications.

NSU reports each case to the Family Health Unit and the EPI Sub-Regional Advisor at PAHO.

Case Investigation Every suspected case of tetanus must be investigated within 48 hours using the appropriate investigation form. Completion of the form is the responsibility of a public health nurse assigned to the case by the parish MO(H) and must be done and submitted within 6 weeks of case notification.

The Public Health Nurse, along with the Public Health Inspector, is responsible for: • Case review to obtain the clinical history, date and site of injury, date of illness onset, signs and symptoms, and current presentation; • obtain details of immunization history; • Ensuring specimen collection and referral to the appropriate laboratory (optional depending on the case’s history and presentation); • Conducting a home visit to evaluate living conditions (this goes towards education for injury prevention, proper cleaning of wounds, etc.) and to review immunization status of household members, especially children and pregnant women. Follow-up of case review with physician to obtain final diagnosis; • Follow-up home visit to review the case, ensure implementation of previous recommendations, and follow-up vaccinations as necessary.

Laboratory Investigation An appropriate specimen from debridement, or wound swab should be collected and sent to NPHL or CRH (Bacteriology section) along with a copy of the investigation form.

Note: The diagnosis may be made without laboratory tests. The isolation of the organism from the wound is of little value since it may be recovered from the wounds of persons who show no signs of tetanus.

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Prevention and Control Preventive measures There are three main lines of prevention: • Active immunization against tetanus, • Antibacterial measures for wounds and deliveries of babies, and • Passive immunization of possible cases with immune globulin. a) Active Immunizations: Active immunization with tetanus toxoid is the most satisfactory method of preventing tetanus. Ideally everyone should be given a course of active immunization. The immunization schedule for children in Jamaica is as follows:

Children: • • • • •

Age 6 weeks: Age 3 months: Age 6 months: Age 18 months: Age 4 – 6 years:

First DPT vaccine Second DPT Third DPT 1st DPT Booster 2nd DPT Booster

Adults: • Booster doses (with DT or Td, as appropriate) can then be given periodically, e.g. every 5 to 10 years or whenever the person is seriously injured. Special attention should be paid to high risk groups e.g. military, farm workers and veterinarians.

• Women of childbearing age should be fully immunized (at least 5 doses). If there is no documentation of this, women should have a minimum of 2 doses during their current pregnancy in order to protect newborn babies against tetanus during that pregnancy. Following delivery, they should complete the Tetanus vaccine series.

•

•

•

b) Antibacterial Measures The general public should be educated on the hazards of puncture wounds, proper cleansing of wounds with soap and water, and seeking medical intervention when appropriate.

Medical institutions must employ appropriate measures for adequate cleaning of wounds and careful debridement as well as protection of wounds to avoid contamination.

Maternity personnel and institutions should institute/maintain clean delivery programmes to prevent cases of neonatal tetanus.

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•

Antibiotics, especially long acting penicillin, can also be given to suppress bacterial multiplication. If the wound is old, i.e. more than 12 hours, tetanus may occur despite adequate doses of penicillin.

c) Passive Immunization: Tetanus antitoxin (ATS) or Tetanus Immune Globulin (TIG) are used for treatment.

Fifteen hundred (1500) units of ATS are given in the average case although a larger dose may be required for patients who present with heavily contaminated wounds. TIG is administered intramuscularly at a dose of 3000 to 6000 IU. Note: A test dose of ATS should be given to patients in order to test for adverse reactions. Repeated doses are not recommended, as it will lead to sensitization of the patient thereby creating the hazard of allergic reaction. These later doses are also rapidly eliminated from the body and are therefore less effective for prevention and treatment.

Treatment 1. Proper cleansing and debridement of wounds; 2. Tetanus Immune Globulin given intramuscularly or intravenously; 3. Penicillin in large doses.

9.6.8 Tuberculosis The overall objective of tuberculosis control is to reduce morbidity, mortality and transmission of the disease until it no longer poses a threat to public health.

Case Definition Suspected TB case: Persistent cough for greater than three (3) weeks, with fever, night sweats and weight loss.

Confirmed TB case: • Bacteriologically confirmed case is one from which a biological specimen is positive by smear microscopy, culture or WHO recognized rapid diagnostic test, e.g. Xpert MTB/RIF • Clinically diagnosed TB case is one who does not fulfill the criteria for bacteriological confirmation but has been diagnosed with active TB by a medical practitioner who has decided to give a complete course of treatment.

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See the Tuberculosis manual and the National Surveillance Manual for details on surveillance for this disease.

Classification of Tuberculosis 1. Pulmonary tuberculosis Bacteriologically confirmed or clinically diagnosed case of tuberculosis involving the lung parenchyma or the tracheobronchial tree. Miliary tuberculosis is classified as pulmonary tuberculosis. A person with both pulmonary and extrapulmonary tuberculosis should be classified as pulmonary tuberculosis.

2. Extrapulmonary tuberculosis Any bacteriologically confirmed or clinically diagnosed case of tuberculosis involving organs other than the lungs, e.g. pleura, lymph nodes, joints, bones, meninges.

Laboratory Investigation Specimen required: - Adults: three (3) consecutive early-morning sputum samples - Children: three (3) consecutive early-morning gastric washings

Interpretation of Tuberculin skin test (Mantoux) Tuberculin testing in Jamaica is done using bioequivalent to 2 IUs of the International Standard of Purified Protein Derivative (PPD).

Immunocompetent persons In general, a skin reaction to tuberculin skin testing that results in an induration of 10 mm or more indicates exposure to Mycobacterium tuberculosis, M. africanum or M. bovis.

This person should be classified as a suspected case of Tb and investigated as such.

Note: A person who has received BCG immunization can have a positive reaction (i.e. >10mm induration). It is therefore important to obtain documentation of BCG immunization on all persons being tested. This documentation, along with review of the personâ&#x20AC;&#x2122;s risk factors for acquiring Tb, chest x-ray and/or clinical examination, can be used to decide whether the person under investigation should be classified as a suspected case or cleared from further Tb-related investigations. A person with positive skin test 222

can only be cleared after evaluation by a senior medical professional in collaboration with the parish MO(H) or Regional Epidemiologist.

Immunocompromised persons The Mantoux skin test in immunocompromised persons is not reliable as immune impairment may result in atypical reactions to the tuberculin antigens. The reaction may be suppressed in tuberculosis patients with advanced disease; during certain acute infectious diseases e.g. measles; by immunization with live attenuated viruses; and in people who are immunosuppressed by disease (especially AIDS), drugs or malnutrition.

For these reasons, an induration of 5 mm or more should be considered indicative of tuberculosis infection for symptomatic household contacts of infectious tuberculosis cases, persons with an abnormal chest radiograph suggesting old healed tuberculosis, and people with HIV infection.

9.6.9 Other Vaccine Preventable Diseases Please see the National Surveillance Manual for the surveillance of other vaccine preventable diseases such as Meningococcal meningitis, Yellow Fever, Gastroenteritis, etc. These diseases should be investigated using the standard investigation form provided by the Surveillance Unit and within the time frames specified by the manual.

223

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Chapter 10: Adult & Older Child Immunization 10.1 Introduction Today fewer children die each year from vaccine-preventable diseases than adults. This is attributable to the tremendous achievement of childhood immunization programmes.

Effort is now required to achieve an equivalent success with adult morbidity and mortality.

Vaccines are an important step in protecting adults and older children against serious, sometime deadly diseases. Even if persons were vaccinated during infancy or early childhood, the protection for some vaccines can wear off with time, or the viruses or bacteria that the vaccine protects against change, so that the individual’s resistance may not be as strong. As one gets older, one may also be at increased risk for vaccine preventable diseases due to age, job, hobbies, travel or health conditions.

The routine vaccination programme established for children under the age of seven years is protected by the Public Health Act Immunization Regulation (Amended 2013). The MOH has also made provisions for the administration of selected vaccines to adults and older children in specified target groups as follows: ● Women of childbearing age ● Adults during special campaigns or who require certain vaccines such as DT, MMR, Polio, Hep B under special circumstances ● People with wounds which require administration of DT ● Contacts of person infected with Hepatitis B ● Healthcare workers ● Travelers ● Adolescent girls

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Table 10.1.1: Vaccines provided by MOH for adults and older children in specified target groups

Vaccine HPV Seasonal influenza (inactivated) DT

Hep B MMR Polio Yellow Fever

Target groups Adolescent girls (Grade 7) Healthcare workers, pregnancy women, children and elderly with chronic illnesses, non-health frontline workers, parliamentarians, institutionalized persons Pregnant women, special high-risk populations e.g. farmers, diabetics, elderly, carpenters and those with similar occupational hazards for tetanus (see section 4.5) Persons at high risk of Hep B infection (e.g. contacts of cases), adolescents with HIV that were not previously vaccinated in childhood Adults and older children that are not fully vaccinated Persons traveling to endemic countries that require booster doses Persons traveling to endemic countries

When a vaccine is given to an adult or older child for any reason, it must be recorded in the adult & older child immunization register, the client health record, and the client immunization card.

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10.2 Special Groups Table 10.2.1: Recommended vaccines for special groups

Special group

Recommended Vaccine

Remarks

Healthcare workers

Flu, Hep B, DT, MMR

See MOH Infection Prevention and Control Manual

Pregnant women

DT, Flu

Special occupations: Emergency responders and Flu, Hep B, DT other frontline workers (fire, armed forces); sanitation workers; fisher folk Adults with chronic conditions: Cardiovascular disease

Flu

Diabetes mellitus

Flu, DT, Hep B

Liver disease

Flu, DT, Hep B, MMR

Renal disease

Flu, DT, Hep B, MMR

HIV

CD4â&#x2030;Ľ200: Flu, DT, Hep B, MMR CD4<200: Flu, DT, Hep B

Other immunocompromised

Flu, DT

International travelers

Yellow fever, OPV*

Immigrants and refugees

DT, MMR, OPV

Regarding Hep B: only HbsAb and HbsAg negative individuals should be vaccinated; adolescents living with HIV who were not immunized against Hep B should be immunized.

See MOHâ&#x20AC;&#x2122;s: Action Plan for the Medical and Health Management of Refugees / Displaced Persons / Illegal Immigrants

*OPV booster recommended if travelling to an endemic country 227

10.3 Vaccination with DT (Adult) and Prevention of Tetanus Following Injury Table 4.6.1 illustrates when to vaccinate with DT and when to give Tetanus Immune Globulin (TIG) in the case of injury. After an injury, it is very important that all wounds are adequately cleaned, and that foreign material and dead tissue are removed from the wound. The decisions are based on the type of wound and the patient’s immunization history. If vaccines are needed, they should be given as soon as possible following injury.

DT and TIG may be given at the same time as long as they are injected into different limbs, using separate syringes.

Please refer Chapter 4 on Vaccines, section 4.6 entitled “DT ADULT VACCINE: DT (A) or DT or Td” for further details.

10.4 Maternal and Neonatal Immunization ‘Maternal and neonatal immunization’ refers to immunization given prior to pregnancy, during pregnancy, and during the post-partum period. Maternal immunization is intended to provide protection not only to the mother, but also to the foetus and newborn by allowing transfer of high concentrations of protective antibodies from the mother to the child until active immunization of the infant can take place. The WHO highly recommends maternal immunization for preventing neonatal tetanus and influenza.

Figure 10.4.1 illustrates how maternal immunization is aligned with the wider immunization programme and how it is integrated into the continuum of maternal, neonatal, child and adolescent care.

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Figure 10.4.1: Integration of maternal immunization with other health services 37

Recommendations for maternal vaccination in Jamaica are summarized in Table 10.4.1 â&#x20AC;˘

â&#x20AC;˘

Tetanus is particularly common in newborn infants and their mothers when they have not been adequately vaccinated. Neonatal tetanus is on the verge of elimination worldwide and can be prevented by immunizing women of reproductive age with tetanus-containing vaccine, either prior to or during pregnancy.

Pregnant women are at increased risk of influenza illness and its complications, and so are their infants. The negative impact of influenza infection on pregnant women and newborns is well documented. Influenza vaccination is recommended at any stage of pregnancy to protect both mother and infant

37

PAHO/WHO. Maternal and neonatal immunization field guide for Latin America and the Caribbean.

2017

229

Table 10.4.1: Recommended maternal immunization schedule38

Vaccines recommended during pregnancy

Vaccine Tetanus/ diphtheria

Prepregnancy Yes (ideal time)

Inactivated influenza

Vaccines NOT recommended in pregnancy

Vaccines recommended during pregnancy in special situations only

Hepatitis B

Yellow fever

IPV

OPV

Measles, mumps, rubella HPV

Yes (ideal moment) Yes (ideal moment)

Pregnancy Yes, 2 doses if not previously vaccinated Yes (ideal time)

Yes, if she did not complete the schedule and if under a high-risk situation (e.g. >1 sexual partner during previous 6 months, STD, injection drug user, partner +ve for HBsAg Yes, prior to travel to endemic areas under current outbreak, with prior risk/ benefit analysis Yes, prior to travel to endemic areas under current outbreak Yes, prior to travel to endemic areas under current outbreak NO

NO

38

Post-partum Yes, to complete the schedule Yes, if she was not vaccinated during pregnancy, to protect the newborn Yes, to complete the schedule (3 doses)

Yes, if not vaccinated during pre-pregnancy To complete the series if started prior to pregnancy

PAHO/WHO. Maternal and neonatal immunization field guide for Latin America and the Caribbean.

2017

230

When a woman of childbearing age or a pregnant woman comes for health services to the health facility: • • • •

Discuss her previous immunization history Examine her immunization record, maternal record and health centre record Review the tracking register for the year she was born Decide how many doses of DT she needs

There are 3 tetanus toxoid-containing vaccines available for pregnant women: 1. Tetanus toxoid (TT) 2. Diphtheria and tetanus toxoids (Td or DT): provided by MOH 3. Diphtheria and tetanus toxoids + acellular pertussis (Tdap)

If a woman has received one or more doses of DPT/DT in the past, refer to the immunization schedule (see Table 10.4.2).

Table 10.4.2: ‘Catch-up’ immunization schedule for women who have received one or more doses of DPT/DT prior to current pregnancy 39,40

Number of doses DPT/DT received prior to current pregnancy

Requirements for current pregnancy

Follow-up doses required after current pregnancy

1

DT2: at least 4 weeks after 1st dose DT3: at least 6 months after 2nd dose

2 doses: - DT4: at least 1 year after DT3 - DT5: at least 1 year after DT4

2

DT3: at least 6 months after the 2nd dose

2 doses: - DT4: at least 1 year after DT3 - DT5: at least 1 year after DT4

3

DT4: at least 1 year after 3rd dose

DT5: at least 1 year after DT4

4

DT5: at least 1 year after 4th dose

None

None

None

5 or more

39

WHO. Standards for maternal and neonatal care: maternal immunization against tetanus. 2006. http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/immunization_tetanus.pdf 40 PAHO/WHO. Maternal and neonatal immunization field guide for Latin America and the Caribbean.

2017

231

For a woman who has never received DPT/DT or whose immunization history is unknown, refer to Table 10.4.3. This client requires five doses of DT to be considered fully immunized against tetanus.

Table 10.4.3: Recommended DT immunization schedule for previously unvaccinated pregnant women and women of childbearing age, and efficacy of vaccination41

Dose

Schedule

Percentage protection

Duration of protection

DT1

At 1st contact or as early as possible during pregnancy

--

--

DT2

At least 4 weeks after 1st dose

80%

3 years

DT3

6-12 months after 2nd dose or during subsequent pregnancy

85%

5 years

99%

10 years

99%

Probably lifelong

DT4 DT5

Table 10.4.4:

1-5 years after 3rd dose or during subsequent pregnancy 1-10 years after 4th dose or during subsequent pregnancy

MMR Schedule for Women of Childbearing Age (15-44 years)

Vaccine History No history of MMR OR Unknown history History of either: 1 dose of MMR OR 1 dose measles No history of MMR OR Unknown Known history of 2 doses of MMR OR 1 dose measles and 1 dose MMR

Pregnancy Status

At present contact

Not pregnant

Give 2 doses of MMR separated by > 4 weeks

Not pregnant

Give 1 dose of MMR

Pregnant

DO NOT give MMR until postpartum

Not pregnant/pregnant

DO NOT give MMR

41

PAHO/WHO. Maternal and neonatal immunization field guide for Latin America and the Caribbean.

2017

232

10.5 Immunization Recommendations for All Healthcare Workers Table 10.5.1: Immunization Recommendation for All Healthcare Workers 42

10.6 Influenza Vaccination The objectives for influenza vaccination in Jamaica are: 1. To protect at risk individuals from infection and /or serious illness 2. To maintain the health of workers in essential services 3. To prevent or minimize the spread of infection The recommended priority groups for vaccination as indicated by the WHO Strategic Advisory Group of Experts on Immunization (SAGE) are as follows: 1. Health Care Workers – these persons are at risk of acquiring and transmitting the infection to vulnerable patients 2. Pregnant women – these persons are at higher risk of complications and can provide protection for newborns who cannot be vaccinated 3. Population > six months of age with underlying chronic disease 4. Adults > 65 years of age In addition, the recommendations in the Influenza Pandemic Plan for phases 1-3 are as follows: 42

MOH Health Facilities Infection Control – Policies and Procedures Manual, 2014

233

•

•

Persons over 6 months of age with chronic illnesses/ conditions such as: o Pulmonary illnesses, such as emphysema, chronic bronchitis, or asthma o Cardiovascular illnesses such as congestive heart failure o Metabolic diseases including diabetes mellitus o Renal dysfunction o Hemoglobinopathies such as sickle cell disease o Immunosuppression o Long term aspirin therapy Health care and emergency response workers at risk of transmitting the virus to persons at risk of complications

Based on the foregoing, following are the priority groups: • Health care workers, inclusive of all HCWs in the MONIA areas • Non-health frontline workers inclusive of police (JCF), correctional officers (DCS), Passport Immigration & Citizenship Agency (PICA) personnel and Jamaica Defence Force (JDF) personnel • Individuals who are institutionalized or in state care (inmates in correctional facilities, residents in infirmaries/golden age homes/homeless shelters and children’s homes/places of safety) • Pregnant women (all trimesters) • Children with chronic illnesses • Adults 65 years and older with chronic illnesses Vaccination of these groups should be on an annual basis until the pandemic arrives.

This would increase the demand for vaccines and help to force a boost in productive capacity for the influenza vaccine.

10.7 HPV Vaccination The introduction of HPV vaccination into the routine immunization programme is expected to have a significantly positive impact on cervical cancer prevention. The National Strategic and Action Plan for the Prevention and Control of Non-communicable Diseases in Jamaica 2013-2018 includes the introduction the HPV vaccine as an activity toward achieving the targets under: • Priority Area #1: Risk Factor Reduction and Health Promotion • Strategic Objective 1: Reduce exposure to modifiable risk factors for noncommunicable diseases and promotion of health throughout the lifecycle through the creation of health-promoting environments 234

The introduction of the HPV vaccine in Jamaica is supported by the: • • • • • • • •

Cervical cancer burden and its attendant public health priority placement HPV prevalence and genotype distribution in the population Number of abnormal cervical smears and cervical cancer tissue being collected Cost-effectiveness of introducing the vaccine Acceptability of the vaccine Availability of safe, effective quality vaccines Capacity of the national immunization programme Systems that are being implemented to improve the surveillance for HPV related diseases

In June 2015, the WHO Technical Advisor Group (TAG) on Immunization urged all countries to introduce HPV vaccine and recommended that Caribbean countries accelerate the introduction of HPV vaccine.

In October 2016, WHO Strategic Advisory Group of Expert (SAGE) on Immunization indicated that: • Current evidence suggests that the 3 registered vaccines (bivalent, quadrivalent and monovalent vaccines) o Offer relatively similar effectiveness for the prevention of cervical cancer o Offer specific protection against HPV types 16 and 18 which are associated with 71% of cases on cervical cancer • Prevention of cervical cancer is best achieved through immunization of girls, prior to sexual debut • High vaccination coverage of girls also results in herd immunity for boys It is important to note that in Jamaica the HPV vaccine had been administered in the private sector for several years prior to introduction in the national immunization programme.

Goal To prevent cervical cancer in Jamaica.

Objective • To introduce the HPV vaccine as part of the routine immunization schedule starting in October 2017.

• To achieve at least 80% vaccination coverage in Grade 7 girls

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Expected Impact A reduction in the incidence of cervical cancer in Jamaica.

Target population Cohort of girls entering Grade 7 (11-12 years old) Strategies 1. Procurement of bivalent HPV vaccine 2. Administration of HPV vaccine via a school-based vaccination programme 3. Multi-sectoral collaboration and partnership 4. Increasing cold chain capacity at parish stores 5. Social mobilization, communication and advocacy 6. Revision/updating of data management forms and systems 7. Sensitization and training of key stakeholders 8. Risk mitigation against negative public perceptions and adverse events (ESAVIs) 9. Coverage and ESAVI monitoring 10. Surveillance of HPV related diseases Schedule See Chapter 4

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Chapter 11: Monitoring & Evaluation 11.1 Introduction The goal of monitoring and evaluation is to improve the programme and enhance the effectiveness of activities in meeting programme goals. For example, high immunization coverage is a primary goal of the programme and is monitored closely. The efficacy of vaccines is strongly influenced by cold chain integrity, so it is also monitored carefully.

11.2 Definitions Monitoring is ● The systematic and continuous process of examining data, procedures and practices in order to assess progress in achieving programme goals, identify problems and develop solutions for implementation ● Done on an ongoing basis (daily, monthly, quarterly, annually)

Evaluation is ● A set of procedures based on qualitative and quantitative methods ● Used to obtain information regarding the fulfillment of objectives, activities, costs, results, and impact in order to correct or modify programme activities. ● Implemented periodically (less frequent than monitoring).

237

11.3 Tools Used to Monitor and Evaluate the EPI Monitoring systems are linked to programme goals (See Table 11.3.1 below).

Table 11.3.1: EPI Goals and Tools*

Programme Goal 1

Tool

Purpose

High vaccination Immunization Register rates (child; adult & older child)

• • •

Provides data on coverage Identifies children who are due for vaccination Monitors missed opportunities

Immunization tally sheet

•

Monitors the number of doses of vaccines administered in immunization sessions

Child Health Development Passport/ Immunization Card

•

Allows individual-based approach for parents/ guardians, teachers and health workers to monitor progress towards full immunization for each client

Combined Monthly Immunization Report Form

•

Captures and communicates vaccines administered and facilitates calculation of coverage rates by age cohort and/or target population

Immunization Monitoring Chart

•

Monitors cumulative progress toward coverage objectives on a monthly basis

EPI Database

•

Captures, calculates and reports doses of vaccines given and coverage rates per antigen by age group Enables reporting and analysis of coverage data at all levels

•

Table 11.3.1 (Continued)

238

Programme Goal Tool 2

Purpose

Low incidence of Surveillance System vaccine• Disease notification preventable forms diseases • Case investigation forms

• • •

Identifies cases/deaths due to vaccine-preventable diseases Provides data on cases as a measure of programme impact Investigates and follows-up on cases and contacts

3

High-level cold Audit tools: chain • Refrigerator performance temperature record • Cold chain checklist

•

Monitors threats to and the integrity of the cold chain

4

High-level vaccine Adverse Events Reporting safety System: • Report form for Adverse Events following Immunization • Adverse Events Register • ESAVI database

•

Monitors vaccination safety and identifies cases of ESAVIs Enables follow-up and investigation of ESAVIs

5

High quality vaccination service delivery

Checklist Supervisory Monitoring of Programme (see checklist)

•

Monitors quality of vaccination service delivery and other programme activities

6

Adequate Vaccination Supplies

Vaccine Inventory Log Book

•

Monitors weekly vaccine supplies (received, dispatched, balance) at local stores

Web-based Vaccination Supplies Stock Management (wVSSM) System software

•

Monitors vaccine supplies (received, dispatched, balance) in real time at all levels of the supply chain

•

*Samples of monitoring tools and charts available in the Appendices

239

11.4 Monitoring Vaccination Coverage and Dropout Rates Coverage and dropout rates are used as indicators to providing information regarding: • Accessibility, availability and acceptability of immunization services • Proportion of target population vaccinated • Proportion of target population not vaccinated, and contributing factors • Quality of services delivered • Efficiency of resource use

11.4.1 Calculating Immunization Coverage Vaccination coverage is defined as follows: % Vaccination Coverage = Number of persons vaccinated in target population --------------------------------------------------------------- x 100 Total number of persons in target population

It is important to evaluate the percentage of the target population that has been vaccinated to determine vaccination coverage, and to intervene appropriately.

11.4.2 Target populations The number of persons vaccinated in the target population is based on parish reports (public and private) of vaccines administered to the target populations.

240

Table 11.4.2.1: Vaccines administered to target populations

Target population

Estimated from

1

0-11 months

2

12-23 months The 0-11 months target population from the previous year

3

4-6 years

The number of registered or estimated live births minus infant deaths in one year

The average of the 4, 5 and 6 year-old age cohorts; the appropriate 0-11 months target populations from previous years are used, e.g.:

Antigen Primary schedule: BCG, Polio, DPT, HepB, Hib MMR 1 and 2, DPT4, Polio4 DPT5, Polio5

Target populations for - Children 4 years old, 2017 = 0-11 months target population for 2013 - Children 5 years old, 2017 = 0-11 months target population for 2012 - Children 6 years old, 2017 = 0-11 months target population for 2011 4

Pregnant women

The 0-11 months target population is used as a Tetanus proxy

11.4.3 Calculating Dropout Rates It is also important to count the number of children who have â&#x20AC;&#x153;dropped outâ&#x20AC;? of the immunization programme, as they represent missed opportunities for vaccination.

Measure dropout rates, by comparing the number of infants who started receiving immunizations, to those who received all needed doses.

Dropout rates can be estimated by comparing the following vaccine doses:

241

Table 11.4.3.1: Estimating dropout rates

Antigens

Calculate dropout number

Calculate drop-out rate

BCG and DPT3

# doses of BCG - # doses of DPT3

# doses of BCG # doses of DPT3 x 100 # doses of BCG

BCG and MMR

# doses of BCG - # doses of MMR

# doses of BCG # doses of MMR x 100 # doses of BCG

DTP1 and DTP3

#doses of DTP1 - # doses of DTP3

# doses of DTP # doses of DTP3 x 100 # doses of DTP3

DTP1 and MMR

# doses of DTP1 - # doses of MMR

# doses of DTP1# doses of MMR x 100 # doses of MMR

-

minus

11.4.4 Analysis of Situations Related to the EPI The World Health Organization document â&#x20AC;&#x153;Increasing immunization coverage at the health facility levelâ&#x20AC;? 43 provides a number of useful tools to assist programs in analyzing their data and developing action plans. The following figures and tables outline 4 scenarios for dropout and coverage rates.

43

WHO. Increasing immunization coverage at the health facility level. 2002 http://apps.who.int/iris/bitstream/10665/67791/1/WHO_V%26B_02.27.pdf

242

What proportion of children have access to immunization services (What is the DPT1 coverage?)

↙

↘

HIGH coverage with DPT1(⋝95%)

LOW coverage with DPT1(<95%)

↓

↓

What proportion of Children complete the immunization schedule (What are the drop-out rates?)

↙

Drop-out rates<10%

↙

Drop-out rates>10%

● ●

Drop-out rates are low = Good Utilization Coverage rates are high ==Good access Category 1: No Problem

Drop-out rates<10%

↘

Drop-out rates>10%

Categorize the problems

↓ ●

↘

↓ ●

● ●

↓

Drop-out rates are High = Poor Utilization Coverage rates are high = Good access Category 2

●

● ●

Drop-out rates are low = Good Utilization Coverage rates are Low = Poor access Category 3

Figure 11.4.4.1: Algorithm for interpretation of drop-out rates

243

↓ ● ● ●

Drop-out rates are high Poor Utilization Coverage rates are Low = Poor access Category 4

Table 11.4.4.1: The four (4) situations/scenarios that can be interpreted from dropout rates and DPT1 coverage

➢ 1: No problem

Drop-out rates are low = good utilization DPT1 Coverage is high = good access

➢ 2: Problem

Drop-out rates are high = poor utilization DPT1 Coverage is high = good access

➢ 3: Problem

Drop-out rates are low = good utilization DPT1 Coverage is low = poor access

➢ 4: Problem

Drop-out rates are high = poor utilization DPT1 Coverage is low = poor access

Category key: 1 - high coverage, low dropout; 2 - high coverage, high dropout; 3 - low coverage, low dropout; 4 - low coverage, high dropout

11.5 Reporting Antenatal Tetanus Coverage On the Ministry of Health’s Combined Monthly Immunization Report Form, there is a section for recording antenatal immunization (see Figure 11.5.1 below).

A pregnant woman who has previously received five or six doses of tetanus-containing vaccine (as part of DPT, DT or Pentavalent-DPT/Hib/HepB) should be counted and recorded in the final row of Figure 11.5.1 as ‘previous full immunization’.

Doses of tetanus-containing vaccine (as part of DT) given to women who are not previously fully immunized should be recorded according to the number of the dose (1st, 2nd, etc.) and the gestational age at which it is given.

244

COMMENTS / REMARKS ANTENATAL

IMMUNIZATION

WEEKS OF PREGNANCY TETANUS

DOSE

0 – 15

16–23

24–31

(DT)

32 & OVER

TOTAL

1st 2ND 3rd 4th 5th 6th Boosters Previous Full Immunization Figure 11.5.1: Combined Monthly Immunization Report Form: section for antenatal immunization

From the reporting form, calculate tetanus coverage in antenatal clients as follows:

Antenatal Tetanus = Coverage

# women who have received previous full immunization status

+

# women who received 2nd, 3rd, 4th, 5th or 6th doses of DT during this pregnancy

Target population

Figure 11.5.2: Calculation of Antenatal Tetanus Coverage

245

x 100

11.6 Steps in Monitoring the EPI Table 11.6.1: Five Key Steps to Monitor the EPI

EPI officers for each facility should monitor their EPI coverage on a monthly basis using the Coverage Monitoring Chart provided (See Appendix C). This chart should be visibly displayed in the Public Health Nurseâ&#x20AC;&#x2122;s office and the progress of the coverage discussed monthly. A chart should be used for each antigen given by vaccination.

Do not record coverage for the combination vaccine of DTP/HepB/Hib as coverage for â&#x20AC;&#x153;pentavalentâ&#x20AC;? vaccine, but rather separate and report them by the individual antigens.

Likewise, similar charts should be maintained at the parish, regional and national levels and efforts made to ensure steady progress towards antigen coverages of 100%.

Special attention must be paid to accuracy of data collection and collation for coverage and must include information from all sources, private and public.

246

An analysis of the coverage and the dropout rates should be done at least quarterly.

Utilize the tabled information to develop a work plan (Table 11.6.2) to address the problems identified. Implementation of activities should be assigned specific timeframes and responsible personnel.

Monitor tracking registers weekly in order to identify dropouts early. Efforts should be made to locate drop-outs and complete the immunization series according to the schedule.

Close monitoring and maintenance of the cold chain is critical to preserve efficacy of the vaccine. The temperature should be monitored daily using the standard temperature record.

Table 11.6.2: Work plan template to address increased drop-out rates

247

248

Chapter 12: Programme Management & Community Outreach 12.1 Programme Management The policy, goal, objectives and strategies of the immunization programme are outlined in Chapter 1 and all members of the health team should familiarize themselves with these.

Programme management for the immunization programme is done at all levels, from the national, Ministry of Health level, down to the health centre. All members of the health team have a role to play in ensuring the efficient and effective implementation of the EPI towards achievement of the goal and objectives set for the programme.

Ministry of Health Rehional Health Authorities Parish Health Department

Health Centre

Community Outreach

Figure 12.1.1: The EPI Implementation Team

12.1.1 Ministry of Health The direction for the EPI is provided by the Director of the Family Health Unit, which is the designated National EPI Manager. The FHU, through its director and technical officers (programme development officers and programme officer), is responsible for the following activities: â&#x20AC;˘ Development of standards, guidelines, norms 249

• • •

• •

• • • • •

• • • • • • • • •

Establishment of policy, goals, objectives and strategies Preparation of the budget for the EPI Procurement of vaccines and supplies (needles, syringes, safety boxes, cold chain equipment, immunization cards and Child Health and Development Passports etc.) for the immunization programme Establishment of intra- and inter-sectoral collaboration and coordination of meetings of the Inter Agency Coordination Committee for EPI Ongoing liaison with professional associations (e.g. Paediatric Association of Jamaica), Ministry of Education and Youth as well as the Early Childhood Commission with respect to the Immunization Regulations and their roles and responsibilities in supporting the EPI Data collection, collation, analysis and dissemination of EPI coverage at national, regional and parish levels Annual liaison with the Registrar General’s Department and the Statistical Institute of Jamaica regarding the target populations for vaccinations Ongoing liaison with United Nations agencies, such as PAHO and UNICEF. Provision of other logistical support to the health regions and parishes Monitoring and coordinating the management of vaccination supplies stock at national cold chain store for vaccines, and providing guidance and support for stock management at parish stores Periodic monitoring and audits of service provision Public education on all areas related to immunization Coordination and implementation of training of health and education staff on immunization On-going provision of advice and guidance to the regions and parishes on immunization Monitoring and initiation of the investigation of reports of vaccine-preventable diseases and ESAVIs in collaboration with the Surveillance Unit Convening meetings with parents or patients to resolve serious concerns regarding the immunization programme Provision of country data on immunization to the international community Representing the Ministry of Health at local, regional and international meetings/conferences related to immunization/EPI and making relevant presentations Coordinate the development, provision and administration of technological solutions for the EPI, e.g., electronic information systems to enhance the management and coordination of the EPI at all levels

250

12.1.2 Regional Health Authorities The Regional Health Authority, through the Regional Technical Director (Regional EPI Manager) and the Regional Nursing Supervisor (Regional EPI Coordinator), has the responsibility of overseeing the immunization in each of the parishes that comprise the health region. The Regional Epidemiologist or Regional Surveillance Officer plays a vital role in surveillance for the programme and investigation of reports of vaccine-preventable diseases and ESAVIs. The Regional Health Authority must demonstrate the priority of the immunization programme by implementing the following activities: • Orientation of new staff to the EPI with emphasis on the policy, goal, objectives and strategies; • Supervision of programme implementation through health centre visits and audits using the tools provided; • Monitoring of the programme achievements through monthly, quarterly and annual collection, collation and analysis of the coverage data; • On-going training of health staff in EPI and the sharing/dissemination of information received from the Family Health or Surveillance Unit related to the immunization programme; • Monitoring of the cold chain at parish and health centre levels; • Provision of cold chain equipment; • Provision of budgetary and logistical support to the parishes including provision of transportation; • Provision of generators to the Health Departments for alternate power supply to ensure the integrity of the cold chain; • Public education on all areas related to immunization; • Coordination and implementation of training of health and education staff on immunization; • On-going provision of advice and guidance to the region and parishes on immunization • On-going liaison with regional representatives of medical or health associations, education officers, school principals, early childhood institution operators and private practitioners; • Monitoring and implementation of investigations of reports of vaccine-preventable diseases and ESAVIs; and • Convening meetings with parents or patients to resolve concerns regarding the immunization programme.

251

12.1.3 Parish Health Departments At the parish level, the immunization programme must be managed by the Medical Officer of Health (Parish EPI Manager) and supervised by the Senior Public Health Nurse (Parish EPI Coordinator) to whom this responsibility is assigned. The parish must ensure service delivery in keeping with the policy, goal, objectives and strategies outlined by the Ministry of Health.

The Parish Manager must provide the financial, administrative and logistical support to the programme.

Programme management activities to be implemented at the parish level include: • Orientation of new staff to the EPI with emphasis on the policy, goal, objectives and strategies; • Supervision of programme implementation through health centre visits and audits using the tools provided; • Monitoring of the programme achievements through monthly, quarterly and annual collection, collation and analysis of the coverage data; • Complete collection of coverage data inclusive of data from the private health providers; • Ongoing training of health staff in EPI and the sharing/dissemination of information received from the Family Health or Surveillance Unit related to the immunization programme; • Monitoring of the cold chain at parish and health centre levels; • Provision of cold chain equipment; • Provision of budgetary and logistical support including transportation; • Provision of generators to the Health Department and largest health centres (if required) for alternate power supply to ensure the integrity of the cold chain; • Public education on all areas related to immunization; • Coordination and implementation of training of health and education staff on immunization; • Ongoing provision of advice and guidance to the health centre staff on immunization; • Ongoing liaison with local representatives of medical/health associations, the education officers, school principals, early childhood institution operators and private practitioners with respect to the Immunization Regulations and their roles and responsibilities in supporting the EPI; • Timely collection of vaccines and supplies from the central vaccine stores while ensuring the integrity of the cold chain; • Monitoring and coordinating the management of vaccination supplies stock at parish stores and all health facilities in the vaccine supply chain • Monitoring and implementation of investigations of reports of vaccine preventable diseases and ESAVIs; 252

• •

Timely reporting of ESAVIs to the Surveillance Unit/ Family Health Unit; and Convening meetings with parents or patients to resolve concerns regarding the immunization programme.

12.1.4 Health Centres At the health centre level, the Public Health Nurse is in charge of the management of the immunization programme. She is assisted and supported in service delivery by the Midwife and when necessary by other members of the health team such as the Medical Officer, Registered Nurse and Family Nurse Practitioner. Surveillance for the EPI and the investigation of ESAVIs is also the responsibility of the Public Health Nurse.

The Community Health Aide has the responsibility of liaising with the community to identify clients in the population in need of vaccination especially immunization dropouts. Each week, the tracking register should be monitored for dropouts and efforts made to locate them in a timely manner (within two weeks of the missed appointment) through home visits in the community. They should also be sufficiently knowledgeable on various aspects of the immunization programme in order to educate caregivers and other persons in the community, as well as answer any concerns which may be raised. When in doubt, they must refer the person to the Midwife or the Public Health Nurse.

At the health centre, the following programme management activities must be carried out: • Daily vaccination in keeping with the open vial policy; • Avoidance of missed opportunities for vaccination; • Request for immunization cards/CHDPs for children at each visit to the health centre; • Ongoing education of parents and caregivers; • Adequate and timely documentation of vaccinations given that are recorded in the medical records, tracking register and immunization card/CHDP; • Daily, weekly and monthly tallying of vaccinations given by antigen and dose number; • Verification of accuracy and completeness of coverage data monthly; • Adequate and timely documentation of ESAVIs in medical records and Adverse Events Register; • Timely and complete management and investigation of ESAVIs; • Timely reporting of ESAVIs to the Parish Health Department; • Weekly review of the Tracking Register to identify dropouts; • Home visiting to locate and vaccinate dropouts; • Periodic community outreach immunization sessions as required; 253

• • •

Adherence to the EPI guidelines on safe vaccination practices (ensure correct vaccine, dose, needle size, technique and vaccination site; Daily monitoring of the cold chain using the refrigerator temperature monitoring chart; and Liaison with schools to ensure compliance with the Immunization Regulation.

12.1.5 Community Outreach An outreach clinic is where services from a health facility are taken to the community within the catchment area, then the team returns to the health facility the same day. An outreach immunization session is held in a location where the health workers can go out and return to the facility the same day. For successful outreach sessions, they should be held at a time and place where the community has easy access and are available to participate.

Community outreach immunization sessions should be planned periodically as a strategy for improving vaccination coverage in the target population. However, these sessions must be carefully planned and executed to ensure maximum effectiveness.

Strategies for the outreach sessions in communities include: • House-to-house vaccination • Vaccination in schools • Vaccination at community centres • Vaccination at health fairs

12.2 Execution of Outreach Sessions Activities involved in an outreach clinic include: • Plan outreach based on the level of dropouts in a community or for annual mop-up sessions.

• Determining the number of children that you can immunize in one session.

• Consult with community leaders and clients about dates and time, as they will help mobilize the community.

• Discuss your plans for mobile/outreach clinics with the members of the District Health Management Team / EPI Programme Coordinator/ Zone Management Team.

• Inform mothers which days to expect you, and the time session will start. Be reliable and punctual.

• Ensure that vaccines are kept at the required temperature (+2˚ to +8˚ degrees Centigrade).

254

•

Before the immunization session starts, remove the vaccines you need from the storage vaccine carrier/ igloo and place them in the “active use” vaccine carrier. The volume will be determined by the number of children you expect to vaccinate during the session. Ice packs lining the active use vaccine carrier should be replaced before they completely melt.

• During the session ensure that the potency of the vaccine is maintained by monitoring the thermometer in the igloo. Carry a spare vaccine carrier with icepacks for replacement.

• Supplies needed for vaccination include: o Vaccines and syringes o Educational material (e.g. flyers, pamphlets, posters) o Hand sanitizer and/or water and soap for hand hygiene o Chair and table o Trays o Safety box o Containers for used vials o ESAVI kit with drugs to manage allergic reactions o Stationary (pen, pencil) o Monitoring tools: vaccination register, tally sheets, extra immunization cards, calendar (See Appendix for complete list) • Remember that information must be recorded on immunization cards/CHDP, patient’s medical record, tracking registers and EPI report form

12.3 Completing an Outreach Session 1. Note the temperature inside the vaccine carrier at the end of the session. If the temperature is greater than +8ºC, vaccines should be utilized according to vaccine exposure chart or VVM (if it has not reached discard point). o Pack unopened vaccines and open vials for which multi-dose vial policy is applicable. o Put empty vials and vials to be discarded in a separate container to be carried back to facility for proper disposal.

2. Leave outreach site tidy o Do not leave behind anything that might be a health risk to the community. o Collect safety boxes containing sharps and take the safety boxes back to the facility. Do not to leave any syringes and needles at the site. o Do not to leave any empty or glass vials at the site. o Return tables, chairs and other equipment to the owners.

255

o Thank the local people who have helped to organise the session and remind them when you will return.

3. At the facility, return vaccines to the refrigerator: o Check and note the temperature o Pack vaccines in the refrigerator as per open vial policy. o Put ice packs into the freezer, check and record the temperature.

4. Update immunization tally sheet and EPI reporting forms as required.

12.4 Managing Dropout Clients • • • • • • • •

Identify under-immunized children through review of tracking registers and community survey Locate them through phone calls or home visits Give appointment to attend the health centre for vaccination at the next clinic session Conduct home visits/ house-to-house vaccination sessions if no response after two weeks Plan vaccine sessions in the community If less than 20-30 drop-outs in a community, then house-to-house vaccine sessions should be conducted If more than 30 children are identified, adequate notice should be given and community outreach conducted For maximum yield from outreach sessions, these should be done in the evenings or on week-ends when the likelihood of finding persons at home or in the community is highest

12.5 Management of Vaccine Refusals or Hesitancy “Vaccine hesitancy” is a relatively new term used in research over the past few years to describe anyone who is doubtful about vaccinations or who chooses to delay or refuse immunizations even when they are readily available. Reasons expressed by parents vary widely but can be classified into four overarching categories: religious reasons, personal beliefs or philosophical reasons, safety concerns, and a desire for more information from healthcare providers.

The Public Health (Immunization) Regulations 1986 (Amended 2013) provides that it is the duty of every parent to have their child immunized. The only exemption provided under the Regulation is where a public immunization officer or medical doctor certifies that the child shows signs of contraindication or is not physically fit to be certified.

256

Further, a child may not be admitted to or continue to attend school unless the child is immunized or provides evidence of exemption in accordance with the Regulation. Importantly it is an offence if anyone contravenes any provisions of the Regulations.

The following steps should be taken in the case of vaccine hesitancy or refusal 1. Identify the specific reason for vaccine refusal (use motivational interviewing techniques to elicit information) 2. Clearly outline the benefits and risks of immunization to the individual, community and country 3. Provide information on the safety, benefits and efficacy of vaccines 4. Address any other concerns expressed e.g. pain of immunization 5. If there is continued refusal, report matter to MO(H) and Child Protection and Family Services Agency (CPFSA, formerly called the Child Development Agency) 6. Serve an Immunization Notice on the parents (see sample Immunization Notice in Appendix) 7. Submit report indicating demographics of child, reason for refusal, actions taken 8. The Medical Officer (Health) will initiate prosecution proceedings in the Resident Magistrates Court

12.6 Prosecution Procedures Prosecution is initiated by laying the information, which will contain:  Name and occupation of officer initiating prosecution  Section of the Act or Regulation which was breached  Date the information was laid  Date of the offence (refusal or hesitance)  Name and address of the offender  Brief statement of events which led to breach/prosecution  Request for offender to be summoned to court Go directly to the Clerk of Court for the parish and advise him/her of the situation in order for the information to be completed OR Seek the assistance of the Legal Services Department of the Ministry of Health in order for the information to be completed and forwarded to the Clerk of Court for the parish.

257

258

References/Bibliography/Works Cited 12th Technical Advisory Group Meeting on Vaccine Preventable Diseases, 1997 Centre for Disease Control and Prevention. Possible side effects of vaccinations, accessed at https://www.cdc.gov/vaccines/vac-gen/side-effects.htm Center for Disease Control and Prevention. Epidemiology and Prevention of VaccinePreventable Diseases. Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington D.C. Public Health Foundation, 2015.

Clements CJ, Chandra-Mouli V, Byass P, Ferguson B.J., Global strategies, policies and practices for immunization of adolescents. Geneva: WHO, 1999.

WHO/V&B/99.24 IPV manufacturer’s leaflet, accessed at http://www.who.int/immunization_standards/vaccine_quality/pq_231_282_IPV_Bbio_PI_05_20 15.pdf?ua=1 HPV manufacturer’s leaflet, accessed at https://www.medicines.org.uk/emcmobile/PIL.20207.latest.pdf Pan-American Health Organization/World Health Organization. ESAVI training materials.

Ministry of Health, New Zealand. Immunization Handbook. 1996 Mackett M, Williamson J.D., Human Vaccines and Vaccination. Oxford: Bios; 1995 Pan-American Health Organization/World Health Organization. Methodology for the international evaluation of the expanded program on immunization. Comprehensive Family Immunization Unit (IM) Family, Gender and Life Course Department, Washington, D.C. 2013, page 3 Ministry of Health, Jamaica. Clinical Management of HIV Disease: Guidelines for Medical Practitioners. 2017 Ministry of Health, Jamaica. Health Facilities Infection Control – Policies and Procedures Manual. 2014 Ministry of Health, Jamaica. National Surveillance Manual. 2009

Ministry of Health, Jamaica. Prevention of Mother-to-Child Transmission. ??

259

Nascimento I, Leite L. (2012) Recombinant vaccines and the development of new vaccine strategies. Braz J Med Bio Res 45: 1102-1111.

National Health and Medical Research Council. The Australian Immunisation Handbook, 7th Edition, Australian Government Publishing Services: Canberra. (2000) Pan-American Health Organization/World Health Organization. How to perform the â&#x20AC;&#x153;Shake Testâ&#x20AC;?. Immunization Newsletter. Volume XXXII, Number 2. April 2010 Pan-American Health Organization/World Health Organization. Maternal and neonatal immunization field guide for Latin America and the Caribbean. 2017 Pan-American Health Organization/World Health Organization. ESAVI training materials Pan-American Health Organization/World Health Organization. Safe Vaccination Presentation, Technical Aspects. 2003 World Health Organization. Safe Vaccine Handling, Cold Chain and Immunizations.

WHO/EPI/LHIS/98.02 World Health Organization. Vaccine stock management: Guidelines on stock records for immunization and vaccines store managers. 2006 World Health Organization. Immunization in Practice: A Practical Guide for Health Staff, updated 2015 World Health Organization. PQS devices catalogue. Version date 24 August 2017 World Health Organization. Recommended Surveillance Standards 2nd Edition (WHO/CDS/CSR/ISR/99.2) http://www.who.int/csr/resources/publications/surveillance/whocdscsrisr992.pdf World Health Organization Guidance Note: Vaccine Diluents. The Proper Handling and Use of Vaccines Diluents. Revision 2015 World Health Organization. Immunization in Practice: A Practical Guide for Health Staff.

Updated 2015 Summary of WHO Position Papers (updated March 2013). http://www.who.int/immunization/policy/Immunization_routine_table1.pdf

260

Appendices Appendix A: Public Health (Immunization) Regulations, 1986 -

Regulations (Under section 14) Jamaica Gazette Supplement: Public Health (Immunization) (Amendment) Regulations, 2013 Schedule, Form A: Certificate of Medical Contra-Indications, Unfitness for Immunization Schedule, Form B: Certificate of Immunization

Appendix B: Jamaicaâ&#x20AC;&#x2122;s Immunization Schedule -

Immunization Schedule for Children Immunization Schedule for Adults and Older Children

Appendix C: EPI Monitoring Tools -

-

-

-

Coverage Monitoring Tools o Child Immunization Register o Adult and Older Child Immunization Register o Child Immunization Tally Sheet o HPV Vaccination Tally Sheet o Combined Monthly Immunization Report Form o HPV Vaccination Monthly Report o Influenza Monthly Immunization Report o Monthly Coverage Monitoring Chart Immunization Cards/Records o Children (Child Health and Development Passport, Immunization page) o Children (Immunization Card) o Adults and Older Children o Maternal Record Inventory Monitoring Tools o Vaccine Inventory Log o Vaccine Wastage/Loss Report ESAVI Monitoring Tools 261

-

o Expanded Programme on Immunization Report Form: Adverse Events Following Immunization o Adverse Events Register Audit Tools o Refrigerator Temperature Record o Expanded Programme on Immunization Checklist for Supervisorâ&#x20AC;&#x2122;s Use: Recording and Reporting o Monitoring and Evaluation Tool 1: Cold Chain Checklist

Appendix D: Checklist for Outreach Immunization Sessions

Appendix E: Immunization Notice

Appendix F: Key Messages for Immunization Education and Promotion

Appendix G: Crisis Plan for the Management of Events Supposedly Attributable to Vaccination and Immunization (ESAVIs)

Appendix H: Surveillance Tools and Forms -

Class I Notification Form â&#x20AC;&#x201C; Individual Notification CARPHA Lab Investigation Form Form 7-1: Acute Flaccid Paralysis Investigation Form Acute Flaccid Paralysis Surveillance: Neurological Examination: 60 Day Follow-Up Fever and Rash Case Investigation Form Congenital Rubella Syndrome Case Investigation Form Pertussis Case Investigation Form Diphtheria Case Investigation Form Tetanus and Neonatal Tetanus Case Investigation Form Viral Hepatitis Case Investigation Form

Appendix I: Needle Stick, Sharp Object Injury and Fluid Exposure Report 262

Appendix A: Public Health (Immunization) Regulations, 1986 Regulations (Under section 14)

263

264

265

Jamaica Gazette Supplement: Public Health (Immunization) (Amendment) Regulations, 2013

266

Schedule, Form A: Certificate of Medical Contra-Indications, Unfitness for Immunization

267

Excerpt from Immunization Regulation (1986) (Amended 2013)

268

Appendix B: Jamaicaâ&#x20AC;&#x2122;s Immunization Schedule Immunization Schedule for Children

269

Appendix C: EPI Monitoring Tools Coverage Monitoring Tools Child Immunization Register

270

271

Adult and Older Child Immunization Register

272

273

Child Immunization Tally Sheet

274

275

HPV Vaccination Tally Sheet

276

Combined Monthly Immunization Report Form

277

278

HPV Vaccination Monthly Report

279

Influenza Monthly Immunization Report

280

Monthly Coverage Monitoring Chart

281

Immunization Cards/Records Children (Child Health and Development Passport, Immunization page)

282

Children (Immunization Card)

283

Adults and Older Children

284

Maternal Record

285

Inventory Monitoring Tools Vaccine Inventory Log

286

Vaccine Wastage/Loss Report

287

ESAVI Monitoring Tools Expanded Programme on Immunization Report Form: Adverse Events Following Immunization

288

289

290

291

Adverse Events Register

292

Audit Tools Refrigerator Temperature Record

293

Expanded Programme on Immunization Checklist for Supervisorâ&#x20AC;&#x2122;s Use: Recording and Reporting

294

295

296

Monitoring and Evaluation Tool 1: Cold Chain Checklist

297

298

299

Appendix D: Checklist for Outreach Immunization Sessions Item

Number

Rational

Venue Clean private area

-

To promote confidence and compliance

Table

1

-

Chairs

3

-

Vaccine carriers Lined with Ice pack

Minimum of 2

Maintain viability of the vaccines

Vaccines and diluent

As needed

For immunization

Thermometer

1 for each igloo

To monitor vaccine temperature

Plastic Carrier with the following

-

For ease of transporting items

Container with dry cotton

1

To clean skin

Container with alcohol-soaked swabs

1

To clean skin as necessary

Alcohol

1 bottle

Reserve

Syringes 1ml, 5ml,10ml

Assorted

For injection and reconstitution of vaccines

Needles 23g, 18g, 25g

Assorted

For injection and pulling up vaccines

Hand Towel

1 roll

Cleaning table and hand hygiene

Liquid Soap

1 Bottle

Hand hygiene

Water

2

Drinking and hand hygiene

Hand sanitizers

1 Bottle

Hand Hygiene

Kidney dishes

2

Syringes 300

Artery forceps

2

To mobilize swabs, remove vial stopper

Lined tray

1

Store syringes before use

Emergency drugs

Resuscitation

Adrenalin

Resuscitation

Hydrocortisone

Resuscitation

Emergency response check list

Resuscitation

Water for injection

Resuscitation

Benadryl

Resuscitation

Panadol

To Treat fever

Other items Sharps container

1

Sharp disposal

Garbage Bags

3

Refuse disposal

Immunization cards

As needed

Replacement cards

Immunization Outreach Reporting Forms; Tracking Register

As needed

Recording and reporting

(Adapted from Western Regional Health Authority)

301

Appendix E: Sample Immunization Notice IMMUNIZATION NOTICE The Expanded Programme on Immunization has long been recognized one of the best successes in health, saving the lives of millions of children all over the world. Vaccinations have prevented deaths from very serious diseases such as measles, polio and lock-jaw (tetanus).

Under Jamaicaâ&#x20AC;&#x2122;s Public Health Law - Immunization Regulations (1986) (Amended 2013), every parent/guardian has the responsibility to have his/her child/ward fully immunized by their first birthday, or as soon as possible thereafter. Booster vaccines will be given after the first birthday as needed.

No child should be admitted to school or allowed to continue attending school unless the parent/guardian produces a Certificate of Immunization.

Health centre records in the parish of ____________________ show that your child/ward: _____________________________ age _______ has not attended any of our facilities for vaccination as scheduled. You are therefore asked to report to the _____________________ Health Centre within two (2) weeks from_______________________ (date) to commence/resume vaccination, or present records showing that your child/ward has been vaccinated.

Failure to do so may result in prosecution under the law. Penalty for breaking the law can be up to one million dollars ($1,000,000) or imprisonment for up to twelve months.

Name: ____________________________ Signature:_________________________ Medical Officer (Health) Date:______________________________

(Adapted from the Western Regional Health Authority)

302

Appendix F: Key Messages for Immunization Education and Promotion •

Immunization saves the lives of millions of children every year by preventing serious illnesses.

•

Every child has a right to be immunized and it is the duty and responsibility of parents to take their children for immunization.

•

Immunization is free and available at health facilities and outreach sites (including schools and community).

•

It is safer, easier and costs less to immunize a child than to treat a child for vaccine preventable diseases.

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All vaccines have been tested and approved by regulatory authorities, Ministries of Health, World Health Organization and the United Nations Children’s Fund. They are not used until proven to be safe.

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It is safe to vaccinate a child who has a mild illness, a disability or malnutrition.

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Caregivers should take the immunization card every time they take their children to a health facility or outreach site. A child’s immunization status should be reviewed every time they have a health care visit for any reason.

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The immunization Regulations of 1986 requires all children under the age of 7 years must be immunized before entry to daycare centres, early childhood education centres and schools.

Immunization is a must!

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Appendix G: Crisis Plan for the Management of Events Supposedly Attributable to Vaccination and Immunization (ESAVIs)

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Appendix H: Surveillance Tools and Forms Class I Notification Form â&#x20AC;&#x201C; Individual Notification

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CARPHA Lab Investigation Form

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Acute Flaccid Paralysis Investigation Form

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Acute Flaccid Paralysis Surveillance: Neurological Examination: 60 Day Follow-Up

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Fever and Rash Case Investigation Form

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Congenital Rubella Syndrome Case Investigation Form

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Pertussis Case Investigation Form

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Diphtheria Case Investigation Form

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Tetanus and Neonatal Tetanus Case Investigation Form

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Viral Hepatitis Case Investigation Form

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Appendix I: Needle Stick, Sharp Object Injury and Fluid Exposure Report

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