PGD_No_1_v_7_Pediacel by NHS Kirklees

Patient Group Direction (PGD) for the Administration of:

DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR), INACTIVATED POLIO & HAEMOPHILUS INFLUENZA TYPE B VACCINE DTaP/IPV/Hib (Pediacel)

POM Prescription Only Medicine

This vaccine contains 5 component Acellular Pertussis

YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION OR SITUATION TO WHICH THE DIRECTION APPLIES: For active immunisation against diphtheria, tetanus, pertussis, Indication poliomyelitis and Hib in children aged 2 months to 10th birthday: As a primary course in previously unimmunised children or where there is an unreliable history of previous immunisation against the above diseases To complete a primary course of immunisation against diphtheria, tetanus, pertussis, poliomyelitis and Hib Part of the national immunisation programme recommended to be given at 2 months, 3 months and 4 months of age.

Inclusion Criteria

Informed consent has been given, in accordance with current Locala / PCT guidelines, for the administration of the vaccine Children aged between 2 months and 10th birthday, as a primary course of immunisation against diphtheria, tetanus, pertussis, poliomyelitis and Hib, or to complete a primary course of immunisation against these diseases

Exclusion Criteria

Informed consent has NOT been given, in accordance with current Locala / PCT guidelines, for the administration of the vaccine Aged under 2 months or past 10th birthday. Premature babies – see ‘cautions/need for further advice’ for exclusion criteria. Current acute febrile illness Any individual who has had a confirmed anaphylactic reaction to: (i) A previous dose of a vaccine containing diphtheria, tetanus, pertussis, inactivated polio or Hib. (ii) Any constituent of the vaccine (check the product leaflet). (iii) Neomycin, Polymyxin B, or Streptomycin (which may be present in trace amounts)

Neurological Conditions Detailed guidance on the use of pertussis containing vaccines in patients with neurological conditions, discussed as a precaution PGD No 1 v 7 Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis and Hib Conjugate Vaccine DTaP/IPV/Hib Approval Date: 21/06/12 Review By: 31/12/13 (or earlier in the light of new evidence) Page 1

rather than a contraindication, is given on pages 286 to 289 of ‘Immunisation against Infectious Disease’ (the Green Book). o

Pre-Existing Neurological Conditions Where there is an unstable, evolving or deteriorating neurological abnormality, including poorly controlled epilepsy, immunisation should be deferred and patient should be referred to a paediatrician. See Green Book chapter 24 for details. Neurological Abnormalities Following Immunisation If a child experienced encephalopathy or encephalitis within 7 days of immunisation, OR a seizure associated with a fever within 72 hours of immunisation, further immunization should be deferred and the child referred to a paediatrician.* *NB – For children with a history of seizure associated with fever within 72 hours of immunization, if a cause is identified, or the child recovers within 24 hours, immunization should continue as recommended.

Cautions/Need For Further Advice

Please also see Cautions/Need for further advice section Previous severe reaction to vaccination. The Green Book (chapter 24) states that immunisation with pertussis-containing vaccine should continue following a history of: o Fever, irrespective of its severity; o Hypotonic-hyporesponsive episodes (HHE); o Persistent crying or screaming for more than three hours; o Severe local reaction, irrespective of extent. within 72 hours of a preceding vaccine. Whilst these are not contraindications, individuals working under this PGD must seek further clinical advice from an appropriate prescriber before the vaccine is administered if there is a history of a previous severe reaction. Pre-existing neurological conditions. For stable pre-existing neurological abnormalities, such as spina bifada, congenital abnormality of the brain or perinatal hypoxic ischaemic encephalopathy, the Green Book (chapter 24) advises that immunisation can continue. Hypersensitivity to: (i) A previous dose of a vaccine containing diphtheria, tetanus, pertussis, inactivated polio or Hib., (ii) Any constituent of the vaccine (check the product leaflet). (iii) Neomycin, Polymyxin B, or Streptomycin (which may be present in trace amounts). Refer to a prescriber for further advice.

PGD No 1 v 7 Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis and Hib Conjugate Vaccine DTaP/IPV/Hib Approval Date: 21/06/12 Review By: 31/12/13 (or earlier in the light of new evidence) Page 2

Premature infants - it is important that premature infants have their immunisations at the appropriate chronological age, according to the schedule. The occurrence of apnoea following vaccination is especially increased in infants who were born very prematurely. Very premature infants (born ≤ 28 weeks of gestation) who are in hospital should have respiratory monitoring for 48-72 hrs when given their first immunisation, particularly those with a previous history of respiratory immaturity. If the child has apnoea, bradycardia or desaturations after the first immunisation, the second immunisation should also be given in hospital, with respiratory monitoring for 48-72 hrs.. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. Where there is personal or family history of febrile seizures, there is an increased risk of these occurring after any fever, including that caused by immunisation. These children should be referred to a prescriber. Refer to Green Book chapter 24. Thrombocytopenia, Haemophilia or any other problem that may stop blood from clotting properly, or patient taking anti coagulants. The immunogenicity of the vaccine could be reduced in immunosuppressed patients. Consult with the individual’s clinician to find out whether vaccination should be postponed until immune function has recovered. For individuals with chronic immunodeficiency, such as HIV, vaccination is recommended even if the antibody response might be limited. Some ointments and creams which are prescribed to treat eczema can affect the immune response. DTaP/IPV/Hib vaccine should not be given during treatment with and for 14 days after stopping treatment with either Tacrolimus (Protopic) ointment, or Pimecrolimus (Elidel) cream, or similar preparations which may affect the immune response. Allergy to latex – Vial stoppers and syringe plunger stoppers are often made of this type of rubber and there is a risk of an allergic reaction to the vaccine because of this. However, for latex allergies other than anaphylactic allergies (e.g. a history of contact allergy to latex gloves), vaccines supplied in vials or syringes that contain latex can be administered. Refer to Green Book chapter 6. If an individual has a history of severe (i.e. anaphylactic) allergy to latex, vaccines supplied in vials or syringes that contain latex should not be administered. For these individuals contact the manufacturer to confirm whether the vaccine to be administered contains latex. PGD No 1 v 7 Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis and Hib Conjugate Vaccine DTaP/IPV/Hib Approval Date: 21/06/12 Review By: 31/12/13 (or earlier in the light of new evidence) Page 3

Action if Patient Declines or is Excluded

Refer to supervising doctor if appropriate. Document findings and action taken in patient’s record. Give information about risks of disease Give information about how to recognise signs and symptoms of the diseases Give information about when the vaccine may be given

DESCRIPTION OF TREATMENT Name, Form & Strength of Pediacel Medicine Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Hib conjugate vaccine (adsorbed) - DTaP/IPV/Hib This vaccine contains 5 component Acellular Pertussis

Route/Method

Pediacel is thiomersal-free. VACCINES MUST NOT BE GIVEN INTRAVENOUSLY To be given by intramuscular injection. Using the intramuscular route reduces the risk of localised reactions, which are more common when the vaccine is given subcutaneously. For individuals with a bleeding disorder vaccines should be given by deep subcutaneous injection to reduce the risk of bleeding The preferred sites for IM and SC immunisation are the anterolateral aspect of the thigh or the deltoid area of the upper arm. The anterolateral aspect of the thigh is the preferred site for infants under one year old, because it provides a large muscle mass into which vaccines can be safely injected. See Green Book chapter 4 Shake well immediately before use. The vaccine is a cloudy suspension which may separate upon storage. Inspect the vial contents visually for extraneous particulate matter and discolouration – if present discard the vial and contents. DTaP/IPV/Hib vaccine can be given at the same time as other vaccines including MMR, MenC, Pneumococcal Conjugate and Hep B vaccines. Vaccines should be given at a separate site, preferably a separate limb. If given in the same limb, they should be given at least 2.5 cm apart. The site at which each vaccine was given should be noted in the individual’s record. When three vaccines are given at the same time at 4 months of age, DH suggests that DTaP/IPV/Hib and MenC should be given into one thigh, and PCV into the other thigh.

Dosage Frequency

0.5 ml Primary course consists of three doses with an interval of one month between doses. These doses are recommended to be given at 2, 3 and 4 months of age. If the primary course is interrupted it should be resumed but not repeated, allowing an interval of one month between the remaining doses. Children who receive their third dose of the primary immunisation series later than recommended should have their pre-school immunisation with a minimum one year gap from the third primary immunisation, in accordance with the advice in ‘Immunisation Against Infectious Disease’ (pages 114, 282, 318, 371).

Duration of Treatment

See Frequency

Maximum or Minimum Treatment Period

Usually 3 doses for primary immunisation but see ‘cautions/need for further advice’ section regarding immunosuppression.

Quantity to Supply/Administer

See dose and frequency

Side Effects

Reactions are usually mild and confined to first few days after immunisation. Common side effects include: Local reaction (pain, erythema and oedema at the injection site), irritability, malaise, increased crying, fever, appetite loss, anorexia, diarrhoea, and vomiting. This list is not exhaustive. Please refer to current BNF and product SPC/leaflet for complete list Guillain-Barré-Syndrome has been reported after vaccination with tetanus-toxoid containing vaccines. Anaphylactic reactions to vaccines are extremely rare but have the potential to be fatal. Onset is rapid, usually within minutes but can occur within hours of vaccine administration. It is not possible to define a particular time period in which an individual should be observed following immunisation. See Green Book Chapter 8 (latest edition). Report all serious suspected adverse reactions (ADRs) in adults and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Yellow cards may be completed by a health professional or the patient, but it is the responsibility of the health professional identifying the ADR to report it. Yellow cards and guidance on their use are also available at the back of the BNF.

Additional Facilities

Special Considerations / Additional information

Immediate access to Adrenaline/Epinephrine for treatment of Anaphylaxis Access to a telephone. Vaccines must be stored and transported according to manufacturers’ guidelines and PCT Cold Chain policy o Vaccine and solvent should be stored in the original packaging at a temperature of 2 to 8º C. If the vaccine has been frozen, it should be discarded. o DTaP/IPV/Hib vaccine is compatible with previously administered DTwP-Hib and oral polio vaccines. o

DTaP/IPV/Hib vaccine should only be used as a primary course or to complete a primary course in children aged from 2 months to under 10 years of age.

Healthcare professionals are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary Product Characteristics (SPC) for a particular vaccine. When this occurs, the recommendations in the Green Book are based on current expert advice received from the JCVI and should be followed. Green Book recommendations are reflected in this PGD which in some instances could result in an unlicensed use of a licensed product.

Advice to Patient/Carer/ Parent/Guardian

Follow Up

Explain procedure and further action if required. Give a copy of the manufacturerâ&#x20AC;&#x2122;s patient information leaflet and discuss as required. If administering the vaccine to children aged 4 years and over explain that the patient information leaflet does not include use in this age group. However this use is based on latest clinical research and recommended by the Department of Health. Advice on the management of fever and other common/uncommon post-vaccination adverse effects. Management of local/general reactions. Anaphylaxis is rare but a delayed reaction can occur. Advise to seek urgent medical attention if the patient develops breathlessness, swelling or rash Explain that booster doses will be required in accordance with the national immunisation programme. Booster doses using appropriate vaccines for current age to be given as per the national immunisation programme at the recommended time intervals. When primary immunisation has been delayed see Green Book for guidance on when boosters should be given.

REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements

If patient is excluded from this PGD refer to GP or other appropriate clinician. Any health professional administering a vaccination must be able to identify and contact an appropriate clinician, e.g. GP, or the NHS Kirklees Immunisation Coordinator, as necessary, e.g. in the case of a child with an allergy to components of the vaccine.

Records/Audit Trail

Self referral to GP practice or A&E department if appropriate (post immunisation). The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary. Patientâ&#x20AC;&#x2122;s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented.

Contact details of GP if applicable Dose administered and route. Site of injection. Batch details, expiry date, manufacturer, supplier and brand name Advice given to patient (including side effects) Date administered Signature and name of staff who administered the vaccine. For paperless practices the electronic record should identify the name of the nurse administering the vaccine and should ideally have an electronic signature. Scanned paper records are acceptable. Details of any subsequent adverse drug reaction and actions taken including referral arrangements. (This MUST be documented in the patientâ&#x20AC;&#x2122;s medical record) For all vaccines administered to children or young people up to age 16 or still in full time education. The following records must also be completed. Computerised records and data collection held by Child Health Information Services (CHIS) The Personal Health Child Record (PHCR â&#x20AC;&#x201C;red book) (manual records) should be completed if available, failure to present this is not a reason to refuse to administer vaccination. If the red book is not available vaccination may proceed as long as there is clear information in respect of which vaccinations the child is due to receive. Every effort should be made to complete the red book at the earliest opportunity and the importance of providing it at subsequent vaccination appointments should be communicated to the parent/guardian. If applicable to the vaccine given Travel destination Liaison with HPA

STAFF CHARACTERISTICS Qualifications Specialist Training or Qualifications

Registered nurse with current registration working in Locala CIC or a GP Practice in NHS Kirklees Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent in working under PGDs for the supply and administration of medicines Has undertaken training appropriate to this PGD â&#x20AC;&#x201C; e.g. annual updates in Immunisation and Vaccination. Has undertaken training and is competent in all aspects of immunisation including contraindications and the recognition and treatment of anaphylaxis Has undertaken training and is competent in resuscitation skills.

Continuing training & education

The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their scope of practice. Attends compulsory annual updates in Immunisation and Vaccination. Undertakes mandatory annual updates on Anaphylaxis and Resuscitation. Practitioner should have access to product leaflet, current BNF and green book chapters, and updated DH advice where appropriate. References/Resources SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ and Comments BNF chapter 14 http://www.bnf.org/bnf/ DH Immunisation Against Infectious Disease (The Green Book) chapters 15,16,24,26,30. These can be accessed at: http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/ GreenBook/fs/en (For this review chapter 15 (Nov09), 24 (Oct10) and 30 (Aug09)).

Advice contained in the individual Summary of Product Characteristics (SPC) may have been overridden in accordance with guidance issued by the relevant Dept of Health Green Book Chapter. This will result in an unlicensed use of a licensed product following current DH guidance

This PGD is an amended version of the Kirklees PCT PGD No 1 version 6, â&#x20AC;&#x2DC;Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis and Hib Conjugate Vaccineâ&#x20AC;&#x2122;. Refer to Revision Proforma below for list of amendments made to original document.

The presentation has changed from a vial to a single dose pre-filled syringe with two separate needles. To avoid further amendments to the PGD due to change of presentation all reference to the presentation has been removed. In addition amendments have been made to reflect organisational change.

Reason(s) for amendment

Date of amendment

June 2012

List of persons/groups involved in amending PGD

Dawn Toothill, Specialist Pharmacy Technician Community Services

(including job title) Locala Medicines Management Team

List of persons involved in consultation process

Imms and Vaccs Team Leader NHS Kirklees Medicines Management Committee members

(including job title)

REVISION PROFORMA The following amendments have been made to PGD No 1 v 6 Section No 1 v6 No 1 v 7 Informed consent has been Informed consent has been Inclusion criteria given, in accordance with given, in accordance with current PCT guidelines, for the current Locala / PCT administration of the vaccine guidelines, for the administration of the vaccine

Exclusion criteria

Informed consent has NOT Informed consent has NOT

been given for the been given, in accordance with administration of the vaccine current Locala / PCT guidelines, for the administration of the vaccine

Name, form and strength of medicine Qualifications

Authorisation statement

Side Effects

Presented as a vial containing a suspension for injection Registered nurse with current registration working in Kirklees PCT Individual Authorisation for the Administration of Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis and Hib Conjugate Vaccine (DTaP/IPV/Hib â&#x20AC;&#x201C; Pediacel) by Nurses Employed either by the PCT/KCHS or GP Practices within Kirklees PCT. THE PCT DOES NOT ACCEPT LIABILITY IN RESPECT OF GP EMPLOYED STAFF Yellow cards may be completed by a nurse, pharmacist, the patient or a doctor, but it is the responsibility of the health professional identifying the ADR to report it.

Listing of presentation of vaccine removed Registered nurse with current registration working in Locala CIC or a GP Practice in NHS Kirklees Individual Authorisation for the Administration of Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis and Hib Conjugate Vaccine (DTaP/IPV/Hib â&#x20AC;&#x201C; Pediacel) by Nurses Employed either by Locala CIC or GP Practices within NHS Kirklees THE PCT DOES NOT ACCEPT LIABILITY IN RESPECT OF GP EMPLOYED STAFF Yellow cards may be completed by a health professional or the patient, but it is the responsibility of the health professional identifying the ADR to report it.

Individual Authorisation for the Administration of Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis and Hib Conjugate Vaccine (DTaP/IPV/Hib â&#x20AC;&#x201C; Pediacel) by Nurses Employed either by Locala CIC or GP Practices within NHS Kirklees THE PCT DOES NOT ACCEPT LIABILITY IN RESPECT OF GP EMPLOYED STAFF. PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this PGD. In signing this declaration the nurse is willing to be professionally accountable for this work as defined in the NMC Code of Professional Conduct 2008 Name of Professional Signature Authorising Manager and Date signature

Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials. Authorising Managers For Practice Staff this will be the GP. For Locala staff this will be the team leader or relevant clinical manager (see PGD policy) Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may give vaccinations away from the base should have an individual copy of the relevant signed PGD with them when administering the vaccine. PGD No 1 v 7 Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis and Hib Conjugate Vaccine DTaP/IPV/Hib Approval Date: 21/06/12 Review By: 31/12/13 (or earlier in the light of new evidence) Page 12

Organisational Approval This patient group direction must be agreed to and signed by all health care professionals involved in its use. Locala Community Partnerships will hold the original signed copy. The PGD must be easily accessible in the clinical setting.

Locala Community Partnership ORGANISATION: Director of Clinical and Name: Christina Quinn Operational Services Signature:

Date:

Head of Medicines Name: Lucianne Ricketts Management

Signature:

Medical Lead

Date:

Name: Dr Stephen Warner

Signature:

Date:

PCT Authorisation ORGANISATION: Governance Lead

NHS Kirklees Name: Sue Cannon

Signature:

Date:

Senior Medicines Name: Eric Power Management Advisor

Signature:

Medical Director

Date:

Name: Dr Damian Riley

Signature:

Date: