Patient Group Direction (PGD) for the Administration of:
MENINGOCOCCAL GROUP C CONJUGATE VACCINE
POM Prescription Only Medicine
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 DIRECTION APPLIES Active immunisation of children from 3 months of age, adolescents and adults, for Indication Inclusion Criteria
Exclusion Criteria
the prevention of invasive disease caused by Neisseria Meningitidis serogroup C. Informed consent has been given, in accordance with current Locala / PCT guidelines, for the administration of the vaccine Given as part of the childhood vaccination programme from 3 months, or to older children and young adults to 25th birthday. Adults at elevated risk, regardless of age, including any unprotected individual attending university. To be given to unimmunised/partially immunised close contacts of cases of meningococcal C meningitis and in outbreak control, but only as advised by The Consultant in Public Health Medicine (Health Protection). To be given as a booster to close contacts of meningococcal C meningitis who completed a course more than one year before exposure Informed consent has NOT been given, in accordance with current Locala / PCT guidelines, for the administration of the vaccine. Children under 3 months. The currently available Men C vaccines are licensed for use from 2 months of age, but this is not covered under this PGD Premature infants – 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 meningococcal polysaccharide (ii) Any constituent of the vaccine (refer to product leaflet). (iii) Diphtheria toxoid or the CRM197 carrier protein or tetanus toxoid. Menjugate Kit should NOT be given if individual has had a confirmed anaphylactic reaction to latex. Please also see Cautions/Need for further advice section
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 1
Cautions/Need for Further Advice
Previous severe reaction to vaccination – clarify nature of severe reaction and seek advice from a prescriber. Pregnancy and Breast feeding mothers – whilst this is not necessarily a contraindication, individuals working under this PGD must seek further clinical advice from an appropriate medical practitioner. (e.g. patient’s GP) before the vaccine is administered. The benefits of administration should outweigh the risks. For further information see appropriate Green Book chapters. 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. 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. Meningococcal Group C Conjugate Vaccine should not be given during treatment, and for 14 days after stopping treatment, with either Tacrolimus (Protopic) ointment, 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. At time of writing this PGD, Menjugate Kit contains latex and must not be administered to individuals who have had a confirmed anaphylactic reaction to PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine
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latex. See exclusions. Patients with nephrotic syndrome; there have been reports of relapse of this condition after vaccination.
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 incidence of meningitis in children/young adults and risks of the disease and how to recognise signs and symptoms. Give information about when the vaccine may be given
DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine
Meningococcal Group C Conjugate Vaccine. Always check packaging and leaflets prior to administration. Men C conjugate vaccine does not contain thiomersal. The brands currently listed in the department of Health Green Book are Menjugate Kit and Meningitec. Prior to administration please check Department of Health and relevant reference sources for guidance and updates on preferred brand
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 3
Route/Method 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, however, 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. Meningococcal Group C Conjugate Vaccine must not be mixed with other vaccines in the same syringe. Meningitis vaccines can be given at the same time as other vaccines such as MMR, PCV, diphtheria, tetanus, pertussis, polio and Hib. The 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 suggest that PCV should be given into one thigh, with DTaP/IPV/Hib and Men C into the other thigh. If other vaccines containing either diphtheria or tetanus toxoid are not administered at the same time, it is advisable to administer at a 1-month interval to avoid enhanced reactogenicity. Vaccines containing A,C,W and Y (for travel purposes) may be administered 2 weeks after Meningococcal C Conjugate Vaccine.
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 4
Dosage Frequency
0.5ml The primary course consists of two doses with an interval of one month between doses. The recommended age for vaccination is at three months and four months of age. If the primary course is interrupted, it should be resumed but not repeated. The schedule for vaccination may vary for some groups of patients including: Individuals with unknown or incomplete vaccination history. Children and adults with asplenia, splenic dysfunction or complement deficiency. Vaccination guidance is constantly changing and healthcare professionals have a professional responsibility to check and apply the most current guidance available. The latest Green Book chapters are available on-line at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publica tionsPolicyAndGuidance/DH_079917 For children who did not complete their primary immunisations according to the DH schedule, (including children transferring from other countries), refer to the most current HPA incomplete vaccination schedule. This can be downloaded from: http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/11949474061 56 For children and adults with asplenia, splenic dysfunction or complement deficiency, refer to the most current version of chapter 7 (table 7.1) of the Green Book. This is available online at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Pub licationsPolicyAndGuidance/DH_079917 Children and adults with asplenia or splenic dysfunction may be at increased risk of infection and vaccination is particularly important for this group of patients. Additional vaccinations against meningococcal disease are advised for individuals who develop asplenia or splenic dysfunction or when complement deficiency is diagnosed depending on age and vaccination history. See table 7.1 (web-link above).
Duration of Treatment
Dependant on age
Maximum or Minimum Treatment Period
Dependant on age
Quantity to Supply/Administer
See frequency and dose.
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 5
Side Effects
Reactions are usually mild and confined to first few days after immunisation. Common side effects include: Local reaction (redness, tenderness/pain, swelling), pain in limb in older children, headache, crying and irritability in infants and toddlers, drowsiness, somnolence, impaired sleeping in infants and toddlers, nausea, vomiting, diarrhoea, fever, loss of appetite, malaise, myalgia, arthralgia, and muscle pain in older children and adults. This list is not exhaustive. Please refer to current BNF and product SPC/leaflet for complete list. There have been very rare reports of seizures following Men C Conjugate vaccine administration. Individuals have usually rapidly recovered. Some of the reported seizures may have been faints. The reporting rate of seizures was below the background rate of epilepsy in children. In infants seizures were usually associated with fever and were likely to be febrile convulsions. Symptoms of meningism have also been reported rarely, but there is no evidence that the vaccine causes meningococcal C meningitis. There have been very rare reports of Stevens-Johnson syndrome. The MHRA has advised that vaccination provides benefit in terms of lives saved and disabilities prevented. 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
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
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 6
Special Considerations Vaccine should be stored in the original packaging at a temperature of 2 to 8Âş C. If the vaccine has been frozen, it should be discarded. / Additional Information 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 manufacturer’s patient information leaflet and discuss as required. Explain that the frequency of vaccination described in the patient information leaflet may differ, but that 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. May cause drowsiness (more than 1 in 10 people) and very rarely dizziness, faints or fits (in less than 1 in 10,000 people). If affected advise patient not to drive or operate machinery. Anaphylaxis is rare but a delayed reaction can occur. Advise to seek urgent medical attention if the patient develops breathlessness, swelling or rash. Meningococcal C vaccine does not protect against all strains of meningitis. Advise on symptoms and signs of the disease. The combined Hib/Men C vaccine is given at 12 months of age for children who received their primary doses of Men C at the recommended age. For children who have received previous doses outside the current recommended schedule seek further advice.
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 7
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. Self referral to GP practice or A&E department if appropriate (post immunisation).
Records/Audit Trail
The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary. Patient’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 patient’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 –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
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 8
STAFF CHARACTERISTICS Qualifications Specialist training or qualifications
Continuing Training & Education
Registered nurse with current registration working in Locala CIC or a GP Practice within 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 for working under PGDs for the supply and administration of medicines Has undertaken training appropriate to this PGD – 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. 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 to updated DH advice where appropriate
References/Resources SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ and Comments BNF chapter 14.4 Immunological products and vaccines http://www.bnf.org/bnf/ DH Immunisation Against Infectious disease (The Green Book) chapter 22 2006 (updated 8th April 2011). This can be accessed at:http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publication sPolicyAndGuidance/DH_079917 DH Immunisation Against Infectious disease (The Green Book) chapter 7 2006 (updated 15th April 2011). This can be accessed as above. National Travel Health Network and Centre (NaTHNaC): http://www.nathnac.org/ AND http://www.nathnac.org/pro/factsheets/menigitis_vaccine.htm#inte Interactions with Conjugate C meningococcal menigitis vaccine
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
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 9
This PGD is an updated version of the Kirklees PCT PGD No 5 v 4, ‘Meningococcal Group C Conjugate Vaccine’.
Refer to Revision Proforma for list of amendments made to original document.
Reason(s) for amendment
Date of amendment
Change of brands available to use.The PGD is amended to reflect the unavailability of NeisVac C vaccine. Current brands of Meningococcal C vaccines available to use are Menjugate Kit and Meningitec. To protect the PGD from continual amendments due to future brand changes the vaccine is now described generically and the brand names have been removed. In addition changes have been made to reflect organisational changes within NHS Kirklees. June 2012
List of persons/groups involved Dawn Toothill, Specialist Pharmacy Technician Community
in amending PGD
Services
(including job title) Locala Medicines Management Team
List of persons involved in
Imms and Vaccs Team Leader
consultation process
NHS Kirklees Medicines Management Committee
(including job title)
members
REVISION PROFORMA The following amendments have been made to PATIENT GROUP DIRECTION No 5 v 4 SECTI ON PGD No 5 v 4 PGD No 5 v 5 Title of patient Patient Group Direction (PGD) Patient Group Direction (PGD) for Group Direction for the Administration of: the Administration of:
Inclusion criteria
MENINGOCOCCAL GROUP C CONJUGATE VACCINE (Menjugate Kit, NeisVac-C)
MENINGOCOCCAL GROUP C CONJUGATE VACCINE
Informed consent has been
Informed consent has been given, in accordance with current Locala /
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 10
given, in accordance with current PCT guidelines for the administration of the vaccine
PCT guidelines, for administration of the vaccine
the
Exclusion criteria
Informed consent has NOT been given for the administration of the vaccine
Name, Form & Strength of Medicine
Meningococcal Group C Conjugate Vaccine. Menjugate Kit or Neis Vac-C. Presentation may vary with brand. Always check packaging and leaflets prior to administration. Men C conjugate vaccine does not contain thiomersal.
Side effects
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.
Informed consent has NOT been given, in accordance with current Locala / PCT guidelines for the administration of the vaccine. Meningococcal Group C Conjugate Vaccine. Always check packaging and leaflets prior to administration. Men C conjugate vaccine does not contain thiomersal. The brands currently listed in the Department of Health Green Book are Menjugate Kit and Meningitec. Prior to administration please check Department of Health and relevant reference sources for guidance and updates on preferred brand. 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.
Authorisation statement
Individual Authorisation for the Administration of Meningococcal Group C Conjugate Vaccine 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
Individual Authorisation for the Administration of Meningococcal Group C Conjugate Vaccine 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
Qualifications
Registered nurse with current registration working in Kirklees PCT
Registered nurse with current registration working in Locala CIC or a GP Practice within NHS Kirklees
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 11
Individual Authorisation for the Administration of Meningococcal Group C Conjugate Vaccine 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 5 v 5 Meningococcal Group C Conjugate Vaccine 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:
PGD No 5 v 5 Meningococcal Group C Conjugate Vaccine Approval Date: 21/06/12 Review by: 31/12/13 (or earlier in the light of new evidence) Page 13
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:
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