Patient Group Direction for the Administration of Haemophilus Influenzae Type b and Meningococcal C conjugated vaccine (Hib/MenC - Menitorex )

Transcription

1 Patient Group Direction for the Administration of Haemophilus Influenzae Type b and Meningococcal C conjugated vaccine (Hib/MenC - Menitorex ) This PGD must be read in conjunction with the core PGD (Reference: NHSE(LR)/PGD/Core PGD for Immunisations), which details information that is common to all of the immunisation PGDs. This PGD must only be used by registered healthcare professionals, working within, who have been named and authorised to practice under it. Version number: 1.1 The master copy for this PGD is held N:\2.0 Medical\Clinical Adviser Medicines\Patient Group Directions\Final Signed PGDs\Immunisation PGDs 2014 Change history Version Change details Date number 1.0 First version December Revision of content March 2014 Reference Number: NHSE(LR)/PGD/HIB/MenC v1.1 Page 1 of 9

2 PGD Development and Clinical Approval PGD Working Group This PGD was developed by a working group involving pharmacists from a number of Clinical Commissioning Groups across London, plus nurse representatives. Name and role Jonathan Mason Pharmacist and Lead Author Henrietta Hughes Doctor Eileen Bryant Nurse reviewer Nicola Pratelli Nurse Reviewer Thara Raj Public Health Specialist Nick Beavon Raana Ali Pauline Taylor Helen Tsang Dee Vadukul Seema Buckley Job title and organisation Clinical Adviser (Medicines) Medical Director North Central and East London Area Team Primary Care Nurse Adviser Population Health Practitioner Manager Immunisation South London Public Health Specialist (Immunisation) and Acting Public Health Consultant (Health in the Justice System) Chief Pharmacist Wandsworth Clinical Commissioning Group Senior Prescribing Adviser (Tower Hamlets) North and East London Commissioning Support Unit Head of Medicines Management Haringey Clinical Commissioning Group Practice Link Pharmacist North West London Commissioning Support Unit Senior Practice Pharmacist Richmond Clinical Commissioning Group Chief Pharmacist NHS Kingston Clinical Commissioning Group References: SmPC References for Menitorix. Latest version on emc (accessed March 2014): Green Book chapters on Haemophilius influenza type b and Meningococcal vaccines (accessed March 2014): Reference Number: NHSE(LR)/PGD/HIB/MenC v1.1 Page 2 of 9

3 PGD for Hib/MenC Reference Number: NHSE(LR)/PGD/HIB/MenC v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016 Page 3 of 9

4 PGD for the Administration of Haemophilus Influenzae Type b (Hib) and Meningococcal C conjugated (MenC) vaccine (Hib/MenC) Clinical condition or situation to which this PGD applies Active immunisation against Haemophilus influenzae Type b (Hib) and Neisseria meningitidis serotype C (Meningitis C; Men C). Inclusion criteria Booster dose for a child over 12 months, and under 2 years of age (recommended within 1 month of their 1 st birthday), who has received a complete primary course of 3 doses of Hib-containing vaccine and 2 doses of Men C vaccine; Child over 12 months, and under 10 years of age, who has completed a primary course of diphtheria, tetanus, pertussis and polio vaccination, but has not received a dose of a Hib-containing vaccine; Patient over 12 months of age with asplenia, splenic dysfunction, immunosuppression, or early complement deficiency who requires additional protection from Hib. Exclusion criteria Action if excluded As per the general exclusion criteria stated in the Core PGD, plus: Child under 12 months of age; Any patient who has had a confirmed anaphylactic reaction to a previous dose of either a Hib-containing vaccine, or MenC conjugate vaccine, or a confirmed anaphylactic reaction to any component, including tetanus toxoid; Patient over 10 years of age, unless they require additional protection from Hib due to asplenia, splenic dysfunction, immunosuppression, or early complement deficiency; Patient requiring immunisation against meningitis C alone. Under 12 months of age - assess if primary vaccination schedule has been completed: o If YES, defer HiB/MenC until they reach 12 months of age; o If NO, then complete primary vaccination (refer to PGD for Pediacel ); o If the child has been vaccinated according to a non- UK schedule, and has not received primary immunisation for Hib, refer to ; If patient requires immunisation against meningitis C alone, use a meningitis C single antigen vaccine. Reference Number: NHSE(LR)/PGD/HIB/MenC v1.1 Page 4 of 9

5 Special considerations/ additional information Details of the medicine Name, form and strength of medicine Dose Hib/MenC should be offered with the Pneumococcal conjugate vaccine (PCV13) booster and MMR in one visit, within a month after the child s first birthday. If the parent/carer/guardian refuses three vaccinations at one visit, it is preferable for the MMR and PCV13 vaccines to be given first, followed by Hib/MenC at a further visit; The presence of a neurological condition is not a contraindication; refer to chapter 16 of the Green Book; Allergy to latex as vial stopper contains rubber. Contact manufacturer for further information. Haemophilus influenza type b and Meningococcal C conjugate vaccine (Menitorix ) is presented as a white powder in a vial and a pre-filled syringe containing a clear colourless solvent 0.5ml Follow manufacturer s guidance on handling of vaccine before administration - see package insert: Reconstitute the vaccine by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder. Shake the mixture until the powder is completely dissolved in the solvent; Shake vaccine well immediately before administration. Frequency A single dose to be administered at 12 to 13 months of age, or as a primary dose for previously unvaccinated children over 12 months and under 10 years of age. Patients with asplenia or splenic dysfunction will require an additional dose of Hib/MenC, based on time of diagnosis, as follows: Children diagnosed between 12 and 24 months of age should receive their first dose at 12 to 13 months (as part of the routine programme), and then one dose at 24 months; Children diagnosed over 2 years of age, and adults, who had the first dose at 12 to 13 months (as part of the routine programme), should have a single dose as soon as possible. Refer to Appendices 1 and 2 for details of vaccination schedules. Quantity 1 x 0.5ml (or 2 doses for patients with asplenia or splenic dysfunction) Reference Number: NHSE(LR)/PGD/HIB/MenC v1.1 Page 5 of 9

6 Use Outside the Terms of the Summary of Product Characteristics (SmPC) Adverse effects Menitorix is not licensed for children over 2 years of age, and adults: the JCVI has recommended its use in older children and adults requiring Hib with or without Meningitis C vaccination. As detailed in the core PGD, plus: common: irritability. Refer to SmPC for complete list. Reference Number: NHSE(LR)/PGD/HIB/MenC v1.1 Page 6 of 9

7 Healthcare Professional s Agreement to Practise and Practice/Pharmacy/Local Organisation Authorisation PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTISE ONLY WITHIN THE BOUNDS OF THEIR OWN COMPETENCE AND IN ACCORDANCE WITH THEIR OWN CODE OF PROFESSIONAL CONDUCT. DECLARATION by healthcare professional: I have read and understand this PGD; I have been appropriately trained to understand the criteria listed, and the techniques and record-keeping required to administer the vaccine in accordance with this PGD; The training has included both the theoretical and practical aspects of the techniques required to administer vaccines by the following routes (please tick as appropriate): Intramuscular injection Subcutaneous injection I confirm that I have been assessed for my knowledge and clinical competency, and EITHER am experienced in administering vaccines in the past 12 months, OR I have been observed administering vaccines in practice; I confirm that I am competent to undertake administration of this vaccine; I confirm that I will ensure that I remain up to date in all aspects of the administration of this vaccine. Healthcare Professional s Name:. Registration Number:. Expiry Date:. Signature:.... Date:. Declaration by Authorising Manager * : Managers should only authorise staff who have received the required training and are competent to work to this PGD. Each authorised member of staff should be provided with an individual copy of the PGD, which they should also sign to declare themselves competent. A copy of the signed document should be kept by the individual staff member. The authorising manager should retain a copy of the signed individual authorisation page. I have read and understood the PGD and authorise the staff member named above to operate in accordance with this PGD. Authorising Manager s Name:.. Signature:.... Date:. * The term manager refers to the person taking responsibility for authorising healthcare professionals to operate under the terms of this PGD, and includes lead GPs, nurse managers, pharmacy managers etc. Reference Number: NHSE(LR)/PGD/HIB/MenC v1.1 Page 7 of 9

8 Appendix 1 Meningococcal C Routine Vaccination Schedule (Adapted from Table 22.1: Green Book, Chapter 22) Age Primary/Booster Dose Three months Primary Although the SmPCs for the available MenC conjugate vaccines state that two doses should be given at least two months apart in those less than one year of age, evidence from a UK study shows that immunogenicity is adequate following a primary course of a single dose in infants One dose - Men C vaccine* Use Neisvac C or Menjugate Kit only months Around 14 years Booster Booster One dose - Hib/MenC vaccine* One dose - Men C vaccine* *If no doses of MenC vaccine have been received follow the Individuals with unknown or incomplete vaccination histories table in Appendix 2 Reference Number: NHSE(LR)/PGD/HIB/MenC v1.1 Page 8 of 9

9 Appendix 2 Meningococcal C Vaccination Schedule for Those With unknown or Incomplete Vaccination Histories (Adapted from Table 22.2: Green Book, Chapter 22) Age Under 1 year From 1 year to less than 10 years Over 10 years Dose Give one dose of Men C vaccine (Neisvac C or Menjugate Kit) and follow schedule from months (leaving at least one month between primary and booster doses). Give one dose of Men C (or Hib/MenC if unvaccinated for Hib). If has never received vaccine give one dose of Men C no further vaccination is then required; If received Men C since reaching 10 years of age no further vaccination is required; If last received MenC vaccine under ten years of age, give Men C with teenage booster (at around 14 years of age. Reference Number: NHSE(LR)/PGD/HIB/MenC v1.1 Page 9 of 9