Patient Group Direction for the Administration of Hepatitis A vaccine 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 2013 1.1 Revision of content March 2014 Reference Number: NHSE(LR)/PGD/Hep A v1.1 Page 1 of 6
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 Avaxim, Epaxal, Havrix (Monodose and Junior Monodose) and Vaqta. (Adult and Paediatric) Latest versions on emc (accessed March 2014): http://www.medicines.org.uk/emcmobile/medicine/6206/spc http://www.medicines.org.uk/emcmobile/medicine/26275/spc http://www.medicines.org.uk/emcmobile/medicine/2040/spc http://www.medicines.org.uk/emcmobile/medicine/2041/spc http://www.medicines.org.uk/emcmobile/medicine/6210/spc http://www.medicines.org.uk/emcmobile/medicine/6211/spc Green Book chapter on Hepatitis A vaccine (accessed March 2014): https://www.gov.uk/government/publications/hepatitis-a-the-green-book-chapter- 17 Reference Number: NHSE(LR)/PGD/Hep A v1.1 Page 2 of 6
PGD for Hep A Reference Number: NHSE(LR)/PGD/Hep A v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016 Page 3 of 6
Patient Group Direction for the Administration of Hepatitis A vaccine Clinical condition or situation to which this PGD applies Inclusion criteria Active immunisation against Hepatitis A Adults and children over 1 year old, in the following groups: Patients travelling to areas of moderate or high endemicity for prolonged periods. Includes those posted to or going to reside in virus endemic countries; Patients with chronic liver disease, including those with hepatitis B, or hepatitis C; Occupational exposure, including laboratory workers working directly with the virus, those in contact with raw sewage, staff and residents of large institutions for those with learning disabilities, individuals who work with primates; Injecting drug users; Those at risk due to sexual behaviour, e.g. men who have sex with men; Haemophiliacs treated with plasma-derived clotting factors; Previously unvaccinated contacts of cases of hepatitis A with onset of jaundice within the last week; Previously unvaccinated contacts of a food handler who develops acute jaundice or is diagnosed clinically or serologically with hepatitis A infection, following guidance from the local Health Protection Team. Other groups such as food packagers/handlers, staff in day-care facilities, healthcare workers should not routinely be offered hepatitis A vaccination, however this PGD enables vaccination of other groups, following guidance from the local Health Protection Team, in response to local outbreaks. Exclusion criteria As per the general exclusion criteria stated in the Core PGD, plus: Child under 12 months of age; Previous hypersensitivity reaction to any constituent of the vaccine, in particular: o Confirmed anaphylactic reaction to egg/chick protein: Epaxal o Formaldehyde: Avaxim, Epaxal, Vaqta o Neomycin: Avaxim, Havrix, Vaqta ; In latex-sensitive individuals Vaqta may cause allergic reactions, use a different vaccine for these patients; Reference Number: NHSE(LR)/PGD/Hep A v1.1 Page 4 of 6
Confirmed history of Hepatitis A infection; Patients on haemodialysis (refer to specialist). Special considerations/ additional information Hepatitis A containing vaccines may be given to pregnant women who are at risk of contracting the disease; There is no evidence of risk from vaccinating pregnant women, or those who are breast-feeding with inactivated viral or bacterial vaccines or toxoids. Hepatitis A is an inactivated vaccine. Details of the medicine Name, form and strength of medicine Dose Hepatitis A vaccine (inactivated, adsorbed). Avaxim, Epaxal, Havrix, or Vaqta 1 year and over Epaxal : 0.5ml 1 15 years Havrix Monodose Junior : 0.5ml 1 17 years Vaqta Paediatric : 0.5ml 16 years and over Avaxim : 0.5ml Havrix Monodose : 1.0ml 18 years and over Vaqta : 1.0ml Frequency Quantity Adverse effects Initial dose, followed by booster dose as follows: Avaxim, Havrix Monodose, or Havrix Monodose Junior : 6 12 months (can be given up to 3 years after initial dose); Epaxal : 6-12 months (can be given up to 4 years after initial dose); Vaqta, or Vaqta Paediatric : 6 18 months; a booster can be given 6-12 months after the initial dose if a different brand was used for the initial dose. 2 doses As detailed in the core PGD. Refer to SmPC for complete list. Reference Number: NHSE(LR)/PGD/Hep A v1.1 Page 5 of 6
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/Hep A v1.1 Page 6 of 6