PGD for Hep A and Hep B

Patient Group Direction for the Administration of Combined Hepatitis A and Hepatitis B 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 NHS England (London Region), who have been named and authorised to practice under it.

Version number: 1.1 Expiry date: 31st March 2016 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 Change details Version number 1.0 First version 1.1 Revision of content

Reference Number: NHSE(LR)/HepA/HepB v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016

Date December 2013 March 2014

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PGD for Hep A and Hep B 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 Pharmacist Reviewer Raana Ali Pharmacist Reviewer Pauline Taylor Pharmacist Reviewer Helen Tsang Pharmacist Reviewer Dee Vadukul Pharmacist Reviewer Seema Buckley Pharmacist Reviewer •

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Job title and organisation Clinical Adviser (Medicines) NHS England (London Region) Medical Director North Central and East London Area Team NHS England (London Region) Primary Care Nurse Adviser NHS England (London Region) Population Health Practitioner Manager Immunisation South NHS England (London Region) London Public Health Specialist (Immunisation) and Acting Public Health Consultant (Health in the Justice System) NHS England (London Region) 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

SmPC References for Ambirix®, and Twinrix® (Adult and Paediatric). Latest versions on eMC (accessed March 2014): http://www.medicines.org.uk/emcmobile/medicine/20491/spc http://www.medicines.org.uk/emcmobile/medicine/2061/spc http://www.medicines.org.uk/emcmobile/medicine/2062/spc Green Book chapters on Hepatitis A and Hepatitis B vaccines (accessed March 2014): https://www.gov.uk/government/publications/hepatitis-a-the-green-book-chapter17 https://www.gov.uk/government/publications/hepatitis-b-the-green-book-chapter18

Reference Number: NHSE(LR)/HepA/HepB v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016

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PGD for Hep A and Hep B

Reference Number: NHSE(LR)/HepA/HepB v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016

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PGD for Hep A and Hep B Patient Group Direction for the Administration of Combined Hepatitis A and Hepatitis B Vaccine Clinical condition or situation to which this PGD applies

Active immunisation against both Hepatitis A and Hepatitis B

Inclusion criteria

Patients over 1 year of age at risk of both Hepatitis A and Hepatitis B infection requiring either pre- or post-exposure prophylaxis. Pre-Exposure Prophylaxis: •

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Patients travelling to areas of moderate or high endemicity for prolonged periods. Includes those posted to, or going to reside in virus endemic countries; Occupational exposure, for example healthcare workers (including students and trainees), or laboratory workers, who have direct contact with patient’s blood or bloodstained body fluids or patient’s tissues 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; Those at risk due to sexual behaviour, e.g. men who have sex with men, those who change sexual partners frequently; Haemophiliacs and those receiving regular blood transfusions or blood products and carers responsible for administration of these products; Patients with chronic liver disease, including those with milder liver disease, particularly those infected with hepatitis C; Injecting drug users, their sexual partners, and household contacts, including children, and those who are likely to progress to injecting drugs; Foster carers and their families; Families adopting children from countries with high or intermediate prevalence of both Hepatitis A and Hepatitis B.

Post-Exposure Prophylaxis: •

Babies born to mothers: o Who are chronic carriers of the Hepatitis B virus, or to mothers who have had acute Hepatitis B during pregnancy; o Who have partners who are infected with Hepatitis B virus; o Who are, or who have partners who are, injecting

Reference Number: NHSE(LR)/HepA/HepB v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016

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PGD for Hep A and Hep B drug users. Exclusion criteria

As per 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: neomycin; • Confirmed history of Hepatitis A infection; • Patients known to be Hepatitis B surface antigen positive; • Patients with acute hepatitis; • Patients presenting for post-exposure prophylaxis, except babies as listed in the inclusion criteria – refer to GP; • Patients with chronic renal failure and or requiring dialysis – refer to GP or Specialist for appropriate vaccine (See Green Book for guidance).

Special considerations/ • additional information •

Hepatitis A and B containing vaccines may be given to pregnant women who are at risk of contracting the disease; Refer to the Green Book for advice regarding use of hepatitis B immunoglobulin, and serology testing of babies born to mother infected with hepatitis B.

Details of the medicine Name, form and strength of medicine

Combined Hepatitis A and Hepatitis B vaccine (inactivated, adsorbed). Ambirix®, Twinrix® Adult and Paediatric

Dose

1 – 15 years • Ambirix®: 1.0ml • Twinrix® Paediatric: 0.5ml 16 years and over • Twinrix® Adult: 1.0ml

Frequency

Standard schedule for Twinrix® • 3 doses at 0, 1 and 6 months Standard schedule for Ambirix® • 2 doses at 0 and 6 months Rapid schedule Adults (16 years and over) - Twinrix® Adult • If rapid immunisation is required, for example if the patient is travelling within one month, then a rapid

Reference Number: NHSE(LR)/HepA/HepB v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016

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PGD for Hep A and Hep B

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schedule of Twinrix® Adult can be administered; 3 doses at 0, 7 days and 21 days; A booster dose at 12 months is recommended.

Once initiated, the same vaccine should be used for subsequent doses. Quantity

Depends on vaccine and schedule.

Adverse effects

As detailed in the core PGD. Refer to SmPC for complete list.

Reference Number: NHSE(LR)/HepA/HepB v1.1 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016

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PGD for Hep A and Hep B 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)/HepA/HepB v1.1 Page 7 of 7 st Valid from: 1 April 2014 st Review date: 1 January 2016 st Expiry date: 31 March 2016