Patient Group Direction for Combined Hepatitis A & B vaccine Version: Hep A + B Start Date: 1 st January 2014 Expiry Date: 31 st December 2015
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1 Patient Group Direction for Combined Hepatitis A & B vaccine Version: Hep A + B Start 1 st January 2014 Expiry 31 st December 2015 THIS PATIENT GROUP DIRECTION HAS BEEN AGREED BY THE FOLLOWING ORGANISATIONS: BLACKPOOL TEACHING HOSPITALS NHS FOUNDATION TRUST CUMBRIA PARTNERSHIP NHS FOUNDATION TRUST EAST LANCASHIRE HOSPITALS NHS TRUST LANCASHIRE CARE NHS FOUNDATION TRUST NORTH CUMBRIA UNIVERSITY HOSPITALS NHS TRUST UNIVERSITY HOSPITALS OF MORECAMBE BAY NHS FOUNDATION TRUST CLINICAL COMMISSIONING GROUPS: BLACKBURN WITH DARWEN BLACKPOOL CHORLEY AND SOUTH RIBBLE CUMBRIA EAST LANCASHIRE FYLDE AND WYRE GATESHEAD GREATER PRESTON LANCASHIRE NORTH NEWCASTLE NORTH AND EAST NORTH TYNESIDE NORTHUMBERLAND SOUTH TYNESIDE SUNDERLAND WEST LANCASHIRE [Type text]
2 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR Patient Group Direction Details VERSION Hep A+B (Page 1 of 4) Date comes into effect 1 st January 2014 Date of expiry + review 31 st December 2015 or in the light of significant changes in best practice Staff characteristics Registered nurse or Pharmacist employed by the NHS organisations above or independent contractors within them, who has completed immunisation and vaccination training (theoretical and practical) as per local policy, training in the recognition and treatment of anaphylaxis, including practical training in Basic Life Support (annual practice update session to be undertaken) and working under PGDs. Access to adrenaline and access to the complete updated relevant chapters in the current edition of the Green Book Immunisation against Infectious Disease. Clinical Details Indication Inclusion criteria Exclusion criteria Precautions Management of excluded patients Action for patients not wishing/unable to receive care under this PGD >> YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION << >> OF THIS PGD BEFORE WORKING UNDER IT << This PGD is to be followed by all nurses and pharmacists who carry out immunisations in hospitals, clinics, schools, surgeries, patients homes or other locations. Facilities for treating anaphylaxis must be available. Immunisation against hepatitis A and B Individuals who are at risk of infection from both Hepatitis A and Hepatitis B due to: Travel to areas of moderate or high endemicity At risk of infection due to contact, occupational or lifestyle factors Confirmed anaphylactic reaction to any component or a preceding dose of the Hepatitis A and/or Hepatitis B vaccines. Known hypersensitivity to neomycin. Under 12 months of age Previous Hepatitis A or Hepatitis B infection Immunosuppressed (may have inadequate response and require a higher dose, specialist advice may be required) Post exposure prophylaxis e.g. needlestick injury, ocular or mucous membrane splash. Ambirix should not be used where rapid protection against Hepatitis B is required. Check the manufacturers information prior to administration of any vaccine/immunoglobulin re its latex content. If latex is a component of the vaccine/immunoglobulin or the administration system (e.g. vial or syringe etc.) then a latex-free alternative must be offered to patients with latex sensitivity. Absence of valid consent Immunisation should be postponed in patients with acute febrile illness/infection. Give information about when the vaccine may/may not be given or give a further appointment to attend for vaccination, or in the case of a previous severe allergic reaction be referred to the appropriate medical officer, e.g. CMO, GP Make patient aware of alternative, risks and potential consequences of not being vaccinated. Document refusal. Give advice about how to avoid Hepatitis A and Hepatitis B infection.
3 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR COMBINED HEPATITIS A & B VACCINE VERSION Hep A+B (Page 2 of 4) Description of Treatment Name of medicine Formulation and route Strength Dosage Repeated dose instructions Duration of treatment Quantity to supply Legal status Special Precautions Adverse effects Advice necessary Records and Follow Up Referral arrangements Records to be kept Follow up Twinrix Adult Vaccine, Twinrix Paediatric Vaccine, Ambirix Intramuscular injection in the deltoid region. * Can be given in the anterolateral thigh in infants over 12 months. Vaccination by deep subcutaneous route should be reserved only for individuals with a bleeding disorder. The buttock must NOT be used reduced vaccine efficacy Prepare as per manufacturers instructions. 720 ELISA units of inactivated Hepatitis A virus and 20 micrograms of Hepatitis B virus surface antigen per ml of vaccine Adults and children over 16 years: 1.0mL of Twinrix Adult Children 1-15 years: 0.5mL of Twinrix Paediatric Children 1-15years: 1.0mL of Ambirix Primary course: Twinrix - 3 doses at 0, 1 and 6 months Ambirix - 2 doses at 0 and 6-12 months For Patients over 16 using Twinrix Adult ONLY: Accelerated primary course where rapid immunisation is necessary (e.g. travellers departing within one month): 4 doses at 0, 7 and 21 days, plus 12 months. Primary courses started with Twinrix or Ambirix must NOT be completed with single antigen Hepatitis A / B vaccines Booster doses: (refer to appropriate single antigen vaccine PGD) Monovalent Hepatitis A booster after 20 years if at continuing risk. Monovalent Hepatitis B booster after five years [once only] if at continuing risk of infection. If booster doses of both components are needed at the same time, a single dose of the combined vaccine may be given as above. As above See above Prescription only medicine (POM) Explain indications, contraindications and cautions (refer to Green Book) Pregnancy and breast feeding Hepatitis A-containing vaccines may be given to pregnant women when clinically indicated following a risk assessment Ambirix should only be used when there is a low risk of hepatitis B infection during the vaccination course For more details on these groups refer to the Hepatitis A vaccine PGD and Hepatitis B vaccine PGD or the criteria in the Green Book. The most common reactions are redness and soreness at the site of injection. Other reported reactions include fever, rash, malaise and an influenza-like syndrome, arthritis, arthralgia and myalgia. Serious neurological reactions are very rare and a causal link with vaccination has not been established. This list is not exhaustive. Refer to BNF and SPC for complete list. If serious reaction noted, complete & submit Yellow Card via For up to date SPCs and PILs Ensure that the patient information leaflet is available & offered to every patient/parent/guardian. Advice on the prevention and management of fever and local reactions and other adverse effects. Common post-vaccination adverse effects. Date of next vaccination as required. Advice about how to avoid Hepatitis A and Hepatitis B infection Prior to vaccinating, any health professional administering a vaccination must be able to identify and contact an appropriate medical officer, e.g. CMO, consultant paediatrician, GP, as necessary, e.g. in the case of an immunocompromised child. As per local documentation requirements. Record the brand name of the vaccine given, date and time of administration,batch number, expiry date and immunisation site, supply/administration under PGD. Document any reaction in patient s medical notes. Subsequent vaccination as required as per UK schedule Patient Group Direction, organisation and individual authorisation signatures can be found on the managerial content sheet along with other non-clinical details relating to this patient group direction.
4 MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION FOR Patient Group Direction Owner Details of Patient Group Direction owner Patient Group Direction Details VERSION Hep A+B (Page 3 of 4) Name: Martin Samangaya Position: Screening and Immunisation Manager Contact Address: Public Health England, Lancashire Area Team Contact Telephone: Contact msamangaya@nhs.net Date comes into effect 1 st January 2014 Date of expiry + review 31 st December 2015 or in the light of significant changes in best practice Staff characteristics Registered nurse or Pharmacist employed by the NHS organisations above or independent contractors within them, who has completed immunisation and vaccination training (theoretical and practical) as per local policy, training in the recognition and treatment of anaphylaxis, including practical training in Basic Life Support (annual practice update session to be undertaken) and working under PGDs. Access to adrenaline and access to the complete updated relevant chapters in the current edition of the Green Book Immunisation against Infectious Disease. Patient Group Direction Authorisation Lead Doctor >> YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION << >> OF THIS PGD BEFORE WORKING UNDER IT << Name: Dr Steven Gee Position: Consultant in Health Protection, C&LPHEC Lead Pharmacist Lead Nurse Organisational Authorisation for Lancashire CCGs by Organisational Authorisation for CNTW CCGs by Name: Julie Lonsdale Position: Head of Medicines Performance, Lancashire CSU Name: Ms Kate Brierley Position: Consultant Nurse Health Protection, C&LPHEC Name: Dr J Gardner Position: Medical Director, Lancashire Area Team, NHS England Name: Dr M Prentice Position: Medical Director, CNTW Area Team, NHS England Authorisation by Independent Contractor (for PGDs being used by the staff of Independent Contractors only) Name: Position: Patient Group Direction Peer Reviewed By Name Position Signature Date Cumbria and Lancashire Vaccine PGD Sub-Group (on behalf of group)
5 MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION FOR Individual Authorisation VERSION Hep A+B (Page 4 of 4) BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT 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 IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT IT IS YOUR REPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION NOTE TO AUTHORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THE PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION Name of Professional Signature Authorising Manager Date
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