PROCEDURE REF NO SABP/EXECUTIVE BOARD/0017 NAME OF PROCEDURE: Medicines Procedure: Patient Group Directions for the Administration of Hepatitis B Vaccine for SABP Drug and Alcohol Teams. PURPOSE OF PROCEDURE: WHAT THE PROCEDURE WILL ACHIEVE? To ensure all members of staff involved in the prescribing, administering and safe custody of vaccines are fully aware of the necessary steps required. Provide guidance to all staff involved in the administration of Vaccines through patient group directions. WHO NEEDS TO KNOW ABOUT IT? All clinical /practitioners within the Drug and Alcohol Services and Pharmacy staff. DATE APPROVED: 6 th April 2017 VERSION NUMBER: 4.0 APPROVING COMMITTEE: Executive Board DATE OF IMPLEMENTATION: 28 th September 2017 DATE OF FORMAL REVIEW: April 2020 AUTHOR/REVIEWER: Simon Whitfield (Chief Pharmacist) Mike Flanagan (Clinical Lead) Lynda Winn (Clinical Nurse Specialist). DISTRIBUTION: SABP Substance Misuse Teams 1
VERSION CONTROL SHEET Version Date Author Status Comment 1 2006 Mayvis Oddoye 2 7/07/10 Lynda Winn and Simon Whitfield Major review to ensure presentation complies with legislative requirements 3 June 2014 Fiona Minor amendments Lockwood and Lynda Winn 3.1 Nov 2016 Simon Whitfield Draft Rationalisation of products 3.1 Dec 16 Simon Whitfield Draft Reviewed by Fiona Lockwood 3.2 Jan 17 Simon Whitfield Draft Reviewed by Linda Wynn 3.3 March 17 Simon Whitfield Draft Added clarity over competency requirements and 2
annual sign off 3.4 April 17 Simon Whitfield Draft Presented at PAG. Query regarding support for nurses who fail competency assessment. 4 July 17 Approved 3
Summary of Changes since Version 3 Page/Paragraph/ Appendix Number Original / New / Amendment / Deleted Statement (select the appropriate action) PGD revised to include Hepatitis B (Engerix B) vaccine only. All other references to other vaccines and brands and preparations have been removed and are no longer covered by this PGD. If a member of staff fails the competency assessment then a tailored training package will be developed, using the available online training resources, coaching and supervision, to support and enable the member of staff to attain the required competency. 4
PATIENT GROUP DIRECTION (PGD) FOR THE ADMINISTRATION OF HEPATITIS VACCINES BY REGISTERED NURSES WORKING IN SABP SUBSTANCE MISUSE SERVICES Version Number: 4 Patient Group Direction drawn up by: NAME: TITLE: Simon Whitfield Mike Flanagan Lynda Winn Chief Pharmacist Clinical Lead for Substance Misuse Clinical Nurse Specialist Patient Group Direction authorised by: Medical Lead Executive Medical Director On behalf of the organisation Chief Pharmacist Director of Nursing Date Protocol Agreed: July 2017 Proposed Review Date: April 2020 Date Protocol Expires: July 2020 5
1. Scope 1.1 The Patient Group Directions included in this document are: Hepatitis B Vaccine (Energix B ) 1.2 If a nurse is asked to supply or supply and administer a medicine not covered by this or any other PGD then a prescription or named written direction is required from a prescriber first. 2. Rationale for Patient Group Directions for the administration of vaccines 2.1 To enable suitably qualified health professionals, who are deemed to be competent, to administer vaccines for people who use our drug and alcohol services 2.2 Key Documents: NMC code of conduct RCN PGD document Green book (2006) 3 rd edition and on-line updates HPA Core Curriculum for Immunisation Training 3. General Guidance for the Administration of Vaccines 3.1 General - The identity of the vaccine must be checked to ensure the right product is used in the appropriate way on every occasion. - The expiry date must be noted. - Vaccines must not be used after the expiry date on the label. - The date of immunisation, title of vaccine and batch number must be recorded on the recipient s record. - It is considered good practice to record the site of administration. - The recommended storage conditions must have been observed. 6
4. Storage, Distribution and Disposal of Vaccines - The Unit Manager should be responsible for the safe storage of vaccines and must have a nominated deputy to cover times of absence. There should be written procedures for storage, distribution and disposal. This should include procedures in case the refrigerator temperature is out of range. - Manufacturers recommendations on storage must be observed. On receipt, vaccines should be checked against the order, examined for leakage or other damage and immediately refrigerated at between 2 0 C and 8 0 C. Vaccines must not be stored below freezing (0 0 C) as this may cause deterioration of the vaccine and breakage of the container. - Vaccines should be stored in the refrigerator in the manufacturer s box as this protects the vaccine from the light and also contains product information. Do not store in the refrigerator door. Allow room for air to circulate in the refrigerator. 5. Cleaning of Skin - The skin does not need to be cleaned as a matter of routine, the exception being if the skin is dirty. 6. Route of Administration - Hepatitis B vaccines must be given as an Intramuscular Injection using the deltoid site. 7. Administration Outside Hospital Based Premises Refer to the BBV Policy document where details are given in full. 7
8. Advice and Referral If a person using our services falls outside the guidelines for vaccination using the PGD medical advice should be sought. 9. Before Giving Vaccine - Patients should be advised of the contra-indications. - Adrenaline 1:1000 and a laerdal facemask must be available. - The consent form must be signed. - Informed consent to be obtained from the patient immediately prior to administration of vaccine, having been given clear explanation of which vaccines are to be administered and their possible side effects. Patient information leaflets should be made available. 10. Contra-indications for Immunisation - Postpone vaccination if the patient reports pyrexia/unwell or is being prescribed antibiotics. - Seek doctor s advice if the patient has had: A severe local or systemic reaction to a previous dose of the vaccine Severe adverse reaction to antibiotics especially neomycin Has an immunosuppressant illness 11. Post Vaccination - Ask patient to wait in waiting room for 10 minutes. - Ensure appropriate advice is given re allergic reactions. - Advise the patient that if any local reaction does not disappear within 1-2 days or if the patient experiences other severe symptoms e.g. confusion, persistent drowsiness etc, advise them to contact their General Practitioner. 8
12. Record Keeping - All immunisations, with their batch numbers and expiry date, should be entered in the patient notes using the vaccination record. - Details should be entered onto the electronic patient record. - Any previous vaccination history should be entered in patient notes. - Any unusual side effects should be recorded on the yellow card available in the BNF and online: https://yellowcard.mhra.gov.uk/theyellow-card-scheme/ 13. Authorised Staff Characteristics Professional qualifications to be held by staff administering vaccines under this Patient Group Direction Authorised nurses must hold a current nursing registration with the Nursing and Midwifery Council. Have a minimum of 6 months experience in substance misuse. Registered nurse working within SABP Competence Each authorised individual administering vaccines in accordance with this Patient Group Direction should be able to demonstrate competency in the areas below, to their line manager on an annual basis: Administration of vaccines including knowledge of recommended sites and routes and understanding of passive / active immunity, storage requirements for vaccines. Recognition and management of anaphylaxis. Self-directed learning programme or training for Hepatitis B vaccination and maintain own level of updating CPD. HPA Core Curriculum of Immunisation including competency checklist to be updated yearly. RCN PGD Document. Hepatitis B Vaccination relevant chapters in Green Book (2006) 3 rd edition and on-line updates. Yearly CPR and anaphylaxis update as per SABP requirements. Assessment of competency The line manager or delegated authority can assess competency via a group assessment process to ensure consistency of practice across the service, however they 9
must be assured that each individual is competent to practice within the framework of the PGD. If a member of staff fails the competency assessment then a tailored training package will be developed by their line manager, using the available online training resources, coaching and supervision, to support and enable the member of staff to attain the required competency. Record of competence and authorisation The record of competence and authorisation forms found in section 17 must be completed and updated on an annual basis. 10
14. PGD for the Supply/Administration of: HEPATITIS B VACCINE Engerix B To Adults accessing SABP Substance Misuse Services. Specific Clinical Condition Indication Specific inclusion criteria Active immunisation for Adults requiring immunisation from Hepatitis B virus infection. Adults who present to SABP Substance Misuse Services and who: Are at risk due to their substance misuse, sexual behaviour or other lifestyle behaviours. Informed consent to be obtained from the client immediately prior to administration of vaccine, having been given clear explanation of which vaccine is to be administered and possible side effects. Patient information leaflet should be made available. Specific exclusion criteria Febrile illness. True allergy or anaphylaxis to any component of vaccine (refer to SPC www.emc.medicines.org.uk) Post exposure prophylaxis. Previous confirmed Hepatitis B infection. Pregnancy (unless definitive risk of Hepatitis B Refer to doctor). No consent. Cautions There are 2 volumes of Engerix B vaccine available. Ensure the 1ml volume (20 micrograms/1ml) is used. Action if excluded Advice about protective effects of the vaccine and risks of infection and disease complications. Inform patient to return when febrile illness resolved. Patients with Hepatitis B or allergy discuss with GP / specialist, advice re minimisation of risk. Document advice given. Reschedule vaccinations. Action if client declines Advise on minimisation of risk and document advice given. Inform or refer to GP if appropriate. Referral arrangements for medical advise Discuss with team doctor if available, refer to GP/Walk-In Centre or Accident and Emergency. 11
Name of medicine Hepatitis B recombinant vaccine adsorbed Engerix B Legal Status POM Dose/route/frequency Engerix B Adults and Children over 16 years: Accelerated course: 1mL (20 micrograms) by IM injection into the deltoid region for initial dose; repeat at 1 month, 2 months and at 12 months after initial dose. Super Accelerated course for adults over 18 years: 1mL (20 micrograms) by IM injection into the deltoid region for initial dose; repeat at 7 days, 21 days and fourth dose at 12 months after initial dose. Refer to Green Book (2006) and on-line updates for further schedules. Specific advice/warnings Soreness at injection site, fever, headache or myalgia may occur Seek medical advice if a systemic reaction is experienced. Rare severe reactions including encephalitis, anaphylaxis, jaundice or neuritis should be reported using the Yellow Card system. Reporting procedure of Adverse Reactions Any serious adverse reaction to the vaccine should be documented in the medical records. The GP should also be informed. Additional Facilities Anaphylaxis pack including Epinephrine (Adrenaline) (1 in 1000, 1ml ampoule), laerdal face mask or resuscitation face shield as a minimum. Facilities for safe disposal of needles, syringes, vials and other clinical waste. Hand decontamination or washing facilities. Vaccines to be stored as specified in their summaries of product characteristics and Trust / Practice medicines storage procedures in a refrigerator between 2 and 8 C and temperature monitored and recorded each working day and defrosted regularly. Additional Information A single booster dose five years after completion of the primary course for individuals who continue to be at risk of infection unless they have already received a booster dose following possible exposure. The vaccine must not be administered by intradermal or intravascular routes The vaccine must not be administered in the buttock as this may result in a lower immune response Vaccine should be maintained at a temperature of 2 0 to 8 0 C. If the vaccine has been frozen, the vaccine should be discarded 12
In some circumstances, the recommendations regarding vaccines given in the Green Book may differ from those in the manufacturers SPC or datasheet. Where this is the case, the recommendations given are based on the current expert advice received from the Joint Committee on Vaccination and Immunisation (JCVI) and should be followed. 13
14. Record of competency and authorisation. The forms below must be completed and updated on an annual basis. Annual Individual Authorisation: By signing this Patient Group Direction (PGD) you are indicating that you agree to its contents and that you will work within it. This PGD does 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 scope of practice. Practitioner: I confirm that I have read and understood the content of this patient group direction and that I am willing and competent to work under it within my professional code of conduct. Signed Date Name (Print).. Authorising Manager: I confirm the above named nurse has satisfactorily completed the annual competency assessment and is authorised to work under this PGD. Signed.Date Name (Print) Team Authorising Consultant: I confirm the above named nurse has satisfactorily completed the annual competency assessment and is authorised to work under this PGD. Signed Date. Name (Print) Team 14
SABP Partnership NHS Foundation Trust Team Name: The following named individuals have completed an annual competency assessment and are authorised to work under this PGD. Name of Nurse Date of authorisation Signature of line manager 15
15. References British National Formulary March 2016 Immunisation Against Infectious Diseases HMSO 2006 16. Websites - Resuscitation Council (UK) www.resus.org.uk - www.emc.medicines.org.uk - www.immunisation.org.uk - www.prodigy.nhs.uk - Electronic Medicines Compendium http://emc/vhn.net/ - Vaccine Update Bulletin http://nww.pase-nhs.uk/pharmacy - BNF www.bnf.org - Consent www.doh.gov.uk/consent - http://www.dh.gov.uk/policyandguidance/healthandsocialcare Topics/GreenBook/GreenBookGeneralInformation/ - PGD and UK guidance on best practise in vaccine administration 16