PATIENT GROUP DIRECTION (PGD) FOR THE ADMINISTRATION OF COMBINED HEPATITIS A&B VACCINE

Transcription

1 PATIENT GROUP DIRECTION (PGD) FOR THE ADMINISTRATION OF COMBINED HEPATITIS A&B VACCINE Valid from: June 2016 Review date: May 2018 Expiry date: June 2018 Developed by Name Job Title Signature Date Senior Pharmacist Yuk Sim Wong Lead Clinical Pharmacist for Substance Misuse Senior Nurse Team Leader for Ruari McCallion Substance Misuse Senior Doctor John Dunn Divisional Clinical Lead for Substance Misuse & Forensic Services This patient group direction has been approved on behalf of C&I by: The PGD must be signed below by the Medical Director Name Signature Date Medical Director Vincent Kirchner 22/06/16 Chief Pharmacist Lucy Reeves 22/06/16 Deputy Director Nursing 1 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

2 YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT NB Information provided in this PGD is based on information given by the Department of Health/ current edition of Immunisation Against Infectious Diseases [The Green Book/ e-green Book]. This may override information in the manufacturer s Summary of Product Characteristics [SPC] Clinical Condition Indication To provide effective protection against both hepatitis A and B infection for clients assessing substance misuse services who meet the inclusion criteria. Inclusion criteria Exclusion criteria Applies to clients accessing substance misuse services Close family or household contacts of a case or individual with chronic hepatitis B infection Injecting drug users, including those who inject intermittently or those who are likely to progress to injecting. See Green Book for details 1 Sexual partners of injecting drug users and non- injecting users who are living with current injectors Individuals who frequently change sexual partners Patients with chronic liver disease Men who have sex with men For mentally incapable adults valid consent for vaccination can be given by a lasting power of attorney or valid advanced directive or vaccination should be given in their best interests unless previous history from next of kin suggest that previously, when the individual retained capacity, they would clearly have declined vaccination. See Mental Health Capacity Act Code of Practice: Section 67 or in line with advice set out in Chapter 2: Consent in the current Green book. Acute severe febrile or systemic illness (postpone immunisation until the patient has fully recovered) Confirmed anaphylactic reaction to previous Hepatitis A or B vaccine Confirmed anaphylactic reaction to any component of the vaccine Pregnancy and breastfeeding- refer to doctor Evolving neurological condition; defer vaccination until condition has resolved or stabilised (Green Book Chapter 6: Contraindication and special conditions 1 ). Consult GP or seek specialist advice if need for vaccine is urgent. Consent withheld by patient/carer. 2 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

3 Special Considerations Hypersensitivity to a component of the vaccine seek advice or refer to doctor as applicable Action to be taken if patient excluded from treatment Immunisation error identified. Pregnancy/Breastfeeding - See Green Book 1 Patients using immune suppressive therapy or patients with immunodeficiency See Green Book 1 and SPC 2 Vaccine needed due to increased risk from lifestyle or other factors see details in Green Book and BNF 3 and discuss with doctor. (Patients may have been immunised elsewhere, e.g. hospital, GUM clinics, occupational health service, substance misuse services. Where appropriate arrange referral to specialist services, and give advice on other preventative measures1) HIV positive Individuals receiving regular blood products e.g., people with haemophilia or blood transfusions e.g. people with thalassaemia. Carers responsible for the administration of such products should also be vaccinated. Patients with chronic renal failure including those on haemodialysis prescription needed for appropriate dose schedule, see Green Book/BNF Record reason for exclusion Refer to doctor or as applicable Document action taken Advise of special precautions required to avoid the disease Advise if the patient can have the vaccine at a later date Action to be taken if patient refuses treatment Advise about how Hepatitis A is transmitted Advise about how to avoid Hepatitis A infection Advise about how Hepatitis B is transmitted Advise about how to avoid Hepatitis B infection - this includes travel health advice about accident prevention and on safe sex Advise about disease complications Record reason for exclusion and advice given in patient s medical notes/rio. If immunisation postponed, advise when vaccine can be given. If appropriate, discuss with or refer to GP 3 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

4 Additional information Local or service specific requirements and policies/guidelines that should be adhered to by those using the PGD: Resuscitation facilities, to include in date adrenaline (epinephrine) 1 in 1,000 IM, with directions for use and dosage. Availability of a telephone. C&I Management of Anaphylaxis guidelines, Current Immunisation against infectious Disease, DH (Green Book) and chapter updates on the website. (If the 2006 hard copy is used, ensure that chapter updates from the website are available at that time). Local Cold Chain Guidelines New publications and updates from DH should also be referred to as they are received. Current Health Information for Overseas Travel. DH (Yellow Book) and chapter updates on the website 1. Other references, and further reading, are listed in these guidelines. New publications and updates from DH should also be referred to as they are received. See also, references and resources below: Current Travel Health Advice on world wide web: PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

5 Drug details Name, form & strength of medicine Combined vaccines containing inactivated hepatitis A virus (grown in human diploid cells) 720 ELISA units/ml adsorbed onto aluminium hydroxide and recombinant (DNA) hepatitis B surface antigen (grown in yeast cells) 20 micrograms/ml adsorbed onto aluminium phosphate as Twinrix 3. Available as 1ml pre-filled syringe or 1ml vial 3. A suspension of inactivated hepatitis A virus (grown in human diploid cells) 720 ELISA units/ml adsorbed onto aluminium hydroxide, and recombinant (DNA) hepatitis B surface antigen (grown in yeast cells) 20 micrograms/ml adsorbed onto aluminium phosphate as Ambirix. Available as 1ml pre-filled syringe. Excipients include neomycin 3. POM/P/GSL/ Dosage POM -Prescription Only Medicine The standard schedule for the combined hepatitis A and hepatitis B vaccine depends on the product. For Twinrix the schedule consists of three doses, the first on the elected date, the second one month later and the third six months after the first dose 2. In exceptional circumstances in adults where insufficient time is available to allow the standard 0, 1, 6 month schedule to be completed, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used. When this schedule is applied, a fourth dose is recommended 12 months after the first dose 2. For Ambirix the schedule consists of two doses, the first administered on the elected date and the second between six and twelve months after the first dose 2. Protection against hepatitis B infections may not be obtained until after the second dose, therefore Ambirix should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course 2. A booster dose of hepatitis A vaccine should be given at six to 12 months after the initial dose. This results in a substantial increase in the antibody titre and will give immunity beyond ten years. Until further evidence is available on persistence of protective immunity, a further booster at 20 years is indicated for those at ongoing risk (Van Damme, 2003) 1. For individuals who have received combined hepatitis A and B vaccine in an accelerated schedule, a booster dose is required at one year 1. If rapid protection against hepatitis A is required for adults, for example following exposure or during outbreaks, then a single dose of monovalent 5 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

6 vaccine is recommended 1. Pregnancy and breast-feeding Hepatitis A-containing vaccines may be given to pregnant women when clinically indicated. There is no evidence of risk from vaccinating pregnant women or those who are breast-feeding with inactivated viral or bacterial vaccines or toxoids Immunosuppression and HIV infection Individuals with immunosuppression and HIV infection can be given hepatitis A-containing vaccines although seroconversion rates and antibody titre may be lower and appear to be related to the individual s CD4 count at the time of immunisation. Re-immunisation should be considered and specialist advice may be required. No further immunisation should be given for at least three months in the arm used for BCG immunisation (always in left arm Green Book). Route/Method Shake vaccine well immediately before administration Routinely given by intramuscular injection, in deltoid area 2, or anterolateral aspect of thigh 1 Vaccination by deep subcutaneous route should be reserved only for individuals with a bleeding disorder 1. Vaccine can be given at the same time as other vaccines, but at a different injection site preferably in different limbs. If given in the same limb, the sites should be at least 2.5cm apart 1. The site at which each vaccine was given should be noted in the patient s records. Follow manufacturer s guidance on handling of vaccine before administration -see package insert Frequency As appropriate to vaccine preparation Adverse reaction / side effects For a comprehensive list refer to the manufacturer s Summary of Product Characteristics Patient should be asked to wait on the premises for a short period (ten minutes) so as to observe the patient after vaccination. Frequencies are reported as: Very common: 1/10 Common: 1/100 to < 1/10 Uncommon: 1/1,000 to < 1/100 Rare: 1/10,000 to < 1/1,000 6 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

7 Very rare: <1/10,000 Blood and lymphatic system disorders Rare: lymphadenopathy Nervous system disorders Very common: headache Uncommon: dizziness Rare: hypoaesthesia, paraesthesia Gastrointestinal disorders Common: gastrointestinal symptoms, diarrhoea, nausea Uncommon: vomiting, abdominal pain* Skin and subcutaneous tissue disorders Rare: rash, pruritus Very rare: urticaria Musculoskeletal and connective tissue disorders Uncommon: myalgia Rare: arthralgia Metabolism and nutrition disorders Rare: decreased appetite Infections and infestations Uncommon: upper respiratory tract infection Vascular disorders Rare: hypotension General disorders and administration site conditions Very common: pain and redness at the injection site, fatigue Common: swelling at the injection site, injection site reactions (such as haematoma, pruritus and bruising), malaise Uncommon: fever ( 37.5 C) Rare: influenza like illness, chills Post-marketing surveillance The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines: Blood and lymphatic system disorders Thrombocytopenia, thrombocytopenic purpura Nervous system disorders 7 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

8 Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions Skin and subcutaneous tissue disorders Angioneurotic oedema, lichen planus, erythema multiforme Musculoskeletal and connective tissue disorders Arthritis, muscular weakness Infections and infestations Meningitis Vascular disorders Vasculitis Immune system disorders Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness Following widespread use of the monovalent hepatitis A and/or hepatitis B vaccines, the following undesirable events have additionally been reported in temporal association with vaccination. Investigations Abnormal liver function tests Nervous system disorders Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain- Barré syndrome (with ascending paralysis), optic neuritis Report all suspected serious reactions for established drugs and all suspected reactions for black triangle drugs, to the MHRA, using the BNF or go to Advice to patient/ carer Inform person of possible side effects and their management, and discuss as required. The patient/parent/guardian should have a copy of the DH immunisation information leaflet - reinforce advice with this Manufacturer s Patient Information Leaflet (PIL) to be given to parent/guardian if requested, or if there is no DH leaflet for the vaccine, and discuss as required. On occasion, the PIL and advice from the Department of Health may differ. In this case, advice from the latter should be followed. This discrepancy needs to be explained Advise about how to prevent hepatitis B infection Follow up Advise about follow-up including when next vaccine is due and give information about any future appointments necessary Individuals with immunosuppression and HIV infection (regardless of CD4 count) may not make a full antibody response. Re-immunisation should be considered after treatment is finished and recovery has 8 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

9 occurred consult doctor. Specialist advice will be required 1. (Not applicable to live vaccines, which may be contra-indicated-see Green Book) The Green Book recommends that individuals at continuing risk of infection should be offered a single booster dose of vaccine, once only, around five years after primary immunisation. Handling and storage Refer to local Cold Chain Guidelines Store between 2 8 C; do not freeze; shake well before use; protect from light Transporting vaccines insulated cool boxes should be used when performing administration away from clinics / Health Centers. Frozen packs are not to be in direct contact with the vaccines to avoid the product freezing. The vaccine should be allowed to reach room temperature before administration. Disposal of vaccines In accordance with Waste Management Policy 4 Records / audit trail Patient s name, address, date of birth and consent given Dose and form administered, batch details, expiry and brand or manufacturer, and site of injection Consent Forms if used Record that vaccine given under and in compliance with current PGD Record on RiO as appropriate Nurses should document any advice given by a doctor. Date of administration Name of staff who administered the medication, plus signature for paper-based records (signature not needed for computer based records with password protection). Details of any adverse drug reaction and actions taken including documentation in the patient s medical record, and reporting to the doctor and/or Commission on Human Medicines if appropriate. See or BNF. Referral arrangements (including self-care) GP letter informing the surgery of the medication given at specialist service All client pathways in relation to BBV screening/testing/treatment to be recorded on CIM or RiO (some client details) and the BBV spreadsheet, which will be managed by the BBV coordinator or NMP Immunisation errors - complete Trust incident report and inform GP. 9 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

10 Staff Characteristics Professional qualifications Registered nurse or Health Visitor on the NMC register employed by Camden & Islington Foundation Trust. Specialist competencies or qualifications Continuing education and training Has undertaken appropriate training for working under PGDs for the supply and administration of medicines. Knowledge of and training in local and national immunisation programmes and guidelines Competency and knowledge in: o Immunisation pharmacology o Administration of immunisations o The relevant diseases o Advising parents on immunisation issues o Assessing individuals fitness for immunisation o Contraindications, specific considerations and possible side effects o Handling and storage of vaccines. o Awareness and understanding of role of immunisation in prevention of communicable disease o Requirements for records of vaccines given The practitioner should be aware of any change to the Summary of Product Characteristics for the medicine and report these to Service Lead, for updating the PGD. It is the responsibility of the individual, to keep up-to-date with continued professional development, in line with Nursing and Midwifery Council (NMC). Attended Trust approved immunisation study day(s) as outlined in the relevant Training Needs Analysis (TNA) in the Mandatory and Statutory Training Policy. Attended training in CPR and recognition and management of anaphylaxis as outlined in the relevant TNA. Updates awareness of current immunisation issues. 10 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

11 References / Resources 1. Salisbury D, Ramsey M and Noakes K. eds. DH Immunisation against Infectious Disease. London: The Stationery Office (The Green book); Also available from, blicationspolicyandguidance/dh_ Summary of Product Characteristics (SPC) (If more than one SPC) SPC References for Vaccine and related vaccines All available from: a. Brand name, name of company, Document last updated on emc (Date of approval/ revision for each brand that may be used under the PGD) b. Brand name, name of company, Document last updated on emc (Date of approval/ revision for each brand that may be used under the PGD) 3. Section 14, British National Formulary. Edition current at time of approval of PGD. London, British Medical Association/ Royal Pharmaceutical Society of Great Britain 4. C&I Waste Management Policy (Trust Intranet) 5. NMC Standards for Medicines Management (2007) nmcstandardsformedicinesmanagementbooklet.pdf 6. Resuscitation Council (UK). Emergency medical treatment of anaphylactic reactions. London: Resuscitation Council, DH. Review of prescribing, supply & administration of medicines. London: DH, NHSE, HSC 2000/026. Patient Group Directions. London: DoH, Department of Health (2004) CMO letter 10/8/04 PL/CMO/2004/3 10. NMC Code of Professional Conduct, C&I (2011) Infection Control Manual 11 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016

12 AUTHORISATION RECORD This patient group direction must be agreed to and signed by all health care professionals involved in its use. The service manager should hold the original signed copy of the authorization record. The PGD must be easily accessible in the clinical setting. A copy should be available on the Trust Intranet. 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 and in accordance with their own Code of Professional Conduct. Authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD. Name of Professional Signature Authorising Professional Manager or Senior Practitioner* Date *Senior Practitioner is a senior person in each profession designated with the responsibility to ensure that only competent, qualified and trained professionals operate within PGDs. Note: PGDs are legal documents and may be required to be viewed as evidence. Obsolete signed copies of PGDs must be archived, according to the Practice Policy. For example PGDs relating to medication given to children must be kept for 25 years after expiry of the PGD, and PGDs relating to medication given to adults for 8 years after expiry. 12 PATIENT GROUP DIRECTION Hep A & B VACCINATION : PHA45 : June 2016