Administration of Hepatitis A and B Vaccine

Transcription

1 PRACTICE: Ref No: PGD/ONEL/2011/006 Valid from December 2011 Valid to December 2013 Supersedes PGD: Any previous PGD used to administer Twinrix Adult and Paediatric vaccine Professional groups covered by this PGD: Registered Nurse within NHS ONEL Name of vaccine used for administration: Twinrix Adult and Paediatric vaccine Staff Characteristics: Competent in immunisation. Competent in recognition and treatment of anaphylaxis Competent in basic life support including paediatric YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Continuing training & education The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of individual scope of practice 1

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3 1. Clinical Condition Indication Immunisation of non-immune adults and children over 1 year who are at risk of both Hepatitis A and Hepatitis B Criteria for Those travelling to high risk areas outside North and West Inclusion Europe, Australia, Japan, New Zealand or North America (country-by-country recommendations for Hepatitis A and other travel vaccines are given in Health information for overseas travel- Those at risk due to occupation e.g. laboratory workers sanitation workers dealing with untreated sewage day care staff dealing with children or those who work with people with learning difficulties residents of large residential institutions other institutions where standards of personal hygiene among clients or patients may be poor people who work with primates Those at risk due to lifestyle (e.g. intravenous drug users, homosexual men) Those at risk due to health problems (e.g. haemophilia, mental handicap, chronic liver disease) During an outbreak of Hepatitis A as advised by the Health Criteria for Exclusion Protection Agency (HPA) No valid consent Patients with severe febrile illness (reschedule) Patients with hypersensitivity to previous dose or components of the vaccine or neomycin (Full details of excipients can be found in the Summary of Product Characteristics at Patients with proven or likely infection with Hepatitis A (normal immunoglobulin may be required instead) Patients who have already had hepatitis B immunisation Post-exposure prophylaxis following percutaneous (needle-stick), ocular or mucous membrane exposure to Hepatitis B virus Caution(s) In pregnancy it is recommended that Hepatitis A-containing vaccines may be given to pregnant women when clinically indicated The risk to the individual of not being immunised must be taken into account 3

4 Action if excluded Action if patient declines treatment Refer to GP or Independent Nurse prescriber specialist Inform the GP/Independent Nurse Prescriber as appropriate Advise about protective effects of vaccine, risks of infection and disease complications and travel hygiene Document advice given and action 2. Description of Treatment 2A. Name of Medicine and Description Dose, Quantity, Frequency and Route of administration Twinrix Adult vaccine, turbid white suspension in prefilled syringe. Shake the vaccine well to obtain a slightly opaque suspension before use Twinrix Adult vaccine (> 16 years): 3 doses of 1.0 ml by intramuscular injection preferably in the deltoid region at 0, 1, 6 month schedule to be completed: Dose 1: 1ml of Twinrix Adult vaccine Dose 2: 1ml, at one month after the first dose Dose 3: 1ml, at six months after the first dose All three doses should be administered within a 12-month period. In exceptional circumstances in adults, when travel is anticipated within one month more after initiating the vaccination course 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. The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine Not to be injected into the buttock. Subcutaneous route preferred for haemophiliacs or those with thrombocytopenia, bleeding disorders but immune response may be reduced 2B. Name of Medicine and Description Twinrix Paediatric vaccine: turbid white suspension for injection in prefilled syringe Upon storage, a fine white deposit with a clear colourless supernatant can be observed 4

5 Dose, Quantity, Frequency and Route of administration Special considerations and additional information Patient advice and follow up Twinrix Paediatric vaccine (1-15 years): 3 doses of 0.5 ml by intramuscular injection preferably in the deltoid region at 0, 1, 6 month schedule to be completed: Dose 1: 0.5ml of Twinrix paediatric vaccine Dose 2: 0.5ml, at one month after the first dose Dose 3: 0.5ml, at six months after the first dose Patients on haemodialysis or immunocompromised: consider testing to ensure Hepatitis B antibody level >10 IU/ml Twinrix Adult vaccine: obesity (defined as BMI 30 kg/m 2 ) has been observed to reduce the immune response to hepatitis A vaccines. A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases. Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Twinrix Adult. Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations As with all Injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine Inform possible side effects and their management Advise patient to remain on the premises for 10 minutes Patients with unusual or persistent side effects should be reviewed by the GP Explain the need to complete the course of Hepatitis A and B vaccination to patient Safe travel advice according to accepted best practice (if applicable) e.g. Always drink bottled water and never accept ice cubes in your drink unless they are made from bottled water Do not eat raw vegetable and fruits that cannot be peeled. When eating raw fruit and vegetables that can be peeled, wash them thoroughly yourself and wash your hands first Make sure foods have been thoroughly cooked and eat them while they are still steaming 5

6 Avoid buying any food from street vendors Wash your hands before and after eating and after going to the toilet Give the patient information leaflet supplied with the product (or a photocopy) Facilities/ supplies required at site Side effects Access to a telephone Vaccines should be stored in original packaging Comprehensive arrangements for security, storage and labelling of medicines Refrigerate at +2 C to +8 C. Do not freeze Protect from light Access to latest edition of Immunisation Against Infectious Disease (refer to website: and BNF (published March and September each year) Equipment used for vaccination, including used vials, ampoules, or partially discharged vaccines should be disposed of at the end of a session by sealing in a proper, puncture-resistant sharps box Vaccine must only be administered when there is access to emergency facilities including adrenaline (refer to the Anaphylaxis guideline) The vaccine should be inspected for any foreign particles and/or variation in physical aspect before use. In the event of either being observed, discard the vaccine Tenderness, redness at site of injection, occasional flu like symptoms, temperature control if pyrexia. Rarely anaphylaxis This list is not exhaustive. Refer to current BNF and SPC for complete List Adverse Drug Reactions All adverse drug reactions must be reported immediately to the patients GP All adverse reactions in children and severe reactions in adults should be reported to the Committee on Safety of Medicines of Medicines and Healthcare Products Regulation Agency (MHRA) using the Yellow Card spontaneous reporting scheme ( Should such a reaction occur, the nurse 6

7 needs to inform their line manager and professional lead and complete a NHS Incident form immediately in accordance with local policy Yellow cards are also available in the BNF Records Record that valid informed consent was given Name of patient, address, date of birth and GP Name and signature of nurse administering the vaccine Date of treatment Dose administered, site, route and time Manufacturer of product, brand, batch number and expiry date The advice given Advice given if excluded or declines treatment Record how the patient s central record or GP surgery record will be updated Details of any ADRs and actions taken The information should be recorded as appropriate in patient-held record or Personal Child Health Record (PCHR, the Red Book) for children All records should be clear, legible and contemporaneous A computer or manual record of all individuals receiving treatment under this PGD should also be kept for audit purposes 3. References: NMC (2007) Standards for medicines management NMC (2008) The Code. Standards of conduct, performance and ethics for nurses and midwives Summary of Product Characteristics for Twinrix adult vaccine and Twinrix paediatric suspension for injection (GlaxoSmithKline UK) available on: BNF 62, September 2011, chapter Department of Health, Immunisation Against Infectious Diseases 2006, The Green Book, plus updates to Hepatitis A and Hepatitis B chapters 7

8 4. Individual Authorisation 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. 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 document showing their authorisation. Practice Stamp: Practitioners covered by this direction Name Designation Signature Date HAVING RECEIVED THIS PGD, PLEASE SEND A COPY OF THE AUTHORISED SIGNED SIGNATURES TO: SAIQA MUGHAL, MEDICINES GOVERNANCE LEAD, MEDICINES MANAGEMENT, 3 RD FLOOR, BECKETTS HOUSE, ILFORD. ESSEX. IG1 2QX OR ALTERNATIVELY FAX TO