Document Details. Patient Group Direction

Transcription

1 Document Details Title Patient Group Direction (PGD) Hepatitis B Vaccine (Engerix ) Trust Ref No Local Ref (optional) Main points the Immunisation against Hepatitis B document covers Who is the document Prison healthcare, substance misuse service aimed at? Author Rita O Brien Approval process Approved by Medicines Management Group (Committee/Director) Approval Date 14/3/2018 Initial Equality Impact yes Screening Full Equality Impact no Assessment Lead Director Director of Quality and Nursing Category Policy Sub Category Patient Group Direction Review date 30/3/2020 Distribution Who the policy (PGD) Prison healthcare, substance misuse service will be distributed to Method notification of entry onto webpage Document Links Required by CQC Required by NHLSA Other Amendments History No Date Amendment 1 February 2014 Reviewed 2 February 2016 Schedule review: 3 February 2018 Scheduled review 4 5 Removal of substance misuse service Changed from over 16 to over 18 to reflect prison population Expiry date: 30/3/2020 Page 1 of 8

2 PATIENT GROUP DIRECTION Drug name: Hepatitis B vaccine (Engerix B ) PGD prepared by: (author / owner) Rita O Brien (updated by Diane Kitching) If any signatures are missing below, then the PGD is not valid APPROVED FOR USE BY: Medicines Management Group Doctor Dr Emily Peer Associate Medical Director 14/3/2018 Pharmacist Rita O Brien Chief Pharmacist 14/3/2018 RATIFIED BY: Quality & Safety Delivery Group Governance Lead Steve Gregory Director of Nursing and Operations 14/3/2018 Expiry date: 30/3/2020 Page 2 of 8

3 STAFF CHARACTERISTICS Employed by Shropshire Community Health NHS Trust Appropriate registered healthcare professional with current registration Specialist competencies or qualifications: The clinical manager has evidence that the health care professional has undertaken training to carry out clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in the patient group direction(pgd) The healthcare professional provide evidence of training, annual updates and continuing professional development to support their competency The clinical manager has proof of training by the health care professional on the legal aspects of supply or administration of medicines under a PGD The clinical manager has assessed the competency (against the national framework) of the healthcare professional to work to a PGD at least every 2 years. The healthcare professional has undertaken training and annual updates in the recognition and treatment of anaphylaxis, including practical in basic life support and has immediate access to an in-date supply of adrenaline 1mg in 1ml (1:1000) at the time of the consultation. The healthcare professional must have access to all relevant sources of information e.g. information issued by the Department of Health (DH), British National Formulary (BNF), Summary of Product Characteristics (SPC), and the clinical guideline concerning medicine(s) within this Patient Group Direction (PGD). The healthcare professional needs to reinforce and update their knowledge and skills in this area of practice with particular reference to changes and national directives, along with a clear understanding of the drug to be supplied including side effects and contraindications. The registered health care practitioner is professionally accountable for supply or administration under the PGD as defined in their own profession s code of professional conduct and ethics. YOU MUST BE AUTHORISED BY NAME BY YOUR MANAGER UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Expiry date: 30/3/2020 Page 3 of 8

4 CLINICAL CONDITION Clinical need addressed Inclusion criteria Exclusion criteria (for full details of interacting medicines refer to current Summary of Product Characteristics (SPC) & BNF) Exclusion under this Patient Group Direction does not necessarily mean contraindicated Management of excluded patients Action for patients not wishing to receive care under this PGD Active immunisation against Hepatitis B virus infection 18 years old or over Valid informed consent Prisoners within custodial institutions Below 18 years No consent Confirmed anaphylactic reaction to any component of the vaccine Confirmed anaphylactic reaction to a previous dose of hepatitis B containing vaccine Current acute febrile illness. Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. If an individual is acutely unwell, immunisation should be postponed until they have fully recovered Allergy to latex. Refer to Green Book chapter 6. If an individual has a severe (i.e. anaphylactic) allergy to latex, vaccines supplied in vials or syringes that contain latex should not be administered. For these individuals contact the manufacturer to confirm whether the vaccine to be administered contains latex Patients using immunosuppressants including the topical immunosuppressant (tacrolimus [Protopic] and /or pimecrlimus [Elidel] Pregnant or breastfeeding Referral to doctor,independent prescriber or other appropriate service if necessary Document action and advice given Refer to doctor, independent prescriber, or other service as appropriate Advise regarding risks of Hepatitis B disease and transmission, signs and symptoms and disease complications Information about protective effects of vaccine and advise on avoiding Hepatitis B infection Expiry date: 30/3/2020 Page 4 of 8

5 Drug details Name form and strength of medicine Hepatitis B Vaccine adsorbed (Engerix B (1 ml vial or pre-filled syringe) Suspension for injection 20 micrograms/ml) Legal classification POM Black triangle warning? No Route / method Shake the vaccine well to obtain a slightly opaque, white suspension Intramuscular injection. The deltoid muscle is the preferred site of injection in adults and older children. Anterolateral thigh is preferred in neonates, infants and young children Deep subcutaneous route should be used for patients with bleeding disorders The vaccine should not be administered into the buttock or intradermally since this may result in a lower immune response Engerix B should not, under any circumstances, be administered intravascularly. Dose / Frequency Number of times treatment may be administered Dose is 20 microgram in 1 ml suspension. 20mch is given on elected date, 20mcg after one month, then 20mcg after six months from the first dose Primary immunisation schedule A series of 3 injections is required to achieve optimal protection. Variations to the standard schedule are listed below that include a fourth dose. 1. Accelerated schedule For pre-exposure prophylaxis in most adult risk groups,.3-4 doses as an accelerated schedule should be used at 0, 1, 2 months and a fourth dose should be administered 12 months after the first dose for those at continued risk. This will confer protection more quickly and is expected to provide better patient compliance. 3. Exceptional circumstances very rapid schedule For adults age 18 years and over where rapid induction of protection is required. For example, intravenous drug users and prisoners. A schedule of 3 doses at 0, 7 and 21 days may be given using the Engerix B brand. A fourth (booster) dose is recommended 12 months after the first dose. Reinforcing immunisation / Booster dose A single booster dose 5 years after the primary course should be sufficient to maintain immunity in individuals at continued risk of hepatitis B infection and no serology testing is necessary Quantity to be supplied or administered Side effects Full details of side effects are available in the SPC. Suspected adverse reactions to drugs including vaccines should be reported on the yellow card available at the back of the BNF. Also at For primary immunisation- 3 doses For booster immunisation- 1 dose Very common Pain and redness at site of injection fatigue Common Nausea, vomiting, diarrhoea, abdominal pain Appetite loss malaise Other reactions that have been reported but may not be causally related Expiry date: 30/3/2020 Page 5 of 8

6 include fever, rash, malaise and an influenza-like syndrome, arthritis, arthralgia, myalgia and abnormal liver function tests Additional Information Advice to patient Vaccine should be maintained at a temperature of 2 C to 8 C and protected from light. Check package insert for any additional special storage precautions The vaccine should be inspected for any foreign particles and / or variation of physical aspect before use. In the event of either being observed, discard the vaccine Shake before use If there is a potential that the vaccine is, or has been frozen, the vaccine should be discarded as special waste. Disposal should be by incineration as per organisational waste management policy and according to current waste regulations Due to the long incubation period of hepatitis B it is possible for unrecognised hepatitis B to be present at the time of the vaccination. The vaccine may not prevent hepatitis B in such cases The vaccine will not prevent infection caused by other agents such as hepatitis A, C and E and other pathogens known to infect the liver When concomitant administration with other vaccine(s) is necessary the vaccines must be given at different injection sites, preferably into different limbs. If given in the same limb the injection sites should be at least 2.5cm apart. The site at which each vaccine was given should be recorded in the individual s records Explain treatment and course of action Provide patient information leaflet if available Administration and side effects to be discussed prior to immunisation Temperature control and management of local reactions Information on further contacts and out-of-hours services if later required Advise patient on the modes of transmission of blood borne viruses and measures to prevent transmission and exposure Some of the side effects may affect the ability to drive and operate machinery Follow up Next vaccination date is advised if appropriate Referral to doctor or independent prescriber if necessary Error reporting Any incidents or near miss issues must be reported via the organisation s internal reporting system (Datix). RECORD KEEPING Documentation needed / treatment records to be kept for audit purposes A computer or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. Patient s name, address, date of birth, allergies and GP and consent Reason for inclusion / exclusion Manufacturer / brand of product, batch number, expiry date Dose Date of administration, route, site, and time Advice given to patient / carer Details of staff who administered (sign and print name) Details of any adverse drug reactions, and action taken including informing GP Reconciliation stock balances should be reconcilable with receipts, administration, records and disposal on a patient by patient basis. REFERENCES Expiry date: 30/3/2020 Page 6 of 8

7 British National Formulary 74 [accessed 20/2/18] The Green Book Chapter 18v3 (2016) [accessed ]. Available at: dh_ pdf Summary of product characteristics - Engerix B [accessed 20/2/18]. Available at: Expiry date: 30/3/2020 Page 7 of 8

8 Register of practitioners qualified to administer and / or supply Hepatitis B vaccine (Engerix B ) under this Patient Group Direction Name of clinical team manager Signature of clinical team manager Date: All PGD documentation must be kept for 8 years and for children until the child is 25 years old A copy of this page should be retained by the authorising manager for audit purposes. Please state clinical area where this PGD is in use Healthcare professional individual declaration: I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD PGDs DO NOT REMOVE INHERANT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence. All practitioners operating in accordance with this PGD should have a current, signed copy of it readily available for reference. If a practitioner is asked to supply, or administer a medicine not covered by this or any other PGD then a patient specific direction is required from a doctor, dentist or independent prescriber. Name of professional (please print) Signature Authorising Manager (Must sign against each entry) Date of authorisation Expiry date: 30/3/2020 Page 8 of 8