Document Details Title Patient Group Direction Hepatitis A vaccine (Havrix Monodose ) Trust Ref No 1506-41174 Local Ref (optional) Main points the Active immunisation against infection caused by Hepatitis A document covers virus Who is the document Clinical staff in appropriate clinical areas aimed at? Author Rita O Brien (Reviewed by Diane Kitching) Approval process Approved by Quality and Safety Development Group (Committee/Director) Approval Date 14/3/2018 Initial Equality Impact yes Screening Full Equality Impact no Assessment Lead Director Director of Quality & Nursing Category Policy Sub Category Patient Group Direction Review date 30/3/2020 Distribution Who the policy (PGD) will be distributed to Method Email notification of entry onto webpage Document Links yes Required by CQC Other Amendments History No Date Amendment 1 May 2012 V1 for Shropshire Community Health NHS Trust 2 February 2014 Reviewed - No changes 3 February 2016 Scheduled review: 4 February 2018 Scheduled review 5 Inclusion criteria changed to over 18s (prison population) Expiry date: 30/3/2020 Page 1 of 7
PATIENT GROUP DIRECTION Hepatitis A vaccine (Havrix Monodose ) PGD prepared by: (author / owner) Rita O Brien Updated by Diane Kitching 17/2/2014 07/02/2018 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 7
STAFF CHARACTERISTICS Employed by Shropshire Community Health NHS Trust Appropriately 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. The healthcare professional provides 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 Patient Group Direction The clinical manager has assessed the competency (against the national framework) of the healthcare professional to work to a Patient Group Direction 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 (BSL) 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 the medicine(s) within this Patient Group Direction (PGD). The healthcare professional r needs to reinforce and update their knowledge and skills in this area of practice with particular reference to changes and national directives The registered health care professional 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 7
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 Caution / need for further advice Management of excluded patients Action for patients not wishing to receive care under this PGD Active immunisation against infection caused by Hepatitis A virus Adults aged 18 years and over considered to be at risk of hepatitis infection. The vaccine should be considered for the following groups at increased risk of infection or transmission: Patients with chronic liver disease of any cause and including patients with chronic hepatitis B or C infection Men who have sex with men Injecting drug users Under 18 years No consent Severe febrile illness postpone vaccination. Minor illness without fever or systemic upset is not a valid reason to postpone immunisation. If an individual is acutely unwell, immunisation should be postponed until they have fully recovered. This is to avoid confusing the differential diagnosis of any acute illness by wrongly attributing any signs or symptoms to the adverse effects of the vaccine A confirmed anaphylactic reaction to a previous dose of a Hepatitis A containing vaccine A confirmed anaphylactic reaction to any component of the vaccine Immunosuppression and HIV infection. Refer specialist advice will be required See administration advice for people with bleeding disorders Referral to doctor, independent prescriber or other appropriate service if necessary Reschedule vaccination if postponed due to febrile illness Document findings and action taken in patient s record Advise the patient on the modes of transmission of hepatitis A Document action and advice given Refer to doctor, independent prescriber or other service as appropriate Advise the patient on the modes of transmission of hepatitis A Expiry date: 30/3/2020 Page 4 of 7
Drug details Name form and strength of medicine Inactivated hepatitis A virus 1440 ELISA units/1ml dose Havrix Monodose (manufactured by GlaxoSmithKline) Legal classification POM Black triangle warning? No Use within licence? The PGD follows Green Book recommendations to administer subcutaneously for those with thrombocytopenia / bleeding disorders. This is off label use for Havrix Monodose Route / method Intramuscular injection given preferably into the deltoid,(anterolateral thigh is mention in the green book) The deep subcutaneous route should be used for patients with haemophilia or bleeding disorders to reduce the risk of bleeding Dose / Frequency Single initial (primary) dose 1ml Havrix Monodose Number of times treatment may be administered 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 www.yellowcard.gov.uk Additional Information A booster dose 6-12 months after the primary dose (however it is unnecessary to restart the primary vaccination schedule as long as the booster dose is given within 5 years of the primary) Once with a later booster dose if necessary Once with a later booster dose if necessary Common side effects include: Loss of appetite, Headache, Drowsiness, Nausea, Diarrhoea, Pain and redness at the injection site Fatigue Fever ( 37.5 C) Swelling Injection site reaction, such as induration Malaise Store in a fridge between 2 C and 8 C Shake the vial before use to produce a slightly opague, white suspension. Discard if any variation, or presence of foreign particles. Do not freeze Store in original packaging Protect from light Reconstitute according to manufacturer s instructions and inspect for any foreign particles and / or variation of physical aspect. If visual inspection is satisfactory, use immediately Hepatitis A vaccine can be given at the same time as other vaccines. The vaccines should be given at a separate site, preferably in a different limb. If given in the same limb, they should be given at least 2.5cm apart. The site at which each vaccine is administered must be recorded in the patient s record. Expiry date: 30/3/2020 Page 5 of 7
Havrix Monodose must not be mixed with other vaccines in the same syringe Advice to patient / carer Explain treatment and course of action Provide patient information leaflet if available Give advice on temperature control and management of local reactions Advise the patient on the modes of transmission of hepatitis A Advise the patient that the vaccine does not protect against other causes of hepatitis than hepatitis A virus Follow up Next vaccination date if booster dose is required Immunocompromised patients may respond less well to the vaccine and are excluded from treatment under the PGD. Refer for specialist advice 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 and GP Patient allergies Reason for inclusion / exclusion Informed consent Manufacturer / brand of product, batch number, expiry date Dose Date and time of administration, route, site Advice given to patient / carer Details of staff who administered (sign and print name or electronic signature on electronic patient record) 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 British National Formulary 74 [last accessed 7/2/2018] The Green Book [last accessed 7/2/2018] Available at: < https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/263309/green_book_ Chapter_17_v2_0.pdf>. Summary of Product Characteristics Havrix Monodose. [Accessed 07.02.2018]. Available at: < https://www.medicines.org.uk/emc/product/1158/smpc>. Expiry date: 30/3/2020 Page 6 of 7
Register of practitioners qualified to administer and / or supply Hepatitis A vaccine (Havrix Monodose ) 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 INHERENT 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 7 of 7