PATIENT GROUP DIRECTION Administration of: By: Practice Nurses Hepatitis A + B Vaccine (Twinrix, Twinrix paediatric, Ambirix ) In: General Practice It is the responsibility of the professional working under this PGD to verify that the patient fulfils the stated criteria for supply or administration of the treatment concerned. It is not appropriate to have a PGD in place that is infrequently used by healthcare professionals because of progressive unfamiliarity with its contents. Any healthcare professional that works to a PGD infrequently should consider whether to cease doing so. This PGD will be reviewed every 3 years, or sooner in light of new guidance. Review date: March 2018 PGD Hepatitis A + B v4.docx Page 1 of 7
1. Reason for introducing PGD Immunisation 2. Clinical Condition or situation to which this PGD applies 2.1 Define condition/situation Immunisation against hepatitis A and B infection 2.2 Criteria for inclusion Adults and children 1 year and over at risk of infection: Parental drug misusers Contacts of a case or carrier Infants born to mothers with a history of hepatitis B Haemophiliacs treated with blood or blood product infusions Sexually promiscuous individuals Travellers to high risk areas Patient with chronic liver disease including chronic hepatitis B and C Personnel working with hepatitis B Personnel in contact with high risk groups or human blood or tissues Subjects on haemodialysis or have chronic renal failure Residents and workers of care facilities for learning disability Workers at risk of exposure to untreated sewage Firefighters 2.3 Criteria for exclusion Hypersensitivity to a component of the preparation or neomycin Postpone if acute illness and infections with fever or systemic upset (consult doctor). Pregnancy unless in a high risk category (consult doctor) Proven history of hepatitis A or B Post-exposure prophylaxis following percutaneous (needle-stick), ocular or mucous membrane exposure to hepatitis B virus (refer to doctor). 2.4 Cautions Breast-feeding (consult doctor) [to include consideration of concurrent medication] 2.5 Patient consent [verbal, written, implied] Informed consent as stated in the local consent policy Parent/guardian consent to be given, where necessary 2.6 Action if patient excluded Advise on the importance of being immunised. Advise on when the subject can be vaccinated, and by whom, where applicable. Advise on potential disease complication Re-assure and provide any practical advice 2.7 Action if treatment declined by patient, parent, or guardian Advise on the importance of being immunised Advice about protective effects of the vaccine and the risks of infection and disease complications Document advice given Inform or refer to GP as appropriate PGD Hepatitis A + B v4.docx Page 2 of 7
3. Characteristics of Staff 3.1 Class of healthcare professional for whom PGD is applicable & Professional qualifications required 3.2 Additional requirements/specialist qualifications required. 3.3 Continued training requirements 4. Description of treatment. 4.1 Generic name of medicine and form (e.g. tablets) 4.2 Legal status POM/P/GSL Licensed or unlicensed use [If unlicensed state rationale for use] 4.3 Dose [Where a range is applicable include criteria for deciding on a dose] 4.4 Route / method of administration Registered Nurse, RN This PGD will only apply whilst you are employed or contracted/working at the time for Dudley CCG. Competent to undertake immunisations under this PGD Specific training in vaccine administration, the immunisation programme and having up-to-date knowledge Has undertaken training and is competent in the recognition and treatment of anaphylaxis, including practical training in Basic Life Support (annual practical update session to be undertaken). Three-yearly update in immunisation and vaccination, and annual update in the management of anaphylaxis and CPR 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. Hepatitis A (inactivated) + Hepatitis B (rdna) (HAB) vaccine (adsorbed) POM Licensed - See under Criteria for Inclusion Primary 16yrs and over: Twinrix : 1ml at 0, 1 month and 6 months accelerated schedule: 1ml at 0, 7 days, 21 days and 12 months 1 to 15yrs: Twinrix Paediatric: 0.5ml at 0, 1 month and 6 month or Ambirix : 1ml at 0, 1 month and 6 months. Single component vaccines given at appropriate intervals may be used for booster dose Booster doses and immunisation schedule may need to be adjusted in those with a low antibody titre Booster doses may be required in immunocompromised patients with a low antibody titre Intramuscular preferably in deltoid region in adults, adolescents and children or in the anterolateral thigh in infants(not in the buttock) or Subcutaneous injection (Avoid IM route in subjects with bleeding disorders e.g. haemophilia, thrombocytopaenia) - immune response may be reduced. PGD Hepatitis A + B v4.docx Page 3 of 7
4.5 Frequency See schedule above 4.6 Total dose and number of times treatment can be administered; state time See schedule above The duration of immunity is not known precisely for hepatitis B frame 4.7 Information on follow-up Advise to seek medical advice if more severe reactions to management 4.8 Written/verbal advice for patient/carer before/after treatment and management injection occur Explain to patient or their carer why treatment is required When appropriate, give the patient or their carer a copy of any relevant patient information leaflet Inform patient or their carer of potential side effects and to alert a clinician should these occur Additionally, immunoglobulin injection needs to be given for antibacterial prophylaxis of a tetanus-prone wound (soil/manure contaminated) Provide patient information leaflet, if available. Advise on potential side-effects and what action to take if they occur Advise on self-treatment for minor reactions Provide patient information leaflet, if available 4.9 Instructions on identifying, managing & reporting adverse drug reactions 4.10 Arrangements for referral for medical advice 4.11 Precautions, facilities & supplies. Injection site reactions Less serious reactions: mild fever, malaise, sweating, rashes, arthralgia, abnormal LFTs Serious reactions rare: anaphylaxis, Guillian-Barre syndrome, demyleinating disease Please refer to current BNF or SPC for full details Treat anaphylaxis according to policy and procedure Advise on self-treatment for minor reactions and to seek medical advice if more severe reactions occur Serious suspected adverse reactions to vaccines should be reported through the Yellow Card scheme. Yellow card and guidance on its use is available at www.yellowcard.mhra.gov.uk or in the back of the BNF. Refer patients to the medical practitioner Contact emergency services for life-threatening reactions Store in a refrigerator between 2-8 0 C Do not use if contents freeze, becomes discoloured or contains large particles Do not contaminate the vaccine with antiseptic, detergent or alcohol Protect from light Shake well before use Immediate access to the following is essential: adrenaline 1 in 1000, telephone Access to the following is desirable: ambu bag and mask, oxygen therapy, defibrillator, ECG machine, plastic airway 4.12 Specify method of recording supply/administration, Obtain supplies from pharmacy or wholesaler Clients notes (Manual, Computerised, Own Held): PGD Hepatitis A + B v4.docx Page 4 of 7
sufficient to enable audit trail. Name, address and DoB of patient PMH, allergies and vital signs Brand, batch number and expiry date Dose, site, route Date given and by whom Patient s GP Any current or previous adverse reactions Any reason for refusing treatment Advice given to patient or carer (including side effects) Record any referral arrangements 5. Audit Serious adverse reactions should be documented in the patient s health record and on their medical records. GP should also be informed The use of this PGD to be monitored by the service in which it is used PGD Hepatitis A + B v4.docx Page 5 of 7
6. Management 6.1 Reviewing authors Noel Aslett Karen Mander Prescribing Adviser, Dudley Office of Public Health Practice Based Pharmacist Dudley CCG Others Lesley Cliff Clinical Nurse Advisor-Immunisation, Dudley Office of Public Health 6.2 Authorisation This PGD has been approved on behalf of the Dudley CCG by: Name Signature Date Specialist in Pharmaceutical Public Health (Pharmacist) CCG Lead Medicines Management Dr D Jenkins Signed 17.03.15 Dr PD Gupta Signed 17.03.15 CCG- Patient Safety and Quality Dr R Edwards Signed 17.03.15 6.3 Persons permitted to authorise staff they are responsible for to operate this PGD Clinical Leads in General Practice 7. References For further information healthcare professionals are recommended to consult the following literature: NMC Guidelines for the administration of medicines NMC Code of Professional Conduct CMO/CNO/CPO updates Immunisation Against Infectious Diseases (Green Book) British National Formulary 68 September 2014 March 2015. Summary of Product Characteristics for Twinrix, Twinrix Paediatric and Ambirix : accessed on 8 th January 2015 via https://www.medicines.org.uk/emc/medicine/2061/, https://www.medicines.org.uk/emc/medicine/2062 and http://www.medicines.org.uk/emc/medicine/20491 PGD Hepatitis A + B v4.docx Page 6 of 7
PGD for administration of Hepatitis A + B by Nurses within Dudley CCG GP practices It is the responsibility of the Authorising Person to keep this list up to date and in a safe place for reference. Any healthcare professionals who no longer meets the competency requirements or leave the service or practice must be removed from the list; likewise, any new healthcare professionals meeting the competency requirements have to be added to the list in order to work under the Patient Group Direction. The Authorising Person is only expected to confirm that the Healthcare Professionals meets the minimum training and competency requirements under this PGD. It is the responsibility of the Healthcare Professional, their Professional Body and the CCG that they are fit to practice. This Patient Group Direction is to be read, agreed to and signed by all healthcare professionals it applies to. One copy should be given to each nurse with the original signed copy being kept by the Authorised Person with responsibility for PGDs within the service or practice. 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. Healthcare Professionals permitted to supply or administer under this PGD Name of Healthcare Professional Signature Authorised Person with responsibility for PGDs Signature Date approved PGD Hepatitis A + B v4.docx Page 7 of 7