Patient Group Direction for HEPATITIS A AND TYPHOID VACCINE. Version No.: 4/2014. Hitesh Patel Pharmaceutical Adviser, NHS Telford & Wrekin CCG

Transcription

1 Document Title: Patient Group Direction for HEPATITIS A AND TYPHOID VACCINE PCT Doc Ref.: Local Doc Ref.: PGD Version No.: 4/2014 Author/Owner: File Reference: Document Overseeing Group: Hitesh Patel Pharmaceutical Adviser, NHS Telford & Wrekin CCG C:\MyDocuments\ApprovedPGDs PGD Working Group Placement in Framework: Approval Level: Medicines Management Committee Date of Approval: Review Date: March 2016 Amendment Dates: Page(s) Brief Description Amended review date 1

2 PATIENT GROUP DIRECTION FOR COMBINED HEPATITIS A AND TYPHOID VACCINE Patient group direction for the supply & administration of: Clinical need which this patient group direction is intended to address HEPATITIS A AND TYPHOID VACCINE Active immunisation against Hepatitis A virus infection and typhoid fever Relevant National Guidance NMC Standards for Medicines Management (NMC 2008) CLINICAL CONDITION Review of Prescribing, Supply and Administration of Medicines. Final Report Annex C. The Review Team, Dr. June Crown. (March 1999). DOH Immunisation against infectious disease Green Book DOH Health information for overseas travel NATHNAC website 1) Definition of condition Prophylaxis/prevention of Typhoid fever and Hepatitis A infection by active immunisation. Hepatitis A is an acute viral disease, transmitted by food or water contaminated by faeces. 2) Criteria under which patient will be eligible for inclusion in the patient group direction Typhoid fever is a systemic infection caused by the gramnegative bacterium Salmonella enterica, subspecies enterica, serotype typhi. Paratyphoid fever is an illness clinically similar but usually less severe than typhoid and is caused by S. paratyphi A, B and C. Transmission is primarily via the oral route following ingestion of food or water contaminated by faeces and occasionally the urine of persons acutely ill with typhoid or those who are chronic carriers. People travelling to or going to reside in areas of high or intermediate prevalence of Hepatitis A and Typhoid fever 3) Those criteria which exclude the patient from the treatment Nurses are advised to use NATHNAC website to confirm immunisation requirements Children under the age of two years - No valid consent - Hepatyrix: Children aged < 15 years - ViATIM: Children aged < 16 years - Confirmed anaphylactic reaction to any component of the vaccine including neomycin which may be present in minute amounts Confirmed anaphylactic reaction to a previous dose of either the combined or single component hepatitis A or typhoid vaccines. - Minor illnesses without fever or systemic upset are not 2

3 valid reasons to postpone immunisation. If an individual is acutely unwell with a febrile illness then immunisation should be postponed until they have fully recovered. - Pregnancy or breastfeeding - Presence of any contraindication as detailed in the - current Summary of Product Characteristics or Immunisation Against Infectious Disease (the green book ) 4) Details of action to be followed for patients excluded under the patient group direction 5) Details of action to be followed for patients who do not wish to receive or do not adhere to care under this patient group direction. Advise and counsel accordingly Give another appointment if appropriate Refer to Medical Practitioner if appropriate Give advice about hygiene and avoidance of typhoid fever and recognition of early symptoms. Advise and counsel accordingly Document reasons for not giving vaccine in patients records Give advice about travel hygiene and recognition of early symptoms Document advice given TREATMENT 1) Name of medicine(s) supplied under this patient group direction Combined Hepatitis A and Typhoid vaccine Hepatyrix ViATIM 2) Storage of vaccine Store in a refrigerator +2 C to +8 C. Do not freeze Store in the original package in order to protect from light. Refer to PCT s Vaccine Storage & Handling Policy If the vaccine has been frozen, the vaccine should be discarded. Disposal should be by incineration. 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 3) Method of obtaining supplies Licensed NHS supplier. Community Pharmacy. 4) Name of medicine(s) administered under this patient group direction Two brands can be given under this PGD Hepatyrix injection (manufactured by GlaxoSmithKline): one dose (1ml) contains inactivated hepatitis A virus (HM175 strain) 1440 ELISA units combined with Vi polysaccharide of Salmonella typhi (Ty2 strain) 25 micrograms ViATIM injection (manufactured by Sanofi Pasteur MSD): 1 dose (1ml) contains inactivated hepatitis A virus (GBM strain) 160 antigen units combined with purified Vi polysaccharide of Salmonella typhi (Ty 2 strain) 25 micrograms 3

4 5) Legal status of medicine(s) POM (Prescription Only Medicine) 6) Doses of medicine(s) which can be administered/supplied 7) Method of route of administration For adolescents aged 15 years: Only Hepatyrix is licensed to be used Dose is 1 ml For adults and adolescents aged 16 years and older: Either Hepatyrix or ViATIM can be used Dose is 1 ml Intramuscular injection (the deltoid region is the preferred site of injection) The vaccine should not be administered into the gluteal region The vaccine should not be administered by the intravenous or intradermal routes The subcutaneous route may be used for patients with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these patients. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes after the injection ViATIM : A dual chamber syringe containing a cloudy white suspension and a clear colourless solution Shake to ensure suspension is fully mixed. The contents of the two compartments are mixed as the vaccines are administered Hepatyrix : Slightly opaque white suspension for injection shake the container well. Note: 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 8) If more than a single dose is permitted, the frequency of dosing 9) Total dose of medicine to be administered. Primary immunisation one dose In order to provide long term protection against infection caused by hepatitis A virus, a booster dose of an inactivated single component hepatitis A vaccine should be given preferably 6 to 12 months (but may be given up to 36 months) after a single dose of combined vaccine. (reinforcing immunisation will give substantial increase in antibody titre and will give immunity beyond 10 years) Hepatyrix or ViATIM may be used as a booster vaccine in patients who have received a primary dose of inactivated hepatitis A vaccine preferably 6 to 12 months previously and also require protection against typhoid fever. The combined vaccine can be given up to 36 months after the single component hepatitis vaccine if necessary. Single Dose (1ml) gives immunity against typhoid for up to 3 years and against Hepatitis A for up to 1 year 4

5 10) Number of times treatment may be administered. 11) Period of time over which medicines may be administered. See section 8 For booster doses of either typhoid or hepatitis A vaccine single antigen vaccines can be used (refer to single antigen PGDs) Hepatyrix or ViATIM may be used as a booster vaccine in patients who have received a primary dose of inactivated hepatitis A vaccine preferably 6 to 12 months previously and also require protection against typhoid fever. The combined vaccine can be given up to 36 months after the single component hepatitis vaccine if necessary. 12) Precautions/warnings Very common ( 10%) Pain, myalgia, asthenia, headache, malaise, injection site disorders (pain, induration, oedema, erythema) Common ( 1% and <10%) General aches, fever, headache, nausea, diarrhoea, itching, arthralgia, swelling Uncommon ( 0.1% and <1%) Dizziness, pruritus, rash Very rare (<0.01%) Urticaria, convulsions, allergic reactions including anaphylaxis and anaphylactoid reactions, syncope 13) Advice to be given to the patient/parent before or after treatment Refer to the current product literature for further information Report all serious suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA), Commission on Human Medicines using a Yellow Card or on-line via BEFORE TREATMENT: Advise patient/parent/guardian of possible side effects. Advise what action to take if side effects experienced. AFTER TREATMENT: Provide patient with the manufacturer s patient information leaflet. Safe travel advice Advise that in order to provide long term protection against infection caused by hepatitis A virus, a booster dose of an inactivated single component hepatitis A vaccine should be given preferably 6 to 12 months (but may be given up to 36 months) after a single dose of combined vaccine Advise that patients who remain at risk of typhoid fever should be revaccinated using a single dose of Vi polysaccharide typhoid vaccine every 3 years Advise of next vaccination date 14) Instructions on identifying and managing possible adverse outcomes. Advise patient/parent/guardian of possible side effects as above and advise to seek medical advice from the most appropriate health professional (GP or practice nurse) 5

6 15) Arrangements for referral to medical advice 16) Site for treatment GP surgeries 17) Facilities and supplies, which should be available. 18) Resources that are desirable within Health Centres, clinics and GP practices. 19) Follow up Actions and Details of Records to be kept Nurse administering vaccine must be able to advise patient/ parent/guardian what action to take in the event of the patient experiencing any side effects and appropriate medical service to contact Health Centres Educational establishments Residential/nursing establishments Patient s own home. Inmates of custodial establishments Recipients of any vaccine should be observed for immediate adverse drug reactions. There is no evidence to support the practice of keeping patients under longer observation in the surgeries( DoH 2006 ) Adequate vaccine supply Vaccine fridge with thermometer to store vaccine Anaphylactic pack containing: Adrenaline 1: amps 1 ml syringes x 3 Needles ( 21G, 23G, 25G ) x 3 of each Gloves Direct access to telephone emergency 999. Facilities for the safe disposal of needles, syringes and clinical waste Thermometer (if needed to check for fever prior to immunisation) Refer to Adrenaline Patient Group Direction Refer to CPR Policy Full entry in patient s notes to include: 1. Date and time of vaccine administration 2. Dose administered. 3. Date when next dose is due. 4. Batch number(s), manufacturer(s) and expiry date(s). 5. Route and site of injection. 6. Name of nurse. 7. Record of informed consent obtained. 8. Patient held record Routine serological testing for response to the hepatitis A vaccine is not necessary. 20) Audit trail for treatment records. Patient s notes or computer records 6

7 21) Special precautions also concerning concurrent medication (checks to ensure patient is not currently taking medicine which duplicates, interacts with or is contraindicated with patient group direction medicine(s) It is possible that patients may be in the incubation period of a hepatitis A infection at the time of vaccination. It is not known whether this vaccine will prevent clinically apparent hepatitis A infections in such cases This vaccine will not prevent infection caused by other hepatitiscausing agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. This vaccine only protects against typhoid fever caused by the Salmonella enterica serotype Typhi. The vaccine does not protect against paratyphoid fever of infections with any other serotype of S enterica Administer vaccine at least 2 weeks prior to risk of exposure to hepatitis A and typhoid. However, if a patient presents for travel advice less than 2 weeks before travel they should still be offered vaccination. The importance of good personal, food and water hygiene must be emphasised to this group of patients as their vaccine response may not be maximal prior to departure. It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved. Such patients may therefore require additional doses of vaccine. Seek specialist advice (BCG vaccine is an exception. Nothing else should be given in that limb at the same time or for the next THREE MONTHS.) STAFF CHARACTERISTICS 1) Professional qualifications to be held by staff undertaking patient group direction 2) Competencies required to be held by staff undertaking this patient group direction 3) Specialist qualifications, training, experience and competence considered necessary and relevant to the clinical condition treated under this patient group direction Qualified Nurse Proficient in resuscitation techniques and basic life support adults/children in accordance with Trust protocols Proficient in recognising anaphylaxis in accordance with Trust protocols Proficient in immunisation techniques Training, recognition and treatment of anaphylaxis including practical training in basic life support in adults and children. Competent and knowledgeable in emergency administration of adrenaline. Competent to follow and administer patient group direction - showing a clear understanding of drug administered, including side effects and contraindications 7

8 4) Requirements for continuing training and education for staff supply/administering medicine under this patient group direction Annual CPR and anaphylaxis management annual updates. Relevant annual immunisation training Awareness of current DH recommendations with respect to Typhoid vaccination All nurses are personally accountable and have a professional responsibility to reinforce and update their knowledge and skills in these areas, with particular reference to recent and current changes in practice and ensure the NMC Standards for Medicines management are met. MANAGEMENT AND MONITORING 1) Professional advisory groups which have contributed to this patient group direction. 2) Name of GP/ nurse manager authorising the use of this patient group direction 3) Name of Nurse(s) authorised to use this patient group direction. Sharon Graham - Specialist Nurse General Practice, Shropshire County PCT Hitesh Patel - Pharmaceutical Advisor Medicine Management, NHS Telford and Wrekin Alison Johnson - Immunisation Facilitator Please complete additional authorisation on back of form if more than six nurses. 4) How can the health professional providing treatment be identified? 5) How can the patient receiving treatment be identified? 6) How can the medicine be identified? 7) Suspected adverse drug reactions Name/ signature in patient s notes. Name/ date of birth/ individual patient record number. Name Dose 8) Date of patient group direction 9) Date this patient group direction becomes due for review Manufacturer, batch number and expiry date Patient presenting with suspected adverse drug reaction should be referred to a doctor for further investigations. Severe adverse reactions should be reported to the MHRA, using the yellow ADR card system available in the BNF. March 2016 or in line with local/national guidelines It is the responsibility of the service lead to initiate the review process. 8

9 References: Current British National Formulary DOH (2006) Immunisation against Infectious Disease. NMC (2008) Standards for Medicines Management DOH Health information for overseas travel - NATHNAC website Summary of Product Characteristics (Hepatyrix &ViATIM ) ( 9

10 Patient Group Direction Sign Off Sheet Staff Group Covered by PGD All qualified nurses registered with the NMC who have read and understood the clinical practice and PGD for anaphylaxis. All qualified nurses registered with the NMC must complete annual training in basic life support and management of anaphylactic shock and relevant immunisation training. A record must be kept of this training. PGD Developed by Title Name Signature Pharmaceutical Adviser Hitesh Patel Immunisation Facilitator Alison Johnson Approved By NHS Telford and Wrekin Name Signature District Immunisation Co-ordinator Medical Director/Clinical Governance Lead Head of Medicines Management GP Lead (PGD has been updated with guidance from Immunisation facilitator Alison Johnson) Dr Jo Leahy Jacqui Seaton Dr Mike Innes 10

11 REVIEW It is the responsibility of the head of the professional group to whom the PGD applies to action the review process. This PGD is to be read, agreed and signed by all Health Care Professionals it applies to: Authorising Doctor/Manager Name. Authorising Doctor/Manager Signature Date Approved Base:.. Name of health professional, designation & Signature Date:.. The Health Care Professional should retain a photocopy of the document after signing 11