Patient Group Direction For the supply and administration of

Transcription

1 Patient Group Direction For the supply and administration of COMBINED HEPATITIS A AND HEPATITIS B VACCINE TWINRIX PAEDIATRIC For Children aged 1 year to under 16 years TWINRIX ADULT For Adults and Adolescents aged 16 years and over By Registered Nurse/Midwife/Health Visitor NOTE : AMBIRIX VACCINE IS NOT INCLUDED IN THIS PGD (REFER TO AMBIRIX PGD) Valid from January 2011 Review Date December Note: This PGD s expiry date has been extended to 30 th September 2013 by agreement with the Clinical Governance Lead. Supercedes Adult and paediatric combined Hep A and Hep B template PGDs V3 9.September 2008 Developed and Produced by Cheshire and Merseyside Childhood Immunisation PGD subgroup: PCT Professional group Current group member Central & Eastern Cheshire Community Matron Cath Lilley Knowsley Immunisation Co-ordinator Pauline Jones Knowsley Governance Pharmacist Carol Humphries Integrated Provider Services Liverpool V&I training Lead Pauline Morris Liverpool (Provider Services) Immunisation Facilitator Liz Kinsella Liverpool Pharmacist PGD Lead Sue Wright Sefton Pharmaceutical Adviser in Public Health Helen Stubbs Warrington Public Health Consultant Marioth Manche Warrington Immunisation Co-ordinator Tracie Duffy Western Cheshire Acting Immunisation Co-ordinator Pauline Moulton Wirral CCDC Dr S Ghebrehewet Cheshire & Merseyside HPU Senior Health Protection Nurse Gill Marsh

2 1. Characteristics of staff Qualifications required Additional requirements Continued training requirements Registered Nurse / Midwife/ Health Visitor having valid registration with the Nursing and Midwifery Council (NMC). Received training to undertake supply and administration of medicines under Patient Group Directions. Received appropriate training and updates on the administration of immunisations, in accordance with local policy and national HPA guidance, and can demonstrate competence in these areas. Received appropriate training and updates on resuscitation and management of anaphylaxis and demonstrates competence in this area. Annual attendance at update on resuscitation skills and the management of anaphylaxis in the community. Able to provide evidence of continued professional development i.e. meeting Post-Registration Education & Practice (PREP) requirements. Page 2 of 8

3 2. Clinical condition or situation Indication For pre-exposure protection against invasive disease caused by both Hepatitis A and Hepatitis B infection with assessment of level of risk and appropriate vaccine brand and schedule NB If rapid protection against hepatitis A is required, for example following exposure or during outbreaks, then a single dose of the monovalent Hepatitis A vaccine is preferred as this may provide protection more quickly than the two injections of combined vaccine. (See Green Book Chapter Hepatitis A and relevant PGDs) Criteria for inclusion Travelling to or going to reside in areas of high or intermediate prevalence of Hepatitis A especially if sanitation and food hygiene is poor AND where Hepatitis B has high or intermediate prevalence and the individual is: a) at risk of requiring medical or dental procedures e.g. those who plan to remain for lengthy periods; children travelling to relatives; people with chronic medical conditions e.g. liver, haemophilia, who may require hospitalisation or those travelling for medical care b) undertaking relief work or participating in contact sports c) An individual who injects drugs, has multiple sexual partners or men having sex with men. Occupational risk groups (See Green Book) Criteria for exclusion Children under 1 year of age A confirmed anaphylactic reaction to a previous dose of vaccine containing Hepatitis A and Hepatitis B A confirmed anaphylactic reaction to another component of the vaccine. (for previous severe hypersensitivity reactions see special precautions) No Valid Consent. Acute febrile illness (defer) Twinrix is not recommended for post exposure prophylaxis e.g. needle stick injury. * Exclusion under this PGD does not necessarily mean contraindicated Page 3 of 8

4 2. Clinical condition or situation Action if excluded Advise when patient may receive vaccine. Advise regarding risks of Hepatitis A and Hepatitis B and disease transmission, signs and symptoms. Immunise as soon as valid consent is obtained if no other reasons for exclusion. Advise on hygiene and avoiding hepatitis A. Seek specialist advice if necessary. Action if patient declines treatment Document refusal and action taken in patient s record. Advise about signs and symptoms of hepatitis A and B and the risks of infection and disease complications Information about protective effects of vaccine. Advise on hygiene and avoiding Hepatitis A Special precautions Current acute febrile illness immunisation should be postponed until recovered This vaccine may be given to pregnant young women and women who are breast feeding when clinically indicated SEEK ADVICE Patient who are immunosuppressed due to disease, e.g. HIV, Hodgkins, or treatment e.g. corticosteroids therapy may not achieve an adequate immune response and may require additional doses. SEEK CONFIRMATION AND ADVICE FROM THE APPROPRIATE MEDICAL OFFICER References to national/local policies or guidelines NMC (2008) Standards for Medicines Management NMC (2008) The Code BNF 60 September Summary of Product Characteristics Twinrix ( ) Twinrix paediatric ( ) - Immunisation Against Infectious Disease The Green Book updated Chapters Hepatitis A (8 th January 2009) & Hepatitis B (19 th November 2009) Page 4 of 8

5 3. Description of treatment Name, strength & formulation of drug Twinrix Paediatric - Hepatitis A (inactivated) 360 ELISA units and Hepatitis B10micrograms /ml vaccine (rdna) (HAB) adsorbed vaccine in suspension for injection in a prefilled syringe containing 0.5ml dose Legal status Black Triangle Dose/Dose range Method/Route Frequency of administration Twinrix Adult - Hepatitis A (inactivated) 720 ELISA units and Hepatitis B 20micrograms /ml vaccine (rdna) (HAB) adsorbed vaccine in suspension for injection in a prefilled syringe containing 1ml dose POM No Children aged 1 year to under 16 years - 0.5ml Twinrix Paediatric Adults and Adolescents over 16 years 1ml Twinrix Adult Intramuscular injection. Individuals with a bleeding disorder should have vaccine by deep subcutaneous injection to reduce risk of bleeding. Primary vaccination schedule - Three doses, 0, 1 month and 6 months after first dose. Once initiated, the primary course of vaccination should be completed with the same vaccine. Accelerated Schedule For Children aged 1 year to under 16 years Specialist paediatric advice should be sought in the case of children who are travelling before the date for completion of the primary schedule For Adults and Adolescents over 16 years of age Twinrix Adult vaccine can also be given at zero, seven and 21 days. This will provide more rapid protection against hepatitis B than other schedules but full protection against hepatitis A will be provided later than with vaccines containing a higher dose of hepatitis A (see Chapter 17). When this schedule is used, a fourth dose is recommended 12 months after the first dose. For travellers, vaccine should preferably be given 2 weeks before departure but can be given up to the day of departure as it may afford some protection. Reinforcing Dose SEEK ADVICE In situations where a booster dose of Hepatitis A and B are desired combined vaccine can be given A booster dose of either of the monovalent vaccines may be administered to patients primed with TWINRIX Boosters Hepatitis A Individuals primed with Twinrix require first booster for Hepatitis A at 20 years if at on going risk Boosters Hepatitis B Individuals primed with Twinrix require booster dose Page 5 of 8

6 3. Description of treatment continued of Hepatitis B once only 5 years after primary immunisation is complete Identification & Management of Adverse Reactions Fever, headache, gastrointestinal symptoms and local reactions such as pain, redness and swelling at the injection site, mostly within 48 hrs after vaccination. Any adverse events should be reported via yellow card system. Additional Facilities Patient advice Follow up Immediate access to Adrenaline 1 in 1000 injection. Inform of possible side effects and their management. Testing for anti HBs is not recommended except for those at occupational risk and patients with renal failure Specific Product Information Records Record fully in Trust clinical record / GP records and as required in parent held records and forward immunisation records to the Child Health Information System (CHIS) / Department. Patient name and date of birth Dose, site and route of injection Antigen(s) given, brand, batch and expiry date of vaccine Date and time given and by whom Consent obtained Stage of immunisation (if appropriate) and if/when next dose is due. State if immunisation was given as scheduled or unscheduled. An indication that the vaccine has been administered under a PGD Advice given Immuniser s signature on appropriate record/ password controlled immunisers record on patient e- records. An electronic or manual record of all individuals receiving immunisation under this PGD should be kept for audit purposes Page 6 of 8

7 4. Authorisations Patient Group Direction Authorisation Lead Doctor Name: Dr Sam Ghebrehewet Position: Unit Director and Consultant in Communicable Disease Control, C&MHPU Lead Pharmacist Name: Helen Stubbs Position: Pharmaceutical Adviser in Public Health, Sefton PCT Lead Nurse Name: Gill Marsh Position: Senior Health Protection Nurse Practitioner, C&MHPU PGD Authorised on Behalf of NHS Wirral by: Governance Lead Name: Dr Phil Jennings Position: Wirral CCG Chair PGD Authorised for use in GP Practice by: Senior Partner (or delegate) for GP employed nurses only Name: Position: Page 7 of 8

8 5. Declaration Practitioner I have read the contents of this Patient Group Direction and will work within this remit. Name Signature Date Employer/ Line Manager I give authorisation for the named Health Care Professional who has signed this PGD to administer those vaccines as prescribed within this direction and in accordance with the current Department of Health guidelines (The Green Book - Immunisation against Infectious Disease, HMSO 2006 and relevant updated chapters). Name Signature Date Page 8 of 8