This Patient Group Direction has been developed/reviewed in accordance with NICE guidance by:- Position of Signatory Name Signed Date

Transcription

1 Patient Group Direction Administration of Hepatitis B Vaccine By Registered Nurses employed by GP Practices within Stafford & Surrounds Clinical Commissioning Group This Patient Group Direction has been developed/reviewed in accordance with NICE guidance by:- Position of Signatory Name Signed Date Senior Pharmacist Samantha Buckingham CCG PN /03/2017 General Practitioner Paddy Hannigan 30/03/2017 Lead Nurse Heather Johnstone 30/03/2017 Governance approval for use of this PGD within Stafford & Surrounds CCG is given by:- Position of Signatory Name Signed Date Chief Officer Andy Donald 30/03/2017 I.General Practitioner give authorisation on behalf of.surgery/medical Practice for the Registered Nurses named below to administer/supply the above in accordance with this Patient Group Direction and the current Depart of Health Guidelines. Signature.. Date.. The named nurses below have read and understand the Patient Group Direction, and in signing have agreed to abide by it. Name Job Title Signed Date Professional Responsibility 1. The nurse will ensure he/she is fully competent in all aspects of immunization including: the reasons for and contraindications to this particular vaccine, the recognition and treatment of anaphylaxis, and provide proof of Basic Life Support training or update within the last year. He/she will attend training updates as appropriate. 2. The nurse will have due regard for the Medicines Management Standards 2016 issued by the NMC 3. Authorised nurses should have access to: Immunization against Infectious Disease2013 (the Green Book) Reviewed by APGMarch 2017 Page 1 of 7

2 Available online Summary of Product Characteristics (SPC) Patient Information Leaflet (PIL) This Patient Group Direction is operational from 1 st April 2017 Review date: January Expires on 31 st March 2019 or until the national programme is stopped. Reviewed by APGMarch 2017 Page 2 of 7

3 Administration of Legal Classification Black Triangle? Presentation Hepatitis B Vaccine POM No Engerix B & HBvaxPRO - Genetically derived Hepatitis B surface antigen (prepared from yeast cells by recombinant DNA technique) adsorbed onto aluminium hydroxide Fendrix adjuvanted by monophosphoryl lipid A and absorbed onto aluminium phosphate. Hepatitis B-containing vaccines are inactivated, do not contain live organisms and cannot cause the diseases against which they protect. Energix B 20micrograms/ml 0.5ml and 1ml presentations available HBvaxPRO 10micrograms/1ml 1ml prefilled syringes HBvaxPRO Paediatric - 5micrograms/0.5ml 0.5ml prefilled syringe HBvaxPRO40-40micrograms/ml 1ml vials Storage Fendrix 20micrograms/0.5ml 0.5ml prefilled syringes In original packaging +2 C to +8 C. Do not freeze. Protect from light. Condition to be treated Active immunisation against Hepatitis B virus in people at high risk. Inclusion Criteria High risk groups: - Injecting drug abusers, and non-injecting drug users living with an injector. Drug users who are at risk of progressing to injecting. Children and sexual partners of illicit drug injectors Close family contacts of a case or carrier Individuals who change sexual partners frequently Infants born to mothers who either have had hepatitis during pregnancy, or are positive for both hepatitis B surface antigen and hepatitis B e-antigen or are surface antigen positive without e- markers. Patients receiving regular blood transfusions or blood products and carers responsible for the administration of such products Patients with chronic renal failure including those on haemodialysis Vaccines formulated for use in chronic renal failure should be used (HBvaxPro 40micrograms/ml or Fendrix) Patients with chronic liver disease Health care personnel who have direct contact with blood, bloodstained fluids or patient tissues e.g. laboratory staff Trainee healthcare workers Occupational risk groups such as morticians and embalmers. Police, ambulance and rescue service personnel if assessed as being at risk. Staff and patients of day care residential accommodation or other accommodation for those with severe learning difficulties Inmates and staff of custodial institutions Those travelling to areas of high prevalence who are at increased risk or plan to remain there for lengthy periods Reviewed by APGMarch 2017 Page 3 of 7

4 Families adopting children from countries with a high prevalence of hepatitis B Short term foster carers who receive emergency placements, or who accept a long-term placement of a high-risk child. Exclusion Criteria No valid consent Any individual who has had an anaphylactic reaction to a previous dose of Hepatitis B Vaccine Hypersensitivity to any component of the vaccine (Full details of excipients can be found in the product s SPC at Severe febrile infection If patient is acutely unwell and suffering from fever, vaccination should be postponed until they have recovered. Reasons for seeking further advice from doctor If excluded - Specialist advice must be sought on the vaccines and circumstances under which they could be given. The risk to the individual of not being immunised must be taken into account. Action if patient declines treatment - 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. In the absence of consent the GP should be advised and records made to the effect that the vaccine was offered and refused. Pregnancy/breast feeding effects not assessed. Utilisation during pregnancy requires that the potential benefit justifies the potential risk to foetus. However the green book advises that the vaccination should not be withheld in high risk women refer to GP. Revaccination should only be considered for high-risk patients (this relates to completed course not single doses). Non-responders-consider offering another course with a different brand Administration Route Patients needing Hepatitis B immunoglobulin. Shake the vaccine well to obtain a slightly opaque, white suspension. Intramuscular injection - deltoid muscle is preferred site of injection in adults; anterolateral thigh in neonates, infants and young children. Not to be injected in the buttock (vaccine efficiency reduced). Deep subcutaneous route for patients with haemophilia/ thrombocytopenia. Dose Hepatitis B-containing vaccines can be given at the same time as other vaccines such as DTaP/IPV/Hib, hepatitis A, MMR, MenC, Td/IPV and other travel vaccines, given at separate sites. NB Check SPC of individual product carefully prior to use. Engerix B: - 16 years and over 20micrograms (1ml of 20micrograms/ml) - birth to 15 years 0.5ml (if compliance likely to be low in child years increase dose to 1ml) - chronic haemodialysis adult patients 2ml (40micrograms) Reviewed by APGMarch 2017 Page 4 of 7

5 HBvaxPRO : - 16 years and over 10micrograms (10micrograms/ml pre-filled syringe) - birth to 15 years 5micrograms (5 micrograms/0.5ml pre-filled syringe) - predialysis and dialysis adult patients 40micrograms (1ml of 40 micrograms/ml vial) Fendrix: - predialysis and dialysis patients 15yrs and over 20micrograms (20micrograms/0.5ml pre-filled syringe) Administration Schedule Two primary immunisation schedules can be recommended for Engerix B 10 or 20micrograms and HBvaxPRO 5 or 10micrograms. For pre-exposure prophylaxis in most adult and childhood risk groups the accelerated schedule should be used. 4 doses accelerated schedule: 0,1,2,12 months: three injections with an interval of one month; a fourth injection 12 months after the first administration.- this is recommended for most patients. The alternative schedule should only be used where rapid protection is not required and there is a high likelihood of compliance. 3 doses alternative schedule: 0,1,6 months: two injections with an interval of one month; a third injection 6 months after the first administration. Engerix B: - A very rapid schedule is possible (adults over 18 years) if travel is planned within three weeks, whereby the second dose may be given seven days after the first and the third 21 days after the first. A booster is needed at 12 months Dialysis Patients HBvaxPRO 40micrograms/ml: 3 doses of 40 micrograms at 0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the firstadministration. Fendrix: 4 doses of 20 micrograms at 0,1,2,6 three injections with an interval of one month; a fourth injection 6 months after the first administration. Once initiated primary course of immunisation should be completed with Fendrix. Engerix B: 4 doses of 40 micrograms at 0,1,2,6 months: three injections with an interval of one month; a fourth injection 6 months after the first administration. A booster dose may be considered in these vaccines if the antibody level against hepatitis B surface antigen is less than 10IU/l. Infants born to hepatitis B surface antigen-positive mothers 4 doses of 0.5ml (10micrograms Engerix B, 5micrograms HBvaxPRO). 1 st dose at birth with hepatitis B immunoglobulin (separate site). 2 nd dose at one month, 3 rd dose at 2 months and the 4 th dose12 months after the 1 st dose. Reviewed by APGMarch 2017 Page 5 of 7

6 Known or presumed exposure to hepatitis B virus (e.g. contaminated needle, neonates of mothers who are hepatitis B virus carriers) - Hepatitis B immunoglobulin should be given as soon as possible after exposure or at birth (within 24 hours) - The first dose of vaccine should be given within 7 days and can be administered simultaneously with immunoglobulin at a separate injection site - Subsequent doses of vaccine, if necessary, should be given as in the recommended immunisation schedule, accelerated schedule advised. Individuals at continued risk should be offered a single booster dose 5 years after the primary course. Side-effects Warnings/Adverse Reactions Advice/Management of Adverse Reactions Follow-up Action Records NB Hepatitis B Immunoglobulin is not authorised for administration under this PGD Local injection site - irritation, erythema, induration. Low-grade fever, malaise, fatigue, headache, nausea, decreased appetite, myalgia, arthralgia, arthritis, syncope, erythema multiforme, urticaria, rash, altered liver function tests, vomiting, abdominal pain, diarrhoea, neuropathy, influenza-like symptoms, dizziness, anaphylaxis. Patients should be reminded that in the event of an adverse reaction, they should report it to either their health visitor, school nurse, midwife,practice nurse or GP. Because of the long incubation period of hepatitis B it is possible for unrecognised infection to be present at the time of immunisation. The vaccine may not prevent hepatitis B infection in such cases. Immunisation takes up to 6 months to confer adequate protection; the duration of immunity is not known precisely, but a single booster 5 years after the primary course may be sufficient to maintain immunity for those who continue to be at risk. In patients having renal dialysis, or those who are immunocompromised, response may be impaired and further vaccinations may be necessary Additional doses may need to be considered for subjects where the immune response may not be very good i.e. over 40 years, male gender, obesity, smokers, administration route. Thiomersal preservative is not used in these hepatitis B vaccines. HBvaxPRO may contain traces of formaldehyde and potassium thiocyanate. Anaphylaxis Emergency Treatment Have Adrenaline (Epinephrine) 1:1000 ready for use in case of anaphylaxis. See PGD for administration of Adrenaline (Epinephrine) 1:1000. If an adverse reaction does occur then: 1. Inform the patients GP as soon as possible 2. As with all vaccines, incidents of adverse reactions should be reported to the Committee on the Safety of Medicines via the Yellow Card system. Record date of vaccination, site of vaccination, batch number. The Reviewed by APGMarch 2017 Page 6 of 7

7 Notes following should be recorded in the patient s notes: Name and brand Batch number and expiry date Dose given Time given Route and site of administration Date Signature Schedules that have more time between the second and third doses, such as 0, 1 and 6 months, may take longer to confer protection, but will produce higher anti-hbs antibody titres. Higher compliance rates have been reported with the accelerated schedule 0,1,2 months and improved compliance is likely to offset the slightly lower immunogenicity of this regimen when compared to 0,1,6 month regimen. Practice nurses should always confirm the schedule options with the latest Green Book Guidance. It can be expected that hepatitis D (caused by the delta agent) will also be prevented as this does not occur in the absence of hepatitis B infection. For full product information, always refer to the latest SPC (Summary of Product Characteristics). Up to date vaccination guidance is available in the DH Green Book Reviewed by APGMarch 2017 Page 7 of 7