Jacqui Seaton, Head of Medicines Management/Hitesh Patel, Pharmaceutical Adviser, NHS Telford & Wrekin CCG

Transcription

1 Document Title: Patient Group Direction for HEPATITIS B VACCINE CCG Doc Ref.: Local Doc Ref.: Author/s: Owner: File Reference: Document Overseeing Group: PGD Version No.: 1/2016 Jacqui Seaton, Head of Medicines Management/Hitesh Patel, Pharmaceutical Adviser, NHS Telford & Wrekin CCG Jacqui Seaton, Head of Medicines Management C:\My Documents\Approved PGDs PGD Working Group Placement in Framework: Approval Level: Date of Approval: PGD working group June 2016 Review Date: June 2018 Amendment Dates: Page(s) Brief Description NB: Always access the electronic version of this PGD to ensure that you are using the most up to date version. The practitioner MUST be authorised by name, under the current version of this PGD before working according to it. June 2016 Version 1/2016 Page 1 of 12

2 Patient Group Direction for administration of HEPATITIS B VACCINE Approved By NHS Telford and Wrekin Name Signature CCG Chair Dr Jo Leahy Head of Medicines Management Jacqui Seaton CCG Director of Primary Care and Quality Christine Morris Date patient group direction approved Date this patient group direction becomes due for review June 2016 June 2018 or in response to new local/national guidelines. June 2016 Version 1/2016 Page 2 of 12

3 STAFF CHARACTERISTICS Provider of NHS services within NHS Telford and Wrekin CCG/NHS England Midlands and East (providers in the Shropshire & Staffordshire area) Nurse with current NMC registration Specialist competencies or qualifications: The healthcare professional must have a good understanding of the NICE Good Practice Guidance on Patient Group Directions 1. The healthcare professional must have a good understanding of the NMC 'Standards for Medicines Management' 2 The NICE competency framework: For health professionals using Patient Group Directions 3 should be used by health care professionals planning to work under this PGD to identify any gaps in their knowledge. The gaps should be addressed before the healthcare professional is authorised to work under this PGD. The clinical manager/ lead GP/commissioner must have evidence that the health care professional has undertaken training to carry out clinical assessment of patient leading to confirmation that the patient requires treatment according to the indications listed in the PGD. The healthcare professional must provide evidence of training, appropriate annual updates and continued professional development undertaken to support their competence for administration of this treatment. The clinical manager/ lead GP/commissioner must have assessed the competency of the healthcare professional to work to this Patient Group Direction. NICE competency framework for people authorising PGDs 4 and the NICE competency framework for healthcare professionals using Patient Group Directions 4 should be used to support this assessment. The health care professional must have undertaken training and annual updates in the recognition and treatment of anaphylaxis, including practical in Basic Life Support and has immediate access to an in-date supply of adrenaline 1mg in 1ml (1:1000) at the time of the consultation. (The practitioner must be deemed competent in basic life support and in emergency administration of adrenaline). The PGD for adrenaline can be accessed from: The health care professional must have access to all relevant sources of information e.g. information issued by the Department of Health (Green Book), British National Formulary (BNF), Summary of Product Characteristics (SPC), and the clinical guideline concerning medicine(s) within this Patient Group Direction (PGD). The practitioner must be competent and knowledgeable in both local and national vaccine cold chain standards. See Public Health England Protocol for ordering, storing and handling vaccines March 2014 & local CCG cold chain policy for Telford and Wrekin practices only see CCG Vaccine cold chain standards The registered health care practitioner 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 CLINICAL LEAD UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY June 2016 Version 1/2016 Page 3 of 12

4 CLINICAL CONDITION Clinical need addressed Active immunisation against infections caused by hepatitis B virus. Hepatitis B (Hep B or HBV) is a liver disease caused by the hepatitis B virus. Approximately 25% of chronic carriers will develop chronic hepatitis, cirrhosis or primary liver cancer. The virus is transmitted by parenteral exposure to infected blood or body fluids. Transmission mostly occurs: Through vaginal or anal intercourse As a result of blood-to-blood contact (e.g. sharing of needles and other equipment by injecting drug users (IDUs), needlestick injuries) Through perinatal transmission from mother to child. Inclusion criteria 5 Primary immunisation in patients at risk of hepatitis B infection (see patient groups below) Patients requiring reinforcing dose (booster) following primary immunisation depending on schedule used and immunisation status Injecting drug users (IDU) - All current IDUs as a high priority - Those who inject intermittently - Those who are likely to progress to injecting for example those who are currently smoking heroin and/or crack cocaine, and heavily dependent amphetamine users. - non-injecting users who are living with current injectors - sexual partners of injecting users - children of injectors Individuals who change sexual partners frequently. Particularly men who have sex with men and male and female commercial sex workers. Close family contacts of a case or individual with chronic hepatitis B infection Families adopting children from countries with a high or intermediate prevalence of hepatitis B Foster carers Individuals receiving regular blood or blood products and their carers (Haemophiliacs) Patients with chronic renal failure including those on haemodialysis Patients with chronic liver disease Inmates of custodial institutions Individuals in residential accommodation for those with learning difficulties (staff and residents) People travelling to or going to reside in areas of high or intermediate prevalence. Vaccination should be provided for travellers who intend to seek employment as healthcare workers, those who intend to reside for long periods (3 months or longer) and travellers with pre-existing medical conditions who may be at a higher risk of requiring medical procedures abroad Individuals who are travelling abroad for dental or medical treatment Individuals at high risk of requiring medical or dental procedures in such countries should be immunised these include: - Those who plan to remain in areas of high or intermediate prevalence for lengthy periods - Children and others who may require medical care while travelling to visit families or relatives in high or moderate-endemicity countries - People with chronic medical conditions who may require hospitalisation June 2016 Version 1/2016 Page 4 of 12

5 while overseas - Those travelling for medical care. Post exposure immunisation: Babies born to mothers who are chronically infected with HBV or to mothers who have had acute hepatitis B during pregnancy. Sexual partners (any sexual partner of individuals suffering from acute hepatitis B, and who are seen within one week of last contact, should be offered protection with HBIG and vaccine. Sexual contacts of an individual with newly diagnosed chronic hepatitis B should be offered vaccine; HBIG may be added if unprotected sexual contact occurred in the past week.) Persons who are accidentally inoculated or contaminated Bites from infected persons Exclusion criteria (for full details of interacting medicines and product excipients refer to current Summary of Product Characteristics (SPC) & BNF) Management of excluded patients Declined consent patient parent/guardian Hypersensitivity to any component of the vaccine or subjects having shown signs of hypersensitivity after previous hep B administration Acute severe febrile illness(the presence of a minor infection is not a contraindication) Pregnancy unless definite risk of hepatitis B Patients who are hepatitis B positive Patients with acute hepatitis B 1st dose in babies born to hepatitis B positive mothers Individuals at occupation risk (these patients should be advised to contact their employers occupational health services) Travellers not meeting the inclusion criteria. (See management of excluded patients. If vaccination is considered necessary patients should be advised about alternative arrangements for vaccination) Exclusion under this Patient Group Direction (PGD) does not necessarily mean the vaccination is contraindicated but it would be outside the remit of the PGD and another form of authorisation (i.e. PSD) will be required. Document reason for exclusion and any action taken in the patients notes. Referral to medical practitioner or other appropriate service if necessary. Travellers to areas of high or intermediate prevalence who place themselves at risk when abroad should be offered immunisation but this would be outside the remit of this the PGD. (The behaviours that place travellers at risk will include sexual activity, injecting drug use, undertaking relief aid work and/or participating in contact sports.) Temporary exclusion In case of postponement due to acute illness, arrange a future date for immunisation Action/Advice for patients not wishing to receive care under this PGD Advise and counsel accordingly Document reasons for not giving vaccine in patients records Document any advice given Refer to medical practitioner if appropriate for further advice June 2016 Version 1/2016 Page 5 of 12

6 Treatment and Drug details Name form and strength of medicine(s) Engerix B 20 micrograms/ml (1ml prefilled syringe) Engerix B paediatric 10 micrograms/0.5ml (0.5ml prefilled syringe) Engerix B 20 micrograms/ml vial (1ml vial) HB VAX PRO Paediatric 5 micrograms/0.5ml (0.5ml prefilled syringe) HB VAXPRO 10 micrograms/ml vial (1ml prefilled syringe) HB VAX PRO40 40 micrograms/ml (1ml vial) Fendrix 20 micrograms/0.5ml (0.5ml prefilled syringe) Legal classification Black triangle warning Suspected adverse reactions. Should be reported using the Yellow Card reporting scheme ( Method of obtaining supply POM ( Prescription only medicine) None of the preparations have a black triangle warning however all suspected adverse reactions should be reported to the MHRA using the yellow card scheme Ordered via licensed NHS supplier Site for treatment GP surgeries Health Centres Route / method Intramuscular injection. Deltoid muscle is preferred site of injection in adults. In infants, the anterolateral aspect of the thigh is recommended. Vaccine should not be given in gluteal region as efficacy could be reduced. Subcutaneous route should be used for patients with thrombocytopenia or bleeding disorders. 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 Dose Dosing Schedules for Hepatitis B Vaccination see Appendix 1 Number of times treatment may be administered Quantity to be supplied or administered See dosing schedules for Hepatitis B vaccination Appendix 1 Booster dose as required It is recommended that individuals at continuing risk of infection should be offered a single booster dose of vaccine, once only, around five years after primary immunisation. As indicated in the dosing schedule see Appendix 1 Off-label use Side effects 6 Suspected adverse reactions to drugs including vaccines should be reported on the Engerix B (20 micrograms) for use in rapid schedule - although not licensed this schedule can be used for those aged 16 to 18 years where it is important to provide rapid protection and to maximise compliance 5 Common side effects: Local reactions (injection site) Transient soreness, erythema and induration June 2016 Version 1/2016 Page 6 of 12

7 yellow card available at the back of the BNF. Also at Very rare side effects may include: Blood and lymphatic system disorders: thrombocytopenia, lymph adenopathy Immune system disorders: serum sickness, angioedema and anaphylaxis Serious suspected neurological reactions such as Guillain Barre syndrome and demyelinating disease have very rarely been reported although a causal relationship with hepatitis B vaccine has not been established. Cardiac and vascular disorders. Hypotension and vasculitis. Respiratory, thoracic and mediastinal disorders. Bronchospasm like symptoms. Metabolism and nutrition disorders: Vomiting, nausea, diarrhoea, and elevation of liver enzymes. Skin and subcutaneous tissue disorders: Rash, alopecia, pruritis, urticaria and erythema multiforme Musculoskeletal, connective tissue and bone disorders: Arthralgia, arthritis and myalgia General disorders. Fatigue, dizziness, syncope, fever, malaise, influenza like symptoms and abdominal pain For full details see individual summary of product characteristics. 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 Storage and disposal Additional Information & Drug Interactions Advice to patient/carer Vaccine Storage Vaccines should be stored in the original packaging at +2 C to +8 C and protected from light. All vaccines may be sensitive to some extent to heat and cold. Heat speeds up the decline in potency of most vaccines, thus reducing their shelf life. Effectiveness of vaccines may be impaired if not stored at the correct temperature 5. Freezing may cause increased reactogenicity and loss of potency for some vaccines. It can also cause hairline cracks in the container, leading to contamination of the contents. Equipment used for immunisation, including used vials, ampoules, or partially discharged vaccines in an oral applicator, should be disposed of at the end of a session by sealing in a proper, puncture-resistant sharps box, according to local authority regulations and guidance in the technical memorandum (Department of Health, 2006) 5. 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. 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 was given should be noted in the individual s records. BEFORE TREATMENT: The patient or parent/carer should be advised to seek medical advice in the event of a severe adverse reaction. AFTER TREATMENT: Supply marketing authorisation holder's patient information leaflet (PIL) provided with the vaccine June 2016 Version 1/2016 Page 7 of 12

8 Inform patient of next dose /booster Safe travel advice if appropriate Follow up Suspected Adverse reactions Error reporting Advise patients/parent/guardian of possible side effects as above and advise to seek medical advice from the most appropriate health professional Patient presenting with suspected adverse drug reaction should be referred to a doctor for further investigations. Healthcare professionals and parents/carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme on: Any incidents or near miss issues must be reported via the organisation s internal reporting system. 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 Manufacturer / brand of product, batch number, expiry date Record of informed consent Dose Date of administration Route of administration Site of administration Advice given to patient/carer (including advice given if vaccination is declined) Details of staff who administered (sign and print name) 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. Details of any Adverse Drug Reactions and actions taken; Record supplied via Patient Group Direction (PGD). All records should be clear, legible and contemporaneous. This information should be recorded in the infant s GP record AND the personal Child Health record (PCHR) the Red Book. A computerised or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. Clinical records must be kept for at least 8 years following completion of treatment. In patients who are aged under 17 years, clinical records must be kept until the patient s 25th birthday, or for 8 years following a child s death. Data must be stored in accordance with Caldicott guidance and the Data Protection Act. June 2016 Version 1/2016 Page 8 of 12

9 Name of clinical manager / GP Lead Register of practitioners qualified to administer and / or supply HEPATITIS B VACCINE under this Patient Group Direction Signature of clinical manager / GP Lead Date: A copy of this page should be retained by the authorising manager for 25 years 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 Healthcare professionals working under a PGD must have received appropriate training and been assessed as competent to administer/supply the medicine referred to in the PGD. The clinical lead should review competency of authorised practitioner/s at least annually. Training certificates must be available for inspection. Authorisation to use this PGD does not remove inherent professional responsibility and accountability A copy of this authorisation form must be printed off, signed and dated by the healthcare professional authorised to use this PGD. This should be retained by the service provider (e.g. GP practice) and readily available for inspection (e.g. CQC). June 2016 Version 1/2016 Page 9 of 12

10 References 1 National Institute for Health and Care Excellence. Patient Group Directions. Medicines practice guideline. August Accessed via: 2 Nursing and Midwifery Council. Standards for Medicines Management. Accessed via: 3 National Institute for Health and Care Excellence. Competency framework: For health professionals using Patient Group Directions Implementing the NICE good practice guidance on Patient Group Directions (GPG2). January Accessed via: 4 National Institute for Health and Care Excellence. Competency framework: For people authorising Patient Group Directions Implementing the NICE good practice guidance on Patient Group Directions (GPG2) January Accessed via: Green Book Chapter 18 Hepatitis B (accessed ) 6 Summary of Product Characteristics for Engerix B, Fendrix and HB VAXPRO (accessed ) June 2016 Version 1/2016 Page 10 of 12

11 Appendix 1 Dose Schedules for Hepatitis B Vaccine Schedule Age Vaccine and dose Accelerated schedule 5 Used for pre-exposure prophylaxis in most adult and childhood risk groups and for post-exposure prophylaxis (including babies born to hepatitis B positive mothers) From birth to 15 years of age Engerix B (10 micrograms) 0.5ml HBvaxPRO Paediatric (5 micrograms) 0.5ml Either brand may be used to complete the course. 3 doses at 0, 1 and 2 months; For patients who are at continued risk, and babies born to hepatitis B positive mothers, a fourth dose is recommended at 12 months (after the 1st dose). From 16 years of age: Engerix B (20 micrograms) 1ml HBvaxPRO (10 micrograms) 1ml Either brand may be used to complete the course. Alternative schedule 5 Should only be used where rapid protection is not required and there is a high likelihood of adherence with the regimen. 3 doses at 0, 1 month and 6 months Two dose schedule 5 Only use when there is low risk of hepatitis B infection during vaccination course and completion of the course can be assured. 2 doses of the adult strength vaccine at 0 and 6 months Rapid schedule 5 To be given where very rapid immunisation is required e.g. travellers departing within one month, injecting drug users, prisoners. 3 doses at 0, 7 days and 21 days; A booster at 12 months (after the 1 st dose) is recommended. From birth to 15 years of age From 16 years of age: From 11 to 15 years of age: From 18 years of age: Although not licensed this schedule can be used for those aged 16 to 18 years where it is important to provide rapid protection and to maximise compliance 5 Engerix B (10 micrograms) 0.5ml HBvaxPRO Paediatric (5 micrograms) 0.5ml Either brand may be used to complete the course. Engerix B (20 micrograms) 1ml HBvaxPRO (10 micrograms) - 1ml Either brand may be used to complete the course. Engerix B (20 micrograms) - 1ml Engerix B (20 micrograms) 1ml June 2016 Version 1/2016 Page 11 of 12

12 Booster 5 A single booster 5 years after the primary course may be sufficient to maintain immunity for those who continue to be at risk Renal insufficiency including dialysis (adults) 5 For schedule see under individual vaccine in vaccine column Once initiated, the primary course must be completed with the same brand. Booster doses may be required. From birth to 15 years of age From 16 years of age From 16 years of age: Engerix B (10 micrograms) 0.5ml HBvaxPRO Paediatric (5 micrograms) 0.5ml Either brand may be used as a booster. Engerix B (20 micrograms) 1ml HBvaxPRO (10 micrograms) 1ml Either brand may be used as a booster. HBvaxPRO40 (40 micrograms) 1ml Three doses at 0, 1 and 6 months after the first dose. Engerix B (20 micrograms) 1ml Four double doses (2 x 20 micrograms) at 0, 1, 2 and 6 months after the first dose 6. Once initiated, the primary course must be completed with the same brand. 15 years and over Fendrix (20 micrograms) 0.5ml Four doses at 0, 1, 2 and 6 months after the first dose. Once initiated, the primary course must be completed with the same brand. June 2016 Version 1/2016 Page 12 of 12