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Patient Group Direction (PGD) for the Administration of:

HEPATITIS B ADULT VACCINE (Engerix B, HBvaxPRO (10mcg/ml), HBvaxPRO40 (40mcg/ml), Fendrix)

POM Prescription Only Medicine

To Adults YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT

CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES Indication

Inclusion Criteria

For immunisation of adults, (aged 16 years and above), at high risk of exposure to the virus or complications of the disease. Preexposure immunisation is used for individuals who are at increased risk of hepatitis B because of their lifestyle or other factors. For post exposure prophylaxis for adults (aged 16 years and over). Immediate post exposure vaccination is used to prevent infection in individuals potentially exposed to hepatitis B-infected blood or body fluids. Refer to inclusion criteria. Hepatitis B vaccine is also indicated for occupational risk. However this PGD does not cover individuals considered to be at occupational risk (EXCEPT for foster carers – see inclusion criteria). Informed consent has been given in accordance with current PCT guidelines for the administration of the vaccine. Membership of High Risk Groups: All current injecting drug users, including those who inject intermittently and those likely to ‘progress’ to injecting. See Green Book Chapter 18 for details. Close family (including children), household contacts and sexual partners of injecting users. Close family, household contacts and sexual partners of patients with infectious Hepatitis B, whether acute, chronic or a carrier. Blood should be taken at the time of the first dose of vaccine to determine if they have already been infected. Those who change sexual partners frequently, particularly men who have sex with men (MSM), and male and female commercial sex workers. Close family, household contacts and sexual partners of patients in any high risk group listed above. Blood should be taken at the time of the first dose of vaccine to determine if they have already been infected Families adopting children from countries with a high or intermediate prevalence of Hepatitis B. All short-term foster carers who receive emergency placements and their families. Permanent Foster carers and their families who accept a child known to have or to be at high risk of Hepatitis B. Individuals receiving regular blood or blood products. Carers responsible for the administration of blood products. Patients with chronic liver disease of any severity (refer to chapter 18 of the Green Book). Inmates of custodial institutions Individuals in residential accommodation for those with learning PGD No 15 v3 Hepatitis B Adult Vaccine

Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


difficulties. Individuals attending day care or schools for those with severe learning difficulties if local risk assessment indicates significant risk. Patients with chronic renal failure including those on haemodialysis or renal transplantation programmes. The vaccines formulated for use in patients with chronic renal insufficiency should be used. See Green Book chapter 18 for details Those travelling to areas of high or intermediate prevalence who are at increased risk or plan to remain there for lengthy periods. See Green Book for details. For post exposure vaccination, bloods should be taken at the time of the first dose of vaccine to determine if Hepatitis B antigen is present. (See Green Book Chapter 18 latest version) Post Exposure Immunisation (Seek Advice)* Individuals who are accidentally inoculated or contaminated with blood or body fluids potentially infected with Hepatitis B, depending on their prior vaccination status and the status of the source, e.g. needle stick injuries, human bites. Sexual contact with an individual suffering from infectious Hepatitis B *Seek advice from local Health Protection Agency or occupational health service as appropriate. Hepatitis B immunoglobulin may also be needed. Refer to prescriber. See Green Book Chapter 18 (latest version) and appendix 1 (table 18.5).

Exclusion Criteria

Cautions/Need for Further Advice

NOTE The vaccine is not effective in patients with acute Hepatitis B, and is not necessary for individuals known to have markers of current or past infection. However, immunisation should not be delayed while awaiting any test results. See Green Book. Informed consent has NOT been given for the administration of the vaccine. Current acute febrile illness. Individuals aged under 16 years of age. A confirmed anaphylactic reaction to a previous dose of a vaccine containing Hepatitis B or to any constituent of the vaccine (check the product leaflet). A confirmed anaphylactic reaction to any component of the vaccine. Occupational risk - individuals should be referred to employer’s occupational health service. Please also see Cautions/Need for Further Advice section Previous severe reaction to vaccination – clarify nature of severe reaction and seek advice from a prescriber. Pregnancy and Breast feeding mothers – whilst this is not necessarily a contraindication, individuals working under this PGD must seek further clinical advice from an appropriate medical practitioner, (e.g. patient’s GP or other appropriate clinician), before the vaccine is administered. The benefits of administration should outweigh the risks. For further information see appropriate Green Book chapters. Thrombocytopenia, Haemophilia or any other problem that may stop blood from clotting properly, or patient taking anti coagulants Response to vaccines may be sub optimal if the patient is PGD No 15 v3 Hepatitis B Adult Vaccine

Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


immunosuppressed because of disease such as HIV, or treatment e.g. chemotherapy, radiation treatment, steroids or other immunosuppressant drugs. See Frequency section Any individual, even if not immunosuppressed can have a poor response to Hepatitis B vaccine. Poor response is particularly associated with age over 40, obesity, smoking, alcoholism and dialysis. Some ointments and creams which are prescribed to treat eczema can affect the immune response. Hepatitis B Vaccine should not be given during treatment with and for 14 days after stopping treatment with either Tacrolimus (Protopic) ointment, or Pimecrolimus (Elidel) cream, or similar preparations which may affect the immune response. Allergy to latex – Vial stoppers and syringe plunger stoppers are often made of this type of rubber and there is a risk of an allergic reaction to the vaccine because of this. However, for latex allergies other than anaphylactic allergies (e.g. a history of contact allergy to latex gloves), vaccines supplied in vials or syringes that contain latex can be administered. Refer to Green Book chapter 6. If an individual has a history of severe (i.e. anaphylactic) allergy to latex, vaccines supplied in vials or syringes that contain latex should not be administered. For these individuals contact the manufacturer to confirm whether the vaccine to be administered contains latex. .

Action if Patient Declines or is Excluded

Refer to supervising doctor if appropriate. Refer to employer’s occupational health service where appropriate. Document findings and action taken in patient’s record. Give information about risks of the disease Give information about when the vaccine may be given

DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine

Hepatitis B vaccine Brand names: Engerix B HBvaxPRO HBvaxPRO40 Fendrix

20mcg in 1ml 10mcg in 1ml 40mcg in 1ml 20mcg in 0.5ml

PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


Route/Method

Where testing for markers of current or past infection is clinically indicated, this should be done at the same time as the first dose is administered. Vaccination should not be delayed while waiting for results of the tests. Further doses may not be required in those with clear evidence of past exposure. See Green Book chapter 18 (latest version). VACCINES MUST NOT BE GIVEN INTRAVENOUSLY

Hepatitis B vaccines are routinely given intramuscularly in the upper arm or anterolateral thigh. The buttock must not be used because vaccine efficacy may be reduced For individuals with a bleeding disorder, however, vaccines should be given by deep subcutaneous injection to reduce the risk of bleeding. 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 a separate limb. If given in the same limb, they should be given at least 2.5 cm apart. The site at which each vaccine was given should be noted in the individual’s record. Hepatitis B vaccine can be given at the same time as specific Hepatitis B Immunoglobulin, where indicated, but at a different site. Different hepatitis B vaccine products can be used to complete a primary immunisation course or, where indicated, as a booster dose in individuals who have previously received another hepatitis B vaccine.

Dosage BRAND Engerix B HBvaxPRO

Fendrix*

HBvaxPRO40*

AGES AND GROUP 16 years or over 16 years or over For use in patients with renal insufficiency aged 15 years and over. (Dialysis and predialysis patients). For adult dialysis and predialysis patients.

DOSE 20micrograms 10micrograms

20micrograms

40micrograms

VOLUME 1ml 1ml

0.5ml

1ml

*Vaccines formulated for use in patients with chronic renal insufficiency.

Frequency

There are many different immunisation regimes for hepatitis B vaccine. Generally the schedule for hepatitis B vaccine consists of three doses, with or without a fourth booster dose. A schedule with doses at zero, one and six months should only be used where rapid protection is not required and there is a high likelihood of PGD No 15 v3 Hepatitis B Adult Vaccine

Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


compliance. For pre-exposure prophylaxis in most adult risk groups and post exposure prophylaxis an accelerated schedule should be used. Accelerated Schedule: Vaccine dose given at zero, one and two months. For those who are at continued risk, a fourth dose is recommended at 12 months. Fendrix is recommended to be given at zero, one, two and six months. Where compliance with a more prolonged schedule is difficult to achieve (e.g. in injecting drug misusers and GUM clinic attenders) higher completion rates for three doses at zero, one, and two months have been reported. Improved compliance is likely to offset the slightly reduced immunogenicity when compared with the zero, one and six month schedule, and similar response rates can be achieved by opportunistic use of a fourth dose after 12 months. Manufacturers of HBvaxPRO advise that those receiving the accelerated schedule must receive the 12 month booster to induce higher antibody titres. Very Rapid Immunisation Schedule For Subjects Aged 18 Years and Above - Licensed for Engerix B only: Vaccine dose given at zero, seven and 21 days. When this schedule is used, a fourth dose is recommended 12 months after the first dose. This schedule is licensed for use in circumstances where adults over 18 years of age are at immediate risk and where a more rapid induction of protection is required. This includes persons travelling to areas of high endemicity, injecting drug users and prisoners. Very Rapid Immunisation Schedule For Subjects Aged 16 to 18 Years - Engerix B Only: Vaccine dose given at zero, seven and 21 days. When this schedule is used, a fourth dose is recommended 12 months after the first dose. Although not licensed for this age group, this schedule can be used in those aged 16 to 18 years where it is important to provide rapid protection and to maximise compliance (e.g. injecting drug users and those in prison). Where immunisation has been delayed beyond the recommended intervals, the vaccine course should be resumed but not repeated. Patients with Chronic Renal Failure/Haemodialysis Patients Vaccines formulated for use in patients with chronic renal insufficiency should be used. Reinforcing Immunisation 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. Measurement of anti-HBs levels is not required either before or after this dose. Booster doses should be offered to any haemodialysis patients who are intending to visit countries with a high endemicity of hepatitis B and who have previously responded to the vaccine, PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


particularly if they are to receive haemodialysis and have not received a booster in the last 12 months. Boosters are also recommended after exposure to the virus. Adjustments may be required in patients with low antibody counts – see BNF, Green Book Chapter 18 and follow up section of this PGD

Duration of Treatment

See Frequency Above

Maximum or Minimum Treatment Period Quantity to Supply/Administer Side Effects

See Frequency Above See Frequency Above Reactions are usually mild and confined to first few days after immunisation. Common side effects include: Local reaction (transient soreness, erythema, induration), headache, GI disorder, fatigue and fever. Guillain-Barre syndrome has been reported very rarely. This list is not exhaustive. Please refer to current BNF and product SPC/leaflet for complete list. Some of the rare side effects listed in the SPC may affect the ability to drive or operate machinery. Anaphylactic reactions to vaccines are extremely rare but have the potential to be fatal. Onset is rapid, usually within minutes but can occur within hours of vaccine administration. It is not possible to define a particular time period in which an individual should be observed following immunisation. See Green Book Chapter 8 (latest version). Report all serious suspected adverse reactions (ADRs) in adults and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Yellow cards may be completed by a nurse, pharmacist, the patient or a doctor, but it is the responsibility of the health professional identifying the ADR to report it. Yellow cards and guidance on their use are also available at the back of the BNF.

Additional Facilities

Special Considerations / Additional information

Immediate access to Adrenaline/Epinephrine for treatment of anaphylaxis Access to a telephone Vaccines must be stored and transported according to manufacturers’ guidelines and PCT Cold Chain policy Vaccine should be stored in the original packaging at a temperature of 2 to 8º C. If the vaccine has been frozen, it should be discarded. Healthcare professionals are reminded that in some circumstances the PGD No 15 v3 Hepatitis B Adult Vaccine

Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary Product Characteristics (SPC) for a particular vaccine. When this occurs, the recommendations in the Green Book are based on current expert advice received from the JCVI and should be followed. Green Book recommendations are reflected in this PGD which in some instances could result in an unlicensed use of a licensed product.

Advice to Patient/Carer/Parent/ Guardian

Follow Up

Explain procedure and further action if required Give a copy of the manufacturer’s patient information leaflet and discuss as required. Advice on the management of fever and other common/uncommon post-vaccination adverse effects. Management of local/general reactions. Anaphylaxis is rare but a delayed reaction can occur. Advise to seek urgent medical attention if the patient develops breathlessness, swelling or rash. Some side effects may affect the ability to drive or operate machinery. If affected advise patient not to drive or operate machinery. Advise blood test may be required 1 – 4 months after third dose if clinically indicated. When explaining blood test results inform the individual whether they are protected. Advise that some individuals are poor responders to the vaccine, give life style advice and advise care with handling sharps, body fluids etc. It is important that immunisation against hepatitis B does not encourage relaxation of other measures designed to prevent exposure to the virus, for example condom use and needle exchange. Healthcare workers giving immunisation should use the opportunity to provide advice on other preventative measures or to arrange referral to appropriate specialist services. Advise all individuals that if they are accidentally exposed to potentially infected hepatitis B blood or body fluids they must seek urgent medical advice. Hepatitis B immunoglobulin may be needed for non-responders or individuals in high-risk situations. See appendix 1 of this PGD (table 18.5). Those at occupational risk should be advised to inform their employer or occupational health department of hepatitis B status. See Green Book Chapter 18. The Green Book states that except in certain groups, (those at continued risk of occupational exposure and patients with renal failure), testing for anti-HBs is not recommended. Blood testing and boosters may be required for those at risk of occupational exposure which is not covered under this PGD. Renal Patients In patients with renal failure antibody levels should be monitored annually and a dose of vaccine given to patients who have previously responded to the vaccine, if antibody levels fall below 10mIU/ml.

PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements

If patient is excluded from this PGD refer to GP or other appropriate clinician. Any health professional administering a vaccination must be able to identify and contact an appropriate clinician, e.g. GP, or the NHS Kirklees Immunisation Coordinator, as necessary, e.g. in the case of a child with an allergy to components of the vaccine.

Records/Audit Trail

Self referral to GP practice or A&E department if appropriate (post immunisation). The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary. Patient’s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented. Contact details of GP if applicable Dose administered and route. Site of injection. Batch details, expiry date, manufacturer, supplier and brand name Advice given to patient (including side effects) Date administered Signature and name of staff who administered the vaccine. For paperless practices the electronic record should identify the name of the nurse administering the vaccine and should ideally have an electronic signature. Scanned paper records are acceptable Details of any subsequent adverse drug reaction and actions taken including referral arrangements. (This MUST be documented in the patient’s medical record). For all vaccines administered to children or young people up to age 16 or still in full time education. The following records must also be completed: Computerised records and data collection held by Child Health Information Services (CHIS) The Personal Health Child Record (PHCR –red book) (manual records) should be completed if available, failure to present this is not a reason to refuse to administer vaccination. If the red book is not available vaccination may proceed as long as there is clear information in respect of which vaccinations the child is due to receive. Every effort should be made to complete the red book at the earliest opportunity and the importance of providing it at subsequent vaccination appointments should be communicated to the parent/guardian. If applicable to the vaccine given Travel destination Liaison with HPA .

PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


STAFF CHARACTERISTICS Qualifications Specialist Training or Qualifications

Continuing Training & Education

References/Resources and Comments

Registered nurse with current registration working in Kirklees PCT Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent for working under PGDs for the supply and administration of medicines. Has undertaken training appropriate to this PGD – e.g. annual updates in immunisation and vaccination. Has undertaken training and is competent in all aspects of immunisation including contraindications and the recognition and treatment of anaphylaxis. Has undertaken training and is competent in resuscitation skills. 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 their scope of practice. Attends compulsory annual updates in immunisation and vaccination. Undertakes mandatory annual updates on anaphylaxis and resuscitation. Practitioner should have access to product leaflet, current BNF and green book chapters, and to updated DH advice where appropriate SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ BNF chapter 14 http://www.bnf.org/bnf/ DH Immunisation Against Infectious disease (The Green Book) chapter 18 (updated 19th November 2009). This can be accessed at:http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicati onsPolicyAndGuidance/DH_079917 National Travel Health Network and Centre (NaTHNaC): http://www.nathnac.org/

Advice contained in the individual Summary of Product Characteristics (SPC) may have been overridden in accordance with guidance issued by the relevant Dept of Health Green Book Chapter. This will result in an unlicensed use of a licensed product following current DH guidance.

PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


This PGD is an updated version of the Kirklees PCT PGD No 15v2 ‘Hepatitis B Adult Vaccine’, April 2009. It was updated for use in Kirklees Primary Care Trust by the individuals listed below:

Name Dr Ebere Okereke Julie Bulmer Jane O’Donnell Lucianne Ricketts Deborah Mitchell Sally Wright Lisa Meeks

Position

Date

Consultant in Communicable Disease Control (West Yorkshire Health Protection Agency) School Nurse Team Leader

17th February 2011

Deputy Director Infection Control

17th February 2011

Senior Medicines Management Adviser - Strategy and Operational Development. GP Practice Nurse

17th February 2011

Immunisation Nurse Team Leader

17th February 2011

Specialist Technician – Community and Support Services

17th February 2011

PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 10

17th February 2011

17th February 2011


Individual Authorisation for the Administration of Hepatitis B Adult Vaccine by Nurses Employed Either by the Primary Care Trust or GP Practices Within Kirklees PCT. THE PCT DOES NOT ACCEPT LIABILITY IN RESPECT OF GP EMPLOYED STAFF. 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 and in accordance with their own Code of Professional Conduct I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this PGD. In signing this declaration the nurse is willing to be professionally accountable for this work as defined in the NMC Code of Professional Conduct 2008. Name of Professional

Signature

Authorising Manager and

Date

signature

Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials. Authorising Managers For Practice Staff this will be the GP. For PCT staff this will be the team leader, or relevant clinical manager (see PGD policy) Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may give vaccinations away from the base should have an individual copy of the relevant signed PGD with them when administering the vaccine.

PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 11


AUTHORISATION This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting ORGANISATION Director of Patient Care & Professions

KIRKLEES PRIMARY CARE TRUST Name: Sheila Dilks

Signature: Assistant Director of Medicines Management & Prescribing

Name: Neill McDonald

Signature: Medical Director

Date:

Name: Dr Judith Hooper

Signature: CEC Chair

Date:

Date:

Name: Dr David Anderson

Signature:

PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 12

Date:


Appendix 1 Table 18.5 Green Book Chapter 18 Post exposure Immunisation Significant Exposure

Non Significant Exposure

HBV status of person exposed

HbsAg positive source

Unknown source

HbsAg negative source

Continued risk

No further risk

1 dose HB vaccine preexposure

Accelerated course of HB vaccine* HBIG x 1 One dose of HB vaccine followed by second dose one month later Consider booster dose of HB vaccine

Accelerated course of HB vaccine*

Initiate course of HB vaccine

Initiate course of HB vaccine

No HBV prophylaxis Reassure

One dose of HB vaccine

Finish course of HB vaccine

Finish course of HB vaccine

No HBV prophylaxis Reassure

Consider booster dose of HB vaccine

Consider booster dose of HB vaccine

Consider booster dose of HB vaccine

No HBV prophylaxis Reassure

HBIG x 1 Consider booster dose of HB vaccine A second dose of HBIG should be given at one month

HBIG x 1 Consider booster dose of HB vaccine A second dose of HBIG should be given at one month

No HBIG Consider booster dose of HB vaccine

No HBIG Consider booster dose of HB vaccine

No prophylaxis Reassure

2 doses HB vaccine pre-exposure (anti - HBs not known) Known responder to HB vaccine (anti- HBs 10mIU/ml Known nonresponder to HB vaccine (anti- HBs 10mIU/ml 2 to 4 months post immunisation

*An accelerated course of vaccine consists of doses spaced at zero, one and two months A booster dose may be given at 12 months to those at continuing risk of exposure to HBV Source:PHLS Hepatitis Subcommittee, 1992. CDR Review 1992:2;R97-R101 PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 13


PGD No 15 v3 Hepatitis B Adult Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 14

/P  

http://www.kirklees.nhs.uk/fileadmin/documents/New/Public_Information/med_mgt/PGDs/Updated_July_11/PGD_No_15_v3_Hepatitis_B_ADULTS.pdf

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