patient group direction (pgd) for the administration … · (antibodies to hepatitis b surface...

1 PATIENT GROUP DIRECTION Hep B VACCINATION : PHA44 : August 2018

PATIENT GROUP DIRECTION (PGD) FOR THE ADMINISTRATION OF HEPATITIS B VACCINATION FOR ADULT CLIENTS IN SUBSTANCE MISUSE SERVICES

Valid from: August 2018

Review date: July 2020

Expiry date: August 2020

Developed by Name Job Title Signature Date

Senior Pharmacist

Audrey Coker

Lead Clinical Pharmacist for Clinical Services

Senior Nurse

Ruari McCallion

Team Leader for Substance Misuse

Senior Doctor

John Dunn

Divisional Clinical

Lead for Substance

Misuse & Forensic

Services

This patient group direction has been approved on behalf of C&I by: The PGD must be signed below by the Medical Director

Name Signature Date

Medical Director

Vincent Kirchner

31/07/18

Chief Pharmacist Lucy Reeves

31/07/18

Deputy Director Nursing

David Curren

31/07/18


YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD

BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT

NB Information provided in this PGD is based on information given by the Department of Health/

current edition of ‘Immunisation Against Infectious Diseases’ [The Green Book/ e-Green Book].

This may override information in the manufacturer’s Summary of Product Characteristics [SPC]

Clinical Condition

Indication To provide effective protection against hepatitis B virus infection (HBV) for clients accessing substance misuse services who meet the inclusion criteria.

Inclusion criteria Applies to clients accessing the substance misuse services who are:

Close family or household contacts of a case or individual with chronic hepatitis B infection

Injecting drug users, including those who inject intermittently or those who are likely to ‘progress’ to injecting. See Green Book for details1

Sexual partners of injecting drug users and non- injecting users who are living with current injectors

Individuals who frequently change sexual partners

Patients with chronic liver disease

NB: Prior Hepatitis B surface antibody check required only if clinically indicated; testing may be done at the same time as the first dose is administered. Vaccination should not be delayed while waiting for the results of the tests1

If level <10 mIU/ml considered non-immune1

If level 10-100 mIU/ml, give single dose1

If level >100 mIU/ml consider immune1

For mentally incapable adults valid consent for vaccination can be given by a lasting power of attorney or valid advanced directive or vaccination should be given in their best interests unless previous history from next of kin suggest that previously, when the individual retained capacity, they would clearly have declined vaccination; See Mental Health Capacity Act Code of Practice: Section 67 or in line with advice set out in Chapter 2: Consent in the current Green book.


Exclusion criteria Applies to clients accessing the substance misuse services

Acute severe febrile or systemic illness (postpone immunisation until the patient has fully recovered)

Previous Hepatitis B immunity confirmed by blood test

Confirmed anaphylactic reaction to previous Hepatitis B vaccine

Confirmed anaphylactic reaction to any component of the vaccine

Pregnancy and breastfeeding- refer to doctor

Evolving neurological condition; defer vaccination until condition has resolved or stabilised (Green Book Chapter 6 :Contra-indication and special conditions1). Consult GP or seek specialist advice if need for vaccine is urgent.

Consent withheld by patient/carer. Special Considerations Immunisation error identified

Pregnancy/Breastfeeding - See Green Book or SPC for further guidance.

Patients using immune suppressive therapy or patients with immunodeficiency– see ‘Follow up’ section

Vaccine needed due to increased risk from lifestyle or other factors – see details in Green Book and BNF and discuss with doctor. (Patients may have been immunised elsewhere, e.g. hospital, GUM clinics, occupational health service, substance misuse services. Where appropriate arrange referral to specialist services, and give advice on other preventative measures1)

HIV positive – Patients with with HIV infection should not be precluded from vaccination against hepatitis B. The vaccine could be advised since HBV infection can be severe in these patients: the HB vaccination should thus be considered on a case by case basis by the physician. See Green Book and BNF

Individuals receiving regular blood products e.g., people with haemophilia or blood transfusions e.g. people with thalassaemia. Carers responsible for the administration of such products should also be vaccinated.

Patients with chronic renal failure including those on haemodialysis – prescription needed for appropriate dose schedule, see Green Book/BNF.

Home carers (of dialysis patients) who are negative for hepatitis B surface antigen

Action to be taken if patient excluded from treatment

Record reason for exclusion

Refer to doctor or as applicable

Document action taken

Advise of special precautions required to avoid the disease

Advise if the patient can have the vaccine at a later date

Action to be taken if patient refuses treatment

Advice about how hepatitis B is transmitted

Advice about how to avoid hepatitis B infection – this includes travel health advice, accident prevention and on safe sex.

Provide information about the disease, risk and complications

Provide information about disease avoidance

If appropriate, discuss with or refer to GP


Document action taken

Additional information Local or service specific requirements and policies/guidelines that should be adhered to by those using the PGD:

Resuscitation facilities, to include “in date” adrenaline (epinephrine) 1 in 1,000 IM, with directions for use and dosage.

Availability of a telephone.

C&I Management of Anaphylaxis guidelines,

Current “Immunisation against infectious Disease”, DH (Green Book) and chapter updates on the website. (If the 2006 hard copy is used, ensure that chapter updates from the website are available at that time).

Local Cold Chain Guidelines

New publications and updates from DH should also be referred to as they are received. • Current “Health Information for Overseas Travel.” DH (Yellow

Book) and chapter updates on the website1 . Other references, and further reading, are listed in these guidelines.

New publications and updates from DH should also be referred to as they are received. See also, references and resources below: Current Travel Health Advice on world wide web:

https://travelhealthpro.org.uk/factsheet/31/the-green-book http://www.fco.gov.uk http://www.hpa.org.uk http://www.who.int/ith

https://travelhealthpro.org.uk/factsheet/31/the-green-book

http://www.fco.gov.uk/

http://www.hpa.org.uk/


Drug details

Name, form & strength of medicine

Suspension of hepatitis B surface antigen (prepared from yeast cells by recombinant DNA technique) 20 micrograms/mL injection adsorbed onto aluminum hydroxide (Engerix B®) in 1ml vial3

POM/P/GSL/▲ POM -Prescription Only Medicine. Dosage Each dose of Engerix B® is 20micrograms/mL of recombinant (DNA)

hepatitis B surface antigen in a 1mL vial.

Accelerated Primary Course

The Green Book recommends that in most adult and childhood risk groups, an accelerated schedule should be used, with vaccine given at day 0, 1 and 2 months. For those at continued risk, a fourth dose is recommended at 12 months (the manufacturers recommend that the fourth dose is administered to all those receiving this accelerated schedule as titres obtained after the third dose are lower than with the standard schedule outlined below).

This schedule confers protection more quickly and is expected to provide better patient compliance1

OR

Standard Primary Course

The standard schedule, one dose at day 0, 1 month and 6 months should only be used where rapid protection is not required and there is a high likelihood of compliance (if sufficient time before travel and for routine occupational requirements)

This schedule gives optimal protection at month 7 and produces high antibody titres2

OR

Rapid Accelerated Primary Course

In exceptional circumstances Engerix B® is licensed for use in those

aged 18 years and above, where an even more rapid induction of protection is required, e.g. persons travelling to areas of high endemicity and who commence a course of vaccination against hepatitis B within one month prior to departure, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used. When this schedule is applied, a fourth dose is recommended 12 months after the first dose.

Reinforcing immunisation

The full duration of protection afforded by hepatitis B vaccine has yet to be established. The Green Book recommends 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 (antibodies to Hepatitis B surface antigen) levels is not required either before or after this dose. Boosters are also recommended after exposure to the virus. Different hepatitis B vaccine products can be used, where indicated, as a booster dose in individuals who have previously received another hepatitis B vaccine.

Except in certain groups (see below), testing for anti-HBs (antibodies to Hepatitis B surface antigen) is not recommended.

Those at risk of occupational exposure:

Hepatitis B surface antibody to be checked 1-4 months after last vaccination of primary course in patients who are at risk of occupational exposure1.

If level < 10 mIU/ml, refer to doctor1.

If level 10-100 mIU/ml, one additional dose is given1.

In immunocompetent individuals (levels >100 mIU/ml), further assessment of antibody levels is not indicated1

A single booster dose 5 years after successful completion of primary course is recommended1

Patients with renal failure:

Antibody levels should be monitored annually and if they fall below 10mIU/ml, a booster dose of vaccine should be given to patients who have previously responded to the vaccine. Booster doses should also 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, particularly if they are to receive haemodialysis and have not received a booster in the last 12 months. For the full list of possible adverse reactions/side effects, refer to the manufacturer’s Summary of Product Characteristics.

Route/Method Shake vaccine well immediately before withdrawal and

administration

Intramuscular injection, in deltoid area, or in the anterolateral aspect of thigh in neonates, infants and young children4.

Not to be given in buttock because of reduced efficacy1,4

Vaccination by deep subcutaneous route should be reserved only for individuals with a bleeding disorder1.

N.B Vaccine can be given at the same time as other vaccines, but at a different injection site – preferably in different limbs. If given in the same limb, the sites should be at least 2.5cm apart. The site at which each vaccine was given should be noted in the patient’s records1.

Follow manufacturer’s guidance on handling of vaccine before administration - see package insert.

Frequency As appropriate to vaccine preparation


Adverse reaction / side effects

For a comprehensive list refer to the manufacturer’s Summary of Product Characteristics

Patient should be asked to wait on the premises for a short period (ten minutes) so as to observe the patient after vaccination.

Frequencies per dose are defined as follows:

Very common: >1/10

Common: >1/100 to <1/10

Uncommon: >1/1000 to <1/100

Rare; >1/10,000 to <1/1000

Very rare: <1/10,000

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Blood and lymphatic system disorders

Rare: lymphadenopathy

Nervous system disorders

Common: drowsiness, headache in adults

Uncommon dizziness,

Rare: paraesthesia

Gastrointestinal disorders

Common: gastrointestinal symptoms (such as nausea, vomiting, diarrhoea, abdominal pain)

Skin and subcutaneous tissue disorders

Rare: urticaria, pruritus, rash

Musculoskeletal and connective tissue disorders

Uncommon: myalgia

Rare: athralgia

Metabolism and nutrition disorders

Common: appetite lost

General disorders and administration site conditions

Very common: pain and redness at injection site, fatigue

Common: fever (> 37.5°C), malaise, swelling at injection site, injection


site reaction (such as induration)

Uncommon: influenza-like illness

Psychiatric disorders

Very common: irritability

In a comparative trial in subjects from 11 years up to and including 15 years of age, the incidence of local and general solicited symptoms reported after a two-dose regimen of Engerix B® 20 µg was similar overall to that reported after the standard three-dose regimen of Engerix B® 10 µg.

Post-marketing surveillance

Blood and lymphatic system disorders

Thrombocytopenia

Nervous system disorders

Encephalitis, encephalopathy, convulsions, paralysis, neuritis, (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis) neuropathy, hypoaesthesia

Respiratory thoracic and mediastinal disorders

Apnoea in very premature infants ( 28 weeks of gestation) (see section 4.4)

Skin and subcutaneous tissue disorders

Erythema multiforme, angioneurotic oedema, lichen planus

Musculoskeletal and connective tissue disorders

Arthritis, muscular weakness

Infections and infestations

Meningitis

Vascular disorders

Vasculitis, hypotension

Immune system disorders

Anaphylaxis, allergic reactions including anaphylactic reactions and mimicking serum sickness

Report all suspected serious reactions for established drugs and all

suspected reactions for black triangle drugs, to the MHRA, using the BNF or go to www.yellowcard.gov.uk

http://www.yellowcard.gov.uk/


Advice to patient/ carer Inform patient/carer of possible adverse reactions, side effects and their management

Manufacturer’s Patient Information Leaflet (PIL) to be given to parent/guardian if requested, or if there is no leaflet for the vaccine, discuss as required. On occasion, the PIL and advice from the Department of Health may differ. In this case, advice from the latter should be followed. This discrepancy needs to be explained

Advise about how to prevent hepatitis B infection Follow up Advise about follow-up including when next vaccine is due and give

information about any future appointments necessary

Individuals with immunosuppression and HIV infection (regardless of CD4 count) may not make a full antibody response. Re-immunisation should be considered after treatment is finished and recovery has occurred –consult doctor. Specialist advice will be required1

. (Not applicable to live vaccines, which may be contra-indicated-see Green Book)

The Green Book recommends that individuals at continuing risk of infection should be offered a single booster dose of vaccine, once only, around five years after primary immunisation.

Handling and storage

Refer to local Cold Chain Guidelines

Store between 2 – 8°C; do not freeze; shake well before use; protect from light. The fridge temperature must be monitored on a daily basis on working days using a trust approved fridge temperature monitoring form.

Transporting vaccines – insulated cool boxes should be used when performing administration away from clinics / Health Centers. Frozen packs are not to be in direct contact with the vaccines to avoid the product freezing.

The vaccine should be allowed to reach room temperature before administration.

Disposal of vaccines – In accordance with Waste Management Policy4

Records / audit trail Patient’s name, address, date of birth and consent given

Dose and form administered, batch details, expiry and brand or manufacturer, and site of injection

Consent Forms if used

Record that vaccine given under and in compliance with current PGD

Record on Carenotes as appropriate

Nurses should document any advice given by a doctor.

Date of administration

Name of staff who administered the medication, plus signature for paper-based records (signature not needed for computer based records with password protection).

Details of any adverse drug reaction and actions taken including documentation in the patient’s medical record, and reporting to the doctor and/or the Medicines Healthcare Regulatory Authority if appropriate. See www.yellowcard.gov.uk or BNF.

Referral arrangements (including self-care)

GP letter informing the surgery of the medication given at specialist


service

All client pathways in relation to BBV screening/testing/treatment to be recorded on CIM or Carenotes (some client details) and the BBV spreadsheet, which will be managed by the BBV coordinator or NMP

Immunisation errors - complete Trust incident report and inform GP.

Staff Characteristics Professional qualifications

Registered nurse or Health Visitor on the NMC register – employed by Camden & Islington Foundation Trust.

Specialist competencies or qualifications

Has undertaken appropriate training for working under PGDs for the supply and administration of medicines.

Knowledge of and training in local and national immunisation programmes and guidelines

Competency and knowledge in: o Immunisation pharmacology o Administration of immunisations o The relevant diseases o Advising parents on immunisation issues o Assessing individuals fitness for immunisation o Contraindications, specific considerations and possible side

effects o Handling and storage of vaccines. o Awareness and understanding of role of immunisation in

prevention of communicable disease o Requirements for records of vaccines given o Recognition and management of anaphylaxis

Continuing education and training

The practitioner should be aware of any change to the Summary of Product Characteristics for the medicine and report these to Service Lead, for updating the PGD.

It is the responsibility of the individual, to keep up-to-date with continued professional development, in line with Nursing and Midwifery Council (NMC).

Attended Trust approved immunisation study day(s) as outlined in the relevant Training Needs Analysis (TNA) in the Mandatory and Statutory Training Policy.

Attended training in CPR and recognition and management of anaphylaxis as outlined in the relevant TNA.

Updates awareness of current immunisation issues.


References / Resources

1. Salisbury D, Ramsey M and Noakes K. eds. DH Immunisation against Infectious Disease. London: The Stationery Office (The Green book); 2006. Also available from, http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079917

2. Summary of Product Characteristics (SPC)

(If more than one SPC) SPC References for Vaccine and related vaccines

All available from: http://www.medicines.org.uk/emc/ a. Brand name®, name of company, Document last updated on

eMC (Date of approval/ revision for each brand that may be used under the PGD)

b. Brand name®, name of company, Document last updated on eMC (Date of approval/ revision for each brand that may be used under the PGD)

3. Section 14, British National Formulary. Edition current at time of approval of PGD. London, British Medical Association/ Royal Pharmaceutical Society of Great Britain

4. C&I Waste Management Policy (Trust Intranet) 5. NMC Standards for Medicines Management (2007)

http://www.nmcuk.org/Documents/Standards/ nmcStandardsForMedicinesManagementBooklet.pdf

6. Resuscitation Council (UK). Emergency medical treatment of anaphylactic reactions. London: Resuscitation Council, 2008.

7. DH. Review of prescribing, supply & administration of medicines.

London: DH, 1999 8. NHSE, HSC 2000/026. Patient Group Directions. London: DoH,

2000. 9. Department of Health (2004) CMO letter 10/8/04 PL/CMO/2004/3 10. NMC The Professional standards of practice and behaviour for

nurses and midwives, 2015: https://www.nmc.org.uk/globalassets/sitedocuments/nmc-publications/nmc-code.pdf

11. C&I (2018) Infection Control Manual: https://www.candi.nhs.uk/sites/default/files/Infection%20Prevention%20and%20Control_Policy%20and%20Procedures_CL05_Jan%202018.pdf

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079917

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079917

http://www.medicines.org.uk/emc/

http://www.nmcuk.org/Documents/Standards/

https://www.nmc.org.uk/globalassets/sitedocuments/nmc-publications/nmc-code.pdf

https://www.nmc.org.uk/globalassets/sitedocuments/nmc-publications/nmc-code.pdf

https://www.candi.nhs.uk/sites/default/files/Infection%20Prevention%20and%20Control_Policy%20and%20Procedures_CL05_Jan%202018.pdf




AUTHORISATION RECORD

This patient group direction must be agreed to and signed by all health care professionals

involved in its use.

The service manager should hold the original signed copy of the authorization record. The

PGD must be easily accessible in the clinical setting. A copy should be available on the Trust

Intranet.

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.

Authorised staff should be provided with an individual copy of the clinical content of the PGD

and a photocopy of the document showing their authorisation.

I have read and understood the Patient Group Direction and agree to supply/administer this

medicine only in accordance with this PGD.

Name of Professional Signature

Authorising Professional Manager or Senior Practitioner*

Date

*Senior Practitioner is a senior person in each profession designated with the responsibility to ensure

that only competent, qualified and trained professionals operate within PGDs.

Note: PGDs are legal documents and may be required to be viewed as evidence. Obsolete signed copies of PGDs must be archived, according to the Practice Policy. For example PGDs relating to medication given to children must be kept for 25 years after expiry of the PGD, and PGDs relating to medication given to adults for 8 years after expiry.