Patient Group Direction (PGD) for the administration of hepatitis B vaccines (Engerix B®, HBVAXPRO® and PreHevbri®)

1. Clinical condition or situation to which the direction applies

Indication

• Active immunisation against hepatitis B virus infection (HBV) for those considered at risk of

exposure to HBV.

Objectives of care

• Pre-exposure immunisation for those who are at an increased risk of HBV infection because of travel, their lifestyle and occupation.

Inclusion criteria

• Valid consent has been obtained from the patient/carer who does not want to consult with their GP and would prefer to access vaccination from the PGD user.

• Individuals from 6 months of age. (N.B. product specific age exclusions must be followed –

  see Description of vaccine).

  Travel purposes

• Individuals travelling to areas of moderate or high endemicity, including:

  • Those who are going to reside in virus endemic countries for long periods

  • Those who may require medical care while travelling to high or moderate- endemicity countries

  • People with chronic medical conditions who may require hospitalisation while overseas

  • Those travelling for medical or dental care

    Occupational health purposes

• Individuals at occupational risk of hepatitis B, including:

  • Healthcare workers, trainees and students in the UK and overseas who may come

    into contact with patients’ blood, blood-stained body fluids or tissues

  • Individuals at risk of injury from blood contaminated sharp instruments, or of being deliberately injured or bitten by patients

  • Laboratory staff who handle material that may contain hepatitis B virus

  • Staff of residential and other accommodation for those with learning difficulties

  • Prison service staff who are in regular contact with prisoners

  • Police, fire and rescue services (dependant on the potential risk and frequency of exposure)

• The decision to vaccinate individuals for occupational health purposes must be decided locally by the PGD user. Furthermore, information regarding the individual's risk of hepatitis B exposure should be obtained from the appropriate occupation health department prior to vaccination if deemed necessary.

• Vaccination should also be considered based on local risk assessment for staff in day-care settings and special schools for those with severe learning disabilities, particularly where the client’s behaviour may lead to significant exposure risk on a regular basis (e.g. biting).

  Other individuals at high risk of disease exposure or complications

• Those at risk due to sexual behaviour, e.g. men who have sex with men, those who change sexual partners frequently and commercial sex workers. Where appropriate, the PGD user should use the opportunity to provide advice on other preventative measures or arrange referral to appropriate specialist services.

• Individuals receiving regular blood or blood products.

• Foster carers, particularly for those who are receiving or have received emergency placements.

• Families adopting children from countries with a high or intermediate prevalence of hepatitis

B.

1. Clinical condition or situation to which the direction applies – continued

Exclusion criteria (Refer to current and relevant SmPC (Great

Britain or Northern Ireland) and online Green Book guidance for additional details)

• Patients for whom no valid consent has been received.

• Hypersensitivity to the active substance(s), or to any of the excipients, or trace residuals in PreHevbri®, HBVAXPRO® or Engerix B® [see section 6.1 and 2 of the relevant Summary of Product Characteristics (SmPC)].

• Hypersensitivity to formaldehyde and/or potassium thiocyanate (HBVAXPRO® only).

• Confirmed anaphylactic reaction to a previous dose of the vaccine.

• Confirmed anaphylactic reaction to a previous dose of a vaccine containing hepatitis B.

• Confirmed immunity due to natural infection or previous vaccination.

• Confirmed non-responder to hepatitis B vaccine.

• Individuals under 6 months of age. (N.B. product specific age exclusions must be followed –

  see Description of vaccine).

• A history of severe (i.e. anaphylactic) allergy to latex (HBVAXPRO® only).

• Patients who require post-exposure immunisation against hepatitis B.

• Patients with renal insufficiency.

• Severe febrile illness or acute infection – postpone administration until completely recovered.

• Patients with an evolving neurological condition or unstable neurological disorder.

Cautions

(including any relevant action to be taken)

Occupational health vaccination

• Public Health England (PHE) currently advises that post vaccination hepatitis B surface antibody (anti-HB) levels should only be checked in those at risk of occupational exposure (1). If the facilities are not available to check antibody levels, refer the patient to their GP or appropriate alternative provider.

  Bleeding disorders

• Hepatitis B vaccines should be given with caution to patients with thrombocytopenia or any coagulation disorder (including those taking anticoagulants) since bleeding may occur following intramuscular (IM) administration to these patients (2) (3) (4) (5) (6) (7). It is recommended that the appropriate healthcare professional (e.g., GP) is consulted prior to injection, to determine if IM injection is suitable and if vaccination should be scheduled shortly after the patient receives their medication/treatment to reduce bleeding. If the vaccine is offered, the patient/carer should be informed about the risk of bleeding from the injection.

• Patients on stable anticoagulation therapy, including patients on warfarin who are up-to-date with their scheduled International Normalised Ratio (INR) testing and whose latest INR was below the upper threshold of their therapeutic range, can receive IM vaccination. If in any

  doubt, the clinician responsible for prescribing or monitoring the patient’s anticoagulant

  therapy should be consulted prior to injection (8).

• Vaccines may alternatively be administered by the subcutaneous (SC) route to individuals with bleeding disorders (N.B. There is a lack of evidence that SC injection is any safer than IM injection in individuals taking anticoagulants, and injection by this route is more likely to cause local reactions) (2) (3) (4) (5) (6) (9). Healthcare professionals who are not professionally competent to perform SC injections should refer the individual(s) to a suitable alternative provider.

• Please note that PreHevbri®▼ is not licensed for subcutaneous administration but may be provided by this route in line with Green Book guidance (10). See ‘Use of PGD outside terms of SmPC’ for further information.

1. Clinical condition or situation to which the direction applies – continued

Cautions

(including any relevant action to be taken)

Vaccine interchangeability

• It is good practice to continue a course of hepatitis B vaccination with the same vaccine. However, should this not be possible, monovalent (single antigen) vaccine products may be used interchangeably (2) (3) (4) (5) (6).

  Latex allergy

• Engerix B® vaccines in pre-filled syringes exist in two different models, with and without a pre- attached needle. Engerix B® pre-filled syringes without a pre-attached needle do not contain components made with natural rubber latex (NRL). Pre-filled syringes with a pre-attached needle are equipped with a skirted rubber needle shield and cannot be considered as latex (NRL) free (11).

  Immunosuppressed patients

• Patients that are immunosuppressed due to disease or treatment, including asplenia or dysfunction of the spleen, or HIV infection (regardless of CD4 count), may not produce a sufficient protective antibody response following vaccination (12).

• Specialist advice may be required - see the Green Book chapters 6 & 7:

  • https://www.gov.uk/government/publications/contraindications-and-special- considerations-the-green-book-chapter-6

  • https://www.gov.uk/government/publications/immunisation-of-individuals-with- underlying-medical-conditions-the-green-book-chapter-7

    Interrupted courses (10)

• It is not necessary to repeat doses if the hepatitis B course has been interrupted.

• Longer than recommended intervals between doses do not appear to reduce the final antibody level or efficacy, however vaccine doses for each schedule should be given at the correct interval.

  Pregnancy and breast-feeding

• The vaccine should be used during pregnancy or breast-feeding only if the potential benefit justifies the potential risk to the foetus or infant. Refer to relevant SmPC for further information. It is recommended that the appropriate healthcare professional (e.g. GP, midwife) is consulted prior to injection (2) (3) (4) (5) (6) (7).

  Predisposition to neurological problems

• When there is a personal or family history of febrile convulsions, there is an increased risk of these occurring during fever from any cause including immunisation. Antipyretic medication should be initiated according to local guidelines.

  Syncope

• Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints (13).

  Other considerations

• For patients with other health conditions, the risks and benefits of vaccination must be weighed on an individual basis.

• Healthcare professionals must not delegate their responsibility and have the right to refuse vaccination to eligible patients based on their own clinical judgement. Where there is doubt, defer vaccination until advice is sought by patient from their appropriate healthcare

professional i.e. Consultant.

1. Clinical condition or situation to which the direction applies – continued

Product interactions

• Prior to administration and where indicated, medication that the patient is using should be checked for product interactions using the British National Formulary (BNF) and SmPC. This

  includes checking that the patient’s medication does not suggest conditions that are excluded

  from vaccination under this PGD.

• Engerix B® and HBVAXPRO® ONLY: Different injectable vaccines should always be administered at different injection sites (2) (3) (4) (5) (6).

• PreHevbri®: The concomitant use of PreHevbri® with other vaccines is not recommended (7).

Action if patient is excluded from the service

• The risk to the patient of not being vaccinated must be considered.

• If administration is postponed, arrange a future date for vaccination as appropriate.

• Discuss with patient and document the reasons for exclusion from vaccination under the PGD.

• If the patient has consented, refer them to their GP and/or inform their GP.

• Signpost to other services if appropriate.

• Patients in risk categories not covered by this PGD (see ‘Exclusion criteria’) or those who require additional or increased doses to improve the hepatitis B surface antibody response should be signposted to other services or their GP where they may be able to receive more specialist advice/vaccination.

• Patients who require post exposure vaccination should be signposted to other more appropriate NHS services.

• Refer patient back to employer’s occupational health service if appropriate.

• Advise travellers to avoid contact with blood and bodily fluids to reduce their risk of hepatitis B, and on active measures they can take to reduce their risk of exposure to the virus.

Action if patient declines the service

• Ensure patient/carer fully understands the risks of declining vaccination.

• Advise the patient/carer about the protective effects of the vaccine.

• Explain NHS eligibility for vaccination where appropriate.

• Reschedule vaccination if appropriate.

• Document the reasons for declining vaccination and any action taken, including advice given to the patient in their medication record.

• If appropriate, provide leaflet/information sheets such as those produced by TravelHealthPro or Fitfortravel.

• Advise travellers to avoid contact with blood and bodily fluids to reduce their risk of hepatitis B, and on active measures they can take to reduce their risk of exposure to the virus.

• Inform or refer patients back to their GP if appropriate.

• Refer patient back to employer’s occupational health service if appropriate.

2. Description of vaccine

Name, strength & formulation of drug

Supplier

Name of

product

Composition

Pharmaceutical form

Excipients

Age

indications

GlaxoSmithKline UK

Engerix B®

10 mcg/0.5ml Hepatitis B (rDNA) vaccine (adsorbed) (HBV)

Suspension for injection in pre-filled syringe

• Sodium chloride

• Disodium phosphate dihydrate

• Sodium dihydrogen phosphate

• Water for injections

6 months to

15 years

Engerix B®

20 mcg/1 ml Hepatitis B (rDNA) vaccine (adsorbed) (HBV)

Suspension for injection in pre-filled syringe

• Sodium chloride

• Disodium phosphate dihydrate

• Sodium dihydrogen phosphate

• Water for injections

*From 16 years

Merck Sharp & Dohme (UK) Ltd

HBVAXPRO®

5mcg/0.5ml Hepatitis B vaccine (recombinant DNA)

Suspension for injection

• Sodium chloride

• Borax

• Water for injections

6 months – 15 years

HBVAXPRO®

10mcg/1ml Hepatitis B vaccine (recombinant DNA)

Suspension for injection

• Sodium chloride

• Borax

• Water for injections

From 16 years

Valneva UK Limited

PreHevbri® ▼

10mcg/1ml Hepatitis B vaccine (recombinant, adsorbed)

Suspension for injection

• Sodium chloride

• Potassium chloride

• Disodium phosphate dodecahydrate

• Potassium dihydrogen phosphate

• Sodium hydroxide (for pH adjustment)

• Hydrochloric acid (for pH adjustment)

• Water for injections

From 18 years

• *The adult Engerix vaccine (20 micrograms) may be used in subjects from 11 years up to and including 15 years of age as a 2-dose schedule in situations when there is a low risk of hepatitis B infection during the vaccination course, and when compliance with the complete vaccination course can be assured (2).

• For a full list of excipients, refer to section 2 and 6.1 of the relevant SmPC.

Legal status

• POM – Prescription Only Medicine.

Dose/dose range

• Engerix B®: 20 micrograms/1ml suspension for injection (2)

• Engerix B®: 10 micrograms/0.5ml suspension for injection (2)

• HBVAXPRO®: 10 micrograms/1ml suspension for injection (3) (5)

• HBVAXPRO®: 5 micrograms/0.5ml suspension for injection (4) (6)

• PreHevbri®: 10 micrograms/1ml suspension for injection (7)

2. Description of vaccine – continued

Use of PGD outside terms of SmPC

• This PGD covers vaccination in England, Scotland, Wales and Northern Ireland. Please note that Northern Ireland may have a separate SmPC from Great Britain and guidance may differ. Please refer to the relevant SmPC for more information.

• Although healthcare professionals have the right to refuse vaccination even where a patient is eligible, they cannot override PGD exclusions.

• Engerix B® very rapid schedule is licensed for those from 18 years of age but may be used off-label in those from 16 to 18 years in accordance with Green Book guidelines. For further information, see ‘Frequency of administration’ (10).

• PreHevbri▼ is not licensed for subcutaneous administration but may be provided by this route off-label in line with Green Book guidance.

• Where a vaccine is recommended off-label, as part of the consent process, inform the

individual/carer that the vaccine is being offered in accordance with national guidance but that this is outside the product licence.

Route/method of administration

• The vaccine should be visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. If either is observed the vaccine should not be administered (2) (3) (4) (5) (6) (7).

• For IM injection. The vaccine must not be injected intravenously or intradermally and must not be mixed with other vaccines in the same syringe (2) (3) (4) (5) (6) (7).

• In children 6 months through to 35 months, the preferred sites for IM injection are the anterolateral aspect of the thigh (if suitably trained), or the deltoid muscle if muscle mass is adequate (14).

• For patients with bleeding disorders, a fine needle (equal to 23 gauge or finer calibre) should be used for the vaccination, followed by firm pressure applied to the site (without rubbing) for at least 2 minutes (8). Exceptionally, these vaccines may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders (see ‘Cautions’ and ‘Use of PGD outside terms of SmPC’) (2) (3) (4) (5) (6).

• Where two or more injections need to be administered at the same time, they should be

given at separate sites, preferably in different limbs. If more than one injection is to be given in the same limb, they should be administered at least 2.5cm apart (14).

2. Description of vaccine – continued

Frequency of administration

Primary immunisation schedule Engerix B® and HBVAXPRO®

• Accelerated schedule – 0, 1 and 2 months: Three injections with an interval of one month. Used for pre-exposure prophylaxis in most adult and childhood risk groups. A fourth (booster) dose should be administered 12 months after the first dose (2) (3) (4) (5) (6).

  Engerix B®, HBVAXPRO® and PreHevbri®

• Conventional schedule – 0, 1 and 6 months: Two injections with an interval of one month; a third injection 6 month after the first administration. This schedule should be used where rapid protection is not required and there is a high likelihood of compliance (2) (3) (4) (5) (6) (7). Engerix B® only

• 2-dose schedule using adult Engerix B® 20mcg/1ml in children aged 11-15 years – 0 and 6 months: For children aged 11-15 years of age, a two-dose schedule of adult strength Engerix B® 20mcg/1ml at zero and six months provides similar protection to three doses of the childhood hepatitis B vaccines. This schedule is to be used where there is a low risk of hepatitis B infection during the course and completion of the course can be assured (2).

• Engerix B® 20mcg/1ml very rapid schedule (from 18 years of age) * – 0, 7 and 21 days: In exceptional circumstances in adults, 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 or for individuals who are at immediate risk, a schedule of three IM injections given at 0, 7 and 21 days may be used (Engerix B® 20mcg/1ml only). When this schedule is applied, a fourth dose is recommended 12 months after the first dose (2).

• *Engerix B® 20mcg/1ml very rapid schedule is licensed for those from 18 years of age but may be used off-label in those from 16 to 18 years of age where it is important to provide

rapid protection and to maximise compliance in accordance with Green Book chapter 18.

Follow up / minimum or maximum period

• Following completion of the primary schedule (primary doses and recommended booster doses), reinforcing doses are not routinely required. Healthcare workers (including students and trainees) should be offered a single booster dose of vaccine, once only, around five years after primary immunisation (10).

• In some instances (e.g. occupational health purposes), anti-HBs titre checks are required following completion of a primary course of vaccine. If the facilities are not available to check the antibody response, the patient should be referred to the appropriate service for testing. Green Book guidance should be followed on the need for additional doses based on the anti-HBs titres (10).

• For occupational exposure, a single booster dose may be administered five years after the

primary course of vaccination unless the patient is no longer considered to be at continued risk of hepatitis B infection (10).

3. Further aspects of vaccination

Adverse reactions and their management

• Follow local SOP on adverse reactions and their management.

• Very common side effects include (≥1/10): Irritability; headache (paediatric use); pain and redness at injection site and fatigue (2).

• Common side effects include (≥1/100 to <1/10): Appetite lost; drowsiness; headache (adult use); gastrointestinal symptoms (such as nausea, vomiting; diarrhoea; abdominal pain); fever (≥37.5°C); malaise; swelling at injection site and injection site reaction (such as induration) (2).

• Uncommon side effects include (≥1/1,000 to <1/100): Dizziness; myalgia and influenza- like illness (2).

• Rare side effects include (≥1/10,000 to <1/1,000): Lymphadenopathy; paraesthesia; urticaria; pruritus; rash and arthralgia (2).

• The above side-effects are for Engerix B®, frequency of side-effects for HBVAXPRO® and PreHevbri® may differ – please refer to the relevant product SmPC.

• Serious suspected neurological reactions such as Guillain-Barré syndrome (2) and demyelinating disease (3) (4) (5) (6) have been reported, although these have been very rare and a causal relationship with hepatitis B vaccine has not been established.

• Emergency equipment must be available including immediate access to epinephrine (adrenaline) 1:1000 for IM injection. Please refer to resuscitation council guidelines.

• Healthcare professionals should confirm with patients that they are fit to leave the premises after a period of observation. Patients should not leave if they are feeling at all unwell without speaking to the healthcare professional.

• The onset of anaphylaxis is rapid, typically within minutes, and its clinical course is unpredictable with variable severity and clinical features. Due to the unpredictable nature of anaphylactic reactions, it is not possible to define a particular time period over which all patients should be observed following immunisation to ensure they do not develop anaphylaxis.

• In the event that the patient exhibits signs of anaphylaxis after injection, healthcare professionals must seek urgent medical attention.

• Advise the patient to consult their GP if there is a severe local reaction at the injection site, if they have a fever or if any other serious symptoms develop.

• For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current BNF, current and relevant SmPCs (Great Britain or Northern Ireland) and the

Green Book - Immunisation against infectious disease.

Reporting procedure of adverse reactions

• Report to GP if appropriate & document in patient’s medication records.

• Follow local SOP for reporting of adverse events.

• PreHevbri® is a black triangle product and is subject to additional monitoring (7).

• All suspected adverse reactions must be reported via the Yellow Card scheme to the MHRA or on the website at https://yellowcard.mhra.gov.uk/

• An adverse reaction should be reported even if it is not certain that the medicine has caused it, if it is well recognised, or if other drugs were given at the same time.

• Further information is available online from https://yellowcard.mhra.gov.uk/

4. Further aspects of vaccination – continued

Advice to patient / carer

Vaccine protection

• Explain protection level expected from vaccine. Advise patients that not all those who receive the vaccine will be fully protected, and the vaccine only protects against infections for which it has been developed.

• In those at risk of occupational exposure, particularly healthcare and laboratory workers, advise on the need to check anti-HBs titres one to two months after the completion of a primary course of vaccine (10).

  Patient information

• Provide a patient information leaflet and discuss as required.

• Provide advice on and explain potential warnings.

• Advise on possible side effects and their management. If the symptoms do not resolve and/or the patient experiences other severe symptoms, they should be advised to contact their GP, NHS 111 or visit A&E.

• Advise the patient on behaviours that place them at risk, such as sexual activity, injecting drug use, undertaking relief aid work and/or participating in contact sports.

• Advise travellers of the risk of acquiring infection as a result of medical or dental procedures carried out in countries where therapeutic injections may be contaminated. Advise travellers that they will also be at risk if they are required to undergo emergency medical treatment (e.g. road traffic accidents).

• It is important that immunisation against hepatitis B does not encourage relaxation of other measures designed to prevent exposure to the virus.

  Vaccine record

• Provide patient with a record of vaccination.

3. Further aspects of vaccination – continued

Records to be kept

• In all cases manual records including any risk assessment forms or computerised records should include:

  ̵ Patient’s name, address and date of birth;

  ̵ Name of immuniser;

  ̵ Dose, site and route of injection;

  ̵ Date of administration;

  ̵ Brand name, batch number & expiry date of vaccine;

  ̵ Confirmation that there are no contraindications; that side effects have been discussed; support literature given (if applicable) and any other advice given;

  ̵ That valid informed consent was given prior to administration;

  ̵ Details of any adverse reactions and actions taken;

  ̵ Signature and printed name and designation (in black ink) for paper records. For computer records, ensure data authentication of practitioner delivering care.

• GP may be notified, if the patient has consented for personalised information to be shared.

• Pharmacy/clinic records should be stored in line with relevant legislation and local policies.

Generally, records should be kept for 8 years in adults and until 25 years of age in children.

Additional facilities / requirements

• Policies and procedures must be in place for providing a private vaccination service including cold chain management, sharps disposal, needlestick injury, consent, record keeping and training requirements.

• Pharmaceutical refrigerator (or validated cool box for storing vaccines if running an “offsite”

  clinic).

• Resuscitation kit, including immediate access to 1:1000 epinephrine (adrenaline).

• Access to medical support (this may be via telephone).

• Disposal - equipment used for vaccination, including used vials or ampoules, should be disposed of at the end of a session by sealing in a proper, appropriately sized puncture-

resistant ‘sharps’ box (UN-approved, BS 320).

3. Further aspects of vaccination – continued

Additional facilities / requirements

PGD users must:

• Be familiar with and have online access to the latest edition of the Green Book, noting that clinical guidance may change and that the Green Book is frequently updated.

• Be aware of current clinical recommendations and be able to undertake administration (where applicable) and discuss any issues that may arise.

• Have been trained and assessed as being competent in the delivery of this medicine covered by this PGD.

• Maintain their skills, knowledge and professional level of competence in this area according to their individual code of professional conduct.

• Possess appropriate professional indemnity.

• Agree to work within the terms of the implementing PGD.

• Be aware of medicine handling, storage and administration guidelines.

• Regularly check BNF/BNFC / Green Book for contraindications, cautions and interactions. The superintendent/clinical lead of the implementing pharmacy/clinic will be responsible for:

• Providing adequate up-to-date clinical resources.

• Ensuring that staff using the PGD, have access to up-to-date resources.

• Ensuring that staff have received adequate training in all areas relevant to this PGD.

  Requirements for Continuing Professional Development (CPD)

• All staff involved in the implementation of this PGD should participate in adequate and appropriate Continual Professional Development to ensure procedures follow the most up to date clinical guidance.

  Facilities and supplies to be available

• Consultations carried out under the authorisation of this PGD should be completed in a private space, physically closed off from interruption such as a pharmacy consultation room, in order to ensure patient confidentiality.

• The following should be available:

  1. Safe storage areas for medicines and equipment

  2. Clean and tidy clinical rooms that allow confidentiality and patient privacy

  3. Copies of the current PGD

  4. Access to a current BNF and Green Book

     Audit

• All health risk assessment, advice and medicine supply record forms should be stored in the pharmacy/clinic and will be audited by the implementing pharmacy/clinic in order to analyse service delivery. If the service is deemed insufficient, management staff, the superintendent/clinical lead and implementing healthcare professional will be informed

and an action plan drawn up to remedy the service.

3. Further aspects of vaccination – continued

Consent

• Prior to the administration and/or supply of a medicine, consent must be obtained, preferably written, from the patient, and documented either in the patient’s medical records/notes or on an administration form.

  The key points include:

• If a patient’s fitness and suitability cannot be established, supply should be deferred.

• There is no legal requirement for consent to be in writing but written consent serves to record the decision and the discussions that have taken place.

• Consent - either written or verbal - is required at the time of each supply.

• Consent remains valid unless the patient who gave it withdraws it. If there is new information between the time consent was given and when the supply is offered, including new evidence of risk, new medicines becoming available or where there is a significant change in the patient’s condition, it may be necessary for the patient to reconfirm their consent.

• Written and verbal information should be available in a form that can be easily understood by the person who will be giving the consent. Where English is not easily understood, translations and properly recognised interpreters should be used in order that they can make informed consent.

• The attendance of a patient for the supply/administration of treatment after an invitation to attend for this purpose may be viewed as acceptance that the patient may have the treatment/administration.

• Patients should also be informed about how data on the supply will be stored, who will be able to access that information and how that data may be used.

• Where consent is either refused or withdrawn, this decision must be documented.

• Consent obtained before the occasion upon which a patient attends for the

supply/administration is only an agreement for the patient to be included in this instance and does not mean that consent is in place for each future supply/administration.

4. References & Resources

For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current BNF and SmPCs.

References

1. Chapter 12; Immunisation of healthcare and laboratory staff. The Green Book. [Online] 20 March 2013. [Cited: 12 June 2023.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147882/Green-Book-Chapter- 12.pdf.

2. Summary of Product Characteristics; Engerix B 20 micrograms/1 ml Suspension for injection in pre-filled syringe. emc (Great Britain).

   [Online] 02 May 2023. [Cited: 12 June 2023.] https://www.medicines.org.uk/emc/product/1637.

3. Summary of Product Characteristics; HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe. emc (Great Britain).

   [Online] 03 January 2023. [Cited: 12 June 2023.] https://www.medicines.org.uk/emc/product/1684.

4. Summary of Product Characteristics; HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe. emc (Great Britain).

   [Online] 03 January 2023. [Cited: 12 June 2023.] https://www.medicines.org.uk/emc/product/1686.

5. Summary of Product Characteristics; HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe. emc (Northern Ireland). [Online] 02 June 2022. [Cited: 12 June 2023.] https://www.emcmedicines.com/en-gb/northernireland/medicine?id=dd564ca4-6a1a- 4f29-b3be-ad327182cf58&type=smpc.

6. Summary of Product Characteristics; HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe. emc (Northern Ireland). [Online] 02 June 2022. [Cited: 12 June 2023.] https://www.emcmedicines.com/en-gb/northernireland/medicine?id=aa6ce645-f398- 4d83-a34b-b2b63fe236a7&type=smpc.

7. Summary of Product Characteristics; PreHevbri suspension for injection. emc (Great Britain). [Online] 24 March 2023. [Cited: 12 June 2023.] https://www.medicines.org.uk/emc/product/14668.

8. Chapter 14a; COVID-19 - SARS-CoV-2. The Green Book. [Online] 26 April 2023. [Cited: 12 June 2023.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1057798/Greenbook-chapter-14a- 28Feb22.pdf.

9. Chapter 19; Influenza. The Green Book. [Online] 16 September 2022. [Cited: 12 June 2023.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/931139/Green_book_chapter_19_ influenza_V7_OCT_2020.pdf.

10. Chapter 18: Hepatitis B. The Green Book. [Online] 04 February 2022. [Cited: 12 June 2023.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1052889/Greenbook-chapter-18- 4Feb22.pdf.

11. Data on file. [Online] GSK.

12. Chapter 7; Immunisation of individuals with underlying medical conditions. The Green Book. [Online] January 2020. [Cited: 12 June 2023.]

    https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/857279/Greenbook_chapter_7_I mmunsing_immunosupressed.pdf.

13. Chapter 8: Vaccine safety and the management of adverse events following immunisation. The Green Book. [Online] August 2012. [Cited: 12 June 2023.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147868/Green-Book-Chapter-8- v4_0.pdf.

14. Chapter 4; Immunisation procedures. The Green Book. [Online] June 2012. [Cited: 12 June 2023.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147915/Green-Book-Chapter- 4.pdf.

Additional resources

1. Hepatitis B. Travel Health Pro. [Online] [Cited: June 12, 2023.] https://travelhealthpro.org.uk/factsheet/50/hepatitis-b.

2. Patient Group Direction; Medicines practice guideline [MPG2]. National Institute for Health and Care Excellence. [Online] March 27, 2017. [Cited: June 12, 2023.] https://www.nice.org.uk/Guidance/MPG2.

3. Competency framework for health professionals using Patient Group Directions. National Institute for Health and Care Excellence.

[Online] January 4, 2018. [Cited: June 12, 2023.] https://www.nice.org.uk/guidance/mpg2/resources.