Patient Group Direction (PGD) for the administration of Rabies vaccine (inactivated)

1. Clinical condition or situation to which the direction applies

Indication

• Pre-exposure immunisation against rabies for individuals at increased risk of exposure.

Objectives of care

• Reduce the morbidity and mortality from rabies for individuals at increased risk of

exposure.

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.

• Patients from 6 months of age.

• Those living in or travelling to rabies-enzootic areas.

Exclusion criteria

(Refer to current and relevant SPC (Great Britain or Northern Ireland) and online British National Formulary (BNF) 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 Rabipur® or the rabies vaccine. See section 2 and 6.1 of the relevant Summary of Product Characteristics (SPC).

• Individuals under 6 months of age.

• Confirmed anaphylactic reaction to a previous dose of rabies vaccine or a vaccine containing the same components as the rabies vaccine.

• Confirmed allergy to egg or egg products (Rabipur® only).

• Severe allergy to the components neomycin, chlortetracycline, amphotericin B or betapropriolactone.

• Severe allergy to polygeline.

• Hypersensitivity to latex.

• Patients with severe febrile illness.

• When there is an evolving neurological problem, including but not limited to, poorly controlled epilepsy, immunisation should be deferred until the neurological condition

has resolved or stabilised.

Cautions

(including any relevant action to be taken)

Pregnancy and Breastfeeding

• Vaccines can be administered during pregnancy or breast-feeding where there is a high risk of infection, and the benefits of vaccination outweigh the risks (1) (2). It is recommended that the appropriate healthcare professional (e.g. GP, midwife) is

consulted prior to injection.

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

Cautions

(including any relevant action to be taken)

Bleeding disorders

• Rabies 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 (1). 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 (3).

• A fine needle (equal to 23 gauge or finer calibre such as 25 gauge) should be used for the vaccination, followed by firm pressure applied to the site (without rubbing) for at least 2 minutes (6). If in any doubt, the clinician responsible for prescribing or monitoring the patient’s anticoagulant therapy should be consulted prior to injection.

  Co-administration

• The rabies vaccines may be administered at the same time as other vaccines; however, they should be given at separate sites, preferably in separate limbs. If this is not possible, they should be given at least 2.5cm apart (4).

  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(2). 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 (4).

• 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

• Specialist advice should be sought for patients being treated with high doses of corticosteroids (dose equivalents of prednisolone: adults, at least 40 mg daily for more than 1 week or at least 20 mg daily for more than 14 days; children, 2 mg/kg (or more than 40 mg) daily for more than 1 week or 1 mg/ kg (or more than 20 mg) daily for more than 14 days) (5).

  Other considerations

• Healthcare professionals must not delegate their responsibility and they have the right to refuse vaccination to eligible patients based on their own clinical judgement. Where there is doubt, vaccination should not be initiated until the patient has sought advice

from the appropriate healthcare professional.

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 SPC. This includes checking that the patient’s medication does not suggest conditions that are excluded from vaccination under this PGD.

• Hydroxychloroquine is predicted to decrease efficacy rabies vaccine (5).

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.

• Offer patient advice, based on current national guidance, on how to minimise their risk of becoming infected with rabies together with general travel health advice.

• Make the patient aware of steps they need to take if they suspect they have been

exposed to rabies.

Action if patient declines treatment

• 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.

• Advise patients to avoid contact with wild or domestic animals during travel. (7)

• All travellers should be advised to perform first aid treatment by washing the wound with soap and running water for several minutes. They should then apply a disinfectant to the wound such an iodine solution or 40-70 percent alcohol and seek medical advice as soon as possible (7).

2. Description of vaccine

Name, strength & formulation of drug

Supplier

Name of

product

Composition

Pharmaceutical form

Excipients

Age

indications

Valneva UK Limited

Rabipur®

Rabies virus (Inactivated, strain Flury LEP)

Powder and solvent for solution for injection in pre-filled syringe

Powder:

̵ Trometamol

̵ Sodium chloride

̵ Disodium edetate

̵ Potassium-L-glutamate

̵ Polygeline

̵ Sucrose

Solvent:

̵ Water for injection

6 months and over

Sanofi Pasteur

Rabies Vaccine BP

Rabies virus (inactivated, strain PM/WI 38 1503-3M)

Powder and solvent for suspension for injection

̵ Human albumin solution

̵ Water for Injection

6 months and over

• For a full list of excipients, see section 2 and 6.1 of the relevant SPC.

Legal status

• POM – Prescription Only Medicine

Dose/dose range

• 1.0 ml (1) (2)

Use of PGD outside terms of SPC

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

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

• The accelerated schedule administered on days 0, 3 and 7, is only licenced for Rabipur® in adults aged 18-65 years. However, patients between 6 months -17 years and over 65 years of age may receive the vaccine in accordance with Green Book guidance. Furthermore, the accelerated schedule is not licenced for Rabies Vaccine BP (Sanofi Pasteur), though it may be offered in accordance with Green Book recommendations. 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 inspected for any foreign particulate matter and /or for any variation of physical aspect prior to administration. If either is observed the vaccine should not be administered (1) (2).

• For IM administration only. The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe (1) (2).

• The preferred site of injection is the deltoid muscle of the upper arm (1) (2).

• In children 12 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 (8).

• 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 (8).

• 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 (see cautions) (3).

• Prepare and reconstitute as per manufacturers’ instructions.

2. Description of vaccine – continued

Frequency of administration

Conventional schedule

• In previously unvaccinated individuals, an initial course of pre-exposure prophylaxis consists of three doses (each of 1.0 ml) administered on days 0, 7, and 28. The third dose can be given from day 21 if there is insufficient time before travel (1) (2).

  Accelerated schedule for adults aged 18-65 using Rabipur®*

• Alternatively, an accelerated schedule can be used in adults (18-65) where there is insufficient time before travel to complete the conventional schedule. This consists of three doses (each of 1.0 ml) administered on days 0, 3 and 7, with an additional dose at one year if they will continue to travel to high risk (enzootic) areas (4).

• The accelerated schedule should only be used when there is insufficient time before travel to complete the 21-28 day course (2).

• *The accelerated schedule may be offered with Rabies Vaccine BP (Sanofi Pasteur) and outside the age ranges of 18-65 years in accordance with Green Book guidance. For

further information, see ‘Use of PGD outside terms of SPC’.

Follow up / minimum or maximum period

Reinforcing immunisation

• Booster doses are not recommended for most travellers following completion of the primary course (i.e. conventional schedule or the accelerated schedule plus an additional dose of vaccine at one year). However, a booster dose may be administered in those who have completed a primary course over one year ago and are travelling again to a high risk area, following a risk assessment (4).

• The need for boosters should be considered based on official recommendations. For

available official recommendations regarding the need for boosters or further doses, see the Green Book- Chapter 27.

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): Headache, dizziness, rash, injection site reactions, malaise, myalgia, fatigue, asthenia and fever (2).

• Common side effects include (≥1/100 to <1/10): Lymphadenopathy, decreased appetite, nausea, vomiting, Diarrhoea, abdominal pain/ discomfort, urticaria, myalgia and arthralgia (2).

• Rare side effects include (≥1/10,000 to <1/1,000): Hypersensitivity, paraesthesia, sweating and chills (2).

• Very rare side effects include (<1/10,000): Anaphylaxis including anaphylactic shock, encephalitis, Guillain-Barré syndrome, presyncope, syncope, vertigo and angioedema (2).

• 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 SPCs (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.

• 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/

3. 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 (1) (2).

  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.

• Give the following advice to patients:

  ̵ Do not to approach animals

  ̵ Do not to attempt to pick up an unusually tame animal or one that appears to be unwell

  ̵ Do not attempt to attract stray animals by offering food

  ̵ Being careless with litter may attract animals

  ̵ Certain activities may attract dogs, such as running, cycling or camping

• All travellers should be advised to perform first aid treatment by washing the wound with soap and running water for several minutes. They should then apply a disinfectant to the wound such an iodine solution or 40-70 percent alcohol and seek medical advice as soon as possible (7).

  Vaccine record

• Provide patient with a record of vaccination.

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

3. Further aspects of vaccination – continued

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).

  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 SPCs.

References

1. Summary of Product Charcteristics; Rabies Vaccine BP. emc (Great Britain). [Online] 28 June 2020. [Cited: 01 April 2022.] https://www.medicines.org.uk/emc/product/1527/smpc.

2. Summary of Product Characteristics; Raibur pre-filled syringe. emc (Great Britain). [Online] 06 April 2021. [Cited: 01 April 2022.] https://www.medicines.org.uk/emc/product/2502/smpc.

3. Chapter 14a; COVID-19-SARS-CoV-2. The Green Book. [Online] 28 February 2022. [Cited: 31 March 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1057798/Greenbook-chapter-14a- 28Feb22.pdf.

4. Public Health England. The Green Book; Chapter 27: Rabies. [Online] June 2018. [Cited: 01 April 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/723607/GreenBook_chapter_27_rabi es.pdf.

5. Rabies Vaccine. BNF; The National Institute for Health and Care Excellence. [Online] [Cited: 01 April 2022.] https://bnf.nice.org.uk/drug/rabies-vaccine.html.

6. Public Health Engalnd. Vaccination against shingles: Information for healthcare professionals. [Online] February 2022. [Cited: 01 April 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1052155/Shingles-vaccination- HCP-guidance.pdf.

7. Rabies. NHS. [Online] 09 January 2020. [Cited: 07 April 2022.] https://www.nhs.uk/conditions/rabies/.

8. Chapter 4; Immunisation procedures. The Green Book. [Online] June 2021. [Cited: 24 March 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147915/Green-Book-Chapter-4.pdf.

Additional resources

1. Rabies. Travel Health Pro. [Online] February 18, 2022. [Cited: April 07, 2022.] https://travelhealthpro.org.uk/factsheet/20/rabies.

2. Patient Group Direction; Medicines practice guideline [MPG2]. National Institute for Health and Care Excellence. [Online] March 27, 2017. [Cited: February 11, 2022.] 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: February 11, 2022.] https://www.nice.org.uk/guidance/mpg2/resources.