Patient Group Directions and prescribing for travel medicines policy (travel clinics)

1. What the regulation says

Care and treatment must be provided in a safe way for service users. (Reg 12(1))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b))

ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c))

where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs, (Reg 12(2)(f))

the proper and safe management of medicines, (Reg 12(2)(g))

Regulation 12 lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning.

The full text of the regulation is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. The Patient Group Directions framework itself sits in the Human Medicines Regulations 2012 at https://www.legislation.gov.uk/uksi/2012/1916/contents. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations. For a travel clinic this means that vaccines and medicines such as antimalarials are supplied or administered only by the right person, under a lawful route (a current Patient Group Direction or a valid prescription), to the right traveller, and properly recorded.

3. Purpose

A travel clinic gives vaccines and supplies medicines such as antimalarials, often through a nurse or pharmacist rather than a doctor. The law sets out exactly how that can be done: many vaccines and medicines are given under a Patient Group Direction (PGD), while prescription-only medicines otherwise need a prescriber. This policy sets out how the Service gives and supplies travel medicines lawfully and safely, so the right person gives the right medicine in the right way.

The Service must verify this policy against the current NICE guidance on Patient Group Directions and the Human Medicines Regulations 2012 before adoption.

4. Scope

This policy applies to:

• the supply and administration of vaccines and medicines for travel, including antimalarials
• the Patient Group Directions the Service uses and the practitioners authorised to use them
• prescribing where a PGD does not cover the situation

5. Patient Group Directions

A travel medicine is supplied or administered only under a lawful authority. The options are:

• an individual prescription from an appropriate prescriber
• a Patient Specific Direction (a written instruction from a prescriber for a named patient)
• a current Patient Group Direction (PGD) that covers the medicine, the patient group and the practitioner
• a national protocol or other lawful vaccination framework, where one applies

Where the Service uses PGDs:

• each PGD is current, covers the specific medicine and situation, and is authorised and signed as the law requires, including by a doctor and a pharmacist and on behalf of the organisation
• a PGD is used only by the named, competent practitioners listed for it, and only within the exact terms of that PGD
• a PGD is reviewed and renewed before its expiry, and an out-of-date PGD is not used
• the Service keeps the signed PGDs and the list of authorised practitioners

A practitioner who is asked to act outside a PGD does not stretch the PGD to fit; the situation is referred to a prescriber instead.

6. Prescribing where a PGD does not apply

• a prescription-only travel medicine that is not covered by a PGD is supplied only against a prescription from an appropriate prescriber
• where the Service supplies private prescriptions, it does so lawfully and records them
• the prescriber takes responsibility for the decision, having assessed the traveller

7. Antimalarials and counselling

Because antimalarials only work if taken correctly, when one is supplied the Service:

• confirms the choice is right for the destination, the traveller and any interactions or contraindications
• explains clearly when to start, how to take it, how long to continue after returning, and the importance of not stopping early
• explains that no antimalarial is fully protective and that bite avoidance still matters
• gives written information the traveller can keep

8. Unlicensed or off-label use

Where a medicine is used outside its licence (for example a particular antimalarial use), this is recognised, justified against current guidance, explained to the traveller, and recorded. A PGD is not used for an unlicensed medicine unless the conditions that allow it are met.

9. Competency

A practitioner supplies or administers under a PGD, or prescribes, only when trained and assessed as competent for it, and that competence is kept current and refreshed on a stated cadence. The Service records who is authorised for which PGD and the next refresher date.

10. Recording

For every supply or administration the Service records: the medicine, dose and form, the batch number where given, the traveller, the practitioner, and the PGD or prescription it was given under. The record shows the supply was lawful.

Operational controls to adapt

Roles and responsibilities

• Registered Manager: owns lawful medicines governance, makes sure PGDs, prescriptions and practitioner authorisations are controlled, and reviews incidents and audit findings.
• Medicines or PGD lead: keeps the PGD register, renewal schedule, authorisation list, version control and withdrawal process current.
• Authorised practitioner: supplies or administers only within a current PGD they are named and competent to use, and stops when an exclusion or caution applies.
• Prescriber: assesses and prescribes where a PGD does not apply, or where individual clinical judgement is needed outside the PGD terms.
• Governance lead: reviews PGD use, out-of-scope attempts, prescribing exceptions, stock issues and improvement actions.

PGD and prescribing procedure

1. Keep a live PGD register. Record each PGD, medicine, indication, version, authorising body, start date, review date, expiry date and withdrawal date.
2. Authorise practitioners by name. A practitioner cannot use a PGD until competence, professional registration and signed authorisation are recorded.
3. Check the legal route before supply. For each vaccine or medicine, confirm whether the route is a PGD, prescription, Patient Specific Direction, national protocol or another lawful route.
4. Assess the traveller against the PGD. Check inclusion criteria, exclusions, cautions, interactions, pregnancy or breastfeeding, allergies, age limits and destination risk before supply.
5. Stop when outside scope. Do not stretch a PGD. Refer to a prescriber, seek advice or decline supply if the traveller falls outside the current terms.
6. Counsel and record. Explain dose, timing, common side effects, urgent warning signs, bite avoidance where relevant, missed-dose advice and when to seek help.
7. Control renewal and withdrawal. Expired, superseded or withdrawn PGDs are removed from use and practitioners are told what has changed.
8. Escalate unsafe medicines events. Wrong medicine, wrong route, expired PGD, unauthorised practitioner, stock concern or missed counselling is opened on the incident register.

Records and register links

The PGD and prescribing record should include:

• PGD title, version, expiry, authorisation status and practitioner sign-off
• traveller eligibility, exclusions, cautions, interactions, allergy and pregnancy or breastfeeding checks where relevant
• medicine, vaccine, dose, route, form, quantity, batch, expiry and date supplied or administered
• legal authority used, including PGD, prescription, Patient Specific Direction, national protocol or other lawful route
• counselling given, written information supplied and advice declined
• prescriber referral, advice sought or reason supply was declined
• incident, risk, medicines, training, complaint or improvement-action reference where the control failed

PGD expiry risk, repeated documentation gaps, out-of-scope requests and practitioner competence gaps are tracked on the risk or improvement-actions register.

11. Audit cadence

The Service checks, on a stated cadence, that:

• PGDs are current, correctly authorised, and used only by listed, competent practitioners within their terms
• prescription-only medicines outside a PGD are supplied only against a valid prescription
• antimalarial counselling and written information are given
• supplies are recorded with the medicine, batch, practitioner and the PGD or prescription used

The Registered Manager and the clinical lead review the results and record the improvement actions that follow.

12. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• CQC Regulation 12: Safe care and treatment
• NICE MPG2, Patient Group Directions: https://www.nice.org.uk/guidance/mpg2
• The Human Medicines Regulations 2012: https://www.legislation.gov.uk/uksi/2012/1916/contents
• Specialist Pharmacy Service, PGD resources: https://www.sps.nhs.uk/
• Immunisation against infectious disease (the Green Book), the legal arrangements for vaccine supply and administration: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
• MHRA alerts; Controlled Drugs Regulations where applicable
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (safe care and treatment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/12

Related reading

• Related policy: Medicines management policy
• Related policy: Pre-travel risk assessment and consultation policy
• Related policy: Vaccine storage and cold chain policy
• Related policy: Training, competency and mandatory training policy
• Related policy: Record keeping and documentation standards policy

13. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

14. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the tenant's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.