Sample policy · Travel clinics

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

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). The primary law governing the supply and administration of travel medicines is the Human Medicines Regulations 2012 (Patient Group Directions), read with NICE guidance on PGDs. · primary source

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:

5. Patient Group Directions

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

Where the Service uses PGDs:

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

7. Antimalarials and counselling

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

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

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 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:

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.

Related reading

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

Version Date Author Changes
v1.1 2026-07-14 Verivius (sample) Added role ownership, PGD procedure, legal-authority records, register links and related reading.
v1 2026-06-10 Verivius (sample) Conformed existing draft to the Verivius policy standard. Added statutory anchor, verbatim Regulation 12 text, plain-English summary and standard source/advice/control blocks; all original sections and source URLs preserved.

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.

What good looks like here

Written from an ex-CQC inspector's chair, but the point is safe, well-led care your team can stand behind. Each row shows what strong evidence looks like, what thin evidence looks like, and where the expectation comes from.

A travel clinic supplies prescription-only medicines, often with no prescriber in the room, to someone who will then take them unsupervised for weeks in a country where falciparum malaria can become life-threatening within days of the first symptom. Two things therefore carry unusual weight: whether the practitioner held lawful authority for that specific supply to that specific traveller, and whether the traveller left understanding when to start, how long to continue after returning, and that no antimalarial is fully protective so bite avoidance still matters. Antimalarial failure rarely shows up back in the clinic. It surfaces in an emergency department once the traveller is home, or while they are still abroad and out of reach. The batch and legal-authority entries are also the only practical way to find the right travellers quickly when a vaccine recall or a medicines alert lands and some of them have already flown. Kept properly, the record stops being paperwork about a consultation and becomes the means of finding and helping someone who is no longer in the room.

  1. Each Patient Group Direction (PGD) in use is current and signed as the law requires (including by a doctor and a pharmacist and on behalf of the organisation), and it is used only by the named, competent practitioners listed on it, so the traveller is seen by someone that direction actually covers, not by any nurse or pharmacist on shift.

    Strong evidence: Section 5 and the PGD register fields title, version, expiry, authorisation status and practitioner sign-off; audit cadence line that PGDs are current, correctly authorised and used only by listed, competent practitioners within their terms.

    Weak evidence: A direction in the folder carrying only one of the two required professional signatures, signed by a doctor but not a pharmacist, or authorised by the clinical lead alone with nothing showing authorisation on behalf of the organisation. A national or supplier template downloaded and put straight into use unchanged. The authorisation list naming roles such as 'all clinic nurses' rather than individual practitioners, with no dated competence sign-off tying a named person to a named direction.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Human Medicines Regulations 2012 (SI 2012/1916), reg 214(1) and Schedule 16 (PGD exemption and mandatory particulars: period of effect, signature by a doctor and a pharmacist, signature on behalf of the authorising body, class of person designated in writing to supply)

  2. Expired, superseded or withdrawn Patient Group Directions are removed from use and practitioners are told what has changed, so nobody supplies under a lapsed direction. The register carries review, expiry and withdrawal dates.

    Strong evidence: Section 5 (an out-of-date PGD is not used) and procedure steps 1 and 7, with the live register recording each PGD's version, authorising body, start date, review date, expiry date and withdrawal date.

    Weak evidence: A register whose review and expiry dates have already passed, with the withdrawal column empty on every row, so nothing shows what became of the versions that were replaced. A superseded version still sitting in the treatment-room folder alongside the current one, and the only proof practitioners were told what changed is a group message with no record of who read it or when.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  3. Where a traveller falls outside the Patient Group Direction terms, the practitioner refers to a prescriber rather than stretching the direction to fit. The record names the lawful authority each supply was made under.

    Strong evidence: Section 5 (does not stretch the PGD, the situation is referred to a prescriber) and procedure step 5, with the record field legal authority used, including PGD, prescription, Patient Specific Direction, national protocol or other lawful route.

    Weak evidence: A record set with no declined supply and no prescriber referral anywhere in it, which would be surprising in a clinic that sees pregnant travellers, unusual destinations and travellers on complex regular medicines. Where a referral is noted it reads 'discussed with prescriber' with no name, date or outcome, and the legal-authority field simply says 'Patient Group Direction' without naming which direction was used.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Human Medicines Regulations 2012 (SI 2012/1916), reg 214(1) read with Schedule 16

  4. The traveller is assessed against the Patient Group Direction's inclusion criteria, exclusions, cautions, interactions, pregnancy or breastfeeding, allergies and age limits before supply, so the medicine is given because it is right for them, not simply because it was asked for.

    Strong evidence: Procedure step 4 and the record fields traveller eligibility, exclusions, cautions, interactions, allergy and pregnancy or breastfeeding checks where relevant.

    Weak evidence: Consultation records where the eligibility fields are pre-populated or read identically across every traveller, for example the same 'no allergies, no contraindications' wording all the way down a clinic list. Pregnancy or breastfeeding left blank for travellers of childbearing age, current medicines and interactions unrecorded, and a record that shows what was supplied but never shows what was asked.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Human Medicines Regulations 2012 (SI 2012/1916), reg 214(1) read with Schedule 16 (PGD must state clinical criteria for eligibility, exclusions and warnings)

  5. Every supply or administration is recorded with the medicine, dose, form, batch, traveller, practitioner and the exact Patient Group Direction or prescription it was given under, so the record itself shows the supply was lawful and the next clinician can see exactly what this traveller was given.

    Strong evidence: Section 10 and the record fields medicine, vaccine, dose, route, form, quantity, batch, expiry and date supplied plus the legal authority used; audit cadence line that supplies are recorded with the medicine, batch, practitioner and the PGD or prescription used.

    Weak evidence: A legal-authority field completed as 'Patient Group Direction' with no title or version, so nobody could reconstruct months later which direction the supply was actually made under. Vaccine entries giving the name and date but leaving the batch number blank or recorded as 'on box', and a paper day-sheet that is never reconciled against the clinical record, so a supply missing from one of them is invisible.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  6. When an antimalarial is supplied the traveller is counselled on when to start, how long to continue after returning, not stopping early and that bite avoidance still matters, and is given written information to keep, not simply handed the medicine.

    Strong evidence: Section 7 and procedure step 6, with the record fields counselling given and written information supplied; audit cadence line that antimalarial counselling and written information are given.

    Weak evidence: A tick marked 'advice given' with nothing behind it, so the record cannot show whether the start date, how long to continue after returning and missed-dose advice were covered at all. The same counselling sentence copied into every traveller's record whichever antimalarial and regimen was supplied, with no note that written information was handed over or that bite avoidance was discussed.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

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Last verified 20 July 2026

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Last reviewed 10 June 2026