1. 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.
2. Sources to verify before adoption
- 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
- 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
3. 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
4. Patient Group Directions
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- a PGD is reviewed and renewed before its expiry, and an out-of-date PGD is not used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.
5. 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
6. 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
7. 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.
8. 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.
9. 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.
10. 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.