WQ89738 (e) Tabled on 22/11/2023

What discussions has Welsh Government had with the UK Government to encourage an amendment to regulation 214 of the Human Medicines Regulations 2012 to allow pharmacists to make minor amendments that don’t require a therapeutic substitution so that a prescription can be dispensed without the requirement to contact the prescriber?

Answered by Minister for Health and Social Services | Answered on 28/11/2023

I set out the extensive measures taken by the Welsh and UK Governments to support pharmacists, prescribers and patients to manage shortages in my written statement on this matter, published on 18 October. The statement can be accessed at: https://www.gov.wales/written-statement-disruptions-supply-medicines

Regulation 214(1) of the Human Medicines Regulations provides that a pharmacist may not sell or supply a prescription-only medicine except in accordance with a prescription given by an appropriate practitioner.

The phrase “in accordance with a prescription” is taken to mean pharmacists must supply the exact product and quantity prescribed by the appropriate practitioner.  There are however exemptions to this requirement, for example when a medicine is ordered by its generic name the pharmacist may supply any product containing that medicine at the requested strength and in the request formulation.

For clinical reasons there will always be occasions where it is important that patients are maintained on a specific medicine.  Therefore, whilst a degree of flexibility may in some situations be preferable this must be balanced with the fact that for some medicines, seemingly small changes to the presentation of a medicine may have serious clinical implications, and the need to respect the clinical autonomy of prescribers.

The Welsh Government has previously consulted alongside the other governments in the UK, on permitting community pharmacists to make certain changes to prescriptions.  In light of concerns raised, a decision was taken not to proceed with those changes. 

However, recent amendments to the regulations permit pharmacists to supply a quantity which differs to that ordered by the prescriber where it allows a manufacturer’s original pack to be supplied and amendments made to the regulations in 2019, allow pharmacists to supply a medicine which differs in strength or pharmaceutical form, or in some cases a different but therapeutically equivalent medicine, in accordance with a serious shortage protocol. 

Powers to make regulations pertaining to the prescribing and supply of medicines are reserved by the UK Government, I can confirm however Welsh Government officials worked closely with UK Government officials during the consultation and drafting of these regulations.