2025-09-21 13:15:44
Prescription flexibilities proposed to meet medicines shortages
The Department of Health and Social Care (DHSC) has launched a consultation on proposals to provide community pharmacists with flexibility in making certain supplies in order to cope with medicine shortages.
Current law
Currently, regulation 214 of the Human Medicines Regulations 2012 (HMR) requires a Prescription Only Medicine (POM) to be supplied in accordance with a prescription.
Proposals
The DHSC proposes to amend the HMR so as to treat a supply of an alternative medicinal product as being in accordance with a prescription if there is an “urgent need” to supply an alternative to what has been prescribed and it would be impracticable to obtain the prescribed product without undue delay. In deciding whether to supply an alternative, pharmacists would be required to exercise their skill and professional judgement.
Alternative medicine
The consultation proposes that the alternative medicine would be a different strength or formulation (which may mean a different quantity) of the same medicine originally prescribed for a POM.
Urgent need
An “urgent need” would include urgent clinical need, for example, where a patient requires an acute medicine, such as an antibiotic or painkiller straight away or where a delay would cause serious inconvenience to the patient, for example where the patient has not run out of a regular medicine but would find it difficult to return to the pharmacy before they run out.
Excluded from proposals
The ability to supply an alternative medicinal product would not apply where the prescribed medicine is covered by:
- a serious shortage protocol (SSP)
- a medicine supply notification (MSN)
- an alert of a shortage through the central alerting system (CAS)
Generic substitution would not be permitted by the proposals.
Controlled drugs are not covered by the proposals, except for those in Schedule 5 to the Misuse of Drugs Regulations 2001.
The proposals are limited to community pharmacies. Hopsital pharmacies and other dispensing settings are excluded.
Record keeping and labelling
The DHSC proposes that pharmacists should have to make a record of an alternative supply in the same way that they currently have to record emergency supplies.
An alternative medicine would also have to be labelled correctly.
Unanswered questions
The consultation leaves open a number of questions, including:
- whether the supply of an alternative medicine should be notified to the prescriber;
- whether the ability to supply an alternative medicine should be limited to Prescription Only Medicines, or whether it should also extend to:
- pharmacy medicines
- general sales list medicines
- medicines with no licensing (such as food supplements and appliances)
- whether pharmacy technicians should be able to supply an alternative product to the one prescribed;
- what each devolved government decides to do in relation to some aspects, in which case amendments would be made to the applicable NHS terms of service.
Procedure and timing
The consultation paper indicates that any change to the law would come into force at the same time that the HMR are amended to allow pharmacy technicians to supervise the supply of medicines. When the DHSC has made a final decision after considering consultation responses, draft Regulations will have to be approved after debate in both Houses of Parliament and the Northern Ireland Assembly. The NHS terms of service in each country would also have to be amended.
The consultation paper can be found here https://www.gov.uk/government/consultations/enabling-pharmacist-flexibilities-when-dispensing-medicines/enabling-pharmacist-flexibilities-when-dispensing-medicines#how-to-respond and responses can be made by 11 December 2025.