Dear Contractor,
The ‘Enabling Pharmacist Flexibilities When Dispensing Medicines’ consultation was published by the Department of Health and Social Care on 18th September 2025. The consultation seeks views on introducing new flexibilities that would allow pharmacists working in community pharmacy to supply a different strength or formulation (which may mean a different quantity) of the same medicine originally prescribed. The key aims of this proposal are to improve patient access to medicines, reduce pressure on the healthcare system, and support more person-centred care.
Under the proposals, a community pharmacist could supply a different strength or formulation of the same medicine originally prescribed when the pharmacy does not have the prescribed item in stock and the pharmacist has assessed that there is an ‘urgent need’ for an alternative. This applies in situations where it would be impracticable to obtain the original product without undue delay, provided the alternative allows the patient to receive the same medicine at the same dose, dosing schedule, and overall treatment duration. An ‘urgent need’ includes urgent clinical need, for example, where a patient requires an acute medicine such as an antibiotic straight away, or where a delay would cause serious inconvenience. However, the flexibilities will not apply (except in limited circumstances) if there is a known serious shortage of either the prescribed medicine or the proposed alternative.
The flexibilities also do not apply where the medicine prescribed, or the alternative, is subject to a serious shortage protocol (SSP), medicine supply notification (MSN), or central alerting system (CAS) notice, unless that notice explicitly permits the flexibility. The consultation does not allow substitution to a different medicine, does not cover unlicensed medicines, and does not include Controlled Drugs in Schedules 2–4.
Implementing these changes would require amendments to the Human Medicines Regulations 2012 (HMRs) through secondary legislation. As the proposals are intended to be UK-wide, devolved administrations, including Northern Ireland, would need to introduce equivalent arrangements.
When assessing these proposals, several important factors need to be considered. Patient safety remains paramount: any substitution of strength or formulation must still deliver the correct dose, an equivalent dosing schedule, and the same treatment duration. Clear patient communication will be essential to minimise confusion, particularly where different strengths or formulations may appear unfamiliar. There are also implications for the wider medicines supply chain. Although the intention is to reduce workload linked to shortages, frequent switching between strengths or formulations could impact manufacturer forecasting and stock allocation, potentially creating additional pressures if not carefully managed. The consultation also highlights potential conflicts of interest. As pharmacists would have increased autonomy in selecting suitable alternatives, safeguards will be required to ensure decisions are based solely on clinical need, not commercial considerations. Operational and workflow impacts must also be recognised. Implementing these flexibilities would require updates to pharmacy SOPs, staff training, and possibly IT system changes. Additional record-keeping, expected to mirror emergency supply requirements, may also increase workload.
These considerations come at a time when community pharmacies are facing significant and ongoing medicines supply challenges. Pharmacies frequently encounter situations where the prescribed strength or formulation is unavailable, leading to delays in patient care and increased administrative burden associated with contacting prescribers. The proposed changes could help alleviate some of these pressures by reducing the need for unnecessary referrals back to GPs.
For Northern Ireland contractors, it is particularly important to engage with this consultation. As UK-wide legislative changes will require local implementation, the voice of NI community pharmacists, who often face distinct supply and operational pressures, is crucial in shaping how these flexibilities might work in practice.
CPNI is seeking responses to the ‘Questions for Pharmacy Workers’ within the consultation to inform our response. Please click here to access the MS Form and complete these questions before 6pm on 27/11/25.
Kind regards,
GERARD GREENE
Chief Executive