The Human Medicines (Amendment) Regulations 2019 order – which comes into force on Saturday (February 9) – includes provisions to allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol” announced by the government – rather than the prescription and without contacting the GP – in the event of a national medicines shortage.

But Dr Andrew Green, the British Medical Association's (BMA) GP committee clinical and prescribing lead, said it does “not believe that it is appropriate for pharmacists to change patients from one drug to a different one without authorisation from an independent prescriber”.

In its response to a government consultation on the powers, the BMA explained that it does not agree with dispensing a therapeutic equivalent as a “blanket approach” to dealing with shortages.

“Patients have idiosyncratic responses to drugs within the same class, and the pharmacist will not know what has already been used,” it added. “This would, effectively, be a new prescription.”

“However, in a crisis situation we would accept a pharmacist amending the prescription – only after discussion with the prescriber, including information about medicines availability.

“This should result in no delay to the patient in receiving the equivalent medicine,” it added.

Brexit could exacerbate shortages

Dr Green added: “GPs and their teams have to contend with medicine shortages on a daily basis, much to the frustration of staff and their patients, and there are obvious concerns that a no-deal Brexit could exacerbate existing issues.”

The association understands the new legislation “is intended to minimise disruption to patients, GPs and pharmacists in the event of a serious shortage, building on how GPs and pharmacists are already working together locally to deal with current issues”, he said.

However, this does not make it appropriate for pharmacists to change a patient’s prescription without authorisation, he stressed.

Develop rules with clinicians

It is “imperative that the specific details of the new rules and their practical application are developed by clinicians, and clearly communicated to doctors, patients and pharmacies”, Dr Green added.

Pharmacy minister Steve Brine told parliament last week that the government would only announce a protocol for a medicine in short supply “if clinicians think it is appropriate” and “when other mitigation measures have been exhausted”.

It is in the process of creating a “national, clinically chaired group” with “national oversight at senior doctor level” to advise ministers on when pharmacists should supply an alternative, he added.