Draft legislation on serious shortage protocols (SSPs) - which will give pharmacists the right to modify medications that are in short supply ‘without going back to the prescriber’ - has been laid before parliament and is set to take force on 9 February.
Currently, if a pharmacy cannot dispense what is on a prescription, patients are sent back to their GP for a new one. But after a DHSC consultation, pharmacists could be given powers to dispense an alternative 'quantity, strength [or] pharmaceutical form' as well as a 'therapeutic equivalent or a generic equivalent' of medicines in serious short supply.
However, the BMA has warned patient safety could be at risk if pharmacists are able to provide 'therapeutic equivalents' - drugs that have the same effect but may be chemically different to the original prescribed medication - without consulting the original prescriber.
GPC clinical and prescribing lead Dr Andrew Green said that, although the legislation will 'minimise disruption to patients, GPs and pharmacists in the event of a serious shortage', the BMA '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 the consultation, the BMA said: 'Patients have idiosyncratic responses to drugs within the same class, and the pharmacist will not know what has already been used. 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.'
The legislation makes clear that these powers will only be granted for medicines against which ministers have issued an SSP - triggering pharmacists’ authority to ‘dispense against a protocol instead of a prescription’. All protocols will be ‘developed with input from clinicians’ and will ‘clearly set out what action can be taken by the retail pharmacy, under what circumstances, for which patients and during which period’.
It adds that the power to issue protocols ‘is a reserve power that the department anticipates would only be used in exceptional circumstances’.
Dr Green said: '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.'
No deal Brexit
Powers for pharmacists to switch prescriptions were initially expected to be triggered only in the event of a no-deal Brexit. However, the DHSC consultation on the legislation reads: ‘The proposal for the serious shortage provisions was prompted by the preparations for a "no deal exit" from the EU. The provisions have however not been linked to a "no deal" EU exit and have not been time limited (although any protocol itself would be time limited).
'Regardless of whether a shortage of a medicine is caused by a ‘no deal’ EU exit or something else, a serious shortage protocol can be a useful tool for managing any shortage and mitigating any impact on patients.’
The BMA has said there are 'obvious concerns that a no-deal Brexit could exacerbate existing issues' with medicines shortages. Experts say shortages have become more acute in the run-up to Brexit, but the DHSC has insisted there is no clear link between the two.
A DHSC spokesperson said: 'We are working with industry on contingency planning, stockpiling and prioritising medicines at the border to ensure that patients continue to get their medication and the supply chain is uninterrupted in a no deal scenario.'