The Human Medicines (Amendment) Regulations 2019 order – which was laid before parliament last Friday (January 18) – includes provisions to allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol”, rather than the prescription, without contacting the GP, in the event of a national medicines shortage.

The amendments would also allow pharmacists to dispense less medicine or a different strength or form to that prescribed.

The Department of Health and Social Care (DH) stressed this would be the more likely solution to medicines shortages, rather than instructing pharmacies to substitute a generic or therapeutic alternative, “which would only be used in very exceptional circumstances”.

In its explanatory note published alongside the order, the DH said the new powers “do not relate to withdrawal from the European Union”. However, if Brexit does affect medicines supplies, a “serious shortage protocol” could be implemented.

The amendments are scheduled to come into force on February 9, but pharmacies will have to wait for ministers to publish a protocol “when they consider that a medicine is or may become in serious shortage” before they can make use of the regulatory change, the DH explained.

Concerns over protocol time lag

Speaking in her personal capacity as a locum pharmacist, Royal Pharmaceutical Society English board member Thorrun Govind told C+D that while the regulation amendments would give community pharmacists the “professional autonomy” they have so far been lacking, she is concerned of a possible time lag from when a shortage is recognised to when a protocol is implemented.

“From our professional training and clinical skills, pharmacists are very capable of managing incidences where there are serious shortages, so overall, I am positive about the [new powers],” she said.

“However, I don't think it goes far enough, because it is the minister who is going to say, ‘You can make that decision’ and we will have to act against a strict protocol. How long is it going to take for the messages to get to the minister that there is a shortage of [a] medicine?”

David Reissner, a consultant at law firm Charles Russell Speechlys, said: “Ministers aren’t keen on admitting there is a problem and they aren’t the first to know, because they aren’t the ones having to spend time on the phone to suppliers to source medicines.”

Risk to pharmacists remains

In their responses to the DH’s informal consultation on the amendments, pharmacy bodies warned that pharmacists could be at risk of prosecution when acting in accordance with the DH’s protocols, as they would be breaching section 64 of the Medicines Act 1968, which prevents the sale of “any medicinal product which is not of the nature or quality demanded by the purchaser”.

Mr Reissner said that while the DH is “aware of the points raised” through the consultation, “they don’t appear to agree that an offence would be committed” (see Mr Reissner's explanation of the legislative changes).

“It is a pity that, even though the [DH’s explanation of the amendments] isn’t legally binding, they didn’t take the opportunity to say something in it about the risk of prosecution,” he told C+D.

The Pharmaceutical Services Negotiating Committee (PSNC) said the practical issues in implementing these new powers are “considerable”, including the costs involved and “implications for community pharmacy contractors’ terms of service”.

“Work to address the practical issues with any [shortages protocol] introduction must now begin,” PSNC stressed.

Contingency planning

In a letter to “NHS pharmacy leaders, system-wide” last week (January 17), England’s chief pharmaceutical officer Keith Ridge said the “serious shortage protocols” form part of the government’s contingency planning in case of a no-deal Brexit.

He also used the letter to reiterate that “it is not helpful or appropriate for anyone to stockpile medicines locally”.

“Any incidence involving the over-ordering of medicines will be investigated,” Dr Ridge said.