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

The Department of Health and Social Care (DH) told C+D in March that it would only announce a protocol in an “exceptional and rare situation”, when other measures taken “behind the scenes” have been “exhausted or are likely to be ineffective”.

But Conservative MP Ann Marie Morris – chair of the all-party parliamentary group on the access to medicines and medical devices – told C+D that “clarification from the government is needed on what level of shortage [is considered] serious enough to trigger a protocol”.

“The government also needs to confirm who will be consulted on in the decision to trigger the protocol and that sufficient clinical input has been sought when publishing guidance to pharmacists to substitute medicines,” Ms Morris said.

Speaking to C+D after the parliamentary group met to discuss the protocol on Tuesday (April 30), Ms Morris said it will be asking the government to “address the concerns raised with the group by stakeholders impacted by the protocol”.

Clinically chaired group

Ahead of the order coming into force in February, pharmacy minister at the time Steve Brine told parliament that the government would only announce a protocol “if clinicians think it is appropriate” and “when other mitigation measures have been exhausted”.

It was 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, Mr Brine said at the time.

Read a GP's view on the shortages protocol for pharmacists