Greater clarification is needed around plans to make urgent legislation changes giving pharmacists powers to dispense under a serious shortage protocol in circumstances such as shortages caused by a no deal Brexit, pharmacy bodies have said in their responses to a Government consultation.

It was announced in December that the Government was planning to make urgent changes to the Human Medicines Regulation such as introducing a serious shortage protocol (SSP) whereby pharmacists would be required to dispense alternative quantities or medicines to those stated on a patient’s prescription.

This “reserve power” is intended to be a safety mechanism “during any serious national shortage” and not just shortages due to Brexit, the Government says.

The Pharmacists’ Defence Association says it “understands” the Government’s motivation in seeking to introduce a serious shortage protocol and “broadly agrees” with the proposals, but adds that the Government “appears to have overlooked the fact that other areas of legislation would also need to be amended in order to make it lawful for a pharmacist to substitute a medicine”.

These “include at the very least” the Human Medicines Regulations section 17 (assembling not in accordance with a prescription) and the Medicines Act 1968 Section 64 (supply of a medicine not of the nature or quality demanded), says the PDA.

The Pharmaceutical Services Negotiating Committee says it broadly supports the proposal but is “not convinced” the current drafting allows the substitution of one branded medicine for another, “which may be vital”.

PSNC also suggests the Government’s use of the term ‘dosage form’ in the draft amendments “should be avoided” as it is undefined.

Time consuming

Both the PDA and the PSNC say the Government’s claim that the proposed changes will “save time and resource” for pharmacists could be negated by the time and effort required to implement SSPs, including explaining the changes to medicine supplies to patients.

Local liaison between GP surgeries and community pharmacies will be needed to ensure GPs are aware of supplies made under the SSP, and “clear communication channels” from DHSC to all parties in the medicines supply chain will be needed to ensure they can advise patients effectively, PSNC says.

PSNC suggests that an IT platform to record SSP actions “may be helpful”, as might “appropriate training” for the community pharmacy sector.

Concerns around ministerial powers

Other changes outlined in the consultation document include giving ministers powers to “continue to make changes to the Human Medicines Regulation 2012 in relation to serious shortages caused by the UK’s exit from the EU” (proposed to be entered as paragraph 344B of the regulation). This amendment to the regulation will, unlike the serious shortage protocol, “only be progressed in case the UK leaves the EU without a deal”, the Government claims.

However, the PDA says, there are serious concerns around the wording of the proposed statute giving ministers regulation-changing powers.

The PDA warns that while the consultation document specifies these powers would only be given in the event of a no-deal Brexit, “on reading the actual statute, these powers would be in effect in the event of any Brexit at all”.

This could pose a threat to patient safety, the PDA argues, and would “open the door to governmental interference in medicines supply in the absence of the usual parliamentary involvement and oversight”.

The PDA recommends that the proposed legislation should be amended to ensure it is only enacted in a no deal Brexit, and that any “modifications to deal with serious shortages” are only in effect until those shortages have been resolved.

In its response, PSNC says that the draft change detailing enhanced ministerial powers is “sensible and pragmatic”.