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

The Department of Health and Social Care (DH) 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”, it told C+D last week (March 22).

These measures include working with the Medicines and Healthcare products Regulatory Agency to “expedite regulatory procedures”, working with manufacturers to manage remaining supplies and “facilitating the import of medicines from other global markets”.

Unclear which drugs could be affected

However, the DH would not confirm whether it expects certain medicines – such as naproxen, which C+D readers have complained has been plagued by shortages for months – to be subject to a protocol.

It pointed out that since January it has been mandatory for manufacturers to report “information that may potentially interrupt the supply of medicines to us in a timely manner”.

“The DH also has close links with NHS networks, [which] are able to notify us about any supply disruption the NHS is experiencing.”

“Several steps will need to be undergone before a protocol is issued, such as exploring all other options to mitigate a supply issue, considering whether a protocol is appropriate, and securing the expertise from clinicians in the relevant area to provide the clinical content for any protocol,” it added.

The DH said it was unable to respond to C+D’s request for the specific job titles of the clinically-chaired governance group, which is developing the framework to consider the suitability of a protocol.

Legal challenge

Not-for-profit organisation the Good Law Project launched legal proceedings against the DH last month, arguing the government had pushed through the regulatory changes “without proper consultation with patient and clinical groups”. 

An oral hearing took place yesterday (March 26) at the Royal Courts of Justice in London and the decision is expected on Friday.