Pharmacists and representatives have slammed the MHRA’s decision to reclassify diclofenac as a prescription-only medicine as a “step too far”.

The medicines watchdog announced last week that OTC packs of the NSAID tablets would be recalled from pharmacies because of a “small but increased risk of serious cardiac side effects”, and Pharmacy Voice and Numark said the move would restrict access to the drug unnecessarily.

Readers posting on the C+D website also raised concerns that the reclassification of the pain and inflammation treatment was the start of a “slippery slope” to more P medicines being removed from the category.

Pharmacy Voice chief executive Rob Darracott said the decision by the MHRA’s Commission on Human Medicines (CHM) was “very disappointing”.

“[It] has a doubly negative effect of undermining pharmacists and pushing more people towards overloaded GPs for simple, pain-relieving medication,” he told C+D.

Numark’s director of pharmacy services Mimi Lau said the news was a “blow” for the profession and suggested that stricter protocols should have been placed on the medicine instead.

The MHRA should have mirrored its approach to pseudoephedrine in 2010, when it retained the drug’s P medicine classification but applied tighter sale controls, Ms Lau said.

"One less drug in the armoury"

Pharmacist Michael Stewart said the reclassification of diclofenac meant pharmacists had “one less drug in our armoury” and asked if it was the start of a trend of P to POM reclassifications.

His concerns were shared by locum pharmacist Edward Rowan: “If we’re not trusted with diclofenac, can we be trusted with loperamide? We will end up with no P category,” he said.

Community pharmacist Michael Mustoe said the MHRA’s decision “runs contrary to the needs of both patients and the NHS”. “We are healthcare professionals and fully able to manage the risk. We need more tools, not less,” he said.

But academic pharmacist Anthony Cox said the sector should not view “every drug withdrawal as a slight against their profession”. “We should be strong enough to agree with this decision based on the clear evidence, and start to agitate for greater access to patient notes and a wider prescribing role,” he said.

The MHRA consulted on the availability of diclofenac in 2013, after a review by the European Medicines Agency the previous year found there was a “small but significant risk of cardiovascular side effects”. The CHM had since concluded that these side effects could not be ruled out, even when the medicine was taken for a short time or at a lower dose, the MHRA said.

What other P medicines are at risk of reclassification?

 

 

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