Wider range of pharmacy category NSAIDs needed
Medicines regulators should consider classifying more non-steroidal anti-inflammatory drugs (NSAIDs) as pharmacy medicines, according to the Royal Pharmaceutical Society.
The call comes in the Society’s official response to a consultation by the Medicines and Healthcare products Regulatory Agency on continuing to supply the NSAID diclofenac without a prescription.
The consultation, launched in August 2013 and which finished this week (28 October 2013), followed warnings that people with serious underlying heart or circulatory conditions should not use diclofenac.
The Commission on Human Medicines is concerned that it is difficult to identify people with high cardiovascular risk, that the wide availability of other NSAIDs presents a risk that the products could be used together, and that indications for over-the-counter diclofenac are wide ranging and include colds, influenza and fever.
The RPS acknowledges that the issues surrounding the use of diclofenac are “extremely complex” and says that it is outside its remit to assess the drug’s safety. However, the Society confirms its support for increased access to medicines where there is a balance between access and risk.
The RPS says: “We … would suggest that a wider range of P category NSAID options would be of benefit to pharmacists.
“Currently the only alternatives to ibuprofen are diclofenac, which may be inappropriate for many patients’ needs, or naproxen with only a single licensed indication.”
It argues that if the MHRA decides to apply restrictions to the availability of diclofenac on safety grounds, then the restrictions should apply to “all supply options”. If the MHRA decides that OTC diclofenac products should continue to have marketing authorisations, the RPS says it would support pharmacists to use their clinical judgement in making sure they are used appropriately.
The MHRA has consulted on this issue across England, Wales, Scotland and Northern Ireland, with any changes set to apply throughout the United Kingdom.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11129440
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