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Diclofenac's return to POM is 'step too far'

The MHRA recalled OTC diclofenac from pharmacies last week because of a risk of "serious cardiac side effects"

Reclassification of NSAID is "slippery slope" towards loss of more P medicines, warn C+D readers

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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What do you make of this story?

Farmer Cyst, Community pharmacist

This is symbolically frustrating maybe but in practice wont really make a difference, as no one bought it anyway. The dose was too low to be effective, it's got a bad side effect reputation when compared to Ibuprofen, was licensed for 3 days use only and cost £9 a box.

Ahmed El-Dabbagh, Community pharmacist

How is dispensing 14 tablets of Diclofenac 25mg could harm patient more than who getting Prescription for 84 diclofenac 50mg from his GP..? The same applied to Domperidone. This Dosn't sound logical. There no one case been reported of someone get hurt by supplying him/her 14 tablets fro a pharmacy but the incidence has happened with Doctors prescriping. Nevertheless you stopped the pharmy from dispensing it while let the GP CARRY ON DISPENSING.if you have sought on our ability to care about patient health with our medical knwledge stop giving us more services then. I f you don't have confidence in pharmacy profession how patients will have his confidence. With pharmacist you go one step forward and two step backs. Are you guys that confused.

Career Miss Take, Locum pharmacist

while I have resevations about the relassification of diclofenac I feel that the price was ridiculous and that too many companies produce their own brands which compromises patient safety

Allan Melzack, Community pharmacist

As Anthony Cox points out Naproxen would be a very useful NSAID if it were allowed for sale OTC. It seems to be more effective than Ibuprofen, easier to take (only twice daily) and as far as we can tell, safer too. Much more useful than diclofenac. Graham Phillips must be aware that while pharmacists are able to control sale of OTC medicines in their own pharmacies it cannot be said that they can control sales overall. We know very well that if patients want to buy inappropriate quantities of a medicine they simply have to go to another pharmacy.

Leon The Apothecary, Student

They certainly do go to other pharmacies, I've given warnings out to local pharmacies on some refused sales, followed by half an hour later said person I've refused the sale to coming back complaining that they've been refused elsewhere. Ultimately with a little bit of effort, you could obtain as much of anything as you wanted.

Tony Schofield, Community pharmacist

This is a "no brainer" and I'm amazed it took so long. Saying more people will now visit GPs for minor ailments is nonsense. I have a prescribing qualification and wouldn't prescribe it so I don't sell it. But pharmacy is bloated with conspiracy theorists and this will keep them amused.

London Locum, Locum pharmacist

Joke Profession

London Locum, Locum pharmacist

Joke Profession

Jenny Etches, Community pharmacist

Does anyone know if the information that it was about to be pulled this week available to the general public as I've never been asked for Diclofenac tabs as frequently as I was just before it went back to POM. And I found myself refusing most requests. It is fair to say that the only info we often have to make a clinical judgement is that proferred by the customer. And a lot of them are very canny about what not to reveal. So I don't take any umbrage at this withdrawal as I cannot make some judgement calls about patient safety when information is not complete due to the nature of our interactions with the buying public

Anthony Cox, Academic pharmacist

I think Rob Darracott's view is interesting: “[It] has a doubly negative effect of undermining pharmacists and pushing more people towards overloaded GPs for simple, pain-relieving medication,” Mainly because if they do have to go to the GP because ibuprofen (still OTC) is ineffective, then they are increasingly unlikely to be put on diclofenac, and if another NSAID might be prescribed it would probably be naproxen. I'd be in favour of extended indications for naproxen for OTC sales (and allowing pharmacists to prescribe diclofenac when is receipt of the full patient notes as other prescribers can if really necessary).

This is hardly a great loss is it?? Prescribing by GPs has nose-dived over the last couple of years and at P dose of 25mg tds is of dubious therapeutic value. Let it go!

Edward H Rowan, Locum pharmacist

If we got rid of all the stuff with dubious therapeutic value, there wouldn't be much left.

Subhas Bhairo, Superintendent Pharmacist

Well if the MHRA published its results and reasons why diclofenac in particular is singled out amongst the NSAID's then we would be much the wiser and able to in a better position to accept or critises. We must bear in mind the new products coming on the market based on new technology with much lesser side-effects in comparison.

R A, Community pharmacist

I am relieved the number of people I have had to refuse voltoral tablets on similar grounds! So now I have one less thing to worry about at work.

Leon The Apothecary, Student

Was there that great a benefit when compared to Ibuprofen when you consider it's 25mg for only three days usage? Perhaps there lies the reasoning.

SP Ph, Community pharmacist

Why is the picture in this article of 50mg ??

Edward H Rowan, Locum pharmacist

That's the only thing they could take a picture of 'cos the OTC version has been recalled!

David Moore, Locum pharmacist


Michael Stewart, Community pharmacist

All good points Graham. And not to keep harping on about this but..... Surely the whole concept of the P category is for medicines that require stricter controls due to increased risk. I do think that if MHRA concludes pharmacists cannot manage safety risks associated with medicines then the P category is doomed.

Graham Phillips, Superintendent Pharmacist

That was my point really. Remember we nearly "lost" pseudoephedrine to POM status at one point due to "the powers that be" making all sorts of unjustified assumptions about risk-management in pharmacy. I would like to be assured that the same false assumptions haven't been made with OTC "P" diclofenac

Concerned pharmacist, Community pharmacist

I don't believe that Diclofenac should ever have been licensed for the POM to P switch in the first place. The cardiovascular risks have been highlighted for some time and prescribers have been actively encouraged to restrict Diclofenac prescribing. The incessant adverts on the telly promote Voltarol as a wonder drug and make no mention of the limitation OTC to 3 days use. Th eBNF makes the point that regular full dosage and the anti-infammatory effect may not be acheived (or may not be clinically assessable) for up to 3 weeks. The decision to withdraw Diclofenac is correct in my opinion. The MHRA is there to protect patients not our profits.

Graham Phillips, Superintendent Pharmacist

Anthony Cox, whom I greatly respect, makes good points. So my question: what is the evidence of likely and actual harm? What is the evidence that patients will benefit overall . Why, if so unsafe, is this still an unrestricted POM rather than being reserved for specialist use? If pharmacists are the experts on medicines is there reasonable credible evidence that we can't safely handle this as a P med? Regards Graham

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