Exclusive Plans to switch a brand of naproxen to the general sales list in pharmacies has been criticised by the BMA and pharmacy leaders, who say it could increase hospitalisations for stomach complications.
Pulse has learnt that the BMA has urged the UK drugs regulator to refuse a request to reclassify a brand of naproxen 250mg tablets indicated for period pain from the pharmacy list and make them available without any checks by a pharmacist.
GPs say the move is ‘potentially harmful’ as women could end up acidentally taking naproxen alongside ibuprofen if pharmacists are not able to advise patients about the medicines they are taking.
But the manufacturer of the tablets says that naproxen would be a ‘valuable alternative’ to ibuprofen for women with dysmenorrhoea and have rejected concerns over the potential for gastrointestinal side-effects after the switch.
The Medicines and Healthcare products Regulatory Agency (MHRA) is currently reviewing a request from Galpharm to switch its 250mg gastro-resistant naproxen tablets to the general sales list.
The tablets are currently sold in small packs sufficient to treat period pain lasting no longer than three days and are currently only available over the pharmacy counter.
In its submission to the MHRA, Galpharm said: ‘Ibuprofen is currently the only NSAID available [on general sales list] and licensed for the relief of dysmenorrhoea. Naproxen would be a valuable alternative.’
But a BMA spokesperson said their submission to the MHRA urged the regulator to reject the application. He told Pulse: ‘We believe the request to reclassify Galpharm Period Pain Relief (250mg) Gastro-Resistant Tablets from pharmacy to general sale list should be refused, as primary dysmenorrhoea is complex and it therefore requires a pharmacist to assess the patient’s symptoms.’
Dr Bill Beeby, deputy chair of the GPC clinical and prescribing subcommittee, rejected the call for greater convenience. He said: ‘It is potentially harmful because someone might pick up a packet of ibuprofen and then pick up a packet of these [naproxen] tablets and just doesn’t twig that these things are the same.
‘You could be taking ibuprofen for joint pain and this [naproxen] for period pain – as this is being specifically marketed for that indication. This is another NSAID that has the potential to be confused by people if they are buying it without advice off the supermarket shelf.’
He added: ‘To consider putting it on the supermarket shelves, when there are already alternatives available such as ibuprofen, isn’t necessary. There’s no need because getting [naproxen tablets] – either buying them or getting them dispensed – safely really is not a big inconvenience.’
The Royal Pharmaceutical Society announced last month that it also has advised the MHRA to reject the application, warning it could lead to increased hospitalisations from stomach complications, ‘as the supply of naproxen without the knowledge and expert advice of a pharmacist could lead to uncontrolled and often unnecessary use’.
But Richard Eggleston, senior director of research and development at Galpharm, said switching naproxen to the general sales list would offer those women who do not respond to analgesics – such as paracetamol and ibuprofen – easier access to an effective alternative.
Mr Eggleston said: ‘Women have a history of safely being able to self-diagnose and treat primary dysmenorrhoea. Naproxen is not a stronger analgesic but an alternative in this setting and for this indication. At the moment, a significant number of those women who might respond to naproxen have to go to a pharmacy rather than just popping into the petrol station or the supermarket.’
Dr Eggleston added there is ‘no evidence whatsoever naproxen is any more likely to cause gastrointestinal upsets in this patient group than ibuprofen’.
He said: ‘We’ve looked at the risk and any potential misuse has been addressed by the produce labelling and pack size.’
A spokesperson for the MHRA said the regulator is currently assessing responses and cannot yet say when a final decision on the reclassification will be made.
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