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MHRA consider large trial for OTC trimethoprim

By Lilian Anekwe

Up to a million patients are set to be able to buy a mainstream antibiotic over the counter for the first time, Pulse can reveal.

The UK drug regulator is considering a large-scale trial of OTC trimethoprim for treatment of uncomplicated cystitis, in a bid to overcome serious concerns over safety.

Pulse revealed in August that the Medicines and Healthcare Regulatory Agency was proposing to reclassify trimethoprim from a prescription only medicine to one available OTC, and was considering doing the same with nitrofurantoin.

Following the uproar from the country's leading infectious disease experts and advisers to the MHRA's Commission on Human Medicines, the MHRA has asked a specially-convened expert advisory group to examine the issue.

The group is considering running pilots in up to a million patients in order to build a large enough evidence base to make a final recommendation.

The move follows smaller pilots of OTC trimethoprim, as part of one-off arrangements between pharmaceutical manufacturers and individual PCTs, in which the MHRA has been satisfied that no ‘inappropriate safety concerns' have arisen.

Dr Thomas Leigh, unit manager of the MHRA's therapeutic review group, told Pulse: ‘When trimethoprim has been supplied under a patient group direction the indications have been that there have been no inappropriate safety concerns.

‘We are currently looking at different ways of being able to provide evidence that the switch can be made safely, like modelling the potential effects, and also running pilots. The pilots would need to be of sufficient size to be able to draw conclusions – possibly up to a million patients.'

In the summer the council of the British Society for Antimicrobial Chemotherapy issued a fiercely-worded letter to the secretary for health Alan Johnson, warning of the ‘disastrous' consequences for the development of antibiotic resistant bacteria.

‘The change in legal status of any systemic antibiotic would destroy the credibility of the Department of Health in promoting prudent antibiotic use', the letter, co-signed by the Society's council, warned.

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