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Fury over decision to make first mainstream antibiotic OTC

By Lilian Anekwe

The Government drug regulator plans to make a mainstream antibiotic available over the counter for the first time – despite fierce opposition from some of its own clinical advisers.

The Medicines and Healthcare Products Regulatory Agency has approved plans to switch trimethoprim OTC for treatment of uncomplicated cystitis, Pulse has learned.

Infectious disease experts condemned the decision by the MHRA's Commission on Human Medicines as ‘disastrous', and the agency's own advisers said it exposed ‘complete double standards' in the UK's antibiotics strategy.

The move contradicts the Government's supposed tough stance on antibiotic prescribing, and comes just weeks after azithromycin became the first oral antibiotic to move OTC, for treatment of uncomplicated chlamydia infections.

Pulse has also learned that a second antibiotic for treatment of uncomplicated cystitis, nitrofurantoin, could also become available without prescription, with a public consultation recommended before a decision is made on its reclassification.

But a clinical adviser at the MHRA, who asked to remain anonymous, told Pulse: ‘It's complete double standards. On the one hand GPs keep being hit over the head and told "we must prescribe responsibly", and then they make more antibiotics available OTC.'

Conclusive evidence has linked antibiotic use in the community and the emergence of antimicrobial resistance. There are particular concerns about trimethoprim, as evidence suggests as many as 30% of UTIs are already resistant to the drug.

A second source at the MHRA warned: ‘My own feeling is that antibiotics shouldn't be made OTC at all, because of the problems of resistance. I'm sure the day will come when UTIs become completely resistant to trimethoprim.'

Pulse has also obtained a fiercely worded letter co-signed by the council of the British Society of Antimicrobial Chemotherapy, urging health secretary Alan Johnson to ‘vigorously reject' the proposal.

‘We believe it would be disastrous for the UK to change the licence of trimethoprim from prescription only to pharmacy availability,' it says.

‘In addition to considerable concerns about the risks attached to this specific drug, the change in legal status of any systemic antibiotic would destroy the credibility of the Department of Health in promoting antibiotic use in the community.'

Dr Imogen Shaw, a GPSI in gynaecology in Finchingfield, Essex, criticised the MHRA's recommendation, which still has to be finally approved by Mr Johnson.

She said: ‘Trimethoprim is not without risks. There are reactions to it. At the moment they are rare but if it is made available OTC there will be more. I'd rather have the extra workload and have my patients treated properly.'

The MHRA insisted: 'there has been no decision in relation to the application for the pharmacy availability of trimethoprim', and that a working group had been set up to look at the key issue of resistance.

'We are very much aware that there are divergent views, and it is entirely appropriate that the points should be considered carefully before any action is taken.'

It said reclassifications were only approved after 'rigorous assessment', adding: 'We are addressing in liaison with Department of Health colleagues any perceived inconsistencies between the Government's wish to widen access to medicines, and to manage antimicrobial resistance in the context of better antimicrobial prescribing.'

But Professor Jonathan Cooke, a council member of the British Society of Antimicrobial Chemotherapy, claimed the recommendation was ‘entirely commercially driven' and would have catastrophic implications on GP prescribing and public health.

‘There's a concern that if these antibiotics are made available from a pharmacist, GPs may switch to stronger antibiotics, particularly quinolones. This has been associated with the development of resistance and can prime the guts of patients – making them more prone to infections such as Clostridium difficile.'

Trimethoprim: as many as 30% of UTIs are resistant to the drug Trimethoprim: as many as 30% of UTIs are resistant to the drug

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