Doctors, pharmacists and members of the Medicines and Healthcare products Regulatory Agency have voiced their concerns over proposals to reclassify certain antibiotics from prescription only to over-the-counter.
The MHRA is currently considering the reclassification of trimethoprim and nitrofurantoin for the management of urinary tract infections.
With trimethoprim, the Agency has carried out two public consultations. It says it is aware that there are ‘divergent views' and that all points raised will be considered before a decision is taken.
‘There has been no decision in relation to the application for the pharmacy availability of trimethoprim in the management of acute uncomplicated cystitis: the consideration of this is continuing, with a Working Group set up to look at the key issue of resistance,’ said the MHRA in a statement.
But the GP magazine, Pulse, has learnt that some of the MHRA’s own clinical advisers are opposed to the plans. One anonymous source told the publication: ‘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.’
In the last 20 years, trimethoprim–sulfamethoxazole and trimethoprim have been used extensively for E. coli urinary tract infections. But evidence shows there is growing resistance of such isolates to these products.
Doctors and pharmacists have shown their opposition to plans. Members of the British Society of Antimicrobial Chemotherapy have written to health ministers in all four UK countries objecting to plans and are still waiting a response.
In the letter, Professor Peter Davey, president of the BSAC and Professor Jonathan Cooke, a council member, call the proposal for change of licensing ‘a potentially disastrous decision’ for public safety.
‘Our concerns are related to the inevitably wider sales and use of any reclassified product. At a time when resistance is rising such use will essentially go unmonitored from a surveillance and indeed safety perspective, despite reassurances to the contrary. We are equally concerned that approvals of this type are determined commercially and not on the basis of medical need,’ the letter says.
A spokeswoman for the Department of Health said the plans were not under consideration by the Health Secretary and the MHRA had still to make its decision on the reclassification of trimethoprim.
The MHRA added it was working with the DoH to addressing any ‘perceived inconsistencies’ between Government plans to widen access to medicines and management of drug resistance.
