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Ministers consider OTC antibiotics ban

By Lilian Anekwe

Exclusive: Ministers are considering banning future reclassifications of antibacterial drugs to prevent them being sold over the counter because of the public health dangers of rising antibiotic resistance, Pulse can reveal.

A Department of Health advisory committee has recommended to ministers that they slap a blanket ban on any future reclassifications of antibiotics, and remove all antibacterials from the list of drugs that can be switched from a prescription-only medicine (POM) to one available for sale in pharmacies (P).

Pulse has learned that DH advisors are seeking to ramp up the legislation governing POM to P switches in a direct response to concerns about antibiotic resistance, in what is seen as a tacit admission that the drive to make antibiotics available over the counter is a public health threat.

It comes as experts wrote in The Lancet Infectious Diseases of an enzyme, called NDM-1, that can bacteria making them resistant to carbapanems, one of the most powerful groups of antibiotics.

Currently manufacturers of prescription-only medicines can apply to the UK drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), for it to be reclassified and sold over the counter at pharmacies.

The reclassification policy began in 2002 when the DH vowed to make more drugs available over the counter, to encourage patient self-care and to reduce prescribing costs and GP appointments for minor illnesses.

But a ban would mean the MHRA could no longer accept applications from manufacturers of antibacterials.

Minutes from the March meeting of the DH's advisory committee on antimicrobial resistance and healthcare associated infection (ARHAI) state: ‘It was discussed whether antibacterials should be excluded from the POM to P policy.'

‘The committee unanimously recommended disengagement of antibacterials from the wider access policy and asked the DH to investigate this.'

An action was set for the ‘DH to investigate disengagement of antibacterials from the wider access POM to P policy.'

A DH spokesperson told Pulse that ministers were investigating a ban, adding ‘the DH aims to reach a decision by the end of the year'.

Professor Jonathan Cooke, chair of ARHAI's clinical prescribing subgroup and clinical director for medicines management and pharmacy at the University of South Manchester NHS Foundation Trust, said the UK was ‘out of sync with the rest of Europe' – where reclassification of antibacterial drugs is commonly not allowed by drug regulators.

‘We have no objections about category switches generally,' he said. 'But we feel as an advisory committee that systemic antibacterials are not appropriate for POM to P switches because of the evidence of rising resistance to these drugs and the risk it poses to the public.'

The move comes after a string of Pulse exclusives revealed the growing opposition to the reclassifications.

Applications to make trimethoprim and nitrofurantoin available over the counter for the treatment of cystitis prompted a furious outcry from both the MHRA's GP advisors and infectious disease experts, who vehemently opposed the switch and wrote to the former health secretary Alan Johnson to decry the proposed reclassification.

UK general practice data has shown that resistance to trimethoprim has risen by 6% in just four years, with 13% of all samples showing resistance.

Primary care researchers have also warned that selling antibiotics over the counter leads to a huge increase in their use, and argued that a 48% rise in the overall use of chloramphenicol in the two years after it was made available over the counter was evidence to rule out any further rollout of the policy.

The applications for both trimethoprim and nitrofurantoin were withdrawn by their manufacturers in April, but the DH may now act to prevent any future switches.

Concerns are growing over antibiotic resistance