Government plans to make certain prescription-only drugs for common problems available over-the-counter (OTC) have overwhelmingly been rejected in a survey of readers of the monthly Drug and Therapeutics Bulletin (DTB). The prevailing view among the Bulletin’s readers, many of whom are healthcare professionals working in primary care, is that drug companies, rather than patients, have most to gain from proposed switches to OTC availability. __

The survey asked readers about plans being considered by the Medicines and Healthcare products Regulatory Agency (MHRA) to make two drugs - trimethoprim, an antibiotic originally marketed by GlaxoSmithKline, and Boehringer Ingelheim/Astellas’ Flomax (tamsulosin) - available OTC. __Trimethoprim is commonly used to treat women with symptoms of the urinary infection cystitis, while tamsulosin is prescribed for urinary symptoms related to an enlarged prostate gland (benign prostatic hyperplasia).
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64.5% of the survey respondents felt the move to make trimethoprim available in pharmacies without prescription was a bad idea, with 58.2% citing a consequent increase in antibiotic resistance as their main concern. Furthermore, 52.2% felt that patients might misdiagnose their symptoms, while 51% thought that OTC availability might encourage patients to overuse or misuse the drug. __

The proposal to make Flomax available without prescription was rejected by even more respondents - four out of five (79.7%) - with most (just under 73%) citing the risk of misdiagnosis by patients as their main concern. And seven in 10 said that OTC availability could delay patients from seeking help for more serious underlying disease. __

Overall, most respondents felt that the needs and wishes of the public and the National Health Service (NHS) should be the key driver for a switch to OTC status, but 32% felt that drug companies would benefit most from an OTC switch for trimethoprim, while 54% felt this about an OTC switch for Flomax.
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In both cases, more respondents felt that the needs and wishes of drug companies, rather than those of the public and the NHS, would have the most sway on whether the switch happened.

The survey’s findings also revealed that respondents are less than impressed with the reclassification of the 10mg dose of the cholesterol-lowerer simvastatin (originally Merck & Co’s Zocor) to OTC availability. This switch, which was made in 2004, was hailed by both the government and the MHRA as promoting much wider access to a safe and effective drug that would help prevent serious heart disease among people at risk.

However, around three in five respondents (58.6%) to the DTB survey said that there was a lack of evidence that this low dose was effective for those in the target group, while 57% said the move was unlikely to have substantially reduced the number of heart attacks and deaths from coronary heart disease in the general population. _
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57% also did not believe that OTC availability of simvastatin had reduced general practitioners’ workloads, and just under 70% said that they did not think the public even knew that the drug could be purchased over the counter in pharmacies. __

Commenting on the survey results, DTB editor Dr Ike Iheanacho said: “the survey indicates major concerns about proposals to make certain medicines available without prescription. Healthcare professionals seem largely unconvinced that these changes would provide net benefits to patients. They are also sceptical about the motives underlying the proposed switches. We believe that the regulator must take such worries seriously.”