Thumbs down by experts on plans to make certain meds OTC

Jan 13 2009

Government plans to make certain prescription-only drugs for common problems available over the counter have overwhelmingly been given the thumbs down by healthcare professionals, reveals a survey of readers of the influential Drug and Therapeutics Bulletin (DTB).

The prevailing view among 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.

DTB readers were quizzed about plans being considered by the drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), to make trimethoprim and tamsulosin (Flomax) available over the counter.

Trimethoprim is an antibiotic, 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).

Most of the 251 survey respondents disagreed with the plans.

Almost two thirds (64.5%) felt the move to make trimethoprim available in pharmacies without prescription was a bad idea. And over half (58.2%) of all respondents cited a consequent increase in antibiotic resistance as their main concern.

Furthermore, just over half (52.2%) felt that patients might misdiagnose their symptoms, while a similar proportion (51%) thought that OTC availability might encourage patients to overuse or misuse the drug.

The proposal to make tamsulosin 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 (70.9%) 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 NHS should be the key driver for a switch to OTC status.

But one in three (32%) felt that drug companies would benefit most from an OTC switch for trimethoprim, while over half (54%) felt this about an OTC switch for tamsulosin.

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 results also show that respondents are less than impressed with the reclassification of the 10 mg dose of the cholesterol-lowering statin drug simvastatin to OTC availability.

This switch, which happened in 2004, was hailed by government and the regulator as promoting much wider access to a safe and effective drug that would help prevent serious heart disease among people at risk. But around three in five respondents (58.6%) said that there was a lack of evidence that this low dose was effective for those in the target group.

And almost six out of 10 (57.0%) said the move was unlikely to have substantially reduced the number of heart attacks and deaths from coronary heart disease in the general population.

The same proportion (57%) said that they did not think OTC availability had reduced GPs' workload either.

And almost seven out of 10 (68.9%) said that they didn't think the public even knew that the drug could be bought over the counter in pharmacies.

Commenting on the survey results, Dr Ike Iheanacho, editor of DTB, 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."