Doctors doubt benefits of OTC switches
pharmafile | January 15, 2009 | News story | Sales and Marketing |Â Â OTCÂ
A survey of doctors has found many doubt that patients benefit from more prescription-only drugs being made available over-the-counter.
Some surveyed said pharma companies, rather than patients, were the main beneficiaries of the government push to make POM-to-P switches easier.
The survey of doctors and other healthcare professionals by the Drug and Therapeutics Bulletin (DTB) focused on plans to make trimethoprim and Flomax (tamsulosin) available without prescription.
Antibiotic trimethoprim is used to treat women with symptoms of the urinary infection cystitis.
Meanwhile Flomax treats urinary symptoms related to an enlarged prostate gland (benign prostatic hyperplasia).
It is marketed in prescription-only form as Flomax XL by Astellas, and last month Boehringer Ingelheim applied to make it available from pharmacists without a prescription under the brand name Flomax Relief.
Four out of five (79%) respondents said Flomax should not be reclassified, with 73% citing the risk of misdiagnosis by patients.
And 70% said that having the drug available from pharmacists could delay patients from seeking help for more serious underlying diseases.
More than half (54%) felt drug companies would benefit most from a switch.
"Healthcare professionals seem largely unconvinced that these changes would provide net benefits to patients," said DTB editor Dr Ike Iheanacho.
"They are also sceptical about the motives underlying the proposed switches. We believe that the regulator must take such worries seriously."
However, the Royal Pharmaceutical Society defended POM-to-P reclassifications in the light of the survey.
David Pruce, director of policy and communications, said switches could enhance customer choice, convenience and access to medicines.
"Pharmacists are highly qualified professionals and experts in medicines and reclassification enables them to better use their clinical skills," he said.
When it came to trimethoprim, they would also receive extra training, he added, and already followed strict protocols, referring patients to their doctor where appropriate.
He dismissed concerns that OTC status would increase usage or adversely affect antibiotic resistance.
This was a major concern in the survey results, with more than half of respondents also saying patients might misdiagnose symptoms and overuse or misuse trimethoprim.
In all, 64% felt the POM-to-P move for trimethoprim was a bad idea.
These switches have been relatively common over the past few years, with Zocor Heart-Pro (simvastatin) 10mg becoming the world's first OTC statin when it launched nearly five years ago.
It was a high profile case: Merck Sharpe & Dohme's Zocor had been the biggest-selling prescription drug in the UK in 2003.
While part of the justification was that greater availability would help prevent serious heart disease among people at risk, but this view was not shared by most DTB respondents.
Around three in five (58%) said that there was a lack of evidence that this low dose was effective for those in the target group.
At the same time 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.
Nearly 70% said the public did not even know the drug could be bought OTC in pharmacies.
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