I am still processing this concept. Cholesterol drug to be sold without prescription in Britain
In a bid to prevent heart attacks and strokes, Britain will be the first country to permit nonprescription sales of a cholesterol-lowering drug, the government said Wednesday.
Some expert groups welcomed the decision, but others said people taking such drugs needed supervision and an assessments of risks.
Health officials said a low-dose version of simvastatin, marketed as Zocor by Merck & Co. of Whitehouse Station, N.J., will be available without a prescription at pharmacies across the country starting later this year. No date was announced.
Simvastatin belongs to a class of drugs called statins, considered a powerful weapon against the buildup of fat deposits that clogs arteries, leading to heart attacks and strokes.
Pharmacists will ask people a series of questions and, if needed, will offer a range of optional health tests to ensure it is safe to take the drug, said Health Secretary John Reid. Pharmacists will have the power to refuse to sell the drug.
The Royal College of General Practitioners and the British Medical Association raised concerns.
The drugs still are available only by prescription in the United States.
“We are concerned that there won’t have been a sufficiently thorough risk assessment before the drug is purchased,” said Dr. John Chisholm, chairman of the British Medical Association’s general practitioner committee. Patients on statins should be regularly monitored to assess the effectiveness of the treatment, he added.
“For those patients who do need to take statins,” he said, “the low dosage available over the counter may not be enough to reduce cholesterol to safe levels.”
The drug may be sold to people who do not need it, said Dr. Jim Kennedy of the Royal College of General Practitioners.
I still do not understand the reasoning used to consider OTC statins. The class provides excellent secondary prevention. However, OTC advertising will probably stress primary prevention. And primary prevention provides a much smaller benefit (except in very selected patients). I suspect many patients will take an OTC statin with their steak dinner.
On the other hand, if OTC statins decrease the price significantly, then we may have a cost benefit. If I recall correctly, simvastatin will soon come off patent. Is that the stimulus for this request?
And will the US follow?
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{ 17 comments… read them below or add one }
I’m all for cost benefits, but these drugs need monitoring. Liver function, for instance, has a tendancy to drop with statin use in many patients. They also have not been tested very well in younger populations: concerned parents will be putting kids on the stuff, which may do a good deal of harm.
I daresay the reasoning is, an OTC drug is now out of that country’s socialized healthcare system, the patient now has to pay out-of-pocket.
Don’t worry about anyone trying to sell statins OTC here. The hyenas of the trial bar are out there, ready to pick over the bones of any hapless pharmaceutical company that might be willing to try to improve the health of Americans in this fashion.
Simvastatin came off patent in the UK a while ago (around christmas if I remember correctly), so the move probably has something to do with increasing profit.
Having said that, as I understand it, the licence for the OTC product will be quite restricted: men over 55; women over 55 and men over 45 with additional risk factors for CHD. The fact is that with the NHS, there has to be some rationing of drugs: the guidelines for statins restrict them patients at high risk, when other patients could also benefit from statins.
As a pharmacy student, I welcome the move as it will enable me to better implement the clinical knowledge I will have gained at university, rather than just dispensing prescriptions.
This has been on the cards over here for some time, so no surprise. I guess someone has persuaded the government here that this will have a population impact and reduce the burden of cardiovascular disease, and thereby its cost to the National Health Service and the public purse. Expect other components of the ‘polypill’ to follow suit. The main problem with this gesture is that then dose of simvastatin available is probably too low to have much impact.
Never gonna happen.
Baycol was pulled and now Crestor is taking heat. The risk of rhabdo or serious liver problems is still very low with statins but as long as there are 3 ads by lawyers about class action suits over Baycol and other statins, no drug company will have the nuts to make it OTC.
Another obvious point would be that Zocor is going for $90 and Lipitor for $110 if you’re paying cash at local pharmacies – making them OTC will make it real hard to foot the bill, which insurance would no longer pay for, even if prices halved.
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After researching my recent change to Advicor from Zocor, I found it interesting that the change may have something to do with the Merck & Co. patent on Zocor ending soon. Prior to the change, I noticed my last renewal was w/o refills and that made me wonder about recent articles concerning perks to doctors and now that I am being switched to another drug has 99.44% convinced me that recent articles are true. Really has lowered my opinion and confidence in my personal physician.
In the Philippines, Statin are not that regulated as prescription drugs. I dont know why.. Thanks for posting. I’ll be posting too in my blog pinoypharmacist.blogspot.com