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From the Medical Post, vol 36, issue 29, Sept 5, 2000


Jumping over the counter
Regulators are increasingly taking drugs off the prescription pad and letting them be sold over the counter. Is this good for patients?
By Marvin Ross

The recent application to the U.S. Food and Drug Administration by two drug makers to have statins switched from prescription to over-the-counter (OTC) products has taken the lid off a debate over just which drugs should be kept behind the pharmacist's counter—and which shouldn't.

Both Merck & Co. and Bristol-Myers Squibb applied to market OTC versions of their cholesterol lowering drugs Mevacor (lovastatin) and Pravachol (pravastatin sodium). Although the initial requests were rejected this summer by an FDA advisory committee, the applications are seen as round one only, and should stimulate continuing debate over patient involvement in their own health care, potential cost savings for the health system and other issues.

North of the border at least one player, the Nonprescription Drug Manufacturers Association of Canada (NDMAC), sees merit in seriously examining more category switching. "Canada is in a better position to cope with an increased switch to OTC status than the Americans because of our tiered system of selling pharmaceuticals," says NDMAC spokesperson Jerry Harrington.

"In the U.S., a drug is either prescription or it can be purchased in a convenience store," said Harrington. But in Canada, some OTCs can only be purchased from behind the pharmacy counter, others can only be paid for at the pharmacy but are on the open shelf, while others can be sold anywhere, he said.

 Unfortunately, statistics on just how many prescription items are moving to OTC status are not available. But Intercontinental Medical Statistics (IMS Health), a pharmaceutical industry research organization based in Montreal, does see strong growth in the OTC sector. And part of that, they say in their most current report on the industry, "is accounted for by what we have observed to be a gradual increase in drugs moving off prescription."

Over the past few years in Canada, there has been a switch to OTC for a number of drugs that treat specific symptoms.

The vaginal anti-fungals, non-sedating antihistamines and H2 antagonists are now available without a prescription, as is the nicotine patch. The H2 antagonists are at a lower dose than the prescription version and the higher dose is still available by prescription.

All of these drugs treat symptomatic conditions and, it is presumed, if they do not resolve the symptoms then the individual will pay a visit to a doctor. Harrington of NDMAC says making these drugs OTC is saving the health-care system money.

NDMAC sponsored a study by Dr. Malcolm Anderson (PhD), a senior associate at the Queen's University health policy unit, on the impact of switching the non-sedating antihistamines. His economic model concluded that the health-care system was saving a total of $16 million per year because of this move. Almost $12 million was saved by reducing visits to doctors and eliminating the pharmacy dispensing fee. Additionally, more than $4 million was saved by patients and employers when patients didn't have to take time off work to visit doctors.

Harrington says NDMAC is now funding a study at the University of Ottawa "to see if the switch of vaginal anti-fungals and H2 antagonists are also saving money in two different health systems—Ontario's and Quebec's."

According to Harrington, the NDMAC position is: "One way to maximize appropriate self-care is to ensure that Canadians have the tools they need to practise it. If a prescription drug offers safe and effective relief for a self-recognizable ailment, switching that drug to non-prescription status can save the health-care system money."

But when it comes to the statins, the drugs are used to treat a symptomless, chronic condition. Merck is suggesting marketing a 10-mg OTC dose that would be suitable for a target population of consumers who have average to moderately elevated cholesterol levels but who are at risk for cardiovascular disease. This would include men over age 40; and post-menopausal women who do not have cardiovascular disease or diabetes, whose total cholesterol levels are 200 to 240 and whose LDLs are 130 or above.

Harrington argues that patients in these categories could first be "identified and counselled by their doctor but would then manage their own care if they were willing to do so."

The issue for Harrington is the growing demand by many consumers to more actively participate in their own health care.

He points out that "the huge growth in the herbal market caught the drug industry off guard. They totally underestimated the desire of people to self-medicate."

In some cases, it may be the presence of an herbal product that is driving some pharmaceutical companies to ask for OTC. In the U.S., Cholestin is touted as a natural dietary supplement and is available in health food stores. It is made from red yeast grown on fermented rice and actually contains the same active ingredient as Mevacor—lovastatin. But it sells for about 25% of the price of Mevacor.

Studies by NDMAC have shown that patients are becoming increasingly more aware and knowledgeable about their disease conditions. Surprisingly, most do not get this from the Internet but from books (about 30% for some disease categories) and increasingly from other print media like newspapers and magazines.

"There is," Harrington said, "a continuum from people who are very knowledgeable, look after themselves and listen to the doctor and discuss options with him or her. At the other end are a group who do nothing or who do not follow directions and who will get themselves into trouble.

"The question that has to be addressed," he adds, "is do we make rules and legislation for the small percentage who might get into difficulty or do we make decisions that will benefit the most people, while still keeping some form of safety net for the others?"

Another important issue that has to be addressed is third-party payers. "There has to be enough flexibility in the system to allow those who, for medical or economic reasons, need these drugs on prescription and to have their costs covered," he asserts.

Dr. Joel Lexchin, a Toronto doctor and noted commentator on the drug industry, says "the statins, and all the drugs moved off prescription, are quite safe." But purchasing these drugs in the pharmacy, he says, would require the pharmacist to play more of a role in counselling.

As well, both Dr. Lexchin and Dr. Ann Holbrook, of the Centre for the Evaluation of Medicine at St. Joseph's Hospital in Hamilton, state that switching to OTC allows drug companies to market directly to consumers and to create brand loyalty.

Barry Proust of the Association of Mature Canadians, which provides insurance coverage for the elderly, comments that "the move is strictly for profits."

In fact, some say part of the motivation for Merck and Bristol-Myers Squibb was likely the fact that their patents are running out in the U.S. Switching to OTC would enable them to continue to have exclusive rights for an additional three years. When a generic becomes available, sales of the brand name drug usually drop 80%.

But Christian Blouin, a spokeman for Merck in Canada, says they are perfectly good clinical reasons for switching some prescription drugs to OTC over time. "It is simplistic to suggest this move is strictly for profit. There are many prescription drugs whose patents end and no application is made for a move to OTC status. Some therapeutic products are appropriate for this switch when many years of prescription use have shown them to be safe. The regulatory decision to approve this switch is not based on profit potential but on safety and efficacy. The industry has no desire to jeopardize the safety of the public," says Blouin.

And Harrington of the Nonprescription Drug Manufacturers Association argues that at least "OTCs are governed by true market dynamics, which is not the case with prescription items."

He claims that "since 1984, the price increase for OTC drugs has consistently been below the rate of inflation because the price is governed and set by a market economy."

He also says "many drug companies are willing to make a smaller profit for a longer period of time rather than a huge profit on a particular drug for the life of the patent only."

Still, some American and British consumer groups are not pleased with this trend of taking drugs OTC.

In the U.S., the Public Citizen's Health Research Group is opposed to the move to switch statins. They are concerned that people will be self-treating a lab finding and will not get proper monitoring of liver enzymes, which is necessary for people on statins.

In Britain, the Independent Consumers Association is also opposing any further attempts to switch prescription drugs to OTC. The British government is encouraging the switch to save money on visits to doctors and 30 drugs have been switched in the last couple of years.

The Consumers Association opposition is based on a study where five researchers visited 10 pharmacies in various parts of the country and found that many pharmacists were selling people the wrong medication or not giving the proper advice.

The jury is still out on the value of making switches but there is no question the debate isn't going to go away. There is a need, Harrington says, "to be less paternalistic and anti-consumerist."







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