For those who don’t recall, the FDA earlier this month scheduled a Nov. 14 meeting to debate the creation of a so-called third category of drug - behind-the-counter, in addition over-the-counter and those requiring a prescription. BTC would also make some med available without a prescription, but only after consulting a pharmacist. The idea is that a pharmacist-controlled category of drugs might increase patient access to certain meds while maintaining a measure of oversight to prevent misuse, writes The Star-Ledger of New Jersey (which owns Pharmalot).

“This is an idea that has been discussed for many years and we want to bring to the forefront right now,” Ilisa Bernstein, the FDA’s director of pharmacy affairs, tells the paper. “Health-care delivery has changed, and we must look to see how we can increase access to safe and effective drugs to patients who need them. Now is a good time to have discussion on a more public level.”

Not surprisingly, the strongest support comes from independent pharmacists, and the loudest opposition from docs concerned about a loss of control and OTC drugmakers who fear profits could disappear if products are hidden behind a counter. Some consumer advocates, meanwhile, are skeptical a BTC system can work, while chain drug stores are still assessing the logistical problems, potential costs and financial benefits. PhRMA is on the fence, thanks to differing views among its members, with some raising concerns and others suggesting a BTC class could extend the lives of brand meds about to lose patent protection.

Currently, the UK, Canada, Australia, Germany, New Zealand, Singapore and a number of other countries have a third class of behind-the-counter drugs. In the UK, the Zocor cholesterol med has been approved for behind-the-counter sales, and in Germany, migraine meds are available. But in 1995, the paper points out, the Government Accounting Office looked at BTC systems overseas and found there would be little benefit for such a program in the US and that pharmacist counseling was “infrequent and incomplete,” and there was “no clear pattern of increased or decreased access.”

Sid Wolfe, director of the Health Research Group at Public Citizen says there’s little evidence any of the concerns raised by the GAO have been addressed. “Many questions still remain unanswered,” Wolfe says. “Will pharmacists have the training and the time to explain the drugs and side effects to patients? Who will pay for that training? Will this third class pull more from drugs currently sold over the counter or from those requiring a prescription? And will drug companies push to get their current prescription products into this class to avoid regulation? Will behind-the-counter availability effectively turn the drugstore counter into a vending machine, free from doctor’s oversight?”

Community pharmacists insist they have the expertise to counsel consumers on proper use of medications, and see a BTC system as a way to increase their viability in the era of large chain drugstores and competition from the likes of Wal-Mart and Target. “There are a lot of drugs that are available only by prescription that for all intents and purposes really don’t need to be prescription - drugs for common aliments like coughs and cold and allergies and rashes,” said Tom Greco, owner of Hillsboro Pharmacy in Hillsborough, NJ.

“Pharmacists work with their customers day in and day out and know them well,” Greco said. “With the assistance of professionals like pharmacists who know the limitations, you can certainly go a great distance in helping patients and in avoiding the time and cost of hav ing to go to the doctor for a prescription. I see this as a great benefit to the public.”

The American Medical Association maintains there is no need for a third or transitional class of drugs, suggesting lack of proper medical oversight could pose safety risks for patients. “When a drug product is considered to be unsafe without supervi sion, a physician should be responsible for supervising the use of that drug,” Rebecca Patchin, an AMA board member, tells the paper.

David Spangler, senior vp of the Consumer Healthcare Products Association, the trade group for OTC drugmakers, says a pharmacist-only class of drugs wouldn’t necessarily result in proper consultation and it could end up reducing the number of outlets where consumers could purchase meds that should be available over the counter while potentially raising prices. “We don’t believe there is a need for a behind-the-counter class of medicines,” he says. “The two-class system empowers consumers with a widening choice of safe and effective medicinal health- care options conveniently available at competitive prices.”

The FDA is not yet saying it will move ahead with a BTC plan, or even suggest the specific kinds of drugs that might fit the bill. Bernstein says the agency right now wants input on how and whether such a system can work, and if it can provide benefits to patients in a safe manner. The FDA last year used its authority to allow the Plan B emer gency contraceptive to be available directly from pharmacists for women 18 and older and by prescription-only for those who are younger. Congress also recently re quired that former OTC products containing the decongestant pseudoephedrine be available only from pharmacists because of concern about use of the product in making the illegal drug methamphetamine.

One possible candidate for status as a BTC drug could be cholesterol-lowering medicines. Two years ago, an FDA advisory panel rejected a request by Merck and Johnson & Johnson to sell the cholesterol drug Mevacor over the counter, with several committee members suggesting the FDA establish a behind-the-counter system that would allow customers to buy the drug with a pharmacist’s supervision. Merck has since renewed its request for OTC sales, which will be reviewed by an FDA advisory panel Dec. 13. Pfizer also said earlier this year it was considering seeking OTC status for its sexual-enhance ment drug Viagra, another type of med that might be considered for behind-the-counter status.

Jerry Harrington, a spokesman for the Nonprescription Drug Manufacturers Association of Canada, says in his country, insulin, low- dose codeine, nitroglycerin, the emergency contraceptive, products with pseudoephedrine and some vaccines are among the drugs available without prescription through pharmacists. The system “adds value because it can provide a transition from prescription status to OTC status” for some meds, he says.

But the issue is “an open book,” says the FDA’s Bernstein, adding that if the FDA decides to move forward, it remains to be seen whether it could be done by regulation or whether it would be necessary for Congress to change the law.

Source: The Star-Ledger of New Jersey