Pharmacies offer 'behind the counter' service usatoday.com

In the back of this sprawling drugstore in a busy, nondescript suburban shopping center lies what many pharmacists hope represents the future of their profession
At the end of the over-the-counter products aisle, beneath a huge "Happy Harry's Pharmacy Care Center" sign, two rooms that bear a passing resemblance to a doctor's office offer customers the chance to meet privately with a pharmacist. Besides discussing their medicines, they can get their cholesterol checked for $25 and blood pressure for $10 for 16 readings. If they're diabetic, they can learn about blood sugar meters.
Currently, this type of service is about as common as a doctor who makes house calls. This Happy Harry's pharmacy is the only one of the 75-store chain that offers it. Rite Aid and Kerr Drug, a North Carolina-based chain, also have pilot programs.
Pharmacists, frustrated with being viewed as mere pill-pushers, are clamoring to become more involved in managing their customers' health care. Some professional groups have been pushing for a new category of non-prescription drugs, dubbed "behind-the-counter," that would require customers to talk to a pharmacist before buying them. The United Kingdom and Canada are among a number of other countries that have such a setup.
"None of us went into the profession to stand behind a counter and count by fives," says Janet Engle, a former president of the American Pharmacists Association and associate dean of the University of Illinois at Chicago College of Pharmacy.
Engle and other pharmacists say that the time is right for behind-the-counter non-prescription drugs. For example:
• Some states have laws that allow Plan B, a prescription emergency contraception pill, to be sold without a prescription by pharmacists working collaboratively with doctors. Most women's health groups want it sold OTC nationally, but the Food and Drug Administration (news - web sites) hasn't acted on the maker's request to do so.
• A growing number of states are moving non-prescription cold remedies such as Sudafed from store shelves to behind the counter. Pseudoephedrine, their active ingredient, can be ground up to make crystal methamphetamine, an illegal stimulant. Placing such drugs behind the counter enables pharmacists to limit the amount sold and keep track of buyers.
• Under the Medicare Modernization Act, the government might begin paying pharmacists next year to consult with Medicare patients who take several drugs for chronic diseases. If the program is a success, proponents say, private health plans eventually would begin paying for a similar service.
• Facing generic competition when prescription drugs go off patent, drug companies are looking to switch the drugs to OTC for three more years of exclusivity. If an FDA (news - web sites) advisory panel's vote last month was any indication, though, drugmakers might face resistance when trying to switch drugs for chronic conditions that have no symptoms, such as high cholesterol.
The panel voted 20-3 against Merck's plan to switch Mevacor, a prescription cholesterol-lowering statin drug, to OTC. But several members said they could see selling the drug without a prescription from behind the counter.
Most committee members weren't convinced that consumers could correctly decide on their own whether they needed medication to lower their cholesterol. After all, non-prescription drugs historically have been used to treat only short-lived ailments, such as a headache.
Zocor, another Merck statin, has been available in the United Kingdom without a prescription but behind the counter since last summer. "The behind-the-counter scenario would be a perfect solution" for OTC Mevacor, said FDA panel member Leslie Clapp, a pediatrician in Buffalo.
Convenience, at a price
Dan Taylor, 73, of Wilmington would agree. He has been getting his cholesterol tested at Happy Harry's for more than a year. "This is so much more convenient," says Taylor, who takes Zocor. "I can go in there any time I want."
Plus, Happy Harry's charges only $25 for the service. Even though he has to pay the full amount out of pocket, he says, it's still less than what he'd have to pay if he were tested through his doctor.
Pharmacists' costs are a major obstacle to establishing a behind-the-counter drugs category, says Steven Francesco, publisher of Switch, a newsletter about the OTC market. "In the U.S., the pharmacists think they might get extra business, but no one has sorted out how they are going to get paid for their effort," Francesco says.

James Owen, director of clinical services and professional development for the Happy Harry's chain, acknowledges that few customers have opted to pay the drugstore's $25 fee for a half-hour sit-down with a pharmacist. But Owen says Happy Harry's has plans to launch a pilot program in which insurance would cover pharmacy care for patients with high cholesterol.
Meanwhile, Taylor is satisfied with the service. "I've enjoyed talking to the young man who's the pharmacist there," he says. "He is very knowledgeable about this sort of thing. He then sends a copy of the test results to my doctor."
Happy Harry's pharmacist Michael Capka says the feeling is mutual. "One of the more rewarding things I find about this is you can actually see a patient's face start to light up when they understand" how to manage their condition. "It would help everybody, the public, pharmacists, if there was this third class of drugs."
Legal questions
It's not clear, though, whether the FDA has the authority to put non-prescription drugs behind the counter. Virginia Cox of the Consumer Healthcare Products Association, a trade group of non-prescription drugs and dietary supplements, says it would take an act of Congress. Cox's group opposes such a move, which would limit access to some of its members' products.
Charles Ganley, head of the FDA's OTC drugs division, says he needs to consult agency lawyers on the question. "It's an option we ought to look at," Ganley said after the Mevacor meeting.
Gary Stein, a government affairs specialist for the American Society of Health-System Pharmacists (news - web sites), says drugmakers might insist on it.
"If manufacturers see drugs they'd like to go to OTC status get rejected, that might encourage FDA to move to this," says Stein, whose group favors a third class of drugs. "Consumer groups might get behind this as well."
Merck spokesman Tony Plohoros says his company still hopes that the FDA will approve OTC Mevacor, so it's not considering behind-the-counter sales. The FDA, which usually goes along with its advisory committees, is expected to decide on OTC Mevacor by Feb. 24.
Arthur Levin, director of the Center for Medical Consumers, a New York-based advocacy organization, says he doesn't see the point of a third category of drugs.
"It doesn't surprise me that pharmacists would be grabbing onto this, because it gives them a new lease on life," Levin says. Increasingly, he says, patients are obtaining medications for chronic conditions through the mail, not in drugstores.
Besides, Levin says, "despite the illusion that pharmacists counsel patients, that doesn't happen very much in the hurly-burly of the retail establishment."
Vanderbilt University pharmacologist Alastair Wood, who chaired the FDA advisory committee meeting and voted for OTC Mevacor, says panelists put too much faith in behind-the-counter drugs.
"I've gone into the U.K. and bought something behind the counter," he says. Usually, he says, he's just handed the drug, no questions asked. "It's not that rigorous."
About half of non-prescription drugs in the United Kingdom can be sold only where pharmacists can supervise their sale, says Sheila Kelly, executive director of the Proprietary Association of Great Britain, the British counterpart to the Consumer Healthcare Products Association.
"In practice, of course, most sales are made to people who have bought the products many times before to treat self-recognized, self-limiting conditions where professional advice is not needed," Kelly says.
In Canada, the number of non-prescription drugs sold from behind the counter has shrunk to 176 of the 20,000 self-care products sold there, says David Skinner, president of the Nonprescription Drug Manufacturers Association of Canada. "I can't really recommend it," he says of the behind-the-counter category. "But we've had it for such a long time that we've come to live with it."
Skinner says his local drugstore has an enclosed area where customers can discuss sensitive matters with a pharmacist. "Some are good at it and will take the time, and others don't take the time."