FDA's Behind-the-Counter Drug Plan Riles Docs The Food and Drug Administration is considering creating a new class of drugs that would sit on shelves behind the register, and pharmacists could help people decide whether the drugs are right for them. But some doctors say pharmacists don't have the qualifications to give out medical advice.
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FDA's Behind-the-Counter Drug Plan Riles Docs

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FDA's Behind-the-Counter Drug Plan Riles Docs

FDA's Behind-the-Counter Drug Plan Riles Docs

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MELISSA BLOCK, host:

The Food and Drug Administration is considering whether to create a third category of pharmaceuticals. There are already prescription drugs available only with the doctors' approval and over-the-counter drugs - anyone can buy them. The new category would be called behind-the-counter drugs.

NPR's Joanne Silberner visited a pharmacy to see how behind-the-counter drugs might work.

JOANNE SILBERNER: I'm standing here at Grubbs Pharmacy in Washington, D.C., just a few blocks from the Capitol. It's a busy place. There are six or seven pharmacists and pharmacy assistants counting up pills, putting things into computers. And pharmacist Michael Kim says he like that consultations a little bit more.

Dr. MICHAEL KIM (Pharmacist, Grubbs Pharmacy): I actually think it's a very good idea. I think it's going to allow patients a broader access to drugs currently not available to them.

SILBERNER: Kim already offers blood pressure, diabetes and cholesterol checks to his customers but without a doctor's prescription. He can only sell them over-the-counter treatments or suggests they go see a physician. What the FDA is considering is whether there maybe some drugs where people can diagnose themselves with a help of a pharmacist who can also counsel them about how to take the drugs.

Mr. KIM: It's also going to provide the pharmacist an opportunity to actually use their clinical skills that they've learned in school in a real-life setting.

SILBERNER: And he says behind-the-counter drugs could save people a trip to the doctor or the emergency room. Several other countries have behind-the-counter drugs including Canada. Bridgitte Zirger is with Health Canada. She spoke at an FDA hearing on behind-the-counter drugs in Washington recently. During one of the breaks, she said the system works pretty well.

Ms. BRIDGITTE ZIRGER (Director, Health Canada): In general, I would say it does. I'm not aware of an outcry that behind-the-counter is not working well.

SILBERNER: There's a drug her son uses, it's only available in the U.S. by prescription. But in Canada, it's one of the behind-the-counter drugs. And Zirger likes the category.

Ms. ZIRGER: I do. In fact, the epinephrine auto-injector - my son has allergies so we obtain our auto-injectors. And it's quite good that it's non-prescription. I can just get it from a pharmacist.

SILBERNER: All these is why the FDA has started investigation if and how a behind-the-counter option would work here. Randall Lutter is deputy commissioner for policy at the agency.

Dr. RANDALL LUTTER (Deputy Commissioner for Policy, Food and Drug Administration): Because the pharmacists are there, the key question is do we have an opportunity to improve public health by using their expertise better.

SILBERNER: But there's plenty of opposition to the concept, including from physicians groups. Joseph Cranston is head of science research at the American Medical Association.

Dr. JOSEPH CRANSTON (Director of Science, Research and Technology, American Medical Association): There are a lot of things that a physician is trained to do that a pharmacist isn't trained to do.

SILBERNER: At the FDA hearing, a British analyst described what happened when a cholesterol-lowering drug received behind-the-counter status there. Pharmacists were reluctant to do the blood testing that's required. And many didn't tell their customers about the option. The AMA's Cranston says those pharmacists shouldn't be prescribing statins.

Dr. CRANSTON: What you're missing here is a physician doing a history and physical examination that notice if the patient have other diseases like hypertension or other - or diabetes or is the patient pregnant, in which case you wouldn't want to use that drug.

SILBERNER: Consumer advocate Sydney Wolfe of the Health Research Group says a lot more work needs to be done to determine if there's a need for a behind-the-counter category.

Dr. SIDNEY WOLFE (Director, Health Research Group): Studies by the United State's government and in 10 countries that have had behind the counter availability of drugs have shown there's no evidence of increase access by patients. There is very serious concern about the completeness or promptness of the information that pharmacists give out in the counseling process.

SILBERNER: And what is needed, he says, is new study of how those other countries are doing now. The FDA will continue to gather public comment until mid-December, then it will figure out where to go next. If it does decide to establish a behind-the-counter category, it will have to figure out whether it needs congressional approval.

Joanne Silberner, NPR News, Washington.

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