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Date Published: November 13, 2007

Looking Behind the Counter:
FDA Proposes New Category
of Drugs

November 13, 2007 By Diane Majeske Post-Tribune staff writer

Your neighborhood pharmacist might become a little more important in your life if the FDA's proposal for a new category of drugs comes to fruition. The Food and Drug Administration is examining the possibility of adding "behind the counter" drugs -- drugs available without a prescription but at a pharmacist's discretion -- to the consumer mix.

Currently, there are essentially two categories of drugs -- over the counter and prescription. A third category, the FDA asserts, could potentially benefit consumers, particularly those without health insurance. The type of drugs that would be available in this category have not yet been determined.

"This is a very important issue for pharmacists," said Judy Chi, editor-in-chief of Drug Topics, a leading trade journal for pharmacists that has been covering the issue. "The American Pharmacists Association is in favor of it, because it will increase pharmacy traffic, but among the individual pharmacists, there is some dissension."

One issue, she said, is the workload that would likely come with increased patient counseling and interaction. "Some pharmacists wonder if there'll be reimbursement for the increased counseling," she said. "And some feel it's unrealistic to think they'd have time to provide the additional counseling that would be necessary.

Pharmacists are already incredibly busy." The FDA will host a public meeting Wednesday in Washington, D.C., to sort out the issues that come with the proposal, including the criteria for drug availability, patient safety and privacy, any special training needed for pharmacists and benefits and/or costs to the health-care system.

On its Web site, the FDA brings up a potential benefit to consumers -- and the fact that variations of a "behind the counter" status for drugs are already in effect in other countries. "Some groups have asserted that pharmacist interaction with the consumer could ensure safe and effective use of the drug product that otherwise would require a prescription," the FDA said.

"Because pharmacists have the training and knowledge to provide certain interventions, they may be able to ensure that patients meet the conditions for use and educate patients on appropriate use of the drug product." Jerry Fagen, the CEO of a chain of 22 Fagen Pharmacy drugstores in Indiana and Illinois, supports the proposal.

"I think it's a good idea, and it's long overdue," he said. With the ever-increasing potential for abuse of over-the-counter drugs, he said, the role of the pharmacist is even more important. Without a program like this, he said, it's likely that more medications will simply disappear -- a scenario recently played out with cold medicines for children age 2 and under -- or become prescription.

"If we keep going the way we're going, you'll need a prescription for everything," he said. "And I'm very concerned about that." The National Association of Chain Drug Stores, which represents CVS and Walgreens, among other retail stores, is taking a wait-and-see attitude.

"This is a work in progress," said Chrissy Kopple, spokeswoman. "And our policy council is still reviewing it. Obviously, it's very important that pharmacists do talk with patients and interact with them and provide them with information. Part of the pharmacist's job is to counsel patients and assist them ... but we're still looking at the (proposal) to determine if this is the best way."