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12-25-2007, 11:12 PM
Recently, at a public meeting sponsored by the U.S. Food and Drug Administration (FDA), the American Pharmacists Association (APhA) strongly supported the concept of making certain drugs available without a prescription, but only after consultation with a pharmacist. The FDA is seeking information and views from the public regarding such a "behind-the-counter" (BTC) status of drugs, including the potential impact on patients' access to safe and effective medications, as well as on patient use and compliance.

Currently, medications are available as prescription or non-prescription, referred to as "over-the-counter" (OTC). The pharmacist communication with a patient, reflected in plans for the BTC status, would help ensure safe and effective use of medications, and would increase patient access to medications they previously may not have been able to use - particularly if they do not have health insurance.

"A pharmacist's in-depth knowledge of the risks, proper usage, potential side effects and other key information about the thousands of prescription and OTC products is often an untapped resource for the consumer," said Winnie Landis, APhA President and community pharmacist. "As consumers have become more aware of product risks they are asking for more and better information to make decisions about their health care needs. Making some medications available after pharmacist intervention could increase available therapy options, improve therapeutic outcomes and enhance patient safety."

Pharmacists are uniquely qualified to provide the necessary oversight for BTC drugs and are the medication use expert on a patient's health care team. Many of the products that could be considered for the BTC designation are ones pharmacists already deal with in their practices. Additionally, today's pharmacists have extensive training in self-care management, patient evaluation, patient education, as well as a broad range of clinical knowledge relating to the safe and effective use of medications.

"Several studies demonstrate that when pharmacists assess and assist patients in managing their prescription and non-prescription medications, patient compliance, safety and health outcomes increase significantly," Michael Moné, APhA's expert witness, said during his testimony to FDA representatives today. "With increased access to medications, combined with a pharmacist intervention, a patient is less likely to go untreated or incorrectly treated, and therefore is less likely to deal with more advanced symptoms or the adverse effects of inappropriate usage."

About the American Pharmacists Association (APhA)

The American Pharmacists Association, founded in 1852 as the American Pharmaceutical Association, represents more than 60,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and advance patient care, is the first-established and largest association of pharmacists in the United States.

American Pharmacists Association (http://www.pharmacist.com/)