Behind-the-counter drugs could be on sale in U.S. pharmacies

Oct 3 2007

The Food and Drug Administration (FDA) in the United states is considering creating a new category of drugs.

The 'behind the counter' (BTC) category will be drugs available without prescription at a pharmacy, which will be accessible after consultation with a pharmacist.

The FDA plans to conduct a public meeting next month with regard to the idea to garner feedback.

The BTC concept to be aired on November 14th will broaden the accessibility of some drugs only currently available with a doctor's prescription.

At present in the U.S. only a few BTC drugs, such as the Plan B birth control drug, are available, whereas countries such as Britain, Australia, Canada and New Zealand already use the method widely.

The move has the support of pharmacists trade groups such as the National Community Pharmacists Association and the National Association of Chain Drug Stores, who view it as a means of expanding their role in the delivery of health care.

The FDA says the criteria used in other countries for BTC status are suitability for self-diagnosis and a low potential for serious side effects and overdose.

The FDA says pharmacists have the training and knowledge to provide certain interventions, and are able to ensure that patients meet the conditions for use; they are also able to educate patients regarding the appropriate use of the drugs.

The FDA says better access to some drugs could be of advantage to patients without health insurance where the medications would otherwise only be available with a prescription.

The FDA is hoping for input from the drug industry, the medical community and advocacy groups about which drugs should become available on a BTC basis, along with the impact it would have on patients' use, and the criteria a drug needs to qualify it to be classified as BTC.

The agency also wants suggestions on the role of the pharmacist in counseling and monitoring patients' use of BTC drugs and what measures are needed to ensure patient safety.