“By prescription only” and “over-the-counter” (OTC) are the traditional tiers of drug availability in the U.S. But a third tier may be coming, one that has been available in other parts of the world for some time: so-called “behind-the-counter,” or BTC.

On Nov. 14, 2007, the U.S. Food and Drug Administration (FDA) convened a hearing on whether some drugs should be made available after consultation with a pharmacist rather than a physician. This would add a new classification, dubbed “behind-the-counter” (BTC), to the existing ones of traditional prescriptions and “over-the-counter” (OTC) medications.

In much of the world, BTC is nothing new. Europe, Canada, Australia and New Zealand already feature it. Under a BTC system, the pharmacist, rather than the physician, acts as the intermediary between the patient and select medications.

Barr Pharmaceuticals’ “Plan B,” the so-called “morning after pill,” last year became the first former “prescription-only” drug to move behind-the-counter in the U.S. In 2005, certain over-the-counter decongestants, such as Sudafed and Afrin, were moved behind the counter in response to concerns that they can be turned into illegal methamphetamine.

Determining exactly what drugs would be affected by a move toward BTC in the U.S. are among the many practical and regulatory challenges before BTC becomes a reality in the U.S. IMS’s Scott Lappetito takes a closer look at the ins and outs. Click here to read the full article.