New Drug Class: Behind the Counter

CHRISTINA VEIDERS

The passage of the Combat Methamphetamine Epidemic Act of 2005 unofficially created a new classification of drugs — those sold without prescription from behind the counter (BTC). The regulation, which passed in 2006, placed cold medications containing pseudoephedrine, also used to make the addictive stimulant methamphetamine, behind the counter. The emergency contraception, Plan B, which went over the counter in 2006, also is sold BTC.

The U.S. Government Accountability Office has decided to reexamine the viability of BTC as a drug class and update a 1995 report on the topic. In doing so, it looked at five countries where nonprescription drug availability has increased by altering nonprescription classes or reclassifying some drugs into less restrictive classes.

Proponents are supporting the move to improve public health through increased availability on nonprescription drugs and greater use of pharmacists' expertise. Opponents are concerned that a BTC drug class might become the default for drugs switching from prescription to nonprescription status, thus reducing consumer access to drugs that would otherwise become available OTC. They also argued pharmacists might not be able to provide the support counseling services needed for patients using the drugs.

Jim Wisner, president of Wisner Marketing Group, Libertyville, Ill., sees the BTC movement growing. He said if statin drugs that lower cholesterol go over the counter, they have a good chance of being sold BTC. “Such drugs need a small measure of reliable health care oversight that pharmacists are more than capable of doing. From a medication management standpoint, pharmacists get a lot more training than doctors,” Wisner said.

The movement of drugs to BTC status would help to change pharmacists' role in a good way, he added. “When their activity is primarily confined to dispensing, they're probably being under-utilized in the health care community. These are well-trained, very professional people who do understand medication management, and BTC drugs would enable pharmacists to have a more positive and proactive influence on what's going on with their patients' health.”