INITIATIVE 4:Develop a Strategy for Behind-the-Counter Drugs

Wendy Toth

The Food and Drug Administration held a public hearing last month to gather industry views on the merits of increasing behind-the-counter access to drugs.

Representatives from the retail pharmacy industry presented arguments in favor of what could become a new drug category — drugs whose sale would not call for a doctor's prescription but would require consultation with a pharmacist.

Although supermarket pharmacies already carry cough and cold products containing pseudoephedrine behind the counter, marketing them with shelf tags — as well as carrying the emergency contraceptive Plan B — a new drug category would require significantly more planning, sources said.

This new class of drugs would be a natural progression of the pharmacist's role in counseling consumers and would “reduce consumer health care costs, increase patient convenience and provide a vehicle for post-market safety supervision for consumer protection,” said Steve Giroux, president of the National Community Pharmacists Association, at the hearing.

Clinical protocols would be necessary and could be integrated in much the same way as nutritional counseling is in many retail pharmacies, he said.

“We have to look at the workflow and record keeping that would be required, as well as consider the impact on customers if this new class of drug was not covered by insurance,” said John Fegan, senior vice president, pharmacy, Ahold USA, Quincy, Mass.

There is also a question of liability for the safety of the drugs, he said. “The pharmacists may have to absorb the liability, so we support the concept as long as the liability on the part of pharmacist is somewhat mitigated,” he said.

If drugs that are currently over-the-counter are made behind-the-counter, this will decrease their availability in retail stores lacking a pharmacy, said Eileen Harley, director of government relations for the Food Marketing Institute, Arlington, Va., during the hearing. FMI supports the new drug class while maintaining that customers should have access to those medications that can be taken safely and effectively without a prescription.

For instance, cough and cold products containing pseudoephedrine were moved behind the counter not for “therapeutic counseling, but because of abuse potential,” Fegan said. Rather than repeat this kind of action, he hopes a new drug class would serve as an interim step for drugs that might make the switch from prescription to over-the-counter.

As the FDA continues to consider this new drug class, pharmacies should be thinking about increased shelf space, ways to coordinate with doctors and labs, and the formulation of a standardized documentation system, according to Harley.