The American Pharmacists Association (APhA) is developing a new proposal to create a third class of drugs, which would be sandwiched between prescription and OTC medicines and available only at retail outlets staffed by an on-premises pharmacist.
The products in the new category, which APhA is calling "Pharmacy Care OTCs," would include medications "used for chronic, asymptomatic conditions or other conditions where consumers would benefit from additional interaction with their pharmacist," a representative from the association said.
In addition to enabling consumers to "benefit from the expertise of pharmacists to help them effectively utilize these products," the establishment of such a new class of drugs would create "an opportunity for pharmacists to play a greater role in consumer medication use," an APhA representative said.
Behind the new plan: the steady rise in prescription-to-OTC drug switches approved by the FDAincluding a shift in the status of a number of sophisticated and powerful pharmaceuticals that are now available without a prescription.
"In the past few years, a non-sedating antihistamine, a full-strength H2 receptor antagonist, and a proton-pump inhibitor have made this transition to OTC status," an APhA executive explained. "With the support of consumers, manufacturers, and regulators, all indications point to even more products making the move - including products for asymptomatic conditions like osteoporosis or high cholesterol."
The plan for the new pharmacist-only OTC category was developed by an APhA Task Force, which is now seeking comments on the proposal from pharmacy professionals and others. A final report from that group is expected early in 2005.