APhA Proposes New "Pharmacy Care OTC" Category of Drugs

The American Pharmacists Association(APhA) is developing a new proposalto create a third class of drugs,which would be sandwiched betweenprescription and OTC medicines andavailable only at retail outlets staffedby an on-premises pharmacist.

The products in the new category,which APhA is calling "Pharmacy CareOTCs," would include medications"used for chronic, asymptomatic conditionsor other conditions where consumerswould benefit from additionalinteraction with their pharmacist," arepresentative from the association said.

In addition to enabling consumersto "benefit from the expertise of pharmaciststo help them effectively utilizethese products," the establishmentof such a new class of drugswould create "an opportunity forpharmacists to play a greater role inconsumer medication use," an APhArepresentative said.

Behind the new plan: the steady risein prescription-to-OTC drug switchesapproved by the FDA—including ashift in the status of a number ofsophisticated and powerful pharmaceuticalsthat are now available withouta prescription.

"In the past few years, a non-sedatingantihistamine, a full-strength H₂receptor antagonist, and a proton-pumpinhibitor have made this transitionto OTC status," an APhA executiveexplained. "With the support ofconsumers, manufacturers, and regulators,all indications point to even moreproducts making the move - includingproducts for asymptomatic conditionslike osteoporosis or high cholesterol."

The plan for the new pharmacist-onlyOTC category was developed byan APhA Task Force, which is nowseeking comments on the proposalfrom pharmacy professionals and others.A final report from that group isexpected early in 2005.