NACDS and NCPA speak out at FDA hearing in favor of BTC classification

WASHINGTON Both the National Association of Chain Drug Stores and the National Community Pharmacists Association are heavily in favor of the creation of a third class of drugs, according to testimony provided by both associations before a Food and Drug Administration panel on the matter here this afternoon, provided that the increased pharmacist-patient interaction a behind-the-counter class of drugs would generate would be duly compensated.

NCPA president Stephen Giroux suggested three reasons behind retail pharmacy’s strong support of a BTC class of drugs—reduced health costs, increased consumer convenience and the potential utilization of BTC as a vehicle in creating a comprehensive post-marketing tool with pharmacist oversight. “Not only are pharmacists the most accessible healthcare provider [out there], pharmacists have the training and the knowledge to [provide drug] interactions,” he said.

“Pharmacists are uniquely qualified to take on this new role,” testified NACDS’ Mary Ann Wagner, but if an appropriate reimbursement model is not included in that new rule, a BTC class of drugs could evolve into a medicine class that limits access to consumers, and similarly has the potential to increase healthcare costs.

As for concerns raised earlier in the day pertaining to the potential draining a BTC class of drugs would have on pharmacy workflow (see "FDA panel hears arguments in BTC debate"), Giroux suggested pharmacists would take that new challenge in stride. And pharmacists may not have a problem accessing comprehensive patient records, Giroux said, especially as e-prescribing capabilities continue to evolve through association backed partnerships such as SureScripts.

Wagner suggested that a BTC class of drugs not be used as a reverse-switch option. “This class should not be used to enforce age” or any other restrictions, she said. The recently legislated migration of pseudoephedrine to behind the pharmacy counter could serve as an example of an inappropriate use of a BTC model—PSE was first BTC because of concerns over diversion, not concerns over product safety.

Likewise, Wagner opined that the BTC class of drugs should not be a layover for a prescription medicine en route to over-the-counter status. Rather, it should be a permanent class of drugs because of the necessity of pharmacist intervention.

Giroux, however, suggested that BTC might indeed become a new waypoint for drug switching from Rx-to-OTC, and appropriately so.

And while Wagner acknowledged that the FDA had little to do by way of establishing a reimbursement-based business model around the proposed BTC class of drugs, that issue could very well be the most crucial question for pharmacy operators. It is possible, she said, that moving drugs from prescription-only to BTC could prompt maintenance care operators to drop those medicines from their drug formularies. “The additional clinical role [of the pharmacist] must be recognized and compensated,” she said.

Liability is another concern for drug store operators, Wagner said, noting that product liability in a BTC model should not necessarily pass from manufacturer to retailer.

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