FDA opens dialogue of incorporating technology, pharmacy into switch paradigm

SILVER SPRING, Md. — The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing held here.

Those new pathways to improve access included the use of improved communication technology that could enhance the Drug Facts Label, such as making available instructional videos for public consumption, a codified mechanism that would incorporate a pharmacist consultation or diagnosis before a medicine was made available, and a model where pharmacists would serve as physician extenders for medicines treating chronic conditions.

"We're not considering altering the process of the [over-the-counter] switch itself," Woodcock told attendees. But the agency is interested in exploring ways that the pharmacy community and/or advanced communication technology can augment access to nonprescription medicines, and, where appropriate, to create an avenue where patients can be redirected to a medical home. Woodcock also suggested that new regulations governing this new switch paradigm would be necessary.

Pharmacists are "cautiously optimistic" on the proposal to incorporate pharmacists in the administration of medicines not yet considered appropriate for over-the-counter access, Eric Juhl, director of federal public policy for the National Association of Chain Drug Stores, stated in his opening remarks. Any rule-changing would need to recognize the increased costs pharmacy would necessarily incur under such a model, including both counseling time and administrative costs. Juhl also cautioned that this new paradigm should not be used to restrict access to medicines already available over the counter (e.g., pseudoephedrine). "The time of the pharmacist is limited, as is the space behind the counter," Juhl said.

Juhl also suggested that pharmacy operators already are contributing to improved, more efficient and less costly health care through collaborative practice agreements, now allowed in 34 states, where pharmacy operations and physician groups collaborate care to help improve prescription-drug compliance and convenient access to care.

Immunizations are another example where the expansion of a pharmacist's purview helped improve access and increase utilization of health care — for the 2010/2011 influenza season, pharmacists administered more than 20 million influenza vaccines, noted Tom Menighan, EVP and CEO for the American Pharmacists Association. "Immunizations [also are] a good example where the business process developed once the rulemaking was put into place," Menighan said, but reiterated Juhl's concerns that pharmacists be adequately reimbursed for any contribution under a new switch paradigm.

The hallmark of OTC medicines is the consumers’ ability to pick a product off the shelf, read the package label, and appropriately and safely self-select the medicine to treat their condition, noted Scott Melville, president and CEO for the Consumer Healthcare Products Association. Tools and technologies, beyond the traditional Drug Facts label, can assist consumers in making appropriate OTC selections — diagnostic tests, health kiosks, smartphones, self-screeners and pharmacist consultations all can help consumers accurately recognize conditions and select and use an appropriate medicine. “Ultimately, we envision a future where innovative switches are made possible by tools and technologies on a data-driven case-by-case basis,” Melville said.

The meeting, which is scheduled to end at 4 p.m. on Thursday before resuming Friday, is being webcast live by the agency here.

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