Devices Gain Ground On Pharmacists In Switch Paradigm Talk

Industry stakeholders and FDA officials have been paying increased attention to devices and IT developments, which potentially open new routes to make more drugs available nonprescription under conditions of safe use.

FDA’s look at expanding the paradigm for OTC switches has shifted focus by degrees away from pharmacists and toward devices and software as the primary factors for making drugs available nonprescription under “conditions of safe use.”

For decades experts have looked at pharmacy-only distribution – potentially paired with a diagnostic process or consultation by a pharmacist – as a method to make more drugs available without prescriptions while limiting access to an appropriate population.

However, industry stakeholders and FDA officials say the development of information technology, including mobile as well as desktop devices, potentially opens a route to make more drugs nonprescription. IT devices could enable consumers to self-diagnose and, if necessary, self-select a drug (Also see "FDA Novel Switch Meeting Shows Gulf Between Interests" - Pink Sheet, 26 Mar, 2012.).

Steven Francesco, president of Francesco International in Orange, N.J., presented on the potential of IT devices during FDA’s “new paradigm” public hearing March 22-23 in Silver Spring, Md. FDA conducted the hearing to hear OTC drug, pharmacy and health care industry stakeholders’ ideas about novel ways of making drugs available nonprescription (Also see "FDA Novel Switch Meeting Shows Gulf Between Interests" - Pink Sheet, 26 Mar, 2012.).

Francesco suggested that consumers could access drug labels that cover conditions of safe use or self-assessment programs linked to certain conditions on web-enabled mobile phones.

“People could read it off the smartphone in bigger type, or better yet instead of reading, the phone would talk to the person so the person just has to listen and they would answer questions,” he said in an interview.

“We need to engage technology as we contemplate this migration of some prescription drugs to over-the-counter … [but] I think it would be shortsighted to not take advantage of the health care professional who is the medication expert.”

– RxAlly CEO Bruce Roberts

“Those kinds of things are fabulous and can dramatically improve outcomes,” he said, adding, “Limiting it to the pharmacy and the pharmacists is old stuff. That was okay in 2007. We’re way beyond that.” (In 2007 the agency conducted a public hearing that focused largely on a “behind the counter” model, requiring pharmacy-only distribution, for more challenging switches (Also see "Hatch/Waxman Incentives Could Make BTC Status A Win – Consultant" - Pink Sheet, 19 Nov, 2007.).)

Ed Hemwall, a Merck & Co. Inc. consumer business executive with extensive switch process experience, also expects IT devices to make possible more switches. “Our conditions of safe use are technology-based. They do not require a pharmacist as the gatekeeper,” he said at the new paradigm hearing.

The Consumer Healthcare Products Association advocates avoiding barriers to nonprescription drugs access that would come from requirements either for pharmacist intervention or that consumers use self-diagnosis devices. CHPA says conditions for safe use could vary widely among drugs in different categories and perhaps among drugs for the same indication, and FDA should evaluate each product potentially proposed for restricted consumer access on a case-by-case basis .

Pharmacists Argue For Primary Role

The American Pharmacists Association, on the other hand, sees an adjunct role for devices and a primary role for pharmacists in distributing nonprescription drugs approved with restrictions on consumer access.

At the new paradigm public hearing, APhA Executive VP and CEO Tom Menighan said with drugs available nonprescription under conditions of safe use, pharmacists will have the “opportunity to expand patient access, improve public health and provide another avenue to treat people who may have poorly treated chronic health conditions back into the health care system.”

Bruce Roberts, CEO of Rx-Ally, a recently launched firm that provides pharmacies with an interoperable technology platform to improve patient health while reducing costs through personalized pharmacist care, also emphasized that diagnostic devices are helpful but health care professionals are crucial to assisting consumers. The Leesburg, Va.-based firm in February launched its network with more than 20,000 independent and chain pharmacies, including Walgreen Co. stores.

“I do agree to an extent that we need to engage technology as we contemplate this migration of some prescription drugs to over-the-counter,” Roberts said, but added, “I think it would be shortsighted to not take advantage of the health care professional who is the medication expert.”

He acknowledged that OTC drug manufacturers want to eliminate barriers to consumer access to their products. But a pharmacist’s intervention will ensure that a consumer chooses the correct treatment and uses it appropriately, he added.

“It’s safety in one sense, in the other it’s the tremendous value of these drugs being used correctly, making sure that you have somebody there to make sure that the patient gets the full value of what they’re contemplating taking,” said Roberts, who operates pharmacies and a home health care business in Loudoun County, Va.

“It shouldn’t be about just giving the manufacturers the opportunity to sell as many of their medicines as they possibly can. It should be about making sure the appropriate medicine is used … and there is somebody there to make sure that they’re taken properly.”