e-OTC Concept Can Aid in Rx-to-OTC Switches

As more prescription products make the switch to OTC status, pharmacists and patients may see a new option for ensuring optimal treatment: the e-OTC drug.

The e-OTC drug concept has its roots in a 2012 FDA initiative regarding prescription-to-OTC switches. The initiative, called the Non-Prescription, Safe-Use, Regulatory Expansion (NSURE), aims to include health care professions or technology options in helping patients understand the risks and rewards of OTC medications, Hamacher Resource Group vice president David Wendland said in an interview with Pharmacy Times.

“It’s going to keep the pharmacist in the driver’s seat of consultation,” Wendland said.

“The NSURE initiative specifically said we want to look at encompassing the health care professionals and/or innovative technologies to ensure safe and effective use of OTC medications,” he added. “It could be a combination of both.”

Examples of e-OTC technologies combining the health care professional and technology include tablet-based programs to assess patient knowledge, whereas technology-exclusive options include health kiosks or other technologies. Despite the possibility for technology-only options, those are not as favorable when it comes to products newly available over the counter, Wendland said.

“That’s really the safest path for an OTC to launch right now, to use the valued, trusted health care professional,” Wendland said. “I think the second option, the ‘and’ solution, is a real viable option. I think technology-only solutions are probably a little bit farther downfield.”

E-OTC drugs are not yet being used in the United States, nor have any new drug applications specified a desire to use health care professionals or technology means in switching from prescription to OTC status.

Despite this, potential categories that are amenable to an e-OTC program include therapies for chronic conditions, such as statins, sleeping aids, erectile dysfunction medications, and migraine therapies. The potential for these types of switches will likely drive technology or health care provider—driven management strategies.

“If the FDA is serious about reducing health care costs, reducing burden on the health care system, improving the ability for consumers to take responsibility for their health care, then I think some of these chronic categories need to come across the counter, and need to have either a technology and/or professional health care guidance in order to make it a safe and effective switch,” Wendland said.

Apple’s recent announcement of HealthKit, its health-tracking software, and similar offerings from other smartphone manufacturers may aid in the adoption of e-OTC programs. In addition to capitalizing on the technology’s omniscience, the device’s ability to read, track, and store results of various physical tests is also attractive.

“I do see that being a part of the future application,” Wendland said. “I would say it won’t be long before you’ll see an advertisement where the tagline will probably be ‘There’s an app for that.’”

The technology component associated with smartphones is not without pitfalls, Wendland added. Reliance on cloud-based technologies, which store data and other information externally from the device or user, will likely create security concerns, although Wendland said these will not be insurmountable. In addition, authentication features will need to ensure that end users are who they claim to be.

“What we don’t want to see is a flood of new OTCs or a new product coming to market that falls into the wrong hands, or is misused, or causes very, very serious outcomes, including death,” Wendland said. “So we have to make sure it’s safeguarded.”

From the provider’s perspective, technology will likely need to record patient outcomes of OTC therapy, as well as the therapy itself. Given the focus on outcomes, measuring and recording patient progress is likely to be a particular focus, especially if financial models require outcome measures.

“Potentially, the financial model for reimbursement, if indeed any of the managed care companies get involved, will be based on the outcomes,” Wendland said. “Ultimately, that provider’s system is going to have to feed back information about the patient’s cholesterol [to ensure it] is in check, and it had this sort of effect on the patient’s health care spend, and kept her out of the hospital for a heart condition or whatever it may be. . . is the ACO model one that ultimately includes technology that’s tied to an OTC regimen? It’s very feasible, in my opinion.”