Understanding the Criteria, Process for Rx-to-OTC Switches

For many years, over-the-counter (OTC) pharmaceutical products have given patients the ability to conveniently treat themselves, while giving pharmacy businesses greater opportunities for bringing patients into their practice and achieving better front-end profitability. However, many of the OTC products best-known today were once reserved as prescription-only, underscoring the importance of the FDA’s Rx-to-OTC process.

So, how does a drug go from needing a prescription to becoming universally available for any individual in the community?

“At a high level, medications tend to stay prescription-only when they treat conditions that are hard for patients to self-diagnose. Maybe they require some ongoing monitoring, or they carry higher risks that they're using correctly,” Alyssa Billingsley, PharmD, senior director of pharmacy content at GoodRx, told Drug Topics. “On the flip side, medications that make it to the OTC shelf are usually meant for conditions that people can reasonably recognize and manage on their own, as long as the instructions are clear.”

Billingsley, who’s worked in clinical, academic, and administrative roles throughout her career in pharmacy, has seen in real-time the benefits and potential concerns associated with products going from prescription-only to OTC. She joined Drug Topics to help our audience better understand the FDA’s process and how it opens the door for both patients and pharmacists.

Get expert insights from a pharmacy industry professional and her knowledge on the FDA’s approval process for both prescription and OTC drugs. Furthermore, through her collaboration with industry professionals on pharmacy content discussing the Rx-to-OTC process, Billingsley helps us understand the varying perspectives on how this switch can transform outcomes across the nation.

READ MORE: OTC Resource Center

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