FDA Plans Next Round of Rx-to-OTC Switches

Safety concerns loom as the FDA considers making prescription drugs available OTC for conditions including hyperlipidemia, hypertension, migraine, and asthma.

The FDA is considering authorizing OTC versions of prescription drugs for certain chronic conditions, provided that measures can be put in place to ensure that the medications will be used safely. The new paradigm would be likely to significantly increase the role of pharmacists in counseling patients on the appropriateness of medications and monitoring their conditions. The agency will hold a public hearing this Thursday, March 22, and Friday, March 23, to discuss the feasibility of the proposed paradigm and potential benefits and costs.

Making medications for common diseases and conditions such as hyperlipidemia, hypertension, migraine, and asthma available without a prescription could help these medications get to patients who need them but are put off by the cost and time required to get a prescription. The problem is that some of these conditions require testing by a health care practitioner to help in diagnosis, and the medications require monitoring to gauge how well they are working or to fine tune the dose. So, in order for the new paradigm to go forward, means to assist patients in selecting a medication and monitoring its effects would have to be established.

One possibility envisioned by the FDA is that diagnostic technologies, housed in kiosks at pharmacies or accessed via the Internet, could lead patients through a series of questions and help them self-diagnose their condition or determine whether a given medication is contraindicated for them. Pharmacists might also be tasked with confirming a diagnosis or performing routine monitoring using diagnostic tests, such as a blood test to measure cholesterol levels or liver function, as well as determining when a patient should not take a given medication.

At this week’s hearing, the FDA will be seeking input from consumers as well as a variety of interested parties. Of particular interest to pharmacists, the agency wants to know how the conditions that might be put in place to ensure safe use of medications would affect pharmacy business operations, how these conditions would affect chain pharmacies and independent pharmacies differently, and whether making these medications available OTC only at some pharmacies would pose problems. The agency is also interested in whether pharmacists would require any additional specialized training to make the paradigm work.

The hearing will be made available via webcast, which can be accessed by clicking here.