Parsing FDA’s new Rx-to-OTC switch initiative

Heads up practicing and soon-to-be-licensed pharmacists! More than ever, the Food and Drug Administration will soon need more of your help.

The FDA is now mulling a vastly accelerated campaign to shift a slew of prescription medications like statins to over-the-counter status. If the initiative succeeds, it could spawn an explosion of Rx-to-OTC switches affecting a broad range of prescription products generating an estimated $35 billion or more in annual sales, as well as giving patients, government health agencies and health plan sponsors one more reason to turn to pharmacists for their expertise and patient access.

That’s according to a newly released study from Francesco International looking at the new Rx-to-OTC switch paradigm under consideration by the FDA. In a Feb. 8 report, Drug Store News cites the Francesco study’s prediction of a potential boom in OTC sales that could result if the agency’s plan to push many prescription drugs into non-Rx, widely-available status, goes through.

More importantly, according to the report, the FDA “has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.”

Besides statins, the agency’s accelerated switch pathway could also put some meds for conditions like hypertension, COPD and benign prostate hyperplasia within easy reach of Americans, according to the Francesco report. Citing the study, DSN senior editor Michael Johnsen observes, “Enabling access to OTCs through technology or consults with retail pharmacists and clinicians could bring prescription-only medicines like statins into the mass market.” Other potential switch candidates identified by Francesco in the report include medicines for hypertension, benign prostate hyperplasia, chronic obstructive pulmonary disorder and erectile dysfunction.

Pharmacists already do a lot to counsel patients on OTC medicines. What impact do you think OTC status for some of these prescription-only drug classes would have on patients and your own practice?