Historically, there’s been tension between OTC manufacturers who want access to their products to be unfettered and health professionals who would prefer that consumers have access to help that assures safe use. Pharmacists see the challenges that come from a lack of understanding, the influence of advertising, differing disease states and health literacy levels, and many other factors that can complicate OTC use. Consumers don’t know what they don’t know.

Recently, FDA took the first step toward increasing patient access to an array of nonprescription drugs when it released a draft guidance that would expand the methods—including technological methods—sponsors can use to demonstrate a nonprescription product’s safety and effectiveness. Technology, like mobile applications or videos, could supplement labeling or provide additional conditions for safe and effective use to lower the risk of certain switched OTC products. The larger message is that FDA is encouraging innovative approaches to broaden access to nonprescription drugs.

The draft guidance is the first step of a larger FDA effort to modernize its regulatory framework for nonprescription drugs. We maintain that pharmacists must be included in that equation!

As medication experts on the patient’s health care team and the health care provider on the frontlines, we want to work with FDA, manufacturers, and consumers to expand access to OTCs. Yet we see patients struggle with increasingly complex therapies and rising prices. We maintain that pharmacists’ services and expertise need to be readily accessible when OTC decisions are made.

On July 31, 2018, APhA submitted comments to FDA Commissioner Scott Gottlieb. Our comments were not a direct response to the draft guidance, which has a narrow focus on the role technology can play in mitigating risk with OTCs. Rather, we emphasized that technology alone can’t replace the benefits of a relationship with a health care provider like a pharmacist. Technology may be a tool to assist consumers and pharmacists to collectively reduce risks associated with certain products to best address an individual’s needs.

What do you think? Should pharmacists be readily available to consumers when formerly prescription drugs are being considered for self-care? Or can that access be replaced with an app or online questionnaire? We want to hear from you. Members can post their responses on APhA’s Engage Open Forum. We will use your perspectives in our ongoing conversation with FDA about how pharmacists can facilitate switching prescription drugs to OTC status.