The Alliance for Patient Access / IfPA’s Patient Access Policy Blog / Shift to OTC Medications Could Improve Patient Access

Shift to OTC Medications Could Improve Patient Access

By Amanda Conschafter, blog editor

Claritin, Zantac, the nicotine patch – even children’s Advil – were once accessible only by prescription. But, as panelists at Pfizer’s recent “Expanding Consumer Access Through Rx to OTC Switch” briefing noted, more medications are transitioning to an over-the-counter model. That shift could lower costs and improve patients’ access to medical therapies, potentially revolutionizing public health.

Offering medications without a prescription allows patients who might otherwise be deterred by high prices or lack of health insurance to obtain necessary treatment. It also eliminates the time required to visit one’s physician – allowing physicians to focus their limited time on high-risk patients or those with more complex conditions.

The shift encourages consumers to “engage in their own health care,” noted panelist Mark Gelbert, Ph.D. of Pfizer Consumer Healthcare. And data suggests this engagement could improve public health. Panelist Christopher Stomberg, Ph.D. of Bates White LLC detailed a 2013 study indicating that offering OTC forms of a prescription medication increased utilization per drug class by 30 percent, potentially closing treatment gaps. Stomberg characterized the shift from prescription to over-the-counter medications as a “quiet revolution in health care.”

Indeed, the shift highlights the broader trend toward self-care. Increased internet availability grants patients greater access to information on health conditions and available therapies. Meanwhile, personal gadgets such as Fitbits allow patients to monitor their own wellness metrics. OTC medication, along with diet, exercise, and access to personal health information such as lab results, contributes to the growing self-care paradigm.

But what seems to be a win-win for the health care world is not without its challenges. As Dr. Gelbert explained, the FDA has little incentive to transform approved therapies from prescription to OTC status. Amid countless applications for new prescription drug approvals, requests for an OTC switch can require pharmaceutical firms to commit a substantial amount of time and money to the process.

Moreover, the shift requires patients to effectively manage their own OTC treatment. As the FDA bluntly notes, “Drugs aren’t candy;” the agency tasks manufacturers with rigorous requirements for reader-friendly labels when their products switch to OTC status.   Patients must also recognize when self-care reaches its limitations. Even in the era of patient empowerment, the care of a trusted physician plays a central role in addressing complex conditions and in achieving optimal long-term health.

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The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
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