Nonprescription Medications with Conditions of Safe Use as a Novel Solution for Undertreated Diseases or Conditions

On November 8, the Engelberg Center for Health Care Reform convened an expert workshop, “Nonprescription Medications with Conditions of Safe Use as a Novel Solution for Undertreated Diseases or Conditions,” to clarify the goals of the NSURE initiative and to explore potential strategies to utilize health care professionals as a condition of safe use within the NSURE paradigm.

In an effort to address the undertreatment of common diseases and conditions within the United States, the U.S. Food and Drug Administration is exploring how an expansion of nonprescription drugs can serve to increase access to important medications and treatments. This is known as the Nonprescription Safe Use Regulatory Expansion (NSURE) initiative, an effort which is focused on developing innovative approaches for patients to appropriately self-select nonprescription products and maintain their safe and effective use. The objective of this initiative is to make drugs more widely accessible through conditions of safe use.

This expert workshop was the first of a series of meetings that will explore the NSURE initiative. Topics to be discussed in subsequent workshops include the use of innovative technologies to support the safe and effective use of nonprescription products and economic considerations resulting from a nonprescription expansion.