Evolution of self-care with over-the-counter medications

Abstract

Self-care with over-the-counter (OTC) medicines has evolved from the “dark ages” of patent medicine manufacture and sale to a modern era of new drug development involving prescription-to-OTC switch. This evolution is largely due to the OTC Review, which placed science at the cornerstone of safety, effectiveness, and labeling of nonprescription medicines. As self-care with OTC drugs has evolved, the switching of drugs from prescription to nonprescription status has produced important benefits, creating more self-reliant consumers through novel self-care therapeutics, significant cost savings to the health care system, expanded markets for companies, enhanced science for regulatory decisions, a more consumer-friendly label for all OTC agents, and a more consistent and predictable drug approval process. Potential regulatory barriers and an evolving claims environment for prescription drugs and dietary supplements present important challenges for the OTC industry today.