Abstract

The actual use trial is a method for assessing safety of a prescription drug under conditions resembling non-prescription use. Thus, it is generally a key study in an application for the over-the-counter (OTC) switch of a drug in the U.S. Research models commonly used in pharmaceutical development or oversight (efficacy trials, phase 4 studies, and passive surveillance systems) are designed to answer other questions and offer only limited data about the suitability of a switch. We discuss study design elements that contribute to an understanding of the consequences of allowing consumers to carry out the functions normally performed by a physician (diagnosing, prescribing, and monitoring).