Healthy Skepticism Library item: 7890

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Frenia KJ, Maves MD, Toscani MR.
Rx to OTC switching...issues and answers
ASHP Annual Meeting 2001; 58:

Abstract:

Over the past several months there has been a great deal of controversy surrounding the shift of prescription drug products as they attempt to go over the counter (OTC). This session will review the current process involved prescription products gaining OTC approval. The discussion will examine the controversy surrounding the impact an OTC switch will have on the healthcare industry, pharmacists, physicians, and, most importantly, the patients. We will evaluate the research required for a successful product switch and will discuss factors that make a product a good switch candidate. Finally, we will hear comments from the perspective of the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry on the process and procedures required for a product switch. Learning objectives: l. Understand the reasons behind the push to switch drug products from prescription to OTC. 2. Appreciate the product selection process and research required for a successful switch from a prescription product to an OTC product. 3. Understand the impact a product switch will have on patient care within a health system. 4. List three key questions that need to be addressed before a product can qualify as a switch candidate. Self-Assessment questions: 1. True or false: By taking an OTC product for a common medical problem, such as a previously diagnosed recurrent yeast infection, patients can save money by avoiding the expense of a physician’s visit and prescription drug product. 2. Multiple choice: Which of the following issues is not taken into consideration when a product switch is considered? a. Potential for harm; b. Long term data from prescription use, c. Potential for addiction; d. Ease/possibility of self-diagnosis; e. None of the above. 3. Multiple choice: What is the approximate time for a product to switch from prescription to OTC? a. Less than one year; b. One to four years; c. Four to seven years; d. Greater than seven years. 4. True or false: To support a product switch a company is required to prepare a New Drug Application (NDA). Answers: 1. T; 2. e; 3. b; 4. T.