Naming of Chiral Drugs: Should We Revisit?
Mahsa Salsabili, Claire Caschetta, Nicholas Senne & Stephen Schondelmeyer
The purpose of standard nonproprietary, or generic, drug nomenclature is to provide a universally consistent and reliable name that facilitates safe and effective medication use in society. Naming that presents the drug inaccurately may result in erroneous prescribing and potentially puts the patient’s health at risk. This paper tracks the historical record of guidelines for naming stereoisomer drugs both in the United States and on an international basis. We also examine the concordance of current nonproprietary (generic) names with the United States Adopted Names (USAN) stereoisomer naming guidelines currently in place. The USAN stereoisomer naming guidelines have changed throughout the years; however, the nonproprietary names of many drugs designated under previous guidelines have not been updated to reflect these changes. There is a need for key players such as the USAN Council, United States Pharmacopeia (USP), and the Food and Drug Administration (FDA) to come together to establish a practical, informative, and consistent set of guidelines for the naming of stereoisomer drugs. We acknowledge that the naming of stereoisomer drugs to provide useful information for clinicians is not simple, but the current state of affairs is inconsistent and unreliable, putting patient safety at risk. The purpose of the recommendations within this paper is to stimulate thinking and to improve the current stereoisomer naming guidelines, while reducing the future public health risk of continuing inconsistent stereoisomer drug naming practices.
Food and Drug Law Journal
Volume 75, Number 1