Adverse Drug Experience Management

Abstract

The management of adverse drug experiences (ADE) — with respect to reporting those experiences to the Food and Drug Administration and with respect to the medical evaluation of those events — associated with investigational and marketed prescription drugs is an obligation required both by ethical and regulatory considerations. Sophisticated management of that information is best accomplished through the use of a computer — preferably a timeshared computer, which gives the user instant access to the file of information pertaining to the drug in question. To achieve efficient management of such a file, a computer system designed for that purpose is required. This paper describes the Adverse Drug Experience Management System at McNeil Pharmaceutical. The system is described in some detail in order to assist organizations who are developing such systems or who have systems in place to view the management technique from another perspective. McNeil will be pleased if the following information proves of value to those organizations.