This learning module was developed based on a needs survey sent to all third year medicine clerkship directors and all medicine residency program directors in the United States. This module was developed by the Center for Education and Research on Therapeutics (CERT) while at Georgetown University (CERT now located at the University of Arizona Health Sciences Center) in collaboration with the Center for Drug Evaluation and Research at the Food and Drug Administration. The work was sponsored by the Agency for Healthcare Research and Quality (AHRQ). We encourage you to complete the Module Evaluation Form, as it will provide feedback for the development of future learning modules.
Sample Case
ADRs: Prevalence and Incidence
Types of Drug Interactions
Drug Metabolism
ADR Reporting
Preventing Drug Interactions
Acknowledgements
Welcome to the Adverse Drug Reaction (ADR) learning module. The module will begin with a presentation of a case that was published in 1990. This case demonstrates why it is important that health care practitioners report ADRs to the Food and Drug Administration (FDA). It was also a pivotal case resulting in recognition and definition of one type of preventable adverse drug reaction— drug interactions mediated by the cytochrome P450 pathway of drug metabolism.
After discussing this case, we will discuss the prevalence and incidence of adverse drug reactions. We will then examine several well-recognized types of drug interactions that are the causes of preventable adverse reactions. This section will focus primarily on cytochrome P450-mediated drug interactions, although other types of interactions will also be included, as well as examples of drug-drug, drug-diet, and drug-herbal interactions. The emphasis will be on current knowledge that can help healthcare providers predict possible drug interactions. This will be followed by a discussion of ADR reporting via the FDA’s MedWatch program. Finally, a stepwise systems approach to preventing ADRs due to drug interactions will be outlined.