Presenter: Dr. Christine Chamberlain, PharmD, BCPS, CDE, U.S. Food and Drug Administration
Introduction
Adverse drug reactions (ADRs) are undesirable or potentially harmful effects that may occur when taking a drug. All drugs have the potential to cause ADRs, which can range from mild to severe. The incidence and severity of ADRs vary widely.
It is estimated that between 3 and 7 percent of hospitalizations in the United States are due to ADRs and that their rate of occurrence during hospital stays may be as high as 10 to 20 percent.
This module presents a comprehensive overview of ADRs, including factors the increase the likelihood of an ADR occurring, the use and limitations of safety studies, and why it is important for healthcare providers to assess and report ADRs.
How to Use the Module
Begin by completing the self-assessment. This will determine your current level of understanding about ADRs.
Next, watch the video presentation of the module.
When you have completed the video presentation, visit the case study and answer the questions.
Finally, for additional learning, access the resources and references document, which includes further information to expand your knowledge about ADRs.
When you have completed all steps, it is recommended that you return to the self-assessment and test your knowledge again.
About the Presenter
Christine E. Chamberlain, PharmD, is a Safety Evaluator in the U.S. Food and Drug Administration’s Division of Pharmacovigilance I. She is a retired Captain of the U.S. Public Service and has served in various clinical settings at the U.S. Indian Health Service, U.S. Substance Abuse and Mental Health Services Administration and the National Institutes of Health, with experience in internal medicine, endocrinology/diabetes, mental health, and transplantation. Dr. Chamberlain is a certified diabetes educator and board-certified pharmacotherapy specialist. As an FDA Safety Evaluator, she analyzes post-marketing adverse event data from the Food and Drug Administration Adverse Event Reporting System (FAERS) to identify drug safety concerns with diabetes medications and recommends actions to improve product safety. Dr. Chamberlain received a PharmD from Idaho State University and bachelor’s degree in Pharmacy from University of Rhode Island.
Presented by the PhRMA Foundation Safe and Effective Prescribing Project
For more information, please call 202-572-7756
