Adverse Drug Reaction Surveillance: Practical Methods for Developing a Successful Monitoring Program

Josephine A. Vitillo, PharmD, BCPS, CGP


December 18, 2000

In This Article

Abstract and Introduction

With the increasing complexity of medications available today, a comprehensive adverse drug reaction (ADR) surveillance program is necessary to detect, evaluate, and develop mechanisms to prevent ADRs and their associated morbidity, mortality, and increased costs. Barriers to improved reporting of adverse drug events (ADEs) are evaluated and mechanisms to overcome these barriers are presented. The impact of ADR surveillance on the evaluation and modification of the medication-use system at Northeast Health to improve patient quality of care is described.

The significance of adverse drug events (ADEs), including adverse drug reactions (ADRs) and medication errors, has never been so prominent in the lay and medical literature as it is today with the publication of the Institute of Medicine (IOM) report, "To Err is Human: Building a Safer Health System."[1] The national attention given this report should motivate pharmacists to rise to the challenge of critically evaluating the medication-use system to seek opportunity for improvement and prevention of ADEs. The purpose of this article is to review the current literature regarding ADEs, describe the components of a successful ADR reporting program, and make recommendations for improving the detection and monitoring of ADRs to improve patient quality of care.