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KMID : 1011320130060020073
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Journal of Pharmacoepidemiology and Risk Management
2013 Volume.6 No. 2 p.73 ~ p.78
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An Overview of MedWatch System
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Shin Sun-Mi
Jung Soo-Youn
Park Byung-Joo
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Abstract
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Safety monitoring of medicinal products after marketing authorization is becoming a top priority for regulatory agencies and pharmaceutical industry. In the United States, initial post-marketing safety surveillance program began in the 1950s. MedWatch, Food and Drug Administration’s adverse drug reaction (ADR) reporting system, was founded in 1993. Information about voluntary reports by healthcare professionals and consumers, together with mandatory reports from manufacturers, has been accumulated in the Adverse Event Reporting System (AERS) from 1969. By the end of 2010, over 4 million reports are contained in this database. FDA systematically analyzes ADR reports, detects potential safety concerns, and manages them to protect the public health and minimize the risk of adverse drug reactions. Based on comprehensive evaluation of safety issues, the FDA has taken regulatory actions such as issuing safety alerts, restricting the use of the drug, ordering labeling changes, and communicating new information to the public. With advances in pharmacovigilance system accomplished for several decades, FDA is conducting anticipative management of drug safety issues. This paper will describe the architecture of the MedWatch system and explain the flow of data analysis and risk management. Finally it will suggest an outlook over future development of ADR reporting system in Korea.
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KEYWORD
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MedWatch, Adverse drug reaction reports, Drug safety
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