J Korean Med Assoc.  2012 Sep;55(9):819-826. 10.5124/jkma.2012.55.9.819.

Recent international initiatives of drug safety management

• Choi NK
• Lee J
• Park BJ

• KMID: 1787244
• DOI: http://doi.org/10.5124/jkma.2012.55.9.819

Abstract

Adverse drug reactions constitute a major public health problem. In recent years, serious safety issues arose with marketed drugs, and public outcry demanded better safety surveillance. Now regulatory focus is shifting to the active post-marketing safety surveillance. This paper provides an overview of the recent international initiatives of drug safety management especially focused on the US and Europe. The US Food and Drug Administration's (FDA) Sentinel Initiative is a long-term program designed to build and implement a national electronic system for monitoring the safety of FDA-approved drugs and other medical products. The Sentinel System will enable FDA to monitor the safety of medical products with the assistance of a wide array of collaborating institutions throughout the nation. The European Network of Centers for Pharmacoepidemiology and Pharmacovigilance is a collaborative scientific network coordinated by the European Medicines Agency and developed in collaboration with European experts in the fields of pharmacoepidemiology and pharmacovigilance. Its goal is to further strengthen the post-marketing monitoring of medicinal products in Europe by facilitating the conduct of multi-center, independent, post-authorization studies focusing on safety and on benefit-risk. Medicine is a global enterprise that demands worldwide standards for good drug safety practices. In the near future, we have to establish a Korean Sentinel System for active post-marketing safety surveillance to ensure the safety and effectiveness of drugs used in medical practice.

Keyword

Active surveillance; Sentinel Initiative; European Network of Centers for Pharmacoepidemiology and Pharmacovigilance; Pharmacoepidemiology; Pharmacovigilance

MeSH Terms

Cooperative Behavior
Dietary Sucrose
Drug Toxicity
Electronics
Electrons
Europe
Nitriles
Organothiophosphorus Compounds
Pharmacoepidemiology
Pharmacovigilance
Public Health
Pyrethrins
Safety Management
Dietary Sucrose
Nitriles
Organothiophosphorus Compounds
Pyrethrins

Figure

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  Figure 1 Overview of the Mini-Sentinel safety question evaluation process. a)Only those academic institutions with electronic healthcare data will receive safety questions for evaluation. b)Data partners will provide summary results from analysis conducted within their secure data environments. Those summary results will not include directly indentifiable health information. From US Department of Health and Human Services, US Food and Drug Administration. The Sentinel Initiative: a national strategy for monitoring medical product safety [Internat]. Silver Spring: US Food and Drug Administration; 2011 [13].

• 

  Figure 2 European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study process flow chart. CoC, code of conduct; DoI, declaration of interests (From European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ENCePP studies [Internet]. London: European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) [19].

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