A Description of Signals During the First 18 Months of the EMA Pharmacovigilance Risk Assessment Committee
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Background and Objective
New pharmacovigilance legislation in the European Union has underlined the importance of signal management, giving the European Medicines Agency’s newly established Pharmacovigilance Risk Assessment Committee (PRAC) the mandate to oversee all aspects of the use of medicinal products including detection, assessment, minimization, and communication relating to the risk of adverse reactions. In this study, we describe the signals as brought to the PRAC during the first 18 months of its operation and the ensuing regulatory actions.
Data were collected from publicly available sources, for the period July 2012–December 2013, classified according to predefined rules, and described using the appropriate descriptive statistics. Suspected adverse drug reactions were categorized into the Medical Dictionary for Regulatory Affairs and drug names were mapped to the Anatomical Therapeutic Chemical codes.
During the study period, 125 signals concerning 96 medicinal products were discussed by the PRAC. The majority of signals were triggered by spontaneous reports (62 %) and the median drug age (since marketing authorization) for drugs that prompted a signal was 12 years, significantly less compared with drugs that had no signal within the same period (20 years). The mean time until a decision was reached by the PRAC was 75 days (median 30 days, range 0–273) with 43 % of all decisions taken during the first meeting. The decisions to start a referral and to send a direct healthcare professional communication took the least amount of time [54 days (median 27 days, range 0–186) and 51 days (median 0 days, range 0–153)].
The importance of spontaneous reporting in signal detection and monitoring of safety issues throughout the entire life cycle of a medicinal product is confirmed in this study. The amount of time a drug has been on the market is correlated with the number of signals detected. The PRAC decision-making process seems efficient particularly with respect to serious concerns; its role in improving signal prioritization and real-time signal management will be further clarified in its subsequent years of operation.
KeywordsEuropean Union European Medicine Agency Marketing Authorization European Union Level Suspected Adverse Drug Reaction
No sources of funding were used to conduct this study or prepare this manuscript. Georgy Genov is the head of the Signal Management Section at the European Medicines Agency. Miriam Sturkenboom is heading a research group that conducts unconditional research on the safety and effects of drugs for several pharmaceutical companies (AstraZeneca, Pfizer, Eli Lilly), none of which is related to this current research. Alexandra Pacurariu, Preciosa Coloma, Anja van Haren, and Sabine Straus have no conflicts of interest that are directly relevant to the content of this study. The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the Dutch Medicines Agency or the European Medicines Agency or one of its committees or working parties.
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