Abstract
The evolution of EU and US pharmacovigilance legislation highlights two trends. The first is to strengthen the instruments of protection of human health through, inter alia, the continuous monitoring of the risk-benefit ratio of drugs, greater transparency and the power to penalize producers for the failure to meet the pharmacovigilance obligations. The second trend manifests the partial harmonization of the different pharmacovigilance systems. However, this goal is still far away. In order to achieve it would be necessary to establish an identical definition of adverse drug reaction in both the EU and US legislation.
Highlights
According to the European Commission’s data, a) 5% of all hospital admissions are due to Adverse Drug Reaction (ADR); b) 5% of all hospital patients experience an ADR; c) on average, ADRs cause at least 1.91 extra days of hospitalization; d) ADRs are the 5th most common cause of hospital death [1]
According to the European Commission’s data, a) 5% of all hospital admissions are due to ADR; b) 5% of all hospital patients experience an ADR; c) on average, ADRs cause at least 1.91 extra days of hospitalization; d) ADRs are the 5th most common cause of hospital death [1]
U.S legislation has been significantly enhanced by the Title IX of the Food and Drug Administration Amendments Act of 2007 [11]
Summary
According to the European Commission’s data, a) 5% of all hospital admissions are due to ADR; b) 5% of all hospital patients experience an ADR; c) on average, ADRs cause at least 1.91 extra days of hospitalization; d) ADRs are the 5th most common cause of hospital death [1]. This situation makes clear the importance of pharmacovigilance, as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or other drug related problems” [3]
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