Thoughts on Pharmacovigilance in the Future: There Are More Weber-Effects
Over the past few decades, pharmacovigilance, both in terms of execution, responsibilities, and decision making, has dramatically changed, i.e., from the individual vigilant doctor observing something unexpected in a patient and reporting this to his coll
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Thoughts on Pharmacovigilance in the Future: There Are More Weber-Effects Ronald H.B. Meyboom, Hubert G.M. Leufkens, and Eugène P. van Puijenbroek
Over the past few decades, pharmacovigilance, both in terms of execution, responsibilities, and decision making, has dramatically changed, i.e., from the individual vigilant doctor observing something unexpected in a patient and reporting this to his colleagues, to a scientifically and legally enforced social system [1, 2]. Today there are several ways for following up medicinal products after their introduction into medical and pharmaceutical practice, e.g., spontaneous reports, risk management plans, prospective safety studies, registries, and the like. Both the formal requirements of the science of pharmacovigilance and the legal marinade of handling drug safety by industry, authorities, and health care professionals have resulted in a critical transition of the drug safety scenery [3, 4]. Along with the establishment of the first pharmacovigilance centers and the gradual increase in the number of reports to be analyzed new methods evolved. It was not only the individual case report, including an hypothesis about a pharmacological mechanism and individual risk factors, which contributed to the signal, but also numerical information based on the analysis of such spontaneous reports became more important as well. Disproportionality analysis and time trends made their appearance, maneuvering with various statistical methods, but essentially contrasting the number of observed reports against an estimated number of the expected. But still the importance, and appreciation, of the well-documented and the comprehensive, clinically seasoned individual reporting never disappeared. The same holds R.H.B. Meyboom (*) Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands e-mail: [email protected] H.G.M. Leufkens Utrecht Institute for Pharmaceutical Sciences (UIPS) and the Medicines Evaluation Board (MEB), Utrecht, The Netherlands E.P. van Puijenbroek, MD, PhD Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, The Netherlands © Springer International Publishing Switzerland 2017 I.R. Edwards, M. Lindquist (eds.), Pharmacovigilance, DOI 10.1007/978-3-319-40400-4_11
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for the attributed value of chemical structure and mechanism-based pharmacological thinking in pharmacovigilance [5, 6]. A landmark paper in the transition of pharmacovigilance towards more quantification has been the well-known analysis of Peter Weber in 1984, showing temporal patterns of adverse reaction reports in the United Kingdom regarding nonsteroidal anti-inflammatory drug (NSAID), i.e., a rise in the first few years after market introduction, followed by a decline [7]. This pattern has been repeatedly coined as the Weber effect, contrasting time trends of spontaneous reports and the dynamics of the market cycle of individual medical products, i.e., number of years since launch, exposure changes over time and reporti
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