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Clin Transl Sci. 2020 Feb 12. doi: 10.1111/cts.12746. [Epub ahead of print]

Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands.

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Medicines Evaluation Board, Utrecht, The Netherlands.
Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre, Maastricht, The Netherlands.
Department of Pharmacology and Toxicology, Radboud University Medical Centre, Nijmegen, The Netherlands.
National Health Care Institute, Diemen, The Netherlands.
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Pharmaco-Therapy, Epidemiology, and Economics, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands.
Department of Pharmacy, Radboud University Medical Centre, Nijmegen, The Netherlands.


We performed a retrospective cohort study in the Dutch patient population to identify active substances with a relatively high number of adverse drug reactions (ADRs) potentially related to drug switching. For this, we analyzed drug switches and reported ADRs related to switching between June 1, 2009, and December 31, 2016, for a selection of 20 active substances. We also compared pharmacovigilance analyses based on the absolute, switch-corrected, and user-corrected numbers of ADRs. In total, 1,348 reported ADRs and over 23.8 million drug switches were obtained from the National Health Care Institute in The Netherlands and from Lareb, which is The Netherlands Pharmacovigilance Centre. There was no correlation between the number of ADRs and the number of switches, but, on average, we found 5.7 reported ADRs per 100,000 switches. The number was relatively high for rivastigmine, levothyroxine, methylphenidate, and salbutamol, with 74.9, 50.9, 47.6, and 26.1 ADRs per 100,000 switches, respectively. When comparing analyses using the absolute number and the switch-corrected number of ADRs, we demonstrate that different active substances would be identified as having a relatively high number of ADRs, and different time periods of increased numbers of ADRs would be observed. We also demonstrate similar results when using the user-corrected number of ADRs instead of the switch-corrected number of ADRs, allowing for a more feasible approach in pharmacovigilance practice. This study demonstrates that pharmacovigilance analyses of switch-related ADRs leads to different results when the number of reported ADRs is corrected for the actual number of drug switches.


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