Quantification of Adverse Drug Reactions Related to Drug Switches in 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 In... Mehr ...

Verfasser: Pieter J. Glerum
Marc Maliepaard
Vincent deValk
Joep H.G. Scholl
Florence P.A.M. vanHunsel
Eugène P. vanPuijenbroek
David M. Burger
Kees Neef
Dokumenttyp: Artikel
Erscheinungsdatum: 2020
Reihe/Periodikum: Clinical and Translational Science, Vol 13, Iss 3, Pp 599-607 (2020)
Verlag/Hrsg.: Wiley
Schlagwörter: Therapeutics. Pharmacology / RM1-950 / Public aspects of medicine / RA1-1270
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-27582313
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://doi.org/10.1111/cts.12746

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.