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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, 200...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214643/ https://www.ncbi.nlm.nih.gov/pubmed/32052597 http://dx.doi.org/10.1111/cts.12746 |
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author | Glerum, Pieter J. Maliepaard, Marc de Valk, Vincent Scholl, Joep H.G. van Hunsel, Florence P.A.M. van Puijenbroek, Eugène P. Burger, David M. Neef, Kees |
author_facet | Glerum, Pieter J. Maliepaard, Marc de Valk, Vincent Scholl, Joep H.G. van Hunsel, Florence P.A.M. van Puijenbroek, Eugène P. Burger, David M. Neef, Kees |
author_sort | Glerum, Pieter J. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7214643 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-72146432020-05-13 Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands Glerum, Pieter J. Maliepaard, Marc de Valk, Vincent Scholl, Joep H.G. van Hunsel, Florence P.A.M. van Puijenbroek, Eugène P. Burger, David M. Neef, Kees Clin Transl Sci Research 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. John Wiley and Sons Inc. 2020-02-12 2020-05 /pmc/articles/PMC7214643/ /pubmed/32052597 http://dx.doi.org/10.1111/cts.12746 Text en © 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Research Glerum, Pieter J. Maliepaard, Marc de Valk, Vincent Scholl, Joep H.G. van Hunsel, Florence P.A.M. van Puijenbroek, Eugène P. Burger, David M. Neef, Kees Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands |
title | Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands |
title_full | Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands |
title_fullStr | Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands |
title_full_unstemmed | Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands |
title_short | Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands |
title_sort | quantification of adverse drug reactions related to drug switches in the netherlands |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214643/ https://www.ncbi.nlm.nih.gov/pubmed/32052597 http://dx.doi.org/10.1111/cts.12746 |
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