Evidence map›Paper›PMID 32052597›Full record

ArticleClinical and translational science2020

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

Pieter J Glerum, Marc Maliepaard, Vincent de Valk, Joep H G Scholl, Florence P A M van Hunsel, Eugène P van Puijenbroek, David M Burger, Kees Neef

Open access · goldAbstract read
In one paragraph

Article in Clinical and translational science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 38% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Pieter J GlerumMedicines Evaluation Board, Utrecht, The Netherlands.
Marc MaliepaardMedicines Evaluation Board, Utrecht, The Netherlands.
Vincent de ValkNational Health Care Institute, Diemen, The Netherlands.
Joep H G SchollNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Florence P A M van HunselNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Eugène P van PuijenbroekNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
David M BurgerDepartment of Pharmacy, Radboud University Medical Centre, Nijmegen, The Netherlands.
Kees NeefDepartment of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre, Maastricht, The Netherlands.
Netherlands Pharmacovigilance Centre Lareb · NLMaastricht University Medical Centre · NLMedicines Evaluation Board · NLRadboud University Medical Center · NLZorginstituut Nederland · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

AdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overChildChild, PreschoolDrug-Related Side Effects and Adverse ReactionsDrug SubstitutionFemaleHumansInfantInfant, NewbornMaleMiddle AgedNetherlands

Identifiers

PMID32052597
PMCPMC7214643
OpenAlexW3006460095

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.