Dataset Information

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

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.

SUBMITTER: Glerum PJ

PROVIDER: S-EPMC7214643 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Glerum Pieter J PJ Maliepaard Marc M de Valk Vincent V Scholl Joep H G JHG van Hunsel Florence P A M FPAM van Puijenbroek Eugène P EP Burger David M DM Neef Kees K

Clinical and translational science 20200212 3

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, ...[more]

PMID: 32052597

Similar Datasets

Project description:BackgroundIntranasal corticosteroids are one of the cornerstone treatment options for allergic rhinitis and chronic sinusitis complaints. Safety information in the summary of product characteristics may not be representative for observations in daily clinical practice. The Netherlands Pharmacovigilance Center (Lareb) collects post-marketing safety information, using spontaneous reporting systems.ObjectiveOur objective was to analyse reports of adverse drug reactions associated with intranasal corticosteroids reported in the Dutch spontaneous reporting database of the Netherlands Pharmacovigilance Center Lareb to obtain insight into real-world safety data.MethodsWe retrospectively examined all adverse drug reactions of intranasal corticosteroids reported to the Netherlands Pharmacovigilance Center Lareb, entered into the database from 1991 until 1 July, 2020.ResultsIn total, 2263 adverse drug reactions after intranasal corticosteroid use were reported in 1258 individuals. Headache (n = 143), epistaxis (n = 124) and anosmia (n = 57) were reported most frequently. Nasal septum perforation (reporting odds ratio 463.2; 95% confidence interval: 186.7-1149.7) had the highest reporting odds ratio, followed by nasal mucosal disorder (reporting odds ratio 104.5; 95% confidence interval 36.3-301.3) and hyposmia (reporting odds ratio 90.8; 95% confidence interval 45.1-182.7). Moreover, 101 (4.5%) reports were classified as serious by Lareb, including reports of Cushing's syndrome, adrenal cortical hypofunction and growth retardation.ConclusionsMany side effects are consistent with the safety information in the summary of product characteristics of intranasal corticosteroids. Several serious (systemic) side effects are reported and it is important to realise that intranasal corticosteroids may contribute to the development. Healthcare providers and patients should be aware of the potential (individual) adverse drug reactions of intranasal corticosteroids. This information could help in discussing treatment options.

Project description:Medication-related problems (MRPs) are an important healthcare problem. This study aimed at reviewing the published literature in Ethiopia to estimate the prevalence of MRPs and to summarize associated factors. A comprehensive systematic search was conducted in PubMed, EMBASE, CINAHL, Scopus, Google Scholar, and Google databases from inception to April 2020. Articles that addressed MRPs were eligible for inclusion. Article screening, data extraction, and study quality analysis were performed independently by two reviewers. Studies targeting specific disease condition were considered as specific, while the remaining were nonspecific. The prevalence of MRPs was then computed in medians and interquartile ranges (IQR), while associated factors were summarized in a table. Of the thirty-two studies included in this review, the majority of them (n = 24) targeted MRPs, while the remaining studies (n = 8) investigated adverse drug reactions (ADRs). Studies varied in the study design, study population, and definition of MRPs and ADRs used. The overall median prevalence was 70.8% (IQR = 61.0-80.2) with a range of 16.0% to 88.7%. The median prevalence of MRPs in specific and nonspecific patients was 71.2% (IQR = 60.7-71.2) and 69.3% (IQR = 60.7-82.0), respectively. In addition, a median of 36.6% (IQR = 10.0-85.7) of patients experienced ADRs. Indication-related and effectiveness-related MRPs were commonly reported in both specific and nonspecific patients, while noncompliance MRPs were more prevalent among specific patients than nonspecific patients. Increasing age, presence of co-morbidity, and an increasing number of drugs were the commonly identified contributing factors of MRPs. The review showed that more than two-thirds of the study participants developed MRPs. Hence, an integrated approach should be designed to improve the optimal use of pharmacotherapy to reduce the burden of MRPs. Further, future research should be undertaken to prepare cost-effective and efficient prevention mechanisms to reduce or halt the development of MRPs.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets