Adverse drug reaction reporting: how can drug consumption information add to analyses using spontaneous reports?

Adverse drug reaction reporting: how can drug consumption information add to analyses using... Purpose Spontaneous reporting of adverse drug reactions (ADRs) is a cornerstone in pharmacovigilance. However, information about the underlying consumption of drugs is rarely used when analysing spontaneous reports. The purpose of this study was to combine ADR reports with drug consumption data to demonstrate the additional information this gives in various scenarios, comparing different drugs, gender-stratified sub-populations and changes in reporting over time. Methods We combined all Norwegian ADR reports in 2004–2013 from the EudraVigilance database (n = 14.028) with dispens- ing data from the Norwegian Prescription Database (more than 800 million dispensed prescriptions during 2004–2013). This was done in order to calculate drug-specific consumption-adjusted adverse drug reaction reporting rates (CADRRs) by dividing the number of reports for each drug with the number of users of the drug during the same time period. Results Among the ten drugs with the highest number of ADR reports and the ten drugs with the highest CADRR, only four drugs were in both categories. This indicates that drugs with a high number of reports often also have a high number of users and that CADRR captures drugs with potentially relevant safety issues but a smaller number of users. Comparing reported ADRs in females http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Clinical Pharmacology Springer Journals

Adverse drug reaction reporting: how can drug consumption information add to analyses using spontaneous reports?

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Publisher
Springer Berlin Heidelberg
Copyright
Copyright © 2017 by Springer-Verlag GmbH Germany, part of Springer Nature
Subject
Biomedicine; Pharmacology/Toxicology
ISSN
0031-6970
eISSN
1432-1041
D.O.I.
10.1007/s00228-017-2396-y
Publisher site
See Article on Publisher Site

Abstract

Purpose Spontaneous reporting of adverse drug reactions (ADRs) is a cornerstone in pharmacovigilance. However, information about the underlying consumption of drugs is rarely used when analysing spontaneous reports. The purpose of this study was to combine ADR reports with drug consumption data to demonstrate the additional information this gives in various scenarios, comparing different drugs, gender-stratified sub-populations and changes in reporting over time. Methods We combined all Norwegian ADR reports in 2004–2013 from the EudraVigilance database (n = 14.028) with dispens- ing data from the Norwegian Prescription Database (more than 800 million dispensed prescriptions during 2004–2013). This was done in order to calculate drug-specific consumption-adjusted adverse drug reaction reporting rates (CADRRs) by dividing the number of reports for each drug with the number of users of the drug during the same time period. Results Among the ten drugs with the highest number of ADR reports and the ten drugs with the highest CADRR, only four drugs were in both categories. This indicates that drugs with a high number of reports often also have a high number of users and that CADRR captures drugs with potentially relevant safety issues but a smaller number of users. Comparing reported ADRs in females

Journal

European Journal of Clinical PharmacologySpringer Journals

Published: Dec 18, 2017

References

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