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European Journal of Clinical Pharmacology

, Volume 74, Issue 4, pp 497–504 | Cite as

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

  • Kristian SvendsenEmail author
  • Kjell H. Halvorsen
  • Solveig Vorren
  • Hilde Samdal
  • Beate Garcia
Pharmacoepidemiology and Prescription

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 dispensing 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 and males using methylphenidate, we found that the two groups report different ADRs. Finally, we showed that changes in ADR reporting for simvastatin and atorvastatin during 2004–2013 were due to changes in consumption and that atorvastatin had a higher CADRR but fewer reports than simvastatin.

Conclusions

CADRR provides additional information compared with number of reports alone in studies using spontaneous reports. It is important for researchers to adjust for consumption whenever possible in pharmacovigilance studies.

Keywords

Drug consumption Pharmacovigilance Adverse drug reactions Norway EudraVigilance 

Notes

Contributions of authors

KS conceived the project and performed the analysis and first draft of paper. KH, SV and HS all contributed in the planning of the project as well as the writing of the manuscript. BH contributed in planning and writing and is the overall project manager.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Supplementary material

228_2017_2396_MOESM1_ESM.docx (397 kb)
ESM 1 (DOCX 397 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2017

Authors and Affiliations

  1. 1.Tromsø Hospital PharmacyUniversity Hospital of North NorwayTromsøNorway
  2. 2.Department of PharmacyUiT – The Arctic University of NorwayTromsøNorway
  3. 3.Regional Medicines Information and Pharmacovigilance Centre (RELIS)University Hospital of North NorwayTromsøNorway
  4. 4.Norwegian Medicines AgencyOsloNorway

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