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

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

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.

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Author information

Authors and Affiliations

Authors

Contributions

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.

Corresponding author

Correspondence to Kristian Svendsen.

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Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Key points

• Adjusting the ADR reporting rates with consumption data provides important additional information.

• Consumption-adjusted adverse drug reaction reporting rates (CADRRs) can be used when comparing different drugs, different sub-populations and when studying reporting trends over time.

Early preliminary results have been presented as a poster at the 31st ICPE meeting in Boston in 2015.

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Svendsen, K., Halvorsen, K.H., Vorren, S. et al. Adverse drug reaction reporting: how can drug consumption information add to analyses using spontaneous reports?. Eur J Clin Pharmacol 74, 497–504 (2018). https://doi.org/10.1007/s00228-017-2396-y

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  • DOI: https://doi.org/10.1007/s00228-017-2396-y

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