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A prospective analysis of the preventability of adverse drug reactions reported in Sweden

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

Abstract

Purpose

Adverse drug reactions (ADRs) are a major patient safety issue, and a substantial proportion of ADRs are, in fact, preventable. The aim of this study was to describe the proportion and pattern of preventable ADRs in spontaneously reported suspected ADRs and to study the feasibility of using data from an ADR reporting system for this purpose.

Methods

All reports of ADRs, except those in which a vaccine was the suspected drug, submitted to the regional pharmacovigilance center of southeastern Sweden between 2008 and 2009 were analyzed. Causality between the suspected ADR and the medication was assessed using the World Health Organization (WHO) criteria, and preventability was assessed using Hallas criteria.

Results

During the study period, 1,290 ADRs were received and 1,255 were classified as having at least a possible causality between a reaction and a drug. Of these, 172 (14%) ADRs were considered preventable, 35 (20%) were classified as definitely preventable, and 137 (80%) as possibly preventable. Of all preventable ADRs, 96 (56%) were related to prescribing, 35 (20%) to administration, and 41 (24%) to clinical and laboratory monitoring of treatment. Warfarin, oxycodone, and ioversol were the most common drugs with preventable ADRs.

Conclusions

This study found that a substantial part of reported ADRs are preventable. Most of these are related to drug prescription, suggesting that interventions aiming to reduce preventable ADRs should focus on this process. Moreover, systems for ADR reporting may be useful in the mission of reducing the unsafe use of drugs.

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Acknowledgement

This study was funded by the County Council of Östergötland and the Swedish Medical Product Agency.

Conflict of interest

Henrik Lövborg’s wife is an employee of a company (MEDAC) whose products are part of this study (as is the case for many other companies).

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Authors and Affiliations

  1. Regional Pharmacovigilance Centre, Department of Clinical Pharmacology, Linköping University Hospital, 581 85, Linköping, Sweden

    Henrik Lövborg, Linda Ring Eriksson, Anna K. Jönsson, Thomas Bradley & Staffan Hägg

  2. Department of drug research/Clinical Pharmacology, Linköping University, 581 85, Linköping, Sweden

    Staffan Hägg

Authors
  1. Henrik Lövborg
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  2. Linda Ring Eriksson
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  3. Anna K. Jönsson
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  4. Thomas Bradley
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  5. Staffan Hägg
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Correspondence to Henrik Lövborg.

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Lövborg, H., Eriksson, L.R., Jönsson, A.K. et al. A prospective analysis of the preventability of adverse drug reactions reported in Sweden. Eur J Clin Pharmacol 68, 1183–1189 (2012). https://doi.org/10.1007/s00228-012-1237-2

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  • DOI: https://doi.org/10.1007/s00228-012-1237-2

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