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Drug Safety
Published in: Drug Safety 8/2016

Open Access 01-08-2016 | Original Research Article

The Impact of Experiencing Adverse Drug Reactions on the Patient’s Quality of Life: A Retrospective Cross-Sectional Study in the Netherlands

Authors: Leàn Rolfes, Florence van Hunsel, Katja Taxis, Eugène van Puijenbroek

Published in: Drug Safety | Issue 8/2016

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Abstract

Introduction

There is little information as to what extent adverse drug reactions (ADRs) influence patients’ health-related quality of life (HR-QOL). From a pharmacovigilance perspective, capturing and making the best use of this information remains a challenge. The Netherlands Pharmacovigilance Centre Lareb received about 1800 reports after the packaging of the drug Thyrax® (levothyroxine; Aspen Pharma Trading Limited, Dublin, Ireland) changed from a brown glass bottle to a blister package in the Netherlands.

Objective

The objective of this study was to explore the impact of ADRs on HR-QOL in patients who reported a possible ADR to Lareb in relation to the change in the packaging of the drug Thyrax®. A secondary objective was to explore factors correlated with change in HR-QOL.

Methods

Patients who reported an ADR in relation to the Thyrax® packaging change were included in this study. A web-based adapted version of the COOP/WONCA questionnaire was sent to explore the HR-QOL before versus during the ADR, expressed on a 5-point scale from no impact (1) to high impact (5). Multivariable linear regression analysis was used to identify factors correlated with change in HR-QOL.

Results

Overall, 1167 patients returned the questionnaire (71.2 % response rate). The difference in HR-QOL was −0.8 for physical, −1.2 for mental, −1.4 for daily activities, −1.3 for social, and −1.3 for overall health status (p < 0.001 for each domain). Age, sex, educational level of the patient, and absence from work due to an ADR were correlated with at least one domain, while severity of the ADR was found to be correlated with all domains of HR-QOL.

Conclusion

Patients who reported possible ADRs after the Thyrax® packaging change experienced a significant decrease in HR-QOL. This impact was highest for the domains ‘daily activities’, ‘overall health status’, and ‘mental health’ and lowest for ‘physical fitness’.
Appendix
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Metadata
Title
The Impact of Experiencing Adverse Drug Reactions on the Patient’s Quality of Life: A Retrospective Cross-Sectional Study in the Netherlands
Authors
Leàn Rolfes
Florence van Hunsel
Katja Taxis
Eugène van Puijenbroek
Publication date
01-08-2016
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 8/2016
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-016-0422-0

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