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

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 Cen...

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Bibliographic Details
Published in:Drug safety 2016-08, Vol.39 (8), p.769-776
Main Authors: Rolfes, Leàn, van Hunsel, Florence, Taxis, Katja, van Puijenbroek, Eugène
Format: Article
Language:English
Subjects:
Blister packs
Drug Safety and Pharmacovigilance
Funding
International organizations
Marketing
Medicine
Medicine & Public Health
Mental health
Original
Original Research Article
Patients
Perceptions
Pharmacology/Toxicology
Quality of life
Studies
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Summary: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  
ISSN:0114-5916
1179-1942
DOI:10.1007/s40264-016-0422-0