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

Leàn Rolfes (), Florence Hunsel, Katja Taxis and Eugène Puijenbroek
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Leàn Rolfes: Netherlands Pharmacovigilance Centre Lareb
Florence Hunsel: Netherlands Pharmacovigilance Centre Lareb
Katja Taxis: University of Groningen
Eugène Puijenbroek: Netherlands Pharmacovigilance Centre Lareb

Drug Safety, 2016, vol. 39, issue 8, No 8, 769-776

Abstract: 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

Date: 2016
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DOI: 10.1007/s40264-016-0422-0

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