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

Author

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  • Leàn Rolfes

    (Netherlands Pharmacovigilance Centre Lareb
    University of Groningen)

  • Florence Hunsel

    (Netherlands Pharmacovigilance Centre Lareb
    University of Groningen)

  • Katja Taxis

    (University of Groningen)

  • Eugène Puijenbroek

    (Netherlands Pharmacovigilance Centre Lareb
    University of Groningen)

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

Suggested Citation

  • Leàn Rolfes & Florence Hunsel & Katja Taxis & Eugène Puijenbroek, 2016. "The Impact of Experiencing Adverse Drug Reactions on the Patient’s Quality of Life: A Retrospective Cross-Sectional Study in the Netherlands," Drug Safety, Springer, vol. 39(8), pages 769-776, August.
    • Handle: RePEc:spr:drugsa:v:39:y:2016:i:8:d:10.1007_s40264-016-0422-0
    DOI: 10.1007/s40264-016-0422-0
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    Cited by:

    1. Leàn Rolfes & Michelle Haaksman & Florence van Hunsel & Eugène van Puijenbroek, 2020. "Insight into the Severity of Adverse Drug Reactions as Experienced by Patients," Drug Safety, Springer, vol. 43(3), pages 291-293, March.
    2. Sarah Watson & Rebecca E. Chandler & Henric Taavola & Linda Härmark & Birgitta Grundmark & Alem Zekarias & Kristina Star & Florence Hunsel, 2018. "Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre," Drug Safety, Springer, vol. 41(2), pages 203-212, February.
    3. Rike van Eekeren & Leàn Rolfes & Andries S. Koster & Lara Magro & Gurumurthy Parthasarathi & Hussain Al Ramimmy & Tim Schutte & Daisuke Tanaka & Eugène van Puijenbroek & Linda Härmark, 2018. "What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects," Drug Safety, Springer, vol. 41(11), pages 1003-1011, November.
    4. Solomon Shiferaw Nadew & Kidanemariam G/Michael Beyene & Solomon Worku Beza, 2020. "Adverse drug reaction reporting practice and associated factors among medical doctors in government hospitals in Addis Ababa, Ethiopia," PLOS ONE, Public Library of Science, vol. 15(1), pages 1-19, January.
    5. Cristiano Matos & Gerda Weits & Florence Hunsel, 2019. "The Role of European Patient Organizations in Pharmacovigilance," Drug Safety, Springer, vol. 42(4), pages 547-557, April.
    6. Leàn Rolfes & Florence Hunsel & Laura Linden & Katja Taxis & Eugène Puijenbroek, 2017. "The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis," Drug Safety, Springer, vol. 40(7), pages 607-614, July.

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