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Published on: August 1, 2019
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[Drug information for patients (Package Leaflets), and user testing in EU].
Michiko Yamamoto1, Hirohisa Doi, Aya Furukawa
1Showa Pharmaceutical University.
Summary
High-quality patient drug information is essential for shared decision-making. User testing of Patient Information Leaflets (PILs) ensures their quality and readability for better medication understanding.
Area of Science:
- Pharmacovigilance
- Health Communication
Context:
- Patients require high-quality drug information for informed pharmacotherapy and shared decision-making.
- Patient Information Leaflets (PILs) are legally mandated in the UK and EU (as Package Leaflets) to provide essential medication details.
- Ensuring the quality and accessibility of drug information is crucial for patient empowerment.
Purpose:
- To investigate the development and user testing criteria for Patient Information Leaflets (PILs) to improve drug information quality.
- To assess the effectiveness of user testing in assuring the quality and reliability of information provided in PILs.
- To explore methods for enhancing the readability, accessibility, and understandability of drug information for patients in Japan.
Summary:
- This study examines the development and user testing processes of UK-approved Patient Information Leaflets (PILs).
- User testing, implemented since 2005, ensures PILs reflect patient views and are reliable.
- The findings aim to improve future 'Drug Guide for Patients' in Japan by enhancing information quality and comprehension.
Impact:
- Improved quality and accessibility of drug information for patients.
- Enhanced shared decision-making between patients and healthcare professionals regarding medications.
- Potential for more effective patient use of medication guides, particularly in Japan.
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