Yuan, H-CT, Raynor, DK orcid.org/0000-0003-0306-5275 and Aslani, P (2019) Comparison of International Regulations for Written Medicine Information (WMI) on Prescription Medicines. Therapeutic Innovation & Regulatory Science, 53 (2). pp. 215-226. ISSN 2168-4790
Abstract
This paper presents a review of the literature, including government legislations, policies, guidelines, and recommendations available in the European Union, the United States of America, and Australia pertaining to the availability, development, and distribution of written medicine information (WMI) for prescription medicines. The online databases searched were Embase, International Pharmaceutical Abstracts, Medline, and PubMed, together with Google as the Internet search engine. The design and content of WMI documents have similarities and differences across all the 3 geographical regions. All the 3 regions have legislations in place to evaluate and regulate WMI documents for health care professionals (HCPs) and, to some degree, for patients; however, the degree of regulation varies between the 3 regions. The regulations around the content and information design of WMI impacts how well the WMI performs and consequently influences patients’ knowledge and medication-taking behavior. Legislation in certain areas could be seen as more beneficial and can be implemented across the 3 regions. Furthermore, the required legislation on the evaluation of the content of WMIs can be seen in some areas to be more stringent and comprehensive, which when taken onboard across the 3 regions can be valuable when creating WMIs for both patients and HCPs.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2018 The Author(s) 2018. This is an author produced version of a paper published in Therapeutic Innovation & Regulatory Science. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | summary of product characteristics, package leaflet, package insert, consumer medication information, consumer medicine information, product information |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Healthcare (Leeds) > Pharmacy (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 24 Jul 2018 12:59 |
Last Modified: | 29 Mar 2019 08:35 |
Status: | Published |
Publisher: | SAGE Publications |
Identification Number: | 10.1177/2168479018776949 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:133678 |