Dickinson, R orcid.org/0000-0002-5811-8242, Raynor, DK orcid.org/0000-0003-0306-5275, Knapp, P et al. (1 more author) (2017) How much information about the benefits of medicines is included in patient leaflets in the European Union? - A survey. The International journal of pharmacy practice, 25 (2). pp. 147-158. ISSN 0961-7671
Abstract
Patient information leaflets (PILs) are required with all licensed medicines throughout the European Union (EU) and they must include information about all side effects and their likelihood. This has led to criticism of a lack of balance, with little information included about potential benefits. Recent European Medicines Agency guidance proposed the inclusion of benefit information, and this study examined the current prevalence and type of such information in PILs in the EU.A survey and content analysis of the English translation of PILs in the EUwas carried out. Random quota sampling was used on the most frequently dispensed (n = 50) and newly licensed medicines (n = 50) in 2011/2. Leaflets were searched for benefit information meeting predefined criteria, and data synthesised and categorised into 10 categories.Eighty-five (85%) leaflets described how the medicine works, with 45 providing information about the rationale for treatment (more commonly for newly licensed (32/50) than most commonly dispensed medicines (13/50; P < 0.001). Nearly half (47) did not describe whether the medicine was curative, symptomatic or preventative. The terms used to communicate uncertainty were imprecise (such as 'may help'). None communicated numerical benefit information.Current PILs do not appropriately communicate information about benefit. At the basic level, around a half did not include information about treatment rationale or whether the treatment was to treat symptoms, curative or preventative. However, for true informed decision making, patients need quantitative information about benefits and none of the leaflets provided this.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2016 Royal Pharmaceutical Society. This is the peer reviewed version of the following article: Dickinson, R, Raynor, DK, Knapp, P and MacDonald, J (2016) How much information about the benefits of medicines is included in patient leaflets in the European Union? - A survey. The International journal of pharmacy practice, which has been published in final form at http://dx.doi.org/10.1111/ijpp.12285. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving. |
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) > Nursing Adult (Leeds) The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Healthcare (Leeds) > Pharmacy (Leeds) |
Funding Information: | Funder Grant number Department of Health PO 3604 |
Depositing User: | Symplectic Publications |
Date Deposited: | 22 Jul 2016 11:20 |
Last Modified: | 19 Jul 2017 18:27 |
Published Version: | http://dx.doi.org/10.1111/ijpp.12285 |
Status: | Published |
Publisher: | Wiley |
Identification Number: | 10.1111/ijpp.12285 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:102797 |