Patient information leaflets and package inserts of ibuprofen provided in the UK and Thailand: a comparative assessment

Author:

Nualdaisri Pitchaya12ORCID,Corlett Sarah A23ORCID,Krska Janet2ORCID

Affiliation:

1. Faculty of Pharmaceutical Sciences, Prince of Songkla University , Hat Yai , Thailand

2. Medway School of Pharmacy, Universities of Kent and Greenwich , Chatham Maritime , Kent , United Kingdom

3. Pharmacy Department, Medway Foundation NHS Trust , Kent , United Kingdom

Abstract

Abstract Objectives Written medicine information (WMI) is important for ensuring patients understand and use their medicines optimally, but relatively little research has assessed the quality of available WMI. This study assessed the quality of WMI using a sample of leaflets for ibuprofen in the UK and Thailand. Methods Leaflets were obtained by purchasing a product from retail outlets or community pharmacies, 18 from each country. In the UK, these were patient information leaflets (PILs); in Thailand, they were package inserts PIs not specifically designed for patients. Leaflets were assessed for content, layout, and readability using standard methods and compared to relevant guidelines. Key findings The UK PILs were uniform and conformed to EU regulatory requirements for content, whereas Thai PIs varied considerably, many failing to include important information required by Thai regulations. Several forms of Thai PIs were found, including some very short leaflets, containing minimal information. The readability of both was rated as poor, all used small font size and had less than desirable white space. Fewer Thai PIs than UK PILs met the Keystone Criteria for ibuprofen. Conclusions The extent of variation in format and content of Thai WMI could potentially cause confusion and reduce willingness to read it. PILs, conforming to Thai regulatory guidelines, should be provided with medicines instead. Leaflets in both countries would benefit from improved readability and layout.

Funder

Royal Thai Government

Publisher

Oxford University Press (OUP)

Reference56 articles.

1. Patient information leaflets: Informing or frightening? A focus group study exploring patients’ emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices;Herber,2014

2. Provision and need for medicine information in Asia and Africa: a scoping review of the literature;Nualdaisri,2021

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