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

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.

Patients' Experiences and Preferences for Medicine Information: An International Comparison Between Malaysia, Thailand, Uganda, and England.

Background: Verbal and written medicine information are available to the public but the quality, ease of access, ease of understanding and use of these resources varies greatly between countries. Timely access to quality medicine information is essential to support patient safety. Objective: This international cross-sectional survey, conducted in low-to high-income countries, aimed to compare experiences of and preferences for medicine information sources among respondents with recent medicine use. Methods: The survey was originally developed in England (Kent), then adapted and translated for use in southern Thailand (Songkhla), Malaysia (Klang Valley), and central Uganda (Kampala). Data were analysed using simple descriptive statistics and Chi-squared tests. Results: A total 1588 respondents were involved in the study. Community pharmacies were the primary source of medicines in all four countries (40.7 to 65.3%). Most respondents (1460; 92%) had received at least one form of information with their medicine, but provision of written medicine information (WMI) varied between countries. A manufacturer's leaflet was the most frequent information source for patients in England, while verbal information was common in Thailand, Malaysia and Uganda. There was commonality across countries in the desire for verbal information with or without WMI (1330; 84.8%); aspects of medicine information wanted most frequently were instructions on medicine use (98.3%), indication (98.2%), name (94.4%) and possible side effects (94.3%); and the importance of providing leaflets with all medicines (87.5%). Fewer than 10% in Uganda would use internet based WMI, compared to between 20% and 55% elsewhere. Conclusion: Preferences for medicine information are similar across countries: verbal information is seen as most desirable, and the most wanted aspects of information are common internationally. Accessibility and understandability are key influences on preferred information sources. In-country regulations and practices should ensure that all medicine users can access the information necessary to maximise safe medicine use.

The Effectiveness and Value of Written Medicine Information Across Asia and Africa: Systematic Review.

Reviews on the role, value, effectiveness and desirable content of written medicine information (WMI) mostly include studies from high-income countries. We reviewed studies from Africa and Asia published between January 2004 and December 2019 to determine (1) the effect of WMI on knowledge and behaviour and (2) whether patients value WMI and their preferences for WMI. We included 16 intervention studies involving almost 3500 participants and 27 surveys of patients/public totalling over 11,000 people. Both the quality of the intervention studies and the reporting quality varied. Surveys were mostly localised, many with inadequate sampling strategies, and hence, were poorly representative of wider populations. However, most included a high proportion of participants with low educational levels. Most of the intervention studies reported significant improvements in knowledge and/or adherence after provision of WMI. Many utilised specially developed WMI in local languages, enhanced by pictograms. Provision of verbal information in addition to WMI showed variable impact. The proportion of people who read WMI, used as an indicator of its value, was reported in 15 surveys, with an overall figure of 74%. The most desirable aspects of WMI reported in 12 studies were indication, side effects, dose/instructions for use, contraindications, precautions and interactions. Nine studies reported local language was desirable. The studies suggest that WMI can improve both knowledge and adherence and is highly valued by people in many countries across Africa and Asia. Mechanisms should be considered by regulatory authorities and manufacturers to facilitate the provision of leaflets in local languages using simple terminology, perhaps enhanced by pictograms.This study is registered with PROSPERO, registration number: CRD42019127001.

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature.

Published reviews of written medicine information (WMI) have mainly drawn on studies published in high-income countries, including very few Asian or African studies. We therefore set out to scope the research literature to determine the extent and type of studies concerning WMI for patients/consumers across these two continents. We sought empirical studies published between January 2004 and December 2019, conducted in any Asian or African country, as defined by the United Nations, in English or with an English abstract. The majority of the 923 papers identified were from high-income countries. We retained 26 papers from Africa and 99 from Asia. Most African studies (n = 20) involved patients in the development of PILs, in the assessment of the effectiveness of PILs or in surveys. In contrast, the highest proportion of Asian studies concerned the content of WMI (n = 42). WMI is desired, but needs to be in local languages, and there needs to be more use made of pre-tested pictograms. Existing WMI frequently does not meet local regulatory requirements, particularly locally manufactured products. A number of studies reported potentially positive impacts of providing WMI on knowledge and medicine use behaviours. Provision of medicine information is essential for safe use of medicines in all countries. Internationally agreed guidelines, incorporating good design principles, are needed to ensure the optimal content and design of WMI. The World Health Organization should support African and Asian regulatory bodies to share best practice in relation to WMI for patients/consumers and to develop and implement pan-continental guidelines that take into account consumer needs and preferences.