Written medicine information: global considerations
Pitchaya Nualdaisri, Barbra Katusiime, Janet Krska · International Journal of Pharmacy Practice · 2024
The World Health Organisation (WHO) has set a target to “improve access to safe, effective, quality and affordable essential medicines and vaccines for all” by 2030 [1]. Improved information supporting patients to make better use of available medicines is also essential. Now more than ever, patients need greater vigilance and better access to medicine information to avoid preventable harm, given the increasing shortages of essential medicines, product falsification, and increased access to medicines via unregulated sources. Indeed, the WHO recommends that patients pay attention to medicine packaging and look out for unusual features [2]. Written information about medicines seems ubiquitous in many countries, as patient information leaflets (PILs) included in full packs of medicinal products, on the packaging itself, and available on health-related websites. Medicine users perceive the importance of understanding the likely benefits and risks of their medicines and how to use them but may feel overwhelmed by information. Most systematic reviews on written medicine information (WMI) have focused on high-income countries, where it is routinely available and thus where most research has been carried out [3, 4]. These have found limited evidence of improved knowledge of or adherence to medicines, that WMI uses complex language and poor visual presentation [3] and that PILs were not meeting patients’ needs, lacking the information they sought, but including material perceived as non-essential [4]. In many low- and middle-income countries, the situation is very different. Package inserts (PIs), designed for health professionals, therefore containing complex details using technical terms, are often the only available WMI in many African and Asian countries [5]. In addition, PIs often fail to meet regulatory requirements, especially locally manufactured products, and WMI is frequently not available in a language understood by medicine users [5]. A review of regulations in 25 countries across Latin America and the Caribbean found varying requirements regarding WMI, PILs not being a requirement in most countries [6]. Perhaps due to the paucity of WMI, information specifically designed for patients, some including pictograms, has led to improved knowledge and/or adherence in some Asian and African studies [7]. However, others show that poor readability and comprehensibility can reduce adherence, while learning about potential side effects can negatively affect use [8, 9]. Medicines in many low-income countries are frequently not supplied as a full manufacturer’s pack, therefore WMI often consists only of what may be written on the container by the supplier, who may not be a qualified healthcare professional. Usually, this is only the medicine name (or brand), dose, and frequency with little or no additional precautions, warnings, or what to do if adverse events occur. In addition, literacy levels and in particular health literacy levels are often low in these countries, therefore verbal information is crucial. In fact, studies globally consistently find that patients want verbal information, as well as WMI [3–5, 10] hence this remains an important role for health professionals, required by professional and regulatory bodies. Both reviews and empirical studies clearly demonstrate commonality in the basic information patients want from WMI: medicine name/indication, dose/instructions for use, side effects, contraindications, precautions, and interactions [3–5, 10]. Some studies have shown that patients also want to know how a medicine will benefit them [4, 8]. But unless they are read, leaflets cannot support optimal medicine use and the WHO estimates that more than 70% of patients do not read the WMI they are given. The proportion of people who actually read WMI is thus an important indicator of its value. Studies show dramatic variation across countries, ranging from 11% to 94% [3, 7, 9]. Technical terms, provision of a PI designed for health professionals [5] and generic information about a medicine that can be used for different indications in different age groups can confuse recipients or mean leaflets are judged irrelevant [4]. Format, structure, font size, language, and terminology all affect readability and understanding [4, 5, 8], while trustworthiness affects acceptability [3, 10]. Reviews suggest that what is wanted is tailored information [3, 4], some prefer the minimum, others more detail. Many want information only relating to their particular medical condition and some want different information at different times relative to their illness journey. How to achieve this? Research is needed into how information could be produced digitally in varying formats and for different indications and population groups, perhaps using mobile applications to help people access only the information they consider essential at any given time. On-line information provided by government/regulator is desirable [7], but preferences remain for verbal and paper information sources [7, 11]. Could artificial intelligence (AI) help? ChatGPT says: “Medication information will become more interactive and personalized, tailored to individual patient preferences, health literacy levels, and cultural backgrounds. Interactive tools, such as personalized medication summaries and decision aids, can help patients better understand their medications and make informed choices.” While research into AI-generated WMI seems inevitable and is indeed desirable, both its acceptability and perceived credibility must be considered. Meanwhile, for those in low- and middle-income countries who currently receive no written information or a complex PI, interactive, personalized WMI seems inaccessible, and verbal information continues to be essential. Most of the few published studies on the topic in these countries are conducted in large conurbations, where practices are likely to differ from those in rural areas, with poor access to pharmacies. Hence many more studies are needed. Research with the potential to influence and inform regulators is essential. Multiple studies have demonstrated the desirability of PILs in Thailand; an amendment to regulations in 2023 now requires manufacturers to produce PILs. Demonstrating what medicine users want and need should influence the content of WMI, so it includes the desirable aspects, rather than what health professionals, regulators, or manufacturers consider important. More studies are needed to determine how best to provide information about medicines in low-income countries, especially in rural areas. Involving the end-users of medicines in the development of the information they are expected to make use of is essential. Qualitative studies, involving users in the development and testing of pictograms, finding suitable ways of disseminating information, testing on-line materials, and evaluating the ability of WMI to help in decision-making, adherence, and changing health outcomes are all needed. Healthcare professionals, including pharmacists and their teams, and researchers internationally can contribute to ensuring patients receive the information about medicines that they need and can use. P.N.: Design the content; Review literatures, Draft the manuscript. B.K.: Draft the manuscript; Approve the submitted version. J.K.: Design the content; Draft the manuscript; Approve the submitted version. Conflict of interest statement: None declared. There is no funding to report for this submission. No new data were generated or analysed in support of this research.