Communication on Medicine Safety in Low- and Middle-Income Countries (LMICS): Lessons Learned From Medicine Safety Week 2024 in Pakistan

Background & objectives Medication-related harm is known to be the cause for about 1/10th of hospitalizations. Some estimates from India show that about 90 per cent of medicines consumed are inessential or irrational and contribute towards high out-of-pocket expenditure on health. In this context, the Indian Council of Medical Research in 2022 constituted a National Task Force (NTF) to explore possible solutions that could improve safe and rational use of medicines (SRUMs). The objective of this study was to identify research ideas in the field of SRUM through a survey of relevant stakeholders, and further to prioritize the research ideas using a pre-identified set of criteria. Methods The responses from the identified stakeholders were assessed using the Child Health and Nutrition Research Initiative method, which is an established research priority-setting methodology. First, the NTF asked for two to six research ideas from relevant Indian and global stakeholders on solutions to improve SRUM. The ideas were checked for duplicates, re-phrased where necessary and classified into various sub-themes. Subsequently, the research ideas were scored by Indian experts with relevant technical expertise using a pre-defined set of five criteria: innovativeness, effectiveness, translational value, answerability and applicability. Each research idea received from a stakeholder was assigned a score under each of the five criteria. The overall research priority score was calculated as a mean of all five criteria-specific scores and converted into a percentage. Results The final output of the prioritization process was a list of research ideas or questions, ranked by their scores. Total 209 unique ideas were received from 190 respondents, which were scored by 27 experts. The top three research topics on medication safety focused on cost-effective strategies for improving antimicrobial stewardship, safe use of poly-pharmacy in geriatric patients and drug take-back policy interventions. Regarding the rational use of medicine, the top three topics included testing mobile application-based antimicrobial stewardship interventions, development of diagnostics for antimicrobial resistance, and behavioural interventions. Interpretation & conclusions Several priority ideas found in this study also align with those of global priority, e.g., safe disposal practices and enhanced pharmacovigilance, rational use of medicines. Patient engagement, which underlines many of the top scoring ideas found in this study, is also inclined with the top research priorities reported by the WHO priority exercise on research into the safe use of medicines. However, to the best of our knowledge, this is the first such work from a low- and middle- income country on medication safety and rational use of medicines. The findings of this research priority-setting exercise can help to guide research for the development of policy-relevant and novel interventions to improve SRUM in India.

Improvement of information provision for safe and rational use of medicines at pregnancy is a priority task for all system of healthcare in the world. The purpose of this study was to analyze and carry out a systematic analysis of information sources, databases, registries operating on the international, state, professional levels on the safe use of medicines, including duration pregnancy in the countries of the world. Summarized recommendations, directives of the World Health Organization about safety of pharmacotherapy, especially during pregnancy, and the need for improvement information provision for the appointment of drugs during pregnancy, since 50% and more pregnant women use more than 4 drugs.
 Systematized the main sources of information, a database of safe use of medicines during prеgnancy in Europe and the United States on professional levels, as well as specially for patients. The directions of the real word data collection were shown and made the establishment of registries of pregnant women taking medications that allow monitoring of adverse reactions during pregnancy. The modern trends on improving information provision by Food and Drug Administration (FDA) also for instructions and labeling of drugs depending on the risk category of pregnancy were presented. The use of modern information sources, databases, patient registries is relevant to provision of rational use of medicines, especially for pregnant women in Ukraine.

The use of over-the-counter (OTC) and pharmacy-only medicines has significantly increased due to their easy accessibility and the growing trend of self-medication. However, improper use of these medicines can lead to adverse effects, drug interactions, and even resistance. This community service activity aimed to raise public awareness about the rational and safe use of medicines, particularly OTC and pharmacy-only medicines. The activity was conducted using participatory education methods, including the delivery of material on drug classifications, simulation of reading drug labels and understanding usage instructions, as well as interactive sessions such as Q&A and consultations with pharmacists. The evaluation was carried out using pre-test and post-test assessments to measure participants’ knowledge before and after the educational session. The results showed a significant improvement in participants’ knowledge regarding the identification of drug types, label reading, and proper usage instructions. Additionally, participants demonstrated increased awareness of the risks associated with improper medication use and the importance of consulting pharmacists before taking OTC or pharmacy-only medicines. This activity highlights the essential role of pharmacists in public health education and emphasizes the need for structured, interactive educational strategies to promote responsible self-medication practices. Collaboration between healthcare professionals and the community is key to ensuring the safe and appropriate use of non-prescription medicines

By going online or overseas, patients can purchase a range of prescription and over-the-counter drugs and complementary and alternative medicine (CAM), without prescription and without input from a qualified health professional. Such practices raise questions about medicine safety and how and why patients choose to procure medicines using such methods. The aim of this paper is to examine two unconventional types of medicine procurement-medical returns and purchasing medicines online-from the patient perspective. Data are drawn from a large qualitative study examining health-seeking practices among Indian-Australians (28) and Anglo-Australians (30) living with depression in Melbourne, Australia. Semi-structured face-to-face interviews were undertaken. Thematic analysis was performed. A total of 23 (39.6%) participants reported having obtained medicines either through the internet or via medical returns. Indian-Australians sourced medicines from India while Anglo-Australians purchased CAM products from domestic and international e-pharmacies. Neither group encountered any difficulties in the medicines entering Australia. Cost and convenience were the main reasons for buying medicines online but dissatisfaction with Australian health services also influenced why Indian-Australians sought medicines from India. Nearly all participants reported benefits from consuming these medicines; only one person reported adverse effects. The increased availability of medicines transnationally and patients' preparedness to procure these medicines from a range of sources raise important issues for the safe use of medicines. Further research is needed to understand how patients forge their own transnational therapeutic regimes, understand and manage their levels of risk in relation to safe medicine use and what points of intervention might be most effective to promote safe medicine use.

ObjectivesThe aim of this study was to explore the public’s current awareness of the safe use of medicines in general, and over-the-counter (OTC) analgesics (painkillers) in particular, as well as...

ABSTRACTIntroduction: The global burden of cirrhosis is rising, and clinicians increasingly face the challenge of safely prescribing medicines for complications of hepatic disease and comorbidities. Prescribing in patients with cirrhosis is complicated by alterations that can occur in the pharmacology of medicines.Areas covered: This paper provides an overview of current knowledge on the pharmacokinetics and pharmacodynamics of medicines in patients with cirrhosis. We describe the pathophysiological changes that occur and their consequences on pharmacokinetic parameters. We explain that the influence of cirrhosis on the pharmacokinetics depends on several drug and patient characteristics. Patients with cirrhosis also have an increased susceptibility to some toxicological effects of medicines, such as renal impairment and hematological toxicity, which we describe in detail. In addition, we discuss approaches to apply this knowledge in practice and improve safe medication use in patients with cirrhosis.Expert opinion: Tailored pharmacotherapy is needed to ensure safe and appropriate use of medicines in patients with cirrhosis. Clinicians are supported by freely available recommendations on safe drug use in cirrhosis published on a website. In addition, a regular evaluation of medication use in patients with cirrhosis could resolve and prevent medication-related problems.

Although the concept of monitoring the safety of marketed medicines has been with us since the 1960s, at the beginning of the decade few people outside France used the word ‘pharmacovigilance’. In recent years, however, the field has moved on and acquired itself a new name. Pharmacovigilance is now accepted to be a continuous process of evaluation accompanied by steps to improve safe use of medicines which involves pharmaceutical companies, regulatory authorities, health professionals and patients. The methodologies have broadened to encompass many different types of study, with spontaneous reporting remaining the cornerstone. The British Journal of Clinical Pharmacology has responded by publishing an increasing number of articles relating to pharmacovigilance, and a recent editorial entitled ‘Pharmacovigilance in the 1990s’ [1]. In this month's issue we publish the first two papers in a series which will review the state of pharmacovigilance as we approach the turn of the millennium. On page 419, Garcia Rodriguez and Perez Gutthann discuss the use of the UK General Practice Research Database for pharmacoepidemiology, while on page 427 Talbot and Nilsson review the changing face of pharmacovigilance from an industry perspective. Future articles will focus particularly on the variety of methods by which the risks and benefits of medicines can be assessed. The 1990s have already been an important decade for those interested in the safety of medicines. Legitimate increasing public interest is providing pressure for even higher standards, and prescribers too are demanding better information which can help them tailor the treatment of individual patients. Meeting these expectations is a major challenge for all concerned. The methods and developments described in this series will take us in the right direction but there remains plenty of scope for innovation if we are to provide patients with the best protection possible.

BackgroundHerbal medicine use among patients with cancer is prevalent particularly in low- and middle-income countries. However, concerns about safety and potential interactions with chemotherapy emphasize the need to understand the prevalence and factors associated with herbal medicine use in this setting. Therefore, the aim of this study was to determine the prevalence and factors associated with herbal medicine use among patients with cancer at Mbarara Regional Referral Hospital (MRRH).MethodsWe conducted a cross-sectional study between September 2023 and November 2023 at the oncology unit of MRRH. Data analysis was done using SPSS version 27. The demographic characteristics of the study participants were analyzed descriptively and presented as frequency and percentage. The prevalence of herbal medicine use was presented as a percentage. We employed both bivariate and multivariate logistic regression to determine the factors associated with herbal medicine use and statistical significance was considered at a p-value < 0.05.ResultsA total of 358 patients were approached for the study and data from 303 participants was used for analysis. The overall prevalence of herbal medicine use among patients with cancer attending the MRRH was 56.8% (172/303). Of the 172 patients with cancer who use herbal medication, 46.4% (80/172) use herbal medication alongside conventional medication. Factors associated with herbal medicine use among the study participants include: stage III cancer (aOR = 2.7, 95% CI:1.3–5.3; p-value = 0.005), Stage IV cancer (aOR = 3.1, 95% CI: 1.5–6.3; p-value = 0.003), having a comorbid condition (aOR = 1.8, 95% CI:1.1–2.9; p-value = 0.026), and having received three or more cycles of chemotherapy (aOR = 2.5, 95% CI: 1.2–5.0; p-value = 0.014).ConclusionThe high prevalence of herbal medicine use among patients with cancer at MRRH indicates a strong reliance on complementary medicine, especially among those with advanced cancer and multiple comorbidities. Addressing this requires education on safe herbal medicine use and regular monitoring to ensure patient safety and improve treatment outcomes.

Background and Objectives: Patient package inserts (PPIs) are the accessible source of drug information which is expcted to contribute with the safe and efficient use of medicines. The aim of this study was to evaluate the satisfaction of pharmacists in Tabriz with the quality of Iranian and foreign PPIs. Methods: The present study is a descriptive cross-sectional study. The study sample consisted of 170 pharmacists working in community pharmacies in Tabriz, who completed a validated questionnaire with confirmed reliability and validity. The questionnaire included items regarding the scientific quality of Iranian and foreign PPIs. The study data were presented and analyzed using means, percentages, and frequencies. Results: Pharmacists were satisfied with the size of the PPIs, font size and font type of the Iranian PPIs (42.4%) and the foreign PPIs (72.3%). With respect to the amount and method of drug use information in PPIs, satisfaction was higher for foreign PPIs than for Iranian PPIs (P=0.017). Satisfaction with the expression of side effects, contraindications, how to adjust the dose of the drug in the underlying diseases and the necessary warnings for children and the elderly in the PPIs of Iranian medicines was significantly less than foreign medicines (P&lt;0.001). Most of the pharmacists agreed to design specific brochures for medical staff and patients. Conclusion: The results of the present study demonstrated pharmacists’ dissatisfaction with the scientific quality and the availability of sufficient, up-to-date information in domestic drug brochures for the safe use of medicines. Therefore, standardizing the structure of brochures by utilizing the experiences of other countries, using digital innovations and visual tools, implementing user-friendly tests, and continuous monitoring by Iranian Food and Drug Administration are essential.

ContextChildren and young people have a risk of medication errors and those with complex and/or life limiting conditions have a higher risk due to polypharmacy, complex medication regimens, and frequent...

The use of over-the-counter (OTC) medication is widespread among the adult and student populations in Slovenia. The aim of the study was to analyse the prevalence of OTC medicines use among nursing students with respect to sociodemographic characteristics. A total of 241 nursing students in the Faculty of Health Sciences, Ljubljana, were included in the cross-sectional study. A questionnaire was created for the purposes of the study. Statistical analysis was performed with SPSS 20. Descriptive statistics, t-test and the contingency coefficient were calculated. Statistical significance was set at the p-value of < 0.05. The study showed that the use of prescription drugs was significantly higher in women (p = 0.029), students living in rural areas (p = 0.005) and students who described themselves as being of bad health (p = 0.008). At the same time, a third of the respondents had been taking one OTC medicine within the last month; those taking several prescription drugs commonly administered several over-the-counter medicines (p = 0.027). Women used OTC medicines to treat pain and fever (p = 0.001), respiratory issues (p = 0.015), and fungal infections (p < 0.000) more often than men. OTC medicines were also used to treat minor mental health issues by a higher proportion of respondents over 21 years of age (p = 0.005) and women (p < 0.000), while over-the-counter medicines for treating skin conditions were more frequently used in rural areas (p = 0.006). Nursing students tend to use OTC medicines on their own accord, receiving instructions for safe use with their purchase, which points to adequate promotion of safe use of medications in Slovenia. Men's assessment of their personal health tends to be better than that of women, who also use medication more frequently. A connection between poor health and a higher incidence of the use of OTC medicines was established. The use of OTC medicines to treat minor mental health issues increased with age and was more typical of women. The results obtained demonstrate the importance of personal control over the safe use of medicines, motivation for personal good health and a healthy lifestyle.

Approximately 2 billion people globally have limited access to essential medicines, particularly those living in low‐ and middle‐income countries (LMICs). In addition, there is a higher prevalence of substandard and counterfeit medicines in LMICs, which may cause antimicrobial resistance and therapeutic failure. Good manufacturing practice (GMP) is key to ensuring access to high‐quality, safe and effective medicines, including active pharmaceutical ingredients and excipients used for manufacturing finished dosage forms. Compliance with GMP standards saves resources for both manufacturers (e.g. avoiding expensive product recalls) and governments (e.g. minimising compliance inspections). Concerted collaborations among different countries to harmonise GMP standards and procedures have occurred, and the World Health Organisation (WHO) GMP is commonly used in LMICs. However, barriers to GMP compliance remain apparent, particularly in LMICs. Pharmaceutical manufacturers in LMICs face several barriers such as inadequate resources and infrastructure, inefficient or weak regulation, a shortage of skilled people and limited training opportunities for manufacturing personnel. Although national regulatory authorities (NRAs) have been established in LMICs, most NRAs are not fully independent and are placed within the health department. NRAs in LMICs are not able to fully utilise international and regional reliance mechanisms and collaborations. Therefore, both NRAs and pharmaceutical manufacturers must be adequately supported through resources, infrastructure and capacity‐building opportunities. NRAs must be suitably empowered with assured functional independence. A comprehensive guideline for managing conflicts of interest among pharmaceutical manufacturers, procurement agencies and NRAs is needed. NRAs must liaise with other NRAs, participate in joint GMP inspections and leverage the expertise of regional or international collaborations. Pharmaceutical manufacturers in LMICs can leverage WHO GMP standards to improve GMP compliance and expand their market. However, as these solutions may have cost implications, prioritising key gaps for GMP compliance and optimisation of available resources are essential.

Patient information leaflets (PILs) for medicines are legally required across the European Union to support safe medicine use, informed decision-making, and treatment adherence. However, they are often criticised for complexity, poor readability, and anxiety-inducing descriptions of side effects. Health literacy (HL), the ability to access, understand, appraise, and apply health information, may affect how patients engage with PILs. Italy has a high prevalence of limited HL, yet population-based evidence on its influence remains scarce. This study examined patterns of PIL use, comprehension, and related behaviours in the Italian adult population, accounting for HL differences. A cross-sectional survey was conducted between October 2024 and April 2025 among 1,977 adults (mean age 46.5 years; 63% women). Recruitment combined social media dissemination with general practitioner collaboration to reach older and less digitally active individuals. The questionnaire collected sociodemographic data, HL (using the six-item HLS-EU-Q6 and a single-item functional HL screener), and indicators of PIL engagement, including reading frequency, reasons for non-consultation, comprehension of extracts, anxiety, therapy discontinuation, risk interpretation, and perceptions of commercial influence. Data were analysed using descriptive and inferential statistics. 66% of respondents reported always reading PILs for prescription medicines, and 71% did so for over-the-counter products. Overall, 17.2% had inadequate HL, 52.4% problematic, and 30.4% sufficient. Among sociodemographic variables, only education differed by HL level (2.09 vs. 2.02; p = 0.04). Higher HL was associated with more frequent PIL reading, greater confidence in medicine use (mean 2.22 vs. 1.94; p < 0.001), and lower anxiety (2.21 vs. 1.97; p < 0.001). In contrast, respondents with lower HL more often discontinued therapies after reading PILs (37% vs. 28%; p = 0.02) and overestimated vaccine risks compared with analgesics (25% vs. 9%). Perceiving PILs as commercially influenced was also more common among those with limited HL (p < 0.001). HL significantly shapes how Italian adults use and interpret PILs, influencing engagement, confidence, anxiety, and therapy behaviours. Current formats may inadvertently widen inequalities by overburdening readers with limited HL. Public health efforts should prioritise simplification, plain language, balanced risk communication, and perceptions of neutrality to promote equitable and safe medicine use.

Medicines are important health interventions and their appropriate use could improve health outcomes. Throughout the globe, pharmacists play a very important role to improve the use of medicines. Though high-income countries are debating on futuristic approaches, independent prescribing of pharmacists, clinical skills, and to expand pharmacy services; a large majority of low and middle-income countries still lag behind to strengthen pharmacy practice. This paper presents a key set of recommendations that can improve pharmacy practice in low and middle-income countries (LMICs). The ten recommendations include (1) Mandatory presence of graduate-level pharmacists at community pharmacies (2) Clear demarcation of the roles and responsibilities of different categories of pharmacists (3) Effective categorization and implementation of medicines into (a) prescription medicines (b) pharmacists only medicines (c) over the counter medicines (4) Enforcement of laws and regulations for the sale of medicines (5) Prohibiting doctors from dispensing medicines (the dispensing separation between pharmacists and doctors). (6) Involving pharmacies and pharmacists in Universal Health Coverage Schemes to improve the affordability of medicines (7) Strengthening national medicines regulatory authorities to improve the quality, safety, and effectiveness of medicines (8) Training of pharmacists in clinical skills, vaccination, and minor ailment schemes (9) Promoting independent medicines information for consumers and healthcare professionals by developing national medicines information strategy (10) Mandatory Continuing Professional Development (CPD) programs for the Pharmacists.

ABSTRACTIntroductionPrevious studies have highlighted numerous challenges with medicines use for patients with vision impairment, but evidence is lacking on interventions to support safe and effective medicine use for this population. This study aimed to identify potential barriers/facilitators of medicines use from the viewpoint of patients/caregivers, to establish a theory‐informed foundation for a future intervention.MethodsSemi‐structured interviews were conducted with patients with vision impairment and their caregivers in Saudi Arabia. Participants were recruited from low‐vision clinics and a non‐profit organisation. The Theoretical Domains Framework (TDF) informed the topic guide and served as the theoretical basis for examining participants' behaviours. Interviews explored the barriers/facilitators to obtaining and taking medicines (i.e. the target behaviours). Data were analysed using the framework method and content analysis. Key TDF domains were identified by assessing the relative frequency of themes, the existence of conflicting themes and the perceived theme impact on target behaviours.ResultsTwelve patient/caregiver dyads and 18 individual patients were interviewed. Patients' ages ranged from 19 to 88 years, with 21 females and 9 males. Patients/caregivers demonstrated good knowledge of medicines used, and resourcefulness in finding methods to manage medication use (Domains: ‘Knowledge’ and ‘Skills’). ‘Environmental context and resources (ECR)’ and ‘Social influences’ were the two most coded domains. Participants reported the usefulness of several resources including pill organisers and smartphones but described problems with pharmacy environments (Domain: ‘ECR’). Caregivers played a major role in assisting patients with medicines. Participants had some positive encounters with pharmacists but reported difficulties in discussing medication issues with them. Many participants had a narrow view of the pharmacist's role (Domain: ‘Social influences’). Maintaining a routine was a major facilitator under the ‘Memory, attention and decision processes’ and ‘Behavioural regulation’ domains. Six TDF domains were considered ‘key’ to participants' behaviours.ConclusionsThis study is the first to utilise a theoretical approach to understand the behaviour of patients with vision impairment in relation to medication use. It provides a comprehensive understanding of the role of caregivers and what influences their own behaviours. Findings will inform the future development of an intervention to support safe and effective medicine use for patients with vision impairment.Patient or Public ContributionAn author met with an administrator at the ‘National Association of the Blind’ (Kafeef) in Riyadh to enhance the research team's understanding of vision impairment, and the practicality and logistics for identifying and recruiting patients. A draft of the interview guides was piloted with two patients and their caregivers and they were asked for feedback on the questions with amendments made accordingly.