A recent study by Kiguba et al., (2023) titled “Pharmacovigilance in Low‐and Middle‐income Countries: A Review with Particular Focus on Africa” published in the British Journal of Clinical Pharmacology by Wiley shows that pharmacovigilance in low- and middle-income countries (LMIC) can contribute to global health and development goals.
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Pharmacovigilance in low- and middle-income countries, notably Africa, significantly contributes to global health goals, ensuring safe and effective medicine use.– Kiguba et al., 2023
In the dynamic landscape of global healthcare, the crucial role of pharmacovigilance in ensuring the safe and effective use of medicines takes centre stage. In this comprehensive study, the authors delve into the challenges and progress of pharmacovigilance systems in Low- and Middle-Income countries (LMIC), particularly in the diverse and complex context of Africa.
Understanding Pharmacovigilance in LMIC
The study defines pharmacovigilance as a science and set of activities dedicated to the detection, assessment, understanding, and prevention of adverse effects or any other potential drug-related issues. LMIC faces unique challenges, including limited resources, weak regulatory systems, low awareness, and low reporting rates. The burden of substandard and falsified medicines further complicates the landscape, emphasizing the need for robust pharmacovigilance frameworks.
Challenges and Gaps
The authors identify obstacles hindering the development and implementation of robust pharmacovigilance systems. These challenges encompass limited integration and reliability of systems, scarcity of well-trained personnel, budgetary constraints, low awareness and reporting rates, and the high uptake of herbal and traditional medications. Political conflicts and the lack of access to drug utilization data compound these issues, emphasizing the need for targeted interventions.
Areas of Progress and Opportunities
Amidst the challenges, the article shines a light on areas of progress and opportunities. Regional harmonization initiatives, such as the African Medicines Agency, are pivotal steps toward collaboration and regulatory consistency. Innovative methods like cohort event monitoring, mobile apps, and artificial intelligence offer promising avenues for data collection and analysis. Integration of pharmacovigilance into public health programs and active involvement of patients in reporting and decision-making showcase positive strides toward a safer healthcare environment.
Innovations and Collaboration as Catalysts for Change
The study underscores the pivotal role of regional and global initiatives in harmonizing and strengthening pharmacovigilance in LMIC. Regional economic communities and the establishment of the African Medicines Agency exemplify concerted efforts toward collaboration and regulatory coherence. The World Health Organization stands as a crucial partner, providing technical support and guidance to LMIC through diverse programs and tools.
Findings of the Study
The study found that pharmacovigilance in LMIC can contribute to global health and development goals, such as ensuring access to safe, effective, and quality medicines; combating antimicrobial resistance, preventing substandard and falsified medicines, and responding to public health emergencies such as the COVID-19 pandemic. Pharmacovigilance in LMIC can also generate local evidence and knowledge that can inform policy and practice and promote patient empowerment and engagement.
Implications of the study
The study highlights the efforts of regional economic communities and the African Medicines Agency to harmonize the pharmacovigilance rules and regulations in LMIC, which can improve the effectiveness, efficiency and transparency of medicine regulation and safety monitoring. It also emphasizes the importance of political will, budgetary support, and reliance on competent regulatory authorities to foster pharmacovigilance activities in LMIC. The study points out the gaps and opportunities in pharmacovigilance for specific populations in LMIC, such as pregnant and breastfeeding women, children and young people, patients using herbal and traditional medicines, and patients with neglected tropical diseases and noninfectious diseases. These populations may have different or higher risks of adverse drug reactions and may require tailored pharmacovigilance approaches to ensure their safety and well-being.
Recommendations
- The authors conclude with a call to action. Pharmacovigilance in LMIC is deemed essential for the safe and effective use of medicines, particularly with increasing disease burdens and mass drug administration campaigns. Recommendations include strengthening, harmonizing, and integrating pharmacovigilance systems with existing health structures, adequate funding and staffing, heightened awareness and reporting, and transparent communication of pharmacovigilance data to inform regulatory decisions and clinical practice.
- The authors recommend priority areas for LMIC to focus on, ranging from medicines used in public health programs to the pharmacovigilance of herbal and traditional medicines. Special attention is directed towards pregnancy, breastfeeding, children, adolescents, and vaccines. Investment in training, awareness, and research, along with political will and budgetary support, are emphasized as essential elements for strengthening pharmacovigilance activities in LMIC.
In conclusion, the comprehensive review underscores the indispensable role of pharmacovigilance in low- and middle-income countries, particularly within the intricate landscape of Africa. While challenges persist, ranging from resource limitations to diverse healthcare practices, the study illuminates significant progress and opportunities. Regional collaborations, innovative methodologies, and global initiatives emerge as catalysts for change. The findings emphasize the potential of pharmacovigilance to contribute significantly to global health and development goals, urging for sustained efforts, political will, and investment to strengthen these vital systems and ensure the safe and effective use of medicines in diverse populations.
Cite this article as (APA format):
AR Managing Editor (2023). Empowering Global Health: A Comprehensive Review on Pharmacovigilance in Low- and Middle-Income Countries, with a Focus on Africa. Retrieved from https://www.africanresearchers.org/empowering-global-health-a-comprehensive-review-on-pharmacovigilance-in-low-and-middle-income-countries-with-a-focus-on-africa/
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