Strengthening Pharmacovigilance Systems in Africa

Pharmacovigilance (PV) is a critical component of effective healthcare systems, ensuring the safety and efficacy of medicines and vaccines. In Africa, where the burden of disease is high and healthcare resources are often limited, strengthening PV systems is particularly vital.

The Current State

Despite the critical need for robust PV systems, many African countries face significant challenges in monitoring and managing the safety of medicines. The spontaneous adverse events (AE) reporting rate in sub-Saharan Africa is lower than in any other region of the world. Healthcare professionals (HCPs) often have limited awareness of AE surveillance and reporting procedures, which hampers the effectiveness of PV systems.

Challenges and Opportunities

The COVID-19 pandemic highlighted the challenges for PV in Africa, but it also presented an opportunity to strengthen patient safety. The pandemic underscored the importance of having a resilient healthcare system, including a strong PV framework that can respond to new and emerging health threats.

PV systems are also more robust within the controlled environment of clinical trials due to strict regulatory oversight. This ensures a systematic approach to safety monitoring, including case management, signal management, and benefit-risk management. In contrast, clinical settings often exhibit a more relaxed PV system, which can lead to challenges in tracking adverse drug reactions (ADRs) and serious adverse events (SAEs) with the same level of detail and urgency. The discrepancy between the two settings highlights the need for a more integrated and vigilant approach to PV in clinical practice, ensuring patient safety and the efficacy of therapeutic interventions.

System Strengthening Strategies

A scoping review published in BMJ Open suggests that educating healthcare providers (HCPs) on adverse drug reaction (ADR) reporting is a common approach to building PV capacity in low-income and middle-income countries. However, education alone is insufficient. It should ideally be organized within the holistic framework of strengthening national PV systems, focusing also on building capacity for advanced activities such as signal detection.

Projects like the GSK PV enhancement pilot initiative, in collaboration with PATH and national PV stakeholders, aim to strengthen passive safety surveillance through training and mentoring programs for HCPs in healthcare facilities in countries like Malawi, C?te d’Ivoire, and the Democratic Republic of Congo. These initiatives have shown promising results, with significant increases in AE reporting rates.

Establishing clear and comprehensive PV regulations is fundamental. African countries must develop and enforce robust regulations, aligning them with international standards set by organizations such as the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Harmonizing these regulations will facilitate consistency and collaboration across countries, creating a cohesive PV environment.

By creating mobile applications and online portals that are intuitive and easy to navigate, healthcare providers and patients can report adverse drug reactions (ADRs) promptly and efficiently. Such accessible and user-friendly reporting systems can facilitate real-time data collection and analysis, and enable quicker responses to emerging drug safety concerns. Moreover, such systems can be designed to provide educational resources about ADRs, further empowering users to make informed decisions about their medications.

As the field evolves, incorporating advancements in biomedical informatics and analytics could further bridge the gap, enhancing PV systems' responsiveness and reliability in all healthcare facets.

Stronger Culture

For sustainable improvements, country ownership and empowerment are essential. The pilot project in Malawi has enabled the country to train more HCPs and increase the reporting of AEs. Identifying key performance indicators (KPIs) that could be flexibly replicated in each country is crucial for building a stronger Adverse Event (AE) reporting culture.

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Take-Home Points

Strengthening PV systems in Africa requires a multifaceted approach that includes education, capacity building, and the development of a culture that values patient safety and AE reporting. With the right strategies and interventions, there is an opportunity to significantly enhance the impact of PV in medicine safety systems across the continent.

What insights and recommendations would you suggest to strengthen PV systems in Africa? Please share your thoughts with me in the comments or via email at [email protected] or [email protected].

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