Proforma

Background and Problem statement

In sub Sharan Africa, access to medicine including new drugs, vaccines, microbicides for treatment of poverty-related diseases (PRD) continues to grow. But this effort is not well-matched with the capacities of National Medicine Regulatory Authorities (NMRAs) to monitor the quality and safety of new drugs and interventions. The increasing number of global clinical trials being conducted in Africa underlines the need for a robust pharmacovigilance (PV) system in line with international norms and best practices. Pharmacovigilance during clinical trials and post-marketing is vital to monitor and update the risk-benefit ratios and to prevent or minimize drug adverse events.

Preventive chemotherapy through mass drug administrations and vaccination in various public health programs to all eligible individuals are being deployed in many endemic African countries.  However, lack of skilled manpower to lead and manage the regulatory pharmacovigilance process to monitor public safety, and absence of post-marketing surveillance system remains a major gap in sub Sharan Africa. To address this gap, effective collaboration between academia, stakeholder organizations and national medicine regulatory authorities (NMRAs) is binding to produce sustainable regulatory skills and functional national pharmacovigilance system.

PROFORMA consortium* is a joint venture between experts from academia, NMRAs and WHO-collaborating centres in pharmacovigilance and RCOREs to generate a cohort of pharmacovigilance trained human resources from all stockholders including patients, healthcare providers, regulatory staffs that are engaged in pharmacovigilance data collection, analysis, interpretation and data sharing. Emphasis will be given to implement pharmacovigilance in clinical trials regulation and post-marketing surveillance in public health programmes involving mass drug administration and immunization programmes.

Access to medicines in Africa is increasing but inadequate pharmacovigilance regulatory capacity to process new drug registration and monitoring drug safety profiles locally remains a challenge. The increasing number of clinical trials and the large-scale mass drug administration and immunizations programs being deployed through public health programmes in sub Sharan Africa underscores the urgent need to develop/strengthen the pharmacovigilance system for patient safety.