Risk-Based Post-Marketing Surveillance (RB-PMS2) of Antimalarial and MNCH drugs in Mali (PY2)

Abstract

Background and Objectives: The advent of multi-source generic drugs has exacerbated the prevalence of drugs and the spread of counterfeit and sub-standard drugs requiring increased vigilance and collaboration from drug regulatory authorities. Post-marketing surveillance (PMS) of medicines therefore plays an important role in detecting poor quality products on the market. Risk-Based Post-Market Surveillance (RB-PMS) RB-PMS helps optimize resource utilization and create sustainable post-market surveillance programs that are integrated and implemented as a key regulatory function. Methods: The survey concerned points of sale identified by a Technical Working Group in certain geographical areas according to risk-based approaches applied in the selection of the type of drugs to be targeted. It took place from September to December 2021 and aimed to assess the quality of antimalarial and MNCH medicines. Results: A total of 320 samples were taken and analyzed according to a risk-based protocol, of which 306 were compliant with a rate of 96% against 14 were non-compliant or 4% (P≤0,05). Non-compliant drugs were from both the public and private sectors. We found that 84% of drugs were unregistered among which antimalarials were the least registered drugs with a rate of 66% against 34% for MNCH drugs and came mainly from India and China. Conclusion: The RB-PMS allows the optimization of health resources in LMIC. In view of its scientific nature, this sampling and analysis technique must be made permanent to ensure health and guarantee access to quality medicines for the health and well-being of populations.