Ensuring Quality Medical Products in Mali

The multisectoral technical working group is raising awareness about the need to seek evidence and address poor quality medicines circulating in country. Building on this successful first round of surveys, the group will oversee and manage a second round of RB-PMS surveys in late 2021.

Malaria is the leading cause of illness and death in Mali, especially for children under five. While there have been improvements in maternal health, the country’s maternal mortality rates are among the highest in the world and life expectancy remains under sixty. Access to quality-assured medical products is critical to reversing these trends and saving lives. 

In Mali, poor-quality medical products threaten the public’s health and undermine national health programs. Pharmaceutical supply chains are vulnerable to substandard and falsified medical products. Continuous monitoring across all levels of the supply chain is critical to ensure the safety and efficacy of medical products available to the public.

To address these challenges, USAID’s Promoting the Quality of Medicines Plus (PQM+) initiative is supporting the National Health Laboratory (Laboratoire National de Santé) and the Mali Directorate of Pharmacy (Direction de la Pharmacie et du Médicament) to adopt a new risk-based approach to post-marketing surveillance (RB-PMS) of medicines. 

Mali had been conducting standard post-marketing surveillance, but sampling was based on convenience rather than science and it was expensive, complex, and time-consuming. By contrast, the new RB-PMS approach relies on a sampling and testing strategy that produces statistically significant results at a much lower cost. In essence, RB-PMS channels limited resources toward medicines and locations that present the highest risks to patients.

This new approach is providing important and actionable information. Mali’s first RB-PMS survey found 69% of medical products, many antimalarials, to be either unregistered or counterfeit. To implement RB-PMS, PQM+ coordinated with Mali’s Directorate of Pharmacy and National Health Laboratory to launch a multisectoral technical working group. Working group members were trained on use of the Medicines Risk Surveillance Tool (MedRS), and then used MedRS to develop Mali’s first risk-based PMS protocol for antimalaria and maternal and child health (MNCH) medicines.

“In view of the scarcity of resources and its scientific nature, this risk-based sampling and analysis technique must be continued, optimized and sustained to safeguard health and guarantee access to quality medicines for the health and well-being of populations.” - Dr. Ousmane Dembélé, President of the Mali national PMS-technical working group

Working group members used MedRS to identify which antimalaria and MNCH medicines to sample; which geographic regions and facilities to sample from; and the number of samples to be taken from each site. Teams deployed in December 2020 to four regions - Kayes, Sikasso, Koulikoro and Segou - that posed the highest risk in terms of the prioritized medicines. Samples were collected from targeted facilities and subjected to up to three levels of scientific testing: physical/visual inspection; Minilab™ screening; and compendial or confirmatory testing at National Health Laboratory’s medicines quality control laboratory. The Minilab™ is a versatile, portable mini-laboratory that can be used to easily identify poor-quality and counterfeit medicines.

Sixty-nine percent of medicines sampled were unregistered, posing a potential risk to public health and confidence. Four percent of medicine samples failed quality control tests, indicating they were either substandard or counterfeit. By adopting RB-PMS, Mali’s health sector is taking important steps to optimize the use of its limited resources and build sustainability.