Confirmatory Testing of Antimalarial Medicines and Refresher Training in Dissolution and HPLC

Agency for International Development (USAID) and the United States Pharmacopeia (USP) have been assisting the Ministry of Health (MOH] of Mali in strengthening their medicine quality assurance systems. Activities focus on enhancing the capacity of the Direction de la Pharmacie et du Médicament (DPM) and Laboratoire National de la Santé (LNS) in pharmacovigilance, drug registration, and medicine quality control. In 2009, PQM facilitated a workshop to establish a national pharmacovigilance system, conducted a training workshop on drug registration and drug import verification using the World Health Organization's (WHO) SIAMED system, and provided training to the staff of the LNS quality control laboratory. The lab training covered good laboratory practices (GLP) and testing antimalarial samples using high-performance liquid chromatography (HPLC). PQM has also provided refresher training in dissolution, conducted a comprehensive inventory of the lab equipment and supplies, and reviewed the lab quality manual and procedures. In 2010, PQM established a post-surveillance program focused on monitoring the quality of antimalarials in seven regions, including Bamako. The program collected and analyzed antimalarial samples using Minilabs. Review of the data from the sentinel sites showed several quinine sulfate medicines lacking the active pharmaceutical ingredient (API) were detected. In response, Dr. Mustapha Hajjou and Dr. Yanga Dijiba traveled to Bamako, Mali, to assist LNS staff in conducting confirmatory testing on samples that failed Minilab tests. The PQM team met with Dr. Benoît Koumara, Director General of LNS, who expressed his support for the planned testing of antimalarials. The team then met with the lab staff and reviewed the planned pharmacopeial testing of quinine sulfate and sulfadoxine-pyrimethamine (SP) tablets. Nine staff members from LNS participated in the testing. The testing involved nine quinine sulfate samples suspected to lack API after screening at the sentinel sites and one positive control sample. Although the samples were collected from different sectors, all shared the same name: Quinine Sulfate 300 mg. The results of the testing are presented in Table 1. The table shows the results of the confirmatory testing, including the name of the product, lot number, and the presence or absence of the active pharmaceutical ingredient (API). The results indicate that several samples lacked the API, highlighting the need for further investigation and quality control measures to ensure the safety and efficacy of antimalarial medicines in Mali. The PQM team's efforts to strengthen medicine quality assurance systems in Mali are crucial in addressing the challenges posed by counterfeit and substandard medicines. The program's focus on enhancing the capacity of the DPM and LNS in pharmacovigilance, drug registration, and medicine quality control is essential in ensuring the quality and safety of medicines in the country. The President's Malaria Initiative (PMI) has provided funding for the PQM team's activities in Mali, including the confirmatory testing and refresher training in dissolution and HPLC. The PMI's support is critical in addressing the malaria epidemic in Mali and ensuring the availability of quality antimalarial medicines.