APPLICATION D'UNE APPROCHE BASEE SUR LES RISQUES POUR DETECTER LES MEDICAMENTS SRMNI DE QUALITE INFERIEURE ET FALSIFIES (QIF) AU MALI ET MESURES REGLEMENTAIRES PRISES

The advent of multi source generic drugs, the spread of counterfeit and substandard drugs, often with no active ingredients or falsified active ingredients, require greater vigilance by drug regulatory authorities. Post marketing surveillance (PMS) of drugs therefore plays an important role in detecting poor quality products on the market. Risk based post marketing surveillance (RB PMS) is a new form of PMS that is emerging and has been the subject of several publications.The survey focused on selected regions and outlets identified by a technical working group. It aimed to assess the quality of SRMNI drugs available at certain risky distribution levels based on priority sites. The selection of drugs and geographical areas was done using risk based sampling using the Medicines Risk Assessment Tool (MedRS) developed by USP/PQM+. In total, 281 samples were collected and analyzed, of which 251 were compliant with a rate of 89% against 30 were non-compliant or 11% (P0.05). The non-compliant drugs came mainly from the public sector. We found 87% of the unapproved drugs which were mainly constituted and which came from China and India.The results clearly raise the issue of registration of drugs before their market authorization and the importance of continuous quality control and post-marketing drug analysis to ensure health and guarantee access to quality medicines for the health and well-being of populations.