Evaluation of the quality of the main antimicrobial drugs sold in pharmacies in Bamako (Mali) according to a risk-based sampling

Abstract

Objectives: In a world marked by the increase in chemoresistance leading to the adoption of therapeutic combinations, the advent of generic multi-source drugs, the spread of counterfeiting and substandard drugs, often without active ingredients or falsified active ingredients, a greater vigilance by pharmaceutical regulatory authorities is needed. Drug quality control therefore plays an important role in detecting poor quality products on the market. Antimicrobial resistance (AMR) is a growing threat to public health. It occurs when vital antimicrobials can no longer effectively treat bacteria and other microbes. Worldwide, around 700,000 people die each year due to antimicrobial resistance and without global action it could lead to 10 million deaths a year by 2050. This study aimed to assess the quality of major antimicrobials sold in Bamako to determine the prevalence of falsified and substandard antimicrobials.
 Methods: Samples were taken in some pharmacies in Bamako and analyzed according to the standards of the United State Pharmacopoeia (USP), British Pharmacopoeia (BP) and International Pharmacopoeia (IP) by identification and assay methods. Products that do not meet the required specifications described by these pharmacopoeias are declared non-compliant.
 Results: A total of 151 samples were taken according to a protocol based on the risks, of which 145 were compliant and 6 non-compliant due to an under-dosage of active ingredient. We found 58% of unregistered drugs that came from India and China.
 Conclusion: This study allowed us to detect 6 non-compliant products that were withdrawn from the market and regulatory measures were taken.
 Keywords: Antimicrobial, quality control, non-compliance, AMR.