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Conclusion: This study allowed us to detect 6 non-compliant products that were withdrawn from the market and regulatory measures were taken.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.
Downloads
References
2. CDC. What Exactly is Antibiotic Resistance? [Internet]. Centers for Disease Control and Prevention. 2020 [cité 27 nov 2020]. Disponible sur: https://www.cdc.gov/drugresistance/about.html
3. 160518_Final paper_with cover.pdf [Internet]. [cité 27 nov 2020]. Disponible sur: https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf
4. Rousham EK, Unicomb L, Islam MA. Human, animal and environmental contributors to antibiotic resistance in low-resource settings: integrating behavioural, epidemiological and One Health approaches. Proc Biol Sci. 11 2018;285(1876). https://doi.org/10.1098/rspb.2018.0332
5. Antimicrobial resistance [Internet]. [cité 27 nov 2020]. Disponible sur: https://www.who.int/westernpacific/health-topics/antimicrobial-resistance
6. http://www.who.int/medicines/areas/quality_safety/quality_assurance/Local-manufacturing.pdf.
7. pqm-annual-report-2017-12-web.pdf.
8. MedRS | Log In [Internet]. [cité 29 déc 2021]. Disponible sur: https://medrsv2.com/
9. USP-NF USP [Internet]. [cité 7 juill 2021]. Disponible sur: https://online.uspnf.com/uspnf/section/monographs-usp
10. BP 2021 (Ph. Eur. 10.5 update) - British Pharmacopoeia [Internet]. [cité 7 juill 2021]. Disponible sur: https://www.pharmacopoeia.com/bp-2021?date=2021-07-01
11. The International Pharmacopoeia [Internet]. [cité 7 juill 2021]. Disponible sur: https://digicollections.net/phint/2020/index.html#d/b.6.2.2.3
12. GPHF | The GPHF-MinilabTM [Internet]. [cité 7 juill 2021]. Disponible sur: https://www.gphf.org/en/minilab/
13. Dembélé O, Coulibaly S, Dakouo J, Koumaré B. Pre- And Post-Marketing Control Of Drug Quality At The National Health Laboratory, Bamako-Mali. Universal Journal of Pharmaceutical Research. 15 janv 2022; https://doi.org/10.22270/ujpr.v6i6.696
14. Dembélé O, Coulibaly S, Cissé B, Cissé M, Dakouo J, Cissé N, et al. Risk-Based Post-Marketing Surveillance (RB-PMS) of antimalarial drugs and maternal, neonatal and reproductive health (MNCH) in Mali. Journal of Drug Delivery and Therapeutics. 7 mars 2022;12:6‑10. https://doi.org/10.22270/jddt.v12i2.5223
15. A Sidibé O. Quality control of medicines antimalarials in seven (07) administratives regions of Mali and Bamako district: operationalization of minilab kits. Published online 2012. Accessed April 2, 2021.

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).