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

  • Ousmane DEMBELE Faculté de Pharmacie de Bamako, Université des Sciences, des Techniques et des Technologies de Bamako, Mali
  • Bakary Moussa Cissé Faculté de Pharmacie de Bamako, Université des Sciences, des Techniques et des Technologies de Bamako, Mali
  • Mody Cissé Faculté de Pharmacie de Bamako, Université des Sciences, des Techniques et des Technologies de Bamako, Mali
  • Seydou Moussa Coulibaly Laboratoire National de la Santé du Mali
  • Jacques Dakouo Laboratoire National de la Santé du Mali
  • Nana Houmama Cissé Laboratoire National de la Santé du Mali
  • Benoît Yaranga Koumaré Faculté de Pharmacie de Bamako, Université des Sciences, des Techniques et des Technologies de Bamako, Mali

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Conclusion: This study allowed us to detect 6 non-compliant products that were withdrawn from the market and regulatory measures were taken.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.

Keywords: Antimicrobial, quality control, non-compliance, AMR

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Author Biographies

Ousmane DEMBELE, Faculté de Pharmacie de Bamako, Université des Sciences, des Techniques et des Technologies de Bamako, Mali

Laboratoire National de la Santé du Mali

Bakary Moussa Cissé, Faculté de Pharmacie de Bamako, Université des Sciences, des Techniques et des Technologies de Bamako, Mali

Laboratoire National de la Santé du Mali

Mody Cissé, Faculté de Pharmacie de Bamako, Université des Sciences, des Techniques et des Technologies de Bamako, Mali

Laboratoire National de la Santé du Mali

Seydou Moussa Coulibaly, Laboratoire National de la Santé du Mali

Laboratoire National de la Santé du Mali

Jacques Dakouo, Laboratoire National de la Santé du Mali

Laboratoire National de la Santé du Mali

Nana Houmama Cissé, Laboratoire National de la Santé du Mali

Laboratoire National de la Santé du Mali

Benoît Yaranga Koumaré, Faculté de Pharmacie de Bamako, Université des Sciences, des Techniques et des Technologies de Bamako, Mali

Laboratoire National de la Santé du Mali

References

1. WHO | WHO Global Surveillance and Monitoring System [Internet]. WHO. [cité 27 nov 2020]. Disponible sur: http://www.who.int/medicines/regulation/ssffc/surveillance/en/
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.
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DEMBELE O, Cissé BM, Cissé M, Coulibaly SM, Dakouo J, Cissé NH, Koumaré BY. Evaluation of the quality of the main antimicrobial drugs sold in pharmacies in Bamako (Mali) according to a risk-based sampling. JDDT [Internet]. 15Jun.2022 [cited 1Jul.2022];12(3-S):154-9. Available from: https://jddtonline.info/index.php/jddt/article/view/5401

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