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Secretan PH, Antignac M, Yagoubi N, et al. Post hoc study to investigate the potential causes of poor quality of cardiovascular medicines collected in sub-Saharan countries. BMJ Open. 2020;10(11):e039252doi: 10.1136/bmjopen-2020-039252.
Secretan, P. H., Antignac, M., Yagoubi, N., Bernard, M., Perier, M. C., Takombe, J. L., Balde, D., N'Guetta, R., Ikama, M. S., Zabsonre, P., Sidi Aly, A., Jouven, X., & Do, B. (2020). Post hoc study to investigate the potential causes of poor quality of cardiovascular medicines collected in sub-Saharan countries. BMJ open, 10(11), e039252. https://doi.org/10.1136/bmjopen-2020-039252
Secretan, Philippe-Henri, et al. "Post hoc study to investigate the potential causes of poor quality of cardiovascular medicines collected in sub-Saharan countries." BMJ open vol. 10,11 (2020): e039252. doi: https://doi.org/10.1136/bmjopen-2020-039252
Secretan PH, Antignac M, Yagoubi N, Bernard M, Perier MC, Takombe JL, Balde D, N'Guetta R, Ikama MS, Zabsonre P, Sidi Aly A, Jouven X, Do B. Post hoc study to investigate the potential causes of poor quality of cardiovascular medicines collected in sub-Saharan countries. BMJ Open. 2020 Nov 09;10(11):e039252. doi: 10.1136/bmjopen-2020-039252. PMID: 33168557; PMCID: PMC7654128.
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BMJ Open. 2020 Nov 09;10(11):e039252. doi: 10.1136/bmjopen-2020-039252.

Post hoc study to investigate the potential causes of poor quality of cardiovascular medicines collected in sub-Saharan countries.

BMJ open

Philippe-Henri Secretan, Marie Antignac, Najet Yagoubi, Mélisande Bernard, Marie Cécile Perier, Jean Laurent Takombe, Dadhi Balde, Roland N'Guetta, Méo Stéphane Ikama, Patrice Zabsonre, Abdallahi Sidi Aly, Xavier Jouven, Bernard Do

Affiliations

  1. Paris Cardiovascular Research Centre, INSERM U970, Université de Paris, Paris, France [email protected].
  2. Laboratoire Matériaux et santé, Université Paris-Saclay, Chatenay-Malabry, France.
  3. Paris Cardiovascular Research Centre, INSERM U970, Université de Paris, Paris, France.
  4. Department of Pharmacy, Hospital Saint-Antoine, APHP, Paris, Île-de-France, France.
  5. Department of Laboratories, Agence Générale des Equipements et Produits de Sante, AP-HP, Paris, Île-de-France, France.
  6. Department of Internal Medicine of la Gombe (CMCG), Ngaliema Clinic, Kinshasa, The Democratic Republic of the Congo.
  7. Department of Cardiology, University Hospital of Conakry, Conakry, Guinea.
  8. Department of Cardiology, Institute of Cardiology of Abidjan, Abidjan, Lagunes, Côte d'Ivoire.
  9. Department of Cardiology, National University Hospital of Brazzaville, University of Marien NGOUABI, Brazzaville, Congo.
  10. Department of Cardiology, National Sanou Souro de Bobo-Dioulasso Hospital, Ouagadougou, Burkina Faso.
  11. Department of Cardiology, Cardiology Clinics, Nouakchott, Mauritania.
  12. Department of Cardiology, Georges Pompidou European Hospital, AP-HP, Paris, France.
  13. Department of Pharmacy, Henri Mondor Hospital, APHP, Creteil, France.

PMID: 33168557 PMCID: PMC7654128 DOI: 10.1136/bmjopen-2020-039252

Abstract

OBJECTIVES: The incidence of cardiovascular diseases is increasing and there is a growing need to provide access to quality cardio drugs in Africa. In the SEVEN study, we analysed 1530 cardiovascular drug samples randomly collected from 10 African countries. By that time, of the seven drugs products analysed, only those containing amlodipine and captopril had very low assay values with active substance contents that could be less than 75% of those expected. In this article we investigate complementary aspects of the amlodipine and captopril samples so to explain the previously observed low assays for these two drugs.

DESIGN: Post hoc analysis of the captopril and amlodipine drugs samples and their packages collected in the context of the SEVEN study.

SETTING: 10 countries were concerned: Benin, Burkina Faso, Congo, Democratic Republic of the Congo, Guinea, Côte d'Ivoire, Mauritania, Niger, Senegal and Togo.

PARTICIPANTS: Local scientists and hospital practitioners collected the drug samples in the 10 African countries.

OUTCOME MEASURES: The drug amount and the relative amounts of drug impurities, as well as the main compounds of the drugs packaging, were analysed.

RESULTS: Identification of the blister packaging of the samples led to separate both amlodipine and captopril drug samples in two groups. Mann Whitney's bilateral test showed a significant difference (p<0.0001) between the median value of the captopril dosage when tablets are packaged in blisters providing higher protection to humidity (n=105) as opposed to the tablets packaged in blisters providing lower humidity protection (n=130).

CONCLUSION: Based on these results, particular attention should be paid to the materials and types of packaging used in order to minimise the lack of control over the exposures and drug circuits present in these different countries.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords: cardiology; public health; quality in health care; toxicity

Conflict of interest statement

Competing interests: None declared.

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