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

Autor:	Secretan PH; Paris Cardiovascular Research Centre, INSERM U970, Université de Paris, Paris, France phsecretan@yahoo.fr.; Laboratoire Matériaux et santé, Université Paris-Saclay, Chatenay-Malabry, France., Antignac M; Paris Cardiovascular Research Centre, INSERM U970, Université de Paris, Paris, France.; Department of Pharmacy, Hospital Saint-Antoine, APHP, Paris, Île-de-France, France., Yagoubi N; Laboratoire Matériaux et santé, Université Paris-Saclay, Chatenay-Malabry, France., Bernard M; Department of Laboratories, Agence Générale des Equipements et Produits de Sante, AP-HP, Paris, Île-de-France, France., Perier MC; Paris Cardiovascular Research Centre, INSERM U970, Université de Paris, Paris, France., Takombe JL; Department of Internal Medicine of la Gombe (CMCG), Ngaliema Clinic, Kinshasa, The Democratic Republic of the Congo., Balde D; Department of Cardiology, University Hospital of Conakry, Conakry, Guinea., N'Guetta R; Department of Cardiology, Institute of Cardiology of Abidjan, Abidjan, Lagunes, Côte d'Ivoire., Ikama MS; Department of Cardiology, National University Hospital of Brazzaville, University of Marien NGOUABI, Brazzaville, Congo., Zabsonre P; Department of Cardiology, National Sanou Souro de Bobo-Dioulasso Hospital, Ouagadougou, Burkina Faso., Sidi Aly A; Department of Cardiology, Cardiology Clinics, Nouakchott, Mauritania., Jouven X; Paris Cardiovascular Research Centre, INSERM U970, Université de Paris, Paris, France.; Department of Cardiology, Georges Pompidou European Hospital, AP-HP, Paris, France., Do B; Laboratoire Matériaux et santé, Université Paris-Saclay, Chatenay-Malabry, France.; Department of Pharmacy, Henri Mondor Hospital, APHP, Creteil, France.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2020 Nov 09; Vol. 10 (11), pp. e039252. Date of Electronic Publication: 2020 Nov 09.
DOI:	10.1136/bmjopen-2020-039252
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© 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.)
Databáze:	MEDLINE
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