TY - JOUR T1 - Post hoc study to investigate the potential causes of poor quality of cardiovascular medicines collected in sub-Saharan countries JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2020-039252 VL - 10 IS - 11 SP - e039252 AU - Philippe-Henri Secretan AU - Marie Antignac AU - Najet Yagoubi AU - Mélisande Bernard AU - Marie Cécile Perier AU - Jean Laurent Takombe AU - Dadhi Balde AU - Roland N'Guetta AU - Méo Stéphane Ikama AU - Patrice Zabsonre AU - Abdallahi Sidi Aly AU - Xavier Jouven AU - Bernard Do Y1 - 2020/11/01 UR - http://bmjopen.bmj.com/content/10/11/e039252.abstract N2 - 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. ER -