Substandard drugs among five common antihypertensive generic medications: an analysis from 10 African countries.

Autor:	Macquart de Terline D; Paris Cardiovascular Research Centre, INSERM Unit 970.; Paris Descartes University, Sorbonne Paris Cité.; Department of Pharmacy, Saint-Antoine Hospital, HUEP, AP-HP, Paris, France., Diop BI; Cardiology Department, University Hospital of Fann, Dakar, Senegal., Bernard M; Department of Laboratories, Agence Générale des Equipements et Produits de Santé, AP HP, Paris.; Faculty of Pharmacy, Paris-Sud University, UA 401 Matériaux et Santé, Chatenay-Malabry, France., Do B; Department of Laboratories, Agence Générale des Equipements et Produits de Santé, AP HP, Paris.; Faculty of Pharmacy, Paris-Sud University, UA 401 Matériaux et Santé, Chatenay-Malabry, France., Ikama MS; Cardiology Department, National University Hospital of Brazzaville, Marien Ngouabi University, Brazzaville, Congo., N'guetta R; Cardiology Department, Cardiology Institute of Abidjan, Abidjan, Côte d'Ivoire., Balde DM; Cardiology Department, CHU Conakry, Conakry, Guinea., Tchabi Y; Unité de Soins, d'Enseignement et de Recherches en Cardiologie (USERC), National University Hospital of Cotonou, Cotonou, Benin., Sidi Aly A; Cardiology Clinics, Nouakchott, Mauritania., Ali Toure I; Internal Medicine and Cardiology Department, University Hospital of Lamorde, Niamey University, Niamey, Niger., Zabsonre P; Cardiology Department, National Sanou Souro de Bobo-Dioulasso Hospital, Ouagadougou, Burkina Faso., Damorou JF; Cardiology Department, CH Lomé, Lomé, Togo., Takombe JL; Internal Medicine Department General Hospital of Kinshasa, Kinshasa, Democratic Republic of the Congo., Narayanan K; Maxcure Hospitals, Hyderabad, India., Fernandez C; Department of Pharmacy, Saint-Antoine Hospital, HUEP, AP-HP, Paris, France., Tafflet M; Paris Cardiovascular Research Centre, INSERM Unit 970., Plouin PF; Paris Cardiovascular Research Centre, INSERM Unit 970.; Paris Descartes University, Sorbonne Paris Cité.; Cardiology Department, European Georges Pompidou Hospital, AP-HP, Paris, France., Empana JP; Paris Cardiovascular Research Centre, INSERM Unit 970., Marijon E; Paris Cardiovascular Research Centre, INSERM Unit 970.; Paris Descartes University, Sorbonne Paris Cité.; Cardiology Department, European Georges Pompidou Hospital, AP-HP, Paris, France., Jouven X; Paris Cardiovascular Research Centre, INSERM Unit 970.; Paris Descartes University, Sorbonne Paris Cité.; Cardiology Department, European Georges Pompidou Hospital, AP-HP, Paris, France., Antignac M; Paris Cardiovascular Research Centre, INSERM Unit 970.; Department of Pharmacy, Saint-Antoine Hospital, HUEP, AP-HP, Paris, France.
Jazyk:	angličtina
Zdroj:	Journal of hypertension [J Hypertens] 2018 Feb; Vol. 36 (2), pp. 395-401.
DOI:	10.1097/HJH.0000000000001560
Abstrakt:	Objective: Hypertension results in more deaths than any other risk factor and has been on the rise in sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. We performed a quality assessment of five commonly used antihypertensive generic drugs in 10 sub-Saharan African countries and studied the impact of price on quality. Methods: Drug samples were prospectively collected using standardized methods between 2012 and 2014. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Quality was defined based on the percentage ratio of measured to expected dosage of active ingredient. Results: A total of 1185 samples were assessed, of which 70.0% were generic (n = 830). Among the generic drugs, the percentage of poor-quality drugs was 24.3% (n = 202/830). The percentage ratio of measured to expected dosage of active ingredient ranged from 49.2 to 111.3%; the majority (81.7%) of the poor-quality samples had insufficient quantity of the active ingredient. Moreover, poor quality was not associated with purchase price of the drug. Conclusion: In this study from 10 sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low-income and middle-income countries.
Databáze:	MEDLINE
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