Diane Macquart de Terline1,2,3, Bara I Diop4, Melisande Bernard5,6, Bernard Do5,6, Méo S Ikama7, Roland N'guetta8, Dadhi M Balde9, Yessoufou Tchabi10, Abdallahi Sidi Aly11, Ibrahim Ali Toure12, Patrick Zabsonre13, Jean-Marc F Damorou14, Jean-Laurent Takombe15, Kumar Narayanan16, Christine Fernandez3, Muriel Tafflet1, Pierre-François Plouin1,2,17, Jean-Philippe Empana1, Eloi Marijon1,2,17, Xavier Jouven1,2,17, Marie Antignac1,3. 1. Paris Cardiovascular Research Centre, INSERM Unit 970. 2. Paris Descartes University, Sorbonne Paris Cité. 3. Department of Pharmacy, Saint-Antoine Hospital, HUEP, AP-HP, Paris, France. 4. Cardiology Department, University Hospital of Fann, Dakar, Senegal. 5. Department of Laboratories, Agence Générale des Equipements et Produits de Santé, AP HP, Paris. 6. Faculty of Pharmacy, Paris-Sud University, UA 401 Matériaux et Santé, Chatenay-Malabry, France. 7. Cardiology Department, National University Hospital of Brazzaville, Marien Ngouabi University, Brazzaville, Congo. 8. Cardiology Department, Cardiology Institute of Abidjan, Abidjan, Côte d'Ivoire. 9. Cardiology Department, CHU Conakry, Conakry, Guinea. 10. Unité de Soins, d'Enseignement et de Recherches en Cardiologie (USERC), National University Hospital of Cotonou, Cotonou, Benin. 11. Cardiology Clinics, Nouakchott, Mauritania. 12. Internal Medicine and Cardiology Department, University Hospital of Lamorde, Niamey University, Niamey, Niger. 13. Cardiology Department, National Sanou Souro de Bobo-Dioulasso Hospital, Ouagadougou, Burkina Faso. 14. Cardiology Department, CH Lomé, Lomé, Togo. 15. Internal Medicine Department General Hospital of Kinshasa, Kinshasa, Democratic Republic of the Congo. 16. Maxcure Hospitals, Hyderabad, India. 17. Cardiology Department, European Georges Pompidou Hospital, AP-HP, Paris, France.
Abstract
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.
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.
Authors: Danielle Cazabon; Margaret Farrell; Reena Gupta; Lindsay Joseph; Anupam Khungar Pathni; Swagata Sahoo; Abhishek Kunwar; Kate Elliott; Jennifer Cohn; Thomas R Frieden; Andrew E Moran Journal: J Hum Hypertens Date: 2021-10-26 Impact factor: 2.877
Authors: Yusuf Hassan Wada; Abdullahi Abdulrahman; Musabu Ibrahim Muhammad; Vivian Chiemerie Owanta; Pearl Udoka Chimelumeze; Garba M Khalid Journal: Public Health Pract (Oxf) Date: 2022-02-26
Authors: Massimo Leone; Fausto Ciccacci; Stefano Orlando; Sandro Petrolati; Giovanni Guidotti; Noorjehan Abdul Majid; Victor Tamba Tolno; JeanBaptiste Sagno; Darlington Thole; Fabio Massimo Corsi; Michelangelo Bartolo; Maria Cristina Marazzi Journal: Int J Environ Res Public Health Date: 2021-03-09 Impact factor: 3.390