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Quality of antiepileptic drugs in sub‐Saharan Africa: A study in Gabon, Kenya, and Madagascar
Author(s) -
Jost Jeremy,
Ratsimbazafy Voa,
Nguyen Thu Trang,
Nguyen Thuy Linh,
Dufat Hanh,
Dugay Annabelle,
Ba Alassane,
Sivadier Guilhem,
Mafilaza Yattussia,
Jousse Cyril,
Traïkia Mounir,
Leremboure Martin,
Auditeau Emilie,
Raharivelo Adeline,
Ngoungou Edgard,
Kariuki Symon M.,
Newton Charles R.,
Preux PierreMarie
Publication year - 2018
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/epi.14445
Subject(s) - medicine , carbamazepine , environmental health , developing country , confidence interval , odds ratio , public health , rural area , quality (philosophy) , pediatrics , epilepsy , psychiatry , economic growth , nursing , pathology , economics , philosophy , epistemology
Summary Objective Epilepsy is a major public health issue in low‐ and middle‐income countries, where the availability and accessibility of quality treatment remain important issues, the severity of which may be aggravated by poor quality antiepileptic drugs ( AEDs ). The primary objective of this study was to measure the quality of AED s in rural and urban areas in 3 African countries. Methods This cross‐sectional study was carried out in Gabon, Kenya, and Madagascar. Both official and unofficial supply chains in urban and rural areas were investigated. Samples of oral AED s were collected in areas where a patient could buy or obtain them. Pharmacological analytical procedures and Medicine Quality Assessment Reporting Guidelines were used to assess quality. Results In total, 102 batches, representing 3782 units of AED s, were sampled. Overall, 32.3% of the tablets were of poor quality, but no significant difference was observed across sites: 26.5% in Gabon, 37.0% in Kenya, and 34.1% in Madagascar ( P = .7). The highest proportions of substandard medications were found in the carbamazepine (38.7%; 95% confidence interval [ CI ] 21.8‐57.8) and phenytoin (83.3%; 95% CI 35.8‐99.5) batches, which were mainly flawed by their failure to dissolve. Sodium valproate was the AED with the poorest quality (32.1%; 95% CI 15.8‐42.3). The phenobarbital (94.1%; 95% CI 80.3‐99.2) and diazepam (100.0%) batches were of better quality. The prevalence of substandard quality medications increased in samples supplied by public facilities (odds ratio [ OR ] 9.9; 95% CI 1.2‐84.1; P < .04) and manufacturers located in China ( OR 119.8; 95% CI 8.7‐1651.9; P < .001). The prevalence of AED s of bad quality increased when they were stored improperly ( OR 5.4; 95% CI 1.2‐24.1; P < .03). Significance No counterfeiting was observed. However, inadequate AED storage conditions are likely to lead to ineffective and possibly dangerous AED s, even when good‐quality AED s are initially imported.