Jeremy Jost1, Voa Ratsimbazafy1, Thu Trang Nguyen2, Thuy Linh Nguyen2, Hanh Dufat2, Annabelle Dugay2, Alassane Ba3, Guilhem Sivadier3, Yattussia Mafilaza3, Cyril Jousse4, Mounir Traïkia4, Martin Leremboure4, Emilie Auditeau1, Adeline Raharivelo1,5, Edgard Ngoungou1,6, Symon M Kariuki7, Charles R Newton7,8, Pierre-Marie Preux1. 1. INSERM, CHU Limoges, UMR_S 1094, Tropical Neuroepidemiology, Institute of Epidemiology and Tropical Neurology, University of Limoges, Limoges, France. 2. Laboratory of Pharmacology-UMR COMETE 8638, School of Pharmacy of Paris, University of Paris Descartes USPC, Paris, France. 3. CHMP, Humanitarian Center for Pharmaceutical Careers, Clermont-Ferrand, France. 4. Institute of Chemistry of Clermont-Ferrand (ICCF), UMR CNRS 6296, University of Clermont Auvergne, Aubière, France. 5. Joseph Raseta Befelatanana Hospital, Antananarivo, Madagascar. 6. Unit of Neuroepidemiology and Tropical Infectious Diseases, Department of Epidemiology, Biostatistics, University of Health Sciences, Libreville, Gabon. 7. KEMRI-Welcome Trust Programme - Centre for Geographical Medicine (Coast) Kenya Medical Research Institute, Kilifi, Kenya. 8. Department of Psychiatry, University of Oxford, Oxford, UK.
Abstract
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 AEDs 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 AEDs 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 AEDs, 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 AEDs 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 AEDs, even when good-quality AEDs are initially imported. Wiley Periodicals, Inc.
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 AEDs 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 AEDs 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 AEDs, 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 AEDs 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 AEDs, even when good-quality AEDs are initially imported. Wiley Periodicals, Inc.