Quality of antiepileptic drugs in sub-Saharan Africa: A study in Gabon, Kenya, and Madagascar

Jérémy Jost (1, 2) , Voa Ratsimbazafy (1, 2) , Thu Trang Nguyen (3) , Thuy Linh Nguyen (3) , Hanh Dufat (3) , Annabelle Dugay (3) , Alassane Ba (4) , Guilhem Sivadier (4) , Yattussia Mafilaza (4) , Cyril C. Jousse (5) , Mounir Traïkia (5) , Martin Leremboure (5) , Emilie Auditeau (1) , Adeline Raharivelo (6, 1) , Edgard Brice Ngoungou (1, 7) , Symon m. Kariuki (8) , Charles Newton (8, 9) , Pierre-Marie Preux (10, 11, 1)

1 NET - Neuroépidémiologie Tropicale
2 Service de Pharmacie Centrale [CHU Limoges]
3 COMETE - UMR 8638 - Chimie Organique, Médicinale et Extractive et Toxicologie Expérimentale
4 CHMP - Centre Humanitaire sur les Métiers de la Pharmacie
5 ICCF - Institut de Chimie de Clermont-Ferrand
6 Hôpital Joseph Raseta Befelatanana
7 Université des Sciences de la Santé de Libreville
8 KEMRI - Kenya Medical Research Institute
9 POWIC - Department of Psychiatry [Oxford]
10 Laboratoire de Biostatistique et d'Informatique Médicale
11 SIME - Service de l'Information Médicale et de l'Évaluation [CHU Limoges]

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.

Mots clés: Drug quality; Epilepsy; Antiepileptic drug; Developing Countries

Domaines: Santé publique et épidémiologie

Jérémy Jost, Voa Ratsimbazafy, Thu Trang Nguyen, Thuy Linh Nguyen, Hanh Dufat, et al.. Quality of antiepileptic drugs in sub-Saharan Africa: A study in Gabon, Kenya, and Madagascar. Epilepsia, 2018, 59 (7), pp.1351-1361. ⟨10.1111/epi.14445⟩. ⟨hal-01814257⟩