Quality of antiepileptic drugs in sub‐Saharan Africa: A study in Gabon, Kenya, and Madagascar
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 stud...
Saved in:
Published in | Epilepsia (Copenhagen) Vol. 59; no. 7; pp. 1351 - 1361 |
---|---|
Main Authors | , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Wiley Subscription Services, Inc
01.07.2018
Wiley |
Subjects | |
Online Access | Get full text |
Cover
Loading…
Summary: | 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 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. |
---|---|
Bibliography: | Funding information This study was funded by a grant (R15118BB) from the Department of Access to Medicines, chronic diseases of Sanofi. The sponsors of the study had no role in study design, data collection, data interpretation, or writing of the report. All authors have full access to all the data of the study and have final responsibility for the decision to submit for publication. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 0013-9580 1528-1167 1528-1157 |
DOI: | 10.1111/epi.14445 |