Les déterminants du déficit thérapeutique de l'épilepsie : place de la qualité des antiépileptiques en Afrique sub-Saharienne

Abstract : In sub-Saharan Africa, epilepsy remains a neglected public health issue. In addition to a lack of trained healthcare resources, including staff and infrastructure, the high epilepsy treatment gap has been a source of concern. Only a few major first-line antiepileptic drugs are readily available and the quality of these drugs could pose further issues. Currently, there are a few data available to address the question of the quality of antiepileptic drugs in low- and middle-income countries. Two studies have shown the proportion of poor-quality drugs to range from 13.7% for phenobarbital in Mauritania to 65,0% for phenytoin, carbamazepine, and sodium valproate in Vietnam. The aim of this study was to assess the determinants of the treatment gap of people living with epilepsy in low- and middle-income countries. Research objectives were to identify and describe intervention programmes aimed at improving drug management, to extract social determinants of the treatment gap, to evaluate the quality of antiepileptic drugs available in sub-Saharan Africa and to measure the availability, cost and affordability of antiepileptic drugs in sub-Saharan Africa.The study design for intervention and social determinants assessment was a systematic literature review. For quality, availability, cost and affordability issues a multicentre cross-sectional study has been carried out in 9 sub-Saharan Africa countries with an identical data and sample collection protocol. In each country, urban and rural areas have been systematically investigated in the same manner, exploring both the official supply chain and the illicit system in each setting. All the structures where a patient could buy or obtain antiepileptic drugs have been investigated. Community-based care and allied health staff were success factors in resource limited settings. Adherence to treatment has been pointed out to be a corner stone of people living with epilepsy drug management, poorly and slightly controlled. Therapeutic patient education was a promising dimension to be developed. Overall 32.3% of the tablets were of poor quality, but no statistical difference was observed across the sites. Carbamazepine (38.7% [95% Confidence Interval (95%CI)]: 21.8 – 57.8) and phenytoin 83.3% (95% CI 35.8 – 99.5) had the highest proportion of substandard quality, mainly due to dissolution failure. Sodium valproate was the antiepileptic drug with the poorest quality (32.1%; 95% CI 15.8 – 42.3). Phenobarbital (94.1%; 95% CI 80.3 – 99.2) had better quality. Prevalence of substandard quality increased in samples supplied from a public structure (Odds Ratio (OR), 9.9; 95% CI 1.2-84.1; p<.04) as well as those manufactured in China (OR, 119.8; CI 8.7-1651.9; p<.001). The prevalence of antiepileptic drugs with bad quality increased when improperly stored (OR, 5.4; 95% CI 1.2-24.1; p<.03). Phenobarbital and generic formulations remained the most affordable antiepileptic drugs but the least available mainly in the private sector, the supply chain with the largest distribution network in countries.The role of pharmacist and other allied staffs should be enhanced. No counterfeiting has been observed for antiepileptic drugs in this study. However, inadequate storage conditions, including the lack of temperature and humidity control, are likely to lead to ineffective and maybe dangerous antiepileptic drugs, even when good quality antiepileptic drugs are initially imported. Unpacking practice, common and potentially dangerous, must be supervised and secured. Local production of antiepileptic drugs has several positive aspects for decreasing treatment gap by enhancing geographical, financial accessibility and quality of drugs. WHO prequalification program has produced great improvement in diseases management in developing countries. Inclusion of antiepileptic drugs in this program may be highly profitable for people living with epilepsy.
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Jérémy Jost. Les déterminants du déficit thérapeutique de l'épilepsie : place de la qualité des antiépileptiques en Afrique sub-Saharienne. Médecine humaine et pathologie. Université de Limoges, 2018. Français. ⟨NNT : 2018LIMO0038⟩. ⟨tel-01927770⟩

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