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International audience; ObjectiveEpilepsy is a chronic condition treatable by cost‐effective antiepileptic drugs (AEDs), but limited access to treatment was documented. The availability and affordability of good quality of AEDs play a significant role in access to good health care. This study aimed to assess the availability, affordability, and quality of long‐term AEDs in Lao PDR.MethodA cross‐sectional study was performed in both public and private drug supply chains in urban and rural areas in Lao PDR. Data on AEDs availability and price were obtained through drug suppliers. Affordability was estimated as the number of day wages the lowest‐paid government employee must work to purchase a monthly treatment. Samples of AEDs were collected, and the quality of AEDs was assessed through Medicine Quality Assessment Reporting Guidelines.ResultsOut of 237 outlets visited, only 50 outlets (21.1% [95% CI 16.1‐26.8]) had at least one AED available. The availability was significantly different between urban (24.9%) and rural areas (10.0%), P = .017. Phenobarbital 100 mg was the most available (14.3%); followed by sodium valproate 200 mg (9.7%), phenytoin 100 mg (9.7%), and carbamazepine 200 mg (8.9%). In provincial/district hospitals and health centers, AEDs were provided free of charge. In other healthcare facilities, phenytoin 100 mg and phenobarbital 100 mg showed the best affordability (1.0 and 1.2 day wages, respectively) compared to carbamazepine 200 mg (2.3 days) and other AEDs. No sample was identified as counterfeit, but 15.0% [95% CI 7.1‐26.6] of samples were classified as of poor quality. SignificanceWe quantified and qualified the various factors contributing to the high treatment gap in Lao PDR, adding to diagnostic issues (not assessed here). Availability remains very low and phenobarbital which is the most available and affordable AED was the worst in terms of quality. A drug policy addressing epilepsy treatment gap would reduce these barriers.

Epilepsy is the most common neurological disorder encountered in primary care in Southeast Asia. People with epilepsy require long-term therapy management. Nonadherence to antiepileptic drugs (AEDs) has been identified as a major factor in suboptimal control of epilepsy. Pharmacies offer patients a first-line point of contact with the healthcare system. Many pharmacies operate with limited or nonqualified human resources that can lead to insufficient knowledge, inappropriate supply of medicines, and insufficient counseling.The aim of this study was to evaluate the qualification and knowledge concerning epilepsy and AEDs among pharmacy-dispensing workers who sell drugs to people with epilepsy.A cross-sectional qualitative study was conducted in public and private pharmacies, in both urban and rural areas of Cambodia and Lao People's Democratic Republic (Lao PDR). The knowledge was collected through a questionnaire.A total of 180 respondents from 123 outlets in the two countries were included in this study. A proportion of 40.8% (31) of respondents in Cambodia and 38.5% (40) in Lao PDR were pharmacists, followed by sellers who did not received any healthcare training with a proportion of 18.4% (14) in Cambodia compared to 20.2% (21) in Lao PDR. Head trauma was cited as the main cause of epilepsy by 72.4% (55) in Cambodia and 27.2% (28) in Lao PDR (p 0.001). Epilepsy was considered as a contagious disease by 6.6% (5) of respondents in Cambodia compared to 18.4% (19) in Lao PDR (p = 0.03). Eighty-seven percent (66) of respondents in Cambodia knew at least one long-term AED versus 67.3% (70) in Lao PDR (p = 0.003). Phenobarbital was mentioned in more than 90.0% of cases in both countries. In overall, 15.4% (21) thought that if seizures are controlled for some months, people with epilepsy could stop taking their AEDs. Only one respondent from Lao PDR was aware of drug-drug interaction between AEDs and oral contraception.An educational intervention should be implemented to improve the knowledge of epilepsy and AEDs for pharmacy-dispensing workers. This could include advice for all pharmacy-dispensing workers in order to improve AED management and follow-up of therapeutic adherence.

International audience; ObjectiveEpilepsy 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. MethodsThis 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. ResultsIn 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). SignificanceNo 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.

Objective To assess the current status of initiatives carried out in developing countries to improve therapeutic management of people with epilepsy. Methods A literature review was performed in 2015 to identify and analyze interventional programs carried out in countries with low- and middle-income economies. Electronic databases were reviewed with no time restriction. Each intervention was categorized according to the level of evidence achieved (A: blind randomized controlled trial, B: randomized controlled trial, C1: randomized trial, C2: controlled trial, D: prospective cohort, E: retrospective evaluation). Results A total of 46 intervention projects were identified, 13 with no quantitative assessment. The 31 remaining projects were carried out in 18 countries, 52% (16) in Africa, 42% (13) in Asia, and 6% (2) in Latin America. Among those, 13% (4) were level B, 3% (1) C1, 6% (2) C2, 74% (23) D, and 3% (1) were level E. The effectiveness of the intervention, assessed by the efficacy of antiepileptic drugs, was the primary objective in 81% (25). People with epilepsy were on average seizure-free in 44.6% ± 14.4% of cases at one year, ranging from 25.0% to 78.4%. At two years, on average 50.9% ± 29.7% are seizure-free, ranging from 4.6 to 92.7%. The median compliance was 79.3% with a minimum of 21.6% and a maximum of 100.0%. Discussion No blind randomized controlled trial has been used to assess the efficacy of a program to improve access to antiepileptic drugs (AEDs) in developing countries, and the level of evidence was globally low. Phenobarbital remains the AED predominantly used in programs. Adherence to treatment management has been pointed out to be a key element in the success of a program, sometimes not sufficiently considered. Monthly supply of AEDs, at specific and community level, reducing the costs and time spent traveling, appeared to be the most effective strategies. Homogenization and standardization of evaluation practices of programs to improve the management of epilepsy in resource-limited settings would lead to comparison and meta-analysis which would ultimately improve strategies of support for not only epilepsy but also other noncommunicable diseases in developing countries.

Epilepsy is felt to be a stigmatizing condition. Stigma has been considered one of the major factors contributing to the burden of epilepsy and to the treatment gap. Stigma has a negative effect on the management of people with epilepsy (PWE). Furthermore, lack of information and inappropriate beliefs are still the factors that most contribute to stigma and discrimination. In this study, we assessed the level of perceived stigma in urban and rural areas and we report their association with in antiepileptic drug (AED) use, effects on seeking medical care, and stigma-associated factors., A cross-sectional study in urban and rural areas in Ecuador from January 2015 until May 2016. People with a confirmed diagnosis of epilepsy were included using three sources of information. The survey was implemented through a questionnaire to determine perceived stigma and evaluate the factors associated. The perceived stigma was measured using the revised Jacoby's stigma scale to detect differences in levels of stigmatization. Access to treatment was evaluated through self-report of AED use, and attainment of medical care and stigma-associated factors were assessed. Furthermore, a multivariate analysis adjusted for possible confounders was performed using stigma as the outcome variable., A total of 243 PWE were interviewed, 65.8% reported feeling stigmatized and 39.1% reported a high stigmatized level. We found a significant difference in high stigma perception in the urban area compared to the rural area. However, the lack of use of AEDs was significantly higher in the rural areas. No significant correlation was found between use of AEDs and the levels of perceived stigma. PWE who did not talk about their condition and those who did not feel well informed about their epilepsy had significantly higher perceived stigma levels. Additionally, the multivariate analysis demonstrated that area, educational level, type of seizure, talk about epilepsy, and information were associated with perceived stigma., The stigma perception was relevant in all PWE. We found a higher stigma level perception in the urban compared to rural area. Moreover, the lack of treatment was a serious problem mainly in rural areas. Even though we did not find that perceived stigma was associated with AED use, our study pointed out the influence of educational level and information related to stigmatization. Consequently, a coordinated effort to reduce stigma should include strategies focused on PWE education and information about their condition.

Background The prevalence of epilepsy is high in Madagascar (23.5/1000), as is the treatment gap (estimated at 92 %). The health system of the country is underfunded; some AEDs are used, and the national drug policy does not encourage price regulation or the administration of generic agents. We conducted a cross-sectional study to assess the availability and cost of solid oral AED formulations in Antananarivo, capital of Madagascar. Data were gathered from all officially registered pharmacies (according to the drug agency list, updated in 2015) by means of telephone interviews lasting no more than 10 min and conducted by a native Malagasy speaker. With regard to other sources (hospitals, illicit sales) data were obtained at specific visits. The study received ethical approval from the Madagascar Ministry of Health. Findings A total of 91 of 100 pharmacies (the nine not included were because of an inoperative phone number), two of three public hospitals, and two illegal outlets were investigated. Sodium valproate was available in 84.6 % of the pharmacies, while carbamazepine and phenobarbital were available in 68.1 % and 36.3 % of the pharmacies, respectively, but phenytoin was not available in any supply chain. There were more originator brands than generic formulations, with a higher cost (range 20.3–81.1 %, median 40.7 %) compared to the equivalent generic. The public system had only a very limited choice of AED, but offered the lowest costs. Illicit sources were more expensive by 54.3 % for carbamazepine and 62.5 % for phenobarbital. Concerning the annual cost of treatment, the average percentage of the gross national income per capita based on the purchasing power parity was 29.8 %/19.0 % (brand/generic) for sodium valproate, 16.4 %/7.3 % (brand/generic) for carbamazepine, 8.9 %/5.1 % (brand/generic) for phenobarbital. Conclusions The main sources of AEDs were private pharmacies, but the stocks held were low. The financial burden was still important in the capital of Madagascar, mainly the consequence of a highly developed private sector at the expense of the public sector. Although sodium valproate remains the most expensive solution, it still remains the most available instead of phenobarbital. The most striking feature of this study concerns the cost of AEDs in the informal sector, mostly used because they are deemed to provide less costly drugs, the opposite was observed there. The assessment of the cost and availability of medicines was easily and quickly implemented. It provided a relevant focus of the situation in areas difficult to investigate, in terms of road network and geographical situation.

International audience; IntroductionL’épilepsie est l’un des troubles neurologiques les plus fréquents avec une estimation globale de 70 millions de cas. Près de 80 % des patients vivent dans les pays en développement dont le problème majeur est le manque d’accès à un traitement approprié. L’objectif de cette étude était de développer un outil permettant d’identifier les barrières d’accès aux antiépileptiques dans ces pays afin de déterminer les actions prioritaires pour améliorer l’accessibilité à ces traitements.MéthodeUne étude épidémiologique observationnelle a été menée dans deux zones, rurale et urbaine, de deux pays : Bénin et Équateur. Différents questionnaires ont permis d’évaluer les barrières d’accès aux antiépileptiques à tous les niveaux du circuit des médicaments, via une enquête auprès d’échantillons représentatifs des acteurs concernés : ministère de la Santé, prescripteurs, structures de mise à disposition des antiépileptiques ainsi qu’une centaine de personnes vivant avec l’épilepsie.RésultatsLes barrières à plus grand risque d’impact étaient différentes dans les deux pays. En Équateur, six barrières représentaient 73 % du problème de l’accès aux antiépileptiques avec des enjeux liés aux politiques de santé publique ou aux facteurs de capacité dont la stigmatisation (ressentie chez 74 % des patients épileptiques en zone urbaine). Au Bénin, les problématiques étaient différentes avec seulement 28 % des patients urbains qui se sentaient stigmatisés mais 16 % des pharmacies qui substituaient un antiépileptique par une autre molécule antiépileptique en cas de rupture.ConclusionCe travail a permis de mettre en évidence les principaux obstacles à l’accessibilité des antiépileptiques dans ces deux pays. Une enquête porte-à-porte est actuellement en cours en Équateur afin de conforter les résultats en population générale. De plus, la poursuite de l’étude est envisagée dans un pays asiatique. Identifier les principales barrières d’accessibilité aux médicaments est l’une des étapes nécessaires pour déterminer des actions-cibles prioritaires afin d’améliorer durablement l’accès aux médicaments antiépileptiques dans les pays en développement.

International audience; PURPOSE:To determine the accessibility of treatment and the quality of antiepileptic drugs (AEDs) in the Haute Matsiatra district of Madagascar.METHODS:Cross-sectional descriptive study and interviews. Samples of 10 units of each available AED were collected, and the active ingredient was quantified by reversed-phase high-performance liquid chromatography (RP-HPLC) with photodiode-array UV detection. The quality of an AED was considered satisfactory if the quantity of active ingredient in each tablet was in the range ±15% of the average value according to the European Pharmacopeia (6th edition, 2008).RESULTS:The area was well served with health infrastructure but rescue facilities were poorly distributed. Available AEDs were all first-generation, and 73% were generic formulations. People with epilepsy (PWE) surveyed consulted traditional healers and most were treated with plants. PWE did not consider themselves sick but believed they were "possessed"; they consulted a doctor only immediately after a seizure, following the advice of traditional healers. The most prescribed AED was phenobarbital, costing between 0.03 and 0.12 US Dollar (US$) per 100mg. The purchase of full treatment was difficult for 77% of PWE and as a result, 39% took nothing. The quality of AEDs were considered unsatisfactory in 2.8% of cases.CONCLUSION:The AEDs collected in Haute Matsiatra were globally of good quality. The main limiting elements were a lack of knowledge among PWE that epilepsy is a disease, and the cost of traditional treatments.

Hyperphosphatemic familial tumoral calcinosis (HFTC) and hyperphosphatemia hyperostosis syndrome (HHS) are rare diseases characterized by hyperphosphatemia and ectopic calcifications or recurrent episodes of diaphysitis. In the setting of metabolic or inflammatory diseases, recent data suggest that systemic administration of sodium thiosulfate (STS) could be effective in the treatment of ectopic calcifications but may also be poorly tolerated (digestive symptoms, metabolic acidosis). Our group developed a topical formulation of STS to treat ectopic calcifications locally, therefore limiting patient exposure to the drug and its adverse effects.We aimed at describing efficacy and tolerance for a topical formulation of STS in treated patients.We performed a retrospective study wherein clinical, radiological, and biological data before and after the application of the topical STS treatment were collected and analyzed.Three patients admitted to 3 different hospitals with an ectopic calcification secondary to HFTC or HHS were treated with topical STS.The topical STS was applied daily by the patients.A significant clinical and radiological decrease of ectopic calcifications was observed after at least 5 months of treatment. The STS treatment was well tolerated and no clinical or biological side effects were observed.Topical STS appears to be a promising treatment for ectopic calcifications secondary to HFTC or HHS.

International audience; IntroductionL’épilepsie est l’un des troubles neurologiques le plus fréquent avec une estimation globale de 70 millions de cas dont près de 80 % vivent dans les pays en développement. L’un des problèmes majeurs dans ces pays est le manque d’accès à un traitement approprié.ObjectifsL’objectif de cette étude est de développer un outil permettant d’identifier les barrières d’accès aux antiépileptiques (AE) dans les pays en développement afin de déterminer les actions prioritaires pour améliorer l’accessibilité à ces traitements.Patients et méthodesUne étude épidémiologique observationnelle a été menée dans une zone rurale et une zone urbaine de deux pays en développement : le Bénin et l’Équateur. Différents questionnaires ont permis d’évaluer les barrières d’accès aux traitements antiépileptiques à tous les niveaux du circuit des médicaments, via une enquête auprès d’échantillons représentatifs de tous les acteurs concernés : ministère de la Santé, prescripteurs, structures de mise à disposition des AE ainsi qu’une centaine de personnes vivant avec l’épilepsie.RésultatsEn Équateur six barrières représentaient 73 % du problème de l’accès aux médicaments antiépileptiques avec des enjeux liés aux politiques de santé publique ou aux facteurs de capacité tel que la stigmatisation (ressentie chez 74 % des patients épileptiques en zone urbaine). Au Bénin les problématiques sont différentes avec seulement 28 % des patients qui se sentaient stigmatisés à Cotonou, mais 16 % des pharmacies substituaient un AE par une autre molécule antiépileptique en cas de rupture.DiscussionL’outil d’évaluation des barrières d’accès aux AE a permis de mettre en évidence les principaux obstacles à l’accessibilité des AE dans deux pays en développement. Les patients sont issus des registres des hôpitaux ce qui peut biaiser les résultats, c’est pourquoi une enquête porte-à-porte est en cours en Équateur dans les deux zones étudiées. De plus l’outil devrait être mis en place dans le cadre d’un pays asiatique afin de conforter les résultats.ConclusionIdentifier les principales barrières d’accessibilité aux médicaments est l’une des étapes nécessaires pour déterminer des actions-cibles prioritaires afin d’améliorer durablement l’accès aux médicaments antiépileptiques dans les pays en développement.Le texte complet de cet article est disponible en PDF.Mots clés : Accessibilité, Antiépileptiques, Pays en développement

International audience

International audience; The purpose of this research was to evaluate the quality of anti-epileptic drugs (AEDs) in a central city of South Vietnam. A cross-sectional study was conducted in all the outlets for AEDs. Out of 33 pharmacies 54% had AEDs. Where the drugs were available, 89% of the pharmacies, 10 units were purchased, choosing the cheapest ones. The information on the packaging, the galenic form and the aspect of the drug were studied. Each sample's tablet was weighted and was considered satisfactory if it was within +/-10% of the average. A HPLC method was used for dosing the active ingredient (AI), which was considered satisfactory within +/-10% of the theoretical value. Eight samples were based on carbamazepin and eight on phenytoin. None of the 16 samples collected were past their expiring date. Tablets were homogeneous in shape, dimension and color. The uniformity of weight was satisfactory but the AI results were alarming for Carbamazepin and more often for Phenytoin. Only 35% of the tablets were correctly dosed. Because of differences of sensitivities of AEDs to storage conditions, environmental factors (heat, light and humidity) could be responsible for this result. Best results were achieved in structures where storage seemed to be better. The influence of storage conditions must be further studied to confirm this conclusion.