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Free Content Pharmacovigilance through consumer feedback (reporting) in the mass treatment of lymphatic filariasis using diethylcarbamazine and albendazole in two districts of Sri Lanka

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Abstract:

Summary Objective  To document the types and severity of adverse drug reactions to diethylcarbamazine and albendazole in randomly selected urban populations from Colombo and rural populations from Gampaha, Sri Lanka. Methods  Interviewers administered a pre-tested questionnaire to elicit information about the type and severity of adverse drug reactions experienced by recipients. Seeking medical treatment and requiring hospital admission for the adverse drug reactions were used as indicators for severity. The sample population was selected using the cluster sampling method. Results  Two thousand three hundred and nineteen persons aged 10 to 90 years (median 40.0) responded to the questionnaire; 63.9% of them had received and ingested the drugs. 12.6% reported that they had experienced adverse drug reactions, the proportion being similar in urban and rural areas (χ = 0.05; p = 0.82). Commonly reported reactions were drowsiness (34.7%), headache (23.1%), gastrointestinal symptoms (18.7%) and dizziness or faintness (11.9%). However, most symptoms were mild (96.3%) and did not interfere with daily activities or require medical attention. 3.2% said that they sought medical advice for their symptoms; one person (0.5%) who had severe abdominal pain was hospitalized. Conclusions  Fewer people experienced adverse drug reactions than in previous years, possibly due to lower microfilariaemia prevalence after several rounds of mass drug administration against filariasis. Community awareness of adverse drug reactions is essential for improving compliance and for the success of the filariasis elimination programme.

French
Objectif: 

Documenter les types et la gravité des réactions adverses du diéthylcarbamazine et à l’albendazole dans des populations urbaines de Colombo et des populations rurales de Gampaha choisies de façon aléatoire au Sri Lanka. Méthodes: 

Les interviewers ont administré un questionnaire pré-testés afin d’obtenir des informations sur le type et la gravité des réactions adverses vécus par les patients. Le recours au traitement médical et la nécessité d’une admission à l’hôpital pour les effets indésirables ont été utilisés comme indicateurs de sévérité. L’échantillon de population a été choisi en utilisant la méthode d’échantillonnage par grappe. Résultats: 

2319 personnes âgées de 10 à 90 ans (âge médian 40,0) ont répondu au questionnaire. Parmi elles, 63,9% avaient reçu et ingéré le médicament. 12,6% ont indiqué qu’ils avaient connu des réactions adverses aux médicaments, la proportion étant la même dans les zones urbaines et les zones rurales (χ2 = 0,05; p=82). Les réactions fréquemment rapportées étaient la somnolence (34,7%), des céphalées (23,1%), des symptômes gastro-intestinaux (18,7%) et des vertiges ou évanouissements (11,9%). Toutefois, la plupart des symptômes étaient bénins (96,3%) et n’ont pas interféré avec les activités quotidiennes ou nécessité des soins médicaux. 3,2% ont déclaré avoir demandé un avis médical pour leurs symptômes, une personne (0,5%) qui a eu de graves douleurs abdominales a été hospitalisée. Conclusions: 

Peu de personnes ont vécu des réactions adverses par rapport aux années précédentes, peut-être en raison de la prévalence moins élevée de microfilarémie après plusieurs cycles de traitement médicamenteux de masse contre la filariose. La sensibilisation de la communauté sur les réactions adverses aux médicaments est essentielle pour améliorer la compliance et le succès du programme d’élimination de la filariose.

Keywords: MDA; Sri Lanka; administración masiva medicamentos; adverse drug reactions; filariasis; filariose; mass drug administration; reacciones adversas a medicamentos; réactions adverses aux médicaments

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1365-3156.2008.02120.x

Affiliations: 1:  Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka 2:  Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka

Publication date: September 1, 2008

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