PHARMACOVIGILANCE AT UNIVERSITY TEACHING HOSPITAL SOURO SANOU : STUDY OF SPONTANEOUS REPORTS OF ADVERSE DRUG REACTIONS
Journal Title: World Journal of Pharmaceutical Research - Year 2017, Vol 6, Issue 3
Abstract
Introduction: Drugs can cause unwanted adverse effects even at normal dosages. The objective was to study the adverse effects related to medication at University Teaching Hospital Souro SANOU of Bobo-Dioulasso (CHUSS), Burkina Faso. Methodology: Between February 2012 and June 2016, a descriptive cross-sectional study was conducted on spontaneous reporting of adverse drug effects (ADEs) generated by the CHUSS pharmacovigilance system. Cutaneous adverse drug reactions were evaluated according to ALDEN (Sassolas et al. 2010) with a score at least equal to 4. The French method of accountability updated for the other cases, with an accountability score at least equal to I3. Results: A total of 185 declarations at the pharmacovigilance service of CHUSS between 2012 and 2015, that is 46.25 cases per year. In 70.82% of cases, a causal link was established with a drug. Skin was the most affected organ (47.33%). Toxic Epidermal Necrolysis (TEN), 29.0% with a mortality rate of 44.74% was related to the intake of sulfonylurea (47.37%), penicillin (13.16%), nonsteroidal anti-inflammatory agent (13.16%) or tramadol (7.89%). TEN was strongly associated with sulphonylurea (RR: 4.23) frequently consumed, followed by tramadol (RR: 2.72) and by nevirapine (RR: 2.37). Other ADEs were metabolic (22.14%), neuromuscular (10.68%) and digestive (8.4%). Conclusion: This system of pharmacovigilance, although embryonic and characterized by under - reporting, permits to monitor drugs at CHUSS. Continuous sensitization of practitioners can improve reporting.
Authors and Affiliations
Dr. Souleymane Fofana
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