Analysis of Adverse Reactions Related to Drugs and Vaccines Received at the National Centre for Pharmacovigilance from 2009 to 2016 in Togo  

作　　者：Yao Potchoo Mouhoudine Yerima Tante T. Gnandi Mounerou Mounerou Salou Aboudoulatif Diallo Batoyema Bakoma Atani T. Nyansa Mireille Prince-David 

机构地区：[1]Département des Sciences Pharmaceutiques, Faculté des Sciences de la Santé, Université de Lomé, Lomé, Togo [2]Direction de la Pharmacie, du Médicament et des Laboratoires, Ministère de la Santé et de la Protection Sociale, Lomé, Togo [3]Comité de Bioéthique et de la Recherche en Santé, Ministère de la Santé et de la Protection Sociale, Lomé, Togo

出　　处：《Pharmacology & Pharmacy》2018年第8期344-356,共13页药理与制药（英文）

摘　　要：Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.

关 键 词：MEDICINES Vaccines Routine HEALTH Care Public HEALTH Program ADVERSE Events Reporting PHARMACOVIGILANCE 

分 类 号：R73[医药卫生—肿瘤]