Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy:

SAGE Open Medicine

GuenkaPetrova¹ 

关键词: Chronic obstructive pulmonary disease;    adverse drug reaction;    severity;    causality;    seriousness;    expectedness of adverse drug reactions;   

DOI  :  10.1177/2050312117690404

学科分类：医学（综合）

来源: Sage Journals

【 摘 要 】

Introduction:Adverse drug reactions can cause increased morbidity and mortality, and therefore information needs to be studied systematically. Little is known about the adverse drug reactions for chronic obstructive pulmonary disease therapy. The goal of this study is to assess the expectedness, seriousness and severity of adverse drug reactions during chronic obstructive pulmonary disease therapy based on their reporting in the national pharmacovigilance system.Methods:This was a prospective, observational, 1-year, real-life study about the pharmacotherapy of a sample of 390 chronic obstructive pulmonary disease patients. Prescribed medicines were systematized and national pharmacovigilance databases were searched for reported adverse drug reactions. The expectedness was evaluated through the review of the summary of product characteristics, the seriousness was evaluated by the clinicians based on the life threatening nature of the adverse drug reactions, and the severity was evaluated through Hartwig’s ...

【 授权许可】

CC BY