Methodological Approaches to Studying Fatal Adverse Drug Reactions

Abstract

Serious adverse drug reactions (ADRs) to medicinal products can cause death. It is an immediate challenge for modern medicine to prevent the possibility of this outcome and to improve the safety of pharmacotherapy. The aim of this study was to identify and analyse the main methodological approaches to studying the prevalence, patterns, and risk factors of fatal ADRs. The authors identified three main methods for studying such reactions: analysis of death certificates, monitoring of spontaneous reports, and review of clinical trials with a particular focus on safety. Each of these methods has its advantages and limitations. Clinical trials provide the most accurate information on the prevalence of fatal ADRs. For inpatients, this value ranged from 0.05 to 0.95% of the total number of hospital admissions. Data from death certificates may be particularly useful for identifying the groups of medicinal products posing a high risk of death and for making longitudinal comparisons. Monitoring of spontaneous reports is very effective in rapidly identifying fatal adverse reactions to new medicinal products. According to the authors, not only the choice of a data collection method, but also its application can affect the results of an ADR study. It was noted that the data varied across clinical trials conducted in different countries. Such variations indicate the importance of studying the problem of fatal ADRs at the national level, as well as the need for initiating such studies in the Russian Federation.