Causality, severity, seriousness, and preventability of adverse drug reactions: A retrospective analysis

Adverse drug reactions (ADRs) are a significant cause of preventable morbidity and mortality. They account for 10-20% of hospital admissions and have a high economic impact on healthcare infrastructure. This study aims to provide information about the pattern, causality, severity, seriousness, and preventability of an ADR reported during the study period.

This was an observational, rétrospective, record-based study to analyze all submitted spontaneous Individual Case Safety Reports (ICSRs) during three years (April 2020-March 2023) at the ADR monitoring center under PvPI. Data obtained from ICSRs were carefully evaluated for quality, based on their essential elements. The ADR outcome was categorized into recovered, recovering, not recovered upon discharge, fatal, and unknown. The information in the ICSRs was used to assess the causality, preventability, severity, and seriousness of the ADRs.

Out of 380 Individual Case Safety Reports (ICSRs) from April 2020 to March 2023, 313 fully completed ICSRs were analyzed. The number of adverse drug reactions was higher in males (n = 166; 53%) than in females (n = 145; 47%). The highest number of ADRs was reported in the age group of 31-40 years (n = 72; 23%), followed by 21-30 years (n = 68; 21.72%). Most ADRs (83.38%) had recovered. The severity of ADRs was mostly mild (87.53%), with only 2.55% being serious. 37.6% of ADRs were preventable, and 62.3% were not preventable. Concerning the seriousness of ADRs by PvPI criteria, 97.76% were ‹non-serious›, while only 2.23% were serious.

Adverse drug reactions (ADRs) are a global problem and a major concern for patient safety. Monitoring and reporting ADRs is crucial to reduce their incidence and enhance pharmacovigilance. There is a need to increase awareness among patients, clinicians, and staff members about reporting and preventing ADRs.