(P-119) Adverse Drug Reactions and Its Evaluation in Saudi Arabia; Retrospective Observational Study

Background: A voluntary reporting system of adverse drug reactions (ADRs) is fundamental as the source of information for post- Marketing surveillance, and stockholders but under-reporting is its major limitation.

Objectives: This study's objective was to assess all events submitted to the regional spontaneous ADR database, including types, seriousness, outcomes, and causes of adverse drug reactions (ADRs)

Methods: A retrospective observational study was conducted to analyze all ADR reports submitted from the Tabuk region cluster hospitals in Saudi Arabia from January to December 2020.
The database was structured based on the Saudi ADR form fields, similar to the MedWatch® ADR form. The data include information about the patient, drug, event, and reporter. The Naranjo algorithm was used to assess the causality of the ADRs. All data were analyzed by using the Statistical Analysis Software (SAS), version 9.4

Results: A total of (2346) ADR reports along with (242) suspected drugs for (4114) reactions were submitting during one year. The gender distribution found the male gender was more than the female gender (56.3% vs. 44.3%).
In this study, all age groups were existing, and the age group with the most significant number of ADRs was aged 41-50 years, followed by 31-40 years. The antimicrobials (26.9%), then hematologic drugs (19.7%), followed by neuropsychiatric drugs (12.9%), are responsible for the most adverse drug events. Most of the reactions were associated with the use of Ciprofloxacin (7.7%), followed by lopinavir with ritonavir (4.1%) (p < 0.05). There were two deaths as a result of the use of salbutamol and cefazolin. Hematological drugs were associated with serious ADR, and Antimicrobials lead to life-threatening cases (0.46%). Based on the results of the Naranjo assessment of causality, cardiovascular events (9.9%) exhibited the highest score (≥ 9) for a causal relationship with the suspected drugs, followed by Dermatological events (9.5%).

Conclusions: The spontaneous report database is considered an important and valuable source of post-market authorization safety information.
In our study, most drugs used as antimicrobials, cardiovascular and hematologic drugs were associated with a higher risk of developing severe and serious events. Careful monitoring for everyday medication use is recommending to ensure patient safety.