(321) A Retrospective Analysis of Adverse Drug Events Leading to Hospitalization or Prolonged Hospitalization in Saudi Arabia Using the Saudi Food and Drug Authority (SFDA) Spontaneous Reporting System

Publication Number: 995

Background: Adverse Drug Events (ADEs) are a well-known cause of hospital admission and prolonged hospitalization. With the majority of ADEs being preventable, we seek to identify the frequency and characteristic of these events. To our knowledge, no data regarding the rate and frequency of ADE related hospitalization in Saudi Arabia has been published.

Objectives: To measure the rate and percentage of ADEs leading to hospitalization or prolonged hospitalization in Saudi Arabia using the spontaneous reporting system.

Methods: A retrospective analysis of the Saudi Food and Drug Authority (SFDA) spontaneous reporting system during a 12-month period. All cases reported by health care providers that led to hospitalization or prolonged hospitalization from January 2020 until December 2020 were included. All cases that did not cause hospitalization or prolonged hospitalization were excluded. Reports that were received from the public or pharmaceutical companies and ADEs that were not reported during the study period were excluded as well. The outcomes include the rate and percentage of events associated with hospitalization/prolonged hospitalization, the age group and gender of patients in these reports, the five most frequently reported events and medications associated with hospitalization/prolonged hospitalization. All the findings were summarized using descriptive statistics.

Results: A total of 44,719 ADEs were reviewed, in which 1649 (3.68%) met the inclusion criteria, in which 547 (1.23%) caused hospitalization and 1102 (2.45%) prolonged it. Amongst these reports, the majority concerned males with a total of 932 (56.52%) and the rest were females. In terms of age groups, 590 (35.77%) reports were adults and 92 concerned the pediatric population (5.60%), and the rest were not specified. The most frequently reported medications associated with hospitalization/prolonged hospitalization were; Heparin (6.36%), Lopinavir;Ritonavir (5.21%), warfarin (4.7%), Vancomycin (4.18%) and Favipiravir (2.66%). The most frequently reported events associated hospitalization/prolonged hospitalization were; hepatotoxicity (136, 8.25%) allergic reaction (103, 6.2%), Prolonged Partial Thromboplastin Time (PTT) (72, 4.36%), increased International Normalized Ratio (INR) (65, 3.94%), and acute kidney injury (48, 2.91%).

Conclusions: Although the percentage of ADEs associated with hospitalization remains relatively low, recommendation to achieve absolute medication safety should be placed. Future plans include increased efforts to promote awareness regarding medications frequently associated with hospitalization and the implementation of future studies analyzing specific medications and events associated with hospitalization.