POPULATION-BASED ESTIMATES OF COMMUNITY-BASED ADVERSE DRUG REACTIONS (ADRS) IN THE KINGDOM OF SAUDI ARABIA

Abstract

Background: Adverse drug reactions (ADRs) represent important preventable causes of mortality, morbidity, hospitalization and increased healthcare costs. Traditionally, ADRs are studied in a clinical setting, but it is also important to estimate rates of ADRs in the community. The current study aimed to estimate population-based rates of ADRs in the community in the Kingdom of Saudi Arabia (KSA).
 Methods: A nationwide cross-sectional survey was conducted via registered pharmacists at community pharmacies across the 13 regions of KSA. The data were collected on an electronic online platform and included questions about participants’ demographics, health characteristics, experience with ADRs within the last 12 months and assess their knowledge about Saudi Food and Drug Authority (SFDA) reporting system.
 Results: Data collection was conducted between June and August 2018. Data from 5,228 surveys was analyzed. After weighting, the national annual rate of ADRs was estimated to be 28.00% (95% confidence interval 26.10% -30.00%). Of the respondents reporting an ADR, 371 (30.26%) reported that they were aware of the SFDA reporting system. Those who indicated they were aware, were asked if they had ever filed a report in the system; 53 (14.29%) said they had made a report.
 Conclusion: The results of this population-based estimates of community-based ADRs nationally in KSA showed that more than one quarter of the population had experienced ADR in the last 12 months. Future study is needed to better understand why these rates are higher in some regions than others, and what is needed to prevent high rates in subgroups such as women and those with chronic diseases.