Incidence of adverse drug events in public and private hospitals in Riyadh, Saudi Arabia: the (ADESA) prospective cohort study

Abstract

ObjectivesTo determine the incidence of adverse drug events (ADEs) and assess their severity and preventability in four Saudi hospitals.DesignProspective cohort study.SettingThe study included patients admitted to medical, surgical and intensive care units (ICUs) of four hospitals in Saudi Arabia. These hospitals include a 900-bed tertiary teaching hospital, a 400-bed private hospital, a 1400-bed large government hospital and a 350-bed small government hospital.ParticipantsAll patients (≥12 years) admitted to the study units over 4 months.Primary and secondary outcome measuresIncidents were collected by pharmacists and reviewed by independent clinicians. Reviewers classified the identified incidents as ADEs, potential ADEs (PADEs) or medication errors and then determined their severity and preventability.ResultsWe followed 4041 patients from admission to discharge. Of these, 3985 patients had complete data for analysis. The mean±SD age of patients in the analysed cohort was 43.4±19.0 years. A total of 1676 ADEs were identified by pharmacists during the medical chart review. Clinician reviewers accepted 1531 (91.4%) of the incidents identified by the pharmacists (245 ADEs, 677 PADEs and 609 medication errors with low risk of causing harm). The incidence of ADEs was 6.1 (95% CI 5.4 to 6.9) per 100 admissions and 7.9 (95% CI 6.9 to 8.9) per 1000 patient-days. The occurrence of ADEs was most common in ICUs (149 (60.8%)) followed by medical (67 (27.3%)) and surgical (29 (11.8%)) units. In terms of severity, 129 (52.7%) of the ADEs were significant, 91 (37.1%) were serious, 22 (9%) were life-threatening and three (1.2%) were fatal.ConclusionsWe found that ADEs were common in Saudi hospitals, especially in ICUs, causing significant morbidity and mortality. Future studies should focus on investigating the root causes of ADEs at the prescribing stage, and development and testing of interventions to minimise harm from medications.

Analysis of medication errors at a large tertiary care hospital in Saudi Arabia: a retrospective analysis

“…This study shows that most of the errors were near misses and preventable, similar to the findings of a cohort study conducted in the KSA [5]. Adverse events associated with MEs can be prevented with the interception of errors before drug administration [8].…”

“…Similar to earlier reports, majority of the errors occurred at prescribing and transcribing stage of the medication use process while more than eighty percent of these errors were intercepted by pharmacists. Pharmacist interventions prevented MEs by 11-89% during the medication use process, and their role in patient safety has also been addressed in previously published reports [4,5,9]. The high reporting rate of MEs by pharmacists is due to the implementation of appreciation awards for pharmacists, an initiative developed by the pharmaceutical care services.…”

“…However, many MEs remain undetected when outcomes do not affect hospitalized patients [2][3][4]. Previous research in the Kingdom of Saudi Arabia (KSA) revealed that onethird of adverse drug reactions occurred due to MEs [5].…”

MADEx: A System for Detecting Medications, Adverse Drug Events, and Their Relations from Clinical Notes

“…[4] Similar studies reported an incidence rate around 6-8% in Saudi Arabia, 3.22% for England, and 4.78% for Germany. [3, 5, 6] ADEs are reported to increase the healthcare cost, length of stay, and in-hospital mortality rates. [2] A large majority of ADEs are preventable.…”

Assessing the impact of structured education on the knowledge of hospital pharmacists about adverse drug reactions and reporting methods in Saudi Arabia: an open-label randomised controlled trial

“…A study conducted to determine the number of ADR-related emergency hospital admissions in England reported an increase in ADR-led admissions from 1.2% in 2008 to 1.6% in 2015 [2]. In Saudi Arabia, the frequency of ADR-related hospital admissions was reported to be 6.1 per 100 admissions and 7.9 per 1000 patient days [3]. An ADR is defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as "an unwanted or harmful reaction experienced following the administration of a drug or a combination of drugs under normal conditions of use and which is expected to be related to the drug" [4].…”