title: Incidence of adverse drug events in public and private hospitals in Riyadh, Saudi Arabia: the (ADESA) prospective cohort study.
abstract: To determine the incidence of adverse drug events (ADEs) and assess their severity and preventability in four Saudi hospitals.
  
  
  
  Prospective cohort study.
  
  
  
  The 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.
  
  
  
  All patients (≥12 years) admitted to the study units over 4 months.
  
  
  
  Incidents 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.
  
  
  
  We 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.
  
  
  
  We 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.
authors.affiliation: Medication Safety Research Chair, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
authors.forename: Hisham
authors.initials: H
authors.lastname: Aljadhey
authors.affiliation: Medication Safety Research Chair, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
authors.forename: Mansour A
authors.initials: MA
authors.lastname: Mahmoud
authors.affiliation: Medication Safety Research Chair, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
authors.forename: Yusuf
authors.initials: Y
authors.lastname: Ahmed
authors.affiliation: Specialized Medical Center, Riyadh, Saudi Arabia.
authors.forename: Razia
authors.initials: R
authors.lastname: Sultana
authors.affiliation: Specialized Medical Center, Riyadh, Saudi Arabia.
authors.forename: Salah
authors.initials: S
authors.lastname: Zouein
authors.affiliation: King Saud Medical City, Riyadh, Saudi Arabia.
authors.forename: Sulafah
authors.initials: S
authors.lastname: Alshanawani
authors.affiliation: King Khaled University Hospital, Riyadh, Saudi Arabia.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Mayet
authors.affiliation: King Khaled University Hospital, Riyadh, Saudi Arabia.
authors.forename: Mashael K
authors.initials: MK
authors.lastname: Alshaikh
authors.affiliation: Medication Safety Research Chair, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
authors.forename: Nora
authors.initials: N
authors.lastname: Kalagi
authors.affiliation: King Khaled University Hospital, Riyadh, Saudi Arabia.
authors.forename: Esraa
authors.initials: E
authors.lastname: Al Tawil
authors.affiliation: Specialized Medical Center, Riyadh, Saudi Arabia.
authors.forename: Abdul Rahman
authors.initials: AR
authors.lastname: El Kinge
authors.affiliation: Specialized Medical Center, Riyadh, Saudi Arabia.
authors.forename: Abdulmajid
authors.initials: A
authors.lastname: Arwadi
authors.affiliation: King Salman Hospital, Riyadh, Saudi Arabia.
authors.forename: Maha
authors.initials: M
authors.lastname: Alyahya
authors.affiliation: Purdue University and Regenstrief Institute, Indianapolis, Indiana, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Murray
authors.affiliation: Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: David
authors.initials: D
authors.lastname: Bates
mesh_terms: D000328:Adult; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006760:Hospitalization; D016304:Hospitals, Private; D006779:Hospitals, Public; D006784:Hospitals, Teaching; D006801:Humans; D015994:Incidence; D007362:Intensive Care Units; D008297:Male; D008508:Medication Errors / Q000706:statistics & numerical data*; D008875:Middle Aged; D011446:Prospective Studies; D012529:Saudi Arabia / Q000453:epidemiology; D055815:Young Adult
keywords: Adverse Drug Events (ADEs); Saudi Arabia; prospective cohort study