title: Characterization of adverse drug reactions causing admission to an intensive care unit.
abstract: This study aimed to determine the occurrence of adverse drug reactions (ADRs) that caused admission to the intensive care unit (ICU) of a university hospital.
  
  
  
  Clinical records were reviewed for patients meeting the inclusion criteria who were admitted to the ICU between September and December 2012. Suspected cases of ADRs were documented. Nine researchers later evaluated causality using the Naranjo Algorithm, preventability using the Schumock and Thornton criteria, and clinical classification based on the dose-time-susceptibility system.
  
  
  
  In total, 96 patients presented 108 cases of ADR (13.8%, 95% confidence interval 11.2-16.4%) as the cause of admission. The most frequent ADRs were bradyarrhythmias and upper gastrointestinal bleeding (12%). Therapeutic failure accounted for 20%. The most commonly associated medications were acetylsalicylic acid (16%) and losartan (10%). Forty-six cases were categorized as possible, and only one as definite. According to the dose-time-susceptibility classification, in 82% of the cases, the dosage was collateral (within the therapeutic range), and 90% were independent of time; the factors most associated with susceptibility to ADRs were comorbidities (42%) and age (49%). Forty-four percent of the ADRs were considered possibly preventable.
  
  
  
  ADRs contribute significantly to ICU admissions, and a significant number of ADRs are preventable. National studies are needed to assess their incidence and to establish classification standards to reduce their clinical impact.
authors.affiliation: Clínicos IPS, Calle 39B N° 18A - 11, Bogotá D.C., Colombia.
authors.forename: Camilo
authors.initials: C
authors.lastname: Rojas-Velandia
authors.affiliation: Cafesalud EPS, Carrera 24 N° 72 - 92, Bogotá D.C., Colombia.
authors.forename: Jair
authors.initials: J
authors.lastname: Ruiz-Garzón
authors.affiliation: Hospital San Vicente de Paúl, Calle 4 N° 5 - 00, Fómeque (Cundinamarca), Colombia.
authors.forename: Juan-Carlos
authors.initials: JC
authors.lastname: Moscoso-Alcina
authors.affiliation: Faculty of Medicine, Fundación Universitaria de Ciencias de la Salud, Carrera 19 N° 8 - 32, Bogotá D.C., Colombia.
authors.forename: Álvaro
authors.initials: Á
authors.lastname: Vallejos-Narvaéz
authors.affiliation: School of Medicine and Health Sciences, Universidad del Rosario, Carrera 24 N° 63C - 69, Bogotá D.C., Colombia.|Hospital Universitario Mayor, Calle 24 N° 29 - 45. Bogotá D.C., Colombia.
authors.forename: Jenny
authors.initials: J
authors.lastname: Castro-Canoa
authors.affiliation: School of Medicine and Health Sciences, Universidad del Rosario, Carrera 24 N° 63C - 69, Bogotá D.C., Colombia.
authors.forename: Yuri
authors.initials: Y
authors.lastname: Bustos-Martínez
authors.affiliation: Cafesalud EPS, Carrera 24 N° 72 - 92, Bogotá D.C., Colombia.
authors.forename: Max
authors.initials: M
authors.lastname: Flórez-Cutiva
authors.affiliation: Virrey Solís IPS, Carrera 104 N°14 - 50, Bogotá D.C., Colombia.
authors.forename: Mabel
authors.initials: M
authors.lastname: Contreras-Muñoz
authors.affiliation: Cafesalud EPS, Carrera 24 N° 72 - 92, Bogotá D.C., Colombia.
authors.forename: Jully-Carolina
authors.initials: JC
authors.lastname: Gómez-Gil
authors.affiliation: School of Medicine and Health Sciences, Universidad del Rosario, Carrera 24 N° 63C - 69, Bogotá D.C., Colombia.
authors.forename: Carlos-Alberto
authors.initials: CA
authors.lastname: Calderón-Ospina
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006760:Hospitalization; D006785:Hospitals, University; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013997:Time Factors; D055815:Young Adult
keywords: drug-related side effects and adverse reactions; intensive care units; patient admissions; pharmacovigilance; postmarketing; product surveillance