Characterization of adverse drug reactions causing admission to an intensive care unit

• DOI: 10.1111/bcp.13199
• Publication Date: 2016-12-01T09:12:38Z
• Authors: Camilo Rojas‐Vela...; Jair Ruiz‐Garzón; Juan‐Carlos Mosco...; Álvaro Vallejos‐N...; Jenny Castro‐Canoa; Yuri Bustos‐Martínez; Max Flórez‐Cutiva; Mabel Contreras‐M...; Jully‐Carolina Gó...; Carlos‐Alberto Ca...
• Keywords: Contrast medium; Dalteparin; Male; Digoxin; Product surveillance; Dose-response relationship; Ibuprofen; Comorbidity; Time factor; Drug-related side effects and adverse reactions; Nebivolol; Hospitals, University; Naproxen; 0302 clinical medicine; Aged, 80 and over; Morphine; 3. Good health; Algorithm; Retrospective study; Phenobarbital; Metoprolol; Human; Groups by age; Major clinical study; Methylprednisolone; Losartan; Article; Gastrointestinal hemorrhage; Heart block; 03 medical and health sciences; Dose response; Humans; Enoxaparin; Disease exacerbation; Isophane insulin; Capecitabine; Aged; Retrospective Studies; Dose-Response Relationship, Drug; Pig insulin; Time factors; Very elderly; Leukopenia; Retrospective studies; Hyperkalemia; Amlodipine; Time Factors; Chronic kidney failure; Immune deficiency; Etanercept; Pharmacovigilance; Enalapril; Furosemide; Diabetic ketoacidosis; Valproic acid; Cerebrovascular disease; Middle aged; Hydrochlorothiazide plus spironolactone; Priority journal; Intensive care units; Patient admissions; Ascites; drug; Middle Aged; Classification; Respiration depression; Seizure; Hospitals; Clopidogrel; Postmarketing; Hospitalization; Intensive Care Units; Carbamazepine; Female; Hypotension; Adult; Adolescent; Drug-Related Side Effects and Adverse Reactions; Adverse drug reaction; Clonidine; Subdural hematoma; Young Adult; university; Acetylsalicylic acid; Bradycardia; Intensive care unit; Subarachnoid hemorrhage; Mycophenolic acid; Bromocriptine; Upper gastrointestinal bleeding; University hospital; Delirium; Hospital admission; Thrombocytopenia; Hypoglycemia; Young adult; Phenytoin; Carvedilol; Drug treatment failure; Unindexed drug

AimsThis study aimed to determine the occurrence of adverse drug reactions (ADRs) that caused admission to the intensive care unit (ICU) of a university hospital.MethodsClinical 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.ResultsIn 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.ConclusionsADRs 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.