Subject(s)
American Heart Association , Athletes , Cardiology/standards , Cardiovascular Abnormalities/drug therapy , Dietary Supplements , Performance-Enhancing Substances , Adolescent , Adult , Advisory Committees/standards , Cardiovascular Abnormalities/complications , Cardiovascular Abnormalities/diagnosis , Child , Female , Humans , Male , Performance-Enhancing Substances/administration & dosage , Practice Guidelines as Topic/standards , United States/epidemiology , Young AdultABSTRACT
BACKGROUND: We evaluated the effectiveness of a computer clinical decision support system (CDSS) for reducing the risk of QT interval prolongation in hospitalized patients. METHODS AND RESULTS: We evaluated 2400 patients admitted to cardiac care units at an urban academic medical center. A CDSS incorporating a validated risk score for QTc prolongation was developed and implemented using information extracted from patients' electronic medical records. When a drug associated with torsades de pointes was prescribed to a patient at moderate or high risk for QTc interval prolongation, a computer alert appeared on the screen to the pharmacist entering the order, who could then consult the prescriber on alternative therapies and implement more intensive monitoring. QTc interval prolongation was defined as QTc interval >500 ms or increase in QTc of ≥60 ms from baseline; for patients who presented with QTc >500 ms, QTc prolongation was defined solely as increase in QTc ≥60 ms from baseline. End points were assessed before (n=1200) and after (n=1200) implementation of the CDSS. CDSS implementation was independently associated with a reduced risk of QTc prolongation (adjusted odds ratio, 0.65; 95% confidence interval, 0.56-0.89; P<0.0001). Furthermore, CDSS implementation reduced the prescribing of noncardiac medications known to cause torsades de pointes, including fluoroquinolones and intravenous haloperidol (adjusted odds ratio, 0.79; 95% confidence interval, 0.63-0.91; P=0.03). CONCLUSIONS: A computer CDSS incorporating a validated risk score for QTc prolongation influences the prescribing of QT-prolonging drugs and reduces the risk of QTc interval prolongation in hospitalized patients with torsades de pointes risk factors.
Subject(s)
Decision Support Systems, Clinical/statistics & numerical data , Electronic Prescribing/statistics & numerical data , Long QT Syndrome/epidemiology , Torsades de Pointes/drug therapy , Torsades de Pointes/epidemiology , Aged , Coronary Care Units , Drug Therapy, Computer-Assisted , Electrocardiography , Female , Hospitalization , Humans , Long QT Syndrome/etiology , Long QT Syndrome/prevention & control , Male , Risk , Torsades de Pointes/complications , United States , Urban PopulationABSTRACT
Assessing the potential for a new drug to cause life-threatening arrhythmias is now an integral component of premarketing safety assessment. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline (ICH) E14 recommends the "Thorough QT Study" (TQT) to assess clinical QT risk. Such a study calls for careful evaluation of drug effects on the electrocardiographic QT interval at multiples of therapeutic exposure and with a positive control to confirm assay sensitivity. Yet for some drugs and diseases, elements of the TQT Study may be impractical or unethical. In these instances, alternative approaches to QT risk assessment must be considered. This article presents points to consider for evaluation of QT risk when alternative approaches are needed.