Adverse drug events with hyperkalaemia during inpatient stays: evaluation of an automated method for retrospective detection in hospital databases

BackgroundAdverse drug reactions and adverse drug events (ADEs) are major public health issues. Many different prospective tools for the automated detection of ADEs in hospital databases have been developed and evaluated. The objective of the present study was to evaluate an automated method for the retrospective detection of ADEs with hyperkalaemia during inpatient stays.MethodsWe used a set of complex detection rules to take account of the patient’s clinical and biological context and the chronological relationship between the causes and the expected outcome. The dataset consisted of 3,444 inpatient stays in a French general hospital. An automated review was performed for all data and the results were compared with those of an expert chart review. The complex detection rules’ analytical quality was evaluated for ADEs.ResultsIn terms of recall, 89.5% of ADEs with hyperkalaemia “with or without an abnormal symptom” were automatically identified (including all three serious ADEs). In terms of precision, 63.7% of the automatically identified ADEs with hyperkalaemia were true ADEs.ConclusionsThe use of context-sensitive rules appears to improve the automated detection of ADEs with hyperkalaemia. This type of tool may have an important role in pharmacoepidemiology via the routine analysis of large inter-hospital databases.

[1]  Vera Vlahović-Palčevski,et al.  Anatomical Therapeutic Chemical (ATC) drug classification system and Defined Daily Dose (DDD) unit of measurement in drug utilization monitoring. , 2000 .

[2]  B. Bégaud,et al.  Under-reporting of adverse drug reactions Estimate based on a spontaneous reporting scheme and a sentinel system , 1998, European Journal of Clinical Pharmacology.

[3]  Jonathan M. Teich,et al.  Research Paper: Identifying Adverse Drug Events: Development of a Computer-based Monitor and Comparison with Chart Review and Stimulated Voluntary Report , 1998, J. Am. Medical Informatics Assoc..

[4]  Donald R. Miller,et al.  Differential associations of beta‐blockers with hemorrhagic events for chronic heart failure patients on warfarin , 2006, Pharmacoepidemiology and drug safety.

[5]  L. Hazell,et al.  Under-Reporting of Adverse Drug Reactions , 2006, Drug safety.

[6]  Thomas H. Payne,et al.  Review Paper: Medication-related Clinical Decision Support in Computerized Provider Order Entry Systems: A Review , 2007, J. Am. Medical Informatics Assoc..

[7]  P. Neuvonen,et al.  Drug-related deaths in a university central hospital , 2002, European Journal of Clinical Pharmacology.

[8]  International Drug Monitoring the Role of the Hospital — A WHO Report , 1970, World Health Organization technical report series.

[9]  J Jouglard,et al.  [Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France]. , 1985, Therapie.

[10]  E. Hahn,et al.  Implementation of a computer‐assisted monitoring system for the detection of adverse drug reactions in gastroenterology , 2004, Alimentary pharmacology & therapeutics.

[11]  Joshua C. Denny,et al.  Analyses of longitudinal, hospital clinical laboratory data with application to blood glucose concentrations. , 2011, Statistics in medicine.

[12]  Steven H. Brown,et al.  RADARx: Recognizing, Assessing, and Documenting Adverse Rx events , 2000, AMIA.

[13]  David W. Bates,et al.  Review Paper: What Evidence Supports the Use of Computerized Alerts and Prompts to Improve Clinicians' Prescribing Behavior? , 2009, J. Am. Medical Informatics Assoc..

[14]  A R Feinstein,et al.  An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. , 1979, JAMA.

[15]  R Core Team,et al.  R: A language and environment for statistical computing. , 2014 .

[16]  D Yoon,et al.  Detection of Adverse Drug Reaction Signals Using an Electronic Health Records Database: Comparison of the Laboratory Extreme Abnormality Ratio (CLEAR) Algorithm , 2012, Clinical pharmacology and therapeutics.

[17]  Jelena Savović,et al.  Methods for Causality Assessment of Adverse Drug Reactions , 2008, Drug safety.

[18]  M. Kulldorff,et al.  Early detection of adverse drug events within population‐based health networks: application of sequential testing methods , 2007, Pharmacoepidemiology and drug safety.

[19]  G J Kuperman,et al.  A new knowledge structure for drug-drug interactions. , 1994, Proceedings. Symposium on Computer Applications in Medical Care.

[20]  R. Raschke,et al.  A computer alert system to prevent injury from adverse drug events: development and evaluation in a community teaching hospital. , 1998, JAMA.

[21]  Régis Beuscart,et al.  Interoperability of medical databases: construction of mapping between hospitals laboratory results assisted by automated comparison of their distributions. , 2011, AMIA ... Annual Symposium proceedings. AMIA Symposium.

[22]  Subashan Perera,et al.  Research Paper: A Systematic Review of the Performance Characteristics of Clinical Event Monitor Signals Used to Detect Adverse Drug Events in the Hospital Setting , 2007, J. Am. Medical Informatics Assoc..

[23]  D. Madigan,et al.  A Comparison of the Empirical Performance of Methods for a Risk Identification System , 2013, Drug Safety.

[24]  P Ryan,et al.  Novel Data‐Mining Methodologies for Adverse Drug Event Discovery and Analysis , 2012, Clinical pharmacology and therapeutics.

[25]  R. Beuscart,et al.  Detection of adverse drug events: proposal of a data model. , 2009, Studies in health technology and informatics.

[26]  P. Michel,et al.  Etude nationale sur les évènements indésirables graves liés aux soins : analyse approfondie de 45 événements indésirables graves liés aux soins , 2006 .

[27]  P. Corey,et al.  Incidence of Adverse Drug Reactions in Hospitalized Patients , 2012 .

[28]  N. Laird,et al.  Incidence of Adverse Drug Events and Potential Adverse Drug Events: Implications for Prevention , 1995 .

[29]  Jonathan M. Teich,et al.  Potential identifiability and preventability of adverse events using information systems. , 1994, Journal of the American Medical Informatics Association : JAMIA.

[30]  Emmanuel Chazard,et al.  The ADE scorecards: a tool for adverse drug event detection in electronic health records. , 2011, Studies in health technology and informatics.

[31]  Régis Beuscart,et al.  Data Mining to Generate Adverse Drug Events Detection Rules , 2011, IEEE Transactions on Information Technology in Biomedicine.

[32]  D. Bates,et al.  Outpatient prescribing errors and the impact of computerized prescribing , 2005, Journal of General Internal Medicine.

[33]  Régis Beuscart,et al.  Proposal and evaluation of FASDIM, a Fast And Simple De-Identification Method for unstructured free-text clinical records , 2014, Int. J. Medical Informatics.

[34]  D. Greenblatt,et al.  A method for estimating the probability of adverse drug reactions , 1981, Clinical pharmacology and therapeutics.

[35]  N. Madias,et al.  Drug‐Induced Hyperkalemia , 1985, Medicine.

[36]  P. Maurette [To err is human: building a safer health system]. , 2002, Annales francaises d'anesthesie et de reanimation.

[37]  N. Maglaveras,et al.  Constructing Clinical Decision Support Systems for Adverse Drug Event Prevention: A Knowledge-based Approach. , 2010, AMIA ... Annual Symposium proceedings. AMIA Symposium.

[38]  David W. Bates,et al.  Can surveillance systems identify and avert adverse drug events? A prospective evaluation of a commercial application. , 2008, Journal of the American Medical Informatics Association : JAMIA.

[39]  David W. Bates,et al.  Research Paper: Strategies for Detecting Adverse Drug Events among Older Persons in the Ambulatory Setting , 2004, J. Am. Medical Informatics Assoc..