A Method for Detecting Adverse Drug Events through the Chronological Relationship Between the Medication Period and the Presence of Adverse Reactions from Electronic Medical Record Systems: Observational Study (Preprint)

BACKGROUND Medicines may cause various adverse reactions. An enormous amount of money and effort are spent investigating adverse drug events (ADEs) in clinical trials and post-marketing surveillance. Real-world data from multiple electronic medical records (EMRs) can make it easy to understand the ADEs that occur in actual patients. OBJECTIVE In this study, we generated a patient medication history database from physician orders recorded in EMRs, which allowed the period of medication to be clearly identified. METHODS We developed a method for detecting ADEs based on the chronological relationship between the presence of an adverse event and the medication period. To verify our method, we detected ADEs with alanine aminotransferase (ALT) elevation in patients receiving aspirin, clopidogrel and ticlopidine. The accuracy of the detection was evaluated with a chart review and by comparison with the Roussel Uclaf Causality Assessment Method (RUCAM), which is a standard method for detecting drug induced liver injury. RESULTS The calculated rates of ADE with ALT elevation in patients receiving aspirin, clopidogrel and ticlopidine were 3.33% (868 of 26,059 patients), 3.70% (188 of 5,076 patients) and 5.69% (226 of 3,974 patients), respectively, which were in line with the rates of previous reports. We reviewed the medical records of the patients in whom ADEs were detected. Our method accurately predicted ADEs in 90% (27 of 30patients) treated with aspirin, 100% (9 of 9 patients) treated with clopidogrel and 100% (4 of 4 patients) treated with ticlopidine. Only 3 ADEs that were detected by the RUCAM were not detected by our method. CONCLUSIONS These findings demonstrate that the present method is effective for detecting ADEs based on EMR data. CLINICALTRIAL