Failure mode and effects analysis to reduce risk of anticoagulation levels above the target range during concurrent antimicrobial therapy

• Published in: American journal of health-system pharmacy Vol. 72; no. 14; pp. 1195 - 1203
• Main Authors: DANIELS, LISA M, BARRETO, JASON N, KUTH, JOHN C, ANDERSON, JEREMY R, ZHANG, BEILEI, MAJKA, ANDREW J, MORGENTHALER, TIMOTHY I, TOSH, PRITISH K
• Format: Journal Article
• Language: English
• Published: England Copyright American Society of Health-System Pharmacists, Inc. All rights reserved 15.07.2015; Oxford University Press
• Subjects: Anti-Infective Agents - administration & dosage; Anti-Infective Agents - adverse effects; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; Blood Coagulation - drug effects; Blood Coagulation - physiology; Cohort Studies; Drug Interactions - physiology; Healthcare Failure Mode and Effect Analysis - methods; Humans; International Normalized Ratio - methods; Methods; Retrospective Studies; Risk Factors; Warfarin - administration & dosage; Warfarin - adverse effects; United States
• ISSN: 1079-2082; 1535-2900
• DOI: 10.2146/ajhp140632

PURPOSEA failure mode and effects analysis (FMEA) was conducted to analyze the clinical and operational processes leading to above-target International Normalized Ratios (INRs) in warfarin-treated patients receiving concurrent antimicrobial therapy. METHODSThe INRs of patients on long-term warfarin therapy who received a course of trimethoprim–sulfamethoxazole, metronidazole, fluconazole, miconazole, or voriconazole (highly potentiating antimicrobials, or HPAs) between September 1 and December 31, 2011, were compared with patients on long-term warfarin therapy who did not receive any antimicrobial during the same period. A multidisciplinary team of physicians, pharmacists, and a systems analyst was then formed to complete a step-by-step outline of the processes involved in warfarin management and concomitant HPA therapy, followed by an FMEA. RESULTSPatients taking trimethoprim–sulfamethoxazole, metronidazole, or fluconazole demonstrated a significantly increased risk of having an INR of >4.5. The FMEA identified 134 failure modes. The most common failure modes were as follows(1) electronic medical records did not identify all patients receiving warfarin, (2) HPA prescribers were unaware of recommended warfarin therapy when HPAs were prescribed, (3) HPA prescribers were unaware that a patient was taking warfarin and that the drug interaction is significant, and (4) warfarin managers were unaware that an HPA had been prescribed for a patient. CONCLUSIONAn FMEA determined that the risk of adverse events caused by concomitantly administering warfarin and HPAs can be decreased by preemptively identifying patients receiving warfarin, having a care process in place, alerting providers about the patientʼs risk status, and notifying providers at the anticoagulation clinic.