title: Failure mode and effects analysis to reduce risk of anticoagulation levels above the target range during concurrent antimicrobial therapy.
abstract: OBJECTIVE
  A 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.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  Patients 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.
  
  
  CONCLUSIONS
  An 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 patient's risk status, and notifying providers at the anticoagulation clinic.
authors.affiliation: Lisa M. Daniels, M.D., is Resident Physician, Department of Internal Medicine; Jason N. Barreto, Pharm.D., is Assistant Professor of Pharmacy and Pharmacist, Pharmacy Services; John C. Kuth, Pharm.D., is Regional Director of Patient Safety and Pharmacist, Quality Resources; Jeremy R. Anderson, Pharm.D., is Pharmacist, Pharmacy Services; Beilei Zhang, Ph.D., is Systems Analyst, Division of Systems and Procedures; Andrew J. Majka, M.D., is Assistant Professor of Medicine and Physician, Division of General Internal Medicine; Timothy I. Morgenthaler, M.D., is Professor of Medicine and Physician, Division of Pulmonary and CriticalCare Medicine; and Pritish K. Tosh, M.D., is Assistant Professor of Medicine and Physician, Division of Infectious Diseases, Mayo Clinic Rochester, Rochester, MN.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Daniels
authors.affiliation: Lisa M. Daniels, M.D., is Resident Physician, Department of Internal Medicine; Jason N. Barreto, Pharm.D., is Assistant Professor of Pharmacy and Pharmacist, Pharmacy Services; John C. Kuth, Pharm.D., is Regional Director of Patient Safety and Pharmacist, Quality Resources; Jeremy R. Anderson, Pharm.D., is Pharmacist, Pharmacy Services; Beilei Zhang, Ph.D., is Systems Analyst, Division of Systems and Procedures; Andrew J. Majka, M.D., is Assistant Professor of Medicine and Physician, Division of General Internal Medicine; Timothy I. Morgenthaler, M.D., is Professor of Medicine and Physician, Division of Pulmonary and CriticalCare Medicine; and Pritish K. Tosh, M.D., is Assistant Professor of Medicine and Physician, Division of Infectious Diseases, Mayo Clinic Rochester, Rochester, MN.
authors.forename: Jason N
authors.initials: JN
authors.lastname: Barreto
authors.affiliation: Lisa M. Daniels, M.D., is Resident Physician, Department of Internal Medicine; Jason N. Barreto, Pharm.D., is Assistant Professor of Pharmacy and Pharmacist, Pharmacy Services; John C. Kuth, Pharm.D., is Regional Director of Patient Safety and Pharmacist, Quality Resources; Jeremy R. Anderson, Pharm.D., is Pharmacist, Pharmacy Services; Beilei Zhang, Ph.D., is Systems Analyst, Division of Systems and Procedures; Andrew J. Majka, M.D., is Assistant Professor of Medicine and Physician, Division of General Internal Medicine; Timothy I. Morgenthaler, M.D., is Professor of Medicine and Physician, Division of Pulmonary and CriticalCare Medicine; and Pritish K. Tosh, M.D., is Assistant Professor of Medicine and Physician, Division of Infectious Diseases, Mayo Clinic Rochester, Rochester, MN.
authors.forename: John C
authors.initials: JC
authors.lastname: Kuth
authors.affiliation: Lisa M. Daniels, M.D., is Resident Physician, Department of Internal Medicine; Jason N. Barreto, Pharm.D., is Assistant Professor of Pharmacy and Pharmacist, Pharmacy Services; John C. Kuth, Pharm.D., is Regional Director of Patient Safety and Pharmacist, Quality Resources; Jeremy R. Anderson, Pharm.D., is Pharmacist, Pharmacy Services; Beilei Zhang, Ph.D., is Systems Analyst, Division of Systems and Procedures; Andrew J. Majka, M.D., is Assistant Professor of Medicine and Physician, Division of General Internal Medicine; Timothy I. Morgenthaler, M.D., is Professor of Medicine and Physician, Division of Pulmonary and CriticalCare Medicine; and Pritish K. Tosh, M.D., is Assistant Professor of Medicine and Physician, Division of Infectious Diseases, Mayo Clinic Rochester, Rochester, MN.
authors.forename: Jeremy R
authors.initials: JR
authors.lastname: Anderson
authors.affiliation: Lisa M. Daniels, M.D., is Resident Physician, Department of Internal Medicine; Jason N. Barreto, Pharm.D., is Assistant Professor of Pharmacy and Pharmacist, Pharmacy Services; John C. Kuth, Pharm.D., is Regional Director of Patient Safety and Pharmacist, Quality Resources; Jeremy R. Anderson, Pharm.D., is Pharmacist, Pharmacy Services; Beilei Zhang, Ph.D., is Systems Analyst, Division of Systems and Procedures; Andrew J. Majka, M.D., is Assistant Professor of Medicine and Physician, Division of General Internal Medicine; Timothy I. Morgenthaler, M.D., is Professor of Medicine and Physician, Division of Pulmonary and CriticalCare Medicine; and Pritish K. Tosh, M.D., is Assistant Professor of Medicine and Physician, Division of Infectious Diseases, Mayo Clinic Rochester, Rochester, MN.
authors.forename: Beilei
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Lisa M. Daniels, M.D., is Resident Physician, Department of Internal Medicine; Jason N. Barreto, Pharm.D., is Assistant Professor of Pharmacy and Pharmacist, Pharmacy Services; John C. Kuth, Pharm.D., is Regional Director of Patient Safety and Pharmacist, Quality Resources; Jeremy R. Anderson, Pharm.D., is Pharmacist, Pharmacy Services; Beilei Zhang, Ph.D., is Systems Analyst, Division of Systems and Procedures; Andrew J. Majka, M.D., is Assistant Professor of Medicine and Physician, Division of General Internal Medicine; Timothy I. Morgenthaler, M.D., is Professor of Medicine and Physician, Division of Pulmonary and CriticalCare Medicine; and Pritish K. Tosh, M.D., is Assistant Professor of Medicine and Physician, Division of Infectious Diseases, Mayo Clinic Rochester, Rochester, MN.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Majka
authors.affiliation: Lisa M. Daniels, M.D., is Resident Physician, Department of Internal Medicine; Jason N. Barreto, Pharm.D., is Assistant Professor of Pharmacy and Pharmacist, Pharmacy Services; John C. Kuth, Pharm.D., is Regional Director of Patient Safety and Pharmacist, Quality Resources; Jeremy R. Anderson, Pharm.D., is Pharmacist, Pharmacy Services; Beilei Zhang, Ph.D., is Systems Analyst, Division of Systems and Procedures; Andrew J. Majka, M.D., is Assistant Professor of Medicine and Physician, Division of General Internal Medicine; Timothy I. Morgenthaler, M.D., is Professor of Medicine and Physician, Division of Pulmonary and CriticalCare Medicine; and Pritish K. Tosh, M.D., is Assistant Professor of Medicine and Physician, Division of Infectious Diseases, Mayo Clinic Rochester, Rochester, MN.
authors.forename: Timothy I
authors.initials: TI
authors.lastname: Morgenthaler
authors.affiliation: Lisa M. Daniels, M.D., is Resident Physician, Department of Internal Medicine; Jason N. Barreto, Pharm.D., is Assistant Professor of Pharmacy and Pharmacist, Pharmacy Services; John C. Kuth, Pharm.D., is Regional Director of Patient Safety and Pharmacist, Quality Resources; Jeremy R. Anderson, Pharm.D., is Pharmacist, Pharmacy Services; Beilei Zhang, Ph.D., is Systems Analyst, Division of Systems and Procedures; Andrew J. Majka, M.D., is Assistant Professor of Medicine and Physician, Division of General Internal Medicine; Timothy I. Morgenthaler, M.D., is Professor of Medicine and Physician, Division of Pulmonary and CriticalCare Medicine; and Pritish K. Tosh, M.D., is Assistant Professor of Medicine and Physician, Division of Infectious Diseases, Mayo Clinic Rochester, Rochester, MN. tosh.pritish@mayo.edu.
authors.forename: Pritish K
authors.initials: PK
authors.lastname: Tosh
mesh_terms: D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects*; D001777:Blood Coagulation / Q000187:drug effects* / Q000502:physiology; D015331:Cohort Studies; D004347:Drug Interactions / Q000502:physiology; D000067495:Healthcare Failure Mode and Effect Analysis / Q000379:methods*; D006801:Humans; D019934:International Normalized Ratio / Q000379:methods*; D012189:Retrospective Studies; D012307:Risk Factors; D014859:Warfarin / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000890:Anti-Infective Agents; D000925:Anticoagulants; D014859:Warfarin