National Patient Safety Goal Anticoagulant Therapy NPSG.03.05.01 Bonnie Thomas, Pharm.D. Medication Safety Officer Desert Regional Medical Center Palm Springs, CA Special Thanks to content developers: Coralee Johnson, Pharm.D.c, Loma Linda University, School of Pharmacy Vivian Nguyen, Pharm.D.c, Loma Linda University, School of Pharmacy Alison Wong, Pharm.D.c, Loma Linda University, School of Pharmacy

Objectives Understand the goal for NPSG 03.05.01 and the organizations to which this standard applies. Identify the elements of performance for anticoagulation therapy. Recognize current quality indicators used in anticoagulation management. Evaluate how your institution meets or exceeds these standards.

NPSG.03.05.01 Joint Commission revised the 2010 NPSGs on July 1, 2011 Goal: decrease the chance of patient harm with the use of anticoagulants Anticoagulants are among the leading drugs associated with patient harm in U.S. 7.2 % of 446 medication-related sentinel events (January 1997 to December 2007)4 Look-alike and sound-alike drugs Calculation errors Monitoring problems (i.e. lab errors) Drug-drug, drug-food interactions

Who It Applies To? Ambulatory Care (only EPs 2, 3, 7, 8) Critical Access Hospital Hospital Long Term Care Long Term Care (Medicare/Medicaid) ***Note: Applies to organizations that provide anticoagulant therapy used for treatment or long- term prophylaxis

Elements of Performance 1. Use only oral-unit dose products, prefilled syringes, or premixed infusion bags when these types of products are available. Note: For pediatric patients, prefilled syringe products should be used only if specifically designed for children. 2. Use approved protocols for the initiation and maintenance of anticoagulant therapy.

Elements of Performance 3.Before starting a patient on warfarin, assess patient’s baseline coagulation status; for all patients receiving warfarin therapy, use current INR to adjust therapy. Baseline status and current INR are documented in the medical record. Note: The patient’s baseline coagulation status can be assessed in a number of ways, including through a lab test or by identifying risk factors such as age, weight, bleeding tendency, and genetic factors.

GENETIC TESTING FOR WARFARIN CYP2C9 and VKORC1 genotyping has been advocated by FDA for improvement of warfarin dosing Identify optimal stable dose of warfarin Reduce risk of bleeding complications American College of Medical Genetics (ACMG) 2008 Strong association between genetic information and final warfarin dose, but still not clear that having this information impacts patient outcomes Insufficient evidence to recommend for or against routine CYP2C9 and VKORC1 testing in warfarin naïve patients American College of Chest Physicians (ACCP) 2008 Suggest against the use of pharmacogenetic-based initial dosing to individualize warfarin dosing (Grade 2C) Cost: $400-550 for genotype test Cost-effective analysis showed pharmacogenetic testing is not cost-effective with estimated QALY of $170,000 24 Limited analysis since clinical benefit not yet characterized

Elements of Performance 4. Use authoritative resources to manage potential food and drug interactions for patients receiving warfarin. 5. When heparin is administered intravenously and continuously, use programmable pumps in order to provide consistent and accurate dosing. 6. A written policy addresses baseline and ongoing laboratory tests that are required for anticoagulants.

Drug Reversal Agent Monitoring Heparin Protamine 14 aPTT 14 Enoxaparin Anti-Xa 13 by chromogenic assay (not routine) Dalteparin Tinzaparin Argatroban Recombinant factor VIIa 15, 19 aPTT ; Ecarin clotting time 19 (ecarin not widely used) Lepirudin aPTT; Ecarin clotting time 19 Bivalirudin Dabigatran Prothrombin complex concentrate22 Recombinant factor VIIa22 Fresh frozen plasma; Packed red blood cells 16, 18 Ecarin clotting time, aPTT and PT (minimal effects) 12 Fondaparinux Recombinant factor VIIa 14 Anti-Xa 19 Apixaban Recombinant factor VIIa 21 Anti-Xa, dilute PT12 Rivaroxaban Recombinant factor VIIa 20, 21 Prothrombin complex concentrate 21 Activated charcoal 17 Anti-Xa, PT 12 Warfarin Vitamin K; Fresh Plasma; prothrombin complex concentrate; recombinant factor VIIa 14 INR/PT 14

Elements of Performance 7. Provide education regarding anticoagulant therapy to prescribers, staff, patients, and families. Patient/family education includes the following: The importance of follow-up monitoring Compliance Drug-food interactions The potential for adverse drug reactions (i.e. bleeding) and drug-drug interactions New drugs (i.e. rivaroxaban, dabigatran)

Elements of Performance 8. Evaluate anticoagulation safety practices, take action to improve practices, and measure the effectiveness of those actions in a time frame determined by the organization.

Anticoagulation benchmarks Outcome measures 5,6,7, 8, 9, 10 Adverse events (ICD-9 codes) Major bleeding Thromboembolism Anticoagulation therapy-related death Measures of INR control Time in therapeutic range (TTR)  need software to calculate % of patients reaching INRs/TTR in therapeutic range Time to therapeutic range INR variability Extreme INR values # of INR determinations per month Length of stay in hospital Readmission rates

References Joint Commission (2008). Preventing errors related to commonly used anticoagulants. Retrieved Oct 10, 2011. Joint Commission. (2011). National Patient Safety Goals. Retrieved Oct 3, 2011. http://www.jointcommission.org/standards_information/npsgs.aspx Joint Commission. (2009). 2010 National Patient Safety Goals. Retrieved Oct 3, 2011. http://www.allhealth.org/BriefingMaterials/JointCommission-Oct2009- 2010NationalPatientSafetyGoals-1722.pdf ISMP Medication Safety Alert (2007). Anticoagulant safety takes center stage in 2007. Retrieved Oct 10, 2011. Airee A, Guirguis AB, Mohammad RA. Clinical outcomes and pharmacists’ acceptance of a community hospital’s anticoagulation management service utilizing decentralized clinical staff pharmacists. 2009. The Annals of Pharmacotherapy. 43: 621-628. Gouin-Thibault I, Levy C, Pautas, E, Cambus JP, Drouet L, Mahe I, Bal dit Sollier C, Horellou MH, Golmard JL, and Siguret V. Improving anticoagulation control in hospitalized elderly patients on warfarin. Journal of American Geriatrics Society. 2010. 58: 242-247. Witt, Daniel M. Quality measures and benchmarking for warfarin therapy. 2011. Journal of Thrombolysis. 31: 242-248

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