1National Patient Safety Goal Anticoagulant Therapy NPSG.03.05.01 Bonnie Thomas, Pharm.D.Medication Safety OfficerDesert Regional Medical CenterPalm Springs, CASpecial Thanks to content developers:Coralee Johnson, Pharm.D.c, Loma Linda University, School of PharmacyVivian Nguyen, Pharm.D.c, Loma Linda University, School of PharmacyAlison Wong, Pharm.D.c, Loma Linda University, School of Pharmacy
2ObjectivesUnderstand the goal for NPSG 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.
3NPSG.03.05.01 Joint Commission revised the 2010 NPSGs on July 1, 2011 Goal: decrease the chance of patient harm with the use of anticoagulantsAnticoagulants 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)4Look-alike and sound-alike drugsCalculation errorsMonitoring problems (i.e. lab errors)Drug-drug, drug-food interactions
4Who It Applies To? Ambulatory Care (only EPs 2, 3, 7, 8) Critical Access HospitalHospitalLong Term CareLong Term Care (Medicare/Medicaid)***Note: Applies to organizations that provide anticoagulant therapy used for treatment or long- term prophylaxis
5Elements 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.
6Elements 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.
7GENETIC TESTING FOR WARFARIN CYP2C9 and VKORC1 genotyping has been advocated by FDA for improvement of warfarin dosingIdentify optimal stable dose of warfarinReduce risk of bleeding complicationsAmerican College of Medical Genetics (ACMG) 2008Strong association between genetic information and final warfarin dose, but still not clear that having this information impacts patient outcomesInsufficient evidence to recommend for or against routine CYP2C9 and VKORC1 testing in warfarin naïve patientsAmerican College of Chest Physicians (ACCP) 2008Suggest against the use of pharmacogenetic-based initial dosing to individualize warfarin dosing (Grade 2C)Cost: $ for genotype testCost-effective analysis showed pharmacogenetic testing is not cost-effective with estimated QALY of $170,000 24Limited analysis since clinical benefit not yet characterized
8Elements 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.
9Drug Reversal Agent Monitoring HeparinProtamine 14aPTT 14EnoxaparinAnti-Xa 13by chromogenic assay(not routine)DalteparinTinzaparinArgatrobanRecombinant factor VIIa 15, 19aPTT ; Ecarin clotting time 19(ecarin not widely used)LepirudinaPTT; Ecarin clotting time 19BivalirudinDabigatranProthrombin complex concentrate22Recombinant factor VIIa22Fresh frozen plasma; Packed red blood cells 16, 18Ecarin clotting time,aPTT and PT (minimal effects) 12FondaparinuxRecombinant factor VIIa 14Anti-Xa 19ApixabanRecombinant factor VIIa 21Anti-Xa, dilute PT12RivaroxabanRecombinant factor VIIa 20, 21Prothrombin complex concentrate 21Activated charcoal 17Anti-Xa, PT 12WarfarinVitamin K; Fresh Plasma; prothrombin complex concentrate; recombinant factor VIIa 14INR/PT 14
10Elements 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 monitoringComplianceDrug-food interactionsThe potential for adverse drug reactions (i.e. bleeding) and drug-drug interactionsNew drugs (i.e. rivaroxaban, dabigatran)
11Elements 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.
12Anticoagulation benchmarks Outcome measures 5,6,7, 8, 9, 10Adverse events (ICD-9 codes)Major bleedingThromboembolismAnticoagulation therapy-related deathMeasures of INR controlTime in therapeutic range (TTR) need software to calculate% of patients reaching INRs/TTR in therapeutic rangeTime to therapeutic rangeINR variabilityExtreme INR values# of INR determinations per monthLength of stay in hospitalReadmission rates
13ReferencesJoint Commission (2008). Preventing errors related to commonly used anticoagulants. Retrieved Oct 10, 2011.Joint Commission. (2011). National Patient Safety Goals. Retrieved Oct 3,Joint Commission. (2009) National Patient Safety Goals. Retrieved Oct 3, 2011.2010NationalPatientSafetyGoals-1722.pdfISMP Medication Safety Alert (2007). Anticoagulant safety takes center stage in 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 The Annals of Pharmacotherapy. 43: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 :Witt, Daniel M. Quality measures and benchmarking for warfarin therapy Journal of Thrombolysis. 31:
14ReferencesBaker WL, Cios DA, Sander SD, and Coleman CI. Meta-analysis to assess the quality of warfarin control in atrial fibrillation patients in the United States. Academy of Managed Care Pharmacy (3):Burnett A, D’Angio R, Earl LE, Garcia D. Challenges and benefits of an inpatient anticoagulation service: one hospital’s experience Journal of Thrombolysis. 31:Finks SW, Oliphant CS, Manguso AH, Rogers KC, Bridges G, Haidar CE, Lee KR, Lee M, Lobo B, May AM, Reaves A, Swanson JM, Swims M, Vinson J, and Yates MED. Activities of Memphis-area hospitals to meet National Patient Safety goals for warfarin therapy American Journal of Health-System Pharmacy. 66:Rose AJ, Hylek EM, Berlowitz DR, Ash AS, Reisman JI, Ozonoff A. Prompt repeat testing after out-of-range INR values: a quality indicator for anticoagulation care Circulation. 4:Gross PL, Weitz JI. New anticoagulants for treatment of venous thromboembolism. Arterioscler Throm Vasc Biol :Nutescu EA, Spinler SA, Wittkowsky A, Dager WE. Low-molecular-weight heparins in renal impairment and obesity: available evidence and clinical practice recommendations across medical and surgical settings. The Annals of Pharmacotherapy :Crowther MA and Warkentin, TE. Bleeding risk and the management of bleeding complications in patients undergoing anticoagulant therapy: focus on new anticoagulant agents. Blood :
15ReferencesYoung G, Yonekawa KE, Nakagawa PA, Blaine RC, Lovejoy AE, Nugent DJ. Recombinant activated factor VII effectively reverses the anticoagulant effects of heparin, enoxaparin, fondaparinux, argrotraban, and bivalirudin ex vivo as measured using thromboelastography. Blood Coagulation and Thrombolysis (6):Cheng CM, McCurdy MR, Wong HA, and Kayser SR. Pros and cons of dabigatran. American Journal of Health System Pharmacy : 1495.Janssen Pharmaceuticals. Package Insert for Xarelto. Updated 07/2011.Van Ryn J, Stangier J, Haertter S, Liesenfeld KH, Wienen W, Feuring M, Clemens A. Dabigatran etexilate—a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost :Gulseth M. Managing Anticoagulant Patients in the Hospital: the inpatient anticoagulation service. American Society of Health System Pharmacists (2007).Eriksson, BI, Kakkar AK, Turpie AGG, Gent M, Bandel TJ, Homering M, Misselwitz F, Lassen MR. Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement. The Journal of Bone and Joint Surgery B:DeLoughery, TG. Practical aspects of the oral new anticoagulants. American Journal of Hematology. 86:Boehringer Ingelheim. Package Insert for Pradaxa. Updated 03/2011.Kitzmiller JP, Groen DK, Phelps MA, Sadee W. Pharmacogenomic testing: relevance in medical practice. Cleveland Clinic Journal of Medicine. 78 (4):Donohue MM and Tirschwell DL. Implications of pharmacogenetic testing for patients taking warfarin or clopidogrel. Current Neurol Neurosci Rep (1):