National Patient Safety GoalNational Patient Safety GoalAnticoagulant TherapyAnticoagulant TherapyNPSG.03.05.01NPSG.03.05.01

Bonnie Thomas, Pharm.D.Bonnie Thomas, Pharm.D.Medication Safety OfficerMedication Safety OfficerDesert Regional Medical CenterDesert Regional Medical CenterPalm Springs, CA Palm Springs, CA

Special Thanks to content developers:Special Thanks to content developers:Coralee Johnson, Pharm.D.c, Loma Linda University, School of PharmacyCoralee Johnson, Pharm.D.c, Loma Linda University, School of PharmacyVivian Nguyen, 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 PharmacyAlison Wong, Pharm.D.c, Loma Linda University, School of Pharmacy

ObjectivesObjectives 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.03.05.01NPSG.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?Who It Applies To?1. Ambulatory Care (only EPs 2, 3, 7, 8)2. Critical Access Hospital3. Hospital4. Long Term Care5. Long Term Care (Medicare/Medicaid)

***Note: Applies to organizations that provide anticoagulant therapy used for treatment or long-term prophylaxis

Elements of PerformanceElements 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 PerformanceElements of Performance3.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 WARFARINGENETIC 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 PerformanceElements 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 Protamine 14 Anti-Xa 13 by chromogenic assay

(not routine)Dalteparin Protamine 14 Anti-Xa 13

(not routine)Tinzaparin Protamine 14 Anti-Xa 13

(not routine)Argatroban Recombinant factor VIIa 15, 19 aPTT ; Ecarin clotting time 19

(ecarin not widely used)Lepirudin Recombinant factor VIIa 15, 19 aPTT; Ecarin clotting time 19

(ecarin not widely used)Bivalirudin Recombinant factor VIIa 15, 19 aPTT; Ecarin clotting time 19

(ecarin not widely used) 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 PerformanceElements of Performance7. 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 PerformanceElements 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 Anticoagulation benchmarksbenchmarks

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

ReferencesReferences1. Joint Commission (2008). Preventing errors related to commonly used

anticoagulants. Retrieved Oct 10, 2011.

2. Joint Commission. (2011). National Patient Safety Goals. Retrieved Oct 3, 2011. http://www.jointcommission.org/standards_information/npsgs.aspx

3. Joint Commission. (2009). 2010 National Patient Safety Goals. Retrieved Oct 3, 2011.

http://www.allhealth.org/BriefingMaterials/JointCommission-Oct2009-2010NationalPatientSafetyGoals-1722.pdf

4. ISMP Medication Safety Alert (2007). Anticoagulant safety takes center stage in 2007. Retrieved Oct 10, 2011.

5. 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.

6. 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.

7. Witt, Daniel M. Quality measures and benchmarking for warfarin therapy. 2011. Journal of Thrombolysis. 31: 242-248

References References 8. Baker 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. 2009. 15(3): 244-52.

9. Burnett A, D’Angio R, Earl LE, Garcia D. Challenges and benefits of an inpatient anticoagulation service: one hospital’s experience. 2011. Journal of Thrombolysis. 31: 344-352.

10. 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. 2009. American Journal of Health-System Pharmacy. 66:2179-88.

11. 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. 2011. Circulation. 4:276-282.

12. Gross PL, Weitz JI. New anticoagulants for treatment of venous thromboembolism. Arterioscler Throm Vasc Biol. 2008. 28: 380-386.

13. 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. 2009. 43: 1064-83.

14. Crowther MA and Warkentin, TE. Bleeding risk and the management of bleeding complications in patients undergoing anticoagulant therapy: focus on new anticoagulant agents. Blood. 2008. 111: 4874-4879.

15. Young 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. 2007. 18 (6): 547-553.

16. Cheng CM, McCurdy MR, Wong HA, and Kayser SR. Pros and cons of dabigatran. American Journal of Health System Pharmacy. 2011. 68: 1495.

17. Janssen Pharmaceuticals. Package Insert for Xarelto. Updated 07/2011. 18. 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. 2010. 103: 1116-1127.

19. Gulseth M. Managing Anticoagulant Patients in the Hospital: the inpatient anticoagulation service. American Society of Health System Pharmacists (2007).

20. 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. 2009. 91B: 636-44.

21. DeLoughery, TG. Practical aspects of the oral new anticoagulants. American Journal of Hematology. 86: 586-590.

22. Boehringer Ingelheim. Package Insert for Pradaxa. Updated 03/2011. 23. Kitzmiller JP, Groen DK, Phelps MA, Sadee W. Pharmacogenomic testing:

relevance in medical practice. Cleveland Clinic Journal of Medicine. 78 (4): 243-257

24. Donohue MM and Tirschwell DL. Implications of pharmacogenetic testing for patients taking warfarin or clopidogrel. Current Neurol Neurosci Rep. 2011. 11(1): 52-60.

References References