1. 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

2. Objectives
Understand 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.

3. 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

4. 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

5. 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.

6. 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.

7. 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: $ 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

8. 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.

9. 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

10. 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)

11. 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.

12. 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

13. 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,
Joint Commission. (2009) National Patient Safety Goals. Retrieved Oct 3, 2011.
2010NationalPatientSafetyGoals-1722.pdf
ISMP Medication Safety Alert (2007). Anticoagulant safety takes center stage in Retrieved Oct 10, 2011.
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Witt, Daniel M. Quality measures and benchmarking for warfarin therapy Journal of Thrombolysis. 31:

14. References
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15. References
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