1. Venous Thromboembolism (VTE) Prevention and Anticoagulation Management -Part 1: Thromboembolism & National Patient Safety Goal 3E Pharmacy Education

2. Objectives Identify four risk factors for VTE development in hospitalized patients List three symptoms of DVT/PE development List the three patient risk groups for VTE development and two appropriate interventions for each risk group List five requirements for meeting standards for the National Patient Safety Goal 3E - Anticoagulation

3. The Problem….. 2 million Americans will be afflicted with deep vein thrombosis (DVT) each year As many as 600,000 will subsequently develop a pulmonary embolism (PE) In about 300,000 people the PE may prove to be fatal Third most common cause of hospital-related deaths in the U.S. The most common preventable cause of hospital death

4. $$$ Economic burden of VTE $$$ Cost of care related to VTE (cases of DVT and PE together) in the U.S. each year is estimated at 1.5 billion Post-op thromboembolic complications add an average of $18,300 to the total hospital costs for each patient in which they happen

5. Causes for VTE development Venous stasis- immobilization, age>40, obesity, CHF, MI, general anesthesia, varicose veins Vein injury- trauma, surgery, CV catheter, history of thromboembolism (TE), cardiac pacemaker Increased coagulation- malignancy, high dose estrogen, pregnancy, polycythemia vera, activated protein C resistance, AT III deficiency, hyperhomocysteinemia, antiphospholipid syndrome, nephrotic syndrome Virchow’s Triad

6. Risk Factors for VTE development –Decreased mobility –Increased age (especially >75) –Personal history of DVT/PE or clotting disorder –Surgery- LE joint replacement open abdominal, urologic, or gynecologic procedure –Inflammatory conditions –Obesity (BMI≥30) –Current malignancy –Estrogen therapy or pregnancy –History of MI, CHF, COPD, or other respiratory failure –Stroke < 1 month –Admission to the ICU –Sepsis Venous Thromboembolism Prophylaxis, June 2007, ICSI

7. Bed Rest!! … a DVT/ PE Red Flag!!! BEDREST

8. Signs and symptoms of DVT or PE Pain, cramps or heaviness in affected extremity Paresthesias- unexplained numbness or tingling Redness and edema of affected extremity Tenderness and pain in calf upon palpation Shortness of breath Chest heaviness (without cardiac explanation) Sense of “impending doom”

9. DVT Prophylaxis: 3 Patient Groups Low risk Highest risk Moderate/High risk

10. Patient Group: –Age <60 –Minor surgical procedure –Medical patient on bed rest –Pregnant patient or patient on oral contraceptives or hormone replacement Recommendations for prophylaxis: –Early ambulation- this means up walking in hallway 2- 3 times per day –Sequential Compression Devices (SCDs) while in bed Low risk

11. Patient Group: –Age >60 –Central venous access –History of previous malignancy –History of medical risk factors CHF, COPD, inflammatory bowel disease –Medical patient with additional risk factors (CHF, COPD, Sepsis, MI) –Major surgery planned with additional risk factors Recommendations: –Early ambulation- this means up walking in hallway 2-3 times per day –SCDs while in bed –Pharmacologic prophylaxis indicated - start 12-24 hrs. after surgery once hemostasis has occurred –If orthopedic patient- follow orthopedic anticoagulation protocol Moderate/High risk

12. Patient Group: –Age >75 –Elective hip or knee surgery –Active cancer –Hip, pelvis or leg fracture (<1 month) –Stroke (<1 month) –Admission to ICU –Personal history of DVT, PE or clotting disorder Recommendations: –Early ambulation- this means up walking in hallway 2-3 times per day –SCDs while in bed –Pharmacologic prophylaxis indicated - start 12-24 hrs. after surgery once hemostasis has occurred –If orthopedic patient- follow orthopedic anticoagulation protocol Very High Risk

13. Procedure related risk DVT/PE Level of Risk Calf DVTProximal DVT Clinical PE Fatal PE Low2%0.4%0.2%0.002% Moderate10%-20%2%-4%1%-2%0.1%- 0.4% High20%-40%4%-8%2%-4%0.4%-1% Very High40%-80%10%-20%4%-10%0.2%- 0.5% ICSI: Venous Thromboembolism Prophylaxis Fourth Edition/June 2007 Increased risk up to 4-5 weeks postoperatively

14. Medical Condition Risk DVT ConditionRisk of DVT General Medical10%-26% MI17%-34% Stroke11%-75% CHF20%-40% Medical ICU35%-42% Chest 2005; 128;958-969

15. Prevention techniques Risk assessment tools- –Risk stratify patients into risk categories based on current diagnosis and previous medical history Early ambulation Pharmacologic prophylaxis if indicated based on patient’s VTE risk level Venous Thromboembolism Prophylaxis, June 2007, ICSI

16. Contraindications to drug therapy Active, significant bleeding Extreme thrombocytopenia (<50,000) History of heparin induced thrombocytopenia (HIT) Uncontrolled hypertension (SBP >200, DBP >120) Other conditions that could increase risk of bleeding Venous Thromboembolism Prophylaxis, June 2007, ICSI

17. National Patient Safety Goal 3E: Anticoagulation

18. Purpose of the Joint Commission’s National Patient Safety Goals (NPSG’s): Published by the Joint Commission annually Purpose of National Patient Safety Goals (NPSG): –Promote specific improvements in patient safety –Highlight problem areas in health care –Describe evidence-based solutions –Focus on system-wide solutions

19. Purpose of National Patient Safety Goal 3E: Anticoagulation Reduce the likelihood of patient harm with the use of anticoagulation (AC) therapy Goal applies to multiple inpatient and outpatient settings (ambulatory care, hospitals, home care, long-term care, etc.) Rationale: Anticoagulation therapy is a high risk treatment (due to complexity with dosing, patient compliance with treatment, & monitoring)

20. National Patient Safety Goal 3E Goal applies to the use of heparin, low molecular weight heparins, warfarin and other anticoagulants One year phase-in period for all hospitals with full implementation by January 1, 2009

21. Risks with Anticoagulant Therapy AC’s are listed as one of the top 5 drug classes with patient safety incidents ¹ Reported meds involved in harmful events ² : #3 Heparin, #5 Warfarin, #11 Enoxaparin Heparin errors typically involve infusion pump and IV delivery errors ³ 1.Cousins D et al. 2006 2.USP MedMarx data, 2005 3.Fanikos J. et al. 2004

22. National Patient Safety Goal 3E Requires that all JCAHO accredited institutions: –Implement a defined anticoagulation program –Use ONLY oral Unit Dose products & pre- mixed IV’s –Warfarin is dispensed for each individual patient with established monitoring –Use approved protocols for the initiation & maintenance of anticoagulation therapy

23. National Patient Safety Goal 3E Requires that all JCAHO accredited institutions: –With the use of Warfarin – baseline/current INR is available for all patients for therapy adjustment –Dietary services is notified of all pt’s receiving warfarin- food/drug interaction education –Heparin IV is delivered by a programmable IV pump –Policy addresses baseline & ongoing lab tests for Heparin/LMWH

24. National Patient Safety Goal 3E Requires that all JCAHO accredited institutions: –Provide education on anticoagulation therapy for all providers, staff, patients, and families –Pt./family education covers specific areas: follow-up, dietary restrictions, monitoring, complications, and food & drug interactions –Evaluation of Anticoagulation safety practices.

25. National Patient Safety Goal 3E: Surveying and Scoring Joint Commission will evaluate actual performance with standards of the “Goal” All requirements must be implemented Facility will be found either “Compliant or Not Compliant” Failure to comply will result in a “Requirement for Improvement (RFI)”

26. HealthEast’s work on VTE Prevention & Anticoagulant Management Measures (How will we know that a change is an improvement?) –Hospital Acquired DVT per 1000 Discharges –Hospital Acquired PE per 1000 Discharges –Readmissions within 31 Days with DVT per 1000 Discharges –Readmissions within 31 Days with PE per 1000 Discharges –Patient harm associated with anticoagulant therapy as measured by the IHI Adverse Drug Event Trigger Tool

27. HealthEast’s work on VTE Prevention & Anticoagulant Management Aims (What are we trying to accomplish?) –Reduce the incidence of DVT and PE in hospitalized patients by 50% in one year. –Reduce readmissions within 31 days for DVT and PE by 50% in one year. –Reduce patient harm associated with the use of anticoagulant therapy by 50% in one year.

28. DVT Prevention Clinical Goals: –Adult patients (18 & older) are assessed for VTE (DVT & PE) risk within 24 hours of admission –Appropriate pharmacological and/or mechanical prophylaxis begins within 24 hrs of admission –All patients receive education regarding VTE signs & symptoms, preventive methods –All patients begin early and frequent ambulation Venous Thromboembolism Prophylaxis, June 2007, ICSI

29. DVT Prevention Clinical Goals: –All adult medical/surgical patients with moderate-high or very high VTE risk receive pharmacologic prophylaxis unless contraindicated –Reduce the risk of complications from pharmacologic prophylaxis. Venous Thromboembolism Prophylaxis, June 2007, ICSI

30. DVT Prevention Clinical Goals: –Appropriate pharmacological and/or mechanical prophylaxis begins within 24 hrs of admission –Mechanical prophylaxis is used when pharmacologic prophylaxis is contraindicated –Appropriate precautions for patients receiving spinal or epidural anesthesia are implemented Venous Thromboembolism Prophylaxis, June 2007, ICSI

31. HealthEast Current Baseline Data Hospital Acquired DVT per 1000 Discharges Hospital Acquired PE per 1000 Discharges Readmissions with DVT per 1000 Discharges Readmissions with PE per 1000 Discharges Data collected during FY ‘07

32. Hospital Acquired DVT per 1000 Discharges

33. Hospital Acquired PE per 1000 Discharges

34. Readmissions within 31 Days with DVT per 1000 Discharges

35. Readmissions within 31 Days with PE per 1000 Discharges

36. HE Anticoagulation Safety Practices Standardized therapeutic Heparin premixed IV concentration, with infusion rate chart labels Smart Pump for Heparin infusion Restricted access to multiple strengths of Heparin –Heparin Flush 100 units/ml-only strength available for flush use in adults on override Standardized weight based order sets (Heparin, LMWH’s) with standard labs –for orders outside of protocol, direct prescriber to use the order set or obtain separate labs orders

37. HE Anticoagulation Safety Practices Heparin boluses and LMWH doses dispensed by pharmacy as exact doses Do not use abbreviation for “U” on handwritten or typed orders Saline flush used for peripheral catheters –Only central lines (PICC/Port-a-cath) & dialysis catheters require Heparin flush Bar code technology & CPOE (coming to all sites) Heparin-Induced Thrombocytopenia (HIT) Standard orders

38. HE Anticoagulation Safety Practices Warfarin administration at standard time of 1700 –Allows review of laboratory results (INR, etc) Guidelines available for standard and rapid reversal of warfarin Warfarin dispensed in exact patient doses (U/D) Warfarin teach packets and RN patient education New HED documentation available for RN documentation of education RN independent double checks of therapeutic IV Heparin doses

39. HE Anticoagulation Safety Practices Pharmacists role –For any weight based therapeutic orders for use of Heparin or LMWH, verify the order, obtain an accurate weight in kilograms and transcribe the appropriate dose (if needed). Review baseline labs. –Pay attention to drug interactions/duplication of therapy warnings in HMM (e.g. To prevent LMWH and Heparin duplications, significant interactions, etc) –Enter INR monitoring into HMM for warfarin

40. HE Anticoagulation Safety Practices Pharmacists Role: If therapeutic Heparin or LMWH hand written orders received: 1.request use of order set 2.Or, obtain separate lab orders as required by the protocol a.Hgb b.INR and/or PTT c.Cr d.Platelets

41. Future steps….. Development of a VTE Dashboard with all system measures for each site Creation of a VTE Collaborative Practice Committee with participation by representatives from all sites Continue assessing progress with VTE work at each site Annual nursing, pharmacy and provider education

42. NPSG 3E: Anticoagulation- References For more information, see the Joint Commission Website: www.jointcommission.org 1.Cousins D et al. 2006. Risk assessment of anticoagulation therapy. National Patient Safety Agency. United Kingdom 2.USP MedMarx data, 2005 3.Fanikos J. et al. Medication errors associated with anticoagulant therapy in the hospital. Am J Cardiol. 2004; 94: 532-5. 4.ICSI Venous Thromboembolism Prophylaxis Fourth Edition-June 2007 5.Chest 2005; 128; 958-969 6.Santell JP, Hicks RW, Cousins DD. MEDMARX Data Report: A Chart-book of 2000-2004 Findings from Intensive Care Units and Radiological Services. Rockville, MD: USP Center for the Advancement of Patient Safety; 2005 7.ISMP Medication Safety Alert; Volume 12, issue 1; Recommended Safety Improvements for Anticoagulants. January 11, 2007

43. Post-Test Questions 1.Which of the following are requirements for meeting the NPSG 3E standards? a.Yearly nursing, pharmacy and provider education b.Warfarin dosing for all patients will only be managed by pharmacy c.Defined hospital anticoagulation management program d.Nutrition Services is notified of all patient’s receiving warfarin e.all of the above f.none of the above g.a, c and d only h.b, c and d only

44. Post-Test Questions 2. Which are risk factors for VTE development? a. increase mobility, obesity, and sepsis b. decreased mobility, joint, surgery and history of DVT/PE c. decreased mobility, age <40, and history of CHF d. cancer, age >40, and pregnancy

45. Post-Test Questions 3. Which grouping has the correct symptoms of DVT/PE development? a. oxygen use and anxiety b. chest heaviness (without cardiac explanation) and bruising of extremity c. tenderness/pain upon palpation of calf and shortness of breath d. redness/edema of extremity and high INR lab value

46. Post-Test Questions 4. What are the risk factors for the “Very High” risk group? a. age >60, active cancer, and history of CHF b. age >60, central venous access, and major abdominal surgery c. age >75, bedrest and minor surgical procedure d. age >75, active cancer and admission to ICU

47. Post-Test Questions 5. What is the pharmacist’s role in safety with anticoagulation use? a.Verify weight and dose on any therapeutic Heparin or low molecular weight heparin order. b.Review any drug interaction or duplication of therapy notices in HMM for anticoagulants and intervene appropriately if needed. c.Request use of standard order sets and standard labs when hand written orders received for heparin or low molecular weight heparin. d.Dispense exact dose of Heparin boluses and low molecular weight heparin doses. e.All of the above

48. Post-Test Questions 6. Which of the following is NOT part of Virchow’s triad in the development of pathogenic thrombus? a.hypercoaguable state b.endothelial injury c.circulatory status d.none of the above