NoCVA Hospital Engagement Network Safe Surgery Collaborative: Venous Thromboembolism Treatment and Regulation. April 18, 2013

Transcription

1 NoCVA Hospital Engagement Network Safe Surgery Collaborative: Venous Thromboembolism Treatment and Regulation April 18, 2013

2 NoCVA This activity is part of the North Carolina Virginia Hospital Engagement Network(NoCVA) NoCVA is led by the NC Quality Center in partnership with the VA Hospital and Health Association NoCVA exists to support the goals of the CMS national effort - The Partnership for Patients 2

3 Partnership for Patients Goals By the end of 2013, preventable hospital acquired conditions would be reduced by 40%, compared to 2010 By the end of 2013, 30-day hospital readmissions would be reduced by 20%, compared to 2010 Engage Patients and Families in Patient Safety Improvement 3

4 VTE Impact 4

5 How Are We Doing 5

6 NoCVA HEN Performance 6

7 VTE per 1,000 Surgical Discharges VA Safe Surgery Collaborative AHRQ PSI 12 (NoCVA) Jan-11 Apr-11 Jul-11 Oct-11 Jan-12 Apr-12 Jul-12 Measure PforP Goal # Hospitals

8 % Compliance VA Safe Surgery Collaborative 100% 99% VTE2 SCIP (NoCVA) 98% 97% 96% 95% 94% 93% 92% 91% Jan-10 Apr-10 Jul-10 Oct-10 Jan-11 Apr-11 Jul-11 Oct-11 Jan-12 Apr-12 Jul-12 Measure 94.3% 95.1% 94.1% 96.2% 95.7% 96.1% 98.0% 98.9% 99.0% 99.2% 99.0% PforP Goal 95.0% 95.0% 95.0% 95.0% 95.0% 95.0% 95.0% 95.0% 95.0% 95.0% 95.0% # Hospitals

9 Webinar Objectives 1. State 2 reasons why Venous Thromboembolism Prevention is important 2. Name 2 drugs commonly used in the prevention of VTE 3. Give 2 examples of ways in which technology can help meet evidence based recommendations for VTE prevention 9

10 Venous Thromboembolism Treatment and Regulation Michelle Borchart Pharm.D., BCPS Pharmacy Clinical Specialist Fairview Southdale Hospital

11 Why is VTE Prevention important In 2003 there were over 38 million hospital discharges and 51% of them or more than 15 million patients were estimated to be at risk for VTE or PE. Despite significant advances in the prevention and treatment of VTE, pulmonary embolism remains the most common preventable cause of hospital death, being responsible for approximately 150,000 to 200,000 deaths per year in the United States. In the absence of appropriate prophylaxis, the incidence of VTE has ranged from percent in various hospitalized medical and surgical groups. 11

12 Why is VTE prevention important? The Surgical Care Improvement Project Centers for Medicare and Medicaid Services The Agency for Healthcare Research and Quality The Joint Commission The Office of the Surgeon General 12

13 Patient Case TW is a 51 year old female admitted to the hospital for a hemicoloctomy for colon cancer at the hepatic flexure. Past Medical History o Bipolar disorder o Chronic anemia o Chronic Back Pain Home Medications o Gabapentin o Depakote o Zyprexa 13

14 Patient Case Labs on Admission o Hg 9.3 o All other labs WNL Post-op, patient had some hypotension which resolved quickly. Surgeon ordered a medicine consult post-op to help with medical management Medicine recommended mechanical VTE prophylaxis 14

15 Patient Case POD #1 o Patient doing well per MD notes, is ambulating o Has developed post-op ileus POD #2 o Patient with dyspnea and mild lightheadedness with ambulation o Patient also with mild fever, chest X-ray ordered o Ileus resolving POD #2 Afternoon o PE identified in left upper lobe and possible small PE in right upper lobe o Patient started on heparin drip STAT 15

16 Pathophysiology Virchow s Triad o A theory proposes venous thromboembolism results due to: Alterations in blood flow Vascular endothelial injury Alterations in the constituents of the blood (ie inherited or acquired hypercoagulable state) 16

17 Risk Factors for VTE 17

18 Prevention of VTE Available therapies o Low dose unfractionated heparin o Low molecular weight heparin o Fondaparinux o Warfarin o Rivaroxaban 18

19 Unfractionated Heparin MOA - binds to antithrombin (AT) and converts it from a slow progressive thrombin inhibitor to a rapid thrombin inhibitor which results in inactivation of factors IXa, Xa, XIa, XIIa, and IIa (thrombin) Dosing o 5000 units SQ every 8-12 hours 30-70% bioavailable depending on dose Onset 1-2 hours, Half life minutes 19

20 Unfractionated Heparin Monitoring Parameters o Anti-factor Xa level Goal U/mL o Activated Partial Thromboplastin Time (APTT) PTT measures clotting time from factor XII activation through fibrin formation Goal 1.5 to 2.5 times control Adverse Effects o Bleeding o Heparin Induced Thrombocytopenia (HIT) Thrombocytopenia platelet count <150,000 20

21 Low Molecular Weight Heparin MOA binds to antithrombin (AT) enhancing and accelerating inhibition of factor IIa, and to a greater extent, factor Xa (due to smaller chain length) Dosing o Product Specific 3 on market in US Enoxaparin (Lovenox) mg Dalteparin (Fragmin) units of anti-factor Xa activity Tinzaparin (Innohep) units of anti-factor Xa activity o Fixed dose when used for prophylaxis Weight-based when used for treatment Longer half-life allows q12-24h administration (t1/2 can be prolonged in renal failure) 21

22 Low Molecular Weight Heparin Monitoring Parameters o Predictable response so usually not necessary unless renal impairment, <50kg or obese o Anti-factor Xa levels Goal IU/mL for bid (1mg/kg) dosing Goal 1-2 IU/mL for daily (1.5mg/kg) dosing Adverse Effects o Bleeding o HIT o Hematoma 22

23 Fondaparinux MOA binds selectively to antithrombin (AT), which leads to inactivation of factor Xa (no IIa) which inhibits the formation of thrombin Dosing VTE Prophylaxis o 2.5 mg SQ daily ( 50kg) o CI if CrCl <30 Monitoring Parameters o Platelets: Baseline and every 3 days o Renal function o Anti-factor Xa levels IU/mL for daily dosing Adverse Effects o Bleeding Protamine is ineffective as an antidote 23

24 Warfarin MOA interferes with conversion of vitamin K and its 2,3 epoxide which leads to depletion or reduction in activity of vitamin K- dependent coagulation proteins (factors II, VII, IX, and X) produced in the liver Dosing o Typically start around 5mg (higher for obese, young) o Adjust dose based on INR Adverse Effects o Bleeding Reversed with Vitamin K PO or IV Monitoring Parameters o INR (International Normalized Ratio) Standardizes PT Goal range 2-3 or for most indications 24

25 Rivaroxaban MOA: First ORAL direct factor Xa inhibitor in the United States FDA Indications: o DVT/PE prophylaxis after hip and knee surgery o Prevention of stroke in patients with Atrial Fibrillation o DVT/PE treatment and reduction in rate of recurrence Dosing for DVT/PE prophylaxis o Post-hip or knee replacement: 10mg PO once daily o DVT/PE treatment: 15 mg BID for first 21 days then 20mg PO QD o IF CrCl < 30 ml/min, DO NOT USE 25

26 Rivaroxaban Side Effects and Monitoring Side Effects o Bleeding (6%) o Syncope, nausea, increased LFTs Monitoring o Signs/symptoms of bleeding o No routine monitoring needed (aka INR, PT, PTT). PT can be used to determine IF rivaroxaban is on board o Labs affected by Rivaroxaban: INR PT aptt 26

27 CMS VTE Hospital Inpatient Quality Measures Measure ID VTE-1 VTE-2 VTE-3 VTE-4 VTE-5 VTE-6 Measure Short Name Venous Thromboembolism Prophylaxis Intensive Care Unit Venous Thromboembolism Prophylaxis Venous Thromboembolism Patients with Anticoagulation Overlap Therapy Venous Thromboembolism Patients Receiving Unfractionated Heparin with Dosages/Platelet Count Monitoring by Protocol or Nomogram Venous Thromboembolism Warfarin Therapy Discharge Instructions Hospital Acquired Potentially Preventable Venous Thromboembolism 27

28 VTE-1 Patients who received VTE prophylaxis or have documentation of why no VTE prophylaxis was given: o The day of or the day after hospital admission o The day of or the day after surgeries that start the day of or the day after hospital admission o Can use medical or mechanical VTE prophylaxis All inpatients 28

29 VTE-1 Excluded populations oicu patients omental disorder admissions ostroke admission o Obstetrics o Patients on a VTE study opatients on comfort measures only 29

30 VTE-2 ICU VTE Prophylaxis Patients who received VTE prophylaxis or have documentation of why no VTE prophylaxis was given: o The day of or the day after ICU admission or transfer o The day of or the day after surgery end date for surgeries that start the day of or the day after ICU admission or transfer o Can use medical or mechanical VTE prophylaxis 30

31 VTE-1 and 2 allowable values Required to have VTE Prophylaxis documented or documentation why no VTE Prophylaxis was given Allowed for VTE Prophylaxis measure: o Low dose unfractionated heparin o LMWH o Intermittent pneumatic compresison devices o Graduated compression stockings o Factor Xa inhibitor - Arixtra or Fondaparinux o Oral Factor Xa inhibitor rivaroxaban and apixiban (MD or PA have to document reason why) o Warfarin o Venous foot pumps 31

32 Reasons allowed for oral factor Xa inhibitor o History of or new diagnosis of atrial fibrillation or atrial flutter o History of hip or knee replacement surgery (total or partial) o New hip or knee replacement surgery (total or partial) 32

33 Additional elements of VTE-1 and VTE-2 If patient on continuous IV heparin therapy the day of or day after hospital admission this meets the measure If patients are on warfarin prior to admission but it is held for high INR, don t need additional prophylaxis If they are receiving anticoagulant therapy other than warfarin for atrial fibrillation or other conditions this meets the measure 33

34 Allowable Documentation for no VTE Prophylaxis Documentation of the reason for no VTE prophylaxis MUST be written by the day after hospital admission or surgery end date. Physicians, PA or Pharmacists can document reason for no VTE prophylaxis Want the words No VTE Prophylaxis If document no mechanical prophylaxis, they also have to document no pharmacologic prophylaxis 34

35 Prevention of VTE in Hospitalized Medical Patients 2.3 For acutely ill hospitalized medical patients at increased risk of thrombosis, we recommend anticoagulant thromboprophylaxis with LMWH, LDUH bid or tid or fondaparinux (Grade 1B) o Drug choice should be made based on patient preference, compliance and ease of administration 2.4 For patients at low risk recommend against pharmacologic prophylaxis (Grade 1B) 35

36 Risk Factors for VTE in Medical InPatients 36

37 Epic VTE order set forcing function on medicine admission order set 37

38 VTE Patients with anticoagulant overlap therapy VTE-3 Patients who received warfarin and parenteral anticoagulation: o For patients with confirmed VTE o For patients who receives less than five days of overlap therapy, they should be discharged on both medications or have a documented reason for discontinuation of parenteral therapy. o Overlap therapy should be administered for at least five days with an INR greater than or equal to 2 prior to discontinuation of the parenteral anticoagulation therapy, discharged on both medications, or have a reason for discontinuation of parenteral therapy 38

39 VTE Patients with anticoagulant overlap therapy VTE-3 Excluded populations o Less than 18 y/o o Patients with LOS greater than 120 days o Comfort measures only o Patients on a VTE study o Patients discharged to a health care facility or hospice care or home hospice o Patients who leave AMA o Patients who transfer to another hospital o Patients without VTE confirmed by diagnostic testing 39

40 Reasons to Discontinue Parenteral Therapy Early Bleeding risk High INR value, supratherapeutic Patient has severe anemia Patient is actively bleeding Patient not a candidate for long-term anticoagulation Patient previously on warfarin Patient received blood during this timeframe Patient scheduled for surgery Patient/caregiver refusal Thrombocytopenia 40

41 Patients receiving unfractionated heparin with doses/labs monitored by protocol or nomogram VTE-4 Patients who have their IV unfractionated heparin therapy dosages and platelet counts monitored according to defined parameters o Need pathways, orders or documentation that state a nomogram or protocol was used to calculate the UFH therapy dosages and platelet count monitoring. o Documentation must be done by a physician, NP, PA or pharmacist o Suggested data sources include ambulance record, ER record, nursing notes, MAR, and progress notes 41

42 Warfarin Therapy Discharge Instructions VTE-5 Patients with documentation that they or their caregivers were given written discharge instructions or other educational material about warfarin that addresses all of the following: 1. Compliance issues 2. Dietary advice 3. Follow up monitoring 4. Potential for adverse drug reactions and interactions 42

43 Hospital Acquired Potentially- Preventable VTE VTE-6 Patients who received no VTE prophylaxis prior to the VTE diagnostic test order date o All inpatients who develop confirmed VTE during hospitalization o Exclude all patients with VTE present at admission 43

44 SCIP VTE-2 Surgery patients who received appropriate VTE prophylaxis within 24 hours prior to anesthesia start time to 24 hours after anesthesia end time. o Timing of prophylaxis is based on the type of procedure, prophylaxis selection and clinical judgement regarding the impact of patient risk factors. o Due to the inherent variability related to the initiation of prophylaxis for surgical procedures, 24 hours prior to surgery to 24 hours post surgery was recommended by the SCIP expert panel in order to establish a timeframe that would encompass most procedures. 44

45 SCIP VTE-2 Excluded populations o Patients <18 y/o o Patients with LOS > 120d o Burn patients o Patients enrolled in clinical trials o Patients who are on oral anticoagulation prior to admission o Patients whose total surgery time is 60 minutes o Patients who stay less than 2 nights o Patients who expire perioperatively o Patients with documented reason for not administering VTE prophylaxis o Patients who did not receive VTE prophylaxis 45

46 Prophylactic Options for Surgery 46

47 Prophylactic Options for Surgery 47

48 Orthopedic/Surgery Order set example VTE Section 48

49 Prophylaxis Order Tracking 49

50 Quality Measures Performance Tracking 50

51 Review of Misses 51

52 52 Review of Misses

53 FSH Pharmacy Tip Sheet: Anticoagulant Timing in EPIC In EPIC, the standard default time for first dose of enoxaparin and heparin for post-op VTE prophylaxis is T + 18h. You will need to change this for each order to start at 0900 on POD #1. For medical VTE prophylaxis, the first dose will default to when order is entered. When verifying VTE prophylaxis, the pharmacist is responsible for making sure that the start time will be compliant with Surgical Care Improvement Project (SCIP). The SCIP requirement is that VTE prophylaxis must be administered within 24 hours of surgery end time. Patients included in SCIP: intracranial neurosurgery, general surgery (colon, bariatric, ano-rectal), gynecologic, urologic, hip (replacements and fractures) and knee replacement.

54 FSH Pharmacy Tip Sheet: Anticoagulant Timing in EPIC To adjust the start time during order verification: Go to Edit Clinical Information Add correct time to first dose box (will be blank). This will adjust all future dose schedules (see schedule times). In order to maintain compliance with SCIP, nursing should only adjust the time schedule of the doses AFTER the first dose is administered. 54

55 Take-Home Points VTE is a major problem in hospitalized patients More standards around VTE prevention and treatment is being mandated by CMS and the Joint Commission every year All patients admitted to hospitals now need some form of VTE prophylaxis or a documented reason for no VTE prophylaxis Using medical technology to help meet the standards can help improve performance scores Meeting new CMS and Joint Commission VTE standards needs to be a multidisciplinary effort to be successful. 55

56 References QualityNet [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services Center for Clinical Standards and Quality. Specifications Manual for National Hospital Quality Measures Discharges through Venous Thromboembolism National Hospital Inpatient Quality Measures. c2012 [cited 2013 April 10] Available from: FQnetTier4&cid= QualityNet [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services Center for Clinical Standards and Quality. Specifications Manual for National Hospital Quality Measures Discharges through Surgical Care Improvement Project National Hospital Inpatient Quality Measures. c2012 [cited 2013 April 10] Available from: FQnetTier4&cid= Premier Inc Venous Thromboembolism National Hospital inpatient Quality Measures 01/01/ /30/2013 Discharges Session 1. Retrieved from Premier Inc Venous Thromboembolism National Hospital inpatient Quality Measures 01/01/ /30/2013 Discharges Session 2. Retrieved from Bikdeli B. Sharif-Kashani B. Prophylaxis for Venous Thromboembolism: A Great Global Divide between Expert Guidelines and Clinical Practice. Seminars in Thrombosis and Hemostasis, 2012; 38:

57 References Pai M, Douketis JD. Prevention of Venous Thromboembolic Disease in Medical Patients. UpToDate, [Accessed 10 April2013]. Pai M, Douketis JD. Prevention of Venous Thromboembolic Disease in Surgical Patients. UpToDate, [Accessed 10 April2013]. DRUGDEX System [intranet database]. Version 5.1. Greenwood Village, Colo: Thomson Healthcare.[ Accessed 15 August 2012]. Fairview Health Services Dabigatran Dosing Information. Fairview System Pharmacy Anticoagulation Subcommittee updated Sept [Accessed 19 August 2012]. Fairview Health Services Warfarin Dosing Information. Fairview System Pharmacy Anticoagulation Subcommittee updated May [Accessed 19 August 2012]. Fairview Health Services Enoxaparin Dosing Information. Fairview System Pharmacy Anticoagulation Subcommittee updated October [Accessed 19 August 2012]. 57

58 Questions? 58

59 Polling Question #1 How well did this Learning activity meet the stated objectives? 1. Excellent 2. Good 3. Fair 4. Poor 5. N/A 1. State 2 reasons why Venous Thromboembolism Prevention is important 2. Name 2 drugs commonly used in the prevention of VTE 3. Give 2 examples of ways in which technology can help meet evidence based recommendations for VTE prevention 59

60 Polling Question #2 Amount of useful information and ideas provided: 1. Excellent 2. Good 3. Fair 4. Poor 5. N/A 60

61 Polling Question #3 Usefulness to my hospital of the information and ideas provided: 1. Excellent 2. Good 3. Fair 4. Poor 5. N/A 61

62 Polling Question #4 Chance that the information and ideas provided will improve my effectiveness and results: 1. Excellent 2. Good 3. Fair 4. Poor 5. N/A 62

63 Upcoming Events May 16 th, 130pm: Safe Surgery Monthly Webinar June 5 th, 1200pm: Preventing SSI s in Hysterectomy Procedures Dr. Tamara Howell June 9 th : 1200pm: Preventing SSI s in GI Procedures Dr. Elizabeth Wick, Johns Hopkins 63

64 Contact Information Jan Mangun, MT(ASCP), MSA, CPHRM Executive Directive, Quality & Patient Safety