Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar

Transcription

1 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar 9-10 am (PT) am (MT) 11 am-12 pm (CT) 12-1 pm (ET) April 2, 2019

2 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar Anticoagulant Therapy Webinar Series Eight new Anticoagulant Therapy elements of performance (EPs) have been added to the National Patient Safety Goals (NPSG ) These EPs are effective July 1, 2019 for all Joint Commission-accredited hospitals, critical access hospitals, nursing care centers, and medical centers (accredited under the ambulatory health care program) This two-part webinar series will provide information about best practices and assist customers in answering questions before the July 1 effective date

3 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar This session seeks to: Share best practices in anticoagulant therapy Assist health care organizations to better understand and implement the new EPs Answer participant questions about the new Anticoagulant Therapy elements of performance during the live session

4 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar About Our Presenters Scott Kaatz, DO, MSc, FACP, SFHM, Wayne State University and Henry Ford Hospital William Dager, Pharm.D., BCPS, MCCM, FASHP, FACCP, FCSHP, UC Davis Medical Center

5 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar Slides are available for download now! To access the slides, see the Event Resources Pane Select the slides for today s session A new window will open permitting you to download or print the PDFs

6 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar This program is designed to be interactive. Audio is by VOIP use your computer speakers or headphones Participants are connected in listen-only mode Ask questions through the Questions pane Visit any links or resources noted in the slides Download the slides and later share the recording

7 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar Within two weeks, the webinar recording and slide deck will be accessible on The Joint Commission website via the Anticoagulant Therapy Webinar Series landing page at: mission.org/anticoag ulant_therapy_webin ar_series/.

8 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar Disclosure Statement These staff and speakers have disclosed that neither they nor their spouses/partners have any financial arrangements or affiliations with corporate organizations that either provide educational grants to this program or may be referenced in this activity: Andrew Bland, MD, MBA, MSPA, FAAP, FACP, Medical Director, The Joint Commission William Dager, Pharm.D., BCPS, MCCM, FASHP, FACCP, FCSHP, UC Davis Medical Center

9 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar Disclosure Statement Scott Kaatz, DO, MSc, FACP, SFHM, Wayne State University and Henry Ford Hospital

10 Preparing for New Joint Commission EPs Effective July 1: Best Practices in Anticoagulant Therapy (Part 1) April 2, 2019 Speakers: Scott Kaatz, DO, MSc, FACP, SFHM William Dager, Pharm.D., BCPS, MCCM, FASHP, FACCP, FCSHP, Contributors: Jack Ansell, MD Allison Burnett, PharmD Tracy Minichiello, MD

11 Why Anticoagulants? Of the16 NPSGs, 3 apply to medicines Of these 3, 1 applies specifically to anticoagulants For outpatients, anticoagulants (AC) consistently rank as the class of medications most frequently leading to emergency room visits and hospital admissions for adverse drug events (ADEs).[1-3] Warfarin is implicated in: Approximately 32% of emergency visits for ADEs in the elderly 50% of which result in hospitalization.[3] Since 2010 a new class of AC potentially better and safer than warfarin (Direct Oral anticoagulants or DOACs) entered the market 1.Budnitz, D.S., et al. Medication use leading to emergency department visits for adverse drug events in older adults. Ann Intern Med, 2007;147: Budnitz, D.S., et al. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med, 2011;365: Shehab, N., et al. US Emergency Department Visits for Outpatient Adverse Drug Events, JAMA, 2016;316:

12 Comparing DOACs to Warfarin Characteristic Warfarin DOAC Onset of action Slow Rapid Half-life Long Short Dosing Variable Fixed Food effect Yes No Drug interactions Many Few Measuring Required Yes No Antidote Yes Yes Severe complications from DOACs do exist Between 2013 and 2014, rivaroxaban and dabigatran were the 5th and 10th most common drugs for adverse drug reactions (ADE) related emergency room visits in older adults This reflects the increased use of DOACs and their potential for toxicity.[1] Many of these events can be prevented 1.Shehab, N., et al.us Emergency Department Visits for Outpatient Adverse Drug Events, JAMA, 2016;316:

13 Anticoagulants Are Also a Common Cause of Inpatient ADE Inpatients are treated with IV unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in addition to warfarin and DOACs 4% of inpatients experience major bleeding with IV UFH[1] Heparin-related bleeding can be significantly reduced by systematically applying a nomograms for dosing[2] Bleeding rates of 1.8% and 1.1% with LMWH and Fondaparinux in a 40,000 inpatient analysis[3] 18.7% of 20,687 inpatients received an excess dose of LMWH for myocardial infarction significantly associated with major bleeding (OR 1.43) and death (OR1.35) vs those who received correct dose 1.Zidane et al. Frequency of major hemorrhage in patients treated with unfractionated IV heparin for DVT or PE. Arch Intern Med 2000;160: Raschke R, et al. Weight-based heparin dosing nomogram compared with a standard care nomogram. Ann Intern Med 1993;119: Szummer et al. Association between the use of fondaparinux vs LMWH and clinical outcomes in patients with NSTEMI. JAMA 2015;313:707 4.Allen N et al. Enoxaparin dosing and associated risk of in-hospital bleeding and death in patients with NSTEMI. Arch Intern Med 2007;167:1539

14 The Joint Commission Has Revised Anticoagulation Related Safety Goals 8 new or revised Elements of Performance (EP) Applicable to: Acute Care Hospitals Critical Access Hospitals Nursing Care Centers Medical Centers (accredited under Ambulatory Health Care Programs)

15 NPSG EP -1 Use approved protocols and evidence-based guidelines for initiation/maintenance of therapy specifically addressing drug selection, dosing, age/renal/liver function adjustments, drug/food interactions and other risk factors EP-1: The [hospital/organization] uses approved protocols and evidence-based practice guidelines for the initiation and maintenance of anticoagulant therapy that address medication selection; dosing, including adjustments for age and renal or liver function; drug-drug and drug-food interactions; and other risk factors as applicable

16 NPSG EP - 1 Use approved protocols and evidence-based guidelines for initiation/maintenance of therapy specifically addressing drug selection, dosing, age/renal/liver function adjustments, drug/food interactions and other risk factors Why was this chosen? 1 out of 8 patients receive wrong dose of DOAC in community setting and have increased ADEs as a result[1] Example Patient with DVT discharged on rivaroxaban, 15 mg twice daily, with plans to decrease to 20 mg once daily at 3 weeks. Sees his PCP 3 months later, still taking 15 mg twice daily which is overdosing Patient did not know that he had to reduce his dose at 3 weeks, did not receive hospital discharge education Example Patient with acute DVT in entire right leg Discharged on dose of apixaban appropriate for AFIB which has a different dose Returns with recurrent DVT 1.Steinberg B, et al. Off-Label Dosing of Non-Vitamin K Oral Anticoagulants and Risk of Adverse Events: Results from the ORBIT-AF II Study. J Amer Coll Card 2016;68: O Brien e, et al. Physician practices regarding contraindications to oral anticoagulation in atrial fibrillation. Am Heart J. 2014; 167:: Steinberg B et al. Use and associated risks of concomitant ASA therapy with OAC in patients with AF. Circ 2013;128:

17 How Do I Do It? 1. Adopt or develop your own institutional protocols based on evidence-based guidelines to guide therapy. 2. Assure implementation and compliance across care continuum. 3. Monitor performance and outcomes to assess success. 4. As administration: commit needed resources, money, dedicated personal to assure success.

18 What is Meant by Administrative Commitment? Administration provides visible endorsement of efforts to achieve NPSG by incorporating anticoagulation-related priorities into organizational strategic plans or quality improvement action plans (including performance metrics), and Administration budgets and supports resources for development and ongoing support of anticoagulation improvement activities that are appropriately matched to size, function and needs of the organization (e.g. dedicated positions, training, information technology support, data analysts, etc.)

19 What is Meant by Protocols & Guidelines? Just as developing and following check lists in surgical cases has prevented major mishaps (e.g. wrong side surgery) Developing or adopting written protocols or guidelines for drug selection, initiation of therapy, monitoring, etc. and standardizing care will reduce major ADEs related to anticoagulant therapy Reduce prolonged hospital stays; reduce resource use; reduce readmissions; improve overall quality Protocols and guidelines are only as good as to the degree to which they are systematically implemented across the care continuum and uniformly followed

20 Who Should be Engaged? Surgical provider(s) Medical providers(s) Nursing Pharmacy Quality improvement Laboratory Information Technology Data analytics Case management Senior Administration Overseen by an appointed Champion with appropriate expertise

21 Example of Guideline Using DOACs in Atrial Fibrillation ACF Centers of Excellence: Center/resource_files/ pdf

22 Utilizing Informatics G Arg Lep Doses 22

23 Sample Resources: Where Do I Find Them? Craig T, et al AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. JACC 2019; Ansell J. Management of venous thromboembolism: Clinical guidance from the Anticoagulation Forum. J Thromb Thrombolysis 2016;41:1-232 Witt D et al. American Society of Hematology 2018 guidelines for management of VTE: Optimal management of anticoagulation therapy. Blood Advances 2018; : And more

24 Where Do I Find Them? Sample resources can be found at the Anticoagulation Centers of Excellence:

25 Where Do I Find Them? Sample resources can be found at the University of Washington Medicine Pharmacy Services:

26 Where Do I Find Them? Sample resources can be found Michigan Anticoagulation Quality Improvement Initiative (MAQI2):

27 NPSG EP - 2 Use approved protocols and evidence-based guidelines for reversal of AC and management of bleeding for each medication EP-2: The [hospital/organization] uses approved protocols and evidence-based practice guidelines for reversal of anticoagulation and management of bleeding events related to each anticoagulant medication

28 NPSG EP - 2 Use approved protocols and evidence-based guidelines for reversal of AC and management of bleeding for each medication Why was this chosen? Vitamin K has been around a long time for warfarin reversal DOACs and LMWH entered the market without a reversal agent, while warfarin has two (Vitamin K and PCC). Idarucizumab available in 2015 for dabigatran reversal; (~$2500 per dose). Andexanet alfa available in 2018 for apixaban/rivaroxaban reversal (~$27,500-$49,500 per dose). 4 factor PCCs (prothrombin complex concentrates) exist for reversal of warfarin with vitamin K and may reverse apixaban/rivaroxaban; costs about ~$1000-$5000 per dose.

29 Example of Guideline Bleeding Severity Assessment Siegal D et al. How I treat target-specific oral anticoagulant-associated bleeding. Blood 2014;123:1152 Burnett A et al. Guidance for the practical management of the DOACs in VTE treatment. J Thromb Thrombolysis 2016;41:

30 Example of Guideline DOAC Reversal Tomaselli et al ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants. JACC.2017;70:3042

31 Example of Guideline PCC to reverse Warfarin Tomaselli et al ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants. JACC.2017;70:3042

32 Example of Reversal Protocol Henry Ford Health System, Tier 1: Anticoagulation Reversal Guidelines, Policy #MMC-52, 10/16/18

33 Anticoagulation Forum Reversal Guidance Reversal of Direct Oral Anticoagulants: Guidance from the Anticoagulation Forum Published in American Journal of Hematology 1 st authors Adam Cuker, MD, MS and Allison Burnett, PharmD Open access in Spring 2019

34 NPSG EP - 3 Use approved protocols and evidence-based guidelines for perioperative management of all patients on oral anticoagulants EP-3: The [hospital/organization] uses approved protocols and evidence-based practice guidelines for perioperative management of all patients on oral anticoagulants

35 NPSG EP - 3 Use approved protocols and evidence-based guidelines for perioperative management of all patients on oral anticoagulants Why was this chosen? For procedures that increase risk of bleeding anticoagulation needs to be interrupted Any interruption in anticoagulation can theoretically increase risk of clotting Determining how long to interrupt to allow safe procedures and what agents to use to minimize clotting risk is complicated 1.Siegal D et al.periprocedural heparin bridging in patients receiving vitamin K antagonists.circulation 2012;126: Steinberg B et al.use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation. Circulation 2015; 131:488-94

36 NPSG EP - 3 Systems Plan Prior to procedure During procedure Post procedure Effective communication to all involved Process incorporates risk assessment of bleeding and thromboembolism

37 Example of Guideline Suggested management of DOACs & VKAs before an invasive procedure ACF Centers of Excellence: Center/resource_files/ pdf

38 Example of Guideline Suggested management of DOACs & VKAs before an invasive procedure ACF Centers of Excellence: Center/resource_files/ pptx

39 Where Do I Find Them? Doherty J, et al ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with AF. JACC 2017;69:735 Burnett A et al. Guidance for the practical management of the DOACs in VTE treatment. J Thromb Thrombolysis 2016;41: Hornor M, et al. American College of Surgeons guidelines for the perioperative management of antithrombotic medication.j Amer Coll Surg 2018;227(5):521 And more....

40 End of Part One Take home messages: Know and understand the NPSGs as they apply to anticoagulants Administrative commitment with personnel and resources to meet NPSG Empower the appropriate personnel to formulate and carry out policies Develop Institution specific Protocols or Guidelines following evidencebased guidelines Systematically applied Follow up and measure performance Adjust as necessary Join us May 7, 2019 for Part 2 of this webinar series to discuss NPSG EPs 4, 5 and 6

41 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar Please ask questions through the Questions pane Click the arrow to expand and close the pane. Include slide reference numbers when possible

42 Questions All unanswered questions will be reviewed and a Q&A document posted online When the follow-up items from this session are posted, participants will receive an The Joint Commission. All Rights Reserved.

43 Resources NPSG Anticoagulant Therapy R3 Report Requirement, Rationale, Reference Anticoagulant Therapy Webinar Series Landing Page Anticoagulation Centers of Excellence ASH Clinical Guidelines MAQI2 Anticoagulation Toolkit University of Washington Anticoagulation Services

44 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar REMINDER - Slides are available for download now! To access the slides, see the Event Resources Pane Select the slides for today s session A new window will open permitting you to download or print the PDFs

45 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar Session Evaluation Survey Participants will receive an automated with a link to the evaluation survey. We use your feedback to inform future content and assess the quality of our sessions.

46 Preparing for new Joint Commission EPs effective July 1: Best Practices in Anticoagulant Therapy Webinar Thank you for attending this session.