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An Initiative of the Florida Hospital Association Hospital Improvement Innovation Network Anticoagulant Safety A Collaboration with the Florida Society of Health-System Pharmacists April 9, 2019 FSHP Mission Statement The Florida Society of


  1. An Initiative of the Florida Hospital Association Hospital Improvement Innovation Network Anticoagulant Safety A Collaboration with the Florida Society of Health-System Pharmacists April 9, 2019

  2. FSHP Mission Statement The Florida Society of Health-System Pharmacists ( FSHP ) is the professional association of pharmacy practitioners that promotes and supports the continual improvement of pharmaceutical care and the profession of pharmacy as an essential component for the delivery of health care. 2

  3. HIIN Core Topics – Aim is 20% reduction • Adverse Drug Events (ADE) • Catheter-associated Urinary Tract Infections (CAUTI) • Clostridium Difficile Infection (CDI) • Central line-associated Blood Stream Infections (CLABSI) • Hospital-onset MRSA Bacteremia • Injuries from Falls and Immobility • Pressure Ulcers (PrU) • Sepsis • Surgical Site Infections (SSI) • Venous Thromboembolisms (VTE) • Ventilator-Associated Events (VAE/IVAC/PVAP) • Readmissions (12% reduction) • Worker Safety 3

  4. UP Campaign: Spreading Cross Cutting Strategies Designed to reduce multiple forms of harm with simple, easy-to-accomplish activities that cut across several topics to decrease harm. Focused on four components: • SOAP UP: Hardwire Hand Hygiene • GET UP: Mobilize Patients • WAKE UP: Prevent Over-sedation • SCRIPT UP: Optimize Inpatient Medications FHA Mission to Care HIIN Website: http://www.fha.org/health-care-issues/quality-and- safety/mtc-hiin/up-campaign.aspx 4

  5. HIIN Resources & Tools FHA Mission to Care HIIN Website: http://www.fha.org/Health-Care-Issues/Quality-and- Safety/mtc-hiin/Focus-Areas/ADE.aspx 5

  6. Hospital National Patient Safety Goals on Anticoagulation 2019 Nisha Mathew Pharm.D. BCPS Pharmacy Clinical Coordinator Cleveland Clinic Martin Health

  7. Objectives Discuss Anti-coagulation Elements of Performance (EP) for NPSG 03.05.01 Describe best practices designed to improve compliance

  8. NPSG.03.05.01 Goal Reduce the likelihood of patient harm associated with the use of anticoagulant therapy

  9. NPGS Update Rationale New drugs New oral anticoagulants (NOAC) Direct Acting Oral anticoagulants (DOAC) NOAC = DOAC

  10. Comparison Old to New Characteristic Warfarin NOACS Onset of action Slow Rapid Half-life Long Short Drug Food Interactions Yes No Drug Interactions Many Few Lab monitoring Yes No Dosing Variable Fixed based on indication* Adopted and modified from TJC NPSG webinar April 2, 2019

  11. **NOAC Doses Vary Based on Indication

  12. Effective July 1,2019

  13. Reference: https://www.jointcommission.org/assets/1/6/HAP_DOAC_Prepub_Jul2019.pdf Accessed on 3/7/19

  14. Current Modified Content of new EP Changes EP EP 1 7 Use only unit dosed, pre mixed infusions and pre-filled syringes M & R 2 1 Using approved protocols for med selection, dosing, initiation, C maintenance, adjustment including Drug-Drug, drug food interactions - 2 EBM & Protocols for bleeding & reversal related to each NEW anticoagulant - 3 EBM & Protocols for perioperative management of oral NEW anticoagulants 3 4 Written policy on baseline & ongoing lab monitoring to adjust C anticoagulants 4 1 See above C 5 8 For continuous IV heparin, use programmable pumps M & R 6 4 See above C 7 6 Education to patients & families (removed prescribers & staff) on M & R adherence, interactions, monitoring & adverse effects 8 5 Evaluate safety practices, take action & measure change within a M & R defined time period. Establish process to identify, respond & report ADE outcomes. M & R:Moved & Revised; C: Consolidated

  15. Open FDA total reports With RIVAROXABAN : 116,347 With APIXABAN : 57,088 Reference: Open FDA Dashboard of adverse drug event reports; Accessed at: https://openfda.shinyapps.io/dash/

  16. Resources • University of Washington Anticoagulation Excellence Center • Hospital Pharmacy 2016 Chart on transitioning to & from anticoagulants Q U E S T I O N S ?

  17. Hospital National Patient Safety Goals: Anticoagulants Gwenesia Collins, Pharm D Executive Director of Pharmacy, Laboratory and Respiratory Therapy

  18. Adverse Drug Events Statewide Occurrence Q4 2017 – Q3 2018 Drug Class # of ADEs Beneficiaries Rate per 1,000 Beneficiaries Anticoagulants 19,164 80,456 238.2 Diabetic Agents 10,933 77,615 140.9 Opioids 3,076 73,236 42 Overall 33,173 189,809 174.8 Data provided by Health Services Advisory Group (HSAG)

  19. Statewide Readmission Rates for Beneficiaries on an Anticoagulant Quarter 30 day Discharge 30 day Readmission Readmits s Rate Q4 2016 4,842 22,581 21.4% Q1 2017 5,218 23,694 22.0% Q2 2017 5,001 23,097 21.7% Q3 2017 5,002 22,361 22.4% Q4 2017 5,216 23,589 22.1% Q1 2018 5,600 25,704 21.8% Q2 2018 5,159 23,914 21.6% Q3 2018 4,818 22,504 21.4% Data provided by Health Services Advisory Group (HSAG)

  20. Elements of Performance 1 EP 1 Use only oral unit-dose products, prefilled syringes, or premixed infusion bags when available

  21. EP 2 Use protocols for the initiation and maintenance of anticoagulants

  22. **NOAC Doses Vary Based on Indication

  23. EPIC: Require Indication for NOAC at CPOE • Allows Pharmacist monitoring - Scoring point based system - renal based adjustment - Heparin infusion Nursing driven - Warfarin dosing consult service - Daily monitoring of therapeutic anticoagulants

  24. Rules fire based on individual patient lab results RX Anticoagulants & no CBC in 72 hours Best Practice Anticoagulants & Alerts Hgb < 8, Plts < 100 K Heparin Within 12 hours of start infusions If not therapeutic in 24 hours

  25. EP 3 Assess the patient’s baseline coagulation status prior to initiating warfarin and adjust per INR per protocol

  26. EP 3 Peri-operative Management Protocols

  27. Placement of Surgery Order fires an alert Recommends duration of holding & restarting anticoagulants Customized pop-up in Epic

  28. EP 4 Uses resources for warfarin patients Food and drug interactions Drug / Drug (warfarin) interactions

  29. EP 5 Use programmable pumps when heparin is administered by IV and continuously

  30. EP 6 A policy to address baseline and ongoing lab tests required for anticoagulants Drug Warfarin NOACS UFH LAB INR baseline Serum Chemistry PTT baseline and INR prior to To assess renal q 6 hours x 24 change function hours then daily H&H daily H&H daily H&H daily Platelets daily Policy #21700118: Heparin Dosing Per Pharmacy Policy # 00010504: Anticoagulation Safety Policy

  31. EP 7 Provide education to prescribers, staff, patients, and families

  32. • Change in process - Newsletter, EHR tips , sign on message • Onboarding handout

  33. EP 7 Provide education to prescribers, staff, patients, and families Patient education requires more effort and should be led by the pharmacy team

  34. Evaluate anticoagulation safety practices, improve practices, and measure the effectiveness

  35. Changes in New Elements of Performance • Additions: • Use of protocols and guidelines for anticoagulation reversal and management of bleeding events related to each anticoagulant medication • Establish a process to identify, respond to, and report adverse drug events • Use of protocols and guidelines for perioperative management of all patients on oral anticoagulants

  36. Changes in New Elements of Performance • Revisions: • “Assess the patient’s baseline coagulation status prior to initiating warfarin; use current INR to adjust therapy in patients already on warfarin” will be consolidated with EP#6 • “Use resources to manage potential food and drug interactions for patients receiving warfarin” will be consolidated with EP#2

  37. Reference • National Patient Safety Goals Effective January 2019. Jointcommission.org. https://www.jointcommission.org/assets/1/6/NPSG_C hapter_HAP_Jan2019.pdf. Published 2019. Accessed March 5, 2019.

  38. Palm Beach Gardens Medical Center NPSG Anticoagulants Best Practices Brian Mayhue, Pharm.D Director of Pharmacy Services

  39. EP3: The hospital uses approved protocols  and evidence-based practice guidelines for perioperative management of all patients on oral anticoagulants.  EP5: The hospital/organization addresses anticoagulation safety practices through the following:  Establishing a process to identify, respond to, and report adverse drug events, including adverse drug event outcomes.  Evaluating anticoagulation safety practices, taking actions to improve safety practices, and measuring the effectiveness of those actions in a time frame determined by the organization.

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