Welcome to the New England QIN-QIO Medication Safety Webinar!

Transcription

1 Welcome to the New England QIN-QIO Medication Safety Webinar! Thank you for joining. Our presentation will begin shortly. If you haven t already, please dial in to the audio line: Passcode: Slides may be downloaded at:

2 The New England Journey Enhancing Medication Safety Anticoagulation in the Ambulatory Setting Clinical Guidelines & Protocols May 9, :00pm 1:00pm This material was prepared by the New England Quality Innovation Network-Quality Improvement Organization (NE QIN-QIO), the Medicare Quality Improvement Organization for New England, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy CMSQINC

3 Speaker Disclosures Today s speakers have no relevant conflicts of interest to disclose In adherence to the regulation standards of the Connecticut Pharmacists Association, the Accreditation Council of Pharmacy Education, Northeast Multistate Division (NE-MSD) this notice confirms that the information contained in this presentation is free of commercial bias and the speakers have no related vested financial interest in any capacity, inclusion of shareholder, recipient of research grants, consulting or advisory committees. 3

4 Chat in Introduce yourself please type in your name, organization and state. 4

5 Learning Objectives Upon completion of this session, participants will be able to: Discuss the patient types most likely to benefit from using a direct acting oral anticoagulant over warfarin, Describe an appropriate monitoring strategy to prevent adverse drug events in patients receiving direct acting oral anticoagulants, and Explore treatment options and available agents to reverse the effects of direct acting oral anticoagulants. 5

6 Adverse Drug Event (ADE) Defined as injury resulting from medical intervention related to a drug 6

7 Adverse Drug Events Implications 1/3 of hospital adverse events 1 280,000 hospital admissions annually 1 One-quarter of all ADEs are preventable 3 The CDC estimates that $3.5 billion is spent on extra medical costs associated with ADEs every year Hospital admissions related to ADEs in adults > 65 years was 24.9% 2 1 U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). National Action Plan for Adverse Drug Event Prevention. Washington, D.C.: Koh, H. 2 Bourgeois FT, Shannon MW, Valim C, Mandl KD. Adverse drug events in the outpatient setting: an 11-year national analysis. Pharmacoepidemiology and Drug Safety. September 2010;19(9): Neumiller J, Corbett C. Prevention of Medication Errors in the Older Adult Patient. Postgraduate Healthcare Education, LLC. Power- Pak C.E. Mylan Pharmaceuticals,

8 The National Action Plan for Adverse Drug Event (ADE) Prevention Department of Health & Human Services Identifies efforts to measure and prevent ADEs Patient Safety Prevention of ADE among three classes Diabetic agents Opioids Anticoagulants 8

9 Why Anticoagulants? 10% of inpatient ADEs due to anticoagulants 1 Warfarin caused 17% of ER visits in older adults 1 33% of ADE hospitalizations due to warfarin 1 1. U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). National Action Plan for Adverse Drug Event Prevention. Washington, DC: Author.

10 Anticoagulants Prescribed for treatment/prevention of Atrial fibrillation (AFib) and venous thromboembolism (VTE) Warfarin is most commonly prescribed anticoagulant Direct oral anticoagulants (DOACs) Pradaxa (Dabigatran) Xarelto (Rivaroxaban) Eliquis (Apixaban) Savaysa (Edoxaban) 10

11 Anticoagulation in the Ambulatory Setting Clinical Guidelines & Protocols Michael L. Smith, Pharm.D., BCPS, CACP East Region Pharmacy Clinical Manager Hartford Healthcare

12 Anticoagulation Therapy Options Since 1954 warfarin was the only choice for oral anticoagulation therapy Dabigatran ushered in a new era & options Rivaroxaban Apixaban Edoxaban No requirement for consistent monitoring/dose adjustments

13 Are DOACs an option for this patient? Proven safe & effective as warfarin for... Nonvalvular Atrial fibrillation Treatment and prevention of DVT/PE Not proven for... Atrial fibrillation associated with valvular disease Prophylaxis of mechanical valves VTE treatment and prevention in patients with cancer, pregnancy, or antiphospholipid syndrome.

14 Recommended Monitoring Warfarin Adherence counseling Drug interactions Dietary interactions Adverse event monitoring Regular interaction with a healthcare professional DOACs

15 JUST SET IT AND FORGET IT

16 Direct Oral Anticoagulants Standard tenants of drug therapy still apply Why? How? What to look for? Poor Adherence = Poor Outcomes = ADE VA study determined 28% of patients are non-adherent to dabigatran 13% increase in all-cause mortality and stroke for each 10% decrease in adherence Shore S. Am Heart J 2014;167:810-17

17 Direct Oral Anticoagulants Can we improve DOAC outcomes with monitoring? VA study follow-up examined adherence rates across the system Improved adherence demonstrated with a pharmacist review of appropriate patient selection and pharmacist-led monitoring Adherence increased with longer duration of follow-up Shore S. JAMA 2015;313(14):

18 Direct Oral Anticoagulants DOACs, Yes they are complicated! Rivaroxaban Dosing and Administration Atrial fibrillation 20mg once daily with the evening meal for CrCl>50 ml/min 15mg once daily with the evening meal for CrCl ml/min Contraindicated in patients with CrCl<15 ml/min Treatment of DVT/PE 15mg twice daily with food for the first 21 days 20mg once daily with food for the remainder of the treatment Contraindicated in patients with CrCl<30 ml/min Prophylaxis of DVT following hip or knee replacement surgery Administer without regard to food Hip: 10mg once daily for 35 days Knee: 10mg once daily for 12 days Contraindicated in patients with CrCl<30 ml/min Xarelto package insert 18

19 Monitoring Plan At therapy initiation Confirm appropriateness of therapy Obtain baseline labs (CBC/LFTs/SCr) Calculate creatinine clearance (CrCl) using Cockcroft-Gault Conduct medication review to assess potential for drug interactions Review indication for therapy Provide education to patient, supplemented by written materials agement.pdf. Accessed 10/27/2015

20 Patient Monitoring Thrombosis Canada: Suggested follow up in weeks 1 + 3, months 3 and 6, then every 6 months. Adherence Assessment and Counseling Bleeding Risk Assessment Creatinine Clearance Drug Interaction Assessment and Counseling Examination Final Assessment and Follow-up Gladstone DJ, Geerts WH, Douketis J, Ivers N, Healey JS, Leblanc K. Ann Intern Med. 2015;163:

21 Management Plan Flow Chart agement.pdf. Accessed 10/27/2015

22 Anticoagulation Reversal Dabigatran associated bleeding Mild-moderate bleeding: supportive therapy only Severe-life threatening: Praxbind (Idarucizumab) 5gm IV Praxbind package insert 10/2015

23 Anticoagulation Reversal Idarucizumab Indication: Reversal of the anticoagulant effect of dabigatran for emergency surgery/urgent procedures or life threatening or uncontrolled bleeding A humanized monoclonal antibody fragment with a high affinity to dabigatran and neutralizes the effect of dabigatran Onset: 5 minutes Duration: 24 hrs, the complex is renally cleared; no change if patient has severe renal disease Praxbind package insert 10/2015

24 Anticoagulation Reversal Available as 2 X 2.5gm/50ml ready to administer vials Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate. In patients with elevated coagulation parameters and reappearance of clinically relevant bleeding or requiring a second emergency surgery/urgent procedure, an additional 5 g dose may be considered. Praxbind package insert 10/2015

25 Anticoagulation Reversal Warning: In patients with the condition of hereditary fructose intolerance who have received parenteral administration of sorbitol, serious adverse reactions, including fatal reactions, have been reported. Reactions have included hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function. Praxbind package insert 10/2015

26 Anticoagulation Reversal Rivaroxaban, Apixaban, Edoxaban associated bleeding Mild-moderate: Supportive therapy only Severe-life threatening: Tranexamic acid 1gm IV Consider off-label 4 factor PCC (Kcentra ) units/kg, max dose 5000 units. Consider off-label FEIBA units/kg Consider vitamin K for underlying deficiency Faraoni et al. Critical Care (2015) 19:203 Shamoun et al. BioMed Res Int (2015) 2015:424031

27 Anticoagulation Reversal 4 factor Prothrombin Complex Concentrate (PCC)- Kcentra Indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: acute major bleeding or need for an urgent surgery/invasive procedure 25 X more concentrated than FFP Replaces coagulation factors II, VII, IX and X Also contains proteins C and S and *heparin* Onset: 5-10 mins; Duration: 12-24hrs Kcentra package insert 12/2013

28 Anticoagulation Reversal AndexXa (Andexanet alfa) A recombinant protein designed to reverse the activity of both direct and indirect Factor Xa inhibitors Developed as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor. Designated a Breakthrough Therapy by the U.S. Food and Drug Administration

29 Anticoagulation Reversal On August 17, 2016, the FDA released a Complete Response Letter which raised questions regarding manufacturing and clinical data. Currently being studied in ANNEXA-4, a Phase 3b/4 single-arm, open-label confirmatory study in patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present with an acute major bleed.

30 Suggested Resources UW Medicine Anticoagulation Services Thrombosis Canada The Michigan Anticoagulation Quality Improvement Initiative 30

31 We Want to Hear from You We will open the phone lines so you can pose your questions and share own experiences 31

32 Key Takeaways Adverse Drug Events (ADEs), a leading cause of ED visits & hospitalizations, can be prevented Anticoagulants account for approximately 1/3 of the ED visits due to ADEs It s important to understand which anticoagulation therapy is best suited for your patient It s critical to implement a standard monitoring process for all patients on anticoagulation therapy There are known treatment options that can reverse the effects of direct acting oral anticoagulants 32

33 Maine Amanda Gagnon X 3108 Massachusetts Colleen Kordana ckordana@healthcentricadvisors.org X3202 Rhode Island Cynthia Stephanopoulos cstephanopoulos@healthcentricadvisors.org Contact Your Medication Safety State Lead Connecticut, New Hampshire & Vermont Margherita Giuliano, RPh, CAE mgiuliano@ctpharmacists.org Questions regarding CE status may be submitted to Justin Sacramone at jsacramone@healthcentricadvisors.org 5/9/

34 Upcoming Learning Events Medication Safety Lunch & Learn Series (12pm-1pm) July 7/11: Maintaining Glycemic Control 7/25: Tools and Tips to Enhance Safe Care Transitions for Type II Diabetics Learn more, view archived events or register for upcoming session on our event page

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