Developing a management plan to incorporate DOACs into what was a traditional warfarin clinic

Transcription

1 THSNA March 7, 2018, San Diego Nursing Pre Summit Workshop 1 4pm Thrombosis and Hemostasis Patient Education: Kernels and Pearls Developing a management plan to incorporate DOACs into what was a traditional warfarin clinic LYNN B. OERTEL, MS, NP BC, CACP NURSING PRACTICE SPECIALIST ANTICOAGULATION MANAGEMENT SERVICE MASSACHUSETTS GENERAL HOSPITAL

2 Disclosures Alere Roche Pfizer

3 Challenges at the start. Gain consensus among stakeholders that this is the right thing to do Identify knowledge gaps and plan staff education and patient education materials Address technical challenges within clinic and institution Lack of quality examples for how to do this

4 Consensus among stakeholders MISCONCEPTIONS DOACs are easy No monitoring is needed No drug or food interactions It s easy for patients IN ACTUALITY..... Dosing adjustments not well understood and often not done Renal (and liver) function require monitoring There are a few, but important, drug interactions Patients are challenged: affordability, multiple transitions

5 2018 NPSG NPSG Take extra care with patients who take medicines to thin their blood Use approved protocols for initiation and maintenance of therapy Assess baseline coagulation status Provide education regarding anticoagulant therapy to prescribers, staff, patients, and families. Patient/family education includes the following: The importance of follow up monitoring Compliance Drug food interactions The potential for adverse drug reactions and interactions Evaluate anticoagulation safety practices, take action to improve practices, and measure the effectiveness of those actions in a time frame determined by the organization.

6 Identify knowledge gaps and plan education Pre and Post knowledge assessments (AMS staff required to achieve 100% on post test) 23 multiple choice items Pre assessment results GOAL Post assessment open book 60 score

7 Clinical staff education curriculum Blended learning experience Credit hours awarded (5.66 CHs from institution professional development office plus 1 from online program)

8 Required reading assignments RUFF CT ET AL. THE AMERICAN JOURNAL OF MEDICINE (2016) 129, S1 S29 BURNETT AE ET AL. J THROMB THROMBOLYSIS (2016) 41:

9 DOACs At a Glance Reference Tool

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11 Patient and Family Education Slideshow Phone Education Appointment Existing AMS patients transitioning to a DOAC Packet mailed in advance Average time on phone ~ 20 minutes Office Education Appointment New patient to AMS Average time minutes

12 DOAC Medication Guides Spanish translations available

13 Revised existing Patient Agreement to incorporate DOACs

14 Technical Challenges Purchase and install DOAC modules for DawnAC Staff training Interfaces with hospital systems Outbound message from DawnAC to populate AMS Icon for DOAC patients Create DOAC referral and renewal order with Epic/Cadence Team Staff and hospital staff training Develop strategy to measure and validate work Patient risk stratification to guide follow up and measure workload Identify value to institution (safety and quality)

15 DOAC Referral Cascading options presented according to: Indication Drug/dose options Transitioning, if applicable Acknowledge renal/liver assessment Off label use statement RNs complete worksheet to confirm eligibility

16 Standard follow up plan High Risk Age => 75 yrs egfr <51% Hct 6 pts HIGH RISK 6 Mo + LABS 9 Mo INITIAL ASSESSMENT + BASELINE LABS + EDUCATIONAL VISIT 1 MONTH (RN assess need for additional contact for new VTE lead in dose change) LOW RISK 3 MONTHS (LAB if renal risk) Based on risk stratification, continued follow up (F/U) plan RENAL 6 Mo + LABS 9 Mo + LABS ADHERENCE 1 Mo Episodic CLINICAL EVENT 1 Mo F/U and LABS 12 Mo + LABS Then 3 Mo F/Us, LABS twice annually 12 Mo + LABS Then annual F/U with LABS 12 Mo + LABS Then 3 Mo F/U with LABS When resolved, return to previous risk class When resolved, return to previous risk class

17 Patient Follow up: periodic phone assessments, based on risk class, includes assessment of adherence and medication changes Follow up (F/U) Assessment documented in Epic Tel Encounter Hospitalized/ED visit for what reason and when Interruption in DOAC therapy (and details) that AMS unaware of? Seen by MD other than well visits Any side effects? (assess if bruising increased on DOAC when compared with warfarin experience) Verification of change in dose as expected (applies to new VTE type indications only: apix on Day 8 of Trt and riva on Day 22 of Trt) Check on refills provided with initial Rx how many refills? Issues with drug procurement/financial concerns about getting refills as needed? DawnAC Follow Up Questionnaires (QNRs): Adherence* use 80% rule Medication surveillance for potentially interacting meds* that may require dose adjustment or avoid use DawnAC Lab QNR*: egfr, Creatinine and Hct obtained per Standard F/U plan (manual process now, future: via lab interface) Adverse events documented in Events Tab Procedures documented in Procedures Tab * This information displayed in AMS icon via Outbound Interface message along with next scheduled F/U date

18 How do I assess DOAC adherence?

19 Adherence Considered adherent if take medication as prescribed more than 80% of the time (WHO, 2003) Dose regimen Daily Twice daily # missed doses/time period to qualify for 20% (mark as non adherent) 1 out of 7 days 3 out of 2 weeks 6 out of 4 weeks 12 out of 8 weeks 3 out of 7 days 6 out of 2 weeks 12 out of 4 weeks 24 out of 8 weeks

20 How to Dose a DOAC... Indication Age Renal function Potential interacting med

21 FDA approved indications NVAF VTE Treatment Risk reduction of recurrence (dose change for apix and riva after 6 months standard treatment) VTE prophylaxis following hip and knee replacement Betrixaban (Bevyxxa ) VTE prophylaxis in acutely ill medical patient, FDA approval Dose: 80 mg orally daily after bolus of 160mg. Take with food. Duration days. Dose modified by renal function and concomitant P gp inhibitors. Supply: 40 and 80mg capsules. (Prosthetic heart valve patients NOT included.)

22 DOAC Renal Dosing Adjustment in Atrial Fibrillation Fanikos J et al. Am J Med. 2017;130(9):

23 DOACs and potential drug interactions P glycoprotein inhibitors P glycoprotein inducers CYP3A4 inhibitors CYP3A4 inducers Cyclosporine Ketoconazole Clarithromycin Itraconazole Quinidine Ritonavir Lopinavir Saquinavir Telaprevir Tacrolimus Lapatinib Amiodarone, Carvedilol Verapamil Dronedarone Propafenone Carbamazepine Rifampin St. John s Wart Tipranavir Itraconazole Ketoconazole Fluconazole Clarithromycin Verapamil Saquinavir Ritonavir Telaprevir Phenobarbitol Carbamazepine Phenytoin Rifampin St. John s Wart Tipranavir

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25 Dose Accuracy VTE and non recommended doses Initial therapy N=1635 Long Term Therapy N=1725 Nonrecommended dose Nonrecommended dose rivaroxaban 18% rivaroxaban 14% apixaban 50% apixaban 36% OUTCOMES dabigatran 46% If on non recommended dose: Higher rate of VTE recurrences, similar rate of bleeding or death Trujillo Santos et al. Thromb Haemost 2017; 117:

26 Temporary interruptions in therapy Approx. 10% of VTE patients needed a temporary interruption annually Surgical or other invasive procedures were required in: 25% of patients in RE LY 33% of patients in ROCKET AF and ARISTOTLE Thrombotic risk Bleeding risk Burnett AE, et al. J Thromb Thrombolysis 2016; 41: Lip GYH, et al. Up to date

27 Suggested management approach (assumes normal renal function) LOW Bleed Risk Surgery Hold: HIGH Bleed Risk Surgery Hold: Resume therapy LOW Bleed risk Resume HIGH Bleed Risk Dabigatran 2 doses 4 doses 24 h after surgery 2 3 days after surgery Rivaroxaban 1 dose 2 doses 24 h after surgery 2 3 days after surgery Apixaban 2 doses 4 doses 24 h after surgery 2 3 days after surgery Edoxaban 1 dose 2 doses After adequate hemostasis is established warfarin When INR < 1.5, omit 2 3 days When INR <1.2, omit 3 5 days Usually day of or following surgery, provided adequate hemostasis is established Am J Med May;129(5 Suppl):S1 S29

28 Transitions among oral anticoagulants: not an infrequent patient experience Recent real world evidence on medication switching patterns in anticoagulant naïve NVAF patients (N=34,022, Commercial and Medicare claims database): 1 in 5 patients switched from their index DOAC to alternate Older patients switched more than younger Females switched more than males Of those that switched: 29% switched once 70% switched more than twice 45% switched to warfarin, 44% to another DOAC Manzoor BS et al. J Thromb Thrombolysis (2017) 44:

29 Transitions among oral anticoagulants FROM WARFARIN TO DOAC Manufacturer recommended start when INR Institutional recommended start when INR dabigatran 2 2 rivaroxaban 3 2 apixaban 2 2 edoxaban LOW risk Continue DOAC AND begin warfarin for 3 days (days 1, 2,3) Stop DOAC and continue warfarin (days 4, 5) Obtain INR on Day 6 and adjust warfarin accordingly FROM DOAC TO WARFARIN HIGH risk Stop DOAC and begin parenteral anticoagulant AND warfarin at the time of the next scheduled DOAC dose Continue bridge with parenteral anticoagulant and warfarin Obtain INR on Day 3 of bridge and adjust warfarin accordingly Assess patient specific risks and renal function. Collaborate, clarify and document plan with provider.

30 What we re learning from the first 100 DOAC patients MGH AMS Education Visits DOAC recruitment started May 30, 2017 Total touched = 117 Total active (as of 2/27/2018) = Jun'17 Jul'17 Aug'17 Sep'17 Oct'17 Nov'17 Dec'17 Jan'18 Feb'18TD All DOAC Office Visits Phone Visits Warfarin Visits Linear (All DOAC) Linear (Warfarin Visits)

31 What we are monitoring Quality & Safety Issues # of cases Identified dose adjustment based on renal function 5 Non adherence 0 Off label use 3 Transitions among anticoagulant agents 5 VTE dose reduction after 6 months standard treatment 12 Clinical Events Major/Moderate Bleed 5 Major/Moderate TE 1

32 Patients in need of help More than 20 stand alone drug plans offered in MA under Medicare Part D Free help at SHINE Serving the Health Insurance Needs of Everyone (on Medicare) SHINE saved 62,000 MA residents $105 million last year. Visit: mass.gov/health insurancecounseling Other resources: Medicare.gov GoodRx.com Retail pharmacists can print Medicare Plan Finder for patients compares plans, costs and coverage Boston Globe Nov 11, 2017

33 Disseminate information Google: mgh eed

34 Summary Educate Communicate Evaluate Modify