D.19 CL-13 Pharmacy Outpatient Anticoagulation Clinics.docx

New Mexico Veterans Affairs Health Care System Pharmacy SOP #CL-13

PHARMACY OUTPATIENT ANTICOAGULATION CLINICS

1. SCOPE: To reduce the likelihood of harm associated with the use of anticoagulation therapy by outlining policies and procedures for outpatient anticoagulation management. The Anticoagulation Clinic is a Pharmacy-run outpatient consult service available to Veterans established with a New Mexico VA Health Care System (NMVAHCS) primary care provider at the main Albuquerque facility or associated Contract/Community-Based Outpatient Clinics (C/CBOCs). Standardized practices are used to reduce the risk of adverse drug events associated with anticoagulation therapy.

2. RESPONSIBILITY: It is the responsibility of Anticoagulation Clinic staff to provide anticoagulation management as determined by their Functional Statements and Scopes of Practice.

3. PROCEDURE:

a. Definitions

(1) Anticoagulation Management Tool (AMT) – A national VA-developed software program integrated within VA’s Computerized Patient Record System (CPRS). AMT is used for warfarin management and has several key functions including but not limited to: warfarin dose and INR tracking on the Anticoagulation Flowsheet, tracking of bleeding/thromboembolic events, and maintenance of an electronic list of Veterans on warfarin who are enrolled in the Anticoagulation Clinic.

(2) Clinical Pharmacy Specialist (CPS) – A pharmacist with a scope of practice functioning as a midlevel provider in a specialized area, for which there is documented evidence of knowledge, skills, and abilities based on the individual pharmacist's education, training, and experience.

(3) Clinical Pharmacy Technician (CPT) – A pharmacy technician working in a specialized area with documented evidence of knowledge, skills and abilities. Works under CPS oversight.

(4) Clinical video telehealth (CVT) – A modality for remote face-to-face patient encounters using video technology. Patient attends visit via video telehealth from a VA C/CBOC.

(5) DOAC – Direct-acting oral anticoagulant. Includes: apixaban, dabigatran, edoxaban, rivaroxaban, etc.

(6) DOAC Population Management Tool (DMT) – A VA-developed web-based report identifying patients with an active or recently expired prescription for a DOAC. Lists information regarding DOAC therapy, including but not limited to: concomitant medications of interest, laboratory results, refill history, and relevant diagnoses. It is not designed for the monitoring of current inpatients or patients with short term indications for a DOAC (e.g. total hip or knee replacement). The DMT may be accessed at the following link: https://spsites.cdw.va.gov/sites/PBM_MedSafeRpts/_layouts/15/ReportServer/RSViewerPage.aspx?rv:RelativeReportUrl=/sites/PBM_MedSafeRpts/DOAC/DOAC%20Population%20Management%20Tool-%20Scorecard.rdl

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(7) Fast Bypass – A system allowing non-laboratory staff (e.g. C/CBOC clinical staff ) to document point-of-care (POC)/fingerstick INR results in the VISTA laboratory package.

(8) Parenteral anticoagulation – Injectable anticoagulation such as with low-molecular weight heparin (LMWH) or fondaparinux.

(9) VA Pharmacy Benefits Management (PBM) Services Criteria for Use (CFU) – documents created by the VA PBM that outlines the criteria for use for different medications. Latest versions can be found by searching the VA National Formulary at: https://www.pbm.va.gov/apps/VANationalFormulary/

(10) VA Video Connect (VVC) – A modality for remote face-to-face patient encounters using video technology. Patient attends visit via video telehealth from home.

b. Patient Encounters

(1) New-start oral anticoagulation patients will receive clinic enrollment information and anticoagulation education via phone and letter. No formally scheduled appointments will be made unless a video telehealth visit is indicated as determined by the CPS.

(2) Subsequent follow-up will be conducted via phone and/or letter.

(3) The standardized note title “Anticoagulation Clinic Monitoring Note” will be used for documenting anticoagulation encounters in the patient’s electronic medical record.

(4) The Anticoagulation Clinic will use population management tools such as AMT and DMT to monitor patients for safety and efficacy of anticoagulation therapy.

(5) CPS will periodically reassess patient’s clinical status as related to oral anticoagulation therapy and communicate accordingly with the patient's PCP and/or referring provider as appropriate

(a) Clinic staff will review electronic medical record and speak with patients/caregiver(s) to assess for drug interactions, food interactions, adverse drug reactions, medication and treatment adherence, medication tolerability and side-effects, bleeding complications, thrombotic complications, contraception status for female patients of reproductive age and capacity, and changes to diet or medications.

c. Patient Education

(1) Initial anticoagulation education for newly-enrolled Veterans will be performed by a CPS as soon as possible. Initial and ongoing education includes but is not necessarily limited to:

(a) Anticoagulant tablet/capsule identification

(b) Proper storage of medication

(c) Indication for therapy

(d) Risks and benefits of therapy

(e) Anticipated duration of therapy

(f) Interactions (drug, diet, alcohol, and disease)

(g) Daily dosage (including dose changes if applicable)

(h) Administration considerations

(i) Monitoring requirement(s)

(j) Importance of medication adherence

(k) Dangers of using oral anticoagulants from different sources (e.g. VA and community pharmacy)

(l) Management of missed doses

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(m) Contact information and business hours for the clinic and what to do when assistance is required outside of clinic business hours

(n) When and how to get emergent medical attention

(o) Importance of using effective contraception for women of reproductive age

(p) How to obtain supply of medication

(q) Importance of notifying the Anticoagulation Clinic about upcoming procedures for appropriate peri-procedural management.

d. Consult Cancellation

(1) The consult to the Anticoagulation Clinic will be cancelled and referring provider notified if either of the following occurs:

(a) Veteran does not meet clinic enrollment criteria, OR

(b) Veteran is unable to be reached after two phone calls, clinic sends one letter and patient does not return communication to the clinic within 14 calendar days of letter mailing date.

e. Addressing Nonadherent Patients

(1) Warfarin

(a) For warfarin titration patients requiring biweekly INR checks, CPT will call the patient on the assigned dates of INR checks as a reminder.

(b) A warfarin patient who fails to obtain INR as instructed is contacted via telephone and/or letter within 7 calendar days of missed INR date.

(c) If the patient reaches 1 month overdue for INR, they are contacted via letter. If the patient reaches 3 months overdue for INR, they receive another letter (regular and/or certified mail), their warfarin prescription is placed on hold (made non-refillable), and any active outpatient INR order is cancelled. Individuals who continue to be nonadherent and who reach 6 months overdue for INR are discharged from the Anticoagulation Clinic, their warfarin prescription is cancelled, and their PCP is notified. Exceptions may be made on a case-by-case basis at the discretion of the CPS for patients with extenuating circumstances (e.g. short-term stay in rehab facility, extended inpatient stay, etc.)

(2) DOACs

(a) DOAC patients will be monitored for adherence using the National VA DOAC Population Management Report (DMT).

(b) Anticoagulation Clinic staff regularly monitor the DMT to identify patients who are coming due for prescription renewal, are overdue for prescription refill/renewal, and/or who have not obtained follow-up lab monitoring within a specified time period (e.g. 3, 6 or 12 months) as clinically indicated.

(c) Patients flagged by the DMT as overdue for required lab monitoring or prescription refill will be contacted via phone and/or letter. Patients who continue to be non-adherent and reach 6 months overdue for lab monitoring or prescription refill will be discharged from the Anticoagulation Clinic, their DOAC prescription will be cancelled, and their PCP notified.

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(1) A current PT/INR is used to monitor and adjust therapy. All INR results are reviewed/clinically evaluated and patient outreach made via phone or letter no later than the close of the next business day after receipt of the INR result.

(2) Patients taking warfarin are instructed to contact the Anticoagulation Clinic if they do not receive contact from the clinic via phone or letter within 7 calendar days of obtaining INR.

(3) Routine therapeutic (within-goal-range) INRs, including INR values within 0.1 of goal range, do not require warfarin dose adjustment and are managed by the CPT who will contact patients via phone or letter; warfarin dosing and next INR date instructions provided by the CPT to the patient are made within established VA PBM warfarin dosing algorithms (Attachments A and B) and have review and oversight by the CPS. Exceptions that require CPS management include: new-start warfarin patients achieving initial therapeutic INR, patients with newly-identified drug-drug interactions, patients with a recent Emergency Department visit, hospital admission/discharge, surgery/procedure, patients reporting adverse drug events and/or signs/symptoms of bleeding/thrombosis.

(4) Non-therapeutic (outside-goal-range) INRs are managed by the CPS who will contact patients by phone and/or letter for assessment and warfarin dose adjustment as indicated.

(5) Clinic staff will outreach patients with a critical INR result ≥ 5.0 by telephone as quickly as possible and no later than the end of the next business day after receipt of the result. In cases of medically dangerous or unusually problematic situations, clinic staff may contact the Anticoagulation Clinic Medical Director and/or patient’s PCP via phone and/or face-to-face and document this communication accordingly in CPRS. If unable to contact patient, clinic staff may contact local law enforcement to initiate a welfare check with instructions for the patient to stop his/her warfarin and to call the clinic as soon as possible and seek emergency medical attention for any bleeding.

(6) Warfarin prescription days’ supply and number of refills are at prescribing CPS discretion based on indication for and duration of anticoagulation and other relevant patient-specific considerations. Warfarin prescription days’ supply is limited to a maximum of 90 days. In an effort to maximize medication adherence and minimize dosing errors, patients will be maintained on one tablet strength of warfarin as often as possible.

f. DOAC Management

(1) The CPS will refer to the VA PBM CFU that may exist for the oral anticoagulant they would like to prescribe as well as relevant clinical guidelines.

(2) Veterans on DOACs will be monitored and dose adjustments made based on nationally-recognized, evidenced-based guidelines, and clinical judgment.

(3) For patients who have been started on DOAC therapy outside of the VA, clinic staff should document appropriate baseline labs performed outside of the VA. If these lab results are not available, clinic staff should order labs when continuing DOAC therapy.

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(4) The CPS will manually adjust customizable DMT monitoring parameters for enrolled patients as clinically indicated, e.g. desired lab monitoring frequency based on age and renal function.

(5) If a patient is flagged by the DMT for intervention but is not enrolled in the Anticoagulation Clinic, and has DOAC prescribed by a VA provider outside of the Anticoagulation Clinic, clinic staff will outreach the DOAC prescriber with recommendations via view-alert to a note in CPRS and/or phone call as indicated based on the urgency of the issue.

(6) DOAC prescription days’ supply and number of refills are at prescribing CPS discretion based on indication for/duration of anticoagulation and other relevant patient-specific considerations. DOAC prescription days’ supply is limited to a maximum of 90 days.

g. Peri-procedural Management

(1) The Anticoagulation Clinic offers comprehensive peri-procedure anticoagulant management to enrolled Veterans, consistent with national, evidence-based guidelines; this includes verbal and/or written instructions for anticoagulation management surrounding the procedure, and lab monitoring and peri-procedural parenteral bridge therapy as indicated. The clinic must receive adequate advance notice of the procedure and requests 2 weeks’ notice from the performing provider or the Veteran.

(2) The clinic may make recommendations regarding peri-procedure planning for Veterans who are not enrolled with the clinic upon provider request if adequate advance notice is provided; however, the clinic will not manage anticoagulation surrounding the procedure if the patient is not enrolled in the clinic.

h. Quality Improvement (QI) Program

(1) The Anticoagulation Clinics will maintain a QI Program for outpatient anticoagulation management.

(2) Quarterly reports

(a) Quarterly reports will be presented to the Pharmacy Performance Improvement Committee and the Pharmacy & Therapeutics (P&T) Committee. Minutes from the P&T meeting will be presented to the Clinical Executive Board (CEB).

(b) For patients on warfarin, reports will include Time in Therapeutic Range (TTR) utilizing the Rosendaal method, percent of enrolled patients without INR drawn in the previous 42 days, bleeding events, and thromboembolic events. Anticoagulation Clinic staff will attempt to identify the reason(s) for bleeding and thromboembolic events.

(c) For patients on DOACs, reports will include the number of patients prescribed DOACs, the number or percent of patients overdue for required labs, and the number of bleeding and thromboembolic events.

4. REFERENCES:

a. VHA Directive 1033, Anticoagulation Therapy Management dated July 29, 2015

b. VHA Handbook 1101.11(3), Coordinated Care for Traveling Veterans dated April 22, 2015, amended July 20, 2017

c. VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithms

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d. Lip GYH, Banerjee A, Boriani G, et al. Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report. Chest. 2018;154(5):1121-201.

e. Burnett AE, Mahan CE, Vazquez SR et al. Guidance for the practical management of the direct oral anticoagulants (DOACs) in VTE treatment. J Thromb Thrombolysis. 2016 Jan;41(1):206-32.

f. Witt DM, Clark NP, Kaatz S, Schnurr T, Ansell JE. Guidance for the practical management of warfarin therapy in the treatment of venous thromboembolism. J Thromb Thrombolysis. 2016;41(1):187?205. doi:10.1007/s11239-015-1319-y.

g. Douketis JD, Spyropoulos AC, Spencer FA et al. Perioperative management of antithrombotic therapy. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012; 141(2):E326S-W350S.

h. Mar PL, Familtsev D, Ezekowitz MD et al. Periprocedural management of anticoagulation in patients taking novel oral anticoagulants: Review of the literature and recommendations for specific populations and procedure. Int J Cardiol. 2016 Jan 1;202:578-85.

i. Doherty JU, Gluckman TJ, Hucker WJ, et al. 2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With Nonvalvular Atrial Fibrillation: A Report of the American College of Cardiology Clinical Expert Consensus Document Task Force. J Am Coll Cardiol. 2017 Feb 21;69(7):871-898.

j. Online Appendix: Common Procedures and Associated Procedural Bleed Risk. American College of Cardiology.

k. Anticoagulation Forum: Education & Guidance.

l. European Society of Cardiology Clinical Practice Guidelines.

m. Guidance for the Oversight and Monitoring of Direct Oral Anticoagulants (DOACs) Updated December 2017 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives.

n. Direct Oral Anticoagulants (DOACs) (formerly called TSOACs) Dabigatran (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis), and Edoxaban (Savaysa) Criteria for Use for Treatment of Venous Thromboembolism (VTE) December 2017 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives.

o. Direct Oral Anticoagulants (DOACs) (formerly called TSOACs) Dabigatran (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis), and Edoxaban (Savaysa) Criteria for Use for Stroke Prevention in Nonvalvular Atrial Fibrillation (AF) Updated December 2017 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives.

5. RESCISSION: None

6. REVISION HISTORY:

Pharmacy SOP #CL-13 Page 7

October 31, 2019

7. EXPIRATION DATE: November 2022

Signed copy in Pharmacy Adm drive

Darren E. Palmer

DATE

Chief, Pharmacy Service

Attachments:

1. VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Initiation Phase of Therapy)

2. VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Maintenance Phase of Therapy)

VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Initiation Phase of Therapy)

Step 1: Begin with 5 mg or 2 mg daily (if patient requires a lower dose).

Lower initial dosing may be appropriate based on the following patient characteristics:

· Age (generally, frail elderly patients are more sensitive to warfarin)

· Weight (generally, low body weight or malnourished patients are more sensitive to warfarin)

· Past medical history (including liver dysfunction, heart failure, end-stage renal disease, hyperthyroidism, or recent major surgery)

· Social history (including alcohol and tobacco use)

· Interacting medications (prescription, herbal, and over-the-counter products)

· Dietary habits and nutritional status (especially dietary vitamin K content)

· Acute illness (including loss of appetite, fever, vomiting, and diarrhea)

· Risk factors for bleeding (including bleeding disorder, history of bleeding, peptic ulcer disease, history of hemorrhagic stroke, high fall risk, and hypertension) Step 2: Follow warfarin dosing adjustments based on INR results.

1.5-1.9 Increase weekly dose by 5-25% No dosage change

1.5-1.9 Increase weekly dose by 10-25% Increase weekly dose by 0-20%

1.5-1.9 Increase weekly dose by 15-35% Increase weekly dose by 5-20%

1.6-1.9 Increase weekly dose by 15-35% Increase weekly dose by 5-20%

Adapted from: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM: Pharmacotherapy: A Pathophysiologic Approach, 8th Edition: www.accesspharmacy.com (Figure 26-8)

A-1 Additional Considerations:

· If patient has not attained an in-range INR result by Day 14, continue Day 11-14 routine until INR is in-range.

· Holding the dose may complicate efforts at dose-finding and is not usually necessary. In our opinion, it should be reserved for INR values above 5.0 in the initiation phase, when bleeding risk is thought to be very high. For less extreme INR elevations, a dose decrease should be sufficient, especially given that follow-up will be quite soon thereafter.

· In some cases, the following may be considered: For patients sufficiently healthy to be treated as outpatients, we suggest initiating VKA therapy with warfarin 10 mg daily for the first two (2) days followed by dosing based on INR measurements (Grade 2C). [CHEST 2012]

· When the patient has achieved three (3) in-range INR results, use the VISN 1 Anticoagulation Management Algorithm (Maintenance Phase of Therapy).

A-2

VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Maintenance Phase of Therapy)

Disclaimer: This algorithm is for ongoing management of warfarin. As with any algorithm or guideline, the final decision must always rest with the clinical judgment of the responsible provider.

Continues on Next Page Revised July 3, 2014

B-1

Disclaimer/Guide to Use: In a well-designed before and after trial, the use of this algorithm improved percent time in range (TTR) by 6%.3 While clinicians will override these recommendations at times, they should keep in mind that when this algorithm was tested, patients whose management conformed most closely to the algorithm had the best TTR.

Additional Recommendation: In addition to this algorithm, ACC clinicians are urged to avoid non-standard target INR ranges such as 2-2.5 or 1.8-2.5. The 2012 CHEST Guidelines state that there should be two target ranges in clinical practice: 2.5-3.5 for patients with mitral prosthetic valves and 2-3 for everyone else.4 In some instances, practitioners may chose a goal of 2.5-3.5 for patients with aortic prosthetic valves with additional risk factors. This is the recommendations from the most recent AHA guidelines and may be used at the recommendation of a referring provider.5 Other target ranges do not provide additional benefit and place patients at higher risk, and should be avoided.

References

1. Rose AJ, Ozonoff A, Berlowitz DR, Henault LE, Hylek EM. Warfarin dose management affects INR control. J Thromb Haemost. Jan 2009;7(1):94-101.

2. Rose AJ, Ozonoff A, Berlowitz DR, Ash AS, Reisman JI, Hylek EM. Reexamining the recommended follow-up interval after obtaining an in-range international normalized ratio value: results from the Veterans Affairs study to improve anticoagulation. Chest. Aug 2011;140(2):359-365.

3. Kim YK, Nieuwlaat R, Connolly SJ, et al. Effect of a simple two-step warfarin dosing algorithm on anticoagulant control as measured by time in therapeutic range: a pilot study. J Thromb Haemost. Jan 2010;8(1):101-106.

Continues on Next Page Revised July 3, 2014 B-2

4. Whitlock RP, Sun JC, Fremes SE, Rubens FD, Teoh KH. Antithrombotic and thrombolytic therapy for valvular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. Feb 2012;141(2 Suppl):e576S-600S.

5. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. Jun 10 2014;129(23):e521-643.

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