S02 ATTACHMENT FIFTY TWO 52 SOP 119 20 18 ANTICOAGULATION MANAGEMENT PROGRAM.pdf

ANTICOAGULATION MANAGEMENT PROGRAM

MANAGEMENT OF DIRECT-ACTING ORAL ANTICOAGULANTS

SOP 119-20-18

VA Caribbean Healthcare System San Juan, Puerto Rico 00921

Signatory Authority:

Chief, Pharmacy Service

Responsible Owner:

Clinical Program Manager

Service Line(s):

Pharmacy Service

Effective Date:

November 19, 2020

Recertification Date:

November 30, 2025

1. PURPOSE AND AUTHORITY

a. To establish procedure for the management of direct-acting oral anticoagulants (DOAC) and the use of the DOAC Population Management Tool.

b. The Anticoagulation Clinic will manage/monitor all DOAC patients when therapy is initiated. Once stable, long-term management may be transitioned to the primary care provider (PCP) for routine lab work, medication prescribing and appropriate follow-up. The Anticoagulation Clinic will use the DOAC Population Management Tool to identify patient issues falling outside the recommended parameters for DOAC use. The Clinic will contact the patient and/or the Primary Care team to address these issues. DOAC patients requiring close pharmacologic management will remain in the Anticoagulation Clinic if deemed clinically appropriate by the anticoagulation provider.

2. PROCEDURES

a. Initial prescription of DOAC will be requested using a Prior Authorization Drug Request

Consult. Approval will be based on National VA PBM Criteria for Use and nationally recognized professional organizations guidelines.

b. For new DOAC starts, baseline labs should be drawn within 30 days prior to starting therapy. Required labs include CBC, Creatinine, AST/ALT (in patients with underlying liver disease or when the clinical situation dictates), and PT/INR if needed. Anticoagulation provider will review and recommend the most appropriate DOAC therapy and dose based on VA CFU, formulary preference, and patient specific characteristics. If a veteran is presenting to clinic already taking a DOAC from the private sector the CPS will review each veteran’s chart and provide the formulary preferred medication based on patient specific characteristics. If the veteran does not want the medication recommended by the CPS, the veteran may continue to purchase the DOAC outside of the VA.

c. If the veteran will start the DOAC as an outpatient, initial anticoagulation clinic contact should be performed with a face to face appointment or telephone call for initial DOAC patient education. DOAC prescription can be mailed or picked up at Outpatient Pharmacy depending on anticoagulation indication and/or veteran preference.

November 19, 2020 SOP 119-20-18

d. Anticoagulation Clinic follow-up via a telephone appointment will be within 2 weeks of drug initiation (or sooner if clinically indicated) to assess for tolerance, bleeding, thromboembolic events, other adverse events (e.g., gastrointestinal intolerance), adherence, correct dosing (e.g., patients being treated for acute VTE and transitioning from loading doses), duplicate therapy (e.g., patients previously on warfarin who may have leftover supply) and reinforcement of educational points as needed.

e. A second assessment of compliance and tolerability by the AC Clinic is recommended at 3 months of therapy via telephone.

f. Once stable, long-term management may be transitioned to the primary care provider for routine lab work (CBC, renal function), medication prescribing and appropriate follow-up.

This transition will be documented in the medical record and the patient will be oriented about the change in monitoring provider. The note will be as follows:

Patient on DOAC is stable and will be transitioned back to Primary care for routine monitoring. Anticoagulation Clinic will continue to monitor via the DOAC Population Management Tool.

Prescription renewals will be deferred to Primary care provider.

Please, ensure patient has CBC and renal function assessment at least annually. Please, reconsult the Anticoagulation Clinic with any questions or concerns, such as change in anticoagulant therapy or holding anticoagulant for upcoming procedure.

The PC provider and the PACT Clinical Pharmacy Specialist will be added as co-signers of the note.

g. DOAC follow-up monitoring by the PC Provider should include: (1) serum creatinine (to estimate CrCl) as clinically appropriate; SCr should be monitored at least annually and more frequently in those with renal impairment (e.g., CrCl < 60 ml/min), concomitant illness that may lead to worsening renal function, or who are 75 years of age or older; (2) CBC (including platelets) should be monitored at least annually or more frequently as the clinical situation dictates; (3) Liver function testing may be considered in patients with underlying liver disease or when the clinical situation dictates.

h. The Anticoagulation Clinic will utilize the DOAC Population Management Tool to identify and address patient issues falling outside the recommended parameters for DOAC use (e.g.

worsening renal function, significant drop in hemoglobin, platelets, or change in liver function, potentially inappropriate dose for indication, renal function, or duration of therapy, clinically significant drug interactions, and potential non-compliance with medication refills). DOAC patients requiring close pharmacologic management will remain in the Anticoagulation Clinic if deemed clinically appropriate by the clinic provider.

i. Patients may be reconsulted to the Anticoagulation Clinic in case of upcoming procedures or changes in anticoagulation therapy due to ADR or new contraindication.

j. The Anticoagulation Clinic providers will review the DOAC Population Management Tool weekly and issues identified will be addressed via chart review.

k. The Anticoagulation Clinic will try to resolve any flags identified in the Tool. If the issue identified requires additional intervention, the Anticoagulation Clinic provider will send a message to the PACT Clinical Pharmacy Specialist (CPS) to manage the issue in collaboration with the primary provider.

l. The message will contain: patient name and SSN, primary provider name and issue identified

m. The message will be sent via VISTA to G.PACT CLIN PHARM and/or by additional signature alert to the PACT pharmacist and PCP in CPRS Note.

n. The PACT team will address any calls or unscheduled visits from patients being treated with a DOAC for medication renewal, refill, or any questions related to anticoagulation therapy.

3. RESPONSIBILITIES

a. The Chief, Pharmacy Service and the Associate Chief has the overall responsibility for the implementation of this procedure.

b. Anticoagulation Program Manager is responsible for ensuring participation of all anticoagulation clinical pharmacists and pharmacy technicians at the Anticoagulation Clinic under his/her responsibility in supporting efforts for compliance with the requirements established in this procedure.

c. Physicians and other authorized prescribers may follow-up DOAC monitoring at least annually or more frequently as needed if clinically indicated.

4. DEFINITIONS

a. DOAC – direct-acting oral anticoagulants. Includes: apixaban, dabigatran, edoxaban and rivaroxaban and any other agent in this class approved by FDA after the approval of this Standard Operating Procedure (SOP).

b. DOAC Population Management Tool – a report that identifies all patients with an active or recently expired prescription for a DOAC that meet one of several parameters set for the long-term monitoring of these medications. It lists information regarding patients’ therapy, including concomitant medications of interest, laboratory results, refill history, need for prescription renewal and diagnoses to allow the efficient safety monitoring for these agents. 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).

5. REFERENCES

a. Anticoagulants, Direct Oral (DOACs) Oversight and Monitoring Guidance (rev Dec

2017)

b. Anticoagulants, Direct Oral (DOACs) CFU and Algorithm for Nonvalvular Atrial

Fibrillation (NVAF) April 2020 https://dvagov.sharepoint.com/:b:/r/sites/VHAPBM/Formulary/Clinical%20Guidance/Criteria%2 0For%20Use/Anticoagulant,%20Direct%20Oral%20(DOAC)%20CFU%20Atrial%20Fibrillation %20Apr%202020_508.pdf?csf=1&web=1&e=2SW289

c. Anticoagulation Management Program. Center Memorandum No. 00-20-72 https://dvagov.sharepoint.com/sites/caribbean/service/mcp/Center%20Memoranda/00-16- 72.pdf

d. Anticoagulants, Direct Oral (DOACs) CFU and Algorithm in Venous

Thromboembolism (VTE) Treatment April 2020 https://dvagov.sharepoint.com/:b:/r/sites/VHAPBM/Formulary/Clinical%20Guidance/Criteria%2 0For%20Use/Anticoagulant,%20Direct%20Oral%20(DOAC)%20CFU%20Venous%20Thrombo embolism%20Treatment%20Apr%202020_508.pdf?csf=1&web=1&e=AfZsEn

6. REVIEW

This SOP must be reviewed at minimum at recertification and including when there are changes.

7. RECERTIFICATION

This SOP is scheduled for recertification on or before the last working day of November 2025. In the event of contradiction with national policy, the national policy supersedes and controls.

8. SIGNATORY AUTHORITY

JOSE O. ROSA, R.Ph., MBA Chief Pharmacy Service Date Approved: November 19, 2020

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: SOP’s are available at: VACHS Document Management Center NOTE: This is an internal VA Web site that is not available to the public.

https://dvagov.sharepoint.com/sites/caribbean/service/mcp/Center%20Memoranda/00-16-72.pdf https://dvagov.sharepoint.com/sites/caribbean/service/mcp/Center%20Memoranda/00-16-72.pdf https://dvagov.sharepoint.com/:b:/r/sites/VHAPBM/Formulary/Clinical%20Guidance/Criteria%20For%20Use/Anticoagulant,%20Direct%20Oral%20(DOAC)%20CFU%20Venous%20Thromboembolism%20Treatment%20Apr%202020_508.pdf?csf=1&web=1&e=AfZsEn https://dvagov.sharepoint.com/:b:/r/sites/VHAPBM/Formulary/Clinical%20Guidance/Criteria%20For%20Use/Anticoagulant,%20Direct%20Oral%20(DOAC)%20CFU%20Venous%20Thromboembolism%20Treatment%20Apr%202020_508.pdf?csf=1&web=1&e=AfZsEn https://dvagov.sharepoint.com/:b:/r/sites/VHAPBM/Formulary/Clinical%20Guidance/Criteria%20For%20Use/Anticoagulant,%20Direct%20Oral%20(DOAC)%20CFU%20Venous%20Thromboembolism%20Treatment%20Apr%202020_508.pdf?csf=1&web=1&e=AfZsEn https://dvagov.sharepoint.com/sites/caribbean/service/cm/SitePages/Home.aspx Monterrey, Janin There is an updated version. 00-20-72 pending to be uploaded.