CASH Warfarin Standard Operating Procedure.pdf

Department of Veterans Affairs Automatic Review Date:

Anticoagulation Therapy Management

Centralized Anticoagulation Services Hub (CASH) Warfarin Management Standard Operating Procedure

1. PURPOSE: To define the policies and procedures for providing safe and effective outpatient anticoagulation therapy management to veterans managed by the Centralized Anticoagulation Services Hub (CASH), located within VISN 12.

2. RATIONALE: Anticoagulation therapy can confer significant benefits to patients and reduce the risk of events such as pulmonary embolisms, deep vein thrombosis and stroke. However, the therapy may pose risks to patients and can lead to adverse drug events due to complex dosing and inconsistent patient adherence. Proper monitoring and follow-up can mitigate some of the risks involved with therapy. The use of system-wide practices for anticoagulation therapy that include standardized procedures, documentation and patient involvement can improve clinical outcomes while reducing the risk of adverse drug events associated with the use of anticoagulant medications.

3. RESPONSIBILITIES: Please refer to most recent VHA Anticoagulation Therapy Management Directive.

4. POLICY: Patients receiving warfarin prescribed by their VA provider as outpatients may be monitored by the Hub. To be eligible for enrollment in the Hub, the patient must have an assigned VA Primary Care Provider (PCP). All providers or other clinical staff reviewing or adjusting anticoagulation medication dosages must be qualif ied to provide anticoagulation management in accordance with The Joint Commission as outlined in National Patient Safety Goal 03.05.01.

A. Outpatients

(1) All patients referred to the Hub who are receiving outpatient oral anticoagulation therapy (OAT) with warfarin will be managed in accordance with Hub Standard Operating Procedures.

(2) All patients receiving outpatient OAT with direct-acting oral anticoagulants (DOACs) will remain under the care of the Patient Aligned Care Team (PACT) team and/or local procedures.

(3) All laboratory tests for anticoagulation management should be performed at a VA laboratory, to ensure accuracy of results and easy access of information. In the event of an extenuating circumstance (e.g. homebound patients, significant distance), non-VA laboratory results will be accepted through a standardized process. (See non-VA Laboratory results under Procedures)

(3a) Point of Care (POC) testing may be utilized if performed by trained individuals where methods and equipment undergo routine Quality Assurance (QA) and results are readily available in patient’s record.

(3b) Outside labs will be documented in the Outside Lab note template. If verbal results received, results will be read back for confirmation and documented as such.

(4) All INR results will be evaluated in a timely manner by the close of the next business day in accordance with VHA Directive 1088, Communicating Test Results to Providers and Patients.

(5) For all critical INR results, appropriate action will be taken, and documentation of those actions will occur within 24 hours.

(6) If a critical result, as defined per local policy, is obtained outside of normal business hours (after 4:00pm local time), on weekends or federal holidays, laboratory service will contact the responsible clinical entity as defined per the local facility critical test result policy. The responsible clinical entity will call the patient to evaluate and assess risk, if appropriate, and communicate their actions with the Hub. A Hub Clinical Pharmacy Specialist (CPS) will call the patient to further discuss the treatment plan during the next business day.

(7) If clinically pertinent changes in other relevant lab parameters occur, Hub providers will collaborate with PCP and/or specialty provider as appropriate.

(8) The Hub will encourage patients to only have one warfarin tablet strength at home to minimize error. Outpatient pharmacy will limit the strengths dispensed to 2mg and 5mg tablets.

An exception can be made to the tablet strength if clinically indicated, such as warfarin sensitivity, extremely large or small daily doses, complex dose regimens, etc.

(9) Warfarin prescribing will be limited to the Hub staff only, except for the initial prescription written by the referring provider. Outpatient Pharmacy will alert the Hub of VA prescriptions written by providers outside of the Hub to ensure proper referral.

(a) Patients approved for Community Care/MISSION Act will be dispensed warfarin tablets as prescribed by non-VA provider from VA pharmacy. All subsequent management and follow-up will be the responsibility of the non-VA provider per usual Outpatient Pharmacy policy.

(10) If a patient chooses to obtain warfarin outside the VA while still being dosed and managed by the VA Hub, the patient’s VA PCP or specialty provider may call in the prescription to the patient’s preferred local pharmacy. It would be the responsibility of the patient to coordinate this locally with their provider. Note: it is preferred to obtain prescription through VA and use of non-VA Rx should be used only in extenuating circumstances and at the discretion of the VA PCP and/or specialty provider.

(11) New Consults to the Hub will be handled as follows: A Hub enrollment consult must be entered by the patient’s PCP, specialist, Emergency Department provider or hospitalist.

Enrollment consults may also be entered by a Clinical Pharmacy Specialist when transitioning from facility management to Hub management. Information from the referring provider will include but is not limited to:

a. Completion of the following information on the Consult:

1. Diagnosis or indication for anticoagulation;

2. Duration of therapy;

3. Desired therapeutic INR range;

4. Name of referring VA provider;

5. Current warfarin dose schedule or a request to establish the beginning dose; and

6. Laboratory results or orders for the following baseline laboratory studies: CBC, PT/INR, HCG (as applicable).

b. An evaluation to determine the appropriateness of anticoagulation therapy, assessing that the potential benefits of long-term anticoagulation outweigh the potential risks for the patient if initiating therapy.

c. If warfarin is started prior to the initial Hub appointment, prescribing provider will counsel patient on correct starting dose, indication, duration of therapy, and when to seek emergent care, as per local policy.

d. Acknowledgement that management of anticoagulation therapy by the Hub does not begin until the consult is accepted and completed.

(12) New consults will be evaluated within 7 calendar days from time of referral as per VHA Directive 1232. Prompt completion of consults for patients initiating warfarin therapy will occur in accordance to VHA Directive 1108.16

(13) The Hub providers will discontinue anticoagulation treatment after discussion with other VA providers when determined to be appropriate. Reason for medication discontinuation will be documented in the patient record.

(14) It is the responsibility of the VA providers and patients to notify the Hub when clinically relevant changes occur (i.e. interacting medications, ED visits, procedures, clinically significant bleeding episodes, etc.). The Anticoagulation Info-Sharing Consult is the preferred method to alert the Hub to such changes.

(15) Pharmacists processing prescriptions within the VA should notify the Hub of critical drug interactions, as per local policy. The VHA Pharmacy Centralized Anticoagulation Services Hub (Midwest) Outlook email group may be used to alert the Hub to this type of information.

(16) Hub providers are responsible for reviewing critical drug interactions with anticoagulation therapy when alerted, adjusting the anticoagulant dose as appropriate, ordering and following-up of subsequent laboratory tests, and communicating with the ordering provider and/or the patient as appropriate.

(17) Coordination of care for traveling veterans will occur in accordance with the Coordinated Care Policy for Traveling Veterans, VHA Directive 2007-016 or updated versions of this directive and local policy as appropriate.

(18) Prescriptions for warfarin will be limited to a 30-day supply until deemed clinically appropriate to extend to a 90-day supply. Generally, this will be no sooner than 90 days after initiation of warfarin. At that time, if the patient is on a stable dose and is adherent, the prescription may be extended up to a 90-day supply with up to 1 refill as appropriate.

(19) Outpatient prescriptions for warfarin should be labeled appropriately to avoid patient confusion with changes to the instructions for use. Prescriptions will be labeled in accordance to VHA Directive 1108.16. The most recent instructions will be documented in the clinical notes in the medical record.

(20) Non-adherence will be addressed as follows:

a. Patients who are non-adherent with laboratory follow-up and/or fail to contact the clinic after multiple attempts to reach them over eight weeks will be discharged from the Hub as per the Hub discharge protocol. Multiple methods of contacting the patient will be attempted, including phone calls, letters, and secure messaging as applicable. The patient’s primary care and/or specialty provider will be alerted to the intent to discharge after six weeks of delinquency.

Any remaining refills for warfarin will be discontinued at time of discharge. Patients will be informed of this discharge protocol during initial and ongoing patient education with the Hub.

See Appendix I for further details.

b. Patients with chronic non-adherence to medication dosing instructions and/or follow-up recommended by Hub team will be reviewed with PCP and/or specialty provider for risk/benefit of ongoing therapy.

(21) Anticoagulation Hub providers will document the appropriate International Classification of Diseases (ICD) Diagnosis Codes to the problem list of Veterans on long-term anticoagulation therapy. The current ICD, Tenth Revision (ICD-10) diagnosis code is Z79.01 for “Long-term current use of anticoagulants.”

(22) Competency of Hub staff will be assessed in accordance with the PBM Guidance Document on Professional Practice Evaluations for VHA Pharmacists with a Scope of Practice and will follow the VISN Coordinated process for Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Practice Evaluation (OPPE). Hub staff will be required to complete assigned competencies initially and annually. Pharmacy technicians will be assessed for initial and ongoing competency standards for anticoagulation care.

(23) The Hub will undergo a quarterly quality assurance plan of pre-defined metrics. These will be reviewed and reported to participating facilities, VISN Pharmacy Benefits Management (PBM), Clinical Pharmacy Practice Office (CPPO) and annually to the Midwest Consortium.

5. PROCEDURES:

A. Initiation of Warfarin

(1) All patients initiated on warfarin must have an INR measurement within 7 days of initiation, although INR measurement within 4 days of initiation is recommended. Use of CPPO Strong Practice Algorithm is recommended.

B. Maintenance of Warfarin

(1) Use of CPPO Strong Practice Algorithm is recommended.

C. Peri-procedural management of anticoagulants

(1) Hub providers will assume peri-procedural management of anticoagulants, utilizing CHEST Guidelines and other pertinent evidence as appropriate. This may include collaborating with patient’s PCP or provider performing the procedure to evaluate the risks and benefits regarding use of a bridging agent (i.e. low molecular weight heparin), ordering of said bridging agent, developing a peri-procedural schedule for bridging, and/or coordinating any necessary lab work or follow up. Patients will be instructed on injection technique as needed either by the requesting provider, local Outpatient Pharmacy, or the Hub CPS utilizing various modalities.

(2) The Anticoagulation Info-Sharing Consult will be utilized to inform the Hub of upcoming procedures as soon as providers, nurses, case managers, and other healthcare professionals are notif ied of the date, time, and type of procedure, and where the procedure is being conducted. Additionally, patients are instructed during initial and ongoing education to notify the Hub whenever an interruption of therapy is anticipated. Hub staff will inquire about upcoming procedures during all follow-up phone calls.

(3) The decision of when to restart anticoagulation AFTER a procedure will ultimately be made by the provider performing the procedure with appropriate communication to the patient/Hub.

D. Laboratory Monitoring

(1) Baseline Requirements

a. Warfarin: PT/INR and Complete blood count (CBC) NOTE: Initial INR should not be performed using Point of Care Testing (POCT) devices. Note that while baseline INR should be obtained, that Hub may forego if determined that obtaining baseline INR would result in a clinically significant delay in care. HCG is also recommended for women of child-bearing age.

(2) Required Ongoing Laboratory Tests

a. Warfarin: CBC, PT/INR

b. Lab orders will be entered at facility by Hub staff .

(3) Non-VA Laboratory Results

a. If outside labs are used, they will be documented using the standardized note title in the electronic medical record.

E. Reporting of Results to Patient

(1) Patients will receive telephone calls to address lab results in accordance with VHA Directive 1088 unless they are determined to be eligible to receive a letter only. Patients receiving letters only are those with a therapeutic INR without warfarin dose change for three consecutive INR labs over several months and no other clinically relevant changes or per patient request as deemed appropriate by Hub. Letters may be sent in form of physical letters or via MyHealtheVet Secure Messaging as per patient preferences. Patients are responsible for contacting the Hub if any changes have occurred. A letter will also be sent if the patient is unable to be reached after best efforts are made to reach by telephone. Patients will be encouraged to enroll in MyHealtheVet Secure Messaging to allow for timely written communication.

F. Education

(1) Anticoagulation Hub Staff education will be performed periodically based on the needs of the staff in forums such as conferences, staff meetings, memorandums, in-services, and/or newsletters. Anticoagulation Hub staff will be assessed for initial and ongoing competency.

Anticoagulation Hub staff will be available to assist in providing education to local facility staff regarding anticoagulation therapy, when indicated.

(2) Patient education will address, at a minimum, the importance of follow-up monitoring, compliance issues, dietary restrictions and potential for adverse drug reactions and interactions.

G. Risk vs. Benefit Assessment

(1) Hub providers will perform appropriate, periodic risk-benefit assessments for patients receiving warfarin in the anticoagulation management program.

(2) If Hub providers determine through this risk-benefit assessment that anticoagulation therapy with warfarin may no longer be appropriate for a specific patient, the Hub provider may consider discontinuing warfarin therapy in concordance with the patient’s PCP and/or specialist.

H. Quality Assurance

(1) Any identif ied issues found in the quality assurance program will be tracked and trended by the Hub and reported to participating facilities, VISN PBM, CPPO and annually to the Midwest Consortium.

a. Reports for tracking and trending of INR values will be captured on the Hub SharePoint Site that will include time in therapeutic range (TTR), proportion of patients on warfarin that have not had an INR in the last 56 days, and other measures deemed appropriate by the Hub.

b. Proportion of patients with major bleeding events will be tracked and recorded by the Hub (major bleeding events is defined as fatal or life-threatening bleeding [i.e.

intracranial or retroperitoneal] or drop in hemoglobin level of 2 g/dL that leads to a transfusion of one or more units of blood or to hospitalization).

c. Proportion of patients with thromboembolic events will be tracked and recorded by the Hub.

d. Patient incidents, close calls, and near misses associated with an anticoagulant.

Adverse drug events (ADEs) involving anticoagulants should be assessed and analyzed in accordance with the VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

6. ORGANIZATION:

A. Hub responsibilities:

(1) A database will be maintained to ensure that patients are treated appropriately and receive appropriate follow-up.

(2) The Hub will ensure smooth transitions between inpatient and outpatient care by timely completion of the Info-Sharing Consult and the Hub Patient Management Tool (PMT).

(3) The Hub will minimize loss to follow-up and no-show patients by using the Hub PMT.

B. Anticoagulation program manager:

(1) The Hub Program Manager will be allotted an adequate amount of administrative time to perform leadership functions for the anticoagulation management program, including developing policies and procedures, promoting learning and unified practice, quality assurance, promoting evidence-based practice, and coordinating educational activities related to anticoagulation both inside and outside the anticoagulation management program.

C. Staffing:

(1) The Hub will maintain an appropriate staff -to-patient ratio to provide safe and appropriate care.

D. Contact:

(1) During normal business hours, the Hub will have a direct telephone line that is staffed by trained administrative personnel and accessible to facility staff/health care teams and patients as appropriate. Additional methods of communication include MyHealtheVet secure Messaging (for patients), and Outlook email group or Microsoft Teams (for VA employees).

(2) On weekends, federal holidays and off-tour, VA Nurse Triage and/or Emergency Department services should be utilized for acute issues/concerns as appropriate.

(3) Anticoagulation Info-Sharing Consults are available in CPRS as a tool for providers at participating sites to communicate important information with the Hub.

7. REFERENCES:

VHA Directive 1108.16, Anticoagulation Therapy Management VHA Directive 1232(1), Consult Processes and Procedures VHA Directive 1088, Communicating Test Results to Providers and Patients VHA Handbook 1101.11(3) Coordinated Care for Traveling Veterans VHA Directive 1070, Adverse Drug Event Reporting and Monitoring VHA CPPO PBM Strong Practice Recommended Warfarin Management Algorithm (Initiation Phase of Therapy) VHA CPPO PBM Strong Practice Recommended Warfarin Management Algorithm (Maintenance Phase of Therapy) VHA CPPO PBM Guidance Document on Professional Practice Evaluations for VHA Pharmacists with a Scope of Practice

Centralized Anticoagulation Services Hub VISN Program Manager Michael Ignatovich, PharmD, BCACP

Centralized Anticoagulation Services Hub National Program Manager Sandra Hedin, PharmD, BCACP

VISN 12 Pharmacist Executive Donna Leslie, PharmD

VISN 12 Acting Chief Medical Officer Scott Pawlikowski, MD

Appendix I

No-show/Discharge Protocol

Minimum efforts made are outlined below. Additional efforts may be made if clinically warranted (i.e.

last INR in critical range or high risk [Mechanical valve patients, DVT/PE in past 6 months, New start warfarin in past month])

Overdue 1 Day

•CPhT to call patient/caregiver; leave message if able •CPhT to send letter/Secure Message if unable to reach patient/caregiver by phone •CPhT to enter RTC to schedule 'Anticoag Hub F/U' appointment to ensure not lost to follow-up x 1 week

Overdue 1 Week

•CPhT to call patient/caregiver; leave message if able •CPhT to send letter/Secure Message if unable to reach patient/caregiver by phone •CPhT to enter RTC to schedule 'Anticoag Hub F/U' appointment to ensure not lost to follow-up x 1 week

Overdue 2 Weeks

•CPhT to call patient/caregiver; leave message if able •CPhT to send letter/Secure Message if unable to reach patient/caregiver by phone •CPhT to enter RTC to schedule 'Anticoag Hub F/U' appointment to ensure not lost to follow-up x 2 weeks

Overdue 4 Weeks

•CPhT to make two attempts to reach patient/caregiver by phone; alert CPS if unable to reach •CPS will enter Missed Appointment letter documenting intent to discharge if clinic not contacted by 8 week mark (must include explicit date in which patient has to call us back by); alert CPhT to send letter via certified mail and add tracking number to note.

•CPhT to enter RTC to schedule 'Anticoag Hub F/U' appointment to ensure not lost to follow-up x 2 weeks

Overdue 6 Weeks

•CPhT to call patient/caregiver; leave message if able

•CPhT to send letter/Secure Message if unable to reach patient/caregiver by phone (use date from CPS letter)

•CPhT to alert CPS; CPS to notify PACT and/or specialty provider of intent to discharge

•CPhT to enter RTC to schedule 'Anticoag Hub F/U' appointment to ensure not lost to follow-up x 2 weeks

Overdue 8 Weeks

• CPhT to triage to appropriate CPS. CPS to determine if additional call warranted; CPS to discharge patient from the Hub; discontinue warfarin RX

• CPS to mail letter to notify patient of discharge from Hub due to non-adherence

• CPS to notify PACT and/or specialty provider of discharge from Hub due to non-adherence