Anticoagulation Management Program.pdf

ANTICOAGULATION MANAGEMENT PROGRAM

MCP NUMBER 11-27-526

Montana VA Health Care System Fort Harrison, MT 59636

Signatory Authority:

Executive Director

Responsible Owner:

Chief, Pharmacy Service

Rescinded Document:

None

Effective Date:

April 15, 2022

Recertification Date:

April 30, 2027

1. POLICY

The Montana VA Health Care System will apply a defined anticoagulation management program to individualize patient care and reduce the likelihood of patient harm associated with the use of anticoagulants.

2. JUSTIFICATION

Per VHA Directive 1108.16(1), every VA medical facility must maintain a centralized evidence-based anticoagulation management program and implement all requirements of the directive. This MCP provides coordinated processes and procedures ensuring Veterans are appropriately treated and monitored, to ensure safety of anticoagulation therapy through transitions of care.

3. RESPONSIBILITIES

a. Anticoagulation Program Manager. The Anticoagulation Program Manager (APM) will be designated by the facility Chief of Staff and will be a clinical pharmacy specialist (CPS) with a scope of practice in the area of anticoagulation. The APM will serve as the lead subject matter expert (SME) in the oversight, design, implementation, and function of the anticoagulation management program. The APM will promote consistent practice among anticoagulation clinic staff through the development of processes and procedures, the utilization of standardized practice tools, coordination of facility educational programs for staff and patients, and coordination of quality assurance reports and activities for reporting to the Medication Use Review (MUR) Subcommittee of the Pharmacy and Therapeutics (P&T) Committee. The APM will be provided a minimum of 8 hours per week to provide program oversight and ensure compliance with VHA Directive 1108.16(1) and completion of quality assurance activities.

b. Anticoagulation Management Physician Champion. The Physician Champion for the facility anticoagulation management program will be designated by the Chief of Staff to assist with program oversight, including ongoing review of the quarterly quality assurance reports. The Physician Champion will serve collaboratively with the

April 15, 2022 MCP 11-27-526

Anticoagulation Program Manager to advocate for, provide consultation on anticoagulation issues and support facility anticoagulation initiatives.

c. Anticoagulation Provider: Clinical Pharmacy Specialist. The CPS is a pharmacist with an anticoagulation scope of practice with prescriptive authority within that scope. The CPS is an active member of the anticoagulation management program responsible for the initiation, management, monitoring and peri-procedural management of Veterans prescribed long-term anticoagulation therapy, including but not limited to warfarin, DOACs and injectable anticoagulants. The CPS will ensure that all patients have the appropriate diagnosis code included on the problem list, ICD-10 code Z79.01 for “Long-term current use of anticoagulants”. The CPS will serve as a subject matter expert on anticoagulation management to patients and healthcare professionals throughout the facility.

d. Inpatient or CLC Pharmacist. The inpatient or CLC pharmacist will carefully review all orders for anticoagulation therapy for inpatients, including dosage, dosage in context of renal function, allergies, and potential drug-drug interactions for all oral and injectable anticoagulants. The pharmacist will apply the inpatient warfarin protocol or heparin weight-based protocol upon provider request. The pharmacist will ensure all baseline labs (INR, CBC, aPTT and/or anti-Xa level as appropriate) are ordered and has authority to order such labs if needed.

e. Provider. The term “provider” denotes any practitioner (primary care provider or other specialty provider, e.g., cardiology, vascular, pacemaker, etc.) that refers a patient to the anticoagulation program via consultation for initiation/management of anticoagulation therapy, peri-procedural management, or for other clinical reasons (e.g., changing renal function, drug-drug interaction, fall risk assessment, etc.). At the time of referral via consultation the provider will ensure appropriate baseline labs are available for review, identify indication for use, specify treatment goals and/or planned duration of therapy.

f. Inpatient Dietitian. The inpatient dietitian will utilize computer reporting to identify all inpatients receiving warfarin therapy and will ensure a vitamin K consistent diet during the patient's inpatient stay.

g. Inpatient Nurse. The inpatient nurse will review and verify all orders for continuous IV heparin therapy. The nurse will utilize only a programmable infusion pump for continuous heparin IV infusions.

h. Clinical Staff. All healthcare providers directly involved in caring for patients receiving anticoagulation therapy will complete mandatory anticoagulation education, including competency assessment, on a regular basis.

i. Laboratory Staff. Laboratory staff will ensure that a critical INR value has been established and is listed in the Laboratory VistA software package. A Standard Operating Procedure has been established for communication of critical INR results from the laboratory to the provider.

4. PROCEDURES

a. Primary care and specialty service lines will place a consult to the Anticoagulation Program for all patients warranting long term anticoagulation. The initial consult will include at least the following information: indication and duration of therapy.

If a referring provider has a strong preference for the agent selected that should also be stated.

b. All outpatients prescribed warfarin from the Montana VA Health Care System are monitored by an Anticoagulation Clinical Pharmacy Specialist (CPS). Patient diagnosis, INR goal, and projected length of therapy are specified by the provider to the CPS via consult to the Anticoagulation Management Program. Dose is initiated or adjusted by the CPS based upon diagnosis, goal INR range, and INR result, in accordance with the Anticoagulation Program Monitoring and Treatment Protocol (Attachment A). The CPS will utilize a single tablet strength to minimize risk of error. The CPS will assess the risks and benefits of long-term warfarin therapy on an ongoing basis and consult with the provider as appropriate.

c. All outpatients receiving a DOAC (direct oral anticoagulant) for chronic, therapeutic anticoagulation from the Montana VA Health Care System will receive initial evaluation through the Anticoagulation Management Program. The CPS will determine through chart review and/or patient interview what education and follow-up for assessment of adherence/tolerance and laboratory monitoring are clinically indicated. A population-based management approach (MedSafe DOAC Dashboard) will be utilized to monitor for adherence, indicated renal dose adjustments, pathological bleeding and/or thrombotic events. Patients receiving short term or low dose treatment with a DOAC for prophylaxis (e.g. for prevention of VTE in the post-op setting, or for prevention of CV events in select patients with CAD or PAD) will remain under the care of the treating provider for the duration of DOAC use.

d. All outpatients receiving an injectable anticoagulant will receive education on the injection process and the medication itself by the pharmacist or Anticoagulation CPS.

Patients requiring long-term use (beyond 1 month) will be monitored through the Anticoagulation Management Program.

e. All outpatients prescribed anticoagulation therapy through a Care in the Community (CITC) Provider may receive the supply through Montana VA Health Care System through the “Prior Authorization Drug Request” process. The CITC provider assumes the responsibility of monitoring and managing.

f. Residents of the Community Living Center (CLC) receiving long-term anticoagulation therapy (warfarin or injectable anticoagulants) will receive monitoring by the CLC Pharmacist in accordance with the inpatient procedures described below (Attachment B), with exceptions as noted. The CLC Pharmacist will communicate follow-up plans and issues of concern through CPRS documentation and direct communication with the attending provider and CLC staff. The CLC Pharmacist will place inpatient medication and lab orders and will utilize full-tablet dosing whenever possible to accommodate medication administration processes. The CLC Pharmacist will assist with patient education as appropriate.

g. All inpatients newly started on warfarin are monitored by the inpatient pharmacist (Attachment B). Patient diagnosis and INR goal are obtained by the pharmacist from CPRS or provider. Baseline INR and CBC, and follow-up INR results are monitored by the pharmacist. If an INR result is outside of desired range, the pharmacist will recommend a dosing adjustment to provider. The pharmacist will identify and communicate to the provider the presence of any significant drug interactions, and recommendations for alternative medications, based upon inpatient warfarin protocol.

h. All inpatients receiving injectable anticoagulants will be monitored by the pharmacist. Patient diagnosis/indication for use and baseline serum creatinine, CBC, height, and weight are obtained from CPRS (or provider). Creatinine clearance will be calculated, and dose of injectable anticoagulant assessed in light of indication and renal function. If dose is found inappropriate, the pharmacist will advise the provider and suggest adjustment. Concurrent use with epidural anesthesia may be considered only in patients meeting the criteria defined in Attachment C.

i. All inpatients receiving therapeutic dose heparin will be monitored by the pharmacist or provider as outlined by the facility heparin dosing protocol (Attachment D), including aPTT and/or anti-Xa level, and CBC at designated time frames. Dosage adjustment will be pharmacist or provider driven. Pharmacists will evaluate all inpatient heparin orders for appropriateness, including dose, presence of allergies or drug interactions, indication for use, and presence of baseline CBC and aPTT/anti-Xa level.

j. Pharmacy will provide oral anticoagulants to inpatients in unit dose packaging only, and injectable anticoagulant infusions in pre-mixed solutions whenever available. Only programmable infusion pumps will be utilized to administer heparin IV as a continuous infusion.

k. The hospital has established a critical INR value (≥4.5) which is listed in the Laboratory VistA software package. When a critical INR value is identified by laboratory, the report will be communicated to the requesting provider or MOD immediately to ensure that appropriate intervention is started. The MOD or requesting provider must take action on the critical INR within 24hrs.

l. If a non-VA INR result is documented in the laboratory software package a separate entry must be created in file 63 that clearly indicates the lab test was performed at a non-VA laboratory (e.g., the test name is non-VA laboratory INR result).

Prior to entering the non-VA laboratory results into the VistA laboratory package, it must be verified that the result is from a CLIA accredited laboratory and the laboratory's name and address must be documented in the comments field.

m. If a non-VA INR result is not from a CLIA accredited laboratory (for example point of care INR from Home Health Care agency), the Anticoagulation CPS will document in the flowsheet who reported the test result and/or where it was obtained. Health factors will also be utilized to capture this data to most accurately track the facility wide time in therapeutic range (TTR).

n. The dietitian will be notified of all inpatients receiving warfarin via a VistA alert.

The dietitian will make appropriate changes in patient meals to ensure a vitamin K consistent diet.

o. The following laboratory tests are routinely required at baseline and for ongoing monitoring (others may be ordered at the discretion of the provider):

(1) Heparin: CBC, PT/INR, aPTT and/or anti-Xa level.

(2) LMWH and Fondaparinux: CBC, serum creatinine.

(3) Warfarin: CBC, PT/INR, chemistry panel with LFTs if indicated

(4) DOACs: CBC, chemistry panel with LFTs if indicated

p. Patient and/or caregiver education will be provided for outpatients receiving anticoagulants by the pharmacist or Anticoagulation Clinic CPS. Patient education will include the following areas: indication for therapy, potential interactions (drug, diet and disease), daily dosage, importance of adherence, management of missed doses, signs and symptoms of bleeding and thromboembolic events and what to do if signs/symptoms occur, need to inform other healthcare providers about use of anticoagulant, need to inform Anticoagulation Clinic of acute illness, changes in diet or medications and upcoming procedures/surgeries, risks associated with falling, monitoring requirements and proper storage. An anticoagulation education note will be documented on the patient chart.

q. Mandatory training about anticoagulation will be required in the Talent

Management System for all clinical staff (e.g., providers, mid-level providers, nurses, pharmacists, and dietitians) directly involved in caring for patients receiving anticoagulation therapy. In addition, updates and in-services will be provided as needs are identified through quality assurance and performance improvement activities.

r. Periodic evaluation of anticoagulation safety practices will be conducted via the following mechanisms: professional practice evaluations, review of incident reports, root cause analysis reviews, on-going monitoring of the inpatient anticoagulation process, and the Anticoagulation Clinic monitors reported quarterly to the MUR Subcommittee. These will include assessment of time in therapeutic range (TTR), and complications (bleeding and thromboembolic) in anticoagulated patients. Trends identified will be directed to Patient Safety Manager and the P&T Committee.

s. Critically interacting drugs ordered for patients also prescribed warfarin will be identified by a daily VistA report. Action will be taken by the CPS to adjust the warfarin dosage or contact the provider for an alternative medication. (See Attachment F for list of interacting drugs with warfarin).

t. All pharmacists independently managing outpatient anticoagulation therapy will carry an Anticoagulation Scope of Practice and will be credentialed to provide this service. All pharmacists managing inpatients on warfarin according to protocol will complete an anticoagulation competency.

5. DEFINITIONS

A. Montana VA Anticoagulation Services The Montana VA Anticoagulation Clinic/Services refers to a centralized anticoagulation management program. This service line is a part of the pharmacy department. The program is staffed by clinical pharmacy specialists maintaining an anticoagulation scope of practice. The program is also staffed by ancillary team members who offer clinical and administrative support within their own functional statements as directed by the CPS. The program provides direct patient care via telephone and written correspondence (USPS mail). The program utilizes population-based management tools to provide clinical care and interventions. The program operates during normal business hours and has a dedicated direct telephone extension with voicemail capability (406-447-7974). An after-hours telephone extension is provided on the voicemail.

6. REFERENCES

a. VHA Directive 1108.16(1) Anticoagulation Therapy Management, dated January 29, 2021, amended April 23, 2021, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9173.

b. Antithrombotic Therapy for VTE Diseases: American College of Chest Physicians Guideline and Expert Panel Report. CHEST. 2016; 149 (2):315-352: February Supplement.

c. Antithrombotic Therapy for Atrial Fibrillation: American College of Chest Physicians Guideline and Expert Panel Report. CHEST 2018; 154(5):1121-1201.

d. Comparative Indications of Selected VA National Formulary Injectable Anticoagulants. Washington, DC: VHA Pharmacy Benefits Management Service and the Medical Advisory Panel, June 2009.

e. Guidance for the Oversight and Monitoring of Direct Oral Anticoagulants (DOACs). Washington, DC: VHA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives, December 2017.

f. Reversal Agents for Direct Oral Anticoagulants (DOACs) Recommendations for Use. Washington, DC: VHA Pharmacy Benefits Management Service and the Medical Advisory Panel, August 2019

g. Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy. American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines, 4th ED. Regional Anesthesia and Pain Medicine 2018:33(3).

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9173

7. RESCISSION

None

8. REVIEW

This MCP will be reviewed every five (5) years or when there are changes to the governing document.

9. ATTACHMENTS

A. Anticoagulation Program Monitoring and Treatment Protocol

B. Pharmacy Managed Warfarin Protocol – Inpatients

C. Regional Anesthesia and Anticoagulation

D. Heparin Dosing Protocol 6/2020

E. Anticoagulant Reversal and Management of Anticoagulation Related Bleeding

F. Selected Warfarin-Drug Interactions

10. RECERTIFICATION

This MCP is scheduled for recertification on or before the last working day of April 2027.

This MCP will continue to serve as local policy until it is recertified or rescinded. In the event of contradiction with national policy, the national policy supersedes and controls.

11. SIGNATORY AUTHORITY

Judy Hayman, Ph.D.

Executive Director, Montana VA Health Care System

Date Approved: April 15, 2022

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

DISTRIBUTION: MCP Facilitator notifies staff monthly of all new, updated, or rescinded MCPs by sending to Service Chiefs and AOs. MCP Owners should distribute to staff accordingly.

MCPs are stored here within the MTVAHCS Document Control System:

https://spd.portal2.va.gov/apps/QMSQCD/monvamc/default.aspx https://spd.portal2.va.gov/apps/QMSQCD/monvamc/default.aspx

ATTACHMENT A

Montana VA Health Care System

Anticoagulation Program Monitoring and Treatment Protocol

March 2022

1. Warfarin Management

a. Initiation of Warfarin

i. The following algorithm will be utilized: “VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Initiation Phase of Therapy)”

ii. One tablet strength of warfarin will be utilized and dispensed to create the most stable dosing regimen for each patient.

iii. Typically in the outpatient setting, INRs will be obtained at least twice weekly, then weekly then every 2-4 weeks during the initiation and dose finding phase.

iv. Warfarin prescriptions will have general instructions with the anticoagulation clinic phone number built into the instructions.

v. Up to a 60-day supply of warfarin may be dispensed in patients deemed stable and appropriate by the ordering CPS.

b. Maintenance of Warfarin Therapy

i. The following algorithm will be utilized “VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Maintenance Phase of Therapy)

ii. Stable patients will generally have an INR checked every 4 weeks.

The interval may be extended to a maximum of 8 weeks to accommodate transportation or weather issues, or in patients that the CPS determines are appropriate for an extended testing interval (e.g. patients with INRs within goal range 3 times consecutively, or with TTR > 80%). Exception to above: patients on warfarin to maintain central line patency (longer intervals are acceptable, unless toxicity suspected).

https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations%2FWarfarin%5FPBM%5FInitiation%5FAlgorithm%20508%20compliant%20Aug%202019%2Epdf&parent=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations%2FWarfarin%5FPBM%5FInitiation%5FAlgorithm%20508%20compliant%20Aug%202019%2Epdf&parent=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations%2FWarfarin%5FPBM%5FInitiation%5FAlgorithm%20508%20compliant%20Aug%202019%2Epdf&parent=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations%2FWarfarin%5FPBM%5FMaintenance%5FAlgorithm%20508%20compliant%20Aug%202019%2Epdf&parent=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations%2FWarfarin%5FPBM%5FMaintenance%5FAlgorithm%20508%20compliant%20Aug%202019%2Epdf&parent=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations%2FWarfarin%5FPBM%5FMaintenance%5FAlgorithm%20508%20compliant%20Aug%202019%2Epdf&parent=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FClinical%20Recommendations

iii. The CPS will complete an initial review of all INR results. INR results will be addressed via phone and/or letter correspondence within 24 hours of receipt of INR result. In cases where the INR is outside the therapeutic range, the CPS will determine the clinical plan based on chart review and/or patient interview with action taken as deemed appropriate

iv. In cases where the INR is within the therapeutic range for a stable patient or where the patient has annotated on the warfarin worksheet, a reason for a non-therapeutic level, the CPS may refer the case an ancillary team member assigned to the Anticoagulation Program. They will, in turn, complete correspondence with the patient and enter lab orders specified by the CPS. Efforts will be made to contact all patients no less than every 4th month. These calls will be documented in a progress note or in the Anticoagulation Monitoring Tool (AMT).

c. Goals of Therapy

i. To ultimately prevent venous thromboembolism, stroke or systemic embolism all while mitigating bleeding risks

ii. To clarify duration of treatment based on indication.

iii. Objectively, therapeutic anticoagulation with warfarin, is defined by INR goals. At the time of consultation/initiation of therapy, the INR goal will be stated or assumed based on indication. The following INR targets with the INR goal ranges generally align with the medical literature

1. Treatment/prevention of VTE

a. INR goal 2.0-3.0

b. In the setting of antiphospholipid syndrome the INR goal may be adjusted to 2.5-3.5 when the baseline INR is elevated.

2. Stroke prevention in the setting of atrial fibrillation

a. INR goal 2.0-3.0

3. Tissue valves (any position)

a. INR goal 2.0-3.0 for 3 months

4. Mechanical valves

a. Aortic or pulmonic

i. On-X valve: target INR 2.5 for first 3 months;

thereafter 1.5-2.0

ii. Low-risk valves: INR target 2.5 (range 2.0-3.0)

iii. High-risk valves: INR target 3.0 (range 2.5-3.5)

b. Mitral or tricuspid

i. Low-risk valves: INR target 3.0 (range 2.5-3.5)

ii. High-risk valves: INR targe 3.5 (range 3.0-4.0)

c. INR targets in patients with the additional following risk factors may be higher: prior thromboembolism, atrial fibrillation, rheumatic mitral stenosis, LVEF < 35%

5. Different target INR and INR ranges may be recommended by specialty based on off label uses, patient’s thrombotic history or other clinical reasons. The CPS will work collaboratively with specialty to establish target INRs and INR ranges on a case-by-case basis.

d. Laboratory Monitoring

i. Baseline Labs

1. PT/INR

2. CBC (specifically evaluating Hgb/Hct and platelets)

3. Chem 14 (if clinically indicated in the setting of liver dysfunction)

ii. Ongoing monitoring

1. PT/INR as outlined in algorithms

a. PT/INR results received from non-VA labs will be readily retrievable in the VISTA Lab Software package and the Anticoagulation Flow Sheet. If non- VA PT/INR results are not retrievable within the software pckage (for reasons of not being CLIA waived or verbally reported INR from Home Health Agency), the CPS will document in the AMT flowsheet who and where the INR was obtained. Health factors can also be utilized to record PT/INRs that are not readily retrievable within the software package.

2. Critical INR results ≥ 4.5

a. Anticoagulation CPS will advise the patient to hold warfarin for 1 or more doses (taking into consideration INR goal and INR value) in an attempt to return the patient to goal INR range. As a general guideline, a repeat INR should be obtained prior to re-starting the medication; this depending upon patient specific risks and other factors (such as identifiable transient reasons for elevated INR results, or inability to obtain lab on the desired day).

b. For all patients, an interim progress note that documents instructions to the patient and the treatment plan will be completed. The patient’s primary care provider will be identified as an additional signer to the note to keep them apprised of the critical INR.

3. CBC

a. At least on an annual basis or as clinically indicated (more frequent is encouraged if experiencing bleeding events, triple therapy or monitoring for anemia)

b. Upon initiation of warfarin therapy a repeat CBC should be obtained at 3 months, 6 months and then as clinically indicated as stated above

e. Peri-Procedural Management of Warfarin

i. The anticoagulation program will be notified through consultation by primary care or specialty (eg. pain, GI, ortho, etc) provider of the need for peri-procedural management. The date of the procedure and bleeding risks (minimum/low or intermediate/high) should be stratified at the time of consultation.

ii. The CPS will review the patient’s indication and provide a risk stratification of the thrombotic and bleeding risks to determine when warfarin should be stopped and resumed surrounding a procedure.

The following guidance is generally utilized: Periprocedural management (warfarin).

iii. Risk stratification will also be used to help guide clinical judgement if a bridge with an injectable anticoagulant (LMWH, preferably enoxaparin) is utilized in patients stratified as high thrombotic risk (mechanical mitral valve, APLS, VTE < 3 months, etc.) during brief warfarin interruptions. A detailed interruption schedule with LMWH (preferably enoxaparin) will be provided to the patient. The CPS will ensure the patient is educated on injections.

iv. The CPS will provide at least verbal instructions but may also provide written instructions regarding the warfarin interruption.

Included in those instructions is the date at which an INR is requested post warfarin resumption.

v. For all interruptions that are considered full reversal (5-day warfarin hold prior to procedure) with or without bridge, an interim progress note that documents instructions to the patient and the treatment plan will be completed. The patient’s primary care provider will be identified as an additional signer to the note to keep them apprised of the interruption and procedure.

f. Quality Assurance

i. Weekly quality assurance

1. The anticoagulation program will ensure that PT/INRs that are ordered and obtained within VA MT are addressed each week, including and not limited to PT/INRs ordered by a

CPS.

ii. Drug-Drug Interactions

1. A daily report will be made available from VISTA/CPRS identifying critical DDI between warfarin and other agents.

The CPS will intervene as clinically necessary.

http://www.anticoagulationtoolkit.org/sites/default/files/one_pagers/warfarin_periprocedural_management_card_1.0.pdf http://www.anticoagulationtoolkit.org/sites/default/files/one_pagers/warfarin_periprocedural_management_card_1.0.pdf

iii. Bleeding complications

1. Both minor and major complications will be tracked in the AMT software as well as the Bleed/TE Events Report. The primary care provider will be notified of major complications.

a. Minor bleeding management

i. Attempts to obtain INR will be made

ii. The patient may be advised to hold or take a reduced dose of warfarin, especially if a PT/INR is available for clinical review.

b. Major bleeding management

i. The patient will be advised/referred to seek immediate medical attention.

2. A shared decision between patient, provider and possibly specialty of when to resume oral anticoagulation therapy with warfarin.

a. If appropriate in the setting of major bleeding, the CPS may more closely monitor CBC to ensure no signs of bleeding recurrence and ensure adequate Hgb/Hct recover

3. Strategies to mitigate bleeding risks will be documented

4. Bleeding complications will be reported at the quarterly MUR meeting.

iv. Thrombotic complications

1. Thrombotic events will be tracked in the AMT software as well as the Bleed/TE Events Report. The primary care provider will be notified of such events and involved in consideration/re-evaluation of optimal oral anticoagulation therapy (e.g., determining if the event was a treatment failure, INR goal intensification, transition to a different agent, etc.)

2. Thrombotic complications will be reported at the quarterly MUR meeting.

https://vaww.pbi.cdw.va.gov/PBI_RS/report/GPE/PBM_MedSafeRpts/SSRS/Reports/DOAC/Outcome%20Scorecard

v. Time in Therapeutic Range

1. The TTR dashboard provided by the PBM CPPO will be utilized to track TTR within VA MT. This will be reported at the quarterly MUR.

vi. Patient non-adherence to treatment plan and/or PT/INR lab monitoring

1. In cases where patients fail to report for recommended PT/INRs, will be sent a letter requesting that they present for routine/repeat PT/INR as soon as possible. If the patient receives two letters and still does not report for testing, the warfarin prescription will be placed on “hold” and the patient will be notified accordingly. A prescription comment will be entered to reflect the patient’s noncompliance with monitoring requirements.

2. Patients who demonstrate non-adherence to treatment plan, dosing recommendations or laboratory monitoring, will be re-educated on importance of such. The CPS will assess on a case-by-case basis and engage the primary care provider for assistance. Patients who continue to demonstrate documented non-adherence will be discharged from anticoagulation management services (following additional consultation with the primary care provider and/or supervising provider as appropriate) and the oral anticoagulant medication with be discontinued.

2. Direct Oral Anticoagulant (DOAC) Management

a. Initiation of DOACs

i. DOACs will be considered the preferred oral anticoagulant of choice unless contraindicated.

ii. Upon initiation of oral anticoagulation therapy, in the outpatient setting, the anticoagulation CPS will review CPRS and obtain other relevant medical records to determine the most clinically appropriate DOAC to initiate based on patient characteristics.

iii. The anticoagulation CPS will provide specialized education to patients and/or patient representatives regarding their medical https://vaww.pbi.cdw.va.gov/PBIRS/Pages/ReportViewer.aspx?/GPE/PBM_CPPO/SSRS/AnticoagulationTTR/AnticoagFacilitySummary condition and proper use of the DOAC selected. An education note will be recorded in the patient’s CPRS medical record.

iv. The anticoagulation CPS will provide at least one follow up phone call after the initiation of OAC with DOACs (this includes if the DOAC was initiated during a recent hospitalization or within a different facility). The purpose of the follow up is to assess tolerance, adherence and reinforce education. At that time it will be determined if repeat laboratory monitoring is clinically indicated. If the patient is subjectively stable, the patient will be released out of active management from the anticoagulation program and a population-based management tool will be utilized for ongoing monitoring.

b. Maintenance of DOACs

i. In the case a patient has been previously prescribed a DOAC agent outside of the VA and requests to obtain the agent through the VA, the CPS will review each case to ensure the patient meets VA criteria for use. The CPS will determine what labs and formal education are clinically indicated prior to transferring anticoagulation management to the primary care provider and utilizing a population-based management tool for ongoing monitoring.

ii. If after a patient has initiated oral anticoagulation therapy with a DOAC agent and at a follow up interview, subjectively is tolerating and demonstrating adherence. The CPS may release the patient to primary care provider for ongoing prescriptive management. A population based tool will be utilized for ongoing monitoring (DOAC dashboard).

iii. The Anticoagulation Program is available via consultation if issues arise and warrant re-engagement with a CPS for more active management or assessment. Examples include but are not limited to changing clinical status, risk/benefit assessments, initiation of interacting medications, etc.

c. Goals of therapy

i. To ultimately prevent venous thromboembolism, stroke or systemic embolism all while mitigating bleeding risks

ii. To clarify duration of treatment based on indication.

iii. To assist with shared decision discussion between patient and primary care or specialty provider regarding consideration for a https://vaww.pbi.cdw.va.gov/PBI_RS/report/GPE/PBM_MedSafeRpts/SSRS/Reports/DOAC/Scorecard dose reduction after 6 months of therapy in the setting of VTE when rivaroxaban or apixaban are prescribed.

iv. Through the use of a population-based management tool, make clinically relevant interventions to ensure the safe use of DOAC agents.

d. Laboratory Monitoring

i. Baseline Labs

1. Serum creatinine (SCr) (to estimate creatinine clearance (CrCl)

a. Estimated creatinine clearance will be calculated using the appropriate body weight for the individual anticoagulant in accordance with manufacturer’s prescribing information and PBM recommendations.

2. Complete blood count (CBC) (including platelets)

3. Liver function tests may be considered in patients with history or risk of hepatic insufficiency (e.g., cirrhosis, viral hepatitis, alcohol abuse, heart failure, etc.)

4. The timeframe of which lab tests may be considered acceptable “baseline” value and reflective of the patient’s current clinical status is ultimately determined by the CPS using clinical judgement. Reasonably, baseline lab values drawn within the prior 1-3 months may be utilized.

ii. Ongoing Labs

1. SCr (to estimate CrCl) as clinically appropriate; SCr should be monitored at least annually and more frequently when clinically indicated 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) as clinically appropriate; 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.

4. A population based management tool (DOAC Dashboard) will be utilized to identify patients due for laboratory monitoring. An anticoagulation monitoring note will be entered into the patient’s CPRS chart informing a member of the Patient Aligned Care Team of such.

e. Peri-procedural management

i. The anticoagulation program will be notified through consultation by primary care or specialty (eg. pain, GI, ortho, etc.) of the need for peri-procedural management. The date of the procedure and bleeding risks (minimal/low or intermediate/high) should be stratified at the time of consultation.

ii. The CPS will review the patient’s indication and provide a risk stratification of the thrombotic and bleeding risks to determine if and when the DOAC agent should be stopped and resumed surrounding a procedure. Bridging with LMWH is generally not recommended or utilized for brief DOAC interruptions. The following guidance is generally utilized and extrapolated for interruption and resumption (see figure): PAUSE Trial.

iii. The CPS will respond to the consultation with at least written risk stratification and interruption recommendation in addition to a general consideration surrounding resumption. If it is requested by the service line the patient may be contacted and provided verbal and or written instructions, otherwise the service line can provide the instructions.

iv. The CPS recommendations will be documented within the notes of the patient chart. The patient’s primary care provider and if applicable, a member of the proceduralist service line will be identified as an additional signer to the documentation.

f. Quality Assurance

i. Drug-Drug interactions

1. The DOAC Dashboard will be utilized to identify and intervene on clinically relevant and significant DDI https://vaww.pbi.cdw.va.gov/PBI_RS/report/GPE/PBM_MedSafeRpts/SSRS/Reports/DOAC/Scorecard https://acforum-excellence.org/Resource-Center/resource_files/1439-2020-02-14-085825.pdf

2. The CPS will document interventions and recommendations utilizing an “Anticoagulation Monitoring” note and dismiss corresponding flags in the DOAC Dashboard.

ii. Bleeding and Thrombotic Events

1. Bleeding and thrombotic events will be tracked and captured with the following strategies and reported quarterly at MUR.

a. For those patients still actively being managed by the anticoagulation service team, complications will be entered into AMT

b. The DOAC Dashboard will be utilized to capture possible bleeding events with the investigation of clinically relevant changes in Hgb.

c. The Bleed/TE Events Report. will be utilized to capture and intervene as clinically appropriate

2. Management of bleeding complications

a. If the CPS is directly involved (either via consultation or patient engagement) in minor bleeding, interventions may include but are not limited to:

repeat SCr or CBC monitoring to assess DOAC dose and bleeding severity, and/or patient education on minor bleeding management and prevention (nasal or bowel hygiene). In general DOACs are not held for minor bleeding complications unless through risk stratification the CPS deems clinical appropriate.

b. If the CPS is directly involved (either via consultation or patient engagement) in major bleeding, interventions shall include referral/advise to seek immediate medical attention. The CPS may be involved in evaluation of shared decision of DOAC resumption and consideration of change in DOAC agent or dose.

3. Management of thrombotic complications

a. The Anticoagulation Service should be notified via consultation if a patient suffers a thrombotic event while prescribed a DOAC agent. The CPS shall assist with determination and investigation of reasons for of the thrombotic event. Considerations include some of the following: if the thrombotic event was considered a true failure; refill history/adherence; if LMWH is warranted for a brief period of time; if DOAC dose was optimal; investigation for DDI, etc. Referral to hematology/oncology should be made.

3. Long-term Injectable Anticoagulation Management (LMWH or fondaparinux)

a. Initiation and Maintenance of Injectable Anticoagulation therapy

i. Anticoagulation Services will be consulted when long-term (>1 month of therapy) injectable anticoagulation is the preferred and recommended (by specialty) anticoagulation strategy.

ii. A consult will clearly state indication, duration of therapy and justification of use of long-term injectable anticoagulant therapy.

iii. The CPS will review appropriateness of drug, dose while considering indication, patient weight and renal function.

iv. The CPS will collaborate with appropriate specialties in these particular cases.

v. Patients will receive extensive education regarding injection, storage, and self-monitoring of bleeding.

vi. Patients prescribed long-term injectable anticoagulation will be maintained in the AMT software package. CPS will either review the patient chart or provide phone follow up on an ongoing basis as deemed clinically appropriate.1

b. Goals of Therapy

i. To ultimately prevent venous thromboembolism, stroke, or systemic embolism all while mitigating bleeding risks.

ii. To clarify duration of treatment based on indication.

iii. To review appropriateness of continued injectable anticoagulant at least on an annual basis.

c. Laboratory Monitoring

i. Baseline labs

1. Serum creatinine (SCr) (to estimate creatinine clearance (CrCl)

a. Estimated creatinine clearance will be calculated using the appropriate body weight for the individual anticoagulant in accordance with manufacturer’s prescribing information and PBM recommendations.

2. Complete blood count (CBC) (including platelets)

3. Weight

ii. Ongoing laboratory monitoring

1. SCr should be reviewed every 3-6 months or more frequently if there is clinical suspicion of a changing renal function that would impact the dose of the injectable agent.

2. CBC (including platelets) should be monitored within the first 2-4 weeks of initiation then every 3-6 months thereafter.

3. Weight every 1-3 months as indicated to consider dose adjustment.

4. In general anti-Xa levels are not monitored.

d. Peri-procedural Management of injectable anticoagulants

i. The anticoagulation program will be notified through consultation by primary care or specialty (eg. pain, GI, ortho, etc) of the need for peri-procedural management. The date of the procedure and bleeding risks should be stratified at the time of consultation.

ii. Patients prescribed LMWH will be advised to inject the last dose of LMWH the morning dose, the day prior to the procedure.

Resumption of enoxaparin will be at the discretion of the proceduralist.

iii. Patients prescribed fondaparinux will need to hold at least 3-5 days prior to procedure due to long drug half-life.

iv. Patients will be provided at least verbal instructions. The CPS recommendations will be documented within the notes of the patient chart. The patient’s primary care provider and if applicable, a member of the proceduralist service line will be identified as an additional signer to the documentation.

e. Quality Assurance

i. Bleeding and thrombotic events will be tracked as the Anticoagulation Program is notified via either primary care provider or patient and reported at quarterly MUR.

Month Day, Year MCP [NUMBER]

ATTACHMENT B

Montana VA Health Care System

Pharmacy Managed Warfarin Protocol - Inpatients

December 2021

I. Purpose: To define the responsibilities and outline the procedures for the management of warfarin initiation and maintenance dosing through the Inpatient Pharmacy Section at the Fort Harrison VA Medical Center.

II. Responsibilities

A. Provider

1. The provider may request that the inpatient pharmacists coordinate the dosing and follow-up of patient’s warfarin therapy. This may include patients that are newly started on warfarin or patients who are currently receiving warfarin as an outpatient. This may be ordered as a Pharmacy Med Management consult or in the comments of a warfarin order stating it is to be dosed per pharmacy protocol. For new starts, the order and/or consult should include the patient’s indication for warfarin and the goal INR range.

2. The provider is responsible for co-signature and review of all orders and notes entered by the pharmacist.

3. For patients newly started on warfarin, prior to the patient’s discharge, the provider will submit a consult for follow-up on warfarin therapy via the Pharmacy Anticoagulation FH consult ensuring the patient is followed by an Anticoagulation CPS. The consult should include the patient’s indication, the goal INR, and the expected duration of therapy.

4. Prior to discharge, the provider will

a. Coordinate follow-up with the patient’s primary care provider at their respective CBOC.

b. Order a supply of warfarin in either a 2mg or 5mg strength. This should be ordered as #30 doses, with no refills.

B. Pharmacist

1. Upon receipt of a request for pharmacy to coordinate warfarin therapy for an individual patient, the pharmacist will review the patient’s chart for the following information:

a. Patient diagnoses, indication for warfarin, and goal INR

b. Height, weight, age and gender

c. Allergies

d. Concomitant disease states and possible contraindications to therapy (low hg/hct, guaiac positive, and other signs of bleeding)

e. Patient’s current medications, and medications prior to admission (including last outpatient dose of warfarin as applicable). This should include a history of herbal and OTC medications.

Clinically significant concurrent medications that interact with warfarin (such as carbamazepine, metronidazole, rifampin, azole antifungals, erythromycin, sulfamethoxazole/trimethoprim, amiodarone and quinidine) will be noted, as well as existing therapy with heparin or enoxaparin.

f. Diet history

g. Available laboratory values, with particular attention to prothrombin time, INR, Hg/Hct, CBC, LFTs, serum creatinine, TSH and albumin. Abnormal values will be taken into consideration prior to initial dosing of warfarin.

h. For patient’s currently prescribed warfarin, review the most recent notes on the Anticoagulation Clinic flow sheet, outpatient progress note titles for Anticoagulation Clinic (patients managed at other Montana Anticoagulation Clinics), and/or more recent remote data if applicable.

2. New Start Patients: The pharmacist will place the following orders/progress notes:

a. Initial warfarin dose. This will generally be 5mg. A lower starting dose of 2.5mg may be considered if any of the following are met:

interacting medications that have the potential to increase the INR, age greater than 70, weight less than 45Kg, elevated LFTs, albumin < 3, or an increased baseline PT/INR. If any of these conditions apply, the Pharmacist may consult with the provider and/or the Anticoagulation Clinic CPS for recommendations.

b. Daily warfarin dose orders will be placed in VISTA to be administered at 5:00 P.M after a review of the current day’s INR value. The dose ordered will follow the approved dosing protocol.

For any patient who is started on 2.5mg daily vs. 5mg daily, subsequent doses will be ½ the amount as indicated on the protocol or as otherwise advised through consultation with the provider and/or the Anticoagulation Clinic CPS. All orders will be placed as verbal orders, requiring provider signature.

c. For patients having concurrent therapy with heparin or enoxaparin, these medications will be continued until the INR is at least 2 or greater, with a 5-day over-lap. The pharmacist will request the provider to discontinue this order when that condition is met.

d. Laboratory orders: A daily INR order for a 7-day duration will be placed in CPRS. This will be released to service, as a policy order.

e. Progress notes will be completed daily using the template titles Pharmacy Inpatient Anticoagulation, Warfarin, Initiation or Follow-up as applicable.

f. Complete the Warfarin Initiation Flow Sheet within the Pharmacy file to facilitate easier follow-up.

3. Currently Managed Patients: The pharmacist will place the following orders/progress notes:

a. Order a one-time INR if one is not available in the medical record.

b. Consult with patient and/or provider to determine if patient received warfarin on the day of admission.

c. Complete the Pharmacy Inpatient Anticoagulation Monitoring Note – Receives Warfarin as Outpatient.

d. INR therapeutic for the patient’s indication, and no bleeding or new interacting medications are prescribed: Order warfarin as a continuous order according to the most recent Anticoagulation Clinic notes. Order INR for every other day. Complete the Inpatient Monitoring Follow-up Note every other day.

e. INR Subtherapeutic: Review H&P progress note, and interview the patient to determine if any doses of medications were missed within the past 10 days. If this is true, order the patient’s dose per the most recent Anticoagulation Clinic note. If this is not true, increase the current weekly dose by 10 - 15%. Place an INR order for every other day. Complete the Pharmacy Inpatient Anticoagulation Monitoring Note, Warfarin, Follow-up Note every other day.

f. INR Supratherapeutic: Review progress notes and interview the patient for reasons this might be elevated (medication, dietary or alcohol changes, confusion with prescribed dose, exacerbation of CHF, viral illnesses, etc.). Consider holding 1 dose, and order an INR for the following day. Refer to the Anticoagulation Clinic dosing nomogram for recommendations on subsequent dosing, or consult with the Anticoagulation Clinic CPS for further instructions. Order an INR Daily for 7 days. Complete the Pharmacy Inpatient Anticoagulation Monitoring, Warfarin, Follow-up Note daily.

4. Patient Education

a. For newly started patients, the inpatient pharmacist will make every effort to complete the formalized warfarin patient education program on Day 2 or Day 3 of therapy, but definitely before patient discharge. If workload does not permit this to be completed, the pharmacist will telephone the Anticoagulation Clinic and coordinate this with that staff. This session will include taking the patient’s at home history of diet, alcohol, herbal remedies and OTC medications, and updating the Non-VA Med entries in CPRS as appropriate. For patients who have been on warfarin in the past, reinforcement of this education is also desirable, particularly if non-compliance issues or discharge dosage changes are noted.

b.