D.12 MCP 658-119-28 Anticoagulation Management.pdf

D.12 MCP 658-119-28 Anticoagulation Management 36C24621R0068

ANTICOAGULATION MANAGEMENT

Salem VA Medical Center MCP 658-119-28 Salem, VA 24153

Rescinded Document:

Signatory Authority: MCM 658-119-28, Anticoagulation Management

Rebecca Stackhouse, CTRS, FACHE March 24, 2017 Medical Center Director

Responsible Owner: Effective Date:

Chief of Pharmacy September 9, 2020

1. POLICY

Recertification Date:

September 9, 2025

This Medical Center Policy (MCP) establishes a reference for anticoagulation management. In all practice settings of the Salem VAMC, all patients prescribed anticoagulants at therapeutic doses will be managed in accordance with approved hospital protocols, clinical practice guidelines for managing anticoagulation as outlined in the current American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines, the current VHA Directive on Anticoagulation Therapy Management, any applicable Joint Commission standards and national patient safety goals, and supporting evidence from the primary medical literature. Anticoagulation will not be co-managed with non-VA providers per VHA Directive 2009-038, VHA national Dual Care Policy. Peri-procedural management is to be a collaborative effort between the Anticoagulation Management Clinic (AMC) and provider.

2. JUSTIFICATION

To set forth guidelines for the management of anticoagulation therapy for the Salem VAMC and associated Community Based Outpatient Clinics (CBOCs) as required by VHA Directive 1033 Anticoagulation Therapy Management. NOTE: For the purposes of this Medical Center Policy (MCP), the “Salem VAMC” refers to both the Medical Center and all associated community-based outpatient clinics (CBOCs).

3. RESPONSIBILITIES

a. VA Medical Facility Director. The VA Medical Facility Director is responsible for ensuring:

(1) Ensure a medical facility policy exists at the facility that meets all standards identified in VHA Directive 1033, Appendix A.

September 9, 2020 MCP 658-119-28

(2) The medical facility has an established anticoagulation management program for management of inpatients and outpatients on anticoagulants.

(3) An Anticoagulation Program Manager has been designated to lead the medical facility’s anticoagulation management program and has been provided with appropriate time to fulfill these duties consistent with the complexity of the local anticoagulation program.

(4) Adequate staff and resources are allotted for the anticoagulation management program to include anticoagulation providers, nurses, pharmacy technicians, registered dietitian/nutritionists, program administration, and information technology support, as appropriate. This includes ensuring anticoagulation providers have adequate anticoagulation support staff to work at the top of their license and maximize operational efficiency

(5) Competencies specific to anticoagulation management are established for anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy.

(6) The medical facility uses programmable infusion pumps for inpatients receiving parenteral anticoagulants, including, but not limited to unfractionated heparin, argatroban, and bivalirudin.

(7) The medical facility employs standardized, evidence-based, algorithms for the management of patients on anticoagulants as defined in VHA Directive 1033, Appendix A.

(8) Anticoagulants are included on the medical facility’s list of high-alert medications.

b. Facility Chief of Staff. The Facility Chief of Staff is responsible for:

(1) Ensuring that a physician is identified as anticoagulation management champion, to be actively involved in defined components of the anticoagulation management program. This champion will serve collaboratively with the pharmacy anticoagulation management champion to advocate for, provide consultation on anticoagulation issues, and support anticoagulation initiatives at the facility level. NOTE: In the event a facility-level physician lead cannot be identified, a Veterans Integrated Service Network (VISN)-level physician champion may be utilized.

(2) Ensuring that all medical facility policies governing the provision of anticoagulation management are approved by the Executive Committee of the Medical Staff (ECMS). Anticoagulation providers will collaborate in the development of medical facility guidelines/algorithms for anticoagulants.

(3) Ensuring that clinical staff directly involved in caring for patients receiving anticoagulation therapy (e.g., nurses, clinical pharmacists, pharmacy technicians, registered dietitian/nutritionists, Advanced Practice Registered Nurses (APRN), physician assistants, and physicians) are educated on the importance of anticoagulation safety and its associated risks, as well as the principles of anticoagulation management, as appropriate.

(4) Reviewing Quality Assurance (QA) information for the facility anticoagulation management program at appropriate and regular intervals through the Pharmacy and Therapeutics (P&T) Committee (or appropriate facility governing body) and ECMS, as appropriate.

c. Facility Chief Pharmacy Service. The Facility Chief Pharmacy Service is responsible for:

(1) Ensuring that a clinical pharmacist anticoagulation provider is identified as the pharmacy anticoagulation management champion to be actively involved in defined components of the anticoagulation program at the facility level.

(2) Assessing the competency of clinical pharmacist anticoagulation providers and pharmacy technicians who serve in the anticoagulation management program.

(3) Ensuring that only oral unit dose products, pre-filled syringes, or pre-mixed infusion bags for anticoagulants are dispensed for inpatients when these types of products are available.

(4) Ensuring that the number of concentrations and quantities of heparin vials stocked in patient care and procedural areas are limited to the minimum needed to meet patient care needs. No multi-dose heparin product more concentrated than 5,000 units per milliliter is stocked without the prior approval of the Chief of Pharmacy.

(5) Ensuring the safe storage of anticoagulants in automated dispensing devices if the medical center uses automated dispensing devices to store anticoagulants. If multiple strengths or concentrations of the same anticoagulant are stored in the same automated dispensing device, they need to be stored in separate drawers (or single access cubie) and clearly labeled as high alert medications.

d. Facility Chief, Nutrition and Food Services. The Facility Chief, Nutrition and Food Services is responsible for ensuring that:

(1) Warfarin is included in Nutrition and Food Services' established food and medication interaction program.

(2) A process is established to notify Nutrition and Food Services of patients receiving meal services that are also receiving warfarin therapy.

e. Chief of Laboratory Service. The Chief of Laboratory Service is responsible for:

(1) Ensuring a critical INR value is established and listed in the Laboratory Veterans Health Information System and Technology Architecture (VistA) software package.

(2) Establishing a Standard Operating Procedure (SOP), in conjunction with the anticoagulation program manager, for the communication of critical INR results from the laboratory to the ordering provider (or designee).

(3) Ensuring the correct International Sensitivity Index (ISI) value for the lot number of thromboplastin, currently in use, is entered the coagulation testing instrumentation.

(4) Ensuring the correct Geometric Mean Prothrombin Time (PT) is calculated for the current lot number of thromboplastin and is entered into the coagulation testing instrumentation as required for calculation of the INR. The Geometric Mean PT needs to be recalculated with each change of lot number of thromboplastin reagent.

(5) Ensuring the availability of reliable testing of heparin levels (factor Xa levels), heparin associated antibodies and a serotonin release assay for the evaluation of heparin induced thrombocytopenia.

(6) Ensure the availability of appropriate laboratory tests for Target Specific Oral Anticoagulants (TSOAC) in special situations (e.g., suspected overdose, bleeding, urgent procedure, etc.).

f. Facility Anticoagulation Program Manager. The Facility Anticoagulation Manager is responsible for:

(1) Serving as a leader or co-leader and subject matter expert in the oversight, design, implementation, and function of the anticoagulation management program.

(2) Developing medical facility policy related to use of anticoagulants. This encompasses policies to govern practice within the anticoagulation management program, but may also include policies relating to the use of anticoagulants in other areas (e.g., surgical or specialty areas), as directed by the ECMS.

(3) Coordinating and reporting quality assurance activities and results for the anticoagulation management program through the P&T Committee (or appropriate facility governing body) and ECMS, as appropriate.

(4) Coordinating the facility educational program for clinical staff directly involved in caring for patients receiving anticoagulation therapy (e.g. clinical pharmacists, pharmacy technicians, registered dietitians/nutritionists, nurses, APRNs, physician assistants, and physicians).

h. Facility Anticoagulation Providers. The Facility Anticoagulation Providers are responsible for:

(1) Managing anticoagulation patients in accordance with facility and VHA policy including, but not limited to, coordination of anticoagulation management for patients transitioning between care settings (e.g., inpatient to outpatient), peri-procedural anticoagulation, and traveling Veterans.

(2) Serving as subject matter experts on anticoagulation management to patients and health care professionals throughout the facility.

(3) Delivering initial and ongoing patient and family education that includes the importance of follow-up monitoring, compliance issues, dietary restrictions, and potential for adverse drug reactions and interactions.

(4) Conducting appropriate and periodic risk-benefit assessments for all patients receiving anticoagulant therapy and communicating recommendations to the original referring provider and/or Patient Aligned Care Team (PACT) provider as appropriate.

(5) Performing and/or facilitating the day-to-day operations of the anticoagulation management program.

(6) Reporting, as per local policy, adverse drug events (ADE), close calls, and any unsafe conditions of which they are aware, even though the conditions have not yet resulted in an adverse event or close call to the facility Patient Safety Manager (PSM) in accordance with VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

4. ACTION

a. Anticoagulation management will be administered in compliance with VHA Directive 1033 and current clinical best practice.

b. All critical lab PT/INR results will be phoned to ordering provider.

c. Standard Operating Procedure for Anticoagulation Management Clinic (AMC) is established and reviewed at a minimum of every 3 years.

d. Referral to AMC is available only to patients who are under the continuing care of a VA provider/physician through an established outpatient program at the medical center and/or its associated non-contracted CBOC's and is obtained through formal consult placement by referring provider.

e. Providers planning to perform procedures either where anticoagulation may be needed before or after the procedure or on anticoagulated patients, will assist the AMC by placing an Anticoagulation Pre- and Post-Operative Management Consult for review and recommendations. This is only available to patients who are under the continuing care of a VA provider/physician through an established outpatient program at the medical center.

f. Providers planning to perform procedures either where anticoagulation may be needed before or after the procedure or on anticoagulated patients for patients visiting from another VA medical center who are not currently under the continuing care of a Salem VAMC provider may consider placing an Pharmacy Anticoag Chart Review Only E-Consult for review and recommendations per the current guidelines. This does not require face to face visits and provides rapid clinic input. Recommendations are based on review of CPRS, VISTA and scanned outside medical records. Recommendations are provided directly to referring provider.

g. Anticoagulation patients consulted to and receiving care by Home Health may continue to be followed by the AMC. Home Health consults to be placed as appropriate by patient’s provider, including the need for anticoagulation, and may be followed by AMC for up to six (6) weeks or as deemed appropriate per provider who also must continue to re-evaluate the need for consult.

h. Outside labs will be accepted by AMC as long Salem VAMC Provider has obtained approval via Non-VA lab consult and provided with signed standing order to draw labs as per the direction of the anticoagulation clinic and the outside lab must be venipuncture, point of care testing will not be accepted.

i. Patients who desire to monitor their INR through home testing devices will not be followed in AMC.

j. All INR results must be evaluated by provider or AMC provider by the close of business the next day (or within 48 hours).

k. All critical INR values must be reviewed, addressed and appropriate actions taken by provider or AMC provider within 24 hours of results reported.

(1) Critical INR value: Pathology & Laboratory Medicine Service (P&LMS) of Salem VAMC has defined an INR value of >4.7 as “critical” for venipuncture.

(2) Patients’ PCP must be added as additional co-signer on the anticoagulation notes when critical INR values occur.

l. The following statement will be added as a default patient instruction at the orderable item level for warfarin per VHA guidance: “TAKE TABLETS BY MOUTH AS

INSTRUCTED BY ANTICOAGULATION CLINIC 540-982-2463 EXTENSION 4802 AND

AVOID SUDDEN CHANGES IN DIET WITH FOODS THAT HAVE HIGH VITAMIN K

CONTENT”.

m. Only 2mg and 5mg tablet strengths of warfarin will be prescribed in the outpatient setting, with the exception of “fee basis” patients followed by a non-VA provider for anticoagulation management or in the event a 2mg or 5mg tablet strength is not logistically feasible via the electronic non-formulary drug request consult process.

n. Initial and ongoing patient and family education will be provided verbally and in writing for every patient receiving oral anticoagulation therapy from Salem VAMC on an outpatient basis.

o. The patient’s PCP or other responsible physician/provider will be notified by the AMC via phone call and included as an additional signer of AMC documentation in case of:

(1) Patient in whom the INR is found to be >4.7

(2) Patients who report minor/major hemorrhagic complications.

(3) Patients who received vitamin K

(4) Patients who receive a warning for two consecutive no-shows or for being in danger of missing more than 50% of scheduled appointments.

(5) New patients, when the referring provider is not the patient’s PCP

(6) Patients who can no longer be contacted by phone or letter (e.g. become homeless, phone disconnected, there is no next of kin (KOK) or emergency contact listed.

p. AMC patients will be referred back to their PCP, another responsible physician/provider, or the emergency department (ED) to assume anticoagulation management of patient as follows:

(1) Report of major hemorrhagic complication.

(2) Report of thromboembolic complication.

(3) Report of medical problems unrelated to anticoagulation therapy.

(4) Failure to report to the initial appointment.

(5) Failure to participate in a manner consistent with safe and effective anticoagulation therapy.

(6) Discharge from AMC.

(a) The AMC CPS will notify/contact the PCP directly via phone and document via CPRS when a patient is being discharged from clinic.

q. Off-tour treatment of venous thromboembolic (VTE) disease: after diagnosis of VTE – including deep venous thrombosis (DVT) or pulmonary embolus (PE), the provider seeing the patient shall:

(1) Obtain baseline labs to include: renal function, hepatic function, CBC, PT/PTT/INR as appropriate based on the prescribed anticoagulant.

(2) Obtain a complete and accurate list of medications including remote medications from other VA/non-VA, other-the-counter (OTC) medications, and medications ordered from Salem VAMC, and reconcile medication list through patient/caregiver interview as accurately as possible.

(3) Initiate therapy with the appropriate anticoagulant, documenting contraindications to therapy and placing appropriate consultations.

(4) Decide on admission of patient or outpatient treatment after assessing the patient’s medical stability, risk factors, ability to comply with outpatient treatment, and social support. Patient must be admitted if unstable, has a PE, or unable to comply with outpatient treatment for any reason.

(5) If outpatient treatment chosen and AMC will be assisting with anticoagulation management:

(a) Enter a New Patient Anticoagulation Management Pharmacy Consult

(b) Prescribe at least 7 days of supply for warfarin and/or enoxaparin and at least 30 days of supply for DOACS to avoid unnecessary visits to the facility and avoid delay in therapy.

(c) The Emergency Department or outpatient nurse will follow nursing protocol regarding administration of medications, patient education on LMWH with CPRS documentation, and notification of the provider if patient is unable to comply with instructions or has other impediments to safe outpatient care.

(d) Pharmacy will review and verify orders as appropriate, ensuring anticoagulants will not be held on restrictive status if appropriate consults are placed, assist with education as needed, alert ordering provider for concerns and assist provider as needed with anticoagulation consult placement.

r. All inpatient anticoagulation patients will receive a grey armband upon admission.

s. Inpatient management will be accomplished using an interdisciplinary approach with coordination among providers, pharmacists, nursing, and other disciplines.

t. Heparin infusions, Argatroban, and thrombolytics or IIb/IIIa inhibitors will not be administered in the inpatient psychiatry or CLC areas.

u. Quality Assurance:

(1) Periodic evaluation of anticoagulation safety practices will be conducted via review of National Dashboards. The Anticoagulation Program Manager will prepare a quality assurance report for the AMC of Salem VAMC that will be broken down by division, as well as by clinic; Salem VAMC performance will be compared against VISN and National performance over the same time period; the report will be presented to the P&T Committee on a quarterly basis.

(2) Reporting will include the following at a minimum:

(a) Reports for tracking and trending of INR values at the National, Veterans Integrated Service Network (VISN), and facility levels.

(b) Proportion of patients with pathologic bleeding events.

(c) Patient incidents, close calls, and near misses associated with an anticoagulant.

(d) Adverse drug events (ADEs) involving anticoagulants should be assessed and analyzed in accordance with the facility Pharmacy and Therapeutics (P&T) Committee and VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

(e) Any identified issues that are discovered during the quality assurance process will be tracked and trended by the facility APM and reported to the P&T Committee.

Appropriate follow-up actions that are deemed as necessary in order to promote safe and effective use of anticoagulant therapy will be determined by the P&T Committee

5. DEFINITIONS

a. Major Hemorrhagic Complication – Bleeds are considered major if they either

(1) are fatal, (2) are symptomatic in a critical organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartmental syndrome), (3) result in a hemoglobin drop of 2 g/dL or more, or (4) require administration of 2 units or more of whole blood or packed red cells.

b. Minor Hemorrhagic Complication – Minor bleeding, often referred to as nuisance bleeding, is a common problem in patients taking anticoagulants. Some of the most common types of minor bleeding include epistaxis, bleeding gums, prolonged bleeding from small cuts/scrapes, bruising, and small amounts of blood in the urine, stool or sputum.

c. Ancillary Testing - Laboratory testing or services performed within a VA medical center or its outreach functions, but outside of the physical facilities of the main clinical laboratory. It is often referred to as point-of-care testing (POCT).

d. Anticoagulant - The term anticoagulant refers to a medication that inhibits blood coagulation. For the purpose of this Medical Center Policy (MCP), 659-119-28, anticoagulants include warfarin, heparin (unfractionated and low molecular weight), factor Xa inhibitors (e.g. fondaparinux), and Direct oral anticoagulants (DOACS) (e.g.

dabigatran, rivaroxaban, apixaban, edoxaban, and any others which may become available). The term “anticoagulant” refers to anticoagulation therapy or long-term anticoagulation prophylaxis (e.g. atrial fibrillation) and does not include routine situations in which short-term prophylactic anticoagulation is used for venous thromboembolism prevention (e.g. related to procedures or hospitalization). Medications whose primary purpose is to inhibit platelet function are not included under this definition.

e. Anticoagulation Management Clinic - A program for individualizing anticoagulation therapy for each patient that involves the use of standardized practices and patient involvement, and which is specifically designed to reduce the likelihood of harm associated with anticoagulation therapy. The program also encompasses broader functions including coordinating policy and quality assurance relevant to anticoagulation management in the Salem VAMC.

f. Anticoagulation Provider - The term anticoagulation provider refers to a provider who is currently trained and skilled in managing anticoagulant therapy. Anticoagulation therapy providers may be clinical pharmacists, Advanced Practice Registered Nurses (APRN), physician assistants, and/or physicians. The anticoagulation provider is an active member of the anticoagulation therapy management program, responsible to monitor the quality of his/her clinical practice, and has prescriptive authority defined in their scope of practice privileges that includes anticoagulants.

g. Anticoagulation Program Manager (APM) - The APM is an anticoagulation provider that serves as a leader for the anticoagulation management program and is responsible for ensuring that the program meets all elements of the VHA Directive for Anticoagulation Therapy Management. This individual maintains a high standard for continuing education in the area of anticoagulation therapy and serves as a local subject matter expert regarding anticoagulation management. The APM collaborates with other services to ensure that the anticoagulation management program meets all standards as outlined in the VHA Directive for Anticoagulation Therapy Management.

The APM is generally a clinical pharmacist with a scope of practice; however, other providers may be designated based on local needs.

h. Protocol - Evidence-based and/or “best practice” protocols for the initiation and maintenance of anticoagulation therapy, appropriate for the medication used, condition treated, and potential for medication interactions will be utilized. The protocols are reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee as needed and are electronically accessible to providers on the Medical Center Memorandum directory. An algorithm may contain protocols outlined in policy and that specify actions to be implemented based on patient parameters by designated individuals for anticoagulation patient care management (e.g., unfractionated heparin protocols by nursing staff). Any actions or processes outlined in algorithms or protocols must be within the scope of practice (or in policy) of the individual performing the function and competency must be assessed at baseline and on an ongoing basis as appropriate.

i. Bridge Therapy - Bridge Therapy is the temporary use of a short and immediate acting injectable anticoagulant (usually a heparin or Low molecular weight heparin) during periods where the international normalizing ratio (INR) level is sub-therapeutic (e.g., when warfarin is being initiated) or when warfarin is being held in order to perform invasive procedures (e.g., peri-operative or peri-procedural bridging).

j. International Normalizing Ratio (INR) - INR is a standardized measure of the prothrombin time (PT), which is used to determine the clotting tendency of blood for patients who are on warfarin (Coumadin) therapy.

k. International Sensitivity Index (ISI) - ISI is a measure of Thromboplastin sensitivity to an international standard. Each lot number of Thromboplastin used in Prothrombin or INR testing is assigned its own unique ISI value from the manufacturer.

Rebecca J.

Digitally signed by Rebecca J.

Stackhouse 156979

Stackhouse 156979 Date: 2020.10.19 14:00:04 -04'00'

l. Critical INR value - Pathology & Laboratory Medicine Service (P&LMS) of SAMVAMC has defined an INR value of > 4.7 as “critical” for venipuncture that requires paging the responsible provider for prompt attention.

m. Direct Oral Anticoagulants (DOACS) - A Direct Oral Anticoagulant encompasses several drug classes, and includes, but is not limited to, dabigatran, rivaroxaban, apixaban, and edoxaban. DOACS refers to oral anticoagulant medication that target one or more specific steps in the coagulation cascade

6. REFERENCES

a. National Patient Safety Goals 2020, The Joint Commission. National Patient Safety Goals 2020, The Joint Commission

b. The “Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines”, CHEST 2018

c. VHA Directive 1033, Anticoagulation Therapy Management, dated July 29, 2015 https://www.va.gov/vhapublications/publications.cfm?pub=1&order=asc&orderby=pub_ Number.

d. SOP 119-OP-26 – Outpatient Anticoagulation Management

e. SOP 119-IP-37 – Inpatient Anticoagulation Management

7. RESCISSION

a. MCM 658-119-28, Anticoagulation Management Program, March 24, 2017.

8. REVIEW

a. This MCP will be reviewed every five (5) years.

9. RECERTIFICATION

a. This MCP is scheduled for recertification on or before the last working day of September, 2025. 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.

10. SIGNATORY AUTHORITY

Rebecca J. Stackhouse, CTRS, FACHE Salem VA Director http://www.va.gov/vhapublications/publications.cfm?pub=1&order=asc&orderby=pub_

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

DISTRIBUTION: MCPs are available at on the Public Drive of the Salem VA Medical Center website.

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