D.4 JDD VAMC Anticoagulation Therapy Management 11M-4.pdf

JOHN D. DINGELL VA MEDICAL CENTER 11M-4

DETROIT, MI 48201 January 26, 2018

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ANTICOAGULATION THERAPY MANAGEMENT

1. PURPOSE

To establish guidelines for the outpatient follow-up of patients on oral anticoagulant therapy as well as inpatient monitoring of patients receiving anticoagulants.

2. POLICY

The anticoagulation management program ensures that individualized care is provided to each veteran receiving anticoagulant therapy as defined by National VHA Directive 1033.

ICD Code Z79.01 will be added to all patients’ problem list when applicable; long term use of anticoagulation therapy.

3. DEFINITIONS USED THROUGH THIS POLICY

a. Algorithm. The term algorithm refers to a standardized care process which outlines steps used to manage a patient’s anticoagulation therapy and is utilized across the facility.

Algorithms will be evidence-based, approved by the Pharmacy and Therapeutics (P & T) Committee and Executive Committee of the Medical Staff (ECMS), and follow the guidance included in VHA directive 1033. An algorithm may contain protocols which are documented in policy that outline specific 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 of the individual performing the function and competency must be assessed on an ongoing basis as appropriate.

b. Ancillary Testing. Ancillary testing is defined as laboratory testing or services performed within a VHA medical facility or its outreach functions (e.g. clinic), but outside the physical facilities of the main clinical laboratory. It is often referred to as point-of-care testing (POCT).

c. Anticoagulant. The term anticoagulant refers to a medication that inhibits blood coagulation. Anticoagulants include, but are not limited to, warfarin, unfractionated heparin, low molecular weight heparin, other parenteral anticoagulants (e.g., fondaparinux, argatroban), and direct-acting oral anticoagulants (DOACs)) such as dabigatran, rivaroxaban, or apixaban. For purposes of this policy, the term “anticoagulant” refers to anticoagulation therapy or long-term anticoagulation

Medical Center Numbered Memorandum 11M-4 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). In addition, medications whose primary purpose is to inhibit platelet function are not included under this definition.

d. Anticoagulation Management Program. The term anticoagulation management program, commonly referred to as an “anticoagulation clinic", refers to a coordinated program where anticoagulation providers manage anticoagulants for inpatients and outpatients within the facility. In addition to the clinical practice aspect, the program also encompasses broader functions including coordinating policy and quality assurance relevant to anticoagulation management at the facility.

4. RESPONSIBILITY

a. The Medical Center Director. The Medical Center Director is responsible for ensuring:

(1) A medical center policy exists that meets all standards identified in VHA Directive

1033. An interprofessional approach should be utilized in accordance with this policy to ensure the safe management of anticoagulation therapy.

(2) The medical center 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 centers 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, 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) The anticoagulation management program has an appropriate staff-to-patient ratio to provide safe and appropriate care as defined in Appendix A.

(6) Competencies specific to anticoagulation management are established for anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy. Competencies, at a minimum, must include knowledge of standard terminology, pharmacology of anticoagulants, monitoring requirements, dose calculations, common side effects, nutrient interactions, and drug to drug interactions associated with anticoagulation therapy.

(7) The medical center ensures care is coordinated for traveling patients on anticoagulants in accordance with VHA Handbook 1101.11, Coordinated Care Policy for Traveling Veterans, or subsequent policy issue.

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

(9) The medical center employs standardized, evidence-based, algorithms for the management of patients on anticoagulants.

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(10) Anticoagulants are included on the medical centers list of high-alert medications.

b. The Chief of Staff and Associate Director for Patient Care Services. The Chief of Staff and Associate Director for Patient Care Services are responsible for:

(1) Ensuring that a physician is identified as the 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.

(2) Ensuring that all policies governing the provision of anticoagulation management are approved by the ECMS. Anticoagulation providers will collaborate in the development of medical center 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 information for the facility anticoagulation management program at appropriate and regular intervals through the P&T Committee (or appropriate facility governing body) and ECMS, as appropriate.

(5) Ensuring the competency of non-pharmacist anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy to include minimum components outlined in paragraph 4.a.(6) of VHA directive 1033.

(6) Ensuring that anticoagulation providers have adequate anticoagulation support staff to maximize operational efficiency as outlined in VHA Directive 1033

c. The Chief of Pharmacy Service. The Chief of 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. This champion may be the anticoagulation program manager and serves to advocate for and support anticoagulation initiatives at the facility.

(2) Assessing the competency of clinical pharmacist anticoagulation providers and pharmacy technicians who serve in the anticoagulation management program to include the minimum components outlined in paragraph 4.a.(6) of VHA directive 1033.

(3) Ensuring that clinical pharmacists who serve as anticoagulation providers have adequate anticoagulation support staff to work at the top of their license and maximize operational efficiency. Tasks that support the duties of the clinical pharmacist may be performed by pharmacy technicians or other anticoagulation support staff to maximize time for clinical pharmacists to perform direct patient care.

(4) 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.

(5) 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.

(6) 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. The Chief of Nutrition and Food Services. The Chief of 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 who are also receiving warfarin therapy.

(3) Nutrition and Food Services responds according to its established food and medication interaction program to patients receiving meal services and warfarin therapy. Meal planning and educational efforts are focused on steady Vitamin K intake, individualized to meet the overall health needs, and supporting an adequate dietary reference intake for Vitamin K.

e. The Associate Chief of Staff (ACOS) for Pathology and Laboratory Medicine

Service. The ACOS for Pathology and Laboratory Medicine Service is responsible for:

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

(4) Ensuring there is documentation of periodic monitoring to ensure the entered value remains accurate.

(5) Ensuring that 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.

(6) 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.

(7) Ensuring the availability of appropriate laboratory tests for DOACs in special situations (e.g., suspected overdose, bleeding, urgent procedure, etc.).

(8) Educating staff providing clinical services in an outpatient anticoagulant clinic and staff involved in home anticoagulation therapy management on national and local Laboratory policies related to POCT and patient self-testing.

f. The Ancillary Testing Coordinator. The ancillary testing coordinator is responsible for:

(1) Assessing the competency of staff involved in ancillary testing; and

(2) Documenting training, authorization, and annual competence evaluation for all staff that perform ancillary testing.

g. The Anticoagulation Program Manager. The anticoagulation program manager is responsible for the following functions related to the anticoagulation program.

(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 center 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. A multidisciplinary approach to policy development should be employed to include meeting with all disciplines involved in caring for patients receiving anticoagulants to assist with unified practice and education to patients.

(3) Promoting learning and unified practice for the anticoagulation management program through activities such as educational initiatives, regular staff meetings, and journal clubs.

(4) 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.

(5) 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).

(6) Ensuring availability of appropriate patient education materials and classes, as applicable.

h. The Anticoagulation Providers. The anticoagulation providers are responsible for:

(1) Managing anticoagulation patients in accordance with this 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 provider as appropriate.

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

(6) Reporting adverse drug events, 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 in accordance with VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

5. PROCEDURES

a. All licensed and appropriately credentialed VHA healthcare providers can initiate and change anticoagulation therapy at their discretion. All VHA providers and ancillary staff will participate in an annual competency assessment as indicated by the completion of TMS education module(s) for anticoagulation education. Resident physicians will prescribe under the guidance of their VHA attending physician and will follow established guidelines.

b. All anticoagulation therapy will be based on approved, evidence-based protocols to include current treatment guidelines from the American College of Chest Physicians Consensus Conference on Antithrombotic Therapy or other current literature/recommendations as deemed appropriate. Any deviation from these published guidelines should be supported by a sound clinical rationale and entered into the patient’s electronic medical record for effective communication to all other healthcare providers.

c. Utilizing existing software capabilities and established policy and procedure, Nutrition and Food Services will be notified of all patients receiving warfarin therapy and meal services in order to respond accordingly to its Inpatient Food and Medication program.

d. Intravenous Unfractionated heparin (UFH), Low Molecular Weight Heparin (LMWH), and Fondaparinux.

(1) UFH therapy will be administered using programmable infusion pumps. UFH doses will be adjusted based on the established nomogram. (See Appendix B)

(2) All UFH orders are reviewed by a pharmacist for appropriate dosing based on indication, patient weight, and UFH medical center protocol(s).

(3) Low Molecular Weight Heparin (LMWH): see Appendix B for recommended dosing, long term monitoring recommendations, and antiXa monitoring.

(4) Fondaparinux should be reserved for patients unable to take LMWH (i.e. history of heparin induced thrombocytpenia, HIT) and, due it’s long half-life, should not be used for pre-procedural bridging. See Appendix B for recommended dosing and monitoring.

e. For assistance with outpatient anticoagulation therapy care, healthcare providers can submit an electronic consult to the Outpatient Pharmacy Anticoagulation Clinic to https://dvagov.sharepoint.com/sites/VHADetroit/Policies/11M-4%20Appendix%20B.docx receive dosing, monitoring and/or comprehensive management services. Use of the Anticoagulation Therapies Template (available in the electronic health record) for inpatients newly initiated on anticoagulant therapy will provide a mechanism to ensure patient education and facilitate a safe transition to the outpatient setting by providing a consultation for the Pharmacy Anticoagulation Clinic for post hospital discharge follow

up. Delegation of responsibility for monitoring does not absolve the healthcare provider from issues relating to that patient’s anticoagulation therapy.

It is preferred that patients requiring management for chronic oral anticoagulation are referred to the Outpatient Pharmacy Anticoagulation Clinic.

(1) Providers who prescribe anticoagulants are responsible for ensuring the anticoagulant is dosed correctly and for on-going monitoring regardless of whether patient has been referred to the anticoagulation clinic, is currently enrolled in the anticoagulation clinic, or was previously managed by anticoagulation clinic.

(2) Patients prescribed anticoagulants by providers other than those providers in the anticoagulation clinic may be discharged from the anticoagulation clinic.

(3) Providers who receive and use INR results and other laboratory test results from non- VA laboratory facilities must submit the information to be scanned into the patient’s electronic heath record to ensure that the results are readily retrievable.

f. Providers must respond to the electronic health record order checks whenever a new drug is added to the medication regimen that critically interacts with the anticoagulant therapy and ensure that appropriate patient follow-up is arranged. Pharmacists must ensure that the provider executed an appropriate clinical review of the interaction.

g. Warfarin Initiation and Monitoring:

(1) All patients with a prescription for the vitamin K antagonist warfarin will be required to have INR, safety, and efficacy monitoring.

(2) To minimize the risk associated with incorrect tablet strength dosing errors, providers are strongly encouraged to prescribe only one tablet strength of warfarin for outpatients.

(3) Staff performing ancillary testing will meet all requirements as defined in national and local Pathology and Laboratory Medicine Service Procedures.

(4) For patients receiving warfarin therapy, providers must use the current INR value to monitor and adjust therapy. Approved algorithms for warfarin initiation (Appendix C) and maintenance (Appendix D) should be used for dosing.

h. Direct-Acting Oral Anticoagulant Monitoring:

(1) All patients prescribed a DOAC will be required to have safety and efficacy monitoring. It is recommended that patients prescribed chronic therapy with a DOAC be at least initially followed by the Outpatient Pharmacy Anticoagulation Clinic who are able to provide for specialized education to patients regarding their medical condition and proper use of their medication as well as periodic follow-up care for adherence, bleeds, thromboembolic events, or other adverse events.

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(2) A Comprehensive Metabolic Panel (CMP) that includes a serum creatinine and transaminases and Complete Blood Count (CBC) must be documented in CPRS for each DOAC prescription entered. Labs should be within the previous 30 days for all initial prescriptions written at the JDDVAMC and within previous 6 months for renewals.

(3) All initial prescriptions must be limited to a 30-day supply with no refills, to ensure appropriate follow-up. Subsequent prescriptions (renewals) should be prescribed for a 30-90-day supply with refills (max 6-month supply) to coincide with expected laboratory monitoring and follow-up: 1 month, 3 months, or 6 months as warranted.

i. Peri-Procedural Management of Anticoagulants:

(1) The management of oral anticoagulation therapy during invasive procedures performed on an outpatient or inpatient basis will be the responsibility of the provider. The provider has the options of modifying or continuing the current therapy, holding oral anticoagulation therapy or initiating bridge therapy with LMWH. The Outpatient Pharmacy Anticoagulation Clinic is available to assist as consulted.

(2) The following are recommendations for peri-procedural management of anticoagulation in patients on warfarin or DOACs. The provider performing the procedure is responsible for implementing changes.

(a) Warfarin Interruption i.) Special procedures: For surgical or invasive diagnostic procedures, changes in warfarin dosage schedule will be the responsibility of the provider performing the procedure.

ii.) Dental procedures: Most dental procedures can be safely done by experienced providers with the patient’s INR in the therapeutic range and below 3.0. Interruption of anticoagulation therapy prior to dental work will be at the discretion of the oral surgeon. Patients may resume their normal dose of warfarin following the dental procedure when cleared to do so by the oral surgeon.

iii.) Perioperative management: Interruption of antithrombotic therapy exposes patients to an increased risk for thromboembolic events, such as stroke or mechanical valve thrombosis, with the risk varying depending on the indication for antithrombotic therapy and the presence of co-morbid conditions. Decision to initiate low molecular weight heparin bridge will be based on best available evidence.

(b) DOAC Interruption i.) Perioperative management: Interruption of antithrombotic therapy exposes patients to an increased risk for thromboembolic events, such as stroke or venous thromboembolism, with the risk varying depending on the indication for antithrombotic therapy and the presence of co-morbid conditions. For patients on DOACs, patients are stratified based on their renal function and the bleeding risk of the procedure being performed.

j. Pharmacy Outpatient Anticoagulation Clinic:

(1) The Outpatient Anticoagulation Clinic will be staffed by appropriately trained individuals.

(2) The JDDVAMC has an Outpatient Pharmacy Anticoagulation Clinic that is designated to assist healthcare providers in the treatment and management of patients on anticoagulation therapy. The JDDVAMC is a teaching institution and does allow appropriately credentialed providers to manage anticoagulation without the involvement of the outpatient clinic.

(3) As appropriate, JDDVAMC providers may refer patients to this clinic by electronic consult. The Outpatient Anticoagulation Clinic will act as a resource for other providers concerning issues pertaining to anticoagulation for outpatients.

(4) The clinic will be open Monday through Friday during the facility’s core clinic hours (8 am to 4:30 pm). Outside of clinic hours and for urgent issues, please contact the medical center’s Urgent Care or Emergency Department.

(5) Patients to be monitored in the Outpatient Pharmacy Anticoagulation Clinic will include, but not be limited to those with a diagnosis of atrial fibrillation, atrial flutter, prosthetic heart valve, pulmonary embolism (PE), deep vein thrombosis (DVT), hypercoagulable states, stroke, transient ischemic attack, myocardial infarction, pulmonary hypertension, peripheral vascular disease and initiation of bridge therapy for diagnostic, dental and surgical procedures at this facility and associated CBOCs.

(6) Specific issues on individual patients will be forwarded to the patient’s primary care provider via direct communication and/or as an additional signer to the Outpatient Pharmacy Anticoagulation Clinic progress note. Follow up visits with management concerns requiring provider notification will have the primary care or referring provider added as an additional signer to the clinic progress note.

(7) Patients who wish to receive warfarin or DOAC prescriptions from this clinic must agree to be followed for anticoagulation monitoring at this facility. The Outpatient Pharmacy Anticoagulation Clinic does not accept labs from outside laboratories and does not provide anticoagulation monitoring or anticoagulant prescriptions for patients receiving anticoagulation monitoring from outside providers. There is no co-management for anticoagulation monitoring. Except in the event of an emergency, this clinic does not provide services for the Yale CBOC.

(8) All patients will be counseled about the importance of clinic visits, Patients who fail to arrive for scheduled appointments are addressed as follows: letters will be mailed as a reminder of missed appointments, and a failure to show progress note will be documented in the electronic health record. Patients who are determined to be non-adherent are provided with additional counseling along with counseling the family if required.

(9) Discharge from the Outpatient Anticoagulation Pharmacy Clinic is on an individual basis in conjunction with the patient’s primary care provider and/or duration of therapy as indicated. Patients no longer requiring treatment will be discharged from the Outpatient Pharmacy Anticoagulation Clinic upon notification that treatment has been discontinued. Patient may be discharged and referred back to their primary care provider for the following reasons:

(a) Non-adherence to anticoagulant dosing instructions or monitoring.

(b) Risk vs benefit assessment in which the risk of continuing anticoagulation is deemed to outweigh benefits.

(c) Medical history, activities, behaviors that put patients at risk for adverse events as per clinical decision of anticoagulation clinic provider.

(10) Oral Anticoagulant Dosage Adjustment

(a) Warfarin

(i) The therapeutic range for warfarin therapy should be maintained between INR 2 and 3 for “low target” indications and INR 2.5 to 3.5 for “high target” indications as defined by current consensus guidelines. The INR range may also be changed based on the patient’s condition, as well as coexisting co-morbidities.

(ii) Initiating warfarin: See Appendix C for clinic algorithm.

(iii) Dosing adjustments: See Appendix D for clinic algorithm.

(iv) The length of time between visits will be determined by the patient’s individual response. When stable, patients may be scheduled for visits at 4 to 6 week intervals.

(v) Management of critical INR values and bleeding: See Appendix E

(b) DOAC

(i) Providers considering initiation of DOAC management by the Anticoagulation Clinic must submit an Outpatient Pharmacy Anticoagulation Clinic consult.

(ii) Anticoagulation clinic providers will prescribe DOACs for FDA approved Indications only.

(iii) See Appendix F for table that provides dosing recommendations for DOACs

(11) Interruption of Anticoagulant Therapy The following are recommendations for periprocedural management of anticoagulation in patients on warfarin or DOACs.

(a) The provider performing the procedure (inside or outside the VHA) is responsible for informing the clinic of the need for anticoagulation interruption via consult to the outpatient anticoagulation clinic, written request delivered by patient, or per phone conversation between the clinic staff and outside provider.

(b) The decision to suspend anticoagulation therapy is based on the indication for antithrombotic therapy and the presence of co-morbid conditions.

(c) The decision to re-start anticoagulation ultimately is the responsibility of the provider performing the procedure.

(d) Warfarin Interruption or LMWH bridging. Bridging is defined as the administration of a therapeutic-dose regimen of LMWH, factor Xa inhibitor, or IV UFH during interruption of therapy with warfarin. Bridging anticoagulation may also include a regimen of low-dose LMWH.

(i) Published guidance on LMWH bridging therapy historically has not been based on strong evidence, rather on expert opinion. Bridging does not seem to reduce thromboembolism but clearly increases major bleeding.

(ii) Bridging may be appropriate in rare circumstances such as in high-risk patients where adequate data is lacking. The Anticoagulation Clinic uses the table provided in Appendix G to determine if LMWH bridging is indicated along with input from the primary care provider and provider performing the procedure.

(iii) The decision to re-start anticoagulation ultimately the responsibility of the provider performing the procedure, however, the anticoagulation clinic may offer general guidelines.

https://dvagov.sharepoint.com/sites/VHADetroit/Policies/11M-4%20Appendix%20C.docx https://dvagov.sharepoint.com/sites/VHADetroit/Policies/11M-4%20Appendix%20D.docx https://dvagov.sharepoint.com/sites/VHADetroit/Policies/11M-4%20Appendix%20E.docx https://dvagov.sharepoint.com/sites/VHADetroit/Policies/11M-4%20Appendix%20F.docx https://dvagov.sharepoint.com/sites/VHADetroit/Policies/11M-4%20Appendix%20G.docx

(iv) Refer to Appendix G for algorithm for bridging suggestions

(e) DOAC Interruption

For patients on DOAC, patients are stratified based on their renal function and the bleeding risk of the procedure being performed. Refer to Appendix H for algorithm.

(12) Required laboratory tests to monitor patients on anticoagulants

(a) Required baseline laboratory tests for patients on anticoagulation therapy

(i) Warfarin: CBC, CMP, prothrombin time (PT), INR (note: initial INR should not be performed using point of care testing devices).

(ii) DOAC: CBC and CMP

(b) Required Ongoing laboratory tests for patient on anticoagulation therapy:

(i) Warfarin: CBC, CMP, INR

(ii) DOAC: CBC and CMP

(13) Drug Interactions

(a) Warfarin

Providers should endeavor to use medications that are less likely to interact with warfarin. Patients started on drugs known to cause critical drug interactions with warfarin will require close monitoring. The provider prescribing the drug in question is responsible for monitoring the patient, or arranging close follow-up with the Anticoagulation Clinic. Warfarin dosing adjustments may be needed.

(b) DOAC Patients started on drug(s) known to cause critical drug interactions with DOACs will be addressed on a case-by-case basis. A discussion between the anticoagulation provider and the provider prescribing the drug in question should be held to determine treatment options.

(14) Warfarin risk minimization. The following processes have been put in place to minimize risk associated with incorrect tablet strength dosing errors.

(a) Whenever possible, patients are only prescribed one tablet strength of warfarin.

(b) Provide written patient education with instructions whenever a dose change is made

(15) Anticoagulation providers will add the appropriate International. Classification of Diseases (ICD) Diagnosis Codes to the problem list of patients on long-term anticoagulation therapy.

In addition, appropriate Systematized Nomenclature of Medicine-Clinical Terms (SNOMED- CT) codes may be used as applicable.

(16) Timely Evaluation of INR results

(a) All INR results performed by Anticoagulation Clinic providers are to be addressed within

48 hours.

(b) Critical INR results should be addressed immediately. This includes appropriate actions and documentation of those actions within 24hrs of critical INR result.

(17) Outpatient prescriptions for warfarin should be labeled appropriately to avoid patient confusion with changes to the instructions for use. It is strongly recommended to add a statement such as “refer to the latest anticoagulation clinic dosing sheet” and “use as directed by the anticoagulation clinic”

(18) The pharmacist in the anticoagulation clinic will perform appropriate and periodic risk-benefit assessments for all patients receiving anticoagulant therapy and managed in the anticoagulation management program. Components of the risk-benefit assessment include, but are not limited to:

(a) Patient adherence to therapy

(b) Measured Time in Therapeutic Range (TTR) or proportion of values in therapeutic range.

(c) Risk of bleeding and any major changes to that risk

(d) Risk of thrombosis and major changes to that risk

(e) Changes in patient parameters such as kidney and/or liver function

(f) Changes in general health, frailty, fall risk, and other relevant considerations https://dvagov.sharepoint.com/sites/VHADetroit/Policies/11M-4%20Appendix%20H.docx

(19) Educational plan for clinical staff directly involved in caring for patients receiving anticoagulation therapy. Education should include:

(a) The results of anticoagulation quality assurance program and performance improvement activities, as appropriate;

(b) Education based on locally identified learning needs, new algorithms or policies, emerging information regarding anticoagulants, or anticoagulant topics identified as important to the facility;

(c) VHA educational programs as options for staff education; and

(d) Education may be provided in forums such as staff meetings, newsletters, grand rounds, external programs or other venues.

(20) Ongoing patient and family education provided by anticoagulation providers should address the following issues:

(a) Indication for therapy

(b) Interactions (drug, diet, and disease)

(c) Daily dosage

(d) The importance of medication adherence

(e) The management of missed doses

(f) Signs and symptoms of bleeding and thromboembolic events, and what to do if such an event occurs

(g) The need to inform other health care providers about long-term anticoagulation therapy

(h) The need to inform the anticoagulation provider when changes in medications occur or upcoming procedures are expected

(i) Risks associated with falling

(j) Proper tablet identification (for warfarin);

(k) Need to inform the anticoagulation provider about acute illness, major changes in diet, or upcoming travel (for warfarin)

(l) The dangers of using medication from different sources (especially for warfarin)

(m) Monitoring requirements (specifically for warfarin)

(n) Proper medication storage (specifically for dabigatran)

6. QUALITY ASSURANCE

a. An ongoing quality assurance plan must be in place to evaluate the anticoagulation management program. This provides the opportunity to identify practice improvements, ensures appropriate action is taken to improve the practice, and measures the effectiveness of those actions on a regular basis. The plan should include:

(1) Reports for tracking and trending of INR values at the National, Veterans Integrated Service

Network (VISN), and facility levels;

NOTE: Reports should include those such as time in therapeutic range, proportion of patients on warfarin that have not had an INR in the last 42 days, or other reports that assess the quality of care provided at the facility level.

(2) Proportion of patients with pathologic bleeding events;

(3) Proportion of patients with thromboembolic events; and

(4) Patient incidents, close calls, and near misses associated with an anticoagulant. Adverse drug events involving anticoagulants should be assessed and analyzed in accordance with the facility Pharmacy and Therapeutics Committee and VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

7. REFERENCES

a. VHA directive 1033, Anticoagulation Therapy Management

b. VHA Directive 1070, Adverse Drug Event Reporting and Monitoring.

c. VHA Directive 2009-019, Ordering and Reporting Test Results.

d. VHA Handbook 1100.19, Credentialing and Privileging.

e. VHA Handbook 1101.10, Patient Aligned Care Team (PACT) Handbook.

f. VHA Handbook 1101.11, Coordinated Care Policy for Traveling Veterans.

g. VHA Handbook 1106.01, Pathology and Laboratory Medicine Service Procedures.

h. VHA Handbook 1108.05, Outpatient Pharmacy Services.

i. VHA Handbook 1108.06, Inpatient Pharmacy Services.

j. VHA Handbook 1108.11, Clinical Pharmacy Services.

k. Antithrombotic Therapy and Prevention of Thrombosis, 9th edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST. 2012; 141(2):

February Supplement.

l. National Patient Safety Goals 2014, The Joint Commission http://www.jointcommission.org/assets/1/6/HAP_NPSG_Chapter_2014.pdf

m. Rose AJ, Berlowitz DR, Miller DR, et al. INR targets and site-level anticoagulation control:

results from the Veterans AffaiRs Study to Improve Anticoagulation (VARIA). J Thromb Haemost 2012; 10: 590–5.

n. Rose AJ, Hylek EM, Berlowitz DR, et al. Prompt Repeat Testing After Out-of-Range INR Values A Quality Indicator for Anticoagulation Care. Circ Cardiovasc Qual Outcomes.

2011;4:276-282.

o. Range as a Quality Indicator for Outpatient Oral Anticoagulation, Results of the Veterans Affairs Study To Improve Anticoagulation (VARIA). Circ Cardiovasc Qual Outcomes.

2011;4:22-29.

p. Rose AJ, Miller DR, Oronoff A, et al. Gaps in Monitoring During Oral Anticoagulation, Insights Into Care Transitions, Monitoring Barriers, and Medication Nonadherence. CHEST 2013; 143(3):751–757.

q. Rose AJ, Petrakis BA, Callahan P, et al. Organizational Characteristics of High- and Low- Performing Anticoagulation Clinics in the Veterans Health Administration. HSR: Health

r. Services Research 2012; 47:4: 1541-1560.

8. FOLLOW-UP RESPONSIBILITY

Medicine Service is responsible for the contents of this Medical Center Numbered Memorandum. Questions may be referred to the ACOS of Medicine Service.

9. RESCISSION

Medical Center Numbered Memorandum 11M-4, Guidelines for Use of Anticoagulation Therapy, dated November 2, 2010.

10. EXPIRATION DATE

January 26, 2023 //s// Pamela Reeves, M.D.

Medical Center Director

Distribution: Facility Wide