D.13 MM-35 Anticoagulation Therapy Management Program.pdf

Butler VA Health Care System Medical Center Memorandum MM-35 Butler, PA November 1, 2019

ANTICOAGULATION THERAPY MANAGEMENT (70PH)

I. PURPOSE: To establish guidelines and outline the policies and procedures for optimal management of patients receiving anticoagulation therapy at Butler VA Health Care System

II. POLICY: The use or misuse of anticoagulant medications carries a significant potential for patient harm due to complexity of dosing and monitoring, patient compliance, and numerous drug-drug and drug-food interactions. This facility has established the anticoagulation policy to provide coordinated, safe, and effective evidence-based anticoagulation therapy management through assessment and manipulation of therapeutic response at appropriate intervals, systematic detection, and immediate intervention of therapeutic misadventures, as well as a rigorous effort to maintain a well-informed, compliant patient.

III. DEFINITIONS:

A. Ancillary testing: Ancillary testing is defined as laboratory testing or services performed within a VA facility or its outreach functions (clinic, et al.) but outside the physical facilities of the main clinical laboratory. It is often referred to as point-of-care (POC) testing.

B. Anticoagulant: The term anticoagulant refers to a medication that inhibits blood coagulation. This includes, but is not limited to, warfarin, heparin, low-molecular weight heparin (LMWH), fondaparinux, dabigatran, rivaroxaban, apixaban, and edoxaban.

C. Provider: The term provider may include any physician, nurse practitioner, physician’s assistant, or pharmacist who has direct involvement in the care of the patient.

D. International Normalized Ratio (INR): INR is a standardized measure of the Prothrombin Time (PT), which is used to determine the clotting tendency of the blood.

The INR is the ratio of a patient’s PT to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the reagent system used.

E. International Sensitivity Index (ISI): ISI is a measure of thromboplastin sensitivity to an international standard. Each lot number of thromboplastins used in prothrombin or INR testing is assigned its own unique ISI value from the manufacturer.

F. Parenteral anticoagulant: A parenteral anticoagulant is defined as an anticoagulant that is given either subcutaneously or intravenously and includes, but is not limited to, heparin, LMWH, and fondaparinux.

G. Bridge therapy: Bridge therapy is the temporary use of a short and immediate acting parenteral anticoagulant during periods when the INR level is subtherapeutic (e.g., when warfarin therapy is started) or when warfarin is being held in order to

2 Medical Center Memorandum MM-35 perform invasive procedures (peri-procedural bridging).

H. Direct oral anticoagulant: Direct oral anticoagulants (DOAC) are a class of oral anticoagulants that directly inhibit a single target and have similar clinical properties.

This class includes, but is not limited to, dabigatran, rivaroxaban, apixaban, and edoxaban.

I. 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 must be evidence-based, approved by the Pharmacy and Therapeutics (P&T) Committee and the Medical Executive Committee (MEC), and follow the guidance included in VHA Directive 1033, Anticoagulation Therapy Management, or subsequent directive issue.

J. Anticoagulation support staff: The term anticoagulation support staff may refer to a group of professionals assigned to the anticoagulation management program who perform day-to-day operational support functions. They may include, but are not limited to: pharmacy technicians, nurses, health technicians, and clerical associates.

IV. RESPONSIBILITY:

A. The Director is responsible for ensuring that:

1. This policy exists and is implemented in a manner that meets all standards identified in VHA Directive 1033, Anticoagulation Therapy Management, or subsequent directive issue.

2. This 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 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.

5. The anticoagulation management program has an appropriate staff-to-patient ratio to provide safe and appropriate care as defined in VHA Directive 1033, Anticoagulation Therapy Management, or subsequent directive issue.

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

7. The facility ensures care is coordinated for traveling patients on

3 Medical Center Memorandum MM-35 anticoagulants in accordance with VHA Handbook 1101.11, Coordinated Care Policy for Traveling Veterans, or subsequent policy issue.

8. The facility employs standardized, evidence-based, algorithms for the management of patients on anticoagulants as defined in VHA Directive 1033, Anticoagulation Therapy Management, or subsequent directive issue.

B. The Chief of Staff (COS) and Associate Director for Patient Care Services (ADPCS) are responsible for:

1. Ensuring that a physician is identified as anticoagulation management champion to be actively involved in the anticoagulation management program. The champion will serve collaboratively with the pharmacy anticoagulation management program to advocate for, provide consultation on anticoagulation issues, and support anticoagulation initiatives at a facility level.

2. Ensuring that all facility policies governing the provision of anticoagulation management are approved by the MEC.

3. Ensuring that all clinical staff directly involved in caring for patients receiving anticoagulation therapy 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 and MEC, as appropriate.

5. Ensuring the competency of non-pharmacist anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy as defined in VHA Directive 1033, Anticoagulation Therapy Management, or subsequent directive issue.

6. Ensuring that anticoagulation providers have adequate anticoagulation support staff to maximize operational efficiency.

C. Program Managers are responsible for ensuring that staff under their supervision are in compliance with the procedures delineated in this policy and have competencies documented, where required.

D. The Chief of Pharmacy Service (CPS) is responsible for ensuring that:

1. This policy and all procedures delineated for anticoagulation monitoring are implemented and followed.

2. The Clinical Pharmacists/Clinical Pharmacy Specialists practice within his/her scope of practice in accordance with this policy and the facility’s by-laws.

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3. Ensuring that a clinical pharmacist anticoagulation provider is identified as the pharmacy anticoagulation management champion to be actively involved in advocating for and supporting anticoagulation initiatives at VA Butler Healthcare.

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

5. Ensuring that clinical pharmacists that serve as anticoagulation providers have adequate anticoagulation support staff to work at the top of their license and maximize operational efficiency.

6. 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.

7. Ensuring that the number of concentrations and quantities of heparin vials stocked in patient care areas are limited to the minimum needed to meet patient care needs.

8. Ensuring the safe storage of anticoagulants in automated dispensing devices.

If multiple strengths or concentrations of the same anticoagulant are stored in the same automated dispensing device, they must be stored in separate drawers (or single access cubie) and clearly labeled as high alert medications.

E. The Anticoagulation Program Manager is responsible for:

1. Developing facility policy related to use of anticoagulants.

2. Promoting learning and unified practice for the anticoagulation management program.

3. Coordinating and reporting quality assurance (QA) activities and results for the anticoagulation management program through P&T Committee and MEC, as appropriate.

4. Coordinating the facility educational program for clinical staff directly involved in caring for patients receiving anticoagulation therapy.

F. Facility anticoagulation providers are responsible for:

1. Monitoring and managing outpatient and long-term care resident anticoagulation therapy in accordance with facility and VHA policy.

2. Serving as a subject matter expert on anticoagulation management to patients and health care professionals throughout the facility.

3. Delivering initial and ongoing patient and family education on anticoagulation

5 Medical Center Memorandum MM-35 therapy.

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. Reporting, as per local policy, adverse drug events (ADE), close calls, and any unsafe conditions of which they are aware.

G. The Primary Care Provider (PCP) is responsible for the comprehensive medical care of the patient, including initiating and discontinuing anticoagulation therapy when necessary, (i.e. risk outweighs benefit, duration of therapy is completed) as delineated under Procedures.

H. The laboratory supervisor or designee is responsible for ensuring that adequate training on the POC machines has been provided for those who are performing POC testing.

I. Anticoagulation support staff under the supervision of a provider are responsible for:

1. Scheduling anticoagulation patients;

2. Documenting appropriate information in the medical chart;

3. Providing supplemental patient education; and

4. Conducting patient interviews to assess need for medication refills and investigate the causes of therapeutic irregularities and if applicable, communicate changes in anticoagulant medication and/or dose under the supervision of a provider

V. PROCEDURES:

A. Outpatient Anticoagulation Management:

1. It is the policy of this facility that all outpatients on oral anticoagulation therapy (i.e. warfarin or a DOAC) who are managed at a Butler VA location where the services of the Anticoagulation Clinic are offered are consulted to, and followed by, the outpatient Anticoagulation Clinic; excluding medical indications of DOACs that do not include therapeutic anticoagulation. Patients may also be followed by the Home Care Anticoagulation Program if the patient is enrolled in Home Based Primary Care (HBPC).

Veterans receiving long-term parenteral anticoagulants, without concomitant oral anticoagulants, and those on DOACs for indications that do not require therapeutic anticoagulation will continue to be followed closely by the provider prescribing the medication (i.e. the patient’s PCP).

2. During normal business hours, the anticoagulant management program may

6 Medical Center Memorandum MM-35 be reached by calling the outpatient pharmacy extension. This extension will provide access to a pharmacist trained in anticoagulation management. Any inquiries regarding anticoagulation outside of normal business hours are to be directed to the pharmacist on-call.

3. Warfarin patients:

a. Outpatients are referred to the Anticoagulation Clinic or the Home Care Anticoagulation Program using a Computerized Patient Record System (CPRS) electronic consult which will include: indication for anticoagulation, goal INR, duration of therapy, current anticoagulation therapy/dose, most recent or baseline INR result, baseline Complete Blood Count (CBC) with platelets, and plans for cardioversion or ablation therapy when applicable. Prior to referring patients, providers should assess:

(1) Patient/caregiver ability to self-administer medication.

(2) Risk/benefit of anticoagulation in patients with a history of alcohol abuse, psychiatric disorders, dementia, falls, and/or other contraindications or precautions to anticoagulation.

(3) Prior to the initiation of therapy with warfarin, referring providers will order baseline labs through the facility laboratory service, including complete blood count (CBC), prothrombin time (PT), and INR. POC testing should not be utilized to obtain baseline lab values.

b. Co-management (dual-care) of anticoagulation with a non-VA provider is prohibited, except for those patients who are enrolled in Community Care. Otherwise, if medications are to be dispensed from this facility’s Pharmacy or prescribed through the Anticoagulation Clinic, all monitoring of anticoagulant therapies are completed at this facility or at one of its associated Community-Based Outpatient Clinics (CBOCs). This facility will not dispense a parenteral anticoagulant medication to a co-management patient requesting bridge therapy if the patient has not been following with this facility for management of their oral anticoagulant for at least 1 month. Only patients whose chronic anticoagulation therapy has been managed and monitored by facility staff will qualify to receive bridge therapy medications.

c. Except in extreme circumstances, INRs must be obtained at a Department of Veterans Affairs (VA) laboratory/clinic to ensure current values are readily accessible to healthcare staff.

(1) Non-VA laboratory results are entered into the electronic medical record in order for these results to be easily accessible to all staff. Documentation of the non-VA INR result must include the name of the laboratory where the test was performed, the date of the test, and the reference range on the test. Action following receipt of a non-VA laboratory result will include scanning of non-VA laboratory reports into the patient’s medical record. Use Test Result note title with INR result in the subject line.

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(2) For patients enrolled in the HBPC Anticoagulation Program, blood draws for lab monitoring are drawn by Home Care nursing staff in the patient’s home.

Home Care nursing staff will utilize POC testing for ongoing therapy and will document the results of the POC INR test electronically in the medical record and inform the Home Care pharmacist of POC results.

(3) Staff performing ancillary testing (e.g., POC INR testing) undergo competency assessment as defined in national and local Pathology and Laboratory Medicine Service Procedures (see VHA Handbook 1106.01).

(4) This facility does not employ, utilize or provide patient self-testing devices for home INR monitoring or warfarin management.

d. Warfarin use is limited as follows:

(1) Strengths of warfarin available for prescribing and administration are limited to two milligram and five milligram tablets, with the occasional one milligram tablets prescribed. Tablet splitting devices are issued to all outpatients receiving warfarin therapy. Patients are discouraged from having more than one strength of warfarin at home to avoid confusion.

(2) Prescriptions for warfarin are limited to 30 days with a maximum of one refill or a 60-day supply.

(3) Patients who wish to have their warfarin prescription filled at an outside pharmacy are not eligible to be managed by this facility’s Anticoagulation Clinic. All patients managed by the Anticoagulation Clinic must obtain their warfarin prescription through this facility.

e. The Anticoagulation Clinic provider will provide patient/caregiver education to include: proper tablet identification, indication for therapy, interactions (drug, diet, and disease), daily dosage, monitoring requirements, importance of medication adherence and reporting for labwork, management of missed doses, dangers of using warfarin from different sources (e.g., VA and community pharmacy), the need to inform other health care providers about long-term anticoagulation therapy, the need to inform the anticoagulation provider when changes in medications occur or upcoming procedures are expected, signs/symptoms of bleeding and thromboembolic events and what to do if such an event occurs, risks of falling, the need to inform the anticoagulation provider about acute illness, major changes in diet, or upcoming travel, and proper medication storage. At a minimum, education is provided for all new warfarin starts and is ongoing during all follow-up appointments as needed with the Anticoagulation Clinic.

f. Patients should have their blood drawn on the date and time designated by each provider or Anticoagulation Clinic. Ongoing INR testing is conducted using POC testing where available. A venous INR is completed by the laboratory if POC is not available. If the POC INR is greater than or equal to 4.5, a venous INR is drawn.

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(1) It is implicit, as a policy laboratory order, that in all scheduled visits for ongoing warfarin management (i.e., visits where the patient is not being newly started on warfarin anticoagulation therapy) a POC INR is obtained from the patient without the need of a provider placing a per-patient electronic order.

(2) For visits at the main facility, the Anticoagulation Clinic pharmacist is listed as the provider for the POC INR.

(3) For visits occurring at community clinics via video, the pharmacist seeing patients in clinic for that day is listed as the provider for the POC INR.

(4) Venous blood draws will require the requesting pharmacist provider to place a laboratory order for a venous INR under their own name.

g. After INR results are available:

(1) The patient/caregiver is interviewed by the Anticoagulation Clinic provider or Home Care pharmacist.

(2) The provider will enter an electronic progress note using the agreed upon anticoagulation format. The progress note is titled PHARMACY ANTICOAGULATION to allow immediate recognition of the subject.

(3) The warfarin dose is continued or adjusted based on the patient’s INR, clinical condition, and recent medication or dietary changes. Every effort is made to investigate why a patient’s INR is not therapeutic before dose adjustment is initiated. In general, the maintenance dose of warfarin is adjusted by 5-20 percent of the patient’s weekly warfarin dose when the INR is consistently out of range and noncompliance is not suspected. In lieu of adjusting the maintenance warfarin dose, the provider may hold or give supplemental doses of warfarin at their discretion. The degree to which the INR is out of range will impact the provider’s judgment. Algorithms for the adjustment of warfarin have been developed and standardized within the facility for the initiation of warfarin, maintenance of warfarin, and peri-procedural management of anticoagulants.

Please see Attachments A and B for inclusion of facility approved algorithms. Use of the approved algorithms is subject to the anticoagulation provider’s clinical judgement.

(4) The provider must edit or renew the patient’s warfarin prescription accordingly so as to ensure that the patient’s medication list is up to date. All outpatient warfarin prescriptions should include instructions to “Always use as directed by the Anticoagulation Clinic” to avoid confusion with changes in instruction for use.

(5) Whenever possible, patients are provided with both verbal and written instruction on warfarin dose decisions.

(6) In the event that a veteran resides in a nursing home/personal care home, the anticoagulation therapy plan is both verbally communicated by telephone and communicated via a faxed progress note to the nursing home/personal care home

9 Medical Center Memorandum MM-35 personnel by close of business on the same day that the veteran was seen in the Anticoagulation Clinic.

h. All INRs must be reviewed and clinically evaluated no later than close of business the next business day. Management of critical INR values (greater than or equal to 4.5) must have documentation of appropriate action within 24 hours of the critical INR result.

i. All patients are assessed using the same basic criteria regardless of INR results, with special emphasis on current or potential problems. The criteria include:

(1) Signs and symptoms of thromboembolic events or bleeding;

(2) Recent changes in diet, alcohol consumption, and/or tobacco use;

(3) Changes in prescription medications, over-the-counter medications, herbal/supplement use, or antibiotic use;

(4) Compliance to the medication regimen;

(5) Recent illness, falls, hospitalizations, emergency room or physician visits;

(6) Any acute changes in the patient’s health status since last visit; and

(7) Whether warfarin is still indicated, as all anticoagulation providers should perform periodic risk-benefit assessments for all patients receiving anticoagulant therapy.

j. Frequency of monitoring:

(1) New starts: Baseline, then every few days initially, then every 1-2 weeks until INR is stable. This also applies to patients who are restarted on warfarin therapy after an interruption in therapy (e.g., patients on bridge therapy for a procedure). A baseline/initial INR must be documented in CPRS prior to the patient being prescribed warfarin therapy by this facility, regardless of whether the patient is already taking warfarin prescribed by an outside provider.

(2) Stable patients: All veterans who have their warfarin managed and monitored through the Anticoagulation Clinic will undergo evaluation of their bleeding risk using the HAS-BLED bleeding risk score on a yearly basis at a minimum. Please refer to Attachment C for inclusion of this tool. Patients determined to be at a low or intermediate bleed risk based on this tool should have monitoring for warfarin performed at least every 6 weeks. Patients determined to be at a high bleed risk based on this tool should have monitoring for warfarin performed at least every 4 weeks. INR monitoring should not occur any less frequently than at an interval of every 6 weeks.

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(3) A CBC with platelets is monitored prior to initiation of warfarin and then at least yearly for patients prescribed warfarin.

(4) Patients on bridge therapy must have a CBC and serum creatinine drawn at baseline (within the past 30 days). A CBC should also be drawn at least weekly with the INR while the patient remains on the parenteral anticoagulant being utilized for bridge therapy.

k. After the Anticoagulation Clinic provider or Home Care pharmacist determines a follow-up appointment date, the provider or designee schedules the appointment into CPRS. Patients are given dosing/appointment cards.

l. No-shows/missed appointments: If a patient misses a scheduled clinic visit or laboratory appointment, adequate follow-up is ensured by taking the following steps:

(1) Telephone call(s) to the patient to reschedule as soon as possible.

(2) If a patient cannot be reached by phone after a minimum of two documented separate attempts, a letter is mailed to the patient requesting the patient to contact the Anticoagulation Clinic to arrange a new appointment date.

(3) A total of three attempts, including a letter, are made to contact the patient to reschedule with the Anticoagulation Clinic.

(4) PCPs are alerted of consecutive missed appointments (two or more).

(5) Repetitive no-shows may result in discharge from the outpatient Anticoagulation Clinic.

(6) A list of patient cancellations/no-shows is set to print on a daily basis.

This daily list will contain the patient cancellations/no-shows from the previous day and is reviewed each business day by an Anticoagulation Clinic provider who will then contact the patient to reschedule them for follow-up. This has been done to help ensure that no patient on anticoagulants is lost to follow-up.

m. Vitamin K Administration: Vitamin K is not routinely given for elevated INRs without bleeding; however, it is prescribed for the patient when clinically necessary. Providers are referred to the most recent CHEST guidelines for direction. If vitamin K administration is felt to be necessary, the Anticoagulation Clinic provider will consult with a physician preceptor. If the physician preceptor is in agreement with the administration of vitamin K the Anticoagulation Clinic provider may write an order for a one-time dose of vitamin K to be filled by the pharmacy. If the patient is at a CBOC when vitamin K is needed the Anticoagulation Clinic provider will contact a provider at the CBOC to write a prescription for vitamin K to be filled at a local pharmacy through Butler VA Health Care System’s emergent drug program contract.

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n. Perioperative/periprocedural anticoagulation: Anticoagulation Clinic staff is to be alerted by the patient’s PCP in the event of an upcoming planned procedure through CPRS. Alerts to Anticoagulation Clinic staff may be completed through a consult, progress note or note addendum that identifies Anticoagulation Clinic staff.

Alternatively, the patient may call the Anticoagulation Clinic directly to alert clinic staff of an impending planned procedure. The provider who is responsible for the procedure, in conjunction with the patient’s PCP, is responsible for determining the length of time the oral anticoagulant is held prior to the procedure and the patient’s bridge therapy needs.

The Anticoagulation Clinic provider is responsible for ordering the proper quantity and dose of parenteral anticoagulants and for educating patients on the correct administration of these parenteral agents. The Anticoagulation Clinic provider is responsible for providing the patient with instructions on suspending anticoagulation therapy, pursuant to the instructions received from the patient’s PCP and/or provider responsible for the procedure on this matter. The provider who is responsible for the procedure, in conjunction with the patient’s PCP, is responsible for determining when anticoagulation therapy should be resumed following the planned procedure.

(1) It is required that patients have their chronic oral anticoagulation therapy managed and monitored at this facility in order to receive parenteral anticoagulants for bridge therapy from this facility.

(2) If a patient chooses to be enrolled in the Anticoagulation Clinic for long-term management of their chronic oral anticoagulant with the intent of obtaining a parenteral anticoagulant for bridge therapy in the near future he/she must be enrolled in the Anticoagulation Clinic for at least 1 month prior to the upcoming procedure so that the clinic may become familiar with the patient’s anticoagulation history and care.

(3) Patients will not be allowed to enroll in the Anticoagulation Clinic for short-term management of their chronic oral anticoagulation therapy solely for the purpose of obtaining a parenteral anticoagulant for bridge therapy.

o. Medical consultation: The Anticoagulation Clinic will seek medication consultation with the anticoagulation management physician champion or the patient’s PCP if the patient experiences:

(1) Signs/symptoms suggestive of a thromboembolic event;

(2) An acute change in mental status;

(3) Prolonged or copious hemoptysis, persistent large nosebleeds despite a therapeutic INR, bright red blood without straining or black tarry stools, hematuria;

(4) A large bruise with swelling;

(5) An acute change in health status;

(6) An INR of < 1.5 in a patient with a mechanical mitral valve replacement

12 Medical Center Memorandum MM-35 or an INR of < 1.3 in a patient with a mechanical aortic valve replacement;

(7) An INR of < 1.5 and the patient is < 1 month out from a new deep vein thrombus (DVT) or pulmonary embolism (PE) (provided they are not on bridge therapy);

(8) The patient is on parenteral therapy and platelets decrease from baseline by 50 percent or fall to < 100,000;

(9) The INR is > 6 in a patient that is a high bleed risk, or patient is very frail;

(10) The patient has completed a predetermined length of therapy;

(11) The risk-benefit of continued therapy is questioned; or

(12) The use of vitamin K is under consideration

p. A list of recently ordered medications that have the potential to interact with anticoagulants has been set to automatically print on a daily basis. When a drug that may interact with anticoagulants is ordered by a provider for a patient on anticoagulants the drug name and patient name are indicated on this list the following day. This list is reviewed each business day by an Anticoagulation Clinic provider who will then determine if anticoagulant dose adjustments and/or follow-up laboratory tests are needed.

q. Patient Discharges: The patient’s PCP is informed when a patient is discharged from the Anticoagulation Clinic. Patients may be discharged from the Anticoagulation Clinic back to their primary care team for anticoagulation management for any of the following reasons:

(1) The patient continues to drink alcohol and the level of anticoagulation remains unacceptable despite the practitioner’s best efforts and repeated education;

(2) The patient repetitively misses consecutively scheduled clinic appointments due to noncompliance;

(3) The patient refuses medical follow up at this facility;

(4) The patient refuses or is unwilling to follow instructions regarding anticoagulants as provided by the Anticoagulation Clinic;

(5) The patient has a non-VA physician who remains actively involved in his/her anticoagulation therapy (e.g., changes the patient’s warfarin dose). In this case, the patient is informed that his/her warfarin prescription will be canceled, and the patient will need to purchase warfarin outside the VA and anticoagulation therapy must be monitored by a non-VA physician; or

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(6) The patient is noncompliant despite the practitioner’s best efforts and documentation of changing this habit.

r. All outpatients on anticoagulant therapy will have appropriate International Classification of Diseases (ICD) Diagnosis Codes added to the problem list.

Additionally, appropriate Systematized Nomenclature of Medicine-Clinical Terms (SNOWMED-CT) codes may be used as applicable.

4. Direct Oral Anticoagulant (DOAC) patients:

a. Outpatients are enrolled into the Anticoagulation Clinic or the Home Care Anticoagulation Program after a restricted/non-formulary consult for therapeutic anticoagulation with dabigatran, rivaroxaban, apixaban, or edoxaban has been reviewed and approved by the non-formulary committee. All non-formulary consults are entered as a CPRS electronic consult for these agents. In addition, patients are required to have an electronic Pharmacy Anticoagulation Consult entered into CPRS which will include: indication for anticoagulation, duration of therapy, current anticoagulation therapy/dose, baseline laboratory results, and plans for cardioversion or ablation therapy when applicable. Prior to referring patients, providers should assess:

(1) Patient/caregiver ability to self-administer medication.

(2) Risk/benefit of anticoagulation in patients with a history of alcohol abuse, psychiatric disorders, dementia, falls, and/or other contraindications or precautions to anticoagulation.

(3) Prior to the initiation of therapy with a DOAC, referring providers will order baseline labs through the facility laboratory service, including complete CBC, serum creatinine and liver function tests.

b. An Anticoagulation Clinic provider will provide patient/caregiver education to include: capsule/tablet identification, proper handling and storage of medication, indication for therapy, dosing instructions, interactions (drug, diet, and disease), monitoring requirements, importance of medication adherence, the management of missed doses, signs and symptoms of bleeding and thromboembolic events, and what to do if such an event occurs, non-bleeding adverse events, risks associated with falling, and the need to inform other health care providers about long-term anticoagulation therapy, the need to inform the anticoagulation provider when changes in medications occur or upcoming procedures are expected, the need to inform the anticoagulation provider about acute illness, major changes in diet, or upcoming travel, and the dangers of using medication from different sources. At a minimum, education is provided for all new starts and is ongoing during all follow-up appointments with the Anticoagulation Clinic.

c. The pharmacy will ensure that all dabigatran will be dispensed and stored in the manufacturer bottle with the original desiccant cap or blister package. Dabigatran will not be repackaged or stored in any other container. The Anticoagulation Clinic staff

14 Medical Center Memorandum MM-35 will also ensure that it is communicated to patients taking this medication during the provided patient/caregiver education that this product must be used within 4 months of opening.

d. Monitoring:

(1) Baseline tests prior to initiating treatment will include: CBC, serum creatinine to estimate Creatinine Clearance (CrCl), ideal body weight (for estimate of CrCl), and liver function tests.

(2) At least one in person clinic appointment will be completed in the Anticoagulation Clinic two to four weeks after approval of the non-formulary consult approval for a DOAC and enrollment in to the Anticoagulation Clinic (or sooner if clinically indicated) to assess for tolerance, bleeding, thromboembolic events, other adverse events (e.g., gastrointestinal intolerance), adherence, correct dosing, duplicate therapy and reinforcement of educational points as needed.

(3) Ongoing monitoring of DOACs will be completed as advised by the VA Pharmacy Benefits Management Services (PBM), Medical Advisory Panel (MAP), and VISN Pharmacist Executives.

(a) SCr (to estimate CrCl) as clinically appropriate. SCr should be monitored at least annually and more frequently in those with renal impairment (e.g., CrCl < 60 ml/min), concomitant illness that may lead to worsening renal function, or patients who are 75 years of age or older.

(b) CBC (including platelets) as clinically appropriate. CBC (including platelets) should be monitored at least annually or more frequently as the clinical situation dictates.

(c) Liver function testing may be considered in patients with underlying liver disease or when the clinical situation dictates.

(4) Monitoring after the initial in person clinic appointment will be completed through the DOAC Population Management Tool (PMT). The PMT will flag the Anticoagulation Clinic provider of overdue refills, overdue labs, present contraindications to DOAC use, appropriateness of DOAC dosing, lab results that are of notable concern in their level/result, and drug-drug interactions with DOAC use. The PMT will be monitored by Anticoagulation Clinic staff at least daily on business days (Monday through Friday) during normal business hours. Further in person clinic appointments in the Anticoagulation Clinic may be scheduled at the discretion of the Anticoagulation Clinic provider or other designated provider in response to PMT flags or as the clinical situation dictates.

e. Except in extreme circumstances, lab work must be obtained at a Department of Veterans Affairs (VA) laboratory/clinic to ensure current values are readily accessible to healthcare staff.

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(1) Non-VA laboratory results are entered into the electronic medical record in order for these results to be easily accessible to all staff. Documentation of the non-VA lab results must include the name of the laboratory where the tests were performed, the date of the tests, and the reference range on the tests. Action following receipt of a non-VA laboratory results will include scanning of non-VA laboratory reports into the patient’s medical record. Use Test Result note title with lab results in the subject line.

(2) For patients enrolled in the HBPC Anticoagulation Program, blood draws for lab monitoring are drawn by Home Care nursing staff in the patient’s home.

g. No-shows/missed appointments: If a patient misses a scheduled clinic visit or laboratory appointment, adequate follow-up is ensured by taking the following steps:

(1) Telephone call(s) to the patient to reschedule as soon as possible.

(2) If a patient cannot be reached by phone after a minimum of two documented separate attempts, a letter is mailed to the patient requesting the patient to contact the Anticoagulation Clinic to arrange a new appointment date.

(3) A total of three attempts, including a letter, are made to contact the patient to reschedule with the Anticoagulation Clinic.

(4) PCPs are alerted of consecutive missed appointments (two or more).

(5) Repetitive no-shows may result in discharge from the outpatient Anticoagulation Clinic.

h. Medical consultation: The Anticoagulation Clinic will seek medication consultation with the anticoagulation management physician champion or patient’s PCP if the patient experiences:

(1) Signs/symptoms suggestive of a thromboembolic event;

(2) An acute change in mental status;

(3) Prolonged or copious hemoptysis, persistent large nosebleeds, bright red blood without straining or black tarry stools, hematuria;

(4) A large bruise with swelling;

(5) An acute change in health status;

(6) A significant decrease in the patient’s CrCl that would necessitate a change in the patient’s dose of medication or a contraindication to use of the medication;

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(7) Anemia develops (hemoglobin level < 10 g/dL);

(8) Thrombocytopenia develops (platelet count < 100,000/uL);

(9) The patient has completed a predetermined length of therapy;

(10) The risk-benefit of continued therapy is questioned; or

(11) The patient develops known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis, Liver Function Test (LFT) elevations greater than 2-3x the upper limit of normal or hepatic disease associated with coagulopathy).

i. Patient discharges: The patient’s PCP is informed when a patient is discharged from the Anticoagulation Clinic. Patients may be discharged from the Anticoagulation Clinic back to their primary care team for anticoagulation management for any of the following reasons:

(1) The patient repetitively misses consecutively scheduled lab/clinic appointments due to noncompliance.

(2) The patient refuses medical follow up at this facility.

(3) The patient refuses or is unwilling to follow instructions regarding anticoagulants as provided by the Anticoagulation Clinic.

(4) The patient is noncompliant despite the practitioner’s best efforts and documentation of changing this habit.

l. All outpatients on anticoagulant therapy will have appropriate International Classification of Diseases (ICD) Diagnosis Codes added to the problem list. Additionally, appropriate Systematized Nomenclature of Medicine-Clinical Terms (SNOWMED-CT) codes may be used as applicable.

5. Parenteral anticoagulant patients:

a. Patients who are prescribed a parenteral anticoagulant without concomitant oral anticoagulant therapy (i.e. not on bridge therapy) are followed and monitored by the provider who prescribed the anticoagulant (i.e. PCP). For outpatients, only subcutaneous heparin, LMWH, and fondaparinux may be prescribed.

(1) Patients on LMWH or fondaparinux will have a baseline CBC with platelets and serum creatinine (within the last 30 days). Patients will also have a documented weight. Patients should have a CBC with platelets and serum creatinine completed periodically throughout treatment at a minimum of once monthly if they are to receive LMWH or fondaparinux for more than 14 days.

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(2) Patients on a long-term parenteral anticoagulant only must have a “MED-LMWH and Fondaparinux” template entered into CPRS prior to dispensing the parenteral anticoagulant prescription if receiving the medication for more than 14 days.

(3) All of the following areas of the “MED-LMWH and Fondaparinux” template must be filled out prior to dispensing:

(a) New start or ongoing use;

(b) Medication and dose being prescribed;

(c) Indication;

(d) Any adverse events reported;

(e) Pertinent lab information; and

(f) Plan.

(4) No orders for LMWH or fondaparinux are verified by a VA pharmacist if any information is missing from the “MED-LMWH and Fondaparinux” template or if a template has not been completed. These orders are referred back to the PCP for completion of the required template.

(5) All LMWH and fondaparinux prescriptions are ordered for a maximum of a 30-day supply with no refills.

b. Heparin use is limited as follows:

(1) Heparin vials are only stocked in the pharmacy. Heparin vials are not included in ward stock.

(2) Heparin IV boluses and infusions are not used at this facility or at any of its clinics.

(3) The concentration of heparin vials used is limited to 5,000 international units per milliliter.

(4) Only single dose products are used. No multi-dose heparin products are available at this facility.

(5) Prescribing and monitoring of subcutaneous heparin regimens are the responsibility of the Primary Care or Attending Provider.

(6) Patients ordered subcutaneous heparin therapy must have a CBC with platelets and Activated Partial Thromboplastin Time (aPTT), prior to initiation of therapy.

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(7) Regular monitoring should include Hemoglobin (HGB), Hematocrit (HCT), platelet count, and aPTT.

B. Long-Term Care Anticoagulation Management:

1. The initiation of anticoagulation therapy for residents of the CLC is the responsibility of the admitting or attending provider. This includes the responsibility for writing the initial warfarin and/or parenteral anticoagulant order for the resident as well as entering a Pharmacy Anticoagulation Consult for pharmacy to manage ongoing anticoagulation therapy. When writing the initial warfarin and/or parenteral anticoagulant order, the admitting provider should keep in mind that consults entered on Friday may not be seen by pharmacy until Monday. Thus, the provider should make certain that the initial warfarin and/or parenteral anticoagulant order does not result in missed doses of the medication.

2. The Clinical Pharmacists/Clinical Pharmacy Specialists are responsible for ongoing management of residents on oral anticoagulation therapy following the initiation of therapy by the admitting or attending provider.

3. During normal business hours, the inpatient anticoagulant management program may be reached by calling the inpatient pharmacy extension. This extension will provide access to a pharmacist trained in anticoagulation management. Any inquiries regarding anticoagulation outside of normal business hours are to be directed to the pharmacist on-call.

4. Oral unit dose products and pre-filled syringes are used when these products are available.

5. All anticoagulant products stored in automated dispensing devices (Pyxis machines) are stored separately by drug, strength, and formulation.

6. The dietary needs of all residents receiving warfarin are reviewed by the unit dietitian, after notification via notifications/alerts in CPRS/VistA according to MCM MM- 11, Drug Nutrient Interaction Patient Education.

7. Prior to discharge, the attending provider or clinical pharmacist will arrange for patients to have anticoagulation follow-up as an outpatient in order to ensure coordinated transition from the CLC to outpatient status.

C. Risk-Benefit Assessments:

1. All patients receiving anticoagulant therapy who are managed in the anticoagulation clinic will undergo annual risk-benefit assessments.

2. Risk-benefit assessments will be performed by anticoagulation clinic practitioners and will include the following components:

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a. Patient adherence to therapy;

b. Degree of control with warfarin when applicable, measured by Time in Therapeutic Range (TTR) or proportion of values in therapeutic range (if TTR is not available);

c. Risk of bleeding;

d. Risk of thrombosis;

e. Kidney and liver function; and

f. Changes in general health, frailty, and fall risk.

D. Quality Assurance:

1. The use of anticoagulation is monitored to ensure safe practices. The facility will monitor and report to the Pharmacy and Therapeutics (P&T) Committee on a quarterly basis:

a. Supra-therapeutic INRs (above the critical value);

b. That appropriate action has been taken on critical INRs within 24 hours of INR testing and documentation of action(s) taken;

c. Bleeding events;

d. Thromboembolic events;

e. Percentage of INRs maintained within therapeutic range;

f. Patients on warfarin that have not had an INR within the last 42 days;

g. Patient incidents, close-calls, and near misses associated with anticoagulant medications; and

h. Adverse drug events (ADEs) involving anticoagulants.

2. Anticoagulation Competencies and Credentialing:

a. Clinical staff members who are not Licensed Independent Practitioners (LIP) but provide anticoagulation therapy management under a Scope of Practice must undergo experiential training in the Anticoagulation Clinic under the guidance of one or more experienced, credentialed practitioner(s). Direct observation of the practitioner for a minimum of 20 work days and 50 patient care encounters must be met and documented prior to completion of the credentialing process.

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b. To certify competency, a written exam is conducted as a part of experiential training. All questions on the exam must be answered completely and accurately.

c. Written exams are assessed by a credentialed practitioner and returned to the trainee for correction. A total of two revisions are allowed (three total attempts) for all questions to be answered correctly. Trainees who are unable to achieve complete success at the end of three exam attempts are reassessed for suitability to safely provide anticoagulation therapy management and recommended to be remediated or reassigned on an individual basis to ensure patient safety.

d. The final step in certifying competency is a verbal exam to be administered by an experienced and credentialed practitioner. Upon satisfactory completion of the verbal exam, the staff member is deemed certified to practice independently within the Anticoagulation Clinic under the guidance of the Anticoagulation Policy.

e. Re-credentialing of non-LIP anticoagulation providers will occur annually:

(1) Electronic training offered through Talent Management System (TMS) regarding anticoagulation therapy must be documented annually.

(2) A yearly exam and/or staff training will be completed by all Anticoagulation Clinic practitioners to assess competency and/or address emergent information regarding anticoagulants or specific topics identified as important for anticoagulation management.

(3) The facility will require competency assessments for all practitioners who practice in the anticoagulation clinic. A Focused Professional Practice Evaluation (FPPE) will be completed after the first 90 days of practice in the anticoagulation clinic.

Thereafter, an Ongoing Professional Practice Evaluation (OPPE) will be completed every 6 months. At any time, a FPPE will be extended or reinstituted if a practitioner’s performance falls below an acceptable level as defined in the FPPE or OPPE.

(4) To qualify for re-credentialing and continue to practice, practitioners must have practiced within the anticoagulation clinic at a minimum of one time each quarter in the past year, unless there are extenuating circumstances (e.g., maternity leave, extended sick leave, staffing issues, etc.)

VI. REFERENCES:

VHA Directive 1033, Anticoagulation Therapy Management, dated July 29. 2015.

National Patient Safety Goals 2020, The Joint Commission Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST.

February 2012; 141 (2 suppl) 1S-801S.

VII. RESCISSION: Medical Center Memorandum MM-35, dated October 20, 2018.

21 Medical Center Memorandum MM-35 for

SHARON COYLE, MSN, RN, MBA

Interim Director

(Automatic Review Date: November 1, 2022)

ATTACHMENT A

WARFARIN MANAGEMENT ALGORITHM – INITIATION PHASE OF THERAPY

Step1: Begin with 5 mg or 2 mg daily (if patient requires a lower dose).

Lower initial dosing may be appropriate based on the following patient characteristics:

▪ Age (generally, frail elderly patients are more sensitive to warfarin)

▪ Weight (generally, low body weight or malnourished patients are more sensitive to warfarin)

▪ Past medical history (including liver dysfunction, heart failure, end-stage renal disease, hyperthyroidism, or recent major surgery)

▪ Social history (including alcohol or tobacco use)

▪ Interacting medications (prescription, herbal and over-the-counter products)

▪ Dietary habits and nutritional status (especially dietary vitamin K content)

▪ Acute illness (including loss of appetite, fever, vomiting, and diarrhea)

▪ Risk factors for bleeding (including bleeding disorder, history of bleeding, peptic ulcer disease, history of hemorrhagic stroke, high fall risk, and hypertension)

Step 2: Follow warfarin dosing adjustments based on INR results.

Measurement Day INR Action

Measurement PT/INR on Day 1 Baseline

INR

Start patient on 2 to 5 mg depending on risk factors

Measurement PT/INR on Day 3-4 < 1.5 1.5-1.9 2.0-2.5 > 2.5

Increase weekly dose by 5-25% No dosage change Decrease weekly dose by 25-50% Decrease weekly dose by 50% and/or HOLD dose

Measu…