S02_Attachment_26_-__Anticoagulant_Patient_Management_Program.docx

MEDICAL CENTER POLICY MEMORANDUMS

NUMBER/TITLE OF POLICY: 119-05 Anticoagulant Patient Management Program

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POINT OF CONTACT FOR FURTHER INFORMATION:

Melanie Swims x7933

POLICY MEMORANDUM

VA Medical Center 1030 Jefferson Avenue Memphis, TN 38104

Number: 119-05

Dated: December 2, 2017

Expires: December 31, 2022

Title: Anticoagulant Patient Management Program

1. PURPOSE: To individualize and standardize anticoagulation therapy and to reduce the risk of harm with anticoagulant use.

2. POLICY:

a. The Anticoagulant Management Program is coordinated by Pharmacy Service and involves interdisciplinary VA staff (medical professional staff) in its implementation. The Anticoagulation Program Manager, Designated Clinical Pharmacy Specialists and Clinical Pharmacy Residents are responsible for implementation and monitoring of the Anticoagulant Management Program (Attachment A).

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

c. Patients are enrolled in the Anticoagulation Management Program by means of Anticoagulation Consult in Computerized Patient Record System (CPRS) (Attachment B). Patients who are on warfarin, direct oral acting anticoagulants (DOACs), or full dose injectable anticoagulants (i.e., heparin, enoxaparin, argatroban, et.al) are appropriate candidates for this service.

d. The Anticoagulant Management Program will reduce the risk of harm from anticoagulant use via provider education, consultation, medicine order sets, monitoring, and patient/family education. The program will follow VHA Directive 1033, Anticoagulation Therapy Management or subsequent policy issue. The program will also comply with the Joint Commission National Patient Safety Goal Requirement NPSG.03.05.01 “Reduce the likelihood of patient harm associated with the use of antigoagulation therapy.”

3. RESPONSIBILITY: Responsibility for appropriate evaluation of patients' need for anticoagulation and subsequent request of anticoagulation consults rests with the patient's provider. If a patient is on anticoagulation and a procedure is planned the provider is encouraged to follow the periprocedural National guidelines individualized to the patient. The provider doing the surgical procedure necessitating stopping anticoagulation is responsible for determing when it is safe to restart the anticoagulation. Assistance with this process may be obtained by submitting an anticoagulation consult. The Anticoagulant Management staff is responsible for implementation and monitoring of the Anticoagulant Patient Management Program.

4. PROCEDURE:

a. Anticoagulation Initiation (Protocol Initiation): Providers will utilize current guidelines to appropriately initiate anticoagulation on patients when appropriate. Protocols for management of anticoagulation will be based on current guidelines from the American College of CHEST Physicians, American Hearth Association or other appropraiate expert groups.

b. Appropriate unit dose products, pre-filled syringes, pre-mixed infusion bags, and programmable infusion pumps for intravenously-administered anticoagulants will be utilized as available.

c. Anticoagulants will be listed on the High Alert medication list.

d. Baseline labs and maintenance labs will be described in national policy. These lab requirements are listed in the Anticoagulation Guideslines on the CPRS Toolbar. Additional materials are available on the Pharmacy Service SharePoint site.

e. Weight based heparin protocols will be utilized.

f. Traveling veterans will be cared for in accordance the the VHA Handbook 1101.11, Coordinated Care Policy of Traveling Veterans, or subsequent policy issue.

g. At this time, our facility will not routinely utilize patient self testing.

h. Quality Assurance will be reported through the Medication Use Committee to the Clinical Executive Board.

i. Inpatient Setting:

(1) Pharmacy Service staff will be responsible for running a list of inpatients on warfarin, direct oral oral anticoagulants, and full dose injectable anticoagulants. Each patient will be assigned to a pharmacist and any identified problems will be discussed with the treating team.

(2) A list of critically high INRs PTTs, unfractionated heparin assays, and low molecular weight heparin assays will be reviewed by pharmacy staff daily.

(3) Providers initiating anticoagulation should place an anticoagulation consult by entering the consult in Computerized Patient Record System (CPRS). Education for prescribers and protocols are incorporated into the CPRS ordering action. Anticoagulation Guidelines based on the most recent guidelines are available under TOOLS (in CPRS) and online for use. The pharmacy staff is available to aid in anticoagulant management.

(4) Through the use of inpatient anticoagulation consults in CPRS, new orders for prescribing anticoagulants will be placed appropriately to ensure patient treatment and safety. Utilization of this consult will ensure appropriate baseline labs for all anticoagulants and appropriate involvement of the Nutrition & Food Service.

(5) Baseline and routine periodic laboratory values will be monitored as per national guidelines. After the anticoagulation consult is received the pharmacist will review the chart and write an initial anticoagulation note with recommendations to the treating team. After the initial review, notes will be written as clinically appropriate and the patient and or family will be educated prior to discharge.

(6) Indications and therapeutic goals for anticoagulation therapy should be consistent with nationally published guidelines unless provider judgment dictates otherwise.

(7) Prescribers will add (Long Term Use of Anticoaglation) that denotes long term use of anticoagulants to the problem list of outpatients on anticoagulation therapy as well as other appropriate diagnostic codes.

(8) New patients who will be on warfarin will receive the Warfarin Agreement, which is patient education information in written form, and includes a statement for the patient indicating that they accept their responsibility for safe anticoagulation. A Warfarin Agreement Note must be placed in CPRS at the time the patient receives the agreement. Contact phone numbers are also listed on this agreement.

j. Outpatient Setting:

(1) In the VA staffed outpatient setting, after the anticoagulation consult is received, the patient will have an appointment in one of the Therapeutic Monitoring Clinics (TMC) scheduled in a clinically appropriate timeframe. New starts should be seen within 4 – 7 days. There, the pharmacy staff running the clinic will manage the warfarin therapy of the patient.

(2) Patients located at a contracted Community Based Outpatient Clinic (CBOC) who require anticoagulation monitoring through the VA, will be managed by the Therapeutic Monitoring Clinic staff, Primary Care Provider, or designee.

(3) Warfarin:

(a) Should be used for approved indications

(b) Patients on warfarin will be given the Warfarin Agreement at a clinic visit if they have not yet received it. A Warfarin Agreement Note must be placed in CPRS at the time the patient receives the agreement.

(c) INR results will be reviewed and clinically evaluated no later than the close of the next business day.

(d) Notes on warfarin management should contain at minimum the following: indication for warfarin, goal INR, duration of therapy, current warfarin dose and any changes to the dose, compliance, potential adverse drug reactions including bleeding episodes, dietary considerations, medication interactions with warfarin, and appropriate follow up.

(e) Warfarin will be ordered and dispensed for each patient and must not exceed a 30 day supply with 2 refills. Normally only one dosing strength should be prescribed per patient and the therapeutic monitoring note should be compared against the written prescription for any discrepancies. If a dose is changed the staff in the clinic should provide a written dosing sheet so the patient can refer to it until the new prescription bottle arrives.

(f) Warfarin Monitoring and Follow up: (Maintenance Protocol)

1. Baseline and required ongoing labs should be performed as below in section l. Frequency of International Normalized Ratio (INR) testing should be consistent with nationally recognized evidenced-based guidelines. The VHA National Directive recommends that INRs be checked normally at four (4) week intervals in stable patients. To allow for situations where stable patients are unable to have their INR checked in four (4) weeks (e.g., transportation or weather problems), a maximum of a six (6) week interval may be used.

2. Patients with unstable/non-therapeutic INR’s should have their INR checked more frequently. This may include, but is not limited to, those patients who have recently started on warfarin, the warfarin dose was recently changed, those being bridged to a therapeutic INR, or a medication that may interact with warfarin has been started. If a medication that may interact with warfarin is being started, providers may notify TMC by placing a “Notify Anticoagulation Clinic” order under order sets in CPRS. Please see protocol on pharmacy sharepoint site for more specific information.

(4) Direct Oral Anticoagulants:

(a) Should be used for approved indications and in approved doses for specified indications.

(b) Baseline and required ongoing labs should be performed as below in section l. This would then be normally at baseline, one month, three months and then periodically usually every six (6) months. If a patient is approved from outside on these and has been stable long term then the early additional monitoring may be omitted.

(c) Patient education handouts specific to the DOAC prescribed will be used to educate patients. Patients will also be verbally educated during visits.

(5) Injectable Anticoagulants

(a) Should be used for approved indications and in approved doses for specified indications.

(b) Baseline and required ongoing labs should be performed as below in section l. This would then be normally at baseline, one month, then periodically usually every three (3) to six (6) months. Monitoring may be done by specialty provders who monitor the patient on a regular basis (i.e. Hematology/Oncology).

(c) Patient education handouts specific to the anticoagulation prescribed will be used to educate patients. Patients will also be verbally educated during visits.

(6) No Shows / Cancellations:

(a) If a patient is a no-show or cancels without notification the TMC appointment associated with or without a consult, the patient will be rescheduled in one to two weeks as clinically appropriate. If the patient cannot be reached by phone a no contact letter will be mailed. If the patient fails to call back to reschedule their appointment, warfarin will be placed on hold or discontinued and the patient’s primary care provider will be notified.

(b) If after the second appointment is made, but the patient fails to keep the second appointment, an attempt to reach the patient by phone will be made. If the patient cannot be reached by phone, warfarin will be placed on hold or discontinued and the patient’s primary care provider will be notified. A letter notifying the patient of the same will be sent.

(c) Patients can be scheduled back to see a TMC provider only if another consult is placed by the referring provider or at the expressed consent of the TMC provider.

(7) Notes: Patients having anticoagulation monitored by the Memphis VAMC must have CPRS notes entered at each anticoagulation clinic visit.

(8) The dispensing pharmacist will check dosages of anticoagulants and for baseline laboratories as per VISN guidelines. Any warfarin dose over 15 mg daily, dabigatran 150 mg BID, rivaroxaban 20 mg daily, apixaban 5 mg BID (except in case of venous thromboembolism treatment, then 10mg BID), edoxaban 60mg daily, IV heparin dose (standard drip) over 40 ml/hour (1600 units per hour), dalteparin dose over 18,000 units, fondaparinux over 10 mg, or enoxaparin dose over 150 mg will mandate a chart review. Also, baseline labs and potential drug interactions will be reviewed appropriately at this point.

(9) Drug – Drug Interactions: Providers or pharmacists may enter the alert “Notify Anticoagulation Clinic” to immediately alert the anticoagulation clinic of any new prescribed interacting medications. The providers (pharmacists or otherwise) may be paged for urgent issues.

k. Patient Education: As part of the anticoagulant patient management program, pharmacy staff will educate patients on anticoagulation. Patient/family education will include as applicable:

(1) Indication for therapy

(2) Capsule or tablet identification

(3) Daily dose, including subsequent dose changes

(4) Importance of medication adherence and management of missed doses

(5) Administration considerations

(6) Proper storage of medication, as applicable

(7) Anticipated duration of therapy

(8) The danger of using anticoagulants from different sources

(9) Monitoring requirements and proper follow-up

(10) Any dietary restrictions

(11) Risks associated with falling and what to do in the case of a fall

(12) Potential for adverse drug reactions

(13) Drug interactions

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

(15) Non-bleeding adverse events

(16) The need to tell other providers about anticoagulation therapy, when changes in medicines occur or upcoming procedures or travel are expected

(17) Contact information for the anticoagulation or designated provider

(18) Gender-specific considerations for women of childbearing age (e.g., menstrual difficulties, pregnancy)

l. Laboratory monitoring:

(1) Required baseline laboratory tests for patients on anticoagulation therapy:

(a) Heparin: Complete blood count (CBC), activated partial thromboplastin time (aPTT).

(b) LMWH and Factor Xa Inhibitors (Fondaparinux): CBC, serum creatinine.

(c) Warfarin: CBC, PT (prothrombin time), INR (international normalized ratio)

(d) DOAC: CBC, serum creatinine.

(2) Required Ongoing Laboratory tests for patients on anticoagulation therapy:

(a) Heparin: CBC, aPTT.

(b) LMWH and Factor Xa Inhibitors (Fondaparinux): CBC, serum creatinine.

(c) Warfarin: CBC, PT, INR.

(d) DOAC: CBC, serum creatinine.

(3) Any nonVA labs such as home health will be entered into the note/computer via clinical reminder Anticoagulation INR.

m. Periodic Risk Benefit Assessment of patients on anticoagulation therapy:

A periodic risk benefit assessment should be performed to determine if anticoagulation is still appropriate. Recommended components of the risk-benefit assessment include, but are not limited to:

(a) Patient adherence to therapy;

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

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

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

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

(f) Changes in general health, frailty, fall risk, and other possibly relevant considerations.

n. Point of Care (POC) INR Orders

(1) Per the scheduling policy return to clinic orders must be placed in CPRS for those patients who require an appointment for return.

(2) For patients returning to TMC in which an point of care (POC) INR is required, the return to clinic order must include the term “POC-INR” in the comments section of the return to clinic order. This will satify the need for an order for an POC-INR to be completed.

(3) For the purposes of the JC, completed return to clinic order can be found under the CPRS Orders tab click on view at the top Custom order view click on Complete/Expired click on ok

o. Staff Education will be ongoing and may include:

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

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

(3) VA educational programs as options for staff education and educational forums.

5. REPORTING REQUIREMENTS: Quality assurance activities will be reported through the Medication Use Committee (MUC) to the Clinical Executive Board (CEB). The Anticoagulant Therapy Program Coordinator will track INR values greater than the critical value, that appropriate action has been taken on critical INRs within 24 hours of testing, pathologic bleeding events, thromboembolic events (where possible to determine), sub-therapeutic INRs (where possible to determine), and patient incidents, close-calls, and near misses associated with anticoagulant medications.

6. RESPONSIBLE OFFICE: Pharmacy Service (119).

7. REFERENCES: VHA Directive 1033 Anticoagulation Therapy Management and the Joint Commission National Patient Safety Goal Anticoagulation Requirements or subsequent policy issues.

8. RESCISSION: Medical Center Policy Memorandum 119-05, dated July 28, 2014.

Medical Staff Concurrence:

Date: December 2, 2017

/s/

THOMAS C. FERGUSON, M.D.

Chief of Staff

/s/

DAVID K. DUNNING, MPA

Medical Center Director

Attachment A Policy Memorandum 119-05 Date: December 2, 2017

Attachment B Policy Memorandum 119-05 Date: December 2, 2017

All Patients Provider determines if warfarin, direct acting oral anticoagulant,or full dose injectable anticoagulants are necessary and evaluates any comorbidities, drug interactions, and potential for bleeding. Anticoagulation Consult is entered.

Baseline labs and medications are ordered via the consult. Educational material for prescribers present in consult.

Nutrition Consult is ordered for warfarin inpatients.

Pharmacists check dosages, drug interactions, and baseline labs. Medication is dispensed. Education is provided verbally with written materials to reinforce. Patients on warfarin are asked to sign the warfarin agreement.

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