36C24419R0074-033.pdf

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER

Erie, Pennsylvania

Medical Center Memorandum No. 119-32 September 7, 2018

ANTICOAGULATION CLINIC

I. PURPOSE: To establish the policy and procedures relating to the scope of treatment for patients enrolled in the Anticoagulation Clinic.

II. POLICY:

A. Short and long-term oral anticoagulation carry a risk of significant hemorrhage.

This risk can be minimized by strict adherence to evidence based guidelines, outlining appropriate intensity and follow-up of anticoagulation. The

Anticoagulation Clinic is designed to provide a uniform mechanism for the management of anticoagulation therapy for patients. Patients referred to the

Anticoagulation Clinic will be properly anticoagulated for as long as therapeutically indicated so as to minimize risk of adverse effects of anticoagulant therapy and maintain effectiveness of anticoagulation.

B. Effective warfarin and low molecular weight heparin (LMWH) management is often difficult to achieve in primary care clinics. Therefore, patients receiving warfarin and LMWH at this medical center must be enrolled and followed in the

Anticoagulation Clinic.

C. The Anticoagulation (AC) Clinic will manage/monitor all DOAC patients when therapy is initiated. Once stable, long-term management may be transitioned to the primary care provider (PCP) for routine lab work and medication prescribing.

The AC Clinic will use the DOAC Population Management Tool to identify patient issues falling outside the recommended parameters for DOAC use. The

Clinic will contact the Primary Care (PC) team to address these issues. DOAC patients requiring close pharmacologic management will remain in the AC Clinic if deemed clinically appropriate by the Clinic. PCP can reconsult the

Anticoagulation Clinic with any questions or concerns.

D. For the purposes of this policy, the definition of Anticoagulation Clinic provider is clinical pharmacy specialists assigned to this clinic. The healthcare professionals working in the Anticoagulation Clinic (Anticoagulation Clinic

Providers (ACP) and clinical pharmacy specialists (CPS)) have been granted prior authority to perform the functions included in the MCM as outlined in their individual scope of practice or medical center clinical privileges.

MCM 119-32, Anticoagulation Clinic

III. RESPONSIBILITY:

A. The patient's primary care physician (PCP) will retain responsibility for the comprehensive medical care of every patient. The PCP is the initial medical referral for patients requiring further evaluation and/or work-up.

B. The Medical Director, Primary Care, or designee will serve as the supervising physician of the Anticoagulation Clinic. In the absence of the supervising physician, a staff physician will assume the responsibilities of the supervising physician, or will delegate these responsibilities to another staff physician.

C. The supervising physician is responsible for the back-up medical referral for patients requiring further evaluation and/or work-up beyond the scope of written protocols. Additionally, he/she is responsible for evaluating clinic function, reviewing guidelines, reviewing and resolving inconsistencies between requested anticoagulation therapy and standard literature recommendations and participating in performance improvement reviews pertaining to the Anticoagulation Clinic.

D. The ACP will provide direct management of the patient's anticoagulant therapy.

This will include adjusting anticoagulant therapy, assessing therapeutic responses at appropriate intervals, detection and resolution of therapeutic problems related to anticoagulation, ensuring adequate patient education, maintaining appropriate documentation in patient's clinical records regarding: current medications, subjective and objective data regarding hemorrhage (e.g. bleeding, bruising), dosage adjustments, prothrombin time and International Normalized Ratio (INR) values, as well as designated clinical follow-up. ACPs are authorized to write prescriptions for warfarin, LWMH, DOACs, without obtaining an additional countersignature, within their scope of practice/medical center clinical privileges.

E. Anticoagulation clinic staff members will ensure that all patients will also have a scheduled follow up date in the Anticoagulation Clinic electronic database. For patients on warfarin, the Anticoagulation Clinic pharmacy technician can enter

INR orders under the ACP’s name as Hold until Signed. The ACP will then sign all INR orders. For patients on warfarin, the Anticoagulation Clinic pharmacy technician can enter a CBC with platelets under the PCP’s name as a verbal order every 6 months for all patients enrolled in the Anticoagulation Clinic. The ACP can enter INRs, serum creatinine, and CBC orders for patients on warfarin, LMWH and DOAC. The PCP will review all CBC and serum creatinine orders and evaluate these results and take action as deemed medically necessary.

F. DOAC patients deemed stable after at least 3 months of therapy, will be transitioned back to PCP, who will be responsible for CBC and renal function assessment every 6 to 12 months along with renewal of DOAC prescription. AC clinic staff will be available via E-consult for anticoagulation questions concerns that cannot be addressed by PCP. Centralized Clinical Pharmacists will verify

CBC/serum creatinine have been collected within 12 months of any renewed prescription.

G. Serious problems and/or disorders associated with anticoagulant therapy or issues not related to anticoagulation therapy discovered by ACP will be referred to the

PCP, the supervising physician of the Anticoagulation Clinic, hospitalist or the triage physician in emergency situations.

IV. PROCEDURES:

A. Referral and Initial Patient Evaluation:

1. The requesting provider must enter an electronic consult for all anticoagulants with the following information: clinical indication for anticoagulation therapy, anticipated duration of anticoagulation therapy and desired INR goal range for warfarin therapy. Patients on an anticoagulant are evaluated by the Anticoagulation Clinic upon referral from a physician and receipt of a completed consult. An ACP will screen consults within 72-hours of receipt.

2. The ACP will assess the patient for eligibility regarding entrance criteria.

Patients are not eligible if they:

a. Do not have a provider that they see on a regular basis.

b. Have an absolute contraindication to anticoagulation.

c. Do not have a documented indication for therapy.

d. Are unwilling to come to VAMC Erie or Community Based

Outreach Clinics (CBOCs) for lab work. The only exceptions are patients who are residents of long term care facilities, visiting nurse or home lab draws.

e. Have a private physician managing anticoagulation therapy.

(exception CHOICE program)

f. Are unwilling to take the ACP’s recommended anticoagulant and/or specific dose of anticoagulant. In these situations, the patients may opt to continue non-VA management of their anticoagulant.

g. Are unwilling to have their anticoagulant prescription filled through the VA pharmacy

3. Upon referral and/or during the initial patient contact, the ACP will determine the following from the anticoagulation consult, patient record and/or from direct verbal communication with the patient and/or patient’s provider:

a. Patient demographics.

b. Name and phone number of nearest relative or neighbor.

c. Primary Care Provider.

d. Indication for anticoagulation.

e. Goal INR ranges for warfarin therapy.

f. Duration of therapy, if known.

g. Start date of anticoagulation therapy.

h. Anticoagulation dose the patient is receiving at the time of referral, if patient has already been started on anticoagulation therapy.

i. Concurrent medications of importance.

j. Allergies.

k. Current problem list and past medical history of importance.

l. Current use of alcohol and amount consumed.

m. Dietary patterns related to Vitamin K intake for warfarin therapy.

n. Current medications and analysis of any recent medication changes that can affect the INR or interact with DOAC.

o. Fall risk assessment.

p. Education regarding anticoagulant therapy and assessment of patient’s level of understanding of anticoagulation.

q. Explanation of anticoagulation clinic policies and procedures.

r. Assessment of patient’s level of understanding of anticoagulation.

s. For warfarin (Coumadin): Review of Anticoagulation Clinic

Patient Agreement. The agreement will be documented sent and/or signed in the anticoagulation database. The signed agreement will be scanned into the patient’s Permanent Medical Record in CPRS

(see Attachments).

t. The applicable SNOMED CT Code pertaining to Long term use of anticoagulants will be added to the problem list for all patients enrolled in anticoagulation clinic.

u. The patient will be given an anticoagulant education packet with information specific to the anticoagulant the patient is receiving. A

7-day pill organizer and tablet splitter will be offered for warfarin patients and for DOAC patients when appropriate.

v. The patient will also be offered either a medic alert bracelet or necklace to help notify health-care workers in an emergency that patient is taking anticoagulant therapy. If the patient wants a medic alert bracelet or necklace, the patient will be required to fill out the form contained in the Anticoagulation Clinic Educational

Packet and return it to the Anticoagulation Clinic. Upon receipt of the form, the anticoagulation staff will enter an electronic consult to prosthetics, who will then order the bracelet/necklace.

B. Education:

1. Patient Education:

a. Each patient and/or caregiver will be educated about the following

(validation of understanding of instructions will be documented in the patient record):

(1) Indication and therapeutic benefit for anticoagulation (e.g., CVA prevention in atrial fib, DVT/PE, etc.) and anticipated duration of therapy (if known).

(2) Tablet identification to include milligram, dosage, and number of tablets to take and color of tablet.

(3) Importance of compliance with anticoagulation regimen and time to take anticoagulant therapy. Proper medication storage. For patients taking Dabigatran, proper storage and handling of this medication.

(4) Requirement to have lab work (i.e. serum creatinine and

CBC) monitored while on DOACs. For warfarin patients, INR goal range, frequency of INR testing and importance of compliance with testing dates.

(5) Potential drug/drug interactions and importance of contacting the Anticoagulation Clinic when any new medications are prescribed, any medications are stopped or when the doses of existing medications are either increased or decreased.

(6) Avoidance or limiting alcohol intake with anticoagulation therapy.

(7) Safety precautions including risks associated with falling.

(8) Potential for adverse drug reactions including bleeding risks while on an anticoagulant.

(9) Signs and symptoms of bleeding, as well as signs and symptoms of thromboembolic events and what to do if such an event would occur

(10) Prompt notification to provider if any signs/symptoms of bleeding, bruising, thrombi formation such as: prolonged bleeding from cuts, nosebleeds, bleeding of gums, coughing or throwing up blood, increased menstrual flow or vaginal bleeding (if applicable), unusual bruising, red or dark brown urine or red or tarry-black stools, pain or swelling, vomiting, diarrhea, infection, fever, dizziness, trouble breathing, chest pain or weakness.

(11) Importance of informing all health care providers that patient is taking an anticoagulant.

(12) Importance of regular medical follow-up. Notifying anticoagulation clinic of upcoming travel plans.

(13) Importance of informing the Anticoagulation Clinic of any lifestyle changes such as: changes in diet, exercise, OTC use, alternative/herbal medicine therapies and/or alcohol use.

(14) For warfarin patients: Drug-food interactions of significance including the effects of Vitamin K rich foods as well as dietary restrictions.

(15) The schedule of appointments and rules of the clinic are explained or reinforced.

(16) Management of missed anticoagulant doses, specific to the anticoagulant the patient is receiving. Importance of

Compliance.

(17) For warfarin patients: Dangers of using warfarin from different sources (i.e. VA and community pharmacy) as well as dangers of using more than one strength of warfarin.

(18) For warfarin patients: disease state interactions with warfarin and need to inform the Anticoagulation Clinic with new or worsening diseases that could affect warfarin management (i.e. thyroid disease, liver disease, CHF).

(19) Contraindication in pregnancy. Special considerations for women of reproductive age counseling/education (if applicable).

(20) Notify the Anticoagulation Clinic of impending surgical procedures and hospitalizations.

(21) Patient receives FDA med guide with each prescription.

2. Staff Education: All providers and other staff involved in caring for patients receiving anticoagulation therapy will be required to complete initial anticoagulant training. Thereafter, anticoagulant training will be in the form of Pharmacy newsletter articles and in-services.

C. Anticoagulation Clinic Routine/Tasks:

1. Daily Schedule: A clinic daily schedule will be printed at the end of each working day for the following working day. A copy will be faxed to the lab and to the CBOC clinics by the Anticoagulation Clinic pharmacy technician. Additionally, every Friday, the Anticoagulation Clinic pharmacy technician will print a list of the following week's scheduled visits in the event the computer system is not functioning. This will provide a daily list of patients scheduled.

2. Warfarin Dosing and Follow-Up:

a. Starting dose of warfarin will generally be 5 mg daily, however, the warfarin starting dose may be higher or lower if clinically indicated. The warfarin starting dose will be based on but not limited to various factors such as patient's age, disease states, concomitant medications and risk for bleeding. Appropriateness of maintenance warfarin dose is assessed based upon INR within the context of compliance, patient's anticoagulation history, possible interactions, and complications.

b. The initial warfarin prescription will be entered by the referring provider at the time of the Anticoagulation Clinic consult. The

ACP will be responsible for ordering subsequent warfarin prescriptions. A new warfarin prescription should be entered by the ACP whenever a change in the warfarin dose is made. This will ensure that the directions on the warfarin prescription reflect the dose the patient is actually taking. Patients who are enrolled in the

Anticoagulation Clinic must get their warfarin prescriptions filled by the pharmacy at the Erie VAMC. Erie VAMC warfarin prescriptions will be a 30-day supply unless there is a compelling reason for alternative day supply (i.e. truck drivers) at the discretion of the ACP.

c. Dosage of warfarin is adjusted as necessary to maintain INR within the INR goal range specified in the Anticoagulation Clinic consult

(intensity of anticoagulation will follow recommendations published by the most recent ACCP Consensus Conference on

Antithrombotic Therapy published in Chest. See Attachments).

d. The patient or caregiver will be advised of the INR results, any dosage change and the reason for the change. A new warfarin prescription is entered into the electronic medical records

(CPRS)/pharmacy package by the ACP to reflect the change in warfarin dose.

e. To minimize the risk associated with incorrect tablet strength dosing errors, outpatients will be managed using one tablet strength of warfarin. All doses of warfarin will be obtained from the single tablet strength that is dispensed to the patient. Other strategies to prevent incorrect tablet strength dosing errors include:

creating separate outpatient orderable items for each warfarin tablet strength; educating providers to always view the order in

CPRS with emphasis on noting the tablet strength; using warfarin quick orders to standardize warfarin dosing; and informing the patient and/or caregiver whenever a change in warfarin tablet strength or dose schedule is made.

f. Patients are encouraged to request a refill of their warfarin prescription 14 days in advance to avoid running out of their medication. If a patient is running out of warfarin and will not receive a new supply before running out several choices should be offered to the patient. If the patient lives locally, the patient can come to the Erie VA pharmacy for a warfarin refill or partial fill. If the patient lives too far away to come to the Erie VA pharmacy, a warfarin refill or partial prescription can be sent by pharmacy courier for patient pick up at a CBOC. If the patient chooses to have the warfarin prescription called into a local pharmacy, a warfarin partial prescription can be called into the local pharmacy by the ACP and it will be at the patient’s expense. The

Anticoagulation Clinic CPS will call in the warfarin prescription under the name of the Medical Director of Primary Care; the NP may call the warfarin prescription under the NP’s prescriptive authority for a quantity sufficient to last until the patient receives a new supply of warfarin from the Erie VA. All partial prescriptions that are issued will be documented in the electronic

Anticoagulation Clinic database/CPRS.

3. Future clinic appointment(s): Newly started warfarin patients will have their INR monitored at least once or twice weekly until the INR is stable.

The INR can be monitored more often than once or twice weekly if clinically indicated. INR monitoring is decreased to weekly, biweekly, etc. based on stability. Once the INR is stable, the INR can generally be monitored once every 4-6 weeks. The next appointment is entered in the

Anticoagulation Clinic electronic database. Follow-up appointment letters will be printed from the electronic database and mailed to all patients. Lab appointments will be scheduled in VistA.

4. Documentation of findings and actions in the patient's medical record:

a. For each Anticoagulation Clinic encounter, the following data will be recorded in the Anticoagulation Clinic database: Date of INR, INR result, current warfarin dose and tablet strength, progress note, and follow-up date. A progress note will also be entered in the electronic medical record (CPRS) on abnormal INR results, containing the above mentioned data. All orders will be written in the progress notes and recognized as a valid order in the medical center, as indicated by the medical staff bylaws. All normal INR results and follow up date will be entered in the Anticoagulation

Clinic database and CPRS.

b. A follow-up evaluation of each patient will minimally include assessments of medication compliance, side effects, presence of clinical bleeding or thrombosis, diet, changes in the medication regimen, changes in alcohol consumption, review of INR results for warfarin patients, continued need for oral anticoagulation therapy and the level of understanding of anticoagulation principles.

c. Every anticoagulation patient actively enrolled in the

Anticoagulation Clinic will have a CBC with platelets ordered every six months. This will be indicated by a Clinical Reminder in the patient's electronic medical record (CPRS). Lab results received from an outside facility will be entered into the

Laboratory VistA lab package.

D. Anticoagulation Monitoring

1. Outpatient Warfarin Monitoring:

a. The INR will be used to monitor all patients on warfarin therapy.

A baseline INR will be drawn and evaluated on all patients prior to being initiated on warfarin therapy. An INR result within 7 days prior to starting warfarin can be used as a baseline INR. A baseline

CBC with platelets will also be ordered for patients being initiated on warfarin therapy.

b. The provider will specify the INR goal range in the

Anticoagulation Clinic consult for each patient being enrolled into the Anticoagulation Clinic. The two accepted INR goal ranges are

2.0-3.0 and 2.5-3.5 as stated in the current CHEST Guidelines.

The appropriate goal range mainly depends on the indication for warfarin. Providers may choose to select a different INR goal range for a patient if clinically indicated. A patient’s specific INR goal range must be included in the Anticoagulation Clinic consult so that it is clearly communicated to the Anticoagulation Clinic.

c. Patients will have the following labs monitored as long as they remain on warfarin: PT/INR, CBC with platelets. INRs will be obtained via venipuncture only; results from Point of Care (POC) will not be accepted.

d. All INR results for patients enrolled in the Anticoagulation Clinic will be reviewed and clinically evaluated by the ACP no later than close of business the next business day. A critical INR at the Erie

VAMC is defined as any INR equal or greater than 4.0. All critical

INRs must be documented within 24 hours of receiving the critical result.

e. Patients who are initiated on warfarin will have an INR done within 7 days of the first warfarin dose to ensure their INR is increasing at an acceptable rate. Newly started patients will also have their INR monitored at least once or twice weekly until the

INR is stable. The INR can be monitored more often than once or twice weekly if clinically indicated. INR monitoring is decreased to weekly, biweekly, etc. based on stability. Once the INR is stable, the INR can generally be monitored once every 4-6 weeks at the discretion of the ACP

f. All INR results, including the most current INR, will be entered into the electronic medical record (CPRS) and Anticoagulation

Clinic database for patients receiving warfarin therapy. A current

INR will be used to monitor and adjust warfarin therapy.

g. If approved, some patients may have their INR and CBC with platelets drawn and run at a non-VA lab. The non-VA lab will fax the lab results to the Erie VA Anticoagulation Clinic. Upon receipt of the non-VA lab results, a member of the Anticoagulation Clinic staff will evaluate the INR result. The INR result will then be entered into the VistA lab package. A separate INR test called

INR (NON-VA LAB INR RESULTS) has been created and will be used to document all non-VA INR results. Similarly, a separate test has been created to document non-VA results for CBCs. All outside INR lab results will contain the following information:

name and address of non-VA laboratory, reference range for each lab result entered into the VistA lab package. The ACP and

Pharmacy technician, will enter outside labs into the VistA lab package as results are received. If the Anticoagulation Clinic pharmacy technician enters the result into the VistA lab package, the ACP will verify the information entered. These non-VA lab results are kept on file in the Anticoagulation Clinic for two years per lab policy.

2. DOAC Monitoring:

a. For new starts on DOACs, patients will required to have baseline

CBC and serum creatinine (within one month) of starting a DOAC.

For new starts on DOAC, patient will be provided with initial education prior to medication initiation, follow up phone call at two weeks, four weeks if clinically indicated, and then follow up phone call and lab work (CBC and serum creatinine) every 3-6 months based on lab stability. For patients on DOAC at time of

Anticoagulation consult, the clinic will ensure patient has a CBC and serum creatinine on file within the last month and will provide patient education.

b. The initial DOAC prescription will be entered by the referring provider at the time of the Anticoagulation Clinic Consult. The

ACP will be responsible for ordering subsequent DOAC prescriptions. The initial DOAC prescription will be 30-day supply; however, DOAC prescriptions can be increased up to 90-day supplies based on the discretion of the ACP, indication for anticoagulation therapy and planned duration of therapy.

c. After completion of 3-month follow-up labs and phone call, if deemed stable by ACP, patient will be transitioned back to

PCP/PACT team for further anticoagulation monitoring and discharged from AC clinic. At time of transition, patient will receive education concerning transition, PCP & PACT CPS will be alerted of the transition, and DOAC RX will be rewritten with the

PCP’s name and for a 90-day supply. In addition, comment will be added to AC consult and VISTA narrative.

d. The AC Clinic will utilize the DOAC Population Management

Tool to identify and address patient issues falling outside the recommended parameters for DOAC use (e.g. worsening renal function, significant drop in hemoglobin, platelets, or change in liver function, potentially inappropriate dose for indication, renal function, or duration of therapy, clinically significant drug interactions, and potential non-compliance with medication refills).

The ACPs will review the DOAC Population Management Tool at least weekly and issues identified will be addressed via chart review. ACPs will try to resolve any flags in the Tool. If the issue identified requires intervention by PCP, the Anticoagulation Clinic provider will send an alert via CPRS to PCP and/or the PACT CPS to manage issue.

3. LMWH Monitoring:

a. For monitoring of long term use of LWMH: For new starts on

LMWH, patients will be required to have a baseline CBC and serum creatinine (within one month) of starting LMWH. Once a patient starts LMWH, patient will be provided with initial education. Lab work will be ordered once a week, then biweekly, then Q 3 weeks, then labs (CBC and serum creatinine) Q 4- 12 weeks for patients on long-term LMWH, based on lab stability.

Anti-Xa levels not routinely indicated unless specific circumstances dictate.

b. The initial LMWH prescription will be entered by the referring provider at the time of the Anticoagulation Clinic Consult. The

ACP will be responsible for ordering subsequent LMWH prescriptions. LMWH prescriptions are limited to 30-day supplies unless there is a compelling reason for the alternative day supply.

4. Warfarin Compliance Issues:

a. Missed Appointments: Failure to keep appointments will be handled as follows:

(1) First missed appointment- the patient will be notified by phone or letter and a new appointment will be rescheduled.

A progress note is entered in the Anticoagulation Clinic database and electronic medical record (CPRS).

(2) Second missed appointment- the patient will be rescheduled a second time and notified by phone or letter.

A progress note is entered in the Anticoagulation Clinic database and electronic medical record (CPRS).

(3) Third missed appointment-the patient is notified by phone or letter and will be rescheduled a third time. Patient will be advised that the warfarin prescription will be placed on hold if he/she fails to show or call the Anticoagulation

Clinic. A progress note is entered in the Anticoagulation

Clinic database and electronic medical record (CPRS). PCP will be added as cosigner of the progress note.

(4) Fourth Missed appointment- If the patient does not respond to the third letter within ten (10) days, attempts will be made by an ACP to contact the patient by phone and/or a registered letter will be sent to the patient. Additionally, a progress note will be entered into the Anticoagulation

Clinic database and electronic medical record (CPRS) with the patient's Primary Care Provider (PCP) as co-signer, and the warfarin prescription will be placed on hold.

(5) At this point, the patient may be discharged from the

Anticoagulation Clinic if indicated by the provider. Follow up will be at the discretion of the PCP. If the patient is discharged from the Anticoagulation Clinic a progress note is entered in the electronic medical record and

Anticoagulation Clinic database. The PCP is added as a co-signer. A comment of patient’s discharge will be added to the Anticoagulation Clinic consult. These patients will no longer receive warfarin through the Erie VAMC pharmacy.

b. Risk Benefit Assement for Patients Receiving Anticoagulation

Therapy

(1) ACP will refer patients with falls, poor INR control, poor compliance with warfarin/DOAC, ethanol substance abuse, changes in health status, changes in patient parameters or other behaviors that potentially place the patient at unacceptable risk of thromboembolic or bleeding complications will be referred primary care provider for evaluation of anticoagulation therapy

(2) Patients for whom anticoagulation therapy is discontinued will be discharged from the Anticoagulation Clinic.

(3) For those patients who must remain on warfarin, additional attempts will be made to achieve and maintain appropriate level of anticoagulation.

E. Discharge from the Anticoagulation Clinic:

1. Patients may be discharged from the clinic (with consent of Primary Care

Provider) for any of the following reasons:

a. Completion of prescribed course of therapy.

b. Failure to comply with monitoring requirements (clinic appointments, blood work, etc.), or consistent failure to follow directions on dosage.

c. Failure to comply with ACP’s recommended anticoagulant/dose.

d. DOAC patient deemed stable by ACP and transitioned back to

PCP for management after completion of 3-month lab work and follow-up.

2. Procedure for discharging a patient from the clinic:

a. A note detailing the circumstances surrounding the patient's discharge from the clinic will be written in the progress notes in the patient's electronic medical record. The note must contain at least the following information:

(1) Indication for therapy

(2) Duration of therapy to date, if known

(3) Statement that predetermined course of therapy is completed or

(4) If the patient is being discharged under adverse circumstances:

i. History of failure to keep clinic appointments, noncompliance with medications, failure to obtain

INRs that are required for adequate monitoring, or other reason for which the patient is being discharged from the clinic.

ii. Interventions attempted to improve or correct unacceptable behavior, with statement that those have failed.

iii. Statement that the patient cannot be adequately monitored and is a high risk for complications. A statement that risk outweighs potential benefit.

(5) Statement that the patient is discharged from the clinic as of a specific effective date and that thereafter the

Anticoagulation Clinic will not be monitoring the patient.

The PCP is added as a co-signer. A comment will be added to the Anticoagulation Clinic consult. The prescription for anticoagulant should be discontinued.

(6) Registered letter sent to patient, informing patient they have been discharged from the Anticoagulation Clinic.

b. Re-referral of a patient discharged from Anticoagulation Clinic

(1) A new Anticoagulation Consult is required.

(2) Items that will be reviewed for re-entry into the clinic are indication for anticoagulation therapy and objective evidence of compliance (if the patients were previously discharged from the clinic for failure to comply with directions or clinic rules).

3. Procedure for Transitioning DOAC patient to PCP/PACT team for management after completion of 3-month labs. (Please refer to SOP for monitoring direct-acting oral anticoagulants.)

F. Coordination of Patient Admissions and Discharges:

1. Upon Erie VA admission, the admitting physician can view the outpatient medication list that contains the current VA warfarin dose. The admitting physician can also view the most recent INR result in the lab package as well as any Anticoagulation Clinic progress note(s) entered as a result of abnormal or normal INR results. This information can be used to determine if a change in the warfarin dose is warranted upon admission.

2. The Anticoagulation Clinic is notified when a patient enrolled in the

Anticoagulation Clinic is being discharged from a hospital. An ACP evaluates recent INRs from the hospital admission, H&P, discharge summary, warfarin dosage changes, medication changes, etc. The

Anticoagulation Clinic will review all this information, then contact the patient and will determine the appropriate follow up plan and date of next INR. This information will be communicated to the patient and the patient will be scheduled accordingly.

G. Quality Assurance Monitoring:

1. All INR results above the critical value (i.e. greater than 4.0) are monitored each month to determine an associated cause. Staff and/or patient education will be conducted if correctable causes are identified.

Documentation of appropriate action for all INR results 4.0 and greater will be done within 24 hours of notification by lab. If a patient with an

INR of greater than 4.0 is contacted the day of the INR result, the documentation of appropriate action shall be done by the ACP prior to close of business that day.

2. All patients enrolled in the Anticoagulation Clinic will be monitored for any bleeding or thromboembolic events.

3. Percentage of INRs within the therapeutic range as well as percentage of supra/subtherapeutic INRs are also monitored.

4. Patient incidents, close calls and near misses with anticoagulants are reported via the electronic Patient Event Reporting System (JPSR) and monitored.

5. Information on above monitors are continuously collected and reported to the P&T Committee along with National and Veterans Integrated Service

Network (VISN) INR trends on either a monthly or quarterly basis.

6. Reports are generated monthly and forwarded to the Chief of Staff, Medical Director of Primary Care and the Chief of Pharmacy.

H. Peri – Procedural Management of Anticoagulation:

1. Patients are counseled during the initial anticoagulation consult as well as ongoing education while enrolled in the clinic to inform the

Anticoagulation Clinic of any procedure that requires interruption of their anticoagulation therapy.

2. When the patient calls the anticoagulation clinic regarding a procedure.

Anticoagulation personnel obtains the following information from the patient and sends the information to the anticoagulation provider via a progress note titled Anticoagulation Therapy Initial Interruption

Information: date of procedure, name of the procedure being performed, number of days patient is instructed to hold anticoagulant, name and contact number of surgeon/dentist/physician. Patient is instructed to follow the instructions provided the surgeon/physician to hold anticoagulant unless the anticoagulation clinic provider contact them.

Patient is instructed to resume anticoagulant per the surgeons/doctor’s instructions after the procedure.

3. When a procedure is performed at the Erie VA the surgery department personnel notifies the anticoagulation clinic providers of any patient that is having a procedure that requires interruption of anticoagulation therapy by adding the anticoagulation provider as a co-signer to the surgery pre-procedure instruction note. For patients not on LMWH bridge, the ACP provides patient with verbal/written pre-op instructions on when to stop anticoagulant. Patient is instructed to resume anticoagulation per surgeon’s instructions. The ACP orders prep-op INR for the day of the procedure (for warfarin patients).

4. Anticoagulation Clinic provider will enter a separate Anticoagulation

Therapy Interruption note in the electronic medical record (CPRS) once notified that a patient enrolled in the Anticoagulation Clinic is going to have a procedure that requires interruption of their anticoagulant. The note will contain at least; the name of the procedure being performed, date of the procedure, person performing the procedure and any instructions the patient received about holding their anticoagulant. The Anticoagulation provider may need to contact the surgeon/dentist/physician to clarify any information obtained. The Anticoagulation Clinic provider will evaluate each patient to determine risk of thrombosis if the anticoagulant is withheld and also evaluate need for bridge therapy with a Low Molecular

Weight Heparin (LMWH) or Fondaparinux based on the most recent

CHEST Guidelines and literature recommendations available. The information is also entered in the Anticoagulation Clinic database.

5. In the Anticoagulation Therapy Interruption note, the Anticoagulation

Clinic provider will make a recommendation regarding bridge therapy to the patient's primary care provider (PCP). Final decision on anticoagulation bridge therapy will be as directed by patient’s PCP.

6. If decision is made to use anticoagulation bridge therapy, the patient will be contacted and educated and a progress note documenting the LMWH education and instructions will be entered in electronic medical record

(CPRS) and in the Anticoagulation Clinic database. The patient is educated on anticoagulation bridge therapy and provided with instructions on bridge therapy along with directions to resume anticoagulation per the surgeon’s instructions.

7. If DOAC patient transitioned back to PCP requires interruption of anticoagulation, PCP can request AC Clinic recommendation via E-

Consult Anticoagulation Outpatient. ACP will respond to E-Consult via

CPRS note and tag PCP and PACT CPS, who will be responsible for patient education.

I. Drug Interactions with Anticoagulants

1. Drug Interactions with warfarin:

a. It’s important for the Anticoagulation Clinic to be informed of any medication change that may affect the INR. This includes not only prescription medications but also over the counter medications as well as herbal/nutritional supplements.

b. Providers are notified via an electronic alert when ordering a medication that interacts with warfarin. The drug interaction with warfarin will display to the ordering provider as either a significant interaction or a critical interaction.

c. Upon receiving either a significant or critical interaction alert, the provider (or CPS, if not done by the provider) will notify the

Anticoagulation Clinic by entering an electronic notification in

CPRS by clicking on the text order titled “NOTIFY

ANTICOAGULATION CLINIC OF NEW MED”. Clicking on this text order will automatically send a notification to each member of the Anticoagulation Clinic staff and will effectively communicate to the Anticoagulation Clinic staff that a medication that interacts with warfarin has been order.

d. When a notification is received, the drug interaction will be assessed by the ACP. If indicated, the patient will be contacted and informed of the potential drug interaction and need for a follow-up INR to determine if the interacting medication has an effect on the INR. A progress note will be entered in CPRS, the

CPRS alert will be completed by the ACP, and the information will be entered in the Anticoagulation Clinic database. An order for the follow-up INR will be entered into the lab package by the

Anticoagulation Clinic.

e. The follow-up INR result will be assessed by the ACP. The patient will be contacted if the INR is outside of the therapeutic range and any changes to the warfarin dose will be communicated to the patient.

2. Drug Interactions with DOAC:

a. Upon receiving either a significant or critical interaction alert, the provider (or CPS, if not done by the provider) will notify the

Anticoagulation Clinic by entering an electronic notification in

CPRS by clicking on the text order titled “NOTIFY

ANTICOAGULATION CLINIC OF NEW MED”. Clicking on this text order will automatically send a notification to each member of the Anticoagulation Clinic staff and will effectively communicate to the Anticoagulation Clinic staff that a medication that interacts with the DOAC has been ordered.

b. When a notification is received, the drug interaction will be assessed by the ACP. If indicated, the patient will be contacted and informed of the drug interaction as well as the need for a follow-up/education. A progress note will be entered in CPRS, the

CPRS alert will be completed by the ACP, and the information will be entered in the Anticoagulation Clinic database.

c. Drug interactions for DOAC patients transitioned back to PCP will be managed by PCP/ PACT CPS.

J. Elevated INR Management (Vitamin K administration)

1. There are instances where a patient’s INR increases to a level requiring intervention. Intervention may consist of holding one or more doses of warfarin or administration of Vitamin K to reverse the effects of warfarin.

The ACP is permitted to write prescriptions for oral vitamin K for patients enrolled in the Anticoagulation Clinic with an elevated INR who are not actively bleeding. Depending on the situation, patients who are actively bleeding will be referred to either the patient’s PCP, Urgent Care Center

(UCC) at the Erie VA, nearest Emergency Department or instructed to call

911.

2. Patients whose INR is greater than or equal to 4.5 but less than 10 without active bleeding may be instructed to omit the next 1 or 2 doses of warfarin and have their INR monitored more frequently until stable. Warfarin will be resumed at an appropriately adjusted dose when the INR returns to the therapeutic range. In addition, oral vitamin K at a dose of 1-2.5mg may be prescribed by the ACP in patients with high risk of bleeding. Oral

Vitamin K is available at either the Erie VA pharmacy or any of the

CBOC’s. If the patient can’t come into the Erie VA or CBOC to pick up the oral Vitamin K, the prescription can be called into a local pharmacy by the CPS under the Medical Director or Primary Care Provider’s name or by the NP under their prescriptive authority. Prescriptions for oral vitamin

K called into a local pharmacy will be at the patient’s own expense.

3. Patients whose INR is greater than 10 without active bleeding may be instructed to hold one or more doses of warfarin and the INR will be monitored more frequently until stable. Warfarin will be resumed at an appropriately adjusted dose when the INR returns to the therapeutic range.

In addition, oral vitamin K at a dose of 2.5-5mg may be prescribed by the

ACP in patients without active bleeding. Oral Vitamin K is available at either the Erie VA pharmacy or any of the CBOC’s. If the patient can’t come into the Erie VA or CBOC to pick up the oral Vitamin K, the prescription can be called into a local pharmacy by the CPS under the

Medical Director or Primary Care Provider’s name or by the NP under their prescriptive authority. Prescriptions for oral vitamin K called into a local pharmacy will be at the patient’s expense.

K. Management of Anticoagulation Issues after Anticoagulation Clinic Close of

Business

1. If the anticoagulation clinic is unable to contact a patient with a critical

INR (INR greater than 4.0) by the end of their shift, the PCF will be

Paged and information that a critical INR needs to be addressed by the

PCF.

2. A progress note will be entered by the anticoagulation clinic and will include the patients name, INR result, a statement that the patient was not able to be reached by the end of the shift and specific instructions on what the patient should be told regarding their warfarin dose. The anticoagulation clinic will include the evening PCF as an additional signer to this progress note. If a patient can’t be reached by the anticoagulation clinic by the end of the day on a Friday or any day in which the anticoagulation clinic is closed the following day(s), then the anticoagulation clinic will include specific instructions for the PCF to communicate to the patient until the next anticoagulation clinic business day.

3. The evening PCF will attempt to contact the patient with the critical INR as soon as possible to assess for bleeding/excessive bruising and instruct the patient to hold their next dose of warfarin or follow instructions from the anticoagulation clinic. The PCF should also instruct the patient to contact the anticoagulation clinic at 860-2197 (local calls) or (800)274-

8367 x2197 (long distance calls) as soon as possible the next business day to receive further instructions from the anticoagulation clinic. This information will be added as an addendum to the original progress note entered by the anticoagulation clinic.

4. If a patient is having bleeding/bruising, the PCF should evaluate the need for the patient to be seen in the ER/UCC.

5. If a critical INR occurs when the anticoagulation clinic is closed, lab will page the hospitalist with the critical result, per lab policy this is 4 PM daily. The hospitalist will instruct the patient what to do until the next business day of the anticoagulation clinic. Also, the patient should be instructed to contact the anticoagulation clinic in the morning of the next business day for further instructions.

6. For any anticoagulation issues when the anticoagulation clinic is closed the hospitalist should be contacted. The hospitalist will instruct the patient what to do until the next business day of the anticoagulation clinic.

L. Traveling Veterans:

1. Traveling veterans may present to the Erie VA for lab work to monitor their anticoagulant therapy. If this occurs, the courtesy lab orders can be entered under the ACP’s name, provided the patient presents a signed order for the lab work or an e-mail is received from another VA facility with the requested lab work and information is received on who will take responsibility for the lab work results/management of results. VA facilities can view the lab test results under Remote Data.

2. The Traveling Veterans Coordinator (TVC) can be used when needed to facilitate lab work arrangements for the anticoagulation clinic.

V. REFERENCES:

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

B. Consensus Conference on Antithrombotic Therapy, CHEST Supplement

C. Clinical and Operational Guidelines, "Managing Oral Anticoagulation Therapy", Ansel, Oertel and Wittkowsky, 2009

D. The Joint Commission Comprehensive Accreditation Manual for Hospitals, Home Care, Behavioral Health, and Laboratory & Point-of-Care Testing, (current editions)

VI. FOLLOW UP RESPONSIBILITY: Chief of Pharmacy

VII. REPORTING REQUIREMENTS: QA data monthly and quarterly to P&T Committee

VIII. RESCISSION: MCM 111-29, Anticoagulation Clinic, dated August 9, 2017

(Original signed 9/7/18)

John A. Gennaro

Medical Center Director

Attachments: A. Warfarin Management Algorithm

B. Warfarin Management Guideline

C. Direct-Acting Oral Anticoagulant (DOAC) Monitoring SOP

ATTACHMENT A

Warfarin Management Algorithm

(Initiation Phase of Therapy)

Disclaimer: This is only a guide for initiation of warfarin. Assessment of the patient’s overall clinic status, drug interactions and other factors impacting warfarin therapy and adherence to the prescribed regimen are critical factors in determining an appropriate clinical decision. Rate of change of the INR can be a significant factor and may influence the clinician’s decisions.

As with any guideline, the clinical assessment of the patient is the primary factor in making decisions about warfarin therapy and final decision must always rest with the clinical judgment of the responsible provider.

Step 1: Begin with 5 mg daily or less 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 and 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)

NOTE: ACUTE CARE PATIENTS MUST HAVE DAILY INRS (with the possible exception of patients who no longer require acute care but remain on the service for other reasons)

Step 2a: Warfarin dosing adjustments based on INR results—see Step 2b when getting daily INRs

Day* INR Action

1 Baseline

INR

Generally start 5 mg or lower depending on risk factors

3-4 < 1.5 Evaluate patient and impacting factors, consider no change or increase weekly dose if clinically appropriate

1.5-1.9 Evaluate patient and impacting factors, consider no dosage change if clinically appropriate

2.0-2.5 Evaluate patient and impacting factors, consider no dosage change or decrease dose as clinically appropriate

> 2.5 Evaluate patient and impacting factors, consider hold dose or decrease dose as clinically appropriate

5-7 < 1.5 Evaluate patient and impacting factors, consider increase weekly dose if clinically appropriate

1.5-1.9 Evaluate patient and impacting factors, consider increase weekly dosage if clinically appropriate

2.0-3.0 Evaluate patient and impacting factors, consider no dosage change or change based on impacting factors as clinically appropriate

> 3.0 Evaluate patient and impacting factors, consider hold dose, or decrease dose as clinically appropriate; If the goal is 2.5-3.5 and INR is less than 3.5, depending on risk factors, may consider no dosage change as clinically appropriate.

8 and beyond

< 1.8 Evaluate patient and impacting factors, consider increase weekly dose if clinically appropriate

1.8-1.9 Evaluate patient and impacting factors, consider no change or increase weekly dosage if clinically appropriate

2.0-3.0 Evaluate patient and impacting factors, consider no dosage change or change based on impacting factors as clinically appropriate

> 3.0 Evaluate patient and impacting factors, consider hold dose, or decrease dose as clinically appropriate; If the goal is 2.5-3.5 and INR is less than 3.5, depending on risk factors, may consider no dosage change as clinically appropriate.

*When INR is not on the exact day, may use table for guidance as clinically appropriate. Not required to have INRs on exact days.

Step 2b: Warfarin dosing adjustments based on daily INR results.

Day INR Action 1 Baseline

INR

Generally start 5 mg or lower depending on risk factors (for healthy younger patients, a higher dose may be considered for 1 or 2 days, followed by…