36C24218R0169-057.pdf

VA Western NY Healthcare System Outpatient Anticoagulation Program

Policies and Procedures 7.2017

B

Bleeding Risk Index Assessment, 19 Bridge Therapy Guidance 16

C

Clinic Hours and Scheduling Details, 3 Clinic personnel and scope of practice, 2 Clinic purpose, structure, and policy, 2 Common Drug Interactions 12

D

Dosing guidelines, 12

F

Food and Nutrient Interactions, 5

I

Indications for anticoagulant therapy and target

INR, 9

M

Maintenance therapy, 9 Management and documenation of Therapy

Complications, 18 Mechanical Prosthetic Heart Valves, 11

N

New Patient Appointments, 8 New Patient Referrals, 7

P Patient discharge from clinic, 5 Patient Exclusion, 7 Patient Inclusion, 7 Patient Referral Process, 7 Procedure for Receipt of a Critical Laboratory

Value, 5 Procedures for laboratory monitoring and follow-up, 5

R

References, 20 Risk Stratification 10

S

Snow Birds and Travelent Patients, 4

T

Tablet Strength Policy, 4

V

Vitamin-K Administration, 20

RFP 36C24218R0169

D.31 VA WESTERN NEW YORK HEALTHCARE SYSTEM OUTPATIENT ANTICOAGULATION

PROGRAM POLICIES AND PROCEDURES (7.2017)

Clinic purpose, structure, and policy

CLINIC PURPOSE:

The purpose of the Anticoagulation Clinic (ACC or AC clinic) is to provide continuous outpatient monitoring and management for patients on long-term anticoagulant therapy, with the goal of maximizing benefits of therapy while minimizing any untoward risks. The ACC is structured based on a collaborative agreement with the referring provider. As such, the ACC staff will be responsible for routine and continuous management of fta patient’s anticoagulant therapy, in accordance with the most current American College of Chest Physician guidelines and or Anticoagulation Forum or PBM Guidance. ACC staff can make recommendations for initiation or discontinuation of warfarin or injectable anticoagulants, but the referring provider is ultimately responsible for initiation / termination of anticoagulation as well as the patient's overall medical management. The Direct Oral AntiCoaguants (DOACs) will only be initiated by and followed by the Anticoagulation Clinic after review of the referral. In urgent situations, other anticoagulants such as warfarin and low molecular weight (LMWH) heparin are available. Patients enrolled in the ACC must continue to receive medical follow-up by a primary provider or specialty provider at a minimum of every twelve months in order to maintain good standing.

CLINIC PERSONNEL & SCOPE OF PRACTICE:

The ACC staff is comprised of both Clinical Pharmacists, Registered (or Licensed Practical) Nurses, and pharmacy technicians (where assigned) with a designated VAWNYHS Anticoagulant Therapy Program Coordinator and physician support staff for inter-current anticoagulant-related problems.

VAWNYHS Anticoagulant Therapy Program Director: Kenneth Kellick, Pharm.D.

Anticoagulation Physician Director: Deborah Farolino, MD Clinical Pharmacist- As assigned Nurse- As assigned

The Clinical Pharmacist:

The clinical pharmacist must have a current pharmacy license in a state, must have successfully completed the designated training session within the ACC, and must be able to function as an independent clinician in the ACC.

The Clinical Pharmacist will provide initial and longitudinal patient education, will conduct patient interviews, monitor a patient’s INR (International Normalized Ratio) and adjust a patient’s warfarin dose with the intent to achieve/maintain therapeutic levels for those patients with INRs that are out of their target range or those patients deemed “unstable”, he/she will assess bleeding or thromboembolic complications, will screen for any pertinent changes in medications/diet/health to determine potential interactions, will enter warfarin / enoxaparin prescriptions in CPRS, will establish return visit intervals, will monitor for adverse events, will oversee anticoagulant and non-anticoagulant related problems and refer to alternate medical staff as appropriate, will provide training to new pharmacists, pharmacy residents and students in a structured and approved format.

The Clinical Pharmacist will maintain competency by completing

1) PBM TMS Advanced Anticoagulation course, required

2) At least: One Hour annually of ACPE accredited anticoagulation education.

3) Ongoing OPPE

The Clinical Pharmacist will review the clinic nurse’s patient dosing letters for appropriateness using the CPRS Anticoagulation Management Tool flowsheet. This will ensure that an appropriate follow-up lab date and laboratory order has been entered, and will print the completed dosing letter on designated VA letterhead to the printer assigned to the clinic MSA (Buffalo Only). In Batavia the clinical pharmacist will print and mail the letters.

The Pharmacist-in-Training and the Pharmacy Resident:

The pharmacist-in-training and the pharmacy resident will assist trained clinical pharmacist(s) in managing anticoagulation therapy in patients managed by the AC clinic when assigned, and in a structured and supervised fashion. All pharmacy resident care plans must be approved by a licensed and trained clinical pharmacist in the AC clinic. No pharmacist or resident that is undergoing training will be left unsupervised.

The Registered or Licensed Practical Nurse (RN or LPN):

The Registered or Licensed Practical Nurse must have a current nursing license in a state, must have successfully completed the designated training session in the ACC, and must be able to function as an active support staff member in the ACC.

The clinic nurse will conduct patient education regarding warfarin therapy, will provide education and proper administration technique of enoxaparin injections, will obtain vital signs for clinic patients as appropriate, will contact new referral patients to schedule initial appointments, will complete consults, and will assist the MSA in rescheduling patients who cancel or fail to report to their ACC appointment. The clinic nurse will perform patient interviews to those patients already maintained on warfarin for at least 3 months and deemed “stable; for this AC clinic’s purposes, a “stable” INR is one within the designated target range and which has been generally therapeutic in the past, with the most recent INR having been within 0.2 (above or below) the target range and drawn at least 14 days prior. The three month assessment of stablitiy may be shortened at the discretion of the clinical pharmacist. Clinical judgment can be used to determine stability, and consultation with a Clinical Pharmacist should occur when possible complications or concerns for instability arise. The clinic nurse may extened the patient’s followup interval when there have been 3 within range INR’s within 3 months and no complications. Extended INR interval may be up to 42 days.

The Clinic RN or LPN will attend to other pertinent clinical details including faxing,, special travel will be completed by the nurse as appropriate for thie specific patient.

The Clinic Nurse will maintain competency by completing

1) PBM TMS Advanced Anticoagulation course, required

2) Recommended: One Hour bi-annually of ACPE accredited anticoagulation education.

3) Ongoing progress note review

The Medical Support Assistant (MSA)-Buffalo Only:

The MSA will perform miscellaneous tasks as assigned, not limited to collecting and tally all patient dosing letters to ensure that all have been printed, then will fold and stuff these letters in VA envelopes; the stuffed envelopes will then be transferred to mailroom staff to be mailed to each patient, rescheduling no show pateints. The MSA will alert designated clinic staff of the arrival of a scheduled clinic patient, and will also alert clinic staff in the event of a walk-in patient. The MSA will answer the main ACC phone and triage calls as appropriate. The MSA will send facsimiles as requested by clinic staff, and perform other clerical duties as warranted.

CLINIC HOURS AND SCHEDULING DETAILS

The Buffalo ACC will be staffed with at least 2.5 Clinical Pharmacists, at least 2 Nurses, and a MSA during normal hours of operation, which are Monday through Friday 8:00am to 4:00pm. All federal holidays are excluded. New patients are scheduled for Friday Group Classes.

All clinic charting will be done utilizing the VA Anticoagulation Management Tool (AMT) via CPRS. This is both for warfarin and DOACs. For warfarin and DOACs the letter sent to the patient will have the day and after hours (emergency only) phone numbers. Per patient instructions for both Buffalo and Batavia, for urgent questions or problems on weekends & evenings call the Emergency Room 862-8774.

Once stabilized, most patients will be telemanaged. Clinic appointments comprise mainly of new patients and initial follow-ups. Exceptions to this include patients with no telephone service, patients that have other complications to telephone follow-up (i.e. extreme hearing impairment), or patients who are very unstable or non-compliant with telephone follow-up. Clinic appointments are generally scheduled between the hours of 8am and 12pm Monday through Friday, however, exceptions can be made at the discretion of the Clinical Pharmacist. Afternoons are typically designated for completion of telemanaged patients.

All patients will have lab or clinic appointment check-in / check-out, the follow-up ACC appointment and laboratory orders entered by the ACC staff member caring for that patient on any given day. All patients are provided with clinic contact information in the event they need to cancel and reschedule an appointment; they are encouraged to do so, as a failure to report will deem them a “no-show” for that appointment date. A patient may contact a Clinical Pharmacist, nurse or MSA within the AC clinic to reschedule an appointment.

Walk-ins will be interviewed and seen if there is an urgent issue that needs addressing. Routine walk-ins are discouraged.

TABLET POLICY

Only warfarin (PBM contracted) brand will be used and dispensed to patients enrolled in the AC clinic at the Buffalo VAMC. A patient must receive warfarin through our facility in order to be enrolled in our ACC. Our ACC uses the following strengths of warfarin in managing our patient population:

Warfarin 1mg tablets – pink Warfarin 2.5mg tablets – green

Other strengths of warfarin may be ordered by the clinical pharmacist at his/her discretion, in rare cases and typically to minimize pill burden. In no circumstance will a patient be allowed to split tablets, use more than one strength of warfarin or use a generic equivalent. The lead anticoagulation pharmacist may exempt patients in extreme cases in regards to no tablet splitting.

In cases where a patient needs to be transitioned to an alternate tablet strength, he/she will be informed to only use the strength advised by the ACC. Rational for strengths other than the standard strength should be documented anticoagulation progress note.

Once a maintenance dose of warfarin is established, the ACC may dispense 90-day supplies of warfarin to each patient enrolled in the clinic. Exceptions to this include patients whose compliance is questionable or those patients whose safety is a question with large quantities of tablets. In these cases, a smaller supply will be dispensed for safety and compliance purposes.

VISN and National policy does not allow co-management of warfarin. Patients getting warfarin from the VA MUST have their anticoagulation management within the VA.

Direct Oral AntiCoagulants (DOACs) The Anticoagulation clinic will follow all patients on the DOACS. The director of the anticoagulation clinic (or designee) will be responsible for review and all follow-up of patients on these agents. Providers may request these agents via VISN 2 CPRS approved processes and VA national criteria.

Prior to initiation of any of these agents a face-to-face or telephone visit with the designated patient and the anticoagulation clinic director (or designee) is required to educate patients and explain risk verus benefit of the approved agent. Patients will be followed for hematologic and renal changes according to the below schedule:\ Initial 3 months afer initiation and quarterly thereafter

Tablet supplies will not exceed 30 days for the first month may be extended to 90 days (limit one refill) thereafter.

“SNOW BIRDS” AND TRAVELING PATIENTS

Temporary or Permanent Travel out of the WNY area:

For patients leaving WNY for greater than 4 weeks, anticoagulation therapy will be monitored by AC clinic only if the patient seeks care at a local VA and their policy is to only order blood work.

Labs will not be ordered or monitored via a Non-VA Laboratory or Facility (i.e. Long-term Care Facility.) Additionally, patients discharged home to contracted nursing services will not be managed by ACCc until patient is ambulatory and can come to the clinic for lab work.

Exceptions to these guidelines may be approved by the lead anticoagulation pharmacist, depending on specific patient circumstances, stability of warfarin therapy, ability of the patient to locate alternate means of management while away, etc.

The ACC may discontinue WNY warfarin prescriptions for these patients. Patients will be advised to follow-up at a VA or other healthcare facility while they are away. Upon return to the WNY area, warfarin can be restarted and managed by the Buffalo/Batavia VAMC providing routine follow-up is arranged.

Exceptions to these guidelines may be approved by the Clinical Pharmacist, depending on specific patient circumstances, stability of warfarin therapy, ability of the patient to locate alternate means of management while away, etc.

A traveling (TVC) consult should be initiated to allow for followup blood work as required for warfarin or DOACs.

Traveling Veterans:

At the discretion of the Clinical Pharmacist, and in coordination with a patient’s parent VA facility, traveling veterans may be followed by the ACC for up to 3 months if they are visiting from another VA medical center where their anticoagulation is managed, without requiring enrollment in primary care. When feasible, the traveling veteran should make arrangements for care in advance of his/her travels. Where required, traveling veterans with urgent medical concerns will be referred to the emergency room for medical treatment.

If a patient is planning to relocate to the WNY area, he/she will need to be assigned a Primary Care Provider and will need an ACC consult placed in order for us to continue management of warfarin therapy beyond the 3-month period.

Procedures for laboratory monitoring and follow-up

LABORATORY MONITORING:

Every patient that is warfarin-naïve should have a baseline INR, CMP and CBC obtained prior to initiation of warfarin therapy, in order to evaluate potential sensitivity to therapy and increased bleed risk. In most cases an INR obtained within 30 days of initiation of therapy is appropriate, providing no major health changes have occurred since that time.

INRs are ordered for every patient enrolled in the AC clinic at least monthly (i.e. every 4 weeks).

A CBC will be ordered quarterly, unless closer follow-up is warranted, i.e. if a patient is very anemic or at a high risk of bleeding. Significant changes in the CBC (i.e. 1-unit drop in hgb or 2-unit drop in hct from the last CBC, or a general trend downward) will be forwarded to the patient's provider, either electronically or via telephone, as determined by the urgency of notification. In urgent cases a provider must be reached by phone in addition to the electronic alert. Eg. MOD ,PCP. Renal function will be assessed in all patients, particularly those requiring bridge therapy with enoxaparin. Other laboratory tests may be ordered if the Clinical Pharmacist feels they are warranted and may impact anticoagulant therapy, i.e. LFTs, TSH, urinalysis.

INRr results for Warfarin may be venous or POC (Point of Care). POC INR will follow VA Laboratory service procedures.

FAXED OR OUTSIDE LABORATORY RESULTS:

All laboratory analyses are expected to be done on site here at the Buffalo VAMC or one of the approved Community-Based Outpatient Clinics (CBOCs), which include: Lackawanna, Lockport, Niagara Falls, Jamestown, Olean, and Dunkirk. Patients who wish to have laboratory draws done at one of these CBOCs are educated that we receive lab results the day AFTER they have labwork done. Batavia labs are drawn at that facility and processed at Buffalo.

We do not accept outside laboratory results for INRs due to the potential for variability between laboratory analysis, safety implications that may arise from lapses in receipt of outside INR results, patient noncompliance with having blood draws when recommended, the inability of outside laboratories to accept prescriptions/orders from pharmacists, significant time commitment, and inability to reach patients with results. In very rare instances, and based on the discretion of the Clinical Pharmacist, an outside INR may be used to determine appropriate follow-up, although we should not make dosage adjustments based on outside laboratory results.

If a patient is physically not capable of presenting to a VA lab, we may explore other options such as community nursing for home draws, or referral to Home Based Primary Care for management.

PROCEDURE FOR RECEIPT OF A CRITICAL LABORATORY VALUE (cascade list):

Under coordination with the automated laboratory service, ACC staff at the Buffalo VAMC are alerted for a critical INR value defined as any INR > 4.5. The automated lab technician first attempts to contact the clinical pharmacist who entered the INR order, by page. If he/she is not available, the lab technician then pages alternate staff sequentially until an alternate clinical pharmacist is reached. The laboratory value is verified by the automated lab technician stating the patient’s name, full social security number, and the INR value; this information then needs to be repeated to the lab technician verbatim. Management of all laboratory values, including critical values, will be discussed in the dosing section of this protocol. For Buffalo and Batavia the Laboratory Service will maintain an updated Cascade list for notification of critical INRs for the OAC patients.

Patient discharge from clinic:

Patients may be discharged from the AC clinic by the clinical pharmacist after completion of treatment duration, cases of patient unreliability, or if therapy complications arise. In these instances, any outstanding warfarin/DOAC prescriptions written by the ACC will be discontinued, and the patient & provider will be advised accordingly.

1) COMPLETION OF PRESCRIBED TREATMENT DURATION:

The recommended length of anticoagulant therapy is determined at the time of a new patient’s enrollment into the AC clinic. This is determined by review of the original consult, the patient’s indication for therapy, past medical history, family history if appropriate, and any risk/benefit analysis.

Once the initially intended duration of anticoagulation is completed, the chart will be reviewed by the clinical pharmacist and consultation with the patient’s primary provider is made to determine if it is indeed appropriate to discontinue therapy or if extended therapy is warranted. Although the AC clinic can recommend appropriateness in the initiation or discontinuation of warfarin, this decision falls on the patient’s provider. In cases where further expertise is warranted, a consult may be placed to a specialized discipline (i.e. cardiology or hematology) in order to determine the best approach to a patient’s care. Patients who are re-admitted to the clinic may not require re-education on warfarin.

2) PATIENT UNRELIABILITY:

If a patient is discharged for unreliability, the primary care provider is informed of this discharge and the reasoning behind it. In these cases, the patient will be informed that any warfarin/DOAC prescription within the VA will be canceled, he/she will need to purchase warfarin/DOAC outside the VA, and any further monitoring of warfarin/DOAC therapy will need to be done outside of the Buffalo/Batavia VAMC Anticoagulation Clinic.

Patients who fail to comply with clinic policies may be discharged from the AC clinic for any of the following reasons:

the patient continues to drink excessive alcohol and the level of anticoagulation remains unacceptable despite the pharmacist’s best efforts and continued patient counseling on the risks of this behavior the patient misses three consecutively scheduled ACC appointments without a valid excuse the patient refuses further medical management by the Buffalo/Batavia VAMC Anticoagulation Clinic, or refuses further warfarin/DOAC therapy despite medical advisement the patient does not follow our dosing recommendations and either self-adjusts his/her own warfarin/DOAC or has another provider who adjusts his/her warfarin/DOAC dose, despite our advisement on the safety implications of doing so and also that we would discharge him/her from clinic for this continued behavior.

the patient is noncompliant despite the pharmacists’ best efforts of changing this habit. This includes those patients with compliance issues pertaining to memory deficits, where there is no alternate caregiver to take over medication management and where no other safety measures can be implemented to minimize patient’s bleed risk (which surely outweigh any benefit to therapy in these situations) non-compliant patients may be subject to a contract which will be signed and scanned into CPRS.

3) COMPLICATION(S) TO THERAPY:

A patient may be discharged from the ACC due to untoward complications to therapy which deem further anticoagulant therapy a contraindication. In the event the decision to discontinue warfarin is made by an outside provider or hospital, the ACC will request written documentation to support this decision. Once this is received, the patient will be discharged from the AC clinic and his/her provider will be notified. Additional supportive documentation would then be needed in the future if anticoagulation is re-recommended to support that the benefit of reintroducing warfarin/DOAC is greater than any risks that may be involved (i.e. a GI bleed that has resolved).

New Patient Referrals

PATIENT INCLUSION

Acceptance of referred patients will be dependent upon the following criteria:

Indication for anticoagulation is consistent with those indications depicted in the most current American College of Chest Physician guidelines, Chest supplements, Anticoaglation Forum or PBM guidance.

Reliability of patient, family, and/or caregiver Ability and willingness of the patient to follow our recommendations Ability of the patient to travel to a VA clinic Access to a telephone (in cases where the patient does not have a phone, the patient must wait for lab results and dose changes) Lack of absolute and relative contraindications to anticoagulation Routine follow-up on at least a yearly basis with a VA primary care provider or subspecialty clinic which will assume responsibility for inter-current medical problems Please note that patients may be directly admitted to the clinic as part of transition from inpatient to outpatient care. This function is performed as part or the discharge pharmacist’s responsibility.

PATIENT EXCLUSION

Patients who receive only parenteral anticoagulation (i.e. heparin or LMWH) without warfarin/DOAC or those on only prophylactic-dose warfarin are not eligible for enrollment.

Individuals who are non-compliant with scheduled appointments, or who refuse to follow our clinic policy are excluded from clinic enrollment.

PATIENT REFERRAL PROCESS

The patient’s provider can make patient referrals by any of the following methods:

1) calling or paging a clinical pharmacist within the ACC; an electronic consult must then be completed

2) completing an electronic consult (note separate consults exist for DOACs) The Anticoagulation clinic consult should include the patient’s name and last four digits of his/her social security number, indication for warfarin therapy, baseline INR,target INR, and anticipated length of therapy. Any pertinent information regarding past medical history, risk factors for bleeding or thromboembolism, lifestyle limitations to therapy, etc. should be indicated as such on the consult. Patients may be referred to the AC clinic at any stage of warfarin therapy.

The DOAC consult must meet PBM criteria and have recent (within ~2months) Hemoglobin, Serum Creatinine and ALT. An ECHO for atrial fibrillation/flutter is essential to evaluate valvular function for inclusion or exclusion.

Scheduling New Clinic Patients:

New patients for warfarin managment are scheduled by the ACC clinic nurse or clinical pharmacist once a consult is received. New patients are contacted and an appointment is scheduled within 3 days of receipt of the consult. The initial appointment must occur within 30 days of consult placement, but typically occurs much sooner than this based on how new a patient is to therapy, concurrent health issues, safety concerns and patient availability. All efforts will be made to accommodate a new patient as soon as possible. When a new patient appointment is scheduled, the clinic nurse generates a letter which is then printed to the MSA and mailed to the patient; this letter details to the patient specific instructions for the day of his/her appointment (i.e. “report to the outpatient lab first then proceed to Desk 1 for your appointment”). It also includes contact information in the event this appointment needs to be cancelled by the patient.

For Batavia, the pharmacist will send the patient letter or verbally contact the patient.

All efforts will be made to contact a patient once a consult is received. If the patient cannot be reached by phone the patient will receive an “unable to reach” letter requesting a fall back. If the patient does not contact the clinic within 14 days, the consult is discontinued thereby notifying the ordering provider. If a patient does not meet inclusion criteria for anticoagulation therapy and is not a candidate for warfarin therapy based on evaluation by ACC staff, or if a patient refuses warfarin therapy, the provider responsible for the patient's care will be contacted by ACC staff and the reason for refusal will be explained. A note documenting the enrollment denial will be placed in the medical record.

New DOAC patients will be reviewied by the designated clinical pharmacist, educated in person or telephonically and scheduled for follow-up labs by the clinical pharmacist.

NEW Warfarin patient appointmemnts The initial patient appointment takes 60-90 minutes, depending on the complexity of the case, patient understanding, and whether or not the patient has used warfarin in the past. It comprises of extensive patient education, and so caregivers are encouraged to attend. Patients are seen on a group basis, so that privacy can be upheld and personal attention can be paid to any patient concerns that may arise. The following topics are reviewed and discussed at each initial appointment:

Patient-specific indication for warfarin and how warfarin works

Review of the patient’s past medical history including any previous thromboembolic events;

review of the signs/symptoms of a clot

Review of any previous bleeding events; review of the signs/symptoms of a minor bleed versus major bleed and when to seek help

Review of any previous warfarin dosing history, if applicable and available Evaluation of anticipated duration of treatment with warfarin Review of what an INR is, the patient’s goal INR for his/her therapy indication, frequency of

INR monitoring, and what it means when an INR is “too high” or “too low” Clinic procedures regarding clinic versus telephone follow-up, and available laboratories within the VA system Effect of vitamin-K on warfarin, what foods to pay attention to, what foods to avoid if possible Review of the patient’s current medications, vitamins, alternative medications and dietary supplements. Review of the importance of alerting clinic staff whenever there are changes made; what over-the-counter products and herbal products to avoid while on warfarin

Effect of alcohol on warfarin therapy, acceptable limits, increased fall & bleed risk When to take warfarin, and what to do when a dose is missed Know the strength and color of your warfarin tablets Importance of each patient informing all of his/her providers that they are on warfarin Alerting AC clinic whenever an invasive procedure is planned Importance of female patients informing their provider(s) immediately if they are planning to or become pregnant Verification of all current addresses, telephone number(s) and any alternate phone numbers that the patient feels comfortable allowing us to call for follow-up Review and possible resolution of any potential barriers to adequate follow-up (i.e.

transportation, work) New clinic patients also view the patient education video staying active and healthy with blood thinners, provided by the AHRQ.

Each patient is provided with a Medic Alert bracelet or necklace (via prosthetics consult), a weekly medication box, and a folder containing: ACC staff telephone numbers, a booklet specific to their therapy indications, “Your Guide to Coumadin®/Warfarin Therapy, provided by the AHRQ and an educational sheet titled “Instructions for Patients on Warfarin ”.

Patient education is documented in CPRS under “Anticoagualation Clinic Comprehensive Note” by the clinic nurse and “Anticoagulation Clinic Provider Note” by the Clinical Pharmacist. Any potential barriers to understanding or compliance are documented, and deficiencies are addressed at subsequent visits. Patient education is consistently reinforced throughout therapy.

Maintenance therapy:

All patients maintained on warfarin therapy must have an INR drawn in compliance with the most current American College of Chest Physician guidelines, which currently state a minimum of every 4 weeks. More frequent monitoring will be based upon patient-specific health issues or concerns at the time.

At every routine follow-up, a patient is interviewed by either a clinic nurse (if the INR is stable) or a clinical pharmacist (if unstable). The following list of open-ended questions serves as a guide, with more focused questions being asked where appropriate:

What is your current dose of warfarin?

Did you miss any doses, or accidentally take extra? If so, how many and when?

Any changes in medications, over-the-counter products, or herbal supplements?

Any changes in diet with regards to vitamin-K? Any changes in dietary supplementation?

Any grapefruit or cranberry juices?

Any recent, excessive alcohol consumption?

Any bruising/bleeding issues? If so, when and what were the circumstances? Reinforce when to seek medical attention.

Any recent illness or other changes in health (i.e. CHF exacerbation)?

Any recent ER visits or hospitalizations?

Any upcoming invasive procedures or surgeries?

Based on the information gathered from the telephone (or clinic) interview, the nurse will either advise the patient to continue his/her therapy and schedule follow-up in another 4 weeks, or will defer the patient to a clinical pharmacist if a complication to therapy has been noted. Likewise, based on the information gathered from the telephone (or clinic) interview, the clinical pharmacist will adjust the patient’s warfarin dosage accordingly and schedule appropriate follow-up for unstable patients. Please see the dosing section for general dosing guidelines.

As noted previously, INR monitoring intervals may be extended up to 42 days for stable patients.

Indications for anticoagulant therapy:

INDICATIONS FOR USE

GOAL

INR

RANGE

LENGTH OF THERAPY

Atrial Fibrillation, new onset with planned cardioversion 2.0-3.0

At least 3 consecutive weekly INRs within target range before cardioversion, and at least 4 weeks of maintained warfarin therapy after maintenance of NSR. Cardiology consultation should be sought before cessation of warfarin therapy

Atrial fibrillation/Atrial Flutter, with appropriate CHADS2 score

(see below)±

2.0-3.0 Indefinite

CVA/TIA secondary to atrial fibrillation. Otherwise, aspirin is generally more efficacious 2.0-3.0 Indefinite

Treatment of VTE 2.0-3.0

- Result of transient risk factor = 3 months

- Unprovoked, idiopathic VTE = at least 3 months, with consideration for long-term therapy

- Unprovoked, recurrent VTE = indefinite

- VTE in active cancer patient = LMWH for the first 3-6 months, then warfarin treatment indefinitely or until the cancer is resolved

- First event and hypercoaguable state = at least 3 months, with consideration for long-term therapy

Prevention of Systemic Embolism LV Thrombus

AMI

2.0-3.0 Indefinite

Bileaflet Mechanical Valve in aortic position, NSR 2.0-3.0 Indefinite

Mechanical Prosthetic Valves See below Indefinite

Bioprosthetic (tissue) Heart Valve 2.0-3.0 – see below 3 Months

AMI (to prevent recurrent AMI) 2.0-3.0 1-3 months to prevent thromboembolsim in patients with CHF, severe LV dysfunction, previous emboli, or mural thrombus

±RISK STRATIFICATION:

In patients with the diagnosis of atrial fibrillation (or atrial flutter), the Current American College of Chest Physician guidelines recommend to risk-stratify these patients to determine the optimal course of anticoagulant/antithrombotic treatment.

Definition and Scores for CHA2DS2-VASc Stroke Risk Stratification With the CHADS2 and CHA2DS2-VASc Scores

Score Adjusted stroke rate (% per y)

Congestive HF 1 CHA2DS2-VASc† Hypertension 1 0 0 Age ≥75 y 2 1 1.3 Diabetes mellitus 1 2 2.2 Stroke/TIA/TE 2 3 3.2 Vascular disease (prior MI, PAD, or aortic plaque) 1 4 4.0

Age 65–74 y 1 5 6.7 Sex category (i.e., female sex) 1 6 9.8 Maximum score 9 7 9.6 8 6.7 9 15.20

Recommendations by AHA-ACC/HRS For patients with nonvalvular AF with prior stroke, transient ischemic attack, or a CHA

DS

-VASc score of 2 or greater, oral anticoagulants are recommended. Options include:

• warfarin (INR 2.0 TO 3.0), or

• dabigatran, or

• rivaroxaban, or

• apixaban.

• (edoxaban not in 2014 guideline but mentioned in

2016 performance measure) Among patients treated with warfarin, the INR should be determined at least weekly during initiation of antithrombotic therapy and at least monthly when anticoagulation (INR in range) is stable.

For patients with nonvalvular AF unable to maintain a therapeutic INR level with warfarin, use of a direct thrombin or factor Xa inhibitor (dabigatran, rivaroxaban, or apixaban,*edoxaban not noted*) is recommended.

Re-evaluation of the need for and choice of antithrombotic therapy at periodic intervals is recommended to reassess stroke and bleeding risks.

Recommendations by AHA-ACC/HRS For patients with nonvalvular AF with prior stroke, transient ischemic attack, or a CHA

DS

-VASc score of 2 or greater, oral anticoagulants are recommended. Options include:

• warfarin (INR 2.0 TO 3.0), or

• dabigatran, or

• rivaroxaban, or

• apixaban.

• (edoxaban not in 2014 guideline but mentioned in

2016 performance measure) Among patients treated with warfarin, the INR should be determined at least weekly during initiation of antithrombotic therapy and at least monthly when anticoagulation (INR in range) is stable.

For patients with nonvalvular AF unable to maintain a therapeutic INR level with warfarin, use of a direct thrombin or factor Xa inhibitor (dabigatran, rivaroxaban, or apixaban,*edoxaban not noted*) is recommended.

Re-evaluation of the need for and choice of antithrombotic therapy at periodic intervals is recommended to reassess stroke and bleeding risks.

Mechanical Prosthetic Heart Valves - All require lifelong anticoagulant therapy

Type Model INR therapeutic range Position

Caged ball Star-Edward 2.5-3.5

Single tilting disk

Bjork Shiley

- Spherical disk valve

- Convexo concave

2.5-3.5 2.0-3.0 for AVR unless with Afib

MVR & AVR

Medtronic Hall 2.5-3.5 MVR

2.0-3.0 AVR

Omnicarbon 2.5-3.5 MVR & AVR

Bileaflet

St. Jude 2.5-3.5 MVR AVR + Afib

2-3 AVR*

Carbomedic 2.5-3.5 MVR

2-3 AVR*

Edward-Duromedic 2.5-3.5 MVR

2-3 AVR*

* Provided Left Atrium is of normal size and normal sinus rhythm

Bioprosthetic (tissue) Heart Valves

Type Model

INR

therapeutic range

Position Duration*

Heterograft Hancock 2.0-3.0 MVR & AVR 3 months Carpentier-Edwards 2.0-3.0 MVR & AVR 3 months Ionescu-Shiley 2.0-3.0 MVR & AVR 3 months

*Bioprosthetic valve + Afib = Long term therapy *Evidence of left atrial thrombus at time of surgery = long term therapy *Bioprosthetic valve + Pacemaker = optional therapy; duration uncertain *Bioprosthetic valve + history of systemic emboli = longer therapy (3-12 months)

WarfarinDosing guidelines

The following are dosing “guidelines” and, as such, serve as tools for initiating and maintaining anticoagulation therapy. However, clinical judgment needs to be exercised in each patient’s case to determine a most appropriate course of action.

Initiation of Therapy:

1) In patients naïve to warfarin, a baseline INR should always be obtained. An INR drawn within the last 30 days of initiation of therapy should suffice, assuming no major health changes have occurred since that time. Patients may refused for inclusion into the clinic if a baseline INR is not apparent.

2) Initiation of warfarin therapy will typically begin at 2.5mg-5mg daily:

a. In relatively young, healthy individuals, or those patients who more aggressive treatment is warranted (i.e. new onset VTE), initiation will begin at 5mg daily.

b. In elderly patients or those patients who are suspected to be more sensitive to warfarin therapy (i.e. malnourishment, liver dysfunction, CHF, recent major surgery, concomitant drug interactions such as amiodarone), initiation will typically begin at 2.5mg daily. This is dependent on how aggressive treatment needs to be and the severity of concurrent conditions. The Clinical Pharmacist is expected to use good judgment in these cases. For example, the Clinical Pharmacist may choose to initiate therapy in a very frail, debilitated patient at only 1mg or 2mg daily.

3) An INR should ideally be drawn on day #4 of dosing, but at least within the first 7 days.

If patient availability is a factor in initial follow-up, it is recommended that dosing is not as aggressive in order to minimize potential adverse events and bleeding complications

4) Subsequent follow-up should be tailored to initial patient response, but will typically be at increasing increments. It is important to remember that some patients, especially elderly patients, have slower metabolisms and so the INR may spike after it appears to be at steady state!

5) An example timeline is as follows:

Day #1: baseline INR is obtained and warfarin therapy is initiated Day #4: 1st follow-up INR; dose-adjust accordingly Day #8: 2nd follow-up INR; dose-adjust accordingly Day #15: 3rd follow-up INR; dose-adjust accordingly Day #25: 4th follow-up INR; dose-adjust accordingly

Maintenance Therapy:

Once a patient is on an established dosing regimen and INRs have achieved target range for his/her indication, subsequent INRs can be drawn every 4 weeks. Closer monitoring is warranted in any case where potential instability of anticoagulation may occur. It is important to always screen patients for any pertinent changes, including but not limited to: compliance concerns, changes in medications/vitamins/over-the-counter products, dietary changes, nutritional supplementation, adverse events, alcohol consumption, recent falls, visits to the Emergency Room, recent or upcoming hospitalizations, upcoming procedures, etc.

The following dosing guide should be used as a tool, with good clinical judgment to determine each patient’s best approach to care. Always base dosing on any known causative factors, since an acute factor that resolves will be treated differently than one that is a permanent change or factor. Furthermore, it is important to consider a patient’s indication for warfarin therapy and their bleeding versus thromboembolic risks. For example, a young healthy patient on warfarin for a recent pulmonary embolism will be treated more aggressively than a 90-year-old frail patient on warfarin for atrial fibrillation.

VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Initiation Phase of Therapy) Step 1: 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 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)

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

Measurement Day INR Action

Measure PT/INR on Day 1 Baseline INR Start patient on 2 to 5 mg depending on risk factors

Measure PT/INR on Day 3-4 <1.5 Increase weekly dose by 5-25% 1.5-1.9 No dosage change 2.0-2.5 Decrease weekly dose by 25-50% >2.5 Decrease weekly dose by 50% and/or HOLD dose

Measure PT/INR on Day 5-7 <1.5 Increase weekly dose by 10-25% 1.5-1.9 Increase weekly dose by 0-20% 2.0-3.0 No dosage change >3.0 Decrease weekly dose by 10-25% and/or HOLD dose

Measure PT/INR on Day 8-10 <1.5 Increase weekly dose by 15-35% 1.5-1.9 Increase weekly dose by 5-20% 2.0-3.0 No dosage change >3.0 Decrease weekly dose by 10-25% and/or HOLD dose

Measure PT/INR on Day 11-14 <1.6 Increase weekly dose by 15-35% 1.6-1.9 Increase weekly dose by 5-20% 2.0-3.0 No Dosage Change >3.0 Decrease weekly dose by 5-20% and/or HOLD dose

Adapted from: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM: Pharmacotherapy: A Pathophysiologic Approach, 8th Edition: www.accesspharmacy.com (Figure 26-8)

Additional Considerations:

• If patient has not attained an in-range INR result by Day 14, continue Day 11-14 routine until INR is in-range.

• Holding the dose may complicate efforts at dose-finding and is not usually necessary.

In our opinion, it should be reserved for INR values above 5.0 in the initiation phase, when bleeding risk is thought to be very high. For less extreme INR elevations, a dose decrease should be sufficient, especially given that follow-up will be quite soon thereafter.

• In some cases, the following may be considered: For patients sufficiently healthy to be treated as outpatients, we suggest initiating VKA therapy with warfarin 10 mg daily for the first two (2) days followed by dosing based on INR measurements (Grade 2C).

[CHEST 2012]

• When the patient has achieved three (3) in-range INR results, use the VISN 1 Anticoagulation Management Algorithm (Maintenance Phase of Therapy).

http://www.accesspharmacy.com/

VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Maintenance Phase of Therapy) Disclaimer: This algorithm is for ongoing management of warfarin. As with any algorithm or guideline, the final decision must always rest with the clinical judgment of the responsible provider.

Goal of INR 2.0-3.0 INR Action ≤ 1.5 Increase weekly dose by 10-15%; repeat INR within 7 days.

1.51- 1.79

If falling or low on two or more occasions, increase weekly dose by 5-10%; repeat INR in 7-14 days.

1.80- 1.99

Consider not changing the dose unless a consistent pattern has been observed;1 repeat INR in 7-14 days.

2.00- 3.00 (in-range)

No change in dose. Follow-up within 28 days. If INR has been in-range 3X consecutively, follow-up within 42 days.2

3.01- 3.20

Consider not changing the dose unless a consistent pattern has been observed;1 repeat INR in 7-14 days.

3.21- 3.69

Do not hold warfarin. If rising or high on two or more occasions, decrease weekly dose by 5-10%; repeat INR in 7-14 days.

3.70- 4.99

Hold for 1 day and decrease weekly dose by 5-10%; repeat INR determination within 7 days.

5.00- 9.99

Hold warfarin. Check INR within 5 days. When INR is therapeutic, restart at lower dose (decrease weekly dose by 10- 15%). Check INR at least weekly until stable.

≥ 10.0 (without bleeding)

Hold warfarin and give oral vitamin K, 2.5 mg. Check INR at least weekly until stable.

Serious Bleeding Regardless of

INR

Hold warfarin and refer patient to emergency department immediately.

Goal of INR 2.5-3.5 INR Action ≤ 1.5 Increase weekly dose by 10-15%; repeat INR within 7 days.

1.51- 1.99

If falling or low on two or more occasions, increase weekly dose by 10-15%; repeat INR in 7-14 days.

2.00- 2.29

If falling or low on two or more occasions, increase weekly dose by 5-10%; repeat INR in 7-14 days.

2.30- 2.49

Consider not changing the dose unless a consistent pattern has been observed;1 repeat INR in 7-14 days.

2.50- 3.50 (in-range)

No change in dose. Follow-up within 28 days. If INR has been in-range 3X consecutively, follow-up within 42 days.2

3.51- 3.70

Consider not changing the dose unless a consistent pattern has been observed;1 repeat INR in 7-14 days.

3.71- 4.19

Do not hold warfarin. If rising or high on two or more occasions, decrease weekly dose by 5-10%; repeat INR in 7-14 days.

4.20- 4.99

Hold for 1 day and decrease weekly dose by 5-10%; repeat INR determination within 7 days.

5.00- 9.99

Hold warfarin. Check INR within 5 days. When INR is therapeutic, restart at lower dose (decrease weekly dose by 10- 15%). Check INR at least weekly until stable.

≥ 10.0 (without bleeding)

Hold warfarin and give oral vitamin K, 2.5 mg. Check INR at least weekly until stable.

Serious Bleeding Regardless of

INR

Hold warfarin and refer patient to emergency department immediately.

Disclaimer/Guide to Use: In a well-designed before and after trial, the use of this algorithm improved percent time in range (TTR) by 6%.3 While clinicians will override these recommendations at times, they should keep in mind that when this algorithm was tested, patients whose management conformed most closely to the algorithm had the best TTR.

Additional Recommendation: In addition to this algorithm, ACC clinicians are urged to avoid non-standard target INR ranges such as 2-2.5 or 1.8-2.5. The 2012 CHEST Guidelines state that there should be two target ranges in clinical practice: 2.5-3.5 for patients with mitral prosthetic valves and 2-3 for everyone else.4 In some instances, practitioners may chose a goal of 2.5-3.5 for patients with aortic prosthetic valves with additional risk factors. This is the recommendations from the most recent AHA guidelines and may be used at the recommendation of a referring provider.5 Other target ranges do not provide additional benefit and place patients at higher risk, and should be avoided.

References

1. Rose AJ, Ozonoff A, Berlowitz DR, Henault LE, Hylek EM. Warfarin dose management affects INR control. J Thromb Haemost. Jan 2009;7(1):94-101.

2. Rose AJ, Ozonoff A, Berlowitz DR, Ash AS, Reisman JI, Hylek EM.

Reexamining the recommended follow-up interval after obtaining an in-range international normalized ratio value: results from the Veterans Affairs study to improve anticoagulation. Chest. Aug 2011;140(2):359-365.

3. Kim YK, Nieuwlaat R, Connolly SJ, et al. Effect of a simple two-step warfarin dosing algorithm on anticoagulant control as measured by time in therapeutic range: a pilot study. J Thromb Haemost. Jan 2010;8(1):101-106.

4. Whitlock RP, Sun JC, Fremes SE, Rubens FD, Teoh KH. Antithrombotic and thrombolytic therapy for valvular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. Feb 2012;141(2 Suppl):e576S-600S.

5. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. Jun 10 2014;129(23):e521-643.

BRIDGE THERAPY GUIDELINES

A risk assessment by the clinical pharmacist should be done for all patients requiring bridge therapy; clinic nurses are not authorized to do risk assessments. Patients requiring bridge therapy are those new to warfarin at a high clot risk, or those undergoing invasive procedures that are at a significant clot risk while off warfarin. A patient should be reassessed each time an invasive procedure is scheduled to ensure an appropriate course of therapy is used, and the date of the most recent risk assessment should be indicated as such in the patient’s Anticoaguation Clinic Provider Note. It is NOT the policy of the VAWNY Anticoagulation Clinics to provide bridging with a low molecular weight heparin for patients not currently being followed in the respective anticoagulation clinic.

When enoxaparin therapy is required, typically a 10-12 day supply is prescribed unless the Clinical Pharmacist feels more or less is warranted. A CBC should be ordered during enoxaparin therapy, especially in patients new to warfarin/enoxaparin, to screen for any bleeding complications and the rare possibility of HIT (Heparin Induced Thrombocytopenia).

Contraindications to enoxaparin therapy include prior diagnosis of HIT,severe thrombocytopenia (plateltets <100,000), those patients receiving hemodialysis, or those patients at a significant bleed risk where risks outweigh any benefit that would be received. Spinal or epidural hematomas may occurin patients who are anticoagulated with enoxaparin and receiving neuraxial anesthesia or spinal anesthesia. These risks must be discussed with the proceduralist prior to using in these situation. The optimal timing between administration of enoxaparin and these procedures is not known.

Warfarin-naïve patients:

Those patients initiating warfarin who are deemed high risk of thromboembolic or ischemic event until a therapeutic INR is achieved will require bridge therapy with enoxaparin.