36C24219R0013-025.pdf

Outpatient Anticoagulation Program

Policies and Procedures 2.2019

B

Bleeding Risk Index Assessment, 18

C

Clinic Hours and Scheduling Details, 3

Clinic personnel and scope of practice, 2

Clinic purpose, structure, and policy, 2

Common Drug Interactions 33

D

Dosing guidelines, 14

F

Food and Nutrient Interactions, 34

I

Indications for anticoagulant therapy and target

INR, 11

M

Maintenance therapy, 17

Management and documenation of Therapy

Complications, 18

Mechanical Prosthetic Heart Valves, 13

N

New Patient Appointments, 9

New Patient Referrals, 8

P

Patient discharge from clinic, 7

Patient Exclusion, 8

Patient Inclusion, 9

Patient Referral Process, 6

Peri-procedural gudance 18 Procedure for Receipt of a Critical Laboratory

Value, 6

Procedures for laboratory monitoring and follow-up, 2

R

References, 20

Risk Stratification 5,7

T

Tablet Strength Policy, 4

Traveling Patients5

V

Vitamin-K Administration, 21

RFP 36C24219R0013

D.31 VAWNYHS OUTPATIENT ANTICOAGULATION PROGRAM MANUAL

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 the patient’s anticoagulant therapy, in accordance with the most current American College of Chest Physician guidelines American

College of Cardiology, American Society for Hematology and or Anticoagulation Forum or PBM

Guidance. ACC complete initiation or discontinuation of warfarin, direct acting oral anticoagulants (DOACs) or injectable anticoagulants, but the referring provider is ultimately responsible for concurring on initiation / termination of anticoagulation as well as the patient's overall medical management. 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:

For warfarin: 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.

For DOACs: Conduct an initial patient consultation using approved patient information sheets, complete consults for the DOACs, enter prescription information in CPRS, will establish return visit intervals and will monitor for adverse events.

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. A CAC will assure that the CPRS User Class called Anticoagulation Cosignature Required is given to the trainees to force cosignature review.

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 stability 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 extended 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.

A CAC will assure that the CPRS User Class called Anticoagulation Cosignature Required is given to the nurses to force cosignature review.

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 the specific patient.

The Clinic Nurse will maintain competency by completing

1) PBM TMS Advanced Anticoagulation course, required

2) Recommended: One Hour bi-annually of 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 patients. 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 4:30pm. 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.

Fridays are designated for new patients, however exceptions can be made for other days.

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.

WARFARIN 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 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 Anticoagulation clinic 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 telephone or face-to-face visit with the designated patient and the anticoagulation clinic director (or designee) is required to educate patients and explain risk versus benefit of the approved agent. Patients will be followed for hematologic and renal changes according to the below schedule:

Initial prescription of 30 days supply with 1 refill

First follow-up visit approximately 6 week after initiation

Second about 3 months after initiation and quarterly thereafter

If no changes after the second quarterly visit the interval may be extended to 6 months.

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

Traveling Veterans

For all traveling veterans a Traveling Veteran Consult (TVC) must be entered with details of the needs of the coag clinic, be it INR or DOAC labs. The traveling veteran coordinator will communicate with the remote station. If there are any specific details from the remote station (such as they will follow them during the length of time in the remote area, or it is the parent clinic’s responsibility to monitor labs, or there are questions about the labs ordered) a comment will be placed on to TVC to be addresses by the parent clinic. At the request of the veteran they will not be discharged from WNY primary care unless the move is permanent and there is no intent of returning to WNY for a primary care/anticoagulation visit.

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, 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. DOAC patients must have baseline CMP and

CBC. These baseline labs must be done at the local VA Facility and not scanned in order to populate national databases.

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 peri-procedural 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.

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

Laboratory service procedures.

DOACs will be monitored by ordering a CBC(w/o differential) and CMP at the defined intervals.

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 lab work 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, Anticoagulation 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 management 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 reviewed by the designated clinical pharmacist, educated in person or telephonically and scheduled for follow-up labs by the clinical pharmacist.

NEW Warfarin patient appointments

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 via letter only 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 hypercoagulable 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 thromboembolism 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

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

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*

On-X 1.5-2

* 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)

*Doacs may be used in patients with Bioprothetic Valves if there is another indication e.g. A.Flutter/A.Fib.

or VTE.

WarfarinDosing guidelines

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

Step 1: Begin with 5 mg orf 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 Prcactice 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.

Clinic Recommendations

Change in dose return 14days Adjusting weekly dose 14 days One time boost or hold RTC 3 weeks

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.

Peri-procedural policy

A risk assessment by the clinical pharmacist should be done for all patients requiring bridge peri-periprocedural therapy; clinic nurses are not authorized to do risk assessments.

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.

In general peri-procedural bridge therapy with warfarin is not recommended except for very high risk patients.

An assessment using the IPRO algorithm is recommended to determine need for peri-procedural anticoagulation.

Process: the pharmacist/ provider should calculate the CHADS2VASC score as noted

Review the HAS-Bled score may also be used to determine if the patient is at risk for bleeding https://clincalc.com/cardiology/anticoagulation/hasbled.aspx

Use the IPRO application to determine regimen

ADDITIONALLY the 2018 ASH Guidelines recommend against using periprocedural LMWH for VTE patients.

http://mappp.ipro.org

To utilize the application the procedure must be identified to access bleeding risk, as well as the thrombotic risk of the patient.

1. Peri-procedural bridge therapy is NOT indicted for DOACs.

2. Low weight heparin (LMWH) bridge is generally not recommended. If there is a decision to use LMWH,. The pharmacist/provider has the choice of full or prophylactic dose

Enoxaparin (Lovenox ®)

LMWH Treatment Dose:

• 1mg/kg Q12hrs or 1.5mg/kg daily

• CrCl <30 mL/min: 1mg/kg daily

Prophylactic Dose:

• 40mg daily

• CrCl < 30 ml/min: 30mg daily

• CrCl <15 mL/min

• History of HIT

• Plt counts <100,000/mm3

Based on the IPRO algorithm, the clinical pharmacist determine the regimen and contact the patient with peri-procedural instructions.

In the event the clinic is NOT notifed of the procedure the service conducting the provider will be held to the same standards.

Warfarin-naïve patients:

https://clincalc.com/cardiology/anticoagulation/hasbled.aspx http://mappp.ipro.org/

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. This includes any patient with new onset Venous Thromboembolism (VTE), any new valve replacement, prior history of stroke/TIA, and those patients with atrial fibrillation and a CHADS2 score of 3 or more

(note: this will be patient-specific and will weigh risks of ischemic event versus risk of bleeding complications). Please note that bridging is not an exact science and there may be deviations authorized from this protocol. Such deviations should carry an explanation.

In these patients, similar dosing is followed as listed in the “Dosing Guidelines” section.

Typically more aggressive dosing is followed, within reason, in an effort to stop enoxaparin therapy as soon as safely possible. A minimum of 5 days is required in order to allow for inhibition of clotting factors. Ideally an INR should be therapeutic for 2 consecutive days before stopping enoxaparin, however, clinical judgment will be exercised in order to minimize adverse events.

Alternatively, DOACs can be used for initial therapy in most VTE patients.

Invasive procedures requiring warfarin interruption: (refer to above)

Table below provides some guidance, more are included in the IPRO application

MANAGEMENT & DOCUMENTATION OF THERAPY COMPLICATIONS:

Patients reporting a complication to therapy will be referred to either the Emergency Room or their primary care provider as appropriate, based on the severity of the complication. The Clinical

Pharmacist will seek medical consultation with any of the following reported complications:

1) recent trauma (falls, lacerations, etc.)

2) signs/symptoms suggestive of a thromboembolic event

3) an acute change in mental status

4) an acute change in health status

5) uncontrolled bleeding episode (i.e. prolonged or copious hemoptysis, persistent large nosebleeds despite a therapeutic INR, bright red blood without straining, black tarry stools, hematuria)

6) large, spontaneous hematomas

Patients reporting with any recent trauma or uncontrollable bleeding episode will be referred to the Emergency Room for immediate evaluation. Minor episodes will be brought to the attention of the Anticoagulation Physician or the patient's primary care provider, who will then determine the necessary course of action. All events identified by nursing staff must be reported to the clinical pharmacist for appropriate referral. All complications will be documented as such in

CPRS, and all appropriate providers involved in the patient’s care will be alerted to the acute situation. Emergency Room staff will be alerted promptly if a patient is being referred there for care, if they have not already been consulted with.

WARFARIN –HIGH INR

Vitamin-K Administration

The following course of action will be taken by the clinical pharmacist for an elevated INR in patients receiving warfarin therapy:

Condition Intervention

INR ≥5.0 but <10, with no significant bleeding evident

Hold 1 to 2 doses, recheck INR more frequently; resume warfarin once INR is back in target range, and adjust dosage accordingly based on causation. For more rapid reversal

(i.e. surgery), may administer oral vitamin-K

≤5mg

INR ≥ 10.0, with no significant bleeding evident

Hold warfarin; administer oral vitamin-K

2.5mg or 5mg in clinic. Recheck INR 24-48 hours. Administer more vitamin-K if warranted. Resume warfarin once INR is back in target range, and adjust dosage accordingly based on causation

INR >20 or indeterminable (i.e. pt >150 seconds) OR major to life-threatening bleeding at any INR elevation

Hold warfarin therapy; administer vitamin-K

10mg by slow IV infusion; may also administer FFP, prothrombin complex concentrate or rVIIa as warranted.

Management of these patients occurs by ER staff, and the patient should be referred there

ASAP for care

If oral vitamin-K is warranted (i.e. cases where an INR ≥10 with no significant bleeding present), this is typically administered in the clinic setting and in the presence of the Clinical Pharmacist.

In situations where an INR is indeterminable or in cases of major to life-threatening bleeding, the patient should be taken immediately to the Emergency Room for emergent medical attention.

If warfarin therapy is still indicated after receipt of high doses of vitamin-K, heparin or LMWH

(i.e. enoxaparin) may be given if indicated until the effects of vitamin-K have diminished and

INRs can be viewed as reliable values.

Urgent Reversal

WARFARIN reversal:

1. Discontinue warfarin

2. STAT PT/INR, CBC

3. IV vitamin K 10mg in NS 0.9% 50 mls over 30 minutes

a. IV vitamin K is preferred over PO route based on onset of actions

b. Onset of action

i. IV vitamin K: 1 – 2 hours

ii. PO vitamin K: 6 – 10 hours

c. Peak effects:

i. IV vitamin K: 12 – 14 hours

ii. PO vitamin K: 24 – 48 hours

4. FFP 15-30mls/kg of patient weight, with goal to replace…