Anticoagulation Clinic Guidelines (Draft)
DeanMedicalCenter
The Anticoagulation Clinic(AC Clinic) is a service staffed by pharmacists and nurses with specific knowledge in anticoagulation therapy. Anticoagulation care is managed under the supervision of the AC Clinic Medical Director and the patient’s physician.
I. Goals and Objectives
A. To provide services to physicians initiating anticoagulation therapy and assist physicians
in the management of oral and parenteral anticoagulants.
B. To provide consistent management and follow-up care for patients receiving
anticoagulation therapy by evaluating patient-specific data and pertinent laboratory tests
dependent upon the anticoagulant regimen.
C. To provide consistent education to the patient and/or family members about warfarin
and other anticoagulant therapy. To make them aware of potential problems during therapy
and the signs and symptoms of bleeding, embolic events and other adverse effects.
D. To consistently identify patients who are non-adherent with the anticoagulation care plan
and provide education toimprove adherence and reduce the potential for adverse events
and maximize the benefits of treatment.
.
E. To maintain an anticoagulation flowsheet for each patient and provide complete
documentation of the care provided in the patient’s electronic medical record.
F. To consult with other providers involved with the patient’s care when needed.
II. Scope of Care
A. Patient Referral
1. Patients may be referred to the AC Clinic if they have demonstrated the capability to
self-administer medication, or have a responsible caregiver who can supervise the
medication administration, or other acceptable process in place to ensure adherence to
the treatment plan. A reliable method of communicationmust exist for the
patient to be enrolled in the AC Clinic. The AC Clinic is unable to manage the
patients with the following issues:
a. uncontrolled alcohol abuse
b. underlying psychiatric problems hindering adherence to program expectations
c. inability to adhere to care plan
d. patients with no reliable means of communication
- Patients may be referred to the AC Clinic at any point during anticoagulation therapy
provided that a collaborative care agreement exists between the AC Clinic and
the supervising physician(See below: Collaborative Care Agreement). The patient
must be assessed by the supervising physician periodically to determine need for
further anticoagulation therapy.
Dean Anticoagulation Clinics
COLLABORATIVE CARE AGREEMENT
I, ______MD / DO, acknowledge that I have read and approve the Guidelines of the Dean Anticoagulation Clinics (AC Clinic). My signature on this document authorizes the AC Clinic clinician to monitor my patients’ anticoagulation therapy. This collaborative agreement may be terminated at any time for an individual patient either by me or the AC Clinic clinician for any reason including: anticoagulation therapy is discontinued, patient desires to be followed by the primary physician alone, or the patient misses 3 consecutive appointments, blood draws or other laboratory test used to maintain control of the anticoagulation therapy without contacting the AC Clinic staff.
Check all of the following that apply:
___ It is not necessary for the AC Clinic clinician to call me for routine changes in
therapy.
___ The AC Clinic clinician may authorize prescriptions for warfarin to the
patient’s pharmacy on my behalf.
Physician’s Signature______Date______
Please print name______
4. Referrals to the AC Clinic can be made by the primary physician verbally, by
electronic referral, or by written orders. The referral should indicate the reason for use,
desired intensity of treatment, and planned length of treatment. If the physician has
already prescribed a dosage of the anticoagulant, the strength of medication and dosage
per day needs to be indicated.
5. The AC Clinic will establish a computerized patient file for each new referral.
After reviewing the patient’s medical record, the AC Clinic clinician will complete a
initiation form in Epic. The patient’s medical record will be evaluated to obtain
the information listed below. If not specified by the primary physician, the desired INR
range will be based on the current AmericanCollege of Chest Physicians Consensus
Conference guidelines for the specific indication along with individual patient
characteristics. The AC Clinic clinicianwill contact the physician, when needed, to
determine thetarget range and duration of treatment for the intended therapy. The AC
clinician will provide the physician the literature recommendations for usual target
range and duration of therapy for the specified indication, if needed. The computerized
medical record should have the following information available to the AC Clinic
clinician for review:
a. patient name, address and telephone number (home/work)
b. emergency notification contact (telephone number home/work)
c. date of birth, weight, height, gender
d. current medications, including prescription and nonprescription
e. medical history: known diseases and surgeries, drug allergies and reactions,
conditions relating current medication regimen, surgical history, and hospitalizations.
f. indication for anticoagulation therapy
g. target INR range and planned duration of therapy
h. if already receiving anticoagulation therapy include: start date, current dose
i. history of bleeding including major and minor (dates and outcomes)
j. physician name, direct office telephone number, pager number, and fax number
Dean Anticoagulation Clinics
INDICATIONS AND THERAPEUTIC RANGES
Unless the desired INR range is specified by the primary physician on the patient referral form, the AC Clinic will use ranges for the corresponding indications below as recommended by the Commitee on Antithrombotic Therapy of the AmericanCollege of Chest Physicians.
INDICATION / TARGET INR (RANGE) / DURATION / COMMENTAtrial Fibrillation (AF)
Age < 65 no risk factors
Age < 65 with risk factors for stroke (Hx
TIA/stroke/TE; HTN, CHF, LV fxn;
rheumatic mitral valve dz; valve replacement;
DM; CAD; thyrotoxicosis
Age 65-75 no risk factors
Age 65-75 with risk factors
Age > 75
Precardioversion (AF/flutter > 48 hrs in duration
Postcardioversion (in NSR) / None
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0) / Chronic
Chronic
Chronic
Chronic
Chronic
3 weeks
4 weeks / Aspirin alone
Or Aspirin
Weekly INRs
Add antiplatelet Rx
CardioembolicStroke
With risk factors for stroke (AF;CHF;LV
dysfxn; mural thrombus; Hx TIA/Stroke.TE)
Following embolic event despite therapeutic
anticoagulation / 2.5 (2.0-3.0)
2.5 (2.0-3.0) / Chronic
Chronic
Left Ventricular Dysfunction
Ejection fraction <30%
Transient, following myocardial infarction
Following embolic event despite therapeutic
anticoagulation / 2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0) / Chronic
3 months
Chronic / Add antiplatelet Rx
Acute Myocardial Infarction (MI)
Following anterior MI
Following inferior MI with transient risks (AF;
CHF; LV dysfxn; mural thrombus, Hx TE)
Following initial tx with persistent risks / 2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0) / 3 months
3 months
Chronic
Thromboembolism (DVT,PE)
Treatment/prevention of recurrence
Transient risk factors
Idiopathic
Presisitent risk factors (AT-III; protein C;
protein S deficiencies; Factor V Leiden;
malignancy
Antiphospholipid antibody syndrome
Following recurrent DVT/PE / 2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
3.0 (2.5-3.5)
2.5 (2.0-3.0) / 3-6 months
6 months
Chronic
Chronic
Chronic / May need higher range
Valvular Disease
Aortic valve disease with mitral valve disease; AF;
Hx systemic embolization
Mitral annular calcificationwith AF; Hx systemic
embolization
Mitral valve prolapse:
With AF; Hx systemic embolization
With Hx of TIA despite ASA Rx
S/p embolic event despite anticoagulation
Rheumatic mitral valve disease
With AF; Hx systemic embolization;
LA > 5.5cm
S/p embolic event despite anticoagulation / 2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0) / Chronic
Chronic
Chronic
Chronic
Chronic
Chronic
Chronic / Add antiplatelet Rx
Add antiplatelet Rx
Valve Replacement-Bioprosthetic
Aortic or mitral
with LA thrombus
with Hx systemic embolism
with AF
Following systemic embolism / 2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0)
2.5 (2.0-3.0) / 3 months
>3 months
3-12 months
Chronic
Chronic / Followed by aspirin Rx
Followed by aspirin Rx
Followed by aspirin Rx
Add aspirin Rx
Valve Replacement – Mechanical
Aortic
Bileaflet
In NSR, normal EF, normal LA size
All others
Tilting disk
Ball and cage
Mitral
Bileaflet
Tilting disk
Ball and cage
With additional risk factors or following TE / 2.5 (2.0-3.0)
3.0 (2.5-3.5)
3.0 (2.5-3.5)
3.0 (2.5-3.5)
3.0 (2.5-3.5)
3.0 (2.5-3.5)
3.0 (2.5-3.5)
3.0 (2.5-3.5)
3.0 (2.5-3.5) / Chronic
Chronic
Chronic
Chronic
Chronic
Chronic
Chronic
Chronic
Chronic / * 2.0-3.0 + aspirin81mg
* 2.0-3.0 + aspirin81mg
With aspirin
* 2.0-3.0 + aspirin81mg
* 2.0-3.0 + aspirin81mg
With aspirin
Add aspirin
*In patients with risks for hemorrhage.
Hx, history;TIA transient ischemic attack; TE, thromboembolism; HTN, hypertension; CHF, congestive heart failure;
, lowered; LV left ventricular; fxn, function; dysfxn, dysfunction; dx, disease; CAD, coronary artery disease;
AF, atrial fibrillation; NSR, normal sinus rhythm; MI myocardial infarction; tx, treatment; DVT, deep venous thrombosis;
PE pulmonary embolism; s/p, status post; LA, left atrium; EF, ejection fraction
6. All referrals to the AC Clinic must have a supervising DeanMedicalCenterphysician
who is responsible for periodically assessing the patient’s continuing need for
anticoagulation therapy and management of medical/surgical problems.
- If difficulties arise, such as, lack of cooperation, continued non-adherence with
INR blood draws, the primary physician will be made aware of the issues by the
AC Clinic clinician. A note will be placed in the patient’s medical record
describing the problem, discussion with the primary physician, and agreed upon course
of action. If the issue continues to be problematic despite repeated efforts to rectify the
problem, the patient may be referred backto the primary physician for reevaluation.
- In addition to adherence issues, the AC Clinic clinician will notify or, if needed, refer the patient back to the primary physician or proceed to the hospital ER in the following circumstances:
a. consultation with a physician is requested by the patient
b. the AC Clinic cliniciannotes findings suggestive of another worsening medical
problem
c. there is evidence suggestive of gross hematuria, gastrointestinal, or other bleeding
d. there is evidence suggestive of worsening thromboembolic disease
e. assessment of continuing need for anticoagulation is warranted
9. Discontinuation of anticoagulation therapy will only occur by physician order. When the
desired length of treatment has been reached, the the AC Clinic clinician will refer the
patient backto the primary physician to evaluatethe need for continued
anticoagulation.Discharge from the AC Clinic will occur by physician order when:
a. anticoagulation therapy is discontinued
b. the patient desires primary physician to manage anticoagulation
c. the primary physician decides to manage anticoagulation
d. the patient violates adherence policy (see B.3)
10. The AC Clinic clinician must provide consultation only with the patient via an inclinic appointment,
the telephone, US mail or MyChart. The AC Clinic clinician can leave a message on the patient’s
voice mailor answering machine or speak with a family member, activated power of attorney for
healthcare, or other designated person provided that the patient completes and signs the AC Clinic
verbal permission form (see below). The completed and signed formed must be scanned into Epic
by Medical Records.
PERMISSION FOR VERBAL COMMUNICATIONS
(print name of patient or place patient label here) (birthdate)
(street address)(city, state, zip code)
(phone number)
I permit Dean Health Systems, Inc. Anticoagulation (AC) Clinic personnel (“Health Care Providers”) to leave information regarding ongoing anticoagulation therapy on my voice mail or answering machine.
In addition this authorization allows the AC personnel to discuss health information, in person or by telephone with the following family members or friends involved in my medical care: (List family members/friends and state the person’s relationship to the patient).
Name / Phone Number / Relationship1.
2.
3.
4.
Patient’s Signature: Date:
If this Release is signed by a representative on behalf of the patient, complete the following:
Representative’s Name:
Relationship to Patient:
If, at any time, I do not want this information to be left on my answering machine or I want to change the names of the people listed above, I must notify the Anticoagulation (AC) clinic:
by telephone at 608-252-8060, or
by mail at the address listed below, or
in person at the Anticoagulation Clinic at Dean Clinic.
INSTRUCTIONS: Please sign this form and send to the following location:
Dean ClinicAttention: Anticoagulation Clinic
1313 Fish Hatchery Road
Madison, WI53715
\\dhs\dfs\Groups\Pharmacy\Administration\Web Page\Anticoagulation Clinic\AC Verbal Permission form.doc Rev 1/28/09
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- Clinic Procedures -AC Clinics: For Dean Fish Hatchery Road AC Clinics see visio below;
For Riverview and Stoughton AC Clinic, see attached guidelines.
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1. Patients will schedule appointments to the AC Clinic during regular office hours. The
patient will be scheduled by the AC Clinic in Epic. The AC Clinic clinician will see
patients as follow-ups, accept new consults and phone patients with INR results and
changes in the care plan. Hospital patients who are enrolled after discharge need to be
scheduled within 1 week of discharge.
2. For patient who are managed primarily by phone, they may have INRs drawn at any
Dean Medical Center Laboratory, any outlying laboratory, via Home Health Service, or
via point of care self testing. INR test results must betransmitted to the AC Clinic.
When possible a hard copy from outlying laboratories will be scanned into Epic by
Medical Records. Patients with inclinic appointments with the AC Clinic need toarrive
at the Fish Hatchery Clinic Lab 1 hour prior to their appointment for their INR draw.
They need to check in for the appointment at the appointment desk, then be seated at the
AC Clinic Office area. If a patient can not attend a scheduled AC Clinic visit or have
blood drawn on the day arranged the patient needs to call the AC Clinicto reschedule.
3. Missed appointments (no shows) – AC Clinic dismissal process
a. AC Clinic Current No Show Process
__Date______Available INR Reminder Notification_ __Documentation_
INR DUE (Day X)NO NO NO
X+7NO REMINDER CALL #1 FLOWSHEET/EXCEL
X+14NO REMINDER CALL #2 FLOWSHEET/EXCEL
X+21NO REMINDER CALL #3 FLOWSHEET/EXCEL
X+28NO REMINDER LETTER FLOWSHEET/EXCEL
X+35NO AC PROVIDER** YES (AC ROVIDER)
**Per agreement with the Primary Care Leadership at Dean Clinic with the Dean Anticoagulation Clinics in 2011: non adherent patients, who have fully progressed through the process outlined above, will be sent back to their PCP to reassess the appropriateness of continued anticoagulation. If the patient is thought to be best served by anticoagulation, the AC Clinic would consider resuming care if the patient agreed to be compliant (that is, after the PCP has discussed the potential "second chance" with the patient). If during this “second chance” with the AC Clinic, the patient remains non adherent with their recommendations, the AC Clinic would not continue to monitor further anticoagulation therapy . The AC Clinic will inform the PCP of this action. The PCP will need to make the clinical judgment about further treatment and, if continued, the PCP would manage the anticoagulation therapy.
- FLOWSHEET- IS THE ANTICOAGULATION CLINIC SMARTFORM
- EXCEL FILE - FILE AC CLINIC USES TO TRACK THE LIST OF PATIENTS AND NUMBER OF REMINDER CALLS MADE.
4. Initiation of warfarin therapy:
a. Obtain Baseline INR.
b. Begin warfarin at 5 - 10 mg daily (may need lower dose such as 2-2.5 mg/day in
patients with coexisting medical problems, concurrent interacting medications or with
known or suspected sensitivity to warfarin. Have patient take warfarin in the
evening.
c. Return to clinic or laboratory for INR testing as specified in B.5
5. Initiation of anticoagulation therapy will require frequent INR blood tests and subsequent
dosage adjustments until the patient is anticoagulated and the INR results are stable
(defined as two similar, consecutive therapeutic INRs). The AC Clinic will use the
consensus guidelines for the frequency of INR monitoring as follows:
a. After initiation of warfarin therapy, INR drawn at least weekly until stable.
b. Then every 2 weeks until stable.
c. Then every 4 weeks unless special circumstances exist.
d. If previously stable INR, becomes unstable then proceed back to a. or b. above.
e. If INR is slightly out of range, repeat within 1 month. If still out of range then adjust
warfarin regimen.
6. For inclinic appointments, vital signs (blood pressure, pulse, etc.) should be
measuredif not done within last 48 hours, then documented in the medical record. Patients
arriving early will be seen as soon as possible. Walkins will be seen as soon as possible as
space permits in the AC Clinic schedule.
7. If a patient develops uncontrolled bleeding, signs and symptoms of thromboembolism. etc., the
patient will be instructed togo to the nearest Emergency Room or call 911.
8. Using the guidelinesbelowestablished by the Dean Clinical Practice Committeefor Anticoagulation
Bridging, the AC Clinic clinician will consult with the appropriate provider to arrange a care plan
for managing anticoagulationtherapy perioperatively and around other invasive procedures:
Clinical Practice Committee
Anticoagulation Bridging Algorithm
Bridging Regimens
HIGH THROMBOEMBOLIC RISK- VTE
1 4 days prior to procedure- discontinue warfarin
2 2 days prior – start Full Dose Enoxaparin (1mg/KG BID)
3 12 hours prior – discontinue Enoxaparin
4 Day of procedure – check INR, should be <1.5
5 Evening of the day of procedure – restart warfarin
6 Approximately 12 hours post procedure – restart Full Dose Enoxaparin
7 3-5 days post – begin regularly monitoring INR, stop Enoxaparin when INR > 2. NOTE: In pregnant patients continuous unfractionated heparin should be used unless anti-factor Xa activity is measured and the dose of Enoxaparin appropriately adjusted.
HIGH THROMBOEMBOLIC RISK- MECHANICAL HEART VALVE(MHV)
Unfractionated heparin has been the standard bridging anticoagulant for patients with mechanical heart valves. Early studies with Low Molecular Weight Heparin (LMWH) bridging revealed an increased thromboembolic risk in pregnant women with MHV’s. It is now known that LMWH doses require adjustment in pregnancy to account for altered metabolism of the drug (based on measurements of anti-Xa activity). However, because of inadequate comparative trials the AmericanCollege of Cardiology/American Heart Association gives its highest recommendation (Ia) to the use of UFH as outlined below with a IIb recommendation for the LMWH regimen outlined above for VTE.
1 4 days prior to procedure - discontinue warfarin
2 2 days prior (or when INR<2.0) start continuous UFH maintaining aPTT 55-70
3 6 hours prior discontinue heparin
4 Day of procedure – check INR, should be <1.5
5 Evening of the day of procedure – restart warfarin
6 Approximately 12 hours post procedure – restart UFH, continuing until INR>2.0
INTERMEDIATE THROMBOEMBOLIC RISK
This is a heterogeneous group with a relatively low, however broad range of thromboembolic risk during this brief period of inadequate anticoagulation. The vast majority of these patients do not achieve a significant clinical benefit from bridging and can thus be managed using the Low Thromboembolic Risk strategy. The Department of Cardiology at Dean does not bridge this group of patients unless they have had a recent embolic event (i.e. stroke).
LOW THROMBOEMBOLIC RISK
1 4 days prior - discontinue warfarin
2 Day of procedure – check INR, should be <1.5
3 Day of procedure – restart warfarin