MUSC

PHARMACY Collaborative Drug Therapy Management

SERVICES Adult Anticoagulation Protocol

PURPOSE
To establish guidelines for the monitoring of anticoagulation therapy in adult patients and to clearly define the
roles/responsibilities of the physicians and collaborating pharmacists. The purpose of the service is to provide
continuity of care to patients who require anticoagulation, enhance patient care through education, monitoring,
and close follow-up, and reduce adverse events associated with anticoagulation therapy.

PROVIDER QUALIFICATIONS

A pharmacist providing anticoagulation drug therapy management must be credentialed by the Department of
Pharmacy Services and meet minimal competencies required for their practice area. Additionally, until
credentialing is obtained, the pharmacist or pharmacy student will work under direct supervision of the
credentialed pharmacist. The physicians must be an MUSC credentialed physicians and have a signed CDTM
agreement for anticoagulation management with the credentialed pharmacist.

PROCEDURE
q Referral
The referring physician will provide the pharmacist with the following: date of anticoagulation initiation,
present anticoagulation dose, INR goal/range, reason for therapy, length of therapy, and other pertinent
information. It is also the responsibility of the referring physician, or their designee, to be available for
consultation. The pharmacist has the right to decline the management of a patient based on perceived
inappropriateness of therapy.
q Clinic Visits
q Procedure:
The patient will follow the general policies and procedures concerning registration and will report to the
laboratory to have blood work drawn if necessary. Afterwards, the patient will meet with the pharmacist
to discuss lab results and other pertinent information. Other forms of communication may be used and
will be determined by the pharmacist and the patient.
q Physical Assessment
q Visual inspection
q Initiate Drug Therapy
The pharmacist is not authorized to initiate drug therapy under this protocol without first contacting a
physician.
q Modify or Discontinue Drug Therapy
q Therapeutic and Non-therapeutic Values:
After evaluation and consideration of all contributing factors including missed/extra doses,
medication changes, dietary changes, and potential bleeding problems, dosage adjustments will
be made according to the flow sheets found in Figure 1. All orders will be written per CDTM
Anticoag Protocol and signed by the credentialed pharmacist. Patients will then schedule a
PT/INR blood draw and follow up appointment with the clinic. Regardless of the INR value, if a
patient has signs or symptoms of serious bleeding or clotting, the referring physician will be
contacted by the clinic, or the patient will be sent to the emergency department. When the
estimated duration of anticoagulation therapy is complete, the referring physician will be notified
and a consensus reached between the clinic and the physician before therapy discontinuation.

q Planned surgeries and procedures

Patients will be instructed to inform all health care providers about warfarin therapy. Upon
notification of planned procedures, the pharmacist will contact the referring physician. Plans for
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 interruption of therapy will be made and forwarded to the appropriate surgeon/physician. The
patient will follow up for PT/INR labs within 7-10 days of restarting warfarin therapy.
q Order Appropriate Tests
The pharmacist is authorized to order the following laboratory tests for the purpose of monitoring the
efficacy and toxicity of anticoagulation therapy (see Figure 1).
q PT/INR
q CBC
q Perform Point of Care Testing
The pharmacist is authorized to perform INR POC testing, with an MUSC approved device.
q Administer Medications
The pharmacist is not authorized to administer medications under this protocol without first
contacting a physician.
q Refer Patients
The pharmacist is authorized to refer patients to their physician or to the emergency department.
q Participation in / coordination of clinical research
Not applicable in this protocol
q Patient Education
An extensive longitudinal program of patient education will be provided. Patients and family
members/caretakers will be provided with the following information:
q Purpose of the anticoagulation service and follow-up procedures
q Indication for warfarin therapy
q Goal INR
q Signs and symptoms of bleeding and what to do if it occurs
q Signs and symptoms of thrombus or emboli and what to do if it occurs
q Instructions on how to take warfarin and the importance of adherence
q What to do if a dose is missed
q Identification of warfarin dose by color
q Drug – Diet interactions (vitamin K containing foods)
q Drug –Drug interactions (Rx, OTC, and herbal products)
q Documentation
All patient encounters will be documented in the progress notes of the electronic medical record
using the clinical pharmacy anticoagulation note template (Figure 2). All notes will be sent to the
referring provider via the OACIS system or through inter-departmental mail.
q All other procedures will be performed according to the general policies and procedures of the clinic.

QUALITY ASSURANCE/OUTCOMES

Data will be continuously monitored to ensure patients are receiving optimal care. Outcomes of the
anticoagulation protocol will include, but not be limited to % of patients at goal INR, response to therapy, and
adverse events. Process tracking will also occur to confirm adherence to the protocol. These results will be
presented quarterly to the appropriate pharmacy coordinator and manager.

Protocol Number & Title: CDTM 01 Adult Anticoagulation Protocol Dates:

Owner & Author: Pharmacy Services / Alisa Christman, PharmD Originated: 11/3/2005
Approved: 11/17/05
Location / File name: Review: 11/2007

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 FIGURE 1 – Dosage Adjustment Protocols
Low Intensity INR (Goal 2-3)

INR < 1.5 INR 1.5 - 1.9 INR 2.0-3.0 INR 3.1-4.0 INR 4.1-5.0 INR > 5.0

Extra dose(s) and/or increase Extra dose and/or increase No Change Hold dose and/or decrease Hold dose(s) and/or decrease Contact MD
weekly dose by 10-20% weekly dose by 5-15% RTC 4-6 weeks weekly dose by 5-15% weekly dose by 15-20% Hold dose(s) and/or decrease
RTC 1-2 weeks RTC 2-4 weeks* RTC 2-4 weeks* RTC 1-2 weeks weekly dose by 15-20%
RTC within 1 week

High Intensity INR (Goal 2.5 - 3.5)

INR < 2.0 INR 2.0 - 2.4 INR 2.5 - 3.5 INR 3.6 - 4.0 INR 4.1 - 5.0 INR > 5.0

Extra dose(s) and/or increase Extra dose and/or increase No Change Hold dose and/or decrease Hold dose(s) and/or decrease Contact MD
weekly dose by 10-20% weekly dose by 5-15% RTC 4-6 weeks dose by 5-15% dose by 10-20% Hold dose(s) and/or decrease
RTC 1-2 weeks RTC 2-4 weeks* RTC 2-4 weeks* RTC 2-4 weeks dose by 10-20%
RTC 1-2 weeks

*Dosage adjustment may not be necessary

**Dose should be increased or decreased after 2 consecutive super or sub-therapeutic INR values

1
Recommendations for Vitamin K Administration *
INR Patient Situation Action
> 5 and < 9 And No bleeding or risk factors for Omit 1-2 doses
bleeding
No bleeding, but at risk of Omit 1-2 doses and give oral vitamin K (1 –
bleeding 2.5mg)
> 9 and < 20 And No clinically significant bleeding Omit several doses, and give oral vitamin K
(3-5mg. Monitor closely and repeat vitamin
K prn. Resume warfarin when INR in
desired range
> 20 Or Serious bleeding or warfarin Refer immediately back to referring
overdose physician or to emergency department.
st
*The pharmacist must 1 contact the physician before the initiation of vitamin K
1
Warfarin Drug Interactions **
Drug/Food Interactions Which Have Been Reported to Increase the Effects of Warfarin
Acetaminophen, alcohol, amiodarone, anabolic steroids, chloral hydrate, cimetidine, ciprofloxacin, clofibrate,
disulfiram, erythromycin, fluconazole, isoniazid, itraconazole, metronidazole, miconazole, omeprazole,
phenylbutazone, piroxicam, propafenone, propranolol, quinidine, phenytoin, sulfamethoxazole/trimethoprim,
sulfinpyrazone, tamoxifen, tetracycline, flu vaccine
Drug/Food Interactions Which Have Been Reported to Decrease the Effects of Warfarin
Barbiturates, carbamazepine, chlordiazepoxide, cholestyramine, dicloxacillin, griseofulvin, nafcillin, rifampin,
sucralfate, high vitamin K content foods/enteral feeds
**This is not a comprehensive list of warfarin interactions. Any changes in medications will be appropriately addressed.

References:

1. Dalen JE, Hirsh J, Guyatt GH, eds. Seventh ACCP consensus conference on antithrombotic and thrombolytic therapy.
Chest 2004;126: 163S-696S.

2. Kearon C, Hirsh. Management of anticoagulation before and after elective surgery. N Engl J Med 1997;336:1506-11.

3. Ansell JE ed. Managing oral anticoagulation therapy: clinical and operational guidelines. Gaithersburg, MD:Aspen
Publishing Co., 1997.

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