SUBJECT: ANTICOAGULATION CLINIC PROTOCOL
PAGE 1 OF 3
DEPARTMENT OF PHARMACY SERVICES
EFFECTIVE: 12/96
APPROVED BY: Pharmacy and Therapeutics Committee
REVISED: 3/97, 8/98, 1/99, 2/07,
3/08, 2/12
I.
GOALS
a. The William W. Backus Hospital Anticoagulation Clinic is designed to assist physicians in improving
quality of care provided to their patients on anticoagulation therapy. Ultimately, our goal is to assure that
these services improve patients' therapeutic outcomes, reduce complications of anticoagulation therapy,
and reduce hospitalizations. Specific goals include:
i.
ii.
iii.
iv.
Improving continuity of care for patients on anticoagulation therapy
Providing patient education on disease state and drug therapy
Reducing adverse effects of anticoagulation therapy
Maximizing the benefits of anticoagulation therapy
II. OBJECTIVES
a. Provide a monitoring service for physicians initiating and continuing long-term anticoagulation.
b. Provide education and routine follow-up for patients including disease state information, monitoring
requirements, drug therapy consultation, and drug compliance assessment.
c. Reduce adverse effects resulting from warfarin therapy by screening for drug-drug interactions, drugdisease state interactions, drug-food interactions, and for signs and symptoms of unusual bruising or
bleeding or embolic events.
d. Assist physicians in maximizing the benefits of warfarin therapy by maintaining the patients' INR values
within the optimum therapeutic range.
e. Coordinate anticoagulation therapy during perioperative periods.
III. DESIGN
a. The William W. Backus Hospital Anticoagulation Clinic is an outpatient, ambulatory clinic that provides
comprehensive care to individuals diagnosed with coagulation disorders and/or receiving anticoagulation
drugs. The Clinic utilizes a Point of Care (POC) device to assess the effectiveness of warfarin therapy.
Patients are assessed by anticoagulation care providers comprised of advanced trained pharmacists and
nurses. A licensed physician oversees the activities of the care providers. An Anticoagulation Clinic
Physician will be available for consultation during the hours of operation.
IV. PROCEDURE
a. Referral
i. Individuals will fall under the care of the clinic after a physician involved in the care of the patient
completes and forwards an "Anticoagulation Clinic Referral" form. Anticoagulation care by the
Clinic commences once the patient has their first clinic visit. Referrals are only accepted for
ambulatory patients able and willing to visit the clinic in person.
ii. Once received, Referral Forms are immediately reviewed by a Care Provider for appropriateness
and completeness and to determine the urgency of the patient’s first visit. Missing information will
be promptly obtained from the referring physician.
iii. Patients will be contacted as soon as able to schedule their initial visit.
iv. Referred patients without a primary care physician (PCP) or other managing physician (MP).
1. All patients being managed by the clinic need to be under the care of a primary care
physician or other physician managing the patients care. Patients referred to the clinic
that are not under the care of a PCP/managing physician will be managed by the clinic as
soon as clinically required, but will be given a limited time period to obtain a primary care
physician or appropriate specialist.
2. During the initial visit, PCP information will be obtained.
3. Those not having a PCP/managing physician will be given a list of area Family and
Internal Medicine physicians and appropriate specialists and be instructed of this policy
and requested to obtain a physician within three months.
4. If after three months the patient still has not obtained a PCP/MP, A certified letter will be
sent to the patient to inform them that they have 3 more months to secure a PCP/MP or
their anticoagulation therapy will no longer be monitored by the clinic.
5. If after a total of six months, the patient still has not obtained a PCP/MP, a Clinic
discharge letter will be sent to the patient to inform them that they will no longer be
managed by the clinic.
b. Patient’s initial visit
i. After reception of a referral form, the patient will be contacted to arrange for their initial visit to
take place at the earliest opportunity. During the initial visit, an anticoagulation care provider will
review the referral and any additional pertinent medical information. This information will be
recorded in the patient’s anticoagulation clinic chart.
ii. Patients will be notified of their HIPAA rights and Clinic policies and sign the following forms: (See
appendix)
1. Anticoagulation Clinic Consent, Release of Information, Guarantee of Payment Form
2. Clinic Contract with Patient
c.
Education Session
i. Patients will be scheduled for at least one 45-minute educational visit to occur at the earliest
opportunity. This session will consist of a multimedia presentation, a focused lecture, and a
question and answer section. The education will focus on the risk and benefits of
anticoagulation therapy, thromboembolic disorders, and safe medication practices. Information
regarding the clinic’s design, working hours, and procedures will also be discussed. Patients
may elect to refuse this session as well as repeat it at any time during their care. (See appendix)
d. Standard Visit or Encounter
i. At each scheduled appointment, the patient will be interviewed and assessed by a care provider
(or student being overseen by a care provider) for the following current and potential
information:
1. Signs and symptoms of hemorrhagic or embolic complications
2. Changes in dietary or alcohol habits
3. Recent changes in life style or health status
4. Status of medical problem necessitating anticoagulation therapy
5. Changes in medication regimen including OTC and herbal preparations
6. Compliance issues related to medication regimens
7. Confirmation of current anticoagulant regimen
ii. The care provider will perform a POC PT/INR test. (See Policy: Whole Blood Prothrombin Time)
The result of the test will be compared to the therapeutic range that is prescribed for the patient
and their current health status and/or issues discussed as above. For all POC INR results
greater than 4, a confirmatory venipuncture PT/INR should be drawn. For all INR results
greater or equal to 4.5, the clinic physician must be directly consulted. The care provider will
directly evaluate other INR results at the time of visit. The management of the result will depend
on the many patient factors obtained above as well as the patient’s individual risk of
hemorrhagic or embolic complications (if identifiable). Attachment 1 will be used to guide the
management decisions. All appropriate information will be communicated to the patient or
designated caregiver. Follow-up appointments will be scheduled before the end of the visit.
Follow-up should occur no greater than 4 weeks later, but may occur as early as 24 hours. See
Attachment 2 for general guidelines.
iii. When there is clinical suspicion of anemia or occult bleeding including but not limited to sample
error on POC testing device, new onset or worse than baseline, shortness of breath, pale
appearance, or tiredness: A hemoglobin/hematocrit lab test will be ordered as per the Clinic
Medical Director and followed up as follows:
HGB > 10
HGB 7-9
Copy of lab result forwarded to patients primary care provider
Primary care provider notified immediately
HGB < 7
Patient immediately referred to the Emergency Department.
The patient as well as the Clinic Medical Director will also be informed of all results when
available.
iv. At the conclusion of the visit, the patient will be given an appointment card with the Clinic’s phone
number and date and time of follow-up visit on the front. The back of the card will indicate the
patient’s INR result and dosage regimen.
e. Care of Patients Unable to Visit the Clinic
i. Patients unable to travel to the clinic due to medical or temporary logistical reasons may be cared
for through telephone consultations and INR results obtained by other laboratory services. The
telephone interview and management process will be of the same procedure listed above for a
standard visit.
f.
Management of Critical Values
i. INR results >4.5 or otherwise deemed critical by the care provider need to be communicated to
the clinic physician (or patient’s primary care physician) as soon as able. On the direction of a
licensed prescriber, a sample dose of oral phytonidione (Vitamin K) may be dispensed to the
patient by a licensed prescriber (APRN) or pharmacist with proper labeling and instruction and
documented on the “Vitamin K Sample Log”.
ii. Any orders given by the clinic physician by telephone or verbal means must be immediately
transcribed into the patient’s profile and signed by the physician within 24 hours.
g. Perioperative Management
i.
Patients currently receiving anticoagulation therapy offer unique and difficult therapeutic
challenges when needing a percutaneus medical procedure.
ii.
Patients should be interviewed at each visit for the possibility of planned percutaneous
procedures.
iii. When a medical procedure is pending, a thromboembolic and hemorrhagic risk assessment
should be completed and resulting treatment strategies discussed with the patient (see
appendix). When necessary, the patient’s primary care provider, surgeon, dentist,
gastroenterologist or other physicians as well as the clinic physician should be consulted for
final approval of treatment strategies.
h. Documentation
i. Patient Profile
1. An electronic patient profile will be maintained in the Meditech system for all active
patients. Documentation will include a minimum of:
a. Diagnosed reason for anticoagulation
b. Other medical conditions
c. Contact information
d. Current warfarin tablet strength
e. Therapeutic range
f. Expected duration of anticoagulant treatment
g. Referring physician
ii. Individual Visit Documentation
1. At each patient visit the following items will be documented in the Meditech PCS system:
a. PT/INR results
b. Warfarin dosage regimen
c. Education topics covered
d. Whether the encounter was by telephone or in person
e. Relevant clinical information obtained from the patient interview
f. Instructions given to the patient
g. Date of follow-up appointment (entered in Meditech SCH)
h. Billing level
iii. Printing and review of Summary Sheets
1. A patient visit summary sheet containing this information as well as the pertinent profile
information listed above will be printed for all patient visits that occurred that day.
2. These sheets will be reviewed and signed by the clinic physician within 24 hours.
a. The physician’s signature will indicate agreement with the documented treatment
plan including dosage recommendation, date of follow-up visit and any patient
instructions given.
b. If the reviewing physician disagrees with any of the documentation, they may
either notify the patient themselves (if medically warranted), or document the
changes they want to be implemented and notify the Clinic staff of the changes.
c. Any orders given by the clinic physician by telephone or verbal means must be
immediately transcribed into the patient’s profile and signed by the physician
within 24 hours.
i.
Prescriptions
i. Prescriptions for anticoagulant drugs for clinic patients should originate from the clinic. To reduce
the chance of error, telephone prescriptions should only take place when necessary due to time
and technological constraints. Prescriptions should be written and given to patients and/or
faxed to pharmacies. Prescriptions may be filled out by care providers but must be signed by a
licensed prescriber before being telephoned or otherwise transmitted to a pharmacy.
j.
Billing
i. Patients will be billed for the encounter only if all of the following take place:
1. The patient was interviewed and assessed in the clinic by a care provider
2. A PT/INR test was done
3. Education was offered
V. Care Providers
a. Anticoagulation Care Provides must:
i.
Be a Connecticut licensed pharmacist, nurse, physician’s assistant or physician.
ii.
Have completed a basic assessment of knowledge and skills (see appendix).
b. Students may interview, assess and instruct patients providing:
i.
They have completed a basic assessment of knowledge and skills.
ii.
Assessment and instructions are reviewed by a Care Provider prior to the instructions being
given to the patient.
iii.
All documentation done by the student must be reviewed and co-signed by a care provider
before the end of the working day.
VI. HIPAA see The William W. Backus Hospital HIPAA Policy and Procedure Manual
VII. Quality Assurance
a. Quality assurance will be carried out through the following activities:
i.
Monthly tracking of overall percent of patients within their therapeutic range.
ii.
Monthly tracking of overall percent of INR results >4.0
iii.
Monthly tracking of number of clinic patients admitted for hemorrhagic or thrombotic events.
1. “Peer review” is performed on each identified case.
b. Quarterly report of above indicators to the Pharmacy and Therapeutics Committee.
Attachment 1
Recommendations for Managing Bleeding or INRs Outside of the
Therapeutic Range
Condition
INR below therapeutic
range; no signs of
thrombosis
Recommendation
Increase dose in increments of 5 to 20% based on the cumulative weekly
dose or monitor more frequently; a one-time larger dose may be given
followed by more frequent monitoring; if only minimally below therapeutic
range, no dose increase may be required
INR above therapeutic
Lower dose in increments of 5 to 20% based on the cumulative weekly
range but < 5.0; no
dose or omit dose, monitor more frequently, and resume at lower dose
significant bleeding
when INR therapeutic; if only minimally above therapeutic range, no dose
reduction may be required
INR 5.0 but < 9.0; no
Omit next one or two doses, monitor more frequently and resume at lower
significant bleeding
dose when INR in therapeutic range. Alternatively, omit dose and give
vitamin K1 ( 5 mg orally), particularly if at increased risk of bleeding. If
more rapid reversal is required because the patient requires urgent surgery,
vitamin K1 (2 to 4 mg orally) can be given with the expectation that a
reduction of the INR will occur in 24 h. If the INR is still high, additional
vitamin K1 (1 to 2 mg orally) can be given
INR 9.0; no significant
Hold warfarin therapy and give higher dose of vitamin K1 (5–10 mg orally)
bleeding
with the expectation that the INR will be reduced substantially in 24–48 h.
Monitor more frequently and use additional vitamin K1 if necessary.
Resume therapy at lower dose when INR therapeutic
Serious bleeding at any
Hold warfarin therapy and give vitamin K1 (10 mg by slow IV infusion),
elevation of INR
supplemented with fresh plasma or prothrombin complex concentrate,
depending on the urgency of the situation; recombinant factor VIIa may be
considered as alternative to prothrombin complex concentrate; vitamin K1
can be repeated every 12 h
Life-threatening bleeding Hold warfarin therapy and give prothrombin complex concentrate
supplemented with vitamin K1 (10 mg by slow IV infusion); recombinant
factor VIIa may be considered as alternative to prothrombin complex
concentrate; repeat if necessary, depending on INR
*
If continuing warfarin therapy is indicated after high doses of vitamin K1, then heparin or LMWH can be
given until the effects of vitamin K1 have been reversed and the patient becomes responsive to warfarin
therapy. It should be noted that INR values > 4.5 are less reliable than values in or near the therapeutic range.
Thus, these guidelines represent an approximate guide for high INRs.
Adapted from: Ansell J et al. The pharmacology and management of the vitamin k antagonists: the seventh ACCP
conference on antithrombotic and thrombolytic therapy. Chest 2004;126;204-233
Attachment 2
Recommendations for scheduling of follow-up clinic visits
The optimal frequency of long-term INR monitoring is influenced by patient compliance, transient fluctuations in comorbid
conditions, the addition or discontinuation of other medications, changes in diet, the quality of dose-adjustment decisions,
and whether the patient has demonstrated a stable dose response.
In newly treated patients, INR monitoring should be performed daily starting after the second or third dose until the
therapeutic range has been achieved and maintained for at least 2 consecutive days, then two or three times weekly for 1
to 2 weeks, then less often, depending on the stability of INR results.
When the INR response is stable, the frequency of testing can be reduced to intervals as long as every 4 weeks. If
adjustments to the dose are required, then the cycle of more frequent monitoring should be repeated until a stable dose
response can again be achieved. Small dosage adjustments (5-10% of weekly dosage) will require patients return for
follow-up in one weeks time. Larger dosage adjustments may require the patient to return to daily consecutive visits until
dosage stability is regained.
As a general rule, patients with 2 consecutive INR’s within the therapeutic range a week or more apart may be seen again
in two weeks time. Patients with 3 consecutive INR’s within the therapeutic range 3 weeks or more apart may be seen
again in four weeks time. This assume that during this period of time, there has been no change in the patients medical
status, medication regimen, or diet.
Appendix
1.
2.
3.
4.
5.
6.
Anticoagulation Clinic Referral Form
Anticoagulation Clinic Consent, Release of Information, Guarantee of Payment Form
Contract with Patient
Education Guidelines
New Patient Orientation Check List
Anticoagulation Bridging Protocol
The William W. Backus Hospital
Anticoagulation Clinic Referral Form/Ambulatory Summary
Phone #: (860) 892-2711 Fax#: (860) 425-8791
Patient Name: ______________________________ DOB: ___________
Allergies:__________________________ MRN#: ________ Phone #: _______________
Caregiver/Relative’s name & contact information: __________________________________
Check Appropriate Diagnosis Box and Enter Projected End Date
INR
Recommended
Projected End
Check Indication
Range
Length of Therapy date
Stroke Prevention
Atrial Fibrillation
2-3
Indefinite
Atrial Fibrillation with planned cardioversion
2-3
3wks prior/4wks post
Other stroke prevention
2-3
Prosthetic Heart Valve
Aortic
2-3
Indefinite
Mitral
2.5-3.5
Bilateral
Bioprosthetic/tissue valve
DVT/PE Treatment and/or Prevention
DVT/PE Single event w/transient risk factors
DVT/PE Single event no precipitating cause
DVT/PE Thrombophilic disorder
DVT/PE with Hx of multiple thrombotic events
With Cancer (consider LMWH treatment for first 3-6 months)
DVT/PE while receiving adequate anticoagulation
Post orthopedic surgery prophylaxis
2.5-3.5
2-3
3 months
2-3
2-3
2-3
2-3
2-3
2.5-3.5
2-3
3 months
3 mo- indefinite
6 mo- indefinite
Indefinite
1 yr-indefinite
Indefinite
10-35 days
(Recommendations consistent with the 8th ACCP Consensus Conference on Antithrombotic Therapy)
OTHER (please be specific)
DX:
Range
Length of therapy
Other instructions:
Start date of therapy:
Patient is currently on a LMWH
Social History:
Lives alone
PMHx:
Peptic Ulcer Disease
Renal Insufficiency
Pulmonary disease
Warfarin tablet strength ______mg
Current dosing regimen:
Smoker
Alcohol use (Alcohol abuse is a contraindication for warfarin therapy)
Hypertension
Diabetes Mellitus
Arthritis
Cancer of ________
Thyroid disease
Seizures
Anemia
Heart Failure
GI bleeding
Mental Health
Hx of Falls
IV Drug Abuse
Hepatic disease
Hypercholesteremia
Cognitive Impairment
Other: ___________________________________________________
Surgical History:
Referred patients will be managed according to the Anticoagulation Clinic Protocol
Physician:
Signature:
Primary Care Physician (if different):
Date:
Time:
Place addressograph sticker here
Patient Name: ______________________
DOB: ______________
V# ______________
M# ______________
William W. Backus Hospital
Anticoagulation Clinic
111 Salem Turnpike
Norwich, CT 06360
Contract with Patient

I understand that, as a participant in the anticoagulation clinic, I am required to be present
at all clinic appointments.

I understand that I will call the anticoagulation program if I do not receive instructions within
48 hours after a blood test or if my medical condition (including medicines) changes.

I am able to travel to the clinic or arrange for transportation for my appointments.

I am willing to follow instructions involving compliance with Warfarin dosage and
administration, proper diet, and notifying the clinic regarding all drugs that I am taking
(even over-the-counter & herbals).

I have access to a telephone and can be reached by telephone if necessary.

I am taking a medicine that must be followed closely in order to protect me from any
complications. I understand that my noncompliance with any of the above can result in
serious health risks and/or termination with the program.
________________________________________
Patient signature
______________
Date
________________________________________
Anticoagulation Clinic staff signature
______________
Date
PATIENT EDUCATION
Education is one of the most important aspects of successful anticoagulant control. Verbal, written, and audio-visual
patient information materials will be individualized and available for each patient (available in foreign languages). The
education process should begin with a formal session involving the patient and any care takers or family members that
wish to participate. The process of patient education will be continuous and reinforced at every patient encounter.
The care provider will work with the patient to enhance their knowledge. If there is difficulty in assessing patient's
competence or documentation of non-comprehension, the patient will be referred back to the primary care physician.
Topics include, but are not limited to:
Indication of medications
Understanding of disease state
Name, strength, dose, and description of medications
Administration times and method of administration
How to use medication containers and compliance aids
Importance of keeping this medication safely away from children.
Importance of medication wallet cards and MedicAlert bracelets
Potential drug and food interactions
Potential drug and drug interactions
Symptoms of embolic event and emergency symptoms
Symptoms of unusual bruising and bleeding and emergency symptoms
Importance of laboratory monitoring of therapy
Importance of compliance with treatment regimen and follow-up visits
Importance of notifying clinic staff when changes occur to medication regimen, diet, or health status
Importance of notifying clinic staff about planned medical and dental procedures
William W. Backus Hospital
Anticoagulation Clinic
111 Salem Turnpike
Norwich, CT 06360
Patient Name: _______________________
DOB: ______________
M# ______________
New Patient Orientation Checklist
INITIAL VISIT:
Complete “Initial Visit Patient Encounter” sheet
Provide “Patient’s Guide to Using Warfarin Therapy” booklet
Sign consent form & clinic contract
 Clinic hours/Staff
 What is warfarin & why do I need it?
 Taking warfarin (how much, when, missed dose)
 Warfarin tablet identification
 Common side effects of warfarin
 What is PT/INR blood test?
 Signs/symptoms of bleeding/stroke/DVT/PE & actions to take
Address patient questions
Patient education completed on ___/___/___ by __________________________
SECOND VISIT:
Provide “Patient’s Guide to Using Warfarin Therapy” booklet (if needed)
What causes INR to change?
 Drug Interactions
 Warfarin and Vitamin K in diet
 Pregnancy
 “Other things to think of”:
 Surgical & dental procedures
 ID/Medic Alert
 Traveling
 Prescription renewal info
Address patient questions
Patient Education Evaluation Quiz

Patient education completed on ___/___/___ by __________________________
DVD: “Staying Active and Healthy with Blood Thinners” (optional)
Viewed on _______________
Patient Declined ______________
William W. Backus Hospital
Anticoagulation Clinic
Anticoagulation Bridging Protocol
Patient:
Physician:
DOB:
Allergies:
Procedure Date:
Procedure Type:
Clinical trials and expert opinion indicate that oral anticoagulation therapy can be continued without increasing the risk of
major bleeding for single and multiple dental extractions, joint and soft tissue injections and arthrocentesis, cataract
surgery, and upper endoscopy or colonoscopy with or without biopsy. Supporting data will be supplied if requested.
Please carefully consider the effect that stopping warfarin therapy for a few days can have on the patient. A moderate
amount of bleeding is a minor inconvenience compared to a paralyzing stroke or death.
Thromboembolic Risk Assessment
Low Risk
Atrial Fibrillation
Prosthetic Heart Valve
Venous Thromboembolism
CHADS2* 0-2
No prior stroke or TIA
Valve Bileaflet aortic valve
prosthesis without Afib, and no
other risk factors for stroke.
Bileaflet aortic valve prosthesis
and any of the following: atrial
fibrillation, prior stroke or TIA ,
hypertension, diabetes, CHF, age
>75
Single VTE event greater than 12 months
ago and no other risk factors
VTE within past 3-12 months.
Recurrent VTE
Active cancer (treated within 6 months)
Non-severe thrombophilia (heterozygous
factor V Leiden mutation, Heterozygous
factor II mutation)
CHADS2* 5-6
Any mitral valve prosthesis.
VTE within 3 months
High Risk
Stroke or TIA within 3
Caged-ball or tilting disk aortic
Severe thrombophilia (protein C, S or
months; rheumatic
valve prosthesis. Stroke or TIA
antithrombin deficiency, antiphospholipids
valvular heart disease.
within previous six months.
antibody, or multiple abnormalities)
*CHADS2: 1 point each for presence of CHF, hypertension, Age >75, Diabetes and 2 points for prior stroke or TIA.
Intermediate Risk
CHADS2* 3-4
Desired bridging strategy (check one):
Questions concerning bridging may call Clinic Medical Director, Dr. Jan Akus 886-1494
Low Risk
Hold warfarin for 5 days prior to procedure, check INR 1 day prior, If ≥ 1.5 administer 1.25mg Vitamin K PO
Resume warfarin the day of procedure.
Intermediate/High Risk: Hold warfarin for 5 days prior to procedure; enoxaparin 1.5mg/kg/day when INR is below the patient’s
defined therapeutic range. On the day prior to the surgery/procedure, administer 0.75mg/kg.
Minor surgery/low bleeding risk: Resume enoxaparin 1.5mg/kg/day 24 hours after the procedure.
Moderate bleeding risk: Resume enoxaparin 1.5mg/kg/day 48 hours after the procedure.
High bleeding risk: Enoxaparin 40mg Daily start 24 hours after the procedure.
Very high bleeding risk: No post-procedure enoxaparin
Resume warfarin the day of procedure; post procedure enoxaparin orders will be discontinued when patient’s INR is within the
established therapeutic range on two consecutive days.
Other instructions/orders:
Physician:
Signature:
Date: /
/
Time:
Note: Outpatient prescriptions for enoxaparin may be ordered by clinic staff per your authority according to
these orders.
Fax to 860-425-8791