Q: What is the Anticoagulation Advisor for Patients^®?

A: The Anticoagulation-Advisor for Patients® is a method for warfarin dose management that healthcare providers may recommend for their patients who utilize warfarin therapy.

The Anticoagulation-Advisor contains a unique system for warfarin dose management that uses nomograms and a slide-chart.  This system contributes to implementation of expert guidelines that can lead to high quality anticoagulation dose management.   This method should only be used when recommended and overseen by a licensed and experienced health care professional.

Q: How different is this than your original Anticoagulation Advisor for healthcare professionals?

A:  The new slide chart and nomograms were adapted from the healthcare professional version, so that patients can easily follow health care provider prescription for warfarin anticoagulation.  This tool can assist health care providers to communicate thoughtful and reproducible warfarin dose adjustment recommendations with patients.

• Simplified dose rules with pertinent prompts of when to call health care provider

• Recommendations for when to repeat INR measurements

• Expanded font size for ease of use

• A list of practical suggestions for maximizing warfarin safety

• A reminder list of when the patient should call their health care provider

• Commonly asked questions

• Expanded web site with video instructions www.anticoagulaton-advisor.com

Q:   Could this tool be use for patients who self test outside of their physician’s office between office visits?

A:        Yes.  This guide is intended to be used by patients who are already on an established dose of warfarin. This guide is intended to be used as part of a comprehensive warfarin dose self-management program.

Due to the distinct risks of warfarin therapy, a healthcare provider must review the slide chart and expressly recommend that the patient use this method.  Unless specifically recommended by their health care provider, a patient should NOT use this method of warfarin dose adjustment.  In addition patients who use this system should:

• Successfully complete a person-to-person educational program on anticoagulation self-management.

• Patient must know their target INR as prescribed by their licensed health care professional. Patients should have their warfarin dose satisfactorily managed for at least 3 months by a licensed health care professional before beginning self-management.

• The patient and their health care provider should establish a method to report warfarin doses and INR results.

Q:     Fear of self management in the U.S. has been expressed by professionals managing patients on warfarin, particularly self testing patients – is this a self management tool which may calm those fears?

A:        Studies have demonstrated high quality outcomes when trained patients participate in self-management.  In one excellent study published in 2005 (Ann Int Med. 2005; 142(1)1-10) 737 patients eligible for self-management included only patients who had been receiving long-term anticoagulant therapy for at least 3 months.  Self-management patients were compared to patients managed in an anticoagulation clinic.  Children or patients with severe physical or mental illness without a responsible caregiver, or who were not native language speakers were excluded.  The results showed that self-managed patients achieved a level of INR control similar to anticoagulation clinic management.  In fact, the self-management group had fewer major complications and minor hemorrhages.

The Anticoagulation-Advisor for Patients® is a tool that can contribute to similar outcomes.  Certainly, self-management programs must have a clear, thoughtful, and reproducible approach to the details of warfarin dose adjustments. 

Q:       The use of the Anticoagulation-Advisor for Patients^® looks like a piece that requires a partnership between the patient and their healthcare provider, can you describe that partnership?

A:        Patients should have an established plan to communicate as recommended by their healthcare provider.  Many patients who participate in self-management report warfarin dose and INR results weekly and have face-to-face visits at least every 6 months.  In addition, the health care provider must re-confirm that you may or may not use the Anticoagulation-Advisor for Patients system of warfarin dose management.

Q:       How might the Anticoagulation Advisor for Patients^® improve the safety for those taking warfarin?

A:        As discussed above, a study from 2005 documented that the risk of complications in patients treated with warfarin were reduced in patient who used self-management as compared to patients who were managed in a high quality anticoagulation clinic. 

Q:       What reference is used for the 10% and 20% adjustments?

A:  A set of dosing rules, based on clinical experience, was created by Drs. Ansell and Shepro.   In this system, dose change recommendations are expressed in 10% to 20% increments.  While a 10 % dose change appears easy to implement, this can be challenging when patients have, for example, 5 mg tablet strengths.

5 mg/day = 35 mg/week

To decrease weekly dose by 10%= 3.5 mg.

Taking 3.5 mg out of the weekly dose, especially when patient has 5 mg tablets is challenging.

An array of total weekly warfarin doses that are each approximately 10% different from each other was created.   In addition, the daily dose treatment plans are convenient for patients to take and allow for the total weekly dose to be spread out evenly.  A minimum number of tablet strengths are utilized with this method.

5 mg/day = 35 mg/week

To decrease weekly dose by ~10%, the Anticoagulation-Advisor dose plan brings the next weekly dose down to 32.5 mg/week. 

This system was studied by Shepro et al (Shepro DS, Morden N, Shoemaker T. Implementation of a Warfarin Dosing Method at a Community Health Center. Blood 2002;100(11)) and was shown to be readily adopted by health care personnel and contributed to high quality anticoagulation dose management. This system was placed in a slide-chart system and is also available in numerous hand held devices. The array of weekly doses is designed to provide weekly dose levels that are approximately 10% different from each other.  In addition, the daily dose plans are convenient for patients to take and allow for the total weekly dose to be spread out evenly.  A minimum number of tablet strengths are utilized with this method.  Having multiple table strengths in the patients home can lead to confusion regarding proper dose.

Q:       All the self testing/self management studies reviewed by Medicare and responsible for the expanded national coverage decision used a “physician-prescribed algorithm” could this piece be the tool that standardizes outpatient use of warfarin?

Yes.  The responsible healthcare provider must review the slide chart and expressly recommend that the patient use this method.  Unless specifically recommended by your health care provider, the patient should NOT use this method of warfarin dose adjustment.  Successful completion of a person-to-person educational program on anticoagulation self-management should also be mandated before use.  The patient should know their target INR as prescribed by their licensed health care professional. In addition, the patient should have their warfarin dose managed for at least 3 months by a licensed health care professional before beginning self-management.

Before beginning use of the slide-chart, the patient and health care provider should carefully note the daily doses of warfarin in milligrams (mg) that the patient takes.  The total weekly dose of warfarin is determined by adding up the daily doses, in milligrams, of warfarin for the prior 7 days. The health care professional should determine, based on your primary tablet strength, which face of the Anticoagulation-Advisor slider should be used.  One face of the Anticoagulation-Advisor is based on 2.5 mg or 5 mg tablet strength and the other face is based on 2 mg or 4 mg tablet strength.  The patient and the health care provider should establish a method to report warfarin doses and INR results.  It is important to emphasize that the patient should call their health care professional with any questions.

Q:       Can you describe good candidates who might benefit from using the Anticoagulation Advisor for Patients^®?

A: According to the well-respected Cochran Database of Systematic Reviews(Garcia-Alamino JM, Ward AM, Alonso-Coello P, Perera R, Bankhead C, Fitzmaurice D, Heneghan CJ. Self-monitoring and self-management of oral anticoagulation. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.: CD003839. DOI: 10.1002/14651858.CD003839.pub2), intrinsic limitations to self-monitoring and self-management include:

• the reluctance of individuals to participate in self-management

• extensive training required by patients

• certain physical limitations of the patient(which can be overcome by close involvement of a responsible caregiver)

• cost of the test strips unless covered by insurance

According to these criteria and methods in this study, self-management was not feasible for several patients requiring anticoagulation.  However it is important to note that, in effect, self-managed warfarin dosing is analogous to self-adjusted insulin dosing according to a pre-specified sliding scale (Ansell JE, Hughes R. Evolving models of warfarin management: Anticoagulation clinics, patient self-monitoring, and patient self-management. American Heart Journal 1996;132(5):1095–100).  Such self-managed treatment has been practiced for years by people with diabetes and the use of self-monitoring or self-management offers independence and freedom to travel for selected patients.

Q:       How can this piece benefit the healthcare professional side of a busy anticoagulation clinic? Office Efficiency? Clinically? Financially?

A:        This slide chart can be used as a protocol for patients to follow.  It is designed to carefully instruct patients regarding what doses of warfarin that should be taken as guided by the measured INR.  In addition, the slide chart is designed so that the patient is instructed to contact their health care provider at extremely low and extremely high INR so that the health care provider can analyze the clinical situation and provide advice.

Since the Anticoagulation Advisor slide chart provides patient-specific physician-endorsed instructions for many dose adjustment episodes, patients will be able to make these dose adjustments without immediately communicating with their health care provider.  Patients should keep careful records and review these periodically with their health care provider.

Thus, this program can improve health care office efficiency while providing for highest quality of anticoagulation care.

Q:       How would you envision effective training on use of the Anticoagulation Advisor for Patients^®?

A:        There should be training of health care personnel and patients/families.

• Health care personnel training should include:

1. Review of patients appropriate for use of slide-chart

1. Careful review of slide-chart

1. Review mechanism for follow up of patients using slide-chart system

• Patient training should include (as per multiple sources including Ann Int med 2005;142:1-10.)

1. All patient-related aspects of INR measurement device

1. Understand INR and dose adjustments

1. The basic principles of coagulation and oral anticoagulants

1. Discuss usual care of oral anticoagulant treatment in physician office or anticoagulation clinic compared to self-management programs

1. Describe the potential advantages of patient self-management: increased frequency of testing at home, increased accuracy of control, possible decreased risk for bleeding and thrombosis, increased quality of life, and reduced work burden of health care personnel.

1. Medications, dietary, and illness influences of INR

1. teach patients how to adjust doses after obtaining an INR result

1. examples of theoretical cases and determined different doses as required in different situations

Q:       How can professionals order this resource? How much is it and if clinics want to order large quantities, are there volume discounts?

A: www.anticoagulation-advisor.com or call 617-835-3146