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NR I Magazine

Vitamin K and Your Diet... Pay Attention!

Training = Better Manage-

Great Expectations

What patients are saying about self-testing You Might be Surprised

How to Find the Best Monitor for YOU Everything you need to know

NEW Medicare reimbursement


Explain it clearly...

...in print.

www.carleygroup.com

888.200.0399


Patients need to know... The contents of INR Magazine are for informational purposes only. Magazine content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or concern. NEVER disregard professional medical advice or delay seeking it because of something you have read in INR Magazine. If you think you may have a medical condition or emergency, call 911 or your doctor immediately. INR Magazine does not recommend or endorse any specific tests, physicians, products, procedures, opinions, or other information mentioned in this publication. Reliance or actions taken on any information provided by INR Magazine is the sole decision of the reader.

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Contents 4

How to find the best monitor for you.

7

Lab or Point of Care INR Results Which are more reliable?

11

Anticoagulation Self-Testing has Benefits for the Clinic and Patient

17

“Meet the Fats�

20

Patient Self-Testing:

Henry I. Bussey, Pharm.D. Marie B. Walker

A new program from the American Heart Association

More Than Words Can Say By Melissa Johnson

25

Dietary Considerations with Anticoagulant Therapy Diana M. Schneider, Ph.D.

INR Magazine is published by The Carley Group LLC www.inrmagazine.com

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Great Expectations: Patient Training

32

Compliance: The Road to Effective Management

35

Medicare Covers Home PT Monitoring

39

Understanding the Link

43

The Impact of Patient Education on Patient Outcomes

By Theresa Julian

By Theresa Julian

for Atrial Fibrillation and Venous Thromboembolism Patients

between genotype and optimal INR interpretation: pharmacogenetics applies to more than just a dose estimate

Reproduction of contents is prohibited without written permission.


THE COMPLETE WEB-BASED SOLUTION FOR THE MANAGEMENT OF ALL PATIENTS ON WARFARIN THERAPY INTRODUCING

CoagCare

FROM ZYCARE

The CoagCare Anticoagulation Management System provides state-ofthe-art data management and decision support software for your clinic, with remote supervision for your patients who perform self-testing at home. CoagCare is the only FDA-cleared direct-to-patient remote management system for warfarin anticoagulation therapy.

Clinic-Based Management HIPAA-compliant paperless medical record keeping for anticoagulation management Web-based, and accessible from anywhere, anytime; ideal for practices with multiple locations Provides decision support so you can create individualized dosage adjustment Remote algorithms for each patient

Management

Facilitates supervised patient self-testing with secure web-based patient access T

Clinically proven and FDA-cleared automated dosing and frequency algorithm Easy-to-use interface tested in clinical trials; results show that remote management with CoagCare can increase time in therapeutic range (TTR) and maximize patient satisfaction

Time in Therapeutic Range %

Pre

TTR

100 75 50 25 0-

p<.001

Post

Survey Question

Yes

No

Do you prefer home monitoring to routine clinic visits?

98%

2%

Do you trust the instructions provided to 速 you by the CoagCare system?

99%

1%

Do you feel your doctor is monitoring you more closely using this system?

99%

1%

Do you feel your INR is under better control than the last 6 months?

93%

7%

n=100

*Proceedings of the 8th National Conference on Anticoagulant therapy, Journal of Thrombosis and Thrombolysis, Vol 21, No 1, 2006

For more information please visit us at www.CoagCare.com or call 866 419 7228


Interested in testing your PT/INR at home?

How to Find the Best Monitor for YOU

E

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vidence has been building for more than a decade that patients can benefit from testing their own PT/INR. Patients who self-test have the option to monitor from virtually anywhere – a home, an office or on the road.

best makes it easier for you to manage your PT/INR and take care of your health, while allowing you to enjoy life more. It’s important to consider features like accuracy, convenience and the level of customer service the manufacturer provides.

Since many patients have to travel to their doctor’s office or a coagulation clinic as often as once a week to make sure their warfarin is appropriately regulated, self-testing allows patients to have the freedom to enjoy life and not feel limited or bound by frequent office visits.

...peace of mind...

There are many patients who qualify for self-testing, including those who regularly visit their doctor for conditions such as chronic atrial fibrillation or venous thromboembolism, or who have a mechanical heart valve. It is also appropriate for patients who have had a minimum of three months of Coumadin® (warfarin) therapy. Patients who require frequent PT/INR monitoring or those who find it difficult to make frequent office visits due to schedule, location or caregiver limitations may find that self-testing is an option that provides them with flexibility to supplement their regular physician visits from home. While testing at home is convenient, there are several different monitors available to suit differing needs and lifestyles. If you are a candidate for self-testing, it is important to talk with your physician about the available choices in self-testing monitors. Finding the one that fits your needs

The first thing to consider is accuracy. Since you will be relying on your monitor regularly for your PT/INR testing, it is important that you are getting accurate results. Some self-testing monitors on the market today are the same as – or equivalent to – the ones in physician offices , which means you can use the same advanced and accurate technology that your doctor may be using. And studies show that the accuracy of self-testing monitors can be comparable to what you’d find in an expensive laboratory analyzer – giving you peace of mind. An important factor in choosing a monitor is customer service. Since any PT/INR monitor you choose will be an electronic device, it’s important to have a reliable and knowledgeable customer service department available to you in the event you have technical difficulties. Some manufacturers have 24-hour support to answer any questions you may have, from monitor issues to reimbursement. Many also have developed very thorough training programs to ensure that when you call, you can talk to an informed and helpful customer service representative.


COAGUCHEK is a trademark of Roche. ©2009 Roche Diagnostics. All rights reserved. 573-44253-0209

Test your PT/INR—

anytime, anywhere. Take the technology that your physician uses wherever you go and test at your convenience. The CoaguChek XS system for PST uses the same smart technology trusted by doctors around the world. In fact, more PT/INR tests are performed with a CoaguChek system than with all other PT/INR instruments or systems combined.1 The CoaguChek XS system for PST provides you with fast, accurate results from a simple fingerstick test—a convenient, more comfortable way of testing that anticoagulation patients say they prefer.2

Fast, reliable results • Accurate PT/INR results in one minute • Built-in quality control checks every strip automatically • Lab-equivalent accuracy and precision3 Test anytime, anywhere and enjoy the freedom to live your life while being more actively engaged in your healthcare.

For more information about patient self-testing with the CoaguChek XS System, visit www.testyourinr.com or call 1-800-779-7616. The convenience of PT/INR self-testing is now within your reach. 1 Second quarter 2008 total market share of projected distributor unit sales of the Point of Care Testing Coagulation Reagents and Kits product class by HPIS Market Intelligence, a division of GHXMarket Intelligence Data. Data on file at Roche Diagnostics. 2 Giles TD and Roffidal L. Results of the prothrombin office testing benefit evaluation (PROBE), Cardiovascular Review and Reports, Vol XXIII, No. 1, January 2002. 3 CoaguChek XS package insert. Indianapolis, IN. Roche Diagnostics Corporation, 2006.

Convenient and easy to use • Small fingerstick sample— just 10 μl • Handheld meter for easy portability • Code chip programmed automatically • 100-value memory with time and date


Naturally, you may also prefer a monitor that requires minimal effort and provides results quickly, and here you’ll find a range of choices as well. Testing on some monitors only requires a few simple steps, and you can get your results in as little as one minute. With others, you may need to perform some additional steps to test and may need to wait two or three minutes to get your results. You should also consider the size, mobility and battery life of a particular monitor to make sure it fits into your lifestyle. For example, if a monitor is too large, it may be difficult to carry, and may only be convenient for you to use at home.

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Smaller monitors that fit into the palm of your hand can provide convenient testing for the patient who is always “on the go.” Battery life can range from hours to days and can be another important factor to consider for patients with fast-paced lifestyles. As you’re considering a monitor, ask your doctor for help. Here are five key questions you can ask: 1.

How can I be sure this monitor’s results are accurate?

2.

How is the manufacturer’s customer service?

3.

How easy is this monitor to use?

4.

How big is the monitor?

5.

What is the battery life of the monitor?

Only you and your healthcare professional can decide which monitor is right for you. For more information visit www.TestYourINR.com


?

Lab or Point of Care INR Results Which are more reliable Henry I. Bussey, Pharm.D. Marie B. Walker Clotcare Online Resource

Patients occasionally obtain INRs from 2 sources in a short time period and want to know which source to trust. For example, maybe the lab reports an INR of 3.5 when a point of care (fingerstick or POC) device reports an INR of 2.5. What do you do in this situation when one source indicates a high INR and one reports an INR in range? In general, if performed correctly, the INR is usually accurate and reproducible, but there are a number of ways in which an incorrect INR can be obtained. If the INR result does not â&#x20AC;&#x153;fitâ&#x20AC;? with previous values and/or what is expected, it is always reasonable to obtain another blood sample and repeat the test. Lab reliability may differ from one lab to another: One lab (lab A) that I work with is very reliable and reproducible. For example, a few years back we had the lab perform duplicate INRs on 2 blood samples collected at the same time from a number of our warfarin-treated patients. The INR results on simultaneously collected blood samples did not differ by more than 0.1 INR units. Further, over the past 10 years we occasionally would re-test a patient with a POC device if we suspected the lab INR to be incorrect. We practically never see a substantial difference between the lab and the POC in those situations.

What about lab versus POC results? In general, some studies have considered INR results from 2 methods to be in reasonable agreement if the two results are within 0.5 INR units of each other (ex. 2.0 and 2.5 would be in reasonable agreement). We conducted 2 studies years ago to compare lab B INR with POC INR results 1. In both studies, we did simultaneous POC and lab INRs - lab B was actually either of two labs (one at University Hospital, and the other at the VA Hospital - both of which are affiliated with the UT Health Science Center in San Antonio, TX).

If either method (POC or lab) told us that we needed to change the dose of warfarin in


This is the day to take a walk. Or a stroll. A brisk pace wouldnâ&#x20AC;&#x2122;t hurt, either. Itâ&#x20AC;&#x2122;s the day to take the long way around. Or maybe just the stairs. Because for each hour of regular, vigorous exercise, you could gain two hours of life expectancy. This is the day to get fit.

Visit go.heart.org or call 1-888-AHA-2222.

Start! is nationally sponsored by:


An astounding 142 million American adults, 66 percent of Americans, are overweight and 70 percent of Americans don’t get enough physical activity, blaming lack of time and motivation. The American Heart Association’s Start! movement aims to reverse the trend of physical inactivity in this country by encouraging people to walk. Walking can have a positive impact on a person’s overall health. Brisk walking for 30 minutes a day can reduce the risk of stroke, high cholesterol (LDL) levels and high blood pressure. It also has the lowest dropout rate of any type of exercise, largely because walking is free and easy to do. Studies show that adults may gain as many as two hours of life expectancy for each hour of regular, vigorous exercise. “Incorporating walking into your daily routine is one of the easiest changes you can make. You can hop off the bus or subway a stop or two earlier; you can take the stairs at work or park farther away,” said American Heart Association President Dr. Daniel Jones. “There are lots of little ways to incorporate a few more steps, which can truly have life-changing results.” According to the Centers for Disease Control, several risk factors surrounding coronary heart disease and stroke have been on the rise. Most alarming, the rate of physical inactivity has declined by only 2.5 percent since 1999. Inactivity makes a person 1.5 to 2.4 times more likely to have coronary heart disease. Start! focuses on four key elements to help combat the rising epidemic of inactivity:

1. MyStart! Online, a free, Web-based fitness and nutrition tracker, is the focal point for a walking program that offers constant, measurable personal improvement.

2. The Start! Fit-Friendly Companies recognition program officially recognizes employers who champion the health of their employees and work to create a culture of physical activity in the workplace. To be certified as “Fit-Friendly,” companies must implement a majority, if not all, of the wellness areas which include physical activity, nutrition and culture.

3. The Start! Walking Program encourages companies to promote walking at work and recognize and reward employees who move from a sedentary to a more active lifestyle. The program removes the significant barriers of lack of time and place for physical activity for millions of American workers.

4. The Start! Heart Walk, the American Heart Association’s premier fund-raiser, helps people improve their health by walking while helping fund the fight against heart disease and stroke. More than 450 Start! Heart Walks are held each year in cities nationwide.

Start! is sponsored nationally by SUBWAY® Restaurants, Healthy Choice® and AstraZeneca. For more information, call 1-800AHA-USA1 or visit www.heart.org/start.

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INR: International Normalized Ratio

A system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation tests.

INR Magazine

Publisher

Wayne Carley INR Magazine is designed for the INR patient, their physician, and their families to better understand effective warfarin use and management. Improved communication with one another, familiarity with new self-testing INR devices, supplies, technology, vitamin K dietary considerations, management tools, and exercise are key components to accomplishing this understanding. Many of the nations leading authorities on warfarin management, technology and related medical conditions will be featured in these quarterly issues, keeping both physicians and their patients aware of the latest studies, innovations and educational opportunities available. Over 4 million Americans are currently on warfarin therapy. Nearly 400,000 are mechanical heart valve recipients, and that number continues to increase in the United States with new and safer innovations in management and technology. The emergence of patient self-testing and portable point-of-care (POC) INR devices has revolutionized the industry and welcomed the personal involvement of patients in their warfarin management. Historically, warfarin testing has been done with a venous draw at the lab, physicians office, or clinic as needed with test results often taking days. The risks of clotting, stroke and bleeding were an on-going concern for physicians and patients. INR Magazine is committed to the continuing education of the warfarin patient under the supervision of their personal physician, to maintain the highest level of health and safety during their warfarin therapy. Thank you for reading INR Magazine.

Wayne Carley Publisher

Literary Contributors

American Heart Association Henry I. Bussey Pharm.D., FCCP, FAHA Marie B. Walker, BBA Pamela Burgwinkle Roche Diagnostics Melissa Johnson Diana M. Schneider, Ph.D. Theresa Julian Brad Esarey ITC QAS Philips Subscriptions INR Magazine is provided at no cost to all physicians, clinicians and their patients upon request. Simply contact INR Magazine at: free@inrmagazine.com We request that you provide postage to your practice by box. There are 100 copies per box for distribution as you wish over the next year. The estimated postage per box is $40.00 payable to: The Carley Group 6080 Lakeview Rd. Suite 2605 Warner Robins, Ga. 31088 All rights reserved. The Carley Group LLC Copyright 2008


Anticoagulation Self-Testing Benefits Clinic and Patients Pamela Burgwinkle, Nurse Practitioner/Clinical Manager Anticoagulation Center, Heart & Vascular Center of Excellence at UMass Memorial Medical Center,Worcester, Massachusetts

When asked about monitoring International Normalized Ratio (INR) of patients on anticoagulants, both clinicians and patients agree that they would rather spend their energies doing something else. Cardiologists and their staffs are being required to manage ever larger volumes of anticoagulated patients, adding to our already strained medical system resources. Patients prefer to free themselves of the constraints of a monthly visit to the clinic, for what is a routine blood test to monitor their INR levels. How can we continue to provide excellence in patient care while helping patients who are on warfarin have a better quality of lifestyle? Self-testing was the answer in our clinic. A Pioneer in Self-Testing The Anticoagulation Center in the Heart & Vascular Center of Excellence at UMass Memorial Medical Center manages over 1,500 warfarin patients, and has been offering home-based, patient self-testing for the past six years. We decided to create a protocol for patient self-testing after Medicare approved self testing for mechanical heart valve patients in 2001. Our program has been designed to support the high quality anticoagulation therapy management standards that we provide in our clinic, and has grown significantly since CMS expanded coverage last year to patients with atrial fibrillation and venous thromboembolic disease.

Foundations of the Program: Patient Selection and Compliance The two most important factors in the success of our patient self-testing program have been: a) selecting the appropriate patients; and b) our requirement that they comply with our testing and reporting protocols. When selecting patients for self-testing, we first look for patients who have been very compliant with making their monthly scheduled clinic visits. This tells us that these patients take their health seriously, and understand the importance of managing their anticoagulation therapy. We have found that these patients make the best self-testers.

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For more information, call us at 877.729.8350 Product & service available only by prescription.

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We require weekly testing and reporting of their results. To reinforce the importance of compliance and communication, we have self-testing patients read and sign a Patient Self Testing Contract. This document is an agreement between the patient and our clinic, and outlines each party’s responsibility. It makes clear that unless the guidelines for testing and reporting are followed, self testing will no longer be an option, and the patient will have to return to testing at the clinic. This has proved very helpful in gaining patient commitment. Positive Results From a clinical standpoint, we have been able to manage the remote INR testing, medication dosage and education for our patients without sacrifice to our high standard of patient care. At our clinic, we track time in therapeutic range for all of our patients, as well as adverse events, for both those who test at home and at our office. Against a benchmark of 66 percent, our home testers fall within range 80-85 percent of the time. In addition, the major hemorrhagic and thrombotic event rate for our home testers over the past six years has been extremely low. Our results seem to align closely with those seen in the recently published THINRS Study, a large scale clinical trial which demonstrated that clinical outcomes in a well run self testing program can be comparable to those found in clinics providing high-quality anticoagulation management. Our self-testers truly appreciate being freed from their previous requirement to travel to our clinic at least once a month. In addition, many enjoy the added convenience of being able to test regularly even when travelling or on vacation. We also have parents that are taking care of young children with mechanical heart valves. Having a home monitor to test their INR levels lessens the

disruption in the child’s school day and in their daily routine. Perhaps more importantly, many of these patients seem more engaged in their self-care, something that is sorely needed in our medical system today. Improved Staff Productivity Remote monitoring of INR with good patient selection and education has freed up staff resources with a monthly reduction of more than 200 patients coming to the clinic for routine blood tests. Patients “in range” continue activities of daily living uninterrupted, while “out of range” patients are contacted to adjust their therapy or be seen in the clinic, if necessary. An INR test evaluation that is in range can be reduced from 15-20 minutes at our clinic to less than 5 minutes with self-testing. Our staff appreciates having more time to devote to in-clinic patients and procedures. The self-testing services we work with contribute to our productivity by obtaining all insurance approvals, handling details associated with providing the testing meters and supplies, providing compliance support, and communicating timely notification to our office via Fax and phone calls for “out of range” results. We have found patient self-testing to be a simple and practical method of monitoring PT/INR levels, and working with a reputable self-testing service provider has made it relatively easy to implement. Now that CMS has expanded the reimbursement coverage for self-testing to include Atrial Fibrillation, DVT and PE, more patients will be able to benefit from the improved quality of lifestyle it affords, while clinics can manage their patients with greater efficiency.

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these very stable patients, we had the patients come back in 24 to 48 hours and we repeated both the POC and the lab INR; in no instance did the repeat INR results indicate that a dosage change was needed. The POC INR results were more reliable and reproducible than those obtained from lab B; but results from lab A are just as reliable as those from the POC device. What can cause INR results to be incorrect? There are a number of factors that can result in a given lab INR being inaccurate. • Under-filling the tube when blood is collected can lead to a higher INR result. • Performing an INR on a blood sample of a very anemic patient (low hemoglobin and red blood cell content). • Entering the wrong ISI (International Sensitivity Index for the thromboplastin reagent that is used in the test) into the machine. • The patient taking other medications that may alter the test. • Having an interfering substance (such as certain antibodies) in the blood . With the POC INR, since it is performed on fresh whole blood, the problems listed above that relate to blood collection are not a problem; but the other potential sources of error may be. Other factors that may lead to an error in the POC INR result.

• If a patient squeezes his/her finger too hard for a POC test it may accelerate the blood clotting.

• If a patient takes too much time to apply the drop of blood. • Heparin may elevate the POC INR more than the lab INR because of differences in the method and the thromboplastins being used. The POC test is performed on whole blood while the lab INR is performed on plasma that has been separated from the blood cells. • If the POC device is not on a flat and stable surface. • Improper storage of the test strips also may lead to incorrect POC INR results. • Some POC devices require that a computer chip be changed out with each new lot of test strips, failure to do so can yield incorrect INR results. So, if both lab and POC may give bad results, which should I trust? With the POC INRs, you should use appropriate technique, store and care for the device and test strips properly, and be alert to changes in other medications that might alter the INR result. With lab-based INRs, you have to rely on the technique and attention to detail of a particular laboratory. Therefore, my own view is that clinicians should try to identify a laboratory that is reliable and use that lab as much as possible. Regardless of the method, if the INR result does not “fit” with what is expected, it is always reasonable to question the accuracy of the test and repeat the INR with a fresh blood sample.


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Most Americans Don’t Know

“Better Fats”

Benefit Heart Health

American Heart Association expands national fats awareness campaign with “Better Fats Sisters” Facing the Fats with the Better Fats Sisters: Your Heart Helpers The American Heart Association is introducing two new characters, the Better Fats Sisters - Mon and Poly - to help consumers learn more about the benefits of monounsaturated and polyunsaturated fats and the foods where they are found. The Web site (www.AmericanHeart.org/FaceTheFats) features the Better Fats Sisters alongside their Bad Fats Brothers, Sat and Trans. The Sisters help consumers find comprehensive information about fats so that they can eat healthier in restaurants and use the better fats when preparing meals at home. The Better Fats Sisters remind everyone that all fats have the same number of calories: 9 per gram, compared to the 4 calories per gram found in proteins and carbohydrates. That means that even the “better fats” are good only in moderation. Types of Fat and Heart Disease: Many Consumers Know the Bad, Fewer Know the Better. The survey shows that: • Only 41 percent of Americans know that consuming monounsaturated fats decreases the risk of heart disease • Only 44 percent of Americans know that consuming polyunsaturated fats decreases the risk of heart disease In comparison: • 72 percent of Americans understand that consuming saturated fats increases the risk of heart disease

• 68 percent of Americans understand that consuming trans fats increases the risk of heart disease Heart-Healthy Benefits of Better Fats Monounsaturated and polyunsaturated fats can lower your LDL – or “bad” – cholesterol levels in your blood and lower your risk of heart disease. Monounsaturated fats can be found in vegetable oils like olive and canola oils; and many nuts and seeds like almonds, peanuts and sesame seeds. Peanut butter and avocados are also good sources of monounsaturated fats. Polyunsaturated fats can be found in oils like soybean and corn oils and in many nuts and seeds such as walnuts and sunflower seeds. Fatty fish like salmon and trout are also good sources of polyunsaturated fats. Polyunsaturated fats include omega-3 and omega-6, essential fats that your body needs but can’t produce.

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The American Heart Association’s Face the Fats Web site helps consumers make heart-healthy choices, including: • Test Your Fats IQ — An interactive quiz that tests consumers’ knowledge of dietary fats and helps them learn more about fats on the spot. • My Fats Translator — An easy-to-use calculator that gives individuals their personalized daily calorie and fat consumption results. Its food scenarios give ideas for smarter ways to prepare summer favorites, each with three examples of “bad,” “better” and “best” selections. • Better Fats Recipes — New heart-healthy recipes that make use of the better fats.

www.AmericanHeart.org/FaceTheFats


INR Magazine

INR Magazine is provided at no cost to all of your patients through your clinic or practice.

Physicians and Clinicians wishing to request copies of INR Magazine for their practice, clinic and patients may do so by contacting INR Magazine anytime at:

free@inrmagazine.com We ask that you provide shipping cost to your clinic. We have no wish to contact your patients. Patients wishing to receive copies of the magazine are requested to inquire at your physicians office or warfarin clinic. INR Magazine is free of charge and will be shipped immediately upon printing of each issue. Thank you for your interest in INR Magazine and your support of patient education. INR Magazine c/o Wayne Carley 6080 Lakeview Road Suite 2605 Warner Robins, Ga. 31088

19


Patient Self-Testing: By Melissa Johnson

More Than Words Can Say

Comfortable. Reliable. Economical. Accurate, Greater independence. These are a few of the words that patients use to describe their PT/INR home-testing experiences. But their real feelings go beyond words.

20

Comfortable. Eight-year-old Jenny has been on warfarin since the age of one when she underwent a heart valve transplant. Her father, Kent, says that after the transplant, testing her PT/INR level at the hospital was a traumatic experience for her. While in the hospital, Jenny was tested on a daily basis. Even after being discharged, Jenny returned to the hospital once a week for tests. With the help of her family, Jenny is testing in the comfort of her home using a portable device that measures her PT/INR level within one minute. Jenny is part of the growing trend toward Patient Self Testing (PST) which allows individuals to test at home.

The result; fewer trips to the lab, improved time within therapeutic range, and a lifestyle of greater comfort and convenience. “Selftesting has been a godsend,” Kent says. Their service provider was recently awarded “Exemplary Provider” status by a Medicare deeming authority. Kent says he would absolutely recommend patient self testing to others and has in fact already done so to two friends whose children are also on warfarin.

“Self-testing has been a godsend,” Reliable. Steve and Janet, ages 66 and 64, have both been on warfarin for more than 5 years. One of their main concerns is the reliability and accuracy of their PT/INR tests. Steve, a minister, has had three major blood clots and Janet has had one. Janet suffered a stroke after surgery and has lost several siblings prematurely to blood clots. To complicate matters, there are no blood testing clinics close to their home and they were traveling up to an hour every one to four weeks to get tested. This travel was in addition to the many miles they were logging for their missionary work. Then one day their clinic recommended that they begin self testing. Janet contacted a medical provider who sent a nurse educator to their home to conduct a face-to-face training session.


Janet says that the educator was wonderful and that she and her husband are now both testing at home and enjoying much greater reliability, flexibility, and convenience.

to identify it quickly and immediately notify his doctor. Working with his doctor, he was able to get back into therapeutic range quickly. Before self testing, Matthew was traveling to the lab at least once a week and

Because of the confidence they have with PST, they now have more time to devote to their missionary work and more freedom to travel. In fact, they are planning a trip outside of the U.S. in a few weeks and now feel much more comfortable because of their ability to self test. Economical. Danny, 72, estimates that he was spending $5,000 a year between travel costs and testing fees on weekly visits to the hospital to have his PT/INR tested. Danny used to travel to the hospital lab every Tuesday and wait for an hour or more before getting tested. Now that Danny is testing at home, he is not only saving the cost of traveling, but also has more free time and finds that his INR is more on target. Danny says that he is “200% happy” with the service that his medical supplier is providing and that he would absolutely recommend patient self testing to a friend.

“..in range about 99% of the time..” Stability. Matthew 49, is a busy individual who owns several businesses. Matthew says that before he began self testing about 3 years ago his INR varied quite a bit. Now that he is self testing, he is “in range about 99% of the time” and required no dose adjustments by his doctor. The few times that he has been out of range, he has been able

waiting for lengthy periods of time before being tested. Now he only visits the lab once every two to three months. Matthew says he “feels better and definitely feels the difference”. He says he believes that self testing


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“gives you independence”. Matthew adds that the supplier that he’s working with has made it easy for him to receive supplies and he’s already recommended patient self testing to a friend whose mother will soon be on warfarin. Greater independence. Gary, 73, and his wife have been traveling the country in a motor home for the past 11 years. Gary has an irregular heartbeat among other conditions. Before he began home testing Gary says that going to the lab was a “drag on his life” and he felt “locked into one place”. He adds that he is “too fierce and independent to do that”.

Gary believes that self testing is not only a “no brainer” because it takes five minutes from start to finish, but it also saves money because he doesn’t have to visit the lab. Gary says that the nurse who trained him was “delightful” and that the reliable supplier he is working with is “priceless”. According to Gary, self testing allows him and his wife to travel the country and live their lives in “complete freedom”. For more information on how you may benefit from Patient Self-Testing, please visit www. coagnow.com


Dietary Considerations with Anticoagulant Therapy Diana M. Schneider, Ph.D.

Excerpted from The Coumadin® (Warfarin) Help Book, , DiaMedica Publishing, 2008©, New York

The vitamin K in your diet significantly affects the blood clotting process. If you eat a lot of foods that are high in vitamin K, the effect of your anticoagulant will be reduced, and your INR might drop below the therapeutic range. Conversely, reducing foods that contain vitamin K intake can increase the anticoagulant’s effect, raising your INR levels and increasing the possibility of a bleeding episode.

• Essentially all grain products, fruits, and dairy products are low in vitamin K; you can eat them in normal amounts without concern. • Most meats are low in vitamin K, with the exception of liver (where all those clotting factors are made).

In general, leafy green vegetables, some legumes, and some vegetable oils contain high amounts of vitamin K. Foods that are low in vitamin K include roots, bulbs, tubers, grains, the fleshy part of fruits, fruit juices, and other beverages. Here is a guideline, by food group, to vitamin K content: • Vegetables are the group of foods you need to be most concerned about. As a general “rule of thumb,” the greener the vegetable, the more likely it is to contain substantial amounts of vitamin K. This includes lettuce and other “leafy greens” such as kale, broccoli, Brussels sprouts, and cabbage. Vegetables such as corn or carrots are relatively low in vitamin K content, and some vegetables have a medium level. • Some oils, such as canola oil, are high in vitamin K; safflower and corn oil are low in vitamin K.

25 Two good Internet sources with more detailed information about the vitamin K content of a variety of foods are http://www. drgourmet.com/askdrgourmet/warfarin/index.shtml and http://www.ptinr.com/data/ pages/vkregistry.aspx. You might ask whether it would be easier to avoid vitamin K, rather than worrying about eating the same amount every day. All vitamins are necessary for life, and limiting your intake of any of them is most definitely not a good idea! Leafy green vegetables provide important nutrients needed in your diet, and you should not avoid them because of concern that they will alter your INR. The key to managing your diet is just that—


to manage it. The most important issue while taking warfarin is to maintain a healthy and consistent diet, and to keep the amount of vitamin K in your diet reasonably constant from day to day. I make sure to have one serving of a leafy green, such as a salad, broccoli, or Brussels sprouts every day, and my Coumadin dose reflects this—just as it reflects the medications I take on a daily basis.

Try keeping a food diary, which over a period of several weeks will show either that you are eating vitamin K–containing foods on an irregular basis, or that you have been eating foods containing vitamin K without realizing it. A convenient food diary form can be downloaded from www.ptinr.com. Once your INR is stable, you should not make any major changes to your diet without consulting your physician or nurse. You should also tell your health care provider if an illness causes your diet to change. Also, contact your health care provider if you have an illness such as the flu, which can disrupt your normal fluid balance and also affect the ability of the bacteria in your gut to synthesize vitamin K. Remember, the amount of vitamin K that you take in each day adds up. If you eat a lot of foods that contain a medium amount of vitamin K in a single day, your vitamin K intake will be high that day.

Restaurants Most of us eat at least a few meals out each week, and you might be concerned about maintaining your INR within the normal

range in the face of temptation and menu selection. Just be careful that the total of your daily meals remains balanced with respect to the amount of food you eat that contains vitamin K. If you eat one serving of leafy greens each day, be sure that you get it either in a meal out or at home, not both. Be careful about sources of vitamin K that you don’t usually have at home. If you eat in a German restaurant and have red cabbage, don’t have a salad as well. If you usually use a salad dressing that is safflower oilbased and low in vitamin K, remember that a restaurant’s salad dressing might be made with a type of oil that has a higher vitamin K content, such as canola. - Be careful about sources of vitamin K that you don’t usually have at home. - You don’t need to obsess over these changes; small daily imbalances won’t have a long-term effect. Remember to keep your alcohol consumption reasonable. As noted in Chapter 10, this generally means no more than one or two glasses of wine or an equivalent amount of beer or hard liquor in a day.

Travel Issues Unless you have other medical issues that make travel difficult, the fact that you need to take Coumadin® or warfarin should in no way deter you from traveling—on vacations wide and far, business, to see family, and all the many other reasons for getting “on the road.”


• If your trip will last for more than a few days, you might need to have your INR tested before you leave. If a trip is going to last for more than a few weeks, and depending on how consistent your INR has been previously, you might need to be tested during the trip. • Be sure to pack enough medication to last the entire time you will be away. As a reminder, keep a weekly pill sorter in each of your suitcases (I learned this the hard way!). • Just in case, and to be completely safe and avoid stress on an extended trip, call ahead to get the name of a pharmacy that has the brand and strength of medication you need. • Keep all medications in your hand luggage, and make sure you have extra in case any travel delays occur. Do NOT put any medications that you need to take on a regular basis in your checked luggage.

• As noted elsewhere, be sure to wear a piece of jewelry and/or carry a card indicating you are on anticoagulant medication. • Try and keep your eating habits and activity level as close to your everyday routine as possible. • If you travel to areas where you need to be concerned about issues of water quality and eating raw vegetables and salads, be creative about alternatives. For example, when I was in Mexico recently, I regularly substituted guacamole for salad, which was most definitely not a hardship, and it followed the principle of peeling whatever can be peeled! Remember that, in many lesser developed countries, the food and water in restaurants and hotels that cater to visitors from North America and Europe is usually quite safe— look for the word “purificado” in Latin American countries.


Essential reading for anyone taking Coumadin® or warfarin, with the information your patients need to successfully manage their medications and minimize adverse events.

NEW!

The Coumadin® (Warfarin) Help Book Anticoagulation Therapy to Prevent and Manage Strokes, Heart Attacks, and Other Vascular Conditions Diana M. Schneider, Ph.D. “…this highly readable, reassuring little book provides me and all its users the confidence to simply stop worrying, take a deep breath, and get on with your life…” — Maggie Lichtenberg, author of The Open Heart Companion

“…a quick read; packed with vital information, [it] should be a part of prescribed care for all Coumadin® (warfarin) patients.” — Cleo Hutton, author of After a Stroke: 300 Tips for Making Life Easier

“… a comprehensive and thoroughly ‘user friendly’ guide...” — Midwest Book Review

“…read from cover to cover or use as a valuable resource when questions surface… If you or your loved one is told to take Coumadin® or warfarin, (this book) is essential for your understanding.” — Reader Views “…If you take Coumadin® (or the generic form) you need this book!!!” — Amazon.com Reviewer

The Coumadin® (Warfarin) Help Book is essential reading for anyone taking the anticoagulant drug Coumadin® or its generic form warfarin-especially if they find the dietary and medication guidelines confusing or complicated. Emphasizing that consistency is the key to success, the Help Book explains why these drugs require both dietary modifications and careful monitoring of both prescription and over-the-counter medications.

TO ORDER

In this book your patients will learn: • how Coumadin® and warfarin act to prevent the formation of blood clots that can cause strokes, heart attacks, or pulmonary embolisms; • why the level of these drugs must be maintained within a very narrow range; • the potential side effects of anticoagulant therapy, including the risk of bleeding when appropriate levels are not maintained as well as "nuisance" effects such as mild hair loss; • what they should know about the vitamin K content of foods, and how to regulate their diet to maintain clotting at the optimal effective level; • how both prescription and nonprescription drugs, as well as alcohol, can affect anticoagulant effectiveness, and how patients can work with their health care providers to maintain an optimal anticoagulant level while taking needed medications; • how coagulation therapy may be managed when they need surgery or are diagnosed with new medical conditions.

CONTENTS: Introduction. From the Author: How to Use This Book: General Guidelines for Successfully Managing Coumadin® and Warfarin. The Basics: Why Anticoagulation Is Necessary. What Is an Anticoagulant, and Why Is Controlling Blood Clotting So Important?; The Consequences of Abnormal Clot Formation: Stroke, Heart Attacks, and More; Common Conditions That Cause Blood Clots to Form. Successful Anticoagulation Management. How Should I Take Coumadin® or Warfarin?; Monitoring: Maintaining Your Clotting Rate in the Desired Range; Side Effects of Oral Anticoagulant Therapy; Dietary Considerations with Oral Anticoagulant Therapy; How Do Drugs and Supplements Affect Coumadin® or Warfarin Levels?; Anticoagulants and Other Medical Conditions. General Health Concerns. Managing Your General Health; Out and About: Managing Coumadin® or Warfarin Away From Home. Resources. Diana M. Schneider, Ph.D. is a biochemist and health publisher. She wrote this book following her own experience with taking Coumadin®, when she found that there was no single source of information about the drug and the need to balance diet and exercise, exercise care when taking other medications, or deal with side effects. She decided to base this book in her own experience to make it possible for anyone needing anticoagulation medication to live a normal, healthy life with minimal restrictions.

All DiaMedica publications are available at online bookstores, including Amazon.com and Barnesandnoble.com, as well as in your local bookstores. You can also visit our website at www.diamedicapub.com. If you would like to consider purchasing multiple copies of this book for use in your clinic setting or for courses or counseling programs, please contact us for review copies, a brochure written for patients, and for bulk pricing information.

CONTACT US

ISBN: 978-0-9793564-2-1 • Softcover • 112 pages • $14.95

DiaMedica Publishing 150 East 61st Street, New York, NY 10065 Phone: 212-752-2098 Email: info@diamedicapub.com Web: www.diamedicapub.com


Great Expectations: Patient Training By Theresa Julian

Learning a new skill requires proper

training. This is true whether you are learning to play golf for the first time or learning PT/INR self-testing. Just like the golfer who must learn the proper techniques to develop a good golf swing, you will need to learn proper self-testing techniques to ensure the results you generate are accurate and reliable. Your health could depend on it. Without proper training/coaching a poor self-testing technique is just as difficult to correct as a bad golf swing. The consequences of developing poor testing techniques could affect your health, so it makes good sense to take your training seriously. Whether you are considering PT/INR selftesting for the first time or have been selftesting for years, you should consider both the training method and the trainer.

How can you be trained? Several different methods have been used to train new patients. The methods include: • face-to-face training, • telephonic training, • combination of the two in which patients are asked to briefly demonstrate their ability to test in person after being trained by telephone. Telephonic training of new patients is now used less often as a result of recent changes in Medicare payment rules. It is estimated that many patients continue to rely on testing techniques learned over the telephone.

“We were not able to identify training, other than face-to-face, considered suitable for new PST patients.” We spoke with two experts in the field of education and training from the University of Southern Indiana’s (USI) College of Nursing and Health Professions, Victoria Pigott, MSN, CNS, RN and Nance Fiester MS, RN. USI recently introduced the nation’s first Patient Self-Testing (PST) Educator Certificate program. The program was based on scientific principles established by the Food and Drug Administration (FDA) and other widely recognized medical guidelines. The program was co-developed with Tapestry Medical Inc., a company that specializes in PST services.

We could not imagine learning a good golf swing by calling the pro at the local golf course. Therefore, we began by asking Ms. Fiester to define assessment criteria needed to determine if a patient had been “suitably trained”. After reviewing a number of studies and Federal regulations describing training methods currently in use, Ms. Fiester concluded, “We were not able to identify training, other than face-to-face, considered suitable for new PST patients.” This is consistent with Medicare’s policy which states

29


that “non face-to-face training methods do not support the correct use of the device”.

What about patients previously trained by other methods? Like the golfer with the bad swing is it reasonable to expect that they have self-corrected and adopted “suitable” testing techniques over time? Ms. Pigott believes that “it may be possible but there are important testing techniques such as blood sampling that really should be demonstrated and observed by a health care professional in person”. Good patient training begins only after a physician has determined that patient selftesting is appropriate. An ideal program involves three steps: 1. Pre-training Preparation - In this step patients are given educational material, either on a DVD and/or in paper format, to review prior to a face-to-face session. This is a good time to examine your commitment and make sure you are ready for self-testing. 2. Face-to-Face Training – This step occurs either in your home or in your physician’s office. 3. Post-Training Assessment - In this step participants are evaluated to ensure that they have properly learned and retained their training.

physician’s office or a professional trainer employed by the company providing your PT/INR equipment. Recently, Medicare expanded coverage for home PT/INR monitoring to include most warfarin-related conditions such as; atrial fibrillation, mechanical heart valves, deep vein thrombosis, and other indications. The result has been a sharp increase in the use of home PT/INR devices which require intense education and instruction. The need to have well-educated home trainers to instruct patients in the use of home monitoring devices has never been greater. Recently, a new Anticoagulation PST Educator Certificate Program has become available. The Program is a three week, 12 hour continuing education course for nurses, medical assistants and trainers. The program has been reviewed by local and national experts. To facilitate successful teaching strategies important topics such as the body’s clotting system, patient assessment data, and principles of adult learning have been incorporated into the course. Knowing that a trainer has successfully passed a specialized PST program may provide first time PST learners reassurance that they will be learning from a trained professional; one who is committed to your success.

Who can train you? Training should be performed by a health care professional familiar with the PT/INR systems planned for use and should be familiar with patient-training techniques. This professional may be the nurse in your

American College of Chest Physicians. Pharmacology and Management of the Vitamin K Antagonists: American College of Chest Physicians Evidenced-Based Clinical Practice Guidelines (8th Edition). CHEST 2008; 133;160198. Section 4.3.1. CMS National Coverage Decision (CAG-00087R) page 17.


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Compliance:

The Road to Effective Management By Theresa Julian

What are your options to improve the quality of your warfarin management? Scientific studies show that patients who test more frequently reduce the risk of over-dosing which can lead to serious bleeding, or under-dosing which can increase the risk of clot formation. Getting your blood tested in-between your regularly scheduled doctor visits may be impractical for you.

32

The good news is that Medicare and most private insurers now cover the cost of selftesting for most warfarin-related conditions. You may now be able to self-test your PT/ INR using a home-use device just as people with diabetes use glucometers to measure their blood sugar. Unlike glucometers, you can not just simply pick up a PT/INR device at your local pharmacy. Home PT/INR products and related services require a physician prescription. Patients must work closely with their physician to coordinate their home PT/INR testing through a company that specializes in PST services. These services include; verifying your insurance, training you on the proper use of the device, supplying you with your testing supplies, and working with you and your doctor to ensure that you stay in therapeutic range. You can actually be trained

in the comfort of your own home and have your testing supplies sent to you. Healthcare quality can be improved by enabling you to detect those times when your PT/INR drifts out of range due to changes in your diet, other medications or a variety of other reasons. Testing more frequently enables you and your doctor to reduce these risks. Your quality of life can be improved by enabling you to travel more freely and avoid the extra time, inconvenience, and costs associated with going to a lab for your PT/INR test. Whatever your motivation for home testing, you will need a trustworthy company to provide you the products and related services to become a successful PT/ INR home-tester. Because home PT/INR testing is still so new, we asked Sandra C. Canally, RN an expert in the field of assessing the healthcare quality for some helpful suggestions. Ms. Canally is President and Founder of The Compliance Team, Inc. one of only ten organizations approved by Medicare to accredit providers of medical equipment and supplies. Relying on nearly five decades of experience in healthcare delivery,


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which should be thoroughly discussed between you and your doctor. Referrals should be provided in writing after it has been determined that you are a good candidate for home PT/INR testing. Sandra C. Canally, RN

CAUTION: Directly soliciting

Ms. Canally created the Exemplary Provider™ program and explains that the program is based on three basic principles: “The first is that every patient deserves exemplary care; the second is that healthcare delivery excellence does not have to be costly or difficult (to achieve); and the third principle is that all providers should excel in the three areas that matter most to patients—Safety, Honesty and Caring.” We asked Ms. Canally to provide general guidance to these questions and any additional insights based on her experience in working with providers of home-use equipment.

patients is a violation of Medicare regulations.

quality of the product and services they provide. Although Medicare does not yet require providers of home PT/INR products and related services to be accredited, companies can choose to do so voluntarily. Accreditation involves a rigorous evaluation process which independently assesses whether the provider is delivering quality care in an honest and safe manner.

Question: What is the true cost of home PT/INR testing? Answer: Your out of pocket cost will be influenced by how frequently you test. Medicare has approved a maximum of weekly home testing based on studies that showed self-testing 2-4 times per month reduces the risk of being out of therapeutic range. Any PST provider should be willing to give you a written estimate before you begin. CAUTION: Beware of companies

that require you to test at the maximum level in order for you to be eligible for Medicare.

Question: How can you be sure that home PT/INR testing is really right for you?

Question: What factors should be considered when selecting a provider of home PT/INR products and related services?

Answer: As with any care option home PT/INR testing may not be right for everyone. It is a choice that depends on many factors

Answer: Providers of other home-use medical equipment such as glucometers and oxygen must be accredited to insure the

SUGGESTION: When considering

who to select as your PST provider look or ask for the Exemplary Provider seal or other proof of accreditation issued by a deeming authority approved by Medicare. 1.FDA product labeling for warfarin. 2.American College of Chest Physicians. Pharmacology and Management of the Vitamin K Antagonists: American College of Chest Physicians Evidenced-Based Clinical Practice Guidelines (8th Edition). CHEST 2008; 133;160-198. Section 4.3.1. 3.Medicare Claims Processing Manual Chapter 35 Section 20. 4.Medicare Program Integrity Manual Chapter 10 Section 4.19.1.7 5.Medicare National Coverage Decision (CAG00087R)


Medicare Covers Home PT Monitoring

for Atrial Fibrillation and Venous Thromboembolism Pa-

Though 2008 wasn’t a good year for seniors living on income from retirement funds, those with irregular heartbeats not caused by plummeting financial markets but from atrial fibrillation did receive some good news from Medicare. Medicare Part B now covers home blood coagulation monitoring for patients with atrial fibrillation and venous thromboembolism (including deep vein thrombosis and pulmonary embolism) treated with warfarin.

coverage to include all patients on long-term warfarin therapy,” said Lawrence Cohen, president of International Technidyne Corporation. “Now these patients can take an active role in managing their therapy with testing that’s more accessible and convenient.” New Study Shows Benefits of Home PT Testing To assess the benefits of home coagulation testing versus traditional laboratory and

“Now these patients can take an active role.....” 35

For some 4 million patients on long-term warfarin therapy, this change could mean freedom from making weekly visits to laboratories, clinics and physicians’ offices for their blood tests. According to the Centers for Medicare and Medicaid Services (CMS), less than 5 percent of warfarin patients perform self-testing. The prothrombin time (PT) test measures blood clotting speed. Results are reported as a numerical value, the International Standardized Ratio (INR), to show if blood is clotting too slowly and with increased clot formation risk, or too quickly and cause internal bleeding. “CMS has responded to significant scientific evidence documenting that patients who selfmonitor remain in the proper dosage range more often, and the agency wisely expanded

clinic monitoring, a multi-center trial led by Alan Jacobson, MD of Loma Linda VA Hospital and David Matchar, MD of Duke University Hospital evaluated nearly 3,000 atrial fibrillation and mechanical heart valve patients at 28 VA hospitals with their own


anticoagulation clinics. Known as The Home INR Study (THINRS), the objective was to determine if patient self-testing notably improves major health outcomes, such as time to first major adverse event. All patients in the trial were monitored with the ProTime® Microcoagulation System.

Jack Ansell, MD, an internationally recognized expert on hemostasis and thrombosis and chairman of medicine at New York’s Lenox Hill Hospital. “Testing at home allows not only for increased frequency of testing but also improved timeliness, providing the ability to test when it is needed.

The results were presented at the American Heart Association meeting last November and showed that weekly home monitoring improved the time in target range and patient satisfaction with anticoagulation therapy. The data also showed a trend toward fewer strokes, bleeding events and death.

Self-testing may have a subtle impact on patient empowerment, compliance and satisfaction that could be important elements in achieving better outcomes. Once patients get accustomed to self-testing, they don’t want to go back to the old way,” he explained.

“Our results show that home testing is an acceptable alternative to high-quality clinic care and may be preferable when patient access is difficult due to disability or geographic distance,” said Jacobson.

Ansell advises atrial fibrillation and DVT patients to talk with their doctors to learn if it is right for them. “Good candidates are motivated to learn, have adequate motor skills and good eyesight to perform the test procedure, and can view the meter screen. Those less able can be tested at home by a willing caregiver,” he said.

The body of evidence clearly indicates that those who test at home have a higher percent of results in the proper therapeutic range, require fewer dosage changes, and normally avoid bleeding complications or other adverse events. They test more frequently, at least weekly, staying in the proper therapeutic range longer than poorly monitored patients. Advances in technology have made home testing easy to perform and even allow downloading to communicate test results by email to doctors. Studies show home coagulation testing from fingerstick samples is as accurate as conventional testing in a laboratory.

“Infrequent testing is associated with less time in the desired therapeutic range,” said

Home blood coagulation testing requires a prescription from a physician and services are available to assist patients with everything to begin the process. They arrange delivery of the instrument and testing supplies and conduct training sessions. The easy-to-use systems consist of a compact, battery-powered instrument, and small disposable cuvettes or test strips that are inserted into the machine after adding a drop of blood. Built-in quality controls help patients and health care professionals remain confident about the quality of the test results. (Continued page 38)


®

The Point of Care

We Measure More at the Point-of-Care™

© 2009 ITC. All rights reserved. ITC is a wholly-owned subsidiary of Thoratec Corporation.


Warfarin, Atrial Fibrillation and DVT An arrhythmia, or atrial fibrillation, is a leading cause of stroke. The upper chambers of the heart quiver or flutter, inhibiting normal blood flow. Common symptoms are heart palpations, shortness of breath and fatigue. The condition increases risks for blood clots that can cause an embolic stroke. DVT occurs when clots form in deeply located veins, usually in the legs. A warning sign is leg pain and swelling but DVT is often asymptomatic. Left untreated it can have serious, sometimes fatal, complications, most notably pulmonary embolism caused by migration of the clot to a lung. Risks for DVT include prolonged sitting, especially when driving or flying. Though the probability of developing DVT on long drives and flights is relatively low, travelers should take breaks to stand or walk and keep normal circulation in their legs.

researchers who discovered that deficiencies in vitamin K are associated with internal bleeding. About the same time, a diagnostic test for measuring prothrombin time was developed. It soon became the standard for gauging the blood’s ability to clot and for monitoring anticoagulation therapy. In the 1950’s studies were performed to evaluate warfarin sodium, best known as an effective rodent-control agent, as a potential drug to regulate blood clotting. It proved successful in reducing the liver’s ability to use vitamin K to make blood-clotting proteins. Wide clinical acceptance occurred when physicians treating President Dwight Eisenhower prescribed warfarin after one of Ike’s heart attacks. Coumadin®, the leading brand of warfarin, still ranks as the most widely prescribed oral anticoagulant medication for patients with mechanical heart valves, DVT, pulmonary embolism and atrial fibrillation.

...serious side effects if doses aren’t monitored regularly. Warfarin is a standard treatment for atrial fibrillation and DVT. The blood-thinning agent regulates clotting time, but clinicians know very well it has serious side effects if doses aren’t monitored regularly. Too much medication precipitates internal bleeding and under-dosing leads to clot formation. Patients, therefore, are monitored with prothrombin time tests and the process takes only minutes at home. Physicians can maintain or adjust warfarin doses in accordance with the results. Anticoagulation therapy dates back to 1943 when the Nobel Prize was awarded to

Every patient who takes warfarin must be monitored regularly for prothrombin time, and Medicare finally has recognized this need by enacting Part B coverage for home testing. With new freedom from taking trips for lab tests, beneficiaries taking warfarin have more time for hobbies and recreation. Hopefully, the retirement funds will bounce back too. For more information visit www. itcmed.com.


Understanding the Link between genotype and optimal INR interpretation: pharmacogenetics applies to more than just a dose estimate By Brad Esarey

An undescribed hemorrhagic disorder in cattle in 1924 led to the development and completion of warfarin. The name warfarin is derived from the patent holder, Wisconsin Alumni Research Foundation, plus the suffix coumarin. The acceptance of warfarin as a drug was limited in the beginning due to the fear of toxicity. A massive dose of warfarin saved an attempted suicide attempt by an army inductee in 1951 and since then warfarin has become a mainstay. [3] Warfarin is the most commonly used oral anticoagulant, now prescribed to over 1 million patients each year. Warfarin is approved for the prevention and treatment of venous thrombosis, pulmonary embolism, thromboembolic complications associated with atrial fibrillation, cardiac valve replacement, and myocardial infarction. [3] The total number of prescriptions dispensed for warfarin in 1998 was 21 million. It grew 45% from 1998 to 2004 when the total number of prescriptions equaled 31 million. As the numbers of prescriptions have grown, so too have the number of adverse reactions. While warfarin is the anticoagulant of choice for the above mentioned conditions, it does require constant monitoring. Imagine a tightrope walker at a circus, high above the floor. Any slight variation could cause a

disastrous outcome for the walker. A warfarin patient walks a tightrope, and it requires the practitioner to maintain balance. A correct maintenance dose is not easy to achieve, due to the wide variability associated with warfarin dose requirement. Age, gender, body size, and concomitant medications, among other things, all contribute to the variability. The newest addition to these variables that is now widely recognized is a patient’s genetic capacity for metabolism and response to warfarin. Understanding how an individual’s genetic differences can affect their pharmacokinetic and pharmacodynmic responses to warfarin, can improve estimation of appropriate dose, and help refine the practitioner’s monitoring strategy. [1] Warfarin is a 50:50 racemic mixture of R- and S- enantiomers. S- warfarin is threeto-fivefold more potent in its inhibition of the target enzyme vitamin K epoxide reductase, also known has VKOR. Warfarin’s mechanism of action is to inhibit VKOR, which reduces the pool of reduced vitamin K dependent clotting factors, and thrombin formation. [1] There are two genes of significance here: CYP2C9 and VKORC1. Let’s start with a look at VKORC1, and follow-up with a

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look at CYP2C9. VKOR is the target enzyme of warfarin inhibition, and it is encoded by the vitamin K epoxide reductase complex subunit 1 gene (VKORC1). There have been recent studies that have identified noncoding polymorphisms within VKORC1, which lead to warfarin sensitivity and low dose requirements. Patients that have the most prevalent VKORC1 genotype (GA heterozygous) having one variant are reported to require an average of 3.8 mg/day of warfarin. Patients that are homozygous (GG) require an average of 4.5 mg/day of warfarin, and patients that are homozygous with two variants (AA) require an average of 2.2mg/day of warfarin. [1] Cytochrome P-450 2C9 metabolizes 6-10% of prescribed medications, which includes S-warfarin, phenytoin, and some NSAID’s. There are several polymorphisms associated to the CYP2C9 gene. The most common is CYP2C9*1 and it is referenced as normal. Two of the most prevalent variant alleles are CYP2C9*2 and CYP2C9*3. There are consequences for a patient who has a variant allele, or multiple variants. These variants lead to hypersensitivity to warfarin. Patients that have two copies of the CYP2C9*1 allele, require the highest maintenance dose. Patients who have one active and one variant allele (e.g., CYP2C9*1/*2) have impaired metabolic activity and require the lowest daily doses of warfarin. [1]

CYP2C9 and VKORC1 account for respectively, the pharmacokinetic and pharmacodynamic aspects of warfain therapy. CYP2C9 is responsible for setting the rate of drug accumulation and elimination, and VKORC1 is responsible for setting the effective concentration for achieving success regarding warfarin therapy. These two genes account for 35-40% of the variability in a warfarin dose requirement. Genetic variants do exist in these two genes, and understanding these variants could help the practitioner start to develop an individualized dosing and monitoring approach for each patient. [1] There are several types of mathematical algorithms that estimate a patient’s maintenance dose requirement, and typically these algorithms estimate to within 1 mg/day of the optimal dose. INR monitoring and management is of critical importance to the practitioner, and it can also cause the most headaches. Understanding how changes in achieving steady-state concentration differs in each patient helps with the management of a patient’s INR and may, importantly, reduce the amount of out-of-range INR’s. [1] A majority of the patients will achieve steady-state concentration in 5 days, but patients with a CYP2C9 variant will not, and will require more time. The effect of this CYP2C9 variant could lead to the practitioner misinterpreting the INR, based on when it is measured, and result in a premature dose adjustment.


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concentration in 6-9 days, and a patient with a CYP2C9*1/*3 genotype achieves steadystate concentration in 12-15 days. Any adjustment of the dosing before a steady-state is reached leads to serious complications in stabilizing the dosing regimen. [1]

A follow-up appointment after 1-2 weeks may show an elevated INR, due to the previous statement. The INR of 2.5 on day 5 was a transitional measurement, and without the genotype information would be misinterpreted by the practitioner. The practitioner may have considered a different dosage or monitoring protocol if they would have genotyped the patient and received the steady-state information. A genotype-guided maintenance dose-estimate could reduce the chance that a patient is prescribed an inappropriately high dose and understanding the time to transition to steady-state would help the practitioner with the monitoring and management of the patients INR. [1] The effects of CYP2C9 and VKORC1 genetic variants on the pharmacokinetics and pharmacodynamics of warfarin therapy can be used by practitioners to make clinical decisions regarding dose selection and titration and also help with the interpretation of the INR response to changes in dose. The belief is that pharmacogenetic testing will lead to better medicine and more importantly a personalized approach.

What does that mean to the patient and the practitioner, in terms of achieving a therapeutic INR? Please consider the following example: an INR that is measured 3-5 days after a patientâ&#x20AC;&#x2122;s dose adjustment in the maintenance phase is in the therapeutic range (e.g., 2.5) which prompts the practitioner to keep the current dose. If the patient has the CYP2C9*3 variant, the plasma concentration will not have yet reached its appropriate value, and that patient will not achieve steady-state concentration for 12-15 days.

Brad Esarey is the Vice-President of Sales and Marketing with PGXL Laboratories, a CLIA-certified laboratory that offers pharmacogenetic testing.

References 1.Reynolds KK, Valdes Jr. R, Hartung BR, Linder MW: Individualizing warfarin therapy. Personalized Medicine 4(1), 11-31 (2007). 2.Wysowski DK, Nourjah P, Swartz, L: Bleeding Complications With Warfarin Use. Arch Intern Med. 167(13), 1414-1419 (2007). 3.Hardman JG, Limbird LE: The Pharmacological Basis of Therapeutics. Goodman and Gilmanâ&#x20AC;&#x2122;s 10(e), 1526-1530 (2001).


Impact The of

Impact

Patient Education on Patient Outcomes

Patient education is the foundation for a better understanding of warfarin treatment and its side effects. Patients who have a poor understanding of why they take warfarin are more likely to have compliance issues than those who receive patient education however, there is a positive correlation between patients’ warfarin knowledge and the number of INR values within target range. Today’s healthcare practitioners are challenged to meet the rising demand for diverse and sustainable patient education for the growing number of patients taking warfarin. Prescription drug use is on the rise. A 2001 study by pharmacy benefit manager Advance PCS found nearly 80% (78.9%) of their 387,847 patients taking warfarin were taking 6 or more medications in addition to warfarin. New classes of prescription drugs and prescription strength over-the-counter medications have anticoagulation clinics struggling to keep up with patients who strive to take greater control of their health. Prescription drug use alone, for an aging population, is presenting management challenges with less face-to-face time with patients. A Population in Need

Warfarin remains the most common medication involved in drug-drug interactions resulting in warfarin being responsible for the second leading cause of emergency room visits for drug interactions. Despite the

advancement of the systematic patient care model (point of care devices, electronic management systems), bleeding rates remain common outside controlled clinical trials. “The frequency of major bleeding with warfarin use, which is estimated to be as high as 10% to 16%, contrasts with much lower frequencies (1/1000) for known serious adverse events of most drugs.” Additional data suggests that patients may be most vulnerable during their first month of therapy. Bleeding events are 2.7X greater for the first 30 days post-discharge than the following 61 days. For this reason, many clinics front-load patient education and host longer patient counseling sessions during patients’ initial visit. Patient retention remains a concern for many practitioners given the volume of information presented. Dietary supplements could represent the tipping point for some clinics trying to improve their patients’ INR control. Unsubstantiated claims of improved: health and quality of life have many patients on warfarin visiting nutrition stores and often ordering online with little or no communication to their anticoagulation clinics.

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New Standards of Care Following the 2006 black box warning and updated package insert, the Joint Commission added oral anticoagulation to its 2008-2009 National Patient Safety Goals. The goals identify patient education to the patient and their families as part of their strategy to improve the safety of oral anticoagulants. Medicare’s 2008 expanded coverage of weekly patient self-testing for patients with atrial fibrillation, mechanical heart valves and venous thromboembolism also requires specific guidelines on patient training and patient education. A 2008 published study of over 2,000 warfarin patients, demonstrated a 60% reduction in major bleeding events and the benefit extended out to 2 years. The link between patient education to improved INR control to outcomes was published in a December 2008 review article. “Knowledge about warfarin therapy has been positively correlated with improved outcomes and this may improve the quality of anticoagulation management above and beyond the direct effects of increased INR testing.”11 Patient Education – A process versus an event It can take years for professionals to master the nuances of warfarin management. Patients however, have a shorter and steeper learning curve with many facing literacy challenges. Patients’ age and responsibilities

suggest the duration and sustainability of patient education are considerations for effective patient learning and retention, proving patient education consistently over time may improve patient understanding. Ineffective or complete neglect of patient education results given the time it takes to educate a patient and that patients are frequently overwhelmed by the information. Patient decision making will continue to have a significant impact on the patient-nurse-doctor relationship and influence warfarin control. Informed decision making by patients will help clinicians improve warfarin control. Sustained patient education helps new and established patients improve the risk/benefit profile of warfarin. Documentation of the provision of patient education reduces exposure for today’s anticoagulation clinic. 1.Ryan, F., et al. (2008). Managing oral anticoagulation therapy: improving clinical outcomes. A review. Journal of Clinical Pharmacy and Therapeutics, 33(6), 581. 2.Tang, E. et al. (2003). Relationship between patients’ warfarin knowledge and anticoagulation control. Annals of Pharmacology, 37, 34-39. 3.Wallack, Stanley. (Winter, 2001). Growth in prescription drug spending amount insured elders. Health Improvement Report. Brandeis University Schneider Institute for Health Policy 4.(Silverman, H. 2004. The Pill Book. New York. Bantam Books.) 5.Annals of Emergency Medicine, 2002 6.Wykowski, D. (July 2007). Bleeding complications with warfarin use. A prevalent adverse effect resulting in regulatory action. Archives of Internal Medicine, 167 (13), 1414-1419 7.White, H. et al. (Nov. 1999). Major bleeding after hospitalization for deep-vein thrombosis. American Journal of Medicine, 107(5):414-24 8.Bristol-Myers Squibb Company. (2007). Medication Guide for Coumadin Tablets and Coumadin for Injection [Package Insert]. Princeton, NJ: Bristol-Myers Squibb Company. 9.The Joint Commission (2007). 2008 National Patient Safety Goals, Ambulatory Care. Retrieved February 9, 2009, from the Joint Commission Web site: http://www.jointcommission.org/Patient Safety/National Patient Safety Goals/08_amb_npsgs.htm 10.Center for Medicare and Medicaid Services. (2008). Decision Memo for Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087R) [Memorandum]. Baltimore, MD. 11.Metlay, J. (2008). Patient reported receipt of medication instruction for warfarin is associated with reduced risk of serious bleeding events. Journal of General Internal Medicine 12.Wofford, J. et al. (2008). Best strategies for patient education about anticoagulation with warfarin: a systematic review. BMC Health Services Research, 8:40


Keeping good health in range

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The Point of Care

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INR Magazine May 2009