Transcript A Patients Guide to Managing Anticoagulation Before and After

Do’s and Don’ts
of
New Oral Anticoagulants
2013
Jean M. Connors, MD
Assistant Professor of Medicine, HMS
Medical Director, BWH and DFCI AMS
New oral anticoagulants
How they work
Tips on taking them
DEFINITIONS
COAGULATION
COAGULATION: The process by which blood
forms clots.
• It is the process of stopping blood loss from a damaged
vessel, wherein a damaged blood vessel wall is covered
by a platelet and fibrin-containing clot to stop bleeding.
http://en.wikipedia.org/wiki/Coagulation
• Hemorrhage: not enough coagulation; excessive
bleeding
• Thrombosis: too much coagulation; coagulation in the
wrong place at the wrong time
scanning electron micrograph of blood clot
Anticoagulants
• Goal is to prevent blood clots from forming
or getting bigger.
• Anticoagulants do not “thin” the blood.
They make it take longer to form a clot.
• They work by preventing or inhibiting
activation of clotting factors.
Who needs anticoagulation?
• Who needs anticoagulant therapy?
– Atrial fibrillation--irregular heart rhythm
– Deep vein thrombosis (blood clot in big vein)
– Pulmonary embolus (blood clot in lung)
– Mechanical heart valves
– Situations with very high risk:
• Orthopedic joint replacement surgery
• Inherited blood clotting disorders
Anticoagulants
• OLD
– Heparin
• IV, subcutaneous
• LMWH: Lovenox, Fragmin
• injections
– Warfarin
• Only pill anticoagulant available in US until
2010
Anticoagulants
• NEW
–Pradaxa (dabigatran)
–Xarelto (rivaroxaban)
–Eliquis (apixaban)
• “Novel” “new” “target specific” “next-gen”
Anticoagulants
• NEW
–Pradaxa (dabigatran)
Approved in Oct 2010 to prevent strokes in
atrial fibrillation.
Must take twice a day.
Anticoagulants
• NEW
–Xarelto (rivaroxaban)
– Approved to prevent blood clots in orthopedic
surgery patients 2011
– Approved to preevnt stroke in afib 2011
– Approved to treat DVT and PE Nov 2012
– Take once a day to prevent strokes
– Twice a day for three weeks to teat blood clots then
once a day
Anticoagulants
• NEW
–Eliquis (apixaban)
– Approved to prevent stroke in atrial fibrillation
Dec 2012
– Must take twice a day
MECHANISM OF ACTION
NEW ORAL ANTICOAGULANTS
– Pills are swallowed and drug enters the blood
– Binds directly to the activated clotting factor to
prevent it from working
– Pradaxa
• Binds to thrombin = direct thrombin inhibitor
– Eliquis
• Binds to clotting factor Xa = direct inhibitor
– Xarelto
• Binds to Xa = direct factor Xa inhibitor
MECHANISM OF ACTION
WARAFRIN
• Warfarin is different. It affects the
production of some coagulation factors.
• Pills are swallowed. Drug enters the blood
and travels to the liver.
• The liver makes the clotting factors but
doesn’t completely finish them so they are
not able to be activated.
– Vitamin K epoxide reductase
– II, VII, XI, X, protein S and protein C.
MECHANISM OF ACTION
WARAFRIN
• It takes a number of days (4-6) to get the full
anticoagulant effects of warfarin.
• Dose needed for same level of
anticoagulation from person to person is
different.
• Many factors can affect or interfere with
how warfarin works in the liver
– Vitamin K in the diet
– Alcohol, antibiotics and other medications that
affect the same enzymes in the liver
New Anticoagulants
• How are they different from
warfarin?
• Rapid onset of activity
–Warfarin: 3-5 days
–New drugs: 2-4 hours
• Same dose covers a wide
range of people
–110-220 pounds
New Anticoagulants
• How are they different from
warfarin?
• No need for testing drug levels
–coagulation tests are affected and
abnormal but there is no target
range
• No need to watch diet
vitamin K containing foods
alcohol
most antibiotics
New Anticoagulants
• DO
– Take your medication at the same time every day.
– Xarelto 15 mg and 20 mg dose, take with real
meal.
– IF
• You miss a dose do not take it close to the next
dose if you are taking Eliquis or Pradaxa twice a
day.
• Take it when you remember for Xarelto but then
get back on an every 24 hour schedule.
• You miss 2 doses in a row, or 2 days, you will
not be anticoagulated.
New Anticoagulants
• DON’T
– Start one of these medications without checking with
your doctor:
• Antifungal or yeast treatment medications
– Fluconazole (Diflucan)
• Anti-seizure medications
– (Dilantin, carbamazapine)
• Antibiotics for tuberculosis (TB) or certain staph
infections
– (rifampin)
• Treatment for HIV or AIDS
• Certain cardiac medications for heart abnormalities
• Others on package inserts
New Anticoagulants
• DO
– Tell your doctor if you have a history of bleeding
from ulcers or the intestines before starting one
of these drugs.
– Do call your doctor if you are throwing up, have
diarrhea, or are dehydrated, especially if your
kidneys do not work well.
New Anticoagulants
• DO
– Let dentists, surgeons, and others who do
procedures, know that you are on an
anticoagulant.
• Most ask only about Coumadin/warfarin
– Contact your doctor’s office to let them know
that you will be having a procedure.
– No need for “bridging”, most require stopping 2
days before.
New Anticoagulants
• Are they “better” than warfarin?
– Some drugs and doses work equally as well as
warfarin.
– Some drugs and doses work better than
warfarin, or have lower specific bleeding side
effects.
– GI bleeding side effects can be worse than
warfarin with some drugs.
New Anticoagulants
• Maybe not better, just different.
– One standard drug dose may not be correct
dose for people at extremes of weight, or with
strong blood clotting disorders.
– Not measuring levels is easier but in certain
situations you may want or need to measure
levels, we currently can not do this.
– No good reversal agents such as vitamin K or
FFP/plasma for warfarin.
New Anticoagulants
• DON’T
– Take one of these drugs if you have a
mechanical heart valve (RE-ALIGN trial)
– You are on dialysis
– Probably should not take if
• You are pregnant
• You have active cancer and getting chemotherapy
• You have lupus anticoagulant/antiphospholipid
syndrome
New Anticoagulants
ANTICOAGULATION IS ANTICOAGULATION!
• The major side effect of any anticoagulant is
bleeding.
– As with warfarin DO call your doctor if:
• You have unusual or prolonged bleeding
• You hit your head or have other moderate
trauma
This is
Prada
This is
Pradaxa
Do they cost more than warfarin?
Anticoagulants
• 60 years of experience with warfarin.
• Less than 6 years with new agents.
• The more stable your INR, the higher your
TTR, the smaller the differences are
between new drugs and warfarin.
Anticoagulants
Work with your healthcare
team to determine if one of
these new oral
anticoagulants is right for
you.
A Patients Guide to Managing
Warfarin Around the Time of
Surgery and Procedures
Andrea Resseguie, Pharm.D., CACP, R.Ph.
Brigham & Women’s Hospital
Anticoagulation Management Service
November 2, 2013
Learning Objectives

Review the risks of continuing warfarin therapy
while having surgery or a procedure

Identify situations when warfarin should be
stopped for surgery/ procedure

When warfarin is stopped, estimate clotting risk
to determine if a bridging agent should be used
Background

Some patients may require an elective surgery
or procedure while on warfarin therapy

Continuation of warfarin for an upcoming
surgery/ procedure may increase the risk of
bleeding

Some patients may need to stop taking warfarin
around the time of surgery/ procedure to
minimize this bleeding risk
Background cont.

If warfarin needs to be stopped this may increase the
risk of having a blood clot

Individual circumstances will be carefully reviewed
before a decision on modifying warfarin therapy is made



Estimate of bleeding risks
Estimate of clotting risks
Bridging agents, like unfractionated heparin (UFH) or
low-molecular weight heparin (LMWH), can be used to
minimize the risk of having a blood clot in high-risk
patients
Surgery/ Procedures &
Estimate of Bleeding Risk

Risk of bleeding in patients taking warfarin is
dependent upon:







Age
Presence of other disease states (high blood pressure, liver
or kidney disease)
Bleeding tendency or predisposition
Stability of anticoagulation
Use of other anticoagulant/ antiplatelet agents
Type of surgery /procedure
Prolonged, complex, and major surgery is much
more likely to cause significant bleeding problems
than short, simple, and minor surgical procedures
Low Procedural Bleeding Risk
Dental
Restorations, endodontics, prosthetics, dental hygiene treatment, periodontal therapy
Ophthalmologic
Cataract extractions
Dermatologic
Mohs micrographic surgery, simple excisions and repairs
GI
Upper endoscopy without biopsy, flexible sigmoidoscopy with biopsy, colonoscopy
without biopsy, ERCP without sphincterotomy, endosonography without fine-needle
aspiration, push enteroscopy of the small bowel
Orthopedic
Joint aspiration, soft tissue injections, minor podiatric procedures
Other
Pacemaker and cardiac defibrillator insertion and electrophysiologic testing
Noncoronary angiography, Central venous catheter removal
High Procedural Bleeding Risk
Heart valve replacement
Coronary artery bypass
Abdominal aortic aneurysm repair
Neurosurgical/ urologic/ head and neck/ abdominal/ breast cancer surgery
Bilateral knee replacement
Laminectomy
Transurethral prostate resection
Kidney biopsy
Biliary sphincterectomy
PEG placement
Endoscopically guided fine-needle aspiration
Multiple tooth extractions
Specific Recommendations:
Procedure-Related Bleeding Risk from
Gastrointestinal Procedures
Low-risk procedure
Diagnostic upper endoscopy, flexible sigmoidoscopy, and colonoscopy (includes
biopsies); Capsule endoscopy
Diagnostic endoscopic retrograde cholangiopancreatography (ERCP)
Biliary stent insertion without endoscopic sphincterotomy
Endosonography; Push enteroscopy and diagnostic balloon assisted enteroscopy
Enteral stent deployment without dilation
High-risk procedure
Polypectomy or endoscopic resection; Therapeutic balloon assisted enteroscopy
Argon plasma coagulation and thermal ablative therapy
Endoscopic sphincterotomy; Pneumatic/ bougie dilation of benign or malignant
strictures
Percutaneous endoscopic gastrostomy tube placement
Endoscopic ultrasound (EUS)-guided fine needle aspiration
Tissue ablation by any technique; Cystgastrostomy; Treatment of varices
Warfarin & Surgical/
Procedural Bleeding Risk

Most patients can undergo low risk surgery/
procedures without stopping warfarin


Warfarin may either be continued at or below the low
end of the therapeutic INR range
More complex or high risk surgery/ procedures
require discontinuation of warfarin
Clotting Risk if Warfarin is Stopped

Risk varies by indication:
Mechanical Heart Valve
 Atrial Fibrillation (A Fib)
 History of Blood Clot

 Deep
Vein Thrombosis (DVT)
 Pulmonary Embolism (PE)

Other indications: Acute Coronary Syndrome,
Peripheral Vascular Disease
High Risk
Indication for Anticoagulation
Mechanical Heart
Valve
Any mitral valve
prosthesis
Any caged-ball or
tilting disc aortic
valve prosthesis
Recent stroke/ ministroke (within 6
months)
A Fib
High risk for stroke
Recent stroke /ministroke (within 3
months)
Rheumatic valvular
heart disease
Venous
Thromboembolism
(VTE): DVT/ PE
Recent (within 3
months) VTE
Severe thrombophilia
(deficiency of protein
C, protein S, or
antithrombin/
antiphospholipid
antibodies/ multiple
abnormalities)
Moderate Risk
Indication for Anticoagulation
Mechanical Heart
Valve
A Fib
Bileaflet aortic valve
Moderate risk for
prosthesis and 1 or
stroke
more of the following
risk factors: A fib,
prior stroke/ minstroke, hypertension,
congestive heart
failure, age >75 years
Venous
Thromboembolism
(VTE): DVT/ PE
VTE within 3 - 12 months
Nonsevere thrombophilia
(heterozygous factor V
Leiden or prothrombin
gene mutation)
Recurrent VTE
Active cancer (treated
within 6 months or
palliative)
Low Risk
Indication for Anticoagulation
Mechanical Heart
Valve
Bileaflet aortic valve
prosthesis without A
fib and no other risk
factors for stroke
A Fib
Low risk for stroke
(assuming no prior
stroke / mini-stroke)
Venous
Thromboembolism
(VTE): DVT/ PE
VTE > 12 months
previous and no other
risk factors
Clotting Risk/ Use of Bridging Agent

High risk: Use bridging agent

Moderate risk: May consider using a
bridging agent

Low risk: No bridging agent necessary
Bridging Anticoagulation

Bridging can be defined as the
administration of a short-acting
anticoagulant during the interruption of
warfarin

Goal of bridging is to minimize the time
patients are not being anticoagulated

Minimizes patients risk of blood clot
Bridging Anticoagulation cont.

Decisions about bridging should be based upon
the individual patient and surgery-related factors

In addition to high-risk patients already
discussed, bridging may be considered:



Active coronary or peripheral vascular disease
Previous clot during interruption of warfarin therapy
Major cardiac or vascular surgery
Anticoagulants used for Bridging

UFH

LMWH
 Lovenox
(enoxaparin)
 Fragmin (dalteparin)

Arixtra (fondaparinux)
Developing a Specific Plan for
Managing Warfarin around the
Time of Surgery/ Procedure

Once bleeding risk and clotting risk have
been evaluated: plan for management of
warfarin can be established

Decision to use a bridging agent is made
Interruption of Warfarin

After stopping warfarin, it usually takes 2-3 days for
the INR to fall below 2.0, and 4-6 days for the INR to
normalize

The time required for the INR to normalize after
stopping warfarin may be longer in patients
receiving higher-intensity anticoagulation (Ex: INR
range 2.5 - 3.5) and in elderly patients

Once the INR is 1.5 or below, surgery can be
performed with relative safety in most cases,
although a normalized INR is typically required in
patients undergoing surgery / procedure associated
with a high bleeding risk
Timing of Warfarin Resumption

Warfarin may be restarted 12-24 hours after
surgery/ procedure, typically the evening of
surgery/ procedure

If warfarin is resumed alone, without UFH/
LMWH bridging, a full anticoagulant effect will
take 4-6 days to occur
Summary

For minor surgery/ procedure (low bleed risk)
warfarin usually does not need to be stopped


However, still important to check that INR is not
too high
Warfarin should be stopped for surgery/
procedure when there is a high bleeding risk


For most patients, hold warfarin 4 - 5 days to
reach a normal INR
Also, if high clotting risk bridging is may be
necessary
Questions
Brigham and Women’s Hospital
Anticoagulation Management Service
The Warfarin Lifestyle: A Focus on Diet
and Vitamin K
Nicholas Feola, Pharm.D, RPh
November 2, 2013
Objectives
 Discuss the relationship between warfarin
and Vitamin K
 Understand ways to improve warfarin
therapy with Vitamin K
 Identify other dietary and lifestyle factors
which may influence warfarin therapy
What is Warfarin?
 Anticoagulant
– Medication that affects
the blood’s ability to
form a blood clot
 Commonly referred
to as a“blood
thinner”
– It changes the time it
takes to form a blood
clot
Common Reasons for Warfarin Therapy
• Atrial fibrillation
 Deep vein thrombosis (DVT)
 Pulmonary embolism (PE)
 Mechanical or tissue heart valves
 Stroke
 To prevent blood clots after surgery
 Genetic clotting diseases
How Does Warfarin Work?
 Prevents vitamin K
from being
converted to its
active form
 Inhibits hepatic
synthesis of vitamin
K dependent
coagulation factors
(II, VII, IX, X)
Holmes, 2012
Factors Affecting Warfarin Dose
 There is no “standard
dose” of warfarin
 The warfarin dose is
very different for each
patient who takes
warfarin
 Age
 Medications
 Genetics
 Illness/Infection
 Diet
 Activity Level
Vitamin K
• Lipid-soluble vitamin
• Two types:
– K1plants
– K2 bacteria in gastrointestinal tract
• Function
– Blood coagulation
– Bone formation and remodeling
– Recent evidence of its role in brain function, cell growth,
apoptosis
Holmes, 2012
Vitamin K Content of Selected Vegetables
Description
Serving
Vitamin K (ug/measure)
VERY HIGH (>500mcg/serving)
Kale – cooked
1 cup
1062
Collards – frozen, cooked
1 cup
1059
Spinach – frozen, cooked
1 cup
1027
Beet greens – cooked
1 cup
697
Dandilion greens – cooked
1 cup
579
Turnip Greens – frozen,
cooked
1 cup
851
HIGH (200-500 mcg/serving)
Mustard greens – cooked
1 cup
419
Brussels sprouts – cooked
1 cup
300
Broccoli – cooked
1 cup
220
Onion – scallions, raw
1 cup
207
Nutescu, 2006
Other Sources of Dietary Vitamin K
Description
Vitamin K (ug/100g)
Oils
Soy
193
Canola
141
Olive
55.5
Sesame/Walnut
15
Corn/Peanut
Less than 3
Processed Food
Potato Chips
22-347
Tortilla Chips
21-180
French Fries
11.2
Hamburger with cheese (2-4oz)
6
Nutescu, 2006
Vitamin K Effect on INR
Vitamin K rich foods have the ability to lower your INR
Franco, 2004
Should I Stop Eating Vegetables?
USDA Dietary Recommendations
USDA Dietary Recommendations
Nutescu, 2006
scriptions of food were reported (11). If a patient was unable to
give details about either the weight or portion size then the
weight of food eaten was approximated using average portion
sizes (12).
Vitamin K Maintains Stable INRs
Co
uns
The
low
1).
nifi
tien
p<0
nifi
Tab
con
Va
Me
• Patients who achieved stable INR control had greater amount of dietary
intake
of vitamin
k compared
to patients
withfor
unstable
INRswith unFigure
1: Mean
+SD
of Vitamin
K intake
patients
stable and stable control of anticoagulation over the two week
Scone,
2005 period.
study
Sex
Pri
w
How Much Vitamin K Should I Eat?
Dietary Intake of Vitamin K in Patients
Treated with Warfarin
Low dose Vitamin K
Supplementation
150ug/day
TTR
100ug/day
%INR in
range
69
Vitamin K Recommendations
• No specific recommendations regarding amount
of dietary intake of Vitamin K
• Patients should maintain an adequate amount of
vitamin K in their diet
Adequate Intake (AI) of Vitamin K (USA)
Men
120ug/day
Women
90ug/day
• BE CONSISTENT!!!!
Alcohol

Alcohol interferes with the liver’s ability to
breakdown warfarin
Alcohol

INR
Drinking more than 2 alcoholic drinks in one day
can increase your risk of serious bleeding while
taking warfarin
Cranberry Juice
Time response of international normalized ratio (INR)
Placebo - ▲
Cranberry -
■
No significant interaction between the daily consumption
of 1 cup (250mL) cranberry juice and warfarin.
Li, 2006
Dietary Supplements
 Many supplements can interact with warfarin
 Some multi-vitamins and meal replacement
shakes contain vitamin K
 Consult your healthcare provider prior to
starting any supplements
Exercise and Medications
 Increase in physical exercise can alter the
pharmacokinetics of medications
Aerobic exercises Effect on Pharmacokinetics
Lenz, 2004
Characteristic
Effect
Absorption
↓
Volume of Distribution
↓
Metabolism
↑/ ↓
Excretion
↑/ ↓
Exercise and Warfarin
Increase in physical activity can cause a decrease in INR
Shibata, 1998
Conclusion
 Warfarin is effected by many factors including diet
and exercise
 Patients taking warfarin should maintain a
consistent diet of vitamin K to promote stable INRs
 Before making any lifestyle changes, patients
should consult with their healthcare providers to
determine its effect on warfarin
References















Shibata Y, et al. Influence of Physical Activity on Warfarin Therapy. Thromb Haemost, 1998; 80: 203-4
Nutescu E, et al. Warfarin and its interactions with foods, herbs and other dietary supplements. 2006; 5(3): 433-451
Li Z, et al. Cranberry Does Not affect Prothrombin Time in Male Subjects on Warfarin. J Am Diet Assoc. 2006; 106: 2057-2061
Lenz T, et al. Potential Interactions between Exercise and Drug Therapy. Sports Med. 2004; 34 (5): 293-306
Franco V, et al. Role of Dietary Vitamin K Intake in Chronic Oral Anticoagulation: Prospective Evidence from Observational And
Randomized Protocols. Am j Med. 2004;116:651-656
Holmes M, et al. The Role of Dietary Vitamin K in the Management of Oral Vitamin K Antagonists. Blood Reviews. 2012; 26: 1-14
Scone E, et al. Patients with unstable control have a poorer dietary intake of vitamin K compared to patients with stable control of
anticoagulation. Thromb Haemost, 2005; 93: 872-5
Khan t, et al. Dietary Vitamin K influences intra-individual variability in anticoagulant response to warfarin. British Journal of
Hematology. 2004; 124:348-354
Booth SL, Centurelli MA. Vitamin K: Practical Guide to the Dietary Management of Patients on Warfarin. Nutrition Reviews. 1999;
57(9): 288-296
Li RC, et al. Dietary Vitamin K intake and anticoagulation control during the initiation phase of warfarin therapy: A Prospective
cohort study. Thrombosis and Haemostatis 2013; 109: 195-6
Holbrook AM, et al. Systematic Overview of Warfarin and its Drug and Food Interactions. Arch Intern Med. 2005;165:1095-1106
Scone E, et al. Vitamin K supplementation can improve stability of anticoagulation for patient with unexplained variability in
response to warfarin. Blood. 2007 109: 2419-2423
Zikria J, et al. Cranberry Juice and Warfarin: When Bad Publicity Trumps Science. The American Journal of Medicine. 2010. 123;
384-392
Ford SK, et al. Prospective study of supplemental vitamin K therapy in patients on oral anticoagulants with unstable international
normalized ratios. J Thromb Thrombolysis. 2007; 24: 23-7
Rombouts EK, et al. Daily vitamin K supplementation improves anticoagulant stability. Journal of Thrombosis and Haemostasis.
2007; 5:2043-8
Brigham and Women’s Hospital
Main Anticoagulation Management Service
Thank you!
Questions?
Patient Advocacy
Kathryn Z. Mikkelsen
Thrombosis Research Group
Brigham and Women’s Hospital
November 2, 2013
What is Patient Advocacy?
Helping
patients receive
the best care possible.
How You Can Get the Most Out of
Your Health Care





Before Your Clinic Visits
During Your Clinic Visits
Be an ACTIVE Participant
Prescriptions
Resources
Before Your Clinic Visit
 Get a Notebook
 What to Put in that Notebook:
Take Notes (concerns, medication questions, new
sypmtoms)
Updated and Accurate List of Medications
Questions
List of Future Appointments
Get labs/tests done in addition to visit when possible
During Your Visit





Bring Someone With You
Bring Your Notebook
Be Honest
Speak Up!
Review your VSR
Be an ACTIVE Participant

Ask


Any Questions Have
Check

The Information your HCP has on file


Take Notes


Someone to come along with you to your appointments
Vocalize



Symptoms, Concerns – duration, severity
Invite


Contact info, medications
Concerns, unhappiness
YOUR voice (not your spouses, childs, friends)
Educate



Understand your Diagnosis
Know Why You Take Your Medications
Seek Reputable Sources of Information
PRESCRIPTIONS

Keep an Accurate List, bring it with you to every
appointment

Know WHY You Take Every Medication
PRESCRIPTION COSTS


Do Not Stop Taking Your Medication Without
Calling your HCP First
Ways to Lower the Cost of Medications:
Generics when Possible
 Prior Authorizations
 Industry Coupons
 Medicare Part D Financial Assistance
 Manufacturer Coupons/Financial Assistance
 Shop Around

RESOURCES




Pharmaceutical Company Websites
http://scriptyourfuture.org/
Non-profits such as the North American
Thrombosis Forum www.natfonline.org, the
American Heart Association www.aha.org
Local Support Groups
IN SUMMARY



No one knows your body better than YOU
Resources are available to help you pay for your
medications
A lifelong relationship with your HCP(s) is the
MOST IMPORTANT TOOL YOU HAVE
RESULTS RIGHT AWAY:
PATIENT SELF-TESTING
Libby Bak, Operations Supervisor
What is Patient Self-Testing (PST)?



Portable method for INR testing with a home
machine
A fast, easy, safe alternative to traditional testing
at a laboratory or physician’s office
It only requires a fingerstick, a test strip, and a
drop of blood
Prick Finger
Apply Sample
Get Result!
Who is a candidate for PST?

Patients with one or more of the following
conditions:
Atrial Fibrillation
 Heart Valve
 Deep Vein Thrombosis
 Pulmonary Embolism





Patients wanting to be proactive in their care
Patients with visual & manual dexterity OR who
have a caregiver that can provide assistance
Patients on long-term or life-long anticoagulation
Patients with difficult vein access
Advantages of PST
Better control of anticoagulation
therapy
 Decreased risk of events
 Results within minutes
 Active involvement in your own
health

Percent Time in Therapeutic Range
by Testing Frequency
More Time
in Range
Less Bleeding
and Clotting
Events
Disadvantages of PST
Cost of device and test strips
 Difficulty performing test
 Correlation varies from patient to
patient
 Exclusion criteria

How Accurate are PST Results?



Accuracy of PST results decrease as the INR
increase
You will need to correlate your PST result with
the lab 2-3 times
Some variation is acceptable, as long as the
difference is consistent
11/1/13
• HM 2.3 / Lab 2.5
11/8/13
• HM 2.7 / Lab 3.0
11/15/13
• HM 2.4 / Lab 2.6
Results are
consistently
0.2-0.3 lower
on home
machine
PST Result vs. Lab Result
Lab Result
PST Result
What are the Steps in Getting a
Home Machine?
You complete home machine
application and submit to BWH AMS
BWH will complete Rx and work
with supplier to process application
Supplier will contact you with cost
Machine will be delivered to BWH
AMS
What are the Steps in Getting a
Home Machine?
BWH will contact you to schedule
training
You will be trained
Correlate home machine with
laboratory 2-3 times
You are ready to test on home
machine only
What Machines Are Available?
CoaguChekXS by Roche
INRatio2 by Alere
CoaguChek XS





Allows 3 minutes to
apply blood
Strips are packaged in
a small container
Each new batch of
strips are coded
automatically with a
chip
Blood can be applied
to side or top of the
strip
Safe to use when on
LMWH
INRatio2





Allows 5 minutes to
perform the test
Test strips are
individually wrapped
Blood applied to top
of the test strip only
Each new batch of
test strips are coded
manually
Can not be used
while on LMWH
How Will My Testing Process
Change?
Patient
Insurance
Company
BWH
AMS
Supplier
Questions?
Thank you!
Brigham and Women’s Hospital
Anticoagulation Management Service
Third Annual Patient Seminar
Patient Self Management
David DeiCicchi, Pharm.D, CACP
November 2, 2013
Objectives
 Review different models of anticoagulation
management and supporting data
 Discuss patient self management:
– definition
– our program
 Review our educational workshop and how it is
conducted
 Describe how you can begin self managing
Different Models of
Anticoagulation Management
 Routine Medical Care (Usual Care)
– Anticoagulation management by a physician or office staff
– Typically without systematic policies and follow up
 Anticoagulation Management Service (AMS)
– Managed by personnel dedicated to anticoagulation with
systematic policies in place to manage and dose patients
 Patient Self Testing (PST)
– Patient use of point of care monitor to measure INR at home
– Dose managed by usual care or AMS
What is patient self management (PSM)?
 PSM is the process of monitoring your anticoagulation
which includes:
– Testing your own international normalized ratio (INR) with a
point of care monitor
– Interpreting the blood result
– Managing your warfarin (Coumadin) dose based on your (INR)
A medical facility trains the patient and oversees the
quality of anticoagulation using active surveillance
Is patient self management dangerous?
 No!
 You have a much better idea of how outside factors
such as your diet are affecting your INR
 Patients with years of experience will often offer dosing
suggestions
Anticoagulation Management
Models and TTR
Patient Self Dosing Verses AMS
AMS
PSM
98.0%
99.6%
• 188 patients were eligible to
self monitor
• Only 38% completed their
course
71.0%
60.0%
TTR
Time Within Critical
Limits
Gardener et al. Self-monitoring of oral anticoagulation: does
it work outside study conditions. J Clin Pathol. 2009
PST With Or Without PSM
• Compared to usual care
• Meta-analysis of 22 studies
• > 8,400 patients
Bloomfield et al. Annals of Internal Medicine. 2011;154:472-482.
Other Benefits
 Improves quality of life and further achieves
independence
 Alternative for patients with limited time or laboratory
access
 Good alternative for patient with poor venous access
 Eliminates time for provider to patient contact with
dosing recommendations
 Promotes active involvement in your own health care
Limitations
 Self monitoring requires proper identification and
education of suitable candidates
30-50% of patients chosen to self manage opted out or
were not able to self manage
 Inability to perform a self test
 Financial restrictions
How do I begin self managing?
 You must be enrolled in BWH AMS
– Have a reliable mode of communication with AMS
 It is preferred that you utilize PST
– For at least 3 months time
 Discuss your candidacy with your warfarin manager
– PSM is not for everyone
 Sign up for a PSM workshop
– Receive self management training by an AMS clinician
PSM Workshop
 A review of factors that can effect your INR
– Alcohol and diet interactions
– Drug-disease interactions
 Properties of warfarin
– Onset and offset
 Dosing concepts
– Attention to trends
– Different dosing techniques
PSM Workshop
 Dosing practice scenarios
 Documentation
– Recording INRs and dosing recommendations
 Identifying issues related to your anticoagulation
– Bleeding and clotting events
 Appropriate actions to take when an issue arises
– Reporting events and changes to AMS
– Present to the ED
Example of Dosing Card
Dosing Card
INR
Action
Less than 1.5
Call AMS
1.5 – 1.7
Increase 2 levels
1.8 – 1.9
Increase 1 level
2.0 – 3.0
Maintain the same level
3.1 – 3.5
Decrease 1 level
3.5 – 4.0
Decrease 2 levels
Greater then 4.0
Call AMS
Example of Dosing Card
Dosing Card
Level
Dose
Example
1
35mg/week 5mg daily
2
36mg/week 6mg Mon and 5mg others
3
38mg/week 6mg Mon Wed Fri; 5mg rest of week
4
40mg/week 5mg Mon Fri; 6mg rest of week
5
42mg/week 6mg daily
6
44mg/week 7mg Mon Fri; 6mg rest of week
7
46mg/week 6mg Mon Wed Fri; 7mg rest of week
8
48mg/week 6mg Sun; 7mg rest of week
9
51mg/week 8mg Mon Fri, 7mg rest of week
Documentation
Date
INR
Level Sun
Mon Tue
Wed Thu
Fri
Sat
11/4/13
2.5
5
6mg
6mg
6mg
6mg
6mg
6mg
6mg
11/11/13
1.6
7
7mg
6mg
7mg
6mg
7mg
6mg
7mg
11/18/13
2.7
7
7mg
6mg
7mg
6mg
7mg
6mg
7mg
11/20/13
3.1
6
6mg
7mg
6mg
6mg
6mg
7mg
6mg
11/27/13
2.9
6
6mg
7mg
6mg
6mg
6mg
7mg
6mg
Final Exam
 Once you have completed your workshop, you will be
required to give 4 consecutive approved dosing
recommendations prior to self managing.
 You will still need to:
–
–
–
–
report INRs to AMS
be available if AMS has questions or concerns
report any changes in your health or medications.
Inform us of any suspected bleeding or clotting events
Your Role In PSM
 You would asked to:
– test your INR with a home machine at least twice a
month and report all result
– adjust your warfarin dose using your dosing card
– document INRs and dosing
– report any major changes that can affect your INR.
– Report bleeding or clotting events
Our Role in PSM
 We are still fully responsible for your anticoagulation
management
 Your warfarin manager will always be practice active
surveillance
 We are still available for any questions or dosing
consults if needed
 AMS will continue to write prescriptions
Anticoagulation Safety
 Do not double-up to make-up for a missed dose
 Take warfarin at the same time daily
 Consider reminders/triggers
– Calendar
– Pillbox
 Identification cards and bracelets
Summary
 Patient self management is a safe alternative to
warfarin monitoring
 PSM can increase your time spent in your
therapeutic range, decrease emergency room visits,
and minimize clotting events
 You can become more reliant on yourself and
experience greater independence while on warfarin
 Become PRO-active in your warfarin therapy
Brigham and Women’s Hospital
Main Anticoagulation Management Service
Thank you!
Questions?