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
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
DEFINITIONS
scanning electron micrograph of blood
clot
- 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.
Anticoagulants
- 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
Who
needs anticoagulation?
- OLD
- Heparin
- IV, subcutaneous
- LMWH: Lovenox,
Fragmin
- injections
- Warfarin
- Only pill
anticoagulant available in US until 2010
Anticoagulants
- “Novel”
“new” “target specific” “next-gen”
Anticoagulants
Anticoagulants
- 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
- Approved to
prevent stroke in atrial fibrillation Dec 2012
Anticoagulants
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
MECHANISM OF ACTION
- 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
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
- Anti-seizure
medications
- (Dilantin,
carbamazapine)
- Antibiotics
for tuberculosis (TB) or certain staph infections
- 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
- 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
New Anticoagulants
Prada
Pradaxa
This is
This is
Do they cost more
than warfarin?
- 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.
Anticoagulants
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
A Fib
Venous Thromboembolism
(VTE): DVT/ PE
Any mitral valve prosthesis
Any caged-ball or tilting
disc aortic valve prosthesis
Recent stroke/ mini-stroke
(within 6 months)
High risk for stroke
Recent stroke /mini-stroke
(within 3 months)
Rheumatic valvular heart
disease
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
Venous Thromboembolism
(VTE): DVT/ PE
Bileaflet aortic valve
prosthesis and 1 or more of the following risk factors: A fib,
prior stroke/ min-stroke, hypertension, congestive heart failure, age
>75 years
Moderate risk for stroke
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
A Fib
Venous Thromboembolism
(VTE): DVT/ PE
Bileaflet aortic valve
prosthesis without A fib and no other risk factors for stroke
Low risk for stroke (assuming
no prior stroke / mini-stroke)
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
- LMWH
- Lovenox (enoxaparin)
- Fragmin (dalteparin)
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
Nicholas Feola, Pharm.D, RPh
November 2, 2013
Brigham and Women
’
s Hospital
Anticoagulation Management Service
The Warfarin Lifestyle: A Focus on
Diet and Vitamin K
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
- Two types:
- K1plants
- 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
Nutescu, 2006
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
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
Vitamin K Maintains Stable INRs
- Patients who achieved stable
INR control had greater amount of dietary intake of vitamin k compared
to patients with unstable INRs
Scone, 2005
How Much Vitamin K Should I Eat?
Dietary Intake of Vitamin K in Patients
Treated with Warfarin
Low dose Vitamin K Supplementation
150ug/day
100ug/day
69
TTR
%INR in range
Vitamin K Recommendations
Adequate Intake (AI) of Vitamin K
(USA)
Men
120ug/day
Women
90ug/day
- No specific recommendations
regarding amount of dietary intake of Vitamin K
- Patients should maintain
an adequate amount of vitamin K in their diet
Alcohol
- Alcohol interferes with the
liver’s
ability to breakdown warfarin
- Drinking more than 2 alcoholic
drinks in one day can increase your risk of serious bleeding while taking
warfarin
Alcohol
INR
Cranberry Juice
No significant interaction between
the daily consumption of 1 cup (250mL) cranberry juice and warfarin.
Time response of international
normalized ratio (INR)
Placebo -
▲
Cranberry -
■
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
Lenz, 2004
Aerobic exercises Effect on Pharmacokinetics
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
- Check
- The Information
your HCP has on file
- Contact
info, medications
- Take Notes
- Symptoms,
Concerns – duration, severity
- Invite
- Someone
to come along with you to your appointments
- Vocalize
- 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
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
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
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?
What are the Steps
in Getting a Home Machine?
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?
Insurance Company
Thank you!
Questions?
David DeiCicchi, Pharm.D, CACP
November 2, 2013
Brigham and Women
’
s Hospital
Anticoagulation Management Service
Third Annual Patient Seminar
Patient Self Management
- Review different models
of anticoagulation management and supporting data
- Discuss patient self management:
- Review our educational
workshop and how it is conducted
- Describe how you can begin
self managing
Objectives
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
- 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)
What is patient self management (PSM)?
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
- 188 patients were eligible
to self monitor
- Only 38% completed their
course
Gardener et al. Self-monitoring of oral
anticoagulation: does
it work outside study conditions.
J Clin Pathol. 2009
TTR
Time Within Critical Limits
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
- 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
Limitations
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
- 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
- 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
- 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?
