Download Food and Drug Interaction Program

Warfarin and Dietary Interactions:
Developing a Food and Drug Interaction
Program
Rehana Jamali, Pharm.D.
Associate Director, Pharmacy Services
Brookdale Hospital and Medical Center
Brooklyn NY
May 2, 2009
Objectives
• Explain the importance of dietary
interactions in managing warfarin therapy
• Describe the steps involved in developing
a food drug interaction program and
defining program outcomes
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Outline
• Warfarin and dietary interactions
• BHMC:
– Food and Drug Interaction Program
– Measures:
• Food and Drug Interaction Audit
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Warfarin
• Pharmacology
– Interfere with cyclic interconversion of vitamin K and its 2, 3
epoxide (vitamin K epoxide)
– Vitamin K coagulation factors: II, VII, IX and X
• Require У-carboxylation for their procoagulant activity
• Treatment with warfarin results in hepatic production of
partially carboxylated and decarboxylated proteins with
reduced coagulant activity
Vit KH2
Vitamin K reductase
(relatively resistant)
Vit KO
Vitamin K epoxide
reductase (sensitive)
7th ACCP conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines, Chest 2004;
126; 204-233
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Vitamin K
• Vitamin K: essential co-factor for coagulation factors
• Dietary vitamin K
– Vitamin K intake > 250 micrograms/day - decreases warfarin sensitivity
– Decreased Vitamin K intake: 80% decrease intake increased INR 30%
– For each increase in 100 micrograms of vitamin K intake, the INR would
be reduced by 0.2
– Dose response of vitamin K on the effect of warfarin anticoagulation
• dietary intake of vitamin K 65-80 mcg/day is most acceptable practice
Rohde LE et al. Current opinion in clinical nutrition and metabolic care; 2007;10(1):1-5
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Warfarin and Dietary Interactions
• Dietary Vitamin K
– Derived by phylloquinones in plant material
• Act by warfarin-insensitive pathway
– Increased intake
• reduce anticoagulant response by increasing clotting factor synthesis–
reduce INR
• Consumption of green-leafy vegetables, vitamin K containing supplements
(weight reduction diets), vitamin K supplements
– Reduced intake
• Prolong the INR – increase risk of bleeding
• Level I evidence:
– Inhibition of anticoagulant effect of Warfarin: High vitamin K
content food/enteral feeds
7th ACCP conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines, Chest
2004; 126; 204-233
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Dietary Vitamin K intake
• Average intake in most adults: 70 to 80 mcg/day
• Daily value (DV) for vitamin K
• Limit intake of food that provide more 60% of DV for vitamin K, keep
INR/PT in desired range
• Food high in vitamin K (> 200% DV) – limit to 1 serving/day
– Kale, spinach (fresh, boiled), turnip greens (frozen, boiled), collards,
swiss chard, parsley, mustard green
• Food moderate in vitamin K (60 – 199%) – limit to 3 servings/day
– Brussel sprouts, spinach (raw), turnip greens (raw), green leaf lettuce,
broccoli, endive lettuce, romaine lettuce
Drug-Nutrient Interactions Coumadin and Vitamin K. Warren Grant Magnuson Clinical Center, National Institutes of
Health Drug-Nutrient Interaction Task Force.
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Anticoagulation Safety
• High risk medication – anticoagulants
– Warfarin - #1 medication associated with errors in patient homes
– Drugs, nutrients and herbals, disease states – alter warfarin PK/PD
• The Joint Commission
– Medication Management Standards MM.01.01.03
• The hospital implements its process for managing high-alert
medications
– National Patient Safety Goal 3E:
• Elements of Performance
– when dietary services are provided by the hospital, the service
is notified of all patients receiving warfarin therapy and
responds according to its established food/medication
interaction program
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2009 National Patient Safety Goals. www.jointcommission.org. Accessed October 15, 2008
Food and Drug Interaction (FDI)
Program
• Multi-disciplinary team
– Pharmacy, Nursing and Dietary, IS
• Drug/Nutrient Interaction Policy
• Food and Drug Interaction Pamphlet
• Staff education
• Audit – Compliance studies
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Drug/Nutrient Interaction Policy
Pharmacist
 Profiles order; receives alert of FDI in pharmacy information system
 Places FDI report in patient cassette
Nurse
 Acknowledges alert through automated dispensing machine or
medication cassette
 Obtain FDI pamphlet
 Use pamphlet to provide education to patient/family and document
outcomes on patient/family education flowsheet
Nutritionist
 Receive daily Report “Medications with potential for FDI from
pharmacy department
 Reinforce information about the FDI and document on the
patient/family education flowsheet
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Pharmacist
Profiles Warfarin order
Receives FDI alert
Places FDI alert in patient cassette
Nurse
Acknowledges ADM alert or
FDI alert from patient cassette
Provides Pt. Education/provides FDI pamphlet
Documents in Pt/Family Education Sheet
Nutritionist
“Medications with potential for FDI” report”
Reinforce Patient Education
Document in patient/family education flowsheet
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FDI Pamphlet
Anticoagulant
Medication:
Warfarin (Coumadin®)
Interaction:
Keep a consistent diet. Avoid large changes in the amount of Vitamin-K containing
foods.
Reason:
Taking foods rich in Vitamin-K may alter the blood thinning response of the
medication.
Foods high in Vitamin-K include:
Vegetables:
Endive
Chive
Kale
Mustard greens
Collard greens
Swiss Chard
Parsley
Asparagus
Cucumber,
(w/peel) Scallions
Broccoli
Lettuce (bid, red leaf)
Mint leaves
Spinach
Brussels sprouts
Fried/boiled
onions
Cabbage (raw)
Watercress
Turnip greens
Chick peas
Herbals:
Tea leaves (green)
Oils:
Soybean oil, Canola oil
Mayonnaise
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Warfarin Patient Education
Pamphlet
FOOD INTERACTION WITH WARFARIN
Warfarin partially stops the development of Vitamin K in the liver to prevent
blood clotting.
Many foods however contain high, moderate or low amounts of Vitamin K.
Dark green leafy vegetables have very high amounts of Vitamin K.
So does that mean that you have to stop eating foods that contain Vitamin
K?????
THE ANSWER IS NO!!!!!
 Just eat the same amount of food containing Vitamin K every day.
 Avoid making drastic changes in your diet.
 Tell your doctor if your food intake suddenly includes large
amounts of Vitamin K.
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Measures
Drug Nutrient Interaction Compliance Study
Date:_________________
Patient name:____________________ U#:___________
Unit/Room:________
Medication name: _______________________
Date/Time ordered:_____/_______
Policy/Procedure
Yes
No
“Food-Drug Interaction Pamphlet” shall be maintained in all Pharmacy, Nursing, and Food and Nutrition
Services.
Upon profiling an order of a medication that belongs in the “Food-Drug Interaction Pamphlet”, an alert will
automatically appear in the pharmacy information systems.
Upon accessing the ADM to retrieve the medication for administration to the patient, the nurse will need to
acknowledge an alert regarding the drug/nutrient interaction.
With the medication cart, a “Medications with the potential for food drug interaction” report will be sent by
pharmacy services to nursing that will list the name (s) of patient (s) and those medications that interact with
nutrients (as specified in the pamphlet).
Upon exchange of the cart, nursing shall accept this report.
The nurse shall give the “Food-Drug Interaction Pamphlet” to the patient/resident and discuss the identified
drug/nutrient interaction. The nurse shall document the distribution of the pamphlet and counseling on the
interdisciplinary patient/resident teaching form.
The Food and Nutrition Services shall also receive a daily report (Medications with the potential for food drug
interaction) from pharmacy.
The Food and Nutrition Services shall adjust the patient/resident’s diet according to the nutrients specified in
the pamphlet. The dietician shall reinforce the information taught by nursing regarding the drug/nutrient
interaction (s), and document counseling on the Nutritional Assessment Form/Care Plan and the
interdisciplinary patient/resident teaching form.
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Outcomes
Measure
Pre
May 2008 (30 cases)
Post
Feb-April 2009
(12 cases)
FDI pamphlet available
Pharmacy – 100%
Dietary – 100%
PCA – 20%
100%
Alert in Rx system
100%
100%
RN acknowledge alert in ADM
100%
100%
Medication cassettes – alert
0%
N/A (cartless)
RN educates patient
0%
0% (no
documentation)
Dietary receives report
100%
100%
Dietary educates patient
100% (questionable)
33%
(documentation )
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THANK YOU
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