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Warfarin Safety for Nursing Homes Dianne Roux-Lirange January 2010 Overview A Background – Hx of warfarin B How warfarin works C Indications for use D Side effects - Bleeding E Bleeding is minimized with monitoring F Dose adjustment and management G When INR is OK, hemorrhage may occur MedPass charting, charting and F/U H MedPass, I Wrap-Up 2 This program is brought to you by IPRO IPRO is One of largest g health care quality q y improvement organizations in the US Serves federal, state, and private clients nationwide with a comprehensive range of health care assessment and improvement act t es activities Designated by CMS as the Quality Improvement Organization (QIO) for New York State Under contract with CMS to improve the quality of care of New York Medicare beneficiaries 3 A The History of Warfarin Farmers’ Alarm 1920s: Cattle were hemorrhaging to death Found to be due to a contaminant in their diet S Spoiled il d sweett clover l was in i their th i feed f d which hi h contained t i da chemical substance It interfered with the coagulation process 4 The History of Warfarin Discovery of warfarin 1940s: at the University of Wisconsin Synthesized a chemical, dicumarol, And A d proved d that th t it was identical id ti l to t the th naturally occurring agent in sweet clover They yp patent the compound p WARFarin,, a play on the name of their office, Wisconsin Alumni Research Foundation, It is marketed as a rat pesticide/poison 5 The History of Warfarin FDA patent 1954: Endo labs take out the first patent for human use It is filed as Coumadin Coumadin, the brand name of warfarin It was found to be effective and relatively safe for preventing thrombosis and embolism (abnormal formation and migration of blood clots) in many disorders Warfarin, the generic version of Coumadin, was filed in 1995 6 B How Warfarin Works Warfarin is an anticoagulant Substance that “thins” the blood Clinically used to reduce the body’s ability to form bl d clots blood l t – to t preventt blood bl d clots l t Seems to “thin” the blood so that cuts “won’t stop bleeding bleeding” It disrupts the coagulation g process p Other names Coumadin Jantoven ®, ® 7 How Warfarin Works (1a)Understanding coagulation Coagulation converts fluid blood into a fibrin clot at the site of injury Normally, clot formation does not occur within a healthy, intact blood vessel 8 How Warfarin Works (1b)Understanding coagulation Coagu Coagulation at o process p ocess is s activated act ated when e injury/damage into the wall of a blood vessel (cells of the vascular endothelium) A substance b t lleaks k outt Then the vitamin K process Kicks in Vitamin K is a chemical that is one of our vitamins (vitamins are vital/essential to life/health) Vitamin K is absorbed from the digestive tract and travels to the liver to work K Kauses “KOAGULATION” In the liver, Vitamin K produces a clotting g factor 9 How Warfarin Works (1c)Understanding coagulation Then vitamin K process Kicks in In the liver, Vitamin K produces PROTHROMBIN Vitamin K is at the top of one of the coagulation pathways Prothrombin circulates in the blood system A damaged cells triggers it to plug holes in the walls 10 How Warfarin Works (2a)Warfarin stops clots by stopping the action of vitamin K STOPS Vitamin K makes prothrombin When triggered, prothrombin makes clotting factors This leads to making fibrin Fibrin with platelets form the clot 11 How Warfarin Works (2b)Warfarin stops clots by stopping vitamin K It is classified as an anti coagulant It is an anticoagulant known as a vitamin K antagonist (VKA) It turns on the blood flow by disrupting the vitamin K pathway (one path in the coagulation process) 12 How Warfarin Works Warfarin has a delayed effect when first started It takes 2-3 days – compared to other drugs, this is a very y long g onset of action BECAUSE Clotting factors, like Prothrombin, that have already been made by the body are still present and still making fibrin clots Need overlap therapy with an immediate acting anticoagulant ti l t if rapid id response is i desired d i d Heparin, Lovenox (enoxaparin), Arixtra (fondaparinux), Fragmin g (dalteparin) ( p ) 13 C Indication for warfarin therapy It is the most commonly prescribed anticoagulant About 31 Million prescriptions dispensed in 2004 But it is a risky medication and Mostly responsible for serious & lifethreatening adverse reactions Narrow Therapeutic Window Æ Fine line between being helpful and being harmful Among the top 5 drugs contributing to ER visits g the top p 2 drugs g causing g hospitalization p Among 14 Indication for warfarin therapy py Used for abnormal vascular conditions in which there are inappropriate pp p clot formations in an uninjured blood vessel Clots such as Thrombus – is a blood clot. Clotting is normal with blood vessel injury but pathological otherwise. Embolism – occurs when part of a thrombus b breaks k away and d travels t l through th h the th bloodstream. It can block the blood supply to organs. 15 Indication for warfarin therapy Conditions Prevention of embolism in patients: With artificial heart valves With atrial fibrillation to prevent stroke s/p heart attack Prevention & Treatment of venous thromboembolism (VTE) Deep vein thrombosis (DVT) ● Prevent DVT in patients with prolonged bed rest Pulmonary embolism (PE) 16 Atrial Fibrillation Atria of the heart are not contracting properly Pooling of blood in the heart Increased risk of thrombus formation o at o ● May lead to stroke ● Warfarin reduces risk of stroke 17 Venous Thromboembolism VTE Deep vein thrombosis DVT Thrombus develops in the deep veins Usually in the legs Symptoms Swelling, warmth, redness, pain, engorged superficial veins ● Not all symptoms are always present May break away and cause PE 18 Venous Thromboembolism VTE Pulmonary embolism PE Part of a clot formed in th body the b d (usually ( ll in i the th legs) breaks off & travels to the main artery of the lungs Symptoms Chest pain, pain difficulty breathing, cyanosis, rapid breathing and heart rate Some people may cough up blood (but not everyone!) 19 Who is at Risk for VTE Elder Age Risk doubles for every d decade d after ft the th age off 50 History of VTE Strongest known risk factor for DVT/PE Limited mobility Prolonged bed rest Major medical illness (CHF, MI) Paralysis Obesity Vascular Injury Orthopedic surgery Knee/hip replacement Trauma Pelvis, hip, leg fracture Hypercoagulable States Cancer Drugs g Birth control pills Estrogen replacement 20 D Side Effects of Warfarin Bleeding!!! Most common side effect of warfarin use Minor bleeding g occurs in 14% to 36% of patients Major bleeding (serious, lifeth t i threatening, or fatal f t l hemorrhage) occurs in 5% to 7.9% of patients ● Hylek EM, Seminars in Vascular Medicine 2003 and Hylek EM, Circulation 2007 21 Bleeding Minor bleeding is common among warfarin users even when patients are well managed on warfarin Small bleeding from mucous membranes while brushing teeth (friable gums) or from f th nose (epistaxis) the ( i t i ) Easy bruising – may begin with ecchymoses (purple patches) Bleeding from a small cut May be on a nursing care plan for easy bruising and/or bleeding 22 Bleeding Minor bleeding is common among users But Minor becomes serious bleeding when Gums won’t stop p bleeding g A bruise that grows for no reason A cut that is still bleeding g after 10 minutes Requires a nursing note in chart. 23 Signs & symptoms of major bleeding May mean internal hemorrhage, such as, gastrointestinal or cerebral, Follow procedure to place call to doctor Nursing Assessment: Patient Complaint: ^Vomiting Vomiting blood or gastric contents that looks like coffee grounds (hematemesis) ^Stools that are bloody or are dark and tar-like (hematochezia) ^Urine that is red or unusually dark (hematuria) ^Coughing up phlegm that is bloody (hemoptysis) ^Severe abdominal pain ^Persistent headaches ^Confusion or decreased alertness ^Dizziness or weakness 24 (1) Your “Warfarin Watch” List Bleeding may be more serious for patients (1a) With certain conditions (1b) Who fall 25 (1a) Your “Warfarin Watch” List Watch for bleeding in certain patients Bleeding risk is increased with patients having the following conditions Patients also receiving concomitant antiplatelet drugs (clopidogrel (Plavix) and/or aspirin) Patients older than 65 yrs stroke, renal impairment or anemia Patients with prior stroke 26 (1b) Your “Warfarin Watch” List Patients who have a history of falls and/or are not steady on their feet After a fall Aft f ll or hit on th the head, h d The Th IIncident id t R Reportt should have these notes YES or NO 1-Visible bleeding? If so, severity? 2-Symptoms y p of internal bleeding? g 3- Symptoms of IntraCranial Hemorrhage? If so, do first neuro-check Patient is on warfarin With this information, per policy, place call to doctor ● Continue FOLLOW-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 (1b) Your “Warfarin Watch” List . . . .The Incident Report should have these notes Follow-up Continue neuro-check, if started YES or NO Symptoms of bleeding that was not present before? 28 E Bleeding is minimized with monitoring Warfarin therapy is proven to be effective and safe WITH MONITORING Monitoring involves scheduled blood tests and reviewing results so that warfarin may be adjusted accordingly 29 Bleeding is minimized with monitoring (1)Scheduled blood tests Two blood test are available available- both involve measuring prothrombin Because When a blood vessel is damaged, Vitamin Vit i K process kicks ki k in, i Circulating prothrombin is activated Leading to clot formation 30 Bleeding is minimized with monitoring (2)Scheduled blood tests Prothrombin time (PT) assay Measures the time it takes for prothrombin to form a clot International Normalized Ratio (INR) INR value is the patient’s prothrombin time as a ratio using international reference standards 31 Bleeding is minimized with monitoring For patients on warfarin, tests results are: prothrombin time (PT) p ( ) is longer g INR value is greater than normal Normal values (for patients not on warfarin): PT is anywhere between 11 11.0 0 and 13 13.0 0 seconds seconds, and value varies from lab to lab INR is 1.0 (one) 32 (1) INR schedules/guides Dosing is guided by two different INR guides based on g (1a) Initiation dosing – for patients beginning VKA therapy (1b) Maintenance dosing - for chronic VKA therapy 33 (1a) INR schedules/guides When warfarin is started, dosing is guided by INR (per doctor doctor’s s orders) It takes 2-3 days for warfarin to take effect To cover this delay: heparinanticoagulants are coadministered for 4-5 days to provide coverage This is called the “loading phase” 34 (1a) INR schedules/guides When warfarin is started, dosing is guided by INR (per doctor doctor’s s orders) Prescribers use a dose algorithm (a guide) to prescribe the appropriate dose Prescribers order More INR tests in the first several weeks And then weekly until the INR is stable Then monthly – this is the usual scheduling of testing for patients on chronic warfarin therapy 35 (1b) INR schedules/guides For chronic warfarin therapy, dosing is guided by INR (per doctor’s orders) The target INR for most conditions is 2.5 with an acceptable range of 2 2.0 0 to 3 3.0. 0 For some patients the INR goal will be 3.0 with a range g of 2.5 to 3.5 (for ( those with artificial heart valves, recurrent clots, etc.) When INR response is stable, frequency of testing may be reduced to once every 4 weeks 36 (1b) INR schedules/guides For chronic warfarin therapy 2.0 -------------------------3.0 INR 37 Bleeding is minimized with monitoring When surgery or a procedure is scheduled for a p patient on warfarin Per doctor’s orders: y stopped pp some time before and Warfarin may resumed sometime after OR “Bridge therapy” may be ordered (if the risk of clotting is high) which means another anticoagulant is used to bridge the time patient is off warfarin during the peri-operative period 38 F Dose Adjustment and Management Frequent dose changes are common, per doctor’s orders, for these reasons: Each person responds differently to warfarin (age, liver health, CHF, fever) Warfarin W f i is i unpredictable: di t bl it interacts i t t with other medications and foods And the INR range is difficult to achieve Compared to other drugs, the therapeutic window/range g is very y narrow To counteract this, the doctor individualizes dosing based on INR level 39 Dose Adjustment and Management For chronic warfarin therapy 2.0 -------------------------3.0 INR 40 Dose Adjustment and Management (1a)Interaction with other medications Drugs that may prolong PT/increase INR: ANTIBIOTICS, antifungals, H2 blockers, PP inhibitors, antidepressants, CaCblockers, antiarrythmics (amiodarone), lipid lower agents (Zocor), anticonvulsants (phenytoin Dilantin) Drugs that may shorten PT/decrease INR: Barbiturates, anticonvulsants(carbamazepine Tegretol) ● Continue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Dose Adjustment and Management (1b)Interaction with other medications and supplements Over-the-Counter Pain Relievers Salicylates Aspirin, Aspirin NSAIDs: ibuprofen (Motrin, (Motrin Advil), Advil) naproxen (Aleve) Increase bleeding risk Herbal Supplements Ginseng, Gingko, Garlic, St. John’s Wort, & many others! Some increase bleeding risk, others increase clot risk 42 Dose Adjustment and Management (1c) Lists of other medications di ti Drug interaction lists can be found: 1- from your pharmacy vendor 1 2- in patient package insert for Coumadin 3- on the internet – see example of www.drugs.com site for search box and lists of common drugs and 186 major interactions 43 Dose Adjustment and Management (1d) It is often impossible to predict how a specific medication will affect a patient’s INR Always obtain a stat INR within 3-7 days When starting an antibiotic When any change (start, stop, dosing) of any medication 44 Dose Adjustment and Management (2a) Vitamin K and Interacting Foods Sources of vitamin K is through digestion From the diet and bacterial products in the large intestine People on warfarin can eat foods high in Vitamin K, as long as they do so consistently j changes g in Vitamin K intake Concern is about major Nurses on maternity units know: vitamin K shots are given to newborns to prevent bleeding – they are vitamin K deficient because the intestines have not yet been colonized with bacteria 45 (2b) Vitamin K Content of Foods Very High High Medium Low Brussel sprouts Basil Green Apple Fruits Chi k peas Chick B Broccoli li A Asparagus A Avocado d Collard greens Chive Cabbage Beans Coriander Coleslaw Cauliflower Breads/grains Endive Cucumber ((w/ peel) Mayonnaise y Carrots Pistachios Celery Squash, summer Coffee Kale Lettuce, Red Leaf Parsley Spinach Swiss Chard Canola oil Green onion/Scallion Soybean oil (see list) Corn Cucumber (w/o peel) Dairy products Tea, Green Eggs Watercress Lettuce, Iceburg Meats, fish, poultry Pasta Peanuts 46 Dose Adjustment and Management . 47 Dose Adjustment and Management (3a)Expect dose adjustment when INR is nontherapeutic When INR is slightly out of therapeutic range, doctor manages the dosing by No dose change but more frequent INR testing – expecting the INR to return to therapeutic levels OR Adjusting the dose by 5%, 10%, 15% or 20% based on the weekly dose of warfarin Expect an order for INR test after a dose change – may see INR effect of new warfarin dosage in y 2-3 days 48 Dose Adjustment and Management (3b)Expect dose adjustment when <<INR value is out out-of-target of target range>> and no bleeding (asymptomatic) or minor bleeding If INR increased but not > 5.0, dose may be reduced By lowering weekly dose (* ( by certain %) or omitting dose(s) i.e., if patient’s INR is 3.6, doctor will decrease dose by 15% hoping to hit an INR of 2.6 (one whole change in INR value) If INR decreased decreased, doctor may increase dose By increasing weekly dose (* by certain %) 49 Dose Adjustment and Management (3c) Expect other med orders when INR value is out out-of-target of target range >>5.0 and <<10.0 and non-life threatening bleeding Med orders may be: Stop warfarin Give antidote to reverse VKA over-coagulation ● vitamin K (phytonadione Mephyton®) PO ● (note if there’s a repeat dose in 6 -12 hours) – recall vitamin K works in the coagulation process so expect that effects are not immediate (it works slowly) 50 Dose Adjustment and Management Summary – Medex For warfarin management g -orders for adjustments Is not completed 51 Dose Adjustment and Management Summary – Medex For warfarin management g -Adjustments Per doctor’s orders 52 G When INR is OK (in the therapeutic g ) hemorrhage g may y occur range) Consider possibility of hemorrhage with a patient whose complaints don don’tt indicate an obvious diagnosis: Anticoagulated g patients,regardless p g of INR, are at risk of major bleeding events Æ Use your clinical skills and observe your patients for these s&s: M May presentt as pain i in i the th chest, h t abdomen, bd joints, j i t or muscle, paralysis, headache, dizziness, shortness of breath, difficulty breathing or swallowing, unexplained swelling, or weakness. Finally hypotension leading to unexplained shock 53 When INR is OK, hemorrhage may occur Laboratory tests for signs of blood loss For anemia: complete blood count, hemoglobin and hematocrit values, Serum S chemistry, h i t For urinary tract bleeding: urinanalysis Other measures/tests meas res/tests Vital signs showing low blood pressure and fast heart rate For GI bleeding/hematochezia: fecal occult blood test (FOBT) 54 When INR is OK, hemorrhage may occur If life-threatening bleeding THIS IS AN EMERGENCY Follow protocol for calling doctor and transferring patient to ED ED will institute life-saving treatments to reverse anticoagulation F Fresh h frozen f plasma l (FFP) and d vitamin it i K (phytonadione injectable emulsion) are most frequently q y administered Coagulation factor concentrates (i.e., prothrombin complex concentrate (PCC)) may be administered 55 H MedPass, charting, and F/U Routine activities - may have standard policy/procedures for the following) Med M d Pass P (may ( be b new/changes / h in i dosing) d i ) Check-off lab receipt for incoming INR reports Take T k off ff new orders d or monthly hl printed i d Orders Od Follow up phlebotomy / POC finger prick schedule Other activities Lab calls with an alert value Follow up patient care (abnormal BPs or complaints) 56 MedPass, charting, and F/U On Med Run, expect - there is no “typical” dose of warfarin Each person responds differently warfarin to Doses D are iindividualized di id li d Frequent dose changes are common High or low INR levels are not reconciled by changing the daily dose of warfarin, but rather by altering the total weekly dose Results in crazy-wacky dosing schedules 57 MedPass, charting, and F/U Dosing is reconciled with INR levels by altering the total weekly dose The new orders may look unusual – see this example Mr. Smith takes 5 mg daily. His goal INR is 2-3, but today his INR is 3.6 3 6 (too high!) His warfarin dose needs to be decreased Calculate his total weekly dose (= 35 mg/week) Decrease the total weekly dose by 15% (15% equates to one whole INR change.) ● 15% of 35 is 5 mg. Total weekly dose is 30 mg (=35 – 5 mg) New orders are – 5 mg daily, except on Tuesday & Thursday take 2.5 mg 58 MedPass, charting, and F/U The Dosing Game Mrs. Mrs Jones is on 2 mg/day How many ways can we make 2 mg dose of warfarin? ● 3 ways ● 1 tab of a 2 mg tablet ● ½ of a 4 mgg tablet ● 2 tabs, each 1 mg Although the med tray is in unit-dose packets, it is a good opportunity for teaching patients who are going home on warfarin. 1 mg pink 2 mg lavender 2-1/2 mg green 3 mg tan 4 mg blue 5 mg peach 6 mg teal 7-1/2 mg yellow 10 mg white (Dye Free) 59 MedPass, charting, and F/U 60 MedPass, charting, and F/U 61 I Wrap-up Warfarin is a dangerous drug Bleeding is a risk and patients may not complain or show symptoms of internal bleeding Warfarin is a complicated drug regimen Frequent dose change, many drug and food interactions, narrow therapeutic window between b beneficial fi i l and d harmful h f l effects ff t Team work and good communication with physicians and between shifts with everyone aware of policy and procedures is crucial to warfarin safety 62 IPRO provides a full spectrum of healthcare assessment and improvement services that foster the efficient use of resources and enhance healthcare quality to achieve better patient outcomes. This material was prepared by IPRO, the Medicare Quality Improvement Organization for New York State, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents do not necessarily reflect CMS policy. 9SOW-NY-THM6.2-10-05 64 For more information Dianne Roux-Lirange, PhD, MSRN Performance Improvement Coordinator M di Medicare Pharmacy Ph P Projects j t Healthcare Quality Improvement Program (518) 426-3300 ext. ext 106 [email protected] CORPORATE HEADQUARTERS 1979 Marcus Avenue Lake Success, NY 11042-1002 REGIONAL OFFICE 20 Corporate Woods Boulevard Albany, NY 12211-2370 www.ipro.org 65
