Dos and Donts of New Oral Anticoagulants 2013

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: 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, 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 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 l Review the risks of continuing warfarin therapy while having surgery or a procedure l Identify situations when warfarin should be stopped for surgery/ procedure l When warfarin is stopped, estimate clotting risk to determine if a bridging agent should be used

Background l Some patients may require an elective surgery or procedure while on warfarin therapy l Continuation of warfarin for an upcoming surgery/ procedure may increase the risk of bleeding l Some patients may need to stop taking warfarin around the time of surgery/ procedure to minimize this bleeding risk

Background cont. l If warfarin needs to be stopped this may increase the risk of having a blood clot l Individual circumstances will be carefully reviewed before a decision on modifying warfarin therapy is made l l l 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 l Risk of bleeding in patients taking warfarin is dependent upon: l l l l 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 l Most patients can undergo low risk surgery/ procedures without stopping warfarin l l Warfarin may either be continued at or below the low end of therapeutic INR range More complex or high risk surgery/ procedures require discontinuation of warfarin

Clotting Risk if Warfarin is Stopped l Risk varies by indication: l Mechanical Heart Valve l Atrial Fibrillation (A Fib) l History of Blood Clot l Deep Vein Thrombosis (DVT) l Pulmonary Embolism (PE) l Other indications: Acute Coronary Syndrome, Peripheral Vascular Disease

High Risk Indication for Anticoagulation Mechanical Heart Valve Any mitral valve prosthesis A Fib High risk for stroke Recent stroke /mini. Any caged-ball or stroke (within 3 tilting disc aortic valve months) prosthesis Rheumatic valvular Recent stroke/ miniheart disease stroke (within 6 months) 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 l High risk: Use bridging agent l Moderate risk: May consider using a bridging agent l Low risk: No bridging agent necessary

Bridging Anticoagulation l Bridging can be defined as the administration of a short-acting anticoagulant during the interruption of warfarin l Goal of bridging is to minimize the time patients are not being anticoagulated l Minimizes patients risk of blood clot

Bridging Anticoagulation cont. l Decisions about bridging should be based upon the individual patient and surgery-related factors l In addition to high-risk patients already discussed, bridging may be considered: l l l Active coronary or peripheral vascular disease Previous clot during interruption of warfarin therapy Major cardiac or vascular surgery

Anticoagulants used for Bridging l UFH l LMWH l Lovenox (enoxaparin) l Fragmin (dalteparin) l Arixtra (fondaparinux)

Developing a Specific Plan for Managing Warfarin around the Time of Surgery/ Procedure l Once bleeding risk and clotting risk have been evaluated: plan for management of warfarin can be established l Decision to use a bridging agent is made

Interruption of Warfarin l 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 l 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 l 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 l Warfarin may be restarted 12 -24 hours after surgery/ procedure, typically the evening of surgery/ procedure l If warfarin is resumed alone, without UFH/ LMWH bridging, a full anticoagulant effect will take 4 -6 days to occur

Summary l For minor surgery/ procedure (low bleed risk) warfarin usually does not need to be stopped l l 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 l Also, if high clotting risk bridging is may be necessary l

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: – K 1 plants – K 2 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 (>500 mcg/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/100 g) 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 -4 oz) 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

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 150 ug/day TTR 100 ug/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 120 ug/day Women 90 ug/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 (250 m. L) 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 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? n. Helping patients receive the best care possible.

How You Can Get the Most Out of Your Health Care Before Your Clinic Visits n During Your Clinic Visits n Be an ACTIVE Participant n Prescriptions n Resources n

Before Your Clinic Visit q Get a Notebook q What to Put in that Notebook: q. Take Notes (concerns, medication questions, new sypmtoms) q. Updated and Accurate List of Medications q. Questions q. List of Future Appointments q. Get labs/tests done in addition to visit when possible

During Your Visit Bring Someone With You n Bring Your Notebook n Be Honest n Speak Up! n Review your VSR n

Be an ACTIVE Participant n Ask n n Any Questions Have Check n The Information your HCP has on file n n Take Notes n n Someone to come along with you to your appointments Vocalize n n n Symptoms, Concerns – duration, severity Invite n n Contact info, medications Concerns, unhappiness YOUR voice (not your spouses, childs, friends) Educate n n n Understand your Diagnosis Know Why You Take Your Medications Seek Reputable Sources of Information

PRESCRIPTIONS n Keep an Accurate List, bring it with you to every appointment n Know WHY You Take Every Medication

PRESCRIPTION COSTS Do Not Stop Taking Your Medication Without Calling your HCP First n Ways to Lower the Cost of Medications: n Generics when Possible n Prior Authorizations n Industry Coupons n Medicare Part D Financial Assistance n Manufacturer Coupons/Financial Assistance n Shop Around n

RESOURCES Pharmaceutical Company Websites n http: //scriptyourfuture. org/ n Non-profits such as the North American Thrombosis Forum www. natfonline. org, the American Heart Association www. aha. org n Local Support Groups n

IN SUMMARY No one knows your body better than YOU n Resources are available to help you pay for your medications n A lifelong relationship with your HCP(s) is the MOST IMPORTANT TOOL YOU HAVE n

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 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? Coagu. Chek. XS by Roche INRatio 2 by Alere

Coagu. Chek 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

INRatio 2 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 Dei. Cicchi, 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 • 188 patients were eligible to self monitor • Only 38% completed their course 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 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 Level Dose Example 1 35 mg/week 5 mg daily 2 36 mg/week 6 mg Mon and 5 mg others 3 38 mg/week 6 mg Mon Wed Fri; 5 mg rest of week 4 40 mg/week 5 mg Mon Fri; 6 mg rest of week 5 42 mg/week 6 mg daily 6 44 mg/week 7 mg Mon Fri; 6 mg rest of week 7 46 mg/week 6 mg Mon Wed Fri; 7 mg rest of week 8 48 mg/week 6 mg Sun; 7 mg rest of week 9 51 mg/week 8 mg Mon Fri, 7 mg rest of week

Documentation Date INR Level Sun Mon Tue Wed Thu Fri Sat 11/4/13 2. 5 5 6 mg 6 mg 11/11/13 1. 6 7 7 mg 6 mg 7 mg 11/18/13 2. 7 7 7 mg 6 mg 7 mg 11/20/13 3. 1 6 6 mg 7 mg 6 mg 11/27/13 2. 9 6 6 mg 7 mg 6 mg

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?