Anticoagulation Therapy:

Anticoagulation Therapy: Toolkit for Implementing the National Patient Safety Goal Foreword by Jeannell Mansur, R.Ph., Pharm.D., F.A.S.H.P.

Senior Editor: Janet Pimentel Project Manager: Andrew Bernotas Manager, Publications: Paul Reis Associate Director, Production: Johanna Harris Associate Director, Editorial Development: Diane Bell Executive Director: Catherine Chopp Hinckley, Ph.D. Vice President, Learning: Charles Macfarlane, F.A.C.H.E. Joint Commission/JCR Reviewers: Pat Adamski, Diane Bell, Darlene Christiansen, Jeannell Mansur, Paul Reis Joint Commission Resources Mission The mission of Joint Commission Resources (JCR) is to continuously improve the safety and quality of health care in the United States and in the international community through the provision of education, publications, consultation, and evaluation services. Joint Commission Resources educational programs and publications support, but are separate from, the accreditation activities of The Joint Commission. Attendees at Joint Commission Resources educational programs and purchasers of Joint Commission Resources publications receive no special consideration or treatment in, or confidential information about, the accreditation process. The inclusion of an organization name, product, or service in a Joint Commission publication should not be construed as an endorsement of such organization, product, or service, nor is failure to include an organization name, product, or service to be construed as disapproval. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. Every attempt has been made to ensure accuracy at the time of publication; however, please note that laws, regulations, and standards are subject to change. Please also note that some of the examples in this publication are specific to the laws and regulations of the locality of the facility. The information and examples in this publication are provided with the understanding that the publisher is not engaged in providing medical, legal, or other professional advice. If any such assistance is desired, the services of a competent professional person should be sought. 2008 by the Joint Commission on Accreditation of Healthcare Organizations Joint Commission Resources, Inc. (JCR), a not-for-profit affiliate of The Joint Commission, has been designated by The Joint Commission to publish publications and multimedia products. JCR reproduces and distributes these materials under license from The Joint Commission. All rights reserved. No part of this publication may be reproduced in any form or by any means without written permission from the publisher. Printed in the U.S.A. 5 4 3 2 1 Requests for permission to make copies of any part of this work should be mailed to Permissions Editor Department of Publications Joint Commission Resources One Renaissance Boulevard Oakbrook Terrace, Illinois 60181 permissions@jcrinc.com ISBN: 978-1-59940-216-1 Library of Congress Control Number: 2008931365 For more information about Joint Commission Resources, please visit http://www.jcrinc.com.

Contents Foreword...v by Jeannell Mansur, R.Ph., Pharm.D., F.A.S.H.P., Practice Leader, Medication Safety, Joint Commission Resources Introduction...vii Chapter 1. Understanding Joint Commission Requirements...1 The Purpose of the National Patient Safety Goals...1 Meeting Expectations for Anticoagulation Therapy...2 Types of Anticoagulation Medications...5 Common Uses of Anticoagulation Therapy...9 Chapter 1 Tools on the CD-ROM...11 Chapter 2. Planning Strategies for an Anticoagulation Therapy Program...13 The Team Approach to Program Planning...13 Identifying a Program Manager...15 Identifying a Program Champion...16 Data Collection and Analysis: Important Components of Program Planning...16 Deciding the Basics of How the Program Should Function...18 Additional Issues for Program Planners to Consider...21 Chapter 2 Tools on the CD-ROM...36 Chapter 3. Considerations for Managing Patients Using Anticoagulation Medications...37 Warfarin: Facts, Protocols, and Tips...37 Heparin (Unfractionated): Facts, Protocols, and Tips...55 Low Molecular Weight Heparin: Facts, Protocols, and Tips...57 Managing Safe Medication Administration and Storage...57 Chapter 3 Tools on the CD-ROM...59 iii

Anticoagulation Therapy: Toolkit for Implementing the National Patient Safety Goal Chapter 4. Educating Patients About Anticoagulation Therapy...61 Essential Components of Anticoagulation Patient Education...61 Warfarin Education for Patients and Their Families...62 Heparin Education for Patients and Their Families...74 Low Molecular Weight Heparin Education for Patients and Their Families...74 Chapter 4 Tools on the CD-ROM...82 Chapter 5. Evaluation and Performance Improvement for an Anticoagulation Therapy Program...83 Data Collection Tools...83 Plan-Do-Study-Act...83 Six Sigma Methodology...85 Lean Thinking...86 Failure Mode and Effects Analysis...86 Chapter 5 Tools on the CD-ROM...87 Chapter 6. Case Studies: Lessons from the Field...91 Case Study 6-1. Abington Memorial Hospital s Virtual Anticoagulation Clinic...91 Case Study 6-2. University of California Davis Medical Center Anticoagulation Service...97 Case Study 6-3. Iowa Healthcare Collaborative s Resources for Anticoagulation Programs...106 Chapter 6 Tools on the CD-ROM...108 Appendix. Suggested Readings...109 Glossary...111 Index...115 iv

Foreword The potential for some medications to be more likely than others to result in morbidity and mortality if they are used in error was a concept discussed by Cohen and Kilo in 1999. 1 This concept continues to be supported by reports of adverse events as a result of medication error through USP MEDMARX, the largest U.S. Internet-based database for medication error reporting. As a drug category, anticoagulation medications have ranked in the top five resulting in patient safety incidents. 2 USP MEDMARX data from 2005 ranked heparin in third place, warfarin in sixth place, and enoxaparin in ninth place in terms of medications involved in medication error that resulted in patient harm. 3,4 It is concerning to think of enoxaparin being so highly associated with harm as a result of error, considering that it has only been approved for use in the U.S. market for 10 years. In fact, enoxaparin was involved in 4 of the 17 medicationrelated deaths reported to USP MEDMARX in 2005. As a director of pharmacy reviewing adverse drug reactions that were picked up through voluntary reporting as well as by E codes within the medical record, I recall being concerned by the number of reports of patient harm as a result of anticoagulation medications. In fact, these data eventually were used to support the implementation of a pharmacist-managed outpatient anticoagulation service at my former organization more than nine years ago. The concept of a warfarin clinic directed at outpatient management of this problem-prone medication has been around for a generation. Some organizations, appreciating that the risk associated with anticoagulation medications does not apply just to the outpatient setting, have had the vision (and organizational support) to implement inpatient services where patients on this class of medication are managed in an individualized, standardized, and evidenced-based manner. The Joint Commission, through its Sentinel Event Database as well as through evaluation of reports in the literature and feedback from professional organizations and advisory panels, learns of preventable medical events that result in significant adverse outcomes to patients. This analysis has led to the adoption of National Patient Safety Goal 3E (to be renumbered NPSG.03.05.01 effective January 1, 2009) for anticoagulation therapy: Reduce the likelihood of patient harm associated with the use of anticoagulant therapy. This goal is far-reaching in terms of its scope and influence on clinical care pertaining to use of best practices relating to anticoagulation therapy. The goal was announced in 2007, with 2008 being designated as a planning and pilot period, and with the expectation of full implementation in 2009. This goal will ultimately result in fundamental changes in the way patients on this class of medication are managed. As ambitious as the implementation expectations (which will become elements of performance effective January 1, 2009) are for this National Patient Safety Goal, it is important to note that there is work to be done beyond these. A systemsbased analysis of risks associated with anticoagulation medication, according to the six components of the medication system (selection and procurement, storage, ordering and transcribing, preparation and dispensing, administration, and monitoring) and implementation of design features that will mitigate those risks is necessary to ensure the greatest level of safety. I d like to point out that focusing on just the implementation expectations (or elements of performance) of this National Patient Safety Goal would not have prevented the highly publicized events pertaining to stocking errors with heparin. The systems approach does highlight this risk. v

Anticoagulation Therapy: Toolkit for Implementing the National Patient Safety Goal Organizations are looking for ideas on how to meet the objectives of this goal. Since implementation expectations (or elements of performance) spell out the need for the use of standardized approaches to dosing and monitoring patients on these medications, protocols or other methods will need to be either developed or adopted from another source. This requires becoming acquainted with current and evidence-based recommendations on the use of these medications. How will patients be managed? What will be the trigger that begins the process? What will be the steps in the process, and who will be responsible for each step along the way? These issues will need to be defined by organizations as part of their planning. The development of a sound process will be fundamental to ensuring that no patient falls through the cracks. Depending on the types of resources available to organizations, decisions will need to be made about who will have roles in patient management and monitoring, as well as patient instruction. Review of the literature shows us that active management of patients by evidenced-based processes and by competent individuals leads to better outcomes than care without this level of management. Over the next year, much learning will take place in terms of evaluating different strategies for implementing this National Patient Safety Goal. It is important that organizations share their experiences so that those with similar needs and in similar settings can learn from each other. Particularly, smaller hospitals as well as long term care facilities and home care organizations have not traditionally been so involved with anticoagulation management. The level of application of this National Patient Safety Goal will depend on the setting, as all implementation expectations will not be relevant for every setting. However, best practices should be shared to gain new understanding of how to improve the safety of this class of medications. This National Patient Safety Goal has enormous potential to positively impact the safety of patients on this class of medications and result in better outcomes. It is important to note that because this category of medications is more likely than others to cause harm with misuse, it is paramount to ensure that those who take on the responsibility of management of patients have the competency to do so. Care must be taken so that patients are not subjected to more harm as a result of new, untested processes or protocols or management by individuals who are not competent to do so. Jeannell Mansur, R.Ph., Pharm.D., F.A.S.H.P. Practice Leader, Medication Safety Joint Commission Resources References 1. Cohen M.R., et al.: High alert medication: Safeguarding against errors. In Cohen M.R. (ed.): Medication Errors. Washington, DC: American Pharmaceutical Association, 1999, pp. 5.1 5.40. 2. Cousins D., et al.: Risk Assessment of Anticoagulation Therapy. National Patient Safety Agency, 2006. 3. USP MEDMARX data, 2005. 4. Pharmacy Practice News: New Joint Commission Rule Seeks Safer Anticoagulation. http://www.pharmacypracticenews.com (accessed May 2, 2008). vi

Introduction A Midwestern hospital welcomed six prematurely born infants in its neonatal intensive care unit (NICU) in 2006. Like many other prematurely born babies in a NICU, the infants were administered medications intravenously. However, the babies were erroneously given a dangerously high dose of heparin 1,000 times the intended 10-unit dose when their IVs were accidentally flushed with 10,000 units of heparin instead of the prescribed 10-unit flush. When the babies showed signs of excessive internal bleeding, the staff quickly identified the problem. They tried to reverse the problem, but, unfortunately, three of the babies died from the internal bleeding caused by the heparin. Afterward, a careful study determined that the adverse event occurred because vials of the incorrect dose of heparin (the 10,000 units/ml heparin vials versus the 10 unit/ml hep-lock vials) were stocked in the NICU. This devastating event for both the families and the staff involved draws attention to how heparin can be an exceptionally therapeutic treatment that saves lives but has the potential to be very dangerous when not used correctly. Mr. Pritchard was a 53-year-old patient treated for hypertension by his family physician in his home state. While on a family holiday, he experienced cardiac arrest and was rushed to a local emergency room in the same town as his hotel. His condition warranted an immediate response, including the decision to perform open heart surgery. After several days of recovery in the hospital and the administration of key medications, including anticoagulation therapy ordered by the cardiologist, Mr. Pritchard was verbally provided some patient education about his therapy and instructed to consult his private physician when he returned home. After returning home about 10 days later, the patient went to see his physician for a checkup. The physician tested his International Normalized Ratio (INR) and saw that it was too low, so he altered the man s warfarin dose and instructed the patient to return for a follow-up visit. At the follow-up, the patient s INR test result was too high, and the physician adjusted the dose once more. After a few days, the patient was admitted to the emergency room for excessive bleeding due to complications from warfarin. After the patient was stabilized, the physician investigated the issue further by asking the man about any diet or dosing habits. Evidently, the patient stopped eating foods such as broccoli, which he had previously been enjoying regularly, without realizing he needed to monitor his food intake and maintain it at a consistent level due to warfarin use. This accounted for the swings in INR and the adverse outcome. Further analysis determined that the patient did not retain the patient education he received while in the hospital on vacation, and his continuing care did not include follow-up education when he visited his physician for checkups. These two examples are not uncommon occurrences with anticoagulation medications and need to be prevented. Anticoagulants, such as heparin and warfarin, are frequently used as an effective form of treatment; unfortunately, they carry with them a high risk to patient well-being due to the complex monitoring requirements and the prevalence of harm when they are used in error. One study found that 4% of adverse drug events (ADEs) and 10% of potential ADEs are related to anticoagulants. 1 These ADEs have been found to be related to both inpatients and outpatients. 2 The estimated cost of an inpatient major anticoagulation-related bleed ranges from $3,000 to $12,000. 3 Anticoagulant overdosing or insufficient monitoring and adjustments associated with the potential for hemorrhagic events ranked as one of vii

Anticoagulation Therapy: Toolkit for Implementing the National Patient Safety Goal the top three types of ADEs. 4 And along with insulin, warfarin has been shown to cause one in every seven ADEs treated in emergency room settings and more than one-quarter of all estimated hospitalizations. 5 In the case of the elderly, drugs such as insulin, warfarin, and digoxin represent one in every estimated three ADEs treated in the emergency room setting and 41.5% of estimated hospitalizations. 5 The problems are not strictly linked to the inpatient or ambulatory settings. A recent study concluded that, in the home care setting, 9% of ADEs and the highest incidence of all types of home-based ADEs came from warfarin. 6 Of those ADEs, 36% resulted from improper dose or quantity. 6 Having a well-defined anticoagulation therapy program is essential in managing these potentially dangerous drugs. After all, the reason that many anticoagulants become error prone is due to the complexity of dosing and monitoring, patient compliance, numerous drug interactions, and dietary interactions that can affect drug levels. Because the effects of drugs such as warfarin are often easily altered by all the aforementioned elements, and because they have a very narrow therapeutic index, they can quickly lose their status as highly effective drugs and can become ineffective or even dangerous. Maintaining the delicate balance is important to ensure the actual therapeutic qualities of anticoagulation medications. But an anticoagulation therapy program should be designed to appropriately fit the needs of the individual health care organization and the patients it serves. To help promote patient safety, The Joint Commission created a National Patient Safety Goal for anticoagulation therapy, which requires health care organizations to reduce the likelihood of patient harm associated with the use of anticoagulation therapy. This goal became effective starting January 1, 2008, with a requirement for a yearlong implementation process during 2008 and an expectation for organizations that use anticoagulation therapy to have a process in place to reduce patient harm by January 1, 2009. This goal will is discussed in more detail in Chapter 1. Note: As part of its Standards Improvement Initiative (SII), The Joint Commission approved a revised numbering system for its 2009 National Patient Safety Goals in May 2008. As of January 1, 2009, National Patient Safety Goal 3, Requirement 3E, on anticoagulation therapy will become NPSG.03.05.01. The Joint Commission launched the SII in 2006 as part of its continuous quality improvement efforts. The goals of the SII are to enhance the clarity and objectivity of the standards and to better tailor them to the characteristics of specific types of accredited organizations. How to Use This Toolkit Anticoagulation Therapy: Toolkit for Implementing the National Patient Safety Goal is intended to help any health care organization assess the safety of its current anticoagulation practices and/or implement a defined management program, including how to meet the Joint Commission s specific implementation expectations related to anticoagulation therapy. This implementation guide has been divided into some key content components that highlight the most important issues related to anticoagulation therapy and patient safety. The following is a summary of its chapters: Chapter 1, Understanding Joint Commission Requirements, highlights the actual National Patient Safety Goal and its requirements. Chapter 2, Planning Strategies for an Anticoagulation Therapy Program, reviews various strategies and standardized approaches to designing and implementing an anticoagulation therapy program. Chapter 3, Considerations for Managing Patients Using Anticoagulation Medications, provides general information and evidenced-based information on strategies for managing patients on different kinds of anticoagulation therapies. Chapter 4, Educating Patients About Anticoagulation Therapy, features examples of a critical element of an anticoagulation therapy program the need for effective patient education and engagement to ensure consistent safe use. Chapter 5, Evaluation and Performance Improvement for an Anticoagulation Therapy Program, summarizes the need for ongoing assessment and improvement of an anticoagulation therapy program so that an organization can make changes as warranted. Chapter 6, Case Studies: Lessons from the Field, highlights three organizations that are engaged in safe practices with anticoagulation medications by establishing different kinds of therapy management programs. These organizations also share what practices have worked well for their patients and how they have used resources and staff to meet patients needs. The Appendix includes a list of suggested readings as additional resources for readers. The Glossary can be used as a quick reference to common terms used in the book. viii

Introduction The CD-ROM is intended to be a companion to the implementation guide. The CD-ROM contains copies of forms, worksheets, and other tools shown in the implementation guide that can be printed and used at your health care organization. A icon is located next to some figures to remind readers that these tools can be found on the CD-ROM. As a quick reference, readers will find a list at the end of each chapter, recapping all the figures in that chapter that can be found on the CD-ROM. Terms Used in the Toolkit This implementation guide and CD-ROM provide information for individuals in all types of health care organizations. The people who use this toolkit will vary, depending on the type of facility. Users could be the organization s performance improvement directors, pharmacists, directors of nursing, medical staff, and so forth. The information can be used to educate all staff members who work with anticoagulation patients or help plan and/or manage an anticoagulation therapy program. Health care organizations use various terms to refer to the individuals they serve and the care and services those individuals receive. In an effort to avoid confusion, this section reviews some of those terms and their meaning: Anticoagulation is administration of a clot-inhibiting substance, such as warfarin or heparin, either therapeutically for conditions in which there is undesirable clotting (for example, pulmonary embolism) or prophylactically in circumstances in which there is an increased risk of such clotting (for example, during certain surgical operations, such as the insertion of a prosthetic heart valve or a total hip replacement). Adverse event is an unexpected and unwelcome event that affects the health and safety of a patient and could result in harm to that patient. Patient or individual is used throughout the publication to refer to any care recipient, including patients, clients, consumers, or residents, who receive care, treatment, and services at a health care organization. Health care organization is used to refer to all kinds of organizations that provide care, treatment, and services, including, but not limited to, hospitals, ambulatory care organizations, home care organizations, and long term care organizations. International Normalized Ratio is a system established by the World Health Organization and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation (clotting) tests. All results are standardized using the international sensitivity index for the particular thromboplastin reagent and instrument combination utilized to perform the test. Acknowledgments No publication can be well developed without significant input from many sources. Joint Commission Resources (JCR) would like to thank its many internal reviewers and content experts who provided feedback and guidance in the development of this toolkit. We also extend our appreciation to Jeannell Mansur, the JCR Practice Leader for Medication Safety, who shared her expertise about anticoagulation therapy during interviews and also served as a reviewer for this manuscript. JCR also wishes to thank the health care organizations that participated in case study examples or that graciously contributed forms, worksheets, and others tools for examples in the implementation guide and CD-ROM. Their contributions have greatly enhanced this publication. Those organizations that deserve special recognition include the following: Abington Memorial Hospital in Abington, Pennsylvania Allen Health Systems in Waterloo, Iowa American Society of Health-System Pharmacists Barnes-Jewish Hospital at Washington University Medical Center in St. Louis Cedar Rapids Health Care Alliance in Cedar Rapids, Iowa Central Community Hospital in Elkader, Iowa Community Anticoagulation Therapy Clinic in Cedar Rapids, Iowa Guttenberg Municipal Hospital in Guttenberg, Iowa Health Information Translations in Columbus, Ohio Iowa Healthcare Collaborative in Des Moines, Iowa Madison County Healthcare Systems in Winterset, Iowa Mercy North Iowa Hospital in Mason City, Iowa Ohio State University Medical Center in Columbus, Ohio Oregon Health and Science University, Graduate Medical Education Pace Medical Apps UCSD Health, University of California in San Diego University of California Davis Medical Center in Sacramento University of Washington Medical Center in Seattle We also wish to thank writer Ladan Cockshut for her dedication and diligence in providing a quality manuscript. ix

Anticoagulation Therapy: Toolkit for Implementing the National Patient Safety Goal References 1. Bates D.W., et al.: ADE Prevention Study Group: Incidence of adverse drug events and potential adverse drug events: Implications for prevention. JAMA 274:29 34, 1995. 2. Kanjarat P., et al.: Nature of preventable adverse drug events in hospitals: A literature review. Am J Health Syst Pharm 60:1750 1759, 2003. 3. Eckman M.H., et al.: Making decisions about antithrombolytic therapy in health disease: Decision analytic and cost-effectiveness issues. Chest 114:699 714, 1998. 4. Winterstein A.G., et al.: Identifying clinically significant preventable adverse drug events through a hospital s database of adverse drug reaction reports. Am J Health Syst Pharm 59:1742 1749, Sep. 2002. 5. Budnitz D.S., et al.: National surveillance of emergency department visits for outpatient adverse drug events. JAMA 296:1858 1866, 2006. 6. Santell J.P., Cousins D.: Preventing medication errors that occur in the home. U.S. Pharmacist 29:64 68, 2004. x