Managing Oral Anticoagulation Therapy

Transcription

1 Managing Oral Anticoagulation Therapy CLINICAL AND OPERATIONAL GUIDELINES 3rd Edition Editors: Jack E. Ansell, MD Lynn B. Oertel, MS, ANP, CACP Ann K. Wittkowsky, PharmD, CACP Health Kluwer Facts & Comparisons

2 Contents Chapter 1: The Value of an Anticoagulation Management Service 1 Jack E. Ansell, MD Historical Perspectives 1 Vitamin K 2 Optimal Management of Oral Anticoagulation 3 Value of an Anticoagulation Management Service 3 Cost-Effectiveness of Coordinated Care 6 Chapter 2: Guidelines for the Development of an Anticoagulation Management Service 9 David Garcia, MD Introduction 9 Qualifications of Personnel 9 Supervision 10 Care Management and Coordination 10 Documentation 11 Patient Education 11 Patient Selection and Assessment 12 Laboratory Monitoring 12 Initiation and Stabilization of VKA Therapy 13 Maintenance of Therapy 13 Conclusion 13 Chapter 3: Developing a Business Plan for an Anticoagulation Management Service 17 Diane Wirth, ANP-BC, CACP; Jeanne Moore, RN, BSN Introduction 17 Why Develop A Business Plan? 17 How Can A Business Plan Help? 17 Who Writes the Business Plan? 17 Components of a Business Plan 17 Implementation Plan 18 Financial Implication of AMS to Practice/Health Care Organization 19 Evaluation Plan 19 Diagramming 19 Operational Design 22 Developing a Pro Forma for an AMS 22 Executive Summary 23 Conclusion 24 Chapter 4: Staffing Considerations for an Anticoagulation Management Service 25 Edith A. Nutescu, PharmD, FCCP; Laura Earl, RN, BSN, CACP; Lynn B. Oertel, MS, ANP, CACP Introduction 25 Identifying Needs and Considerations to Get Started 25 Staffing Considerations for Anticoagulation Management Services (AMS) 26 Providers in an AMS 27 Nursing 28 Midlevel Practioners 28 Pharmacy 28 Medicine 29 Nonprofessional Staff and Administrative Personnel 29 Collaboration Among All Disciplines to Promote Patient Safety 29 Conclusion 30 VH

3 viii MANAGING ORAL ANTICOAGULATION THERAPY Chapter 5: Guidelines for Anticoagulation Provider Certification 31 Lynn B. Oertel, MS, APN, CACP Introduction 31 Historical Perspective of the NCBAP and Credentialing Process 31 Mission and Goals 31 Requirements for the CACP Credential 32 Opportunities to Prepare for the CACP Credential 32 Requirements for Recertification 33 Current and Future Challenges 33 Summary 33 Chapter 6: Managing Anticoagulation Information 35 Lynn B. Oertel, MS, APN, CACP Introduction 35 Data Collection 35 Management and Quality of Data 35 Benefits of Computerized Databases 36 Selecting an Anticoagulation Software System 36 Software Product Descriptions 37 Clever Clog (Clever Clog) 39 CoagCare (Zycare, Inc.) 39 CoagClinic (Standing Stone, Inc.) 41 CoaguTrak (Medmatics) 43 Dawn AC (4S Dawn Clinical Software) 45 DoseResponse (Keystone Therapeutics) 46 IntraMed CSO/Anticoagulation (MedSoft Systems) 48 Warfarin Dosing Software (Pharmalife Solutions, Inc.) 51 WarfarinDosing.org 52 weblnr (Abington Memorial Hospital) 54 Conclusion 56 Chapter 7: Patient Education 59 Nancy L. Shapiro, PharmD, BCPS Introduction 59 Literacy 59 Cognitive and Physical Impairments 59 Rediness to Learn 59 Baseline Patient Visit and Education 59 Medications 60 Adherence 61 Bleeding 61 Disease Management 62 Diet 62 Acute Illness 62 Alcohol Use 63 Pregnancy 63 Education of Established Patients 63 Phone Contact 63 Sources for Educational Materials 63 Chapter 8: Reimbursement Basics for Anticoagulation Services Coverage, Payment, and Coding 65 Paul Radensky, MD, JD Introduction 65 Coverage, Payment, and Coding for Oral Anticoagulation Management Visits 66 Coverage, Payment, and Coding for Administration of LMWHs 67 "Incident-To" Service Rules 67

4 CONTENTS ix New Anticoagulation and Medication Therapy Management Codes 69 Coverage, Payment, and Coding For Home PT Monitoring 69 Conclusion 70 Chapter 9: Improving the Quality of Anticoagulation Therapy Management 71 Daniel M. Witt, PharmD, FCCP, BCPS, CACP Introduction 71 Measurement 71 Improvement Methodologies 71 Monitoring and Improving Clinical Outcomes 72 Conclusion 78 Chapter 10: Developing an Inpatient Anticoagulation Service 81 Katherine W. Phillips, PharmD, CACP; Geno J. Merli, MD, FACP Introduction 81 Rationale for Service 81 The Scope of Anticoagulant-Associated Problems 82 Defining Members and Involvement 82 Service Framework 82 Scope of Services 83 Defining Outcomes Measures 83 Conclusin 84 Chapter 11: Blood Coagulation, Thrombosis, Antithrombotics, and Hypercoagulable States 85 Stephan Moll, MD Introduction 85 Physiology of Blood Coagulation 86 Pathophysiology of Blood Clotting 92 Antithrombotics 93 Hypercoagulable States 96 Acknowledgment 102 Chapter 12: The Prothrombin Time: Origins, Performance, Interpretation, Standardization, and Quality Control 105 Jack Ansell, MD; Douglas A. Triplett; Linda Barna Cler Historical Development 105 Prothrombin Time: Technical and Procedural Variables 106 Standardization of the Prothrombin Time 106 Standardization and Quality Control 108 Clinical Laboratory Improvement Act 88 (CLIA 88) 109 Conclusion 110 Chapter 13: Point-of-Care INR Monitors 113 Mark W. Wurster, MD Introduction 113 Historical Perspective and Methodology 113 Quality and Efficiency of Care 113 Device History 115 Device Selection 118 CLIA Status 118 Patient Self-Testing 119 Device-Associated Costs 120 Quality Control and Sample Size 120 Connectivity and Software Compatibility 121 Conclusion 121 Chapter 14: Cardiovascular Indications for Oral Anticoagulation 123 Richard C. Becker, MD Introduction 123

5 x MANAGING ORAL ANTICOAGULATION THERAPY Primary Prevention of Cardiovascular Events 123 Secondary Prevention of Cardiovascular Events 124 Indications 126 Recommendations and Management Guidelines 132 Rheumatic Mitral Valve Disease 133 Aortic Valve Disease 133 Mitral Valve Prolapse 133 Mitral Annular Calcification 133 Patent Foramen Ovale and Atrial Septal Aneurysm 133 Infective Endocarditis 133 Nonbacterial Thrombotic Endocarditis 134 Atrial Fibrillation/Flutter 134 Prevention of Thromboembolism in Patients with Atrial Fibrillation Undergoing Cardioversion 135 Special Considerations 135 Conclusion 136 Chapter 15: Anticoagulation in Special Conditions: Antiphospholipid Antibody Syndrome and Pregnancy 139 Kathryn Vokaty, RN, BS, PA; Andra H. James, MD, MPH; Thomas L. Ortel, MD, PhD Introduction 139 Antiphospholipid Antibody Syndrome 139 Pregnancy 142 Chapter 16: Pharmacology of Warfarin and Related Anticoagulants 149 Ann K. Wittkowsky, PharmD, CACP, FASHP, FCCP History 149 Structure 150 Mechanism of Action 150 Effect on Vitamin K-Dependent Proteins 151 Pharmacokinetics 153 Pharmacodynamics 155 Other Oral Anticoagulants 157 Generic Warfarin: Therapeutic Considerations 158 Chapter 17: Pharmacogenetics and Anticoagulation Therapy 161 Farhad Kamali; Hilary A. Wynne Introduction 161 Nomenclature, Terminology, and Background to Pharmacogenetics and Polymorphisms 161 Pharmacogenetics of Warfarin Metabolism 161 CYP2C9 Polymorphisms 162 Polymorphisms in P450 Enzymes Responsible for (R)-Warfarin Metabolism 163 Vitamin K Epoxide Reductase Complex Subunit (VKORC1) 163 Influence of Ethnicity on Sensitivity to Warfarin 164 Other Genes 165 Clinical Aspects of Genetic Polymorphism 166 Combined Influence of Polymorphisms in Candidate Genes Upon Warfarin Dose 167 Pharmacogenetic-Based Dosing 168 Future Prospects of Pharmacogenetic-Based Warfarin Dosing 169 Chapter 18: Initiation and Maintenance Dosing of Warfarin and Monigoring the INR 173 Ann K. Wittkowsky, PharmD, CACP, FASHP, FCCP Introduction 1'^ Initiation Dosing 173 Practical Considerations for Initiation Dosing 178 Maintenance Dosing 178 Chapter 19: Factors That Influence Warfarin Effect 183 Marc Carrier, MD; Greoire Le Gal, MD, PhD; Phillip S. Wells, MD, MSc Introduction 183

6 CONTENTS xi Mechanism of Action and Pharmacokinetics 183 Mechanism of Drug Interactions 183 Interactions with Drugs 184 Nondrug Influences on the Warfarin Effect 186 Management of Warfarin Interactions 189 Chapter 20: Bleeding and Other Adverse Events with Anticoagulation Therapy 193 Sam Schulman, MD, PhD Introduction 193 Bleeding Complications 193 Thrombotic Complications 200 Allergic Reactions 200 Other Adverse Reactions 200 Warfarin-Induced Embryopathy 200 Chapter 21: Perioperative Management of Anticoagulant Therapy Before and After Surgery: A Practical, Patient-Focused Approach 205 James D. Douketis, MD, FRCP(C); Scott Kaatz, DO, MSc, FACP Introduction 205 Objectives 205 Assessment of Thromboembolic Risk During Interruption of Warfarin Therapy 205 Assessment of Bleeding Risk Associated with Surgery or Other Invasive Procedures 206 Weighing Thromboembolic Risk Against Bleeding Risk 207 Perioperative Management of Warfarin 207 Perioperative Management of Bridging Anticoagulation 207 Perioperative Management of Anticoagulant Therapy Patients Who Require Urgent Surgery or Invasive 209 Procedures Summary: Take-Home Messages 210 Chapter 22: Point-of-Care INR Monitoring: Patient Self-Testing and Patient Self-Management 213 Debra Green, MD; Jack Ansell, MD Introduction 213 Patient Self-Testing 213 Patient Self-Management 214 Patient Education 216 Quality Control 218 Management of Results 218 Chapter 23: New Oral Anticoagulants and the Future of Anticoagulant Therapy 221 Alexander G.G. Turpie, MD Introduction 221 Targets Within the Coagulation Cascade 221 Clinical Development of Novel Oral Anticoagulants 222 Direct Factor Xa Inhibitors 222 Rivaroxaban 223 VTE Prevention After Major Orthopedic Surgery 224 VTE Treatment 225 Clinical Development in Other Indications 226 Apixaban 227 VTE Prevention After Major Orthopedic Surgery 227 VTE Treatment 227 Clinical Development in Other Indications 228 DU-176b 228 LY Betrixaban 229 YM Direct Thrombin Inhibitors 230

7 xii MANAGING ORAL ANTICOAGULATION THERAPY Dabigatran 230 VTE Prevention After Major Orthopedic Surgery 231 VTE Treatment 232 Stroke Prevention in Patients with Atrial Fibrillation 232 AZD MCC Conclusion 232