SEVENTH EDITION • BOOK 1 CARDIOLOGY - ACCP

S E VENTH EDITION • BOO K 1

CARDIOLOGY

IMPORTANT INFORMATION ON THE RELEASE OF PSAP-VII BOOK 1 CARDIOLOGY To be eligible to earn 22.0 hours of BCPS recertification credit for PSAP-VII Book 1, you must complete and submit the online post test by 11:59 PM (Central Time) April 15, 2010. Please note that test modules must be completed in their entirety; partial recertification credit is not available for incomplete tests. Post Test Information All post tests for PSAP-VII are Web based. After purchasing a PSAP-VII product, you will receive an e-mail message with instructions on Web access to the post test. If you do not receive this message, please e-mail [email protected]. Access the post test at www.accp.com/ce using your e-mail address and password. Technical support is available from 8 AM to 5 PM (Central Time) weekdays by calling (913) 492-3311. PSAP-VII series errata are at www.accp.com/docs/psap/psap7-errata.pdf

This book is divided into three modules—Cardiology I, Cardiology II, and Cardiology III. You may complete one, two, or all three modules. You may also save or print your test responses before clicking SUBMIT. Answers and explanations for the PSAP-VII Cardiology book post tests will be posted online April 18, 2010. • If you submitted a post test: After April 18, 2010, log in to www.accp.com/ce and return to the post test page. You will see a link to the explained answers. • If you waived a post test: After April 18, 2010, log in to www.accp.com/ce and return to the post test page. You will see a link to the explained answers. The ACPE and BCPS continuing pharmacy education (CPE) statements of credit for the Cardiology book post tests will be available online by June 2010. After this date, log in to www.accp.com/ce and return to the post test page. You will see a link to print CPE statements of credit.

Submitting the online test for BCPS recertification attests that you have completed the test as an individual effort and not in collaboration with any other individual or group. Failure to complete this test as an individual effort may jeopardize your ability to use PSAP for BCPS recertification.

Director of Professional Development: Nancy M. Perrin, M.A., CAE Associate Director of Professional Development: Wafa Y. Dahdal, Pharm.D., BCPS (AQ Cardiology) Recertification Project Manager: Edward Alderman, B.S., B.A. Desktop Publisher/Graphic Designer: Jen DeYoe, B.F.A. Medical Editor: Kimma Sheldon, Ph.D., M.A. Information Technology Project Manager: Brent Paloutzian, A.A.S. For order information or questions, write or call: Pharmacotherapy Self-Assessment Program American College of Clinical Pharmacy 13000 W. 87th St. Parkway Lenexa, KS 66215-4530 Telephone: (913) 492-3311 Fax: (913) 492-4922 E-mail: [email protected]

Note The editors and publisher of PSAP recognize that the development of this volume of material offers many opportunities for error. Despite our best efforts, some errors may persist into print. Drug dosage schedules are, we believe, accurate and in accordance with current standards. Readers are advised, however, to check package inserts to be certain that the recommended dosages and contraindications are in agreement with the recommendations of PSAP. This is especially important for new, infrequently used, and highly toxic drugs.

Library of Congress Control Number: 2009942010 ISBN-13: 978-1-932658-44-6 (11-Volume Set) ISBN-13: 978-1-932658-45-3 (Book 1, Cardiology) Copyright © 2010 by the American College of Clinical Pharmacy. All rights reserved. This book is protected by copyright. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic or mechanical, including photocopy, without prior written permission of the American College of Clinical Pharmacy. Printed in the United States of America. To cite PSAP properly: Authors. Chapter name. In: Richardson M, Chant C, Cheng JWM, Chessman KH, Hume AL, Hutchison LC, et al, eds. Pharmacotherapy Self-Assessment Program, 7th ed. Book title. Lenexa, KS: American College of Clinical Pharmacy, year:page range.

Book 1 Table of Contents Illustrations in This Book PSAP-VII Editorial Board Welcome Acknowledgments Faculty Potential COI Disclosure Role of ACCP Role of BPS CE and Program Instructions Book 1 Post Test Directions Cardiology I Cardiology I Panel Cardiology I Subscriber Evaluation

iv v vi vi vii vii vii viii viii

Pediatric Screening and Treatment Quality Improvement—Pharmacist-Managed Programs Annotated Bibliography Self-Assessment Questions MANAGEMENT OF CHRONIC STABLE ANGINA By Paul P. Dobesh, Pharm.D., FCCP, BCPS (AQ Cardiology); and Zachary A. Stacy, Pharm.D., BCPS Introduction Pathophysiology Clinical Evaluation Clinical Presentation Physical Findings Diagnostic and Prognostic Testing Quality Patient Care Goals of Therapy Nonpharmacologic Treatments Pharmacologic Treatments Medical Therapy vs. PCI Pharmacotherapy with Elective PCI Monitoring Conclusion Annotated Bibliography Self-Assessment Questions

1 3 5

HYPERTENSION: cLINICAL pRACTICE uPDATES By Heath R. Jennings, Pharm.D., BCPS (AQ Cardiology); and Terri S. Cook, Pharm.D., BCPS Introduction 7 Overview 7 Evidence-Based Treatment 8 JNC 7 Guidelines 2003 8 AHA Scientific Statement 2007 8 ESC and ESH Guidelines 2007 12 CHEP 2008 and 2009 12 Changes Expected with the JNC 8 12 New Literature and Clinical Considerations 13 Special Patient Populations 13 Clinical Controversies 13 New Antihypertensive Therapies 14 Aliskiren 14 Nebivolol 14 Pipeline Agents 15 Additional Targets 15 Quality Improvement Programs 16 Home Blood Pressure Monitoring 16 The Pharmacist’s Role in Preventing Clinical Inertia 17 Annotated Bibliography 17 Self-Assessment Questions 21

43 43 44 44 44 44 45 45 45 46 48 49 57 57 57 61

VENOUS THROMBOEMBOLISM PREVENTION AND TREATMENT: eVIDENCE-bASED uPDATES By Nancy L. Shapiro, Pharm.D., BCPS; and Adam J. Bursua, Pharm.D., BCPS Introduction 65 VTE Prophylaxis 65 Formal Strategy to Address VTE Prevention 66 Risk Stratification 66 Moderate-Risk Groups 66 General Surgery 66 Acute Medical Illness 68 High-Risk Groups: Orthopedic Surgery 70 VTE Treatment 72 Initial Treatment Choices 72 Warfarin Intensity 73 Therapy Duration 74 Heparins in Special Populations 76 Malignancy 76 Obesity 76 Kidney Considerations 77 Heparin-Induced Thrombocytopenia 78 Diagnostic Controversies 78 Treatment Approach and Therapeutic Options 78 The Future of Anticoagulation 79 Genetic Screening/Warfarin Dosing 79 Emerging Therapies 79 The Role of the Pharmacist 82 Annotated Bibliography 82 Self-Assessment Questions 87

DYSLIPIDEMIAS: uPDATES AND nEW cONTROVERSIES By Evan Sisson, Pharm.D., MSHA, CDE; and Benjamin W. Van Tassell, Pharm.D., BCPS Introduction 25 Risk of Cardiovascular Disease 25 Novel and Emerging Risks 26 Risk Calculators 28 Risks and Benefits of Treatment 28 Nonprescription Therapy—Therapeutic Lifestyle Change 28 Prescription Therapy 29 Populations Deserving Special Risk Consideration 32 Acute Coronary Syndromes 32 Cardiometabolic Risk 32 Elderly and Stroke Prevention 34

PSAP-VII • Cardiology

34 35 35 39

i

Front Matter

Cardiology II Cardiology II Panel Cardiology II Subscriber Evaluation

91 93 95

Perioperative Treatment of Patients Receiving VKAs Assessment of Bleeding Risk Assessment of Thromboembolic Risk During Interruption Recent ACCP Recommendations Emergency Reversal Management of Perioperative Bleeding Associated with VKAs Perioperative Treatment of Patients Receiving Antiplatelet Therapy Bleeding Risk Thromboembolic Risk During Antiplatelet Interruption ACCP and AHA/ACC Recommendations Management of Perioperative Bleeding Associated with Antiplatelet Agents Issues Unique to Cardiac Surgery Preoperative Considerations Intraoperative Anticoagulation Reversal of Anticoagulation After Separation from CPB Bleeding Associated with Cardiac Surgery Conclusion Annotated Bibliography Self-Assessment Questions

EVOLUTION OF ANTITHROMBOTIC THERAPY USED IN ACUTE CORONARY SYNDROMES By Sarah A. Spinler, Pharm.D., FCCP, FAHA, BCPS (AQ Cardiology) Introduction 97 Timeline for Antiplatelet Development 97 Timeline for Anticoagulant Development 98 General Overview of ACS Therapy 98 Newer Antiplatelet Therapies for ACS 98 Clopidogrel Loading Dose 98 Prasugrel 107 Other P2Y12 Antagonists 109 Newer Anticoagulants for ACS 111 Bivalirudin for STEMI 111 Rivaroxaban 111 Apixaban 112 Quality Patient Care 113 Quality Metrics vs. Quality Performance Measures 113 ACC/AHA 2008 STE and NSTE MI Performance Measures 113 Estimating Bleeding Risk: The CRUSADE Bleeding Risk Score 114 Conclusion 115 Annotated Bibliography 115 Self-Assessment Questions 121

Cardiology III Cardiology III Panel Cardiology III Subscriber Evaluation

ATRIAL AND VENTRICULAR ARRHYTHMIAS: eVOLVING PRACTICES By Cynthia A. Sanoski, Pharm.D., FCCP, BCPS Introduction 125 Atrial Fibrillation 125 Epidemiology 125 Pathophysiology 126 Therapeutic Goals 128 Pharmacologic Therapy 128 Nonpharmacologic Therapy 132 Treatment Plan 133 Ventricular Arrhythmias and Related Emergency Cardiovascular Care 135 Epidemiology 135 Therapeutic Goals 137 Pharmacologic Therapy 138 Nonpharmacologic Therapy 139 Treatment Plan 139 Annotated Bibliography 142 Self-Assessment Questions 147 PERIOPERATIVE MANAGEMENT OF ANTITHROMBOTIC THERAPY By Jeremy D. Flynn, Pharm.D., BCPS; and Kevin W. Hatton, M.D. Introduction Epidemiology Therapeutic Goals

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154 154 155 155 156 157 159 159 159 160 161 162 162 162 163 165 165 165 169 173 175 177

CARDIOVASCULAR DISEASE IN WOMEN By Shannon W. Finks, Pharm.D., BCPS (AQ Cardiology) Introduction 179 Sex-Related Differences and Gender Bias 179 Sex-Related Risk of CVD 180 Risk Awareness 180 Risk Factors 180 Cardiovascular Risk Equations for Women 183 CVD Among Women 186 Disease Presentation 186 Disease Findings 186 Diagnostic Testing Challenges 187 Prognosis and Treatment Outcomes 187 Treatment Disparity Among Men and Women 188 Evidence-Based Treatment Guidelines 190 Sex-Specific Drug Therapy 191 Role of the Pharmacist 194 Conclusion 194 Annotated Bibliography 195 Self-Assessment Questions 201 ANTICOAGULATION MANAGEMENT IN PREGNANCY By Nathan P. Clark, Pharm.D., BCPS, CACP; and Mary Beth M. Dowd, Pharm.D., BCPS, CACP Introduction 205 Pathophysiology 205 Risk Factors for VTE During Pregnancy 206

153 153 154

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Thrombophilia Testing and Interpretation Presentation and Diagnosis of VTE Antithrombotic Drugs Pharmacokinetic Alterations in Antithrombotic Drugs During Pregnancy Risks Implications for Nursing Mothers Prevention of VTE Antenatal VTE Prophylaxis Postpartum VTE Prophylaxis Thromboprophylaxis for the Pregnant Patient with MHV Low-Molecular-Weight Heparin Unfractionated Heparin Warfarin Treatment Recommendations Treatment of VTE Recommended Antithrombotic Agents Thrombolysis and Vena Cava Interruption Obstetric Complications Treatment Recommendations Management of Antithrombotic Drugs at Delivery Role of the Pharmacist Conclusion Annotated Bibliography Self-Assessment Questions

206 206 208 208 208 209 209 210 211 212 212 213 213 213 213 213 214 214 214 215 216 216 216 221

Surrogate Outcomes Composite Outcomes Basic Data Interpretation Power and Sample Size Analysis Selection Survival Analyses Non-inferiority Trials Systematic Reviews and Meta-Analyses Annotated Bibliography Self-Assessment Questions

241 242 243 244 245 248 249 250 250 253

Reference Values for Common Laboratory Tests

258

EVALUATING DRUG-INDUCED Cardiovascular disease: A PHARMACOEPIDEMIOLOGIC PERSPECTIVE By Brian J. Quilliam, Ph.D., RPh; and Marilyn M. Barbour, Pharm.D., FCCP, BCPS Introduction 225 Epidemiology of Adverse Events 225 Necessity of Postmarketing Evaluation of Safety 226 Pharmacoepidemiology 226 Pharmacovigilance 226 History of Pharmacovigilance 226 Pharmacovigilance Methodology 227 Pharmacoepidemiology 230 Cohort Studies 230 Case-control Studies 230 Large, Simple Trials 231 Evaluating the Risk of MI Associated with TZDs: An Example of the Role of Observational Studies 232 Observational Studies Evaluating TZDs and MI 232 Causality: Weighing All Available Evidence 234 Conclusion 235 Annotated Bibliography 235 Self-Assessment Questions 237 Interpreting Data in Cardiovascular Disease Clinical Trials: A Biostatistical Toolbox By Ross T. Tsuyuki, BSPharm, Pharm.D., M.Sc., FCSHP, FACC; and Sipi Garg, M.Sc. Introduction 241 Types of Outcome Variables 241 Continuous and Discrete Variables 241


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Illustrations in this Book Factors contributing to cardiometabolic risk.

33

Treatment algorithm for the patient with stable angina.

47

Evaluation of the patient with acute coronary syndrome.

99

Initial pharmacotherapy for ST-segment elevation myocardial infarction.

101

Initial treatment of non–ST-segment elevation ACS.

102

Cardiovascular death, myocardial infarction, or stroke in the TRITON-TIMI 38 trial.

108

Major bleeding events in the TRITON-TIMI 38 trial.

108

Algorithm for the assessment and management of patients with significant postcardiac surgery hemorrhage.

164

Diagnostic algorithm for venous thromboembolism in pregnancy.

207

Antenatal thromboprophylaxis decision tree.

210

Postpartum thromboprophylaxis decision tree.

212

Possible relationships between surrogate outcomes and clinical outcomes.

242

Relationship between effect size and sample size at a constant power and α.

245

Relationship between sample size and power at a constant effect size and α.

246

Predicted probability of CRUSADE in-hospital major bleeding according to CRUSADE Bleeding Risk Score.

115

Scoring system for assessing the 10-year risk of atrial fibrillation. .

Relationship between event rate and sample size at a constant effect size, power, and α.

246

127

Treatment algorithm for pulseless ventricular tachycardia or ventricular fibrillation.

Types of dependent and independent variables and the analyses associated with them.

247

140

Treatment algorithm for asystole or pulseless electrical activity.

The cumulative incidence curve for mortality in the MERIT-HF trial.

248

142

Schematic diagram of a thromboelastography tracing.

Mortality curve from the Scandinavian Simvastatin Survival Study.

249

158

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Pharmacotherapy Self-Assessment Program Seventh Edition Editorial Board Aurora, Colorado Anne L. Hume, Pharm.D., FCCP, BCPS Professor of Pharmacy Department of Pharmacy Practice University of Rhode Island Kingston, Rhode Island Adjunct Professor of Family Medicine Alpert School of Medicine at Brown University Providence, Rhode Island

Michelle M. Richardson, Pharm.D., FCCP, BCPS (Chair) Special and Scientific Staff William B. Schwartz Division of Nephrology Tufts Medical Center Assistant Professor of Medicine Tufts University School of Medicine Boston, Massachusetts Katherine Hammond Chessman, Pharm.D., FCCP, BCPS, BCNSP (Vice Chair) Professor Department of Clinical Pharmacy and Outcome Sciences Pediatric Pharmacy Practice Residency Program Director South Carolina College of Pharmacy Medical University of South Carolina Campus Clinical Pharmacy Specialist Pediatrics/Pediatric Surgery MUSC Children’s Hospital Charleston, South Carolina

Lisa C. Hutchison, Pharm.D., MPH, FCCP, BCPS Associate Professor Pharmacy Practice University of Arkansas for Medical Sciences Little Rock, Arkansas Emilie L. Karpiuk, Pharm.D., BCPS, BCOP Oncology Pharmacist Department of Pharmacy Froedtert Hospital Milwaukee, Wisconsin

Clarence Chant, Pharm.D., FCCP, FCSHP, BCPS Clinical Pharmacy Specialist Critical Care/Research, Pharmacy Department St. Michael’s Hospital Assistant Professor Leslie Dan Faculty of Pharmacy University of Toronto Toronto, Ontario, Canada

Marianne McCollum, Ph.D., BSPharm, BCPS Assistant Dean for Assessment School of Pharmacy Rueckert-Hartman College for Health Professions Regis University Denver, Colorado Marisel Segarra-Newnham, Pharm.D., MPH, FCCP, BCPS Clinical Pharmacy Specialist, Infectious Diseases Patient Support Service Veterans Affairs Medical Center West Palm Beach, Florida Clinical Assistant Professor of Pharmacy Practice University of Florida College of Pharmacy Gainesville, Florida

Judy W.M. Cheng, Pharm.D., MPH, FCCP, BCPS (AQ Cardiology) Professor of Pharmacy Practice Department of Pharmacy Practice Massachusetts College of Pharmacy and Health Sciences Clinical Pharmacist Department of Pharmacy Brigham and Women’s Hospital Boston, Massachusetts

Jeffrey T. Sherer, Pharm.D., MPH, BCPS Clinical Associate Professor Department of Clinical Sciences and Administration University of Houston College of Pharmacy Houston, Texas

Brian A. Hemstreet, Pharm.D., BCPS Associate Professor Director, Pharmaceutical Care Learning Center Department of Clinical Pharmacy University of Colorado Denver School of Pharmacy


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Welcome from the Editorial Board The Editorial Board and ACCP Publications staff are deeply indebted to the dedicated authors and reviewers who make PSAP possible. The series is well known for its timeliness: with books released every 3 months over a 2.5-year period, it takes a major effort from many dedicated individuals to achieve the series’ mission. We gratefully acknowledge the contribution of these individuals to the publication and, ultimately, the education of our pharmacist readers.

On behalf of the Editorial Board, welcome to the seventh edition of the Pharmacotherapy Self-Assessment Program (PSAP-VII)! For almost two decades, PSAP has been the premier home study tool for pharmacists. We are pleased that you have chosen this edition as a resource for continuing pharmacy education and/or pharmacotherapy specialist recertification. As were our predecessors, the PSAP-VII Editorial Board is committed to providing readers with a high-quality educational series to enhance their skills as pharmacists and, ultimately, improve patient care.

PSAP is a work in progress, and the Editorial Board welcomes constructive feedback from subscribers. In fact, many of the changes in this edition are based on suggestions from readers such as you. Because we routinely evaluate and discuss reader commentary in an effort to continually improve the usefulness of PSAP, your opinions are very important. Constructive comments can be shared through the online evaluations or by contacting the Publications staff at ACCP, or any member of the Editorial Board.

Planning for each edition begins long before the first book is released, and we are very excited about the changes to PSAP-VII. Returning subscribers will immediately notice a new typeface, new table formatting, and a new baseline resources box intended to enhance the learning experience. We have also improved the format of the self-assessment questions, which now include the original question and response options with each explained answer; this will enhance the author’s explanation and make it easier for readers to continue learning after taking the test. With respect to book content, topics related to BPS Domain 2 (i.e., retrieval, generation, interpretation, and dissemination of knowledge in pharmacotherapy) and Domain 3 (i.e., health system-related pharmacotherapy) are integrated throughout all the PSAP-VII books. The Editorial Board believes this more closely reflects actual practice and will better relate Domain 2 and 3 topics to the clinical focus of each book.

Thank you again for choosing PSAP. It is our sincere hope this edition meets your educational needs and is a great addition to your professional library. Michelle M. Richardson, Pharm.D., FCCP, BCPS Chair, PSAP-VII Editorial Board

Acknowledgments The general format of PSAP is modeled after the American College of Physicians’ Medical Knowledge Self-Assessment Program (MK-SAP), currently entering its 15th edition. ACCP gratefully acknowledges the advice and guidance provided by the American College of Physicians in the development of PSAP.

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ACCP and the PSAP Editorial Board also wish to express their appreciation to the authors and reviewers. The success of this unique pharmacotherapy self-assessment program is the direct result of the commitment of these outstanding clinical pharmacotherapy specialists.

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Disclosure of Potential Conflicts of Interest Grants: Kai I. Cheang (NIH NICHD); Judy W.M. Cheng (St. Jude’s Medical Research Center); Nathan Clark (Sanofi-aventis); Amy M. Franks (Pfizer); Brian A. Hemstreet (AstraZeneca); Anne L. Hume (AHRQ [two grants], HRSA); Lisa C. Hutchison (Boehringer Ingelheim, National Institutes of Health); Cynthia Jackevicius (ACCP, CIHR [two grants]); Brian J. Quilliam (Takeda Pharmaceuticals North America); Michelle Richardson (NIH NIDDK [two grants]); Nancy L. Shapiro (University of Illinois – Chicago Vahlteich Award); Anne P. Spencer (Pfizer)

Consultancies: Marilyn M. Barbour (New England Research Institute); Steven A. Baroletti (Sanofi-aventis); Michael A. Crouch (ARCA biopharma); Paul Dobesh (Sanofi-aventis, Eli Lilly, Inc., CV Therapeutics); Michael Dorsch (Merck); Shannon Willhite Finks (Novartis Pharmaceuticals); Jeremy D. Flynn (The Medicines Co., Novo Nordisk); Brian A. Hemstreet (Conexus Health); Lisa C. Hutchison (Arkansas Medicaid); Heath R. Jennings (American Heart Association); Lynette Moser (Michigan Department of Community Health); Kerry K. Pickworth (The Medicines Co., Merck, ARCA biopharma); Brian J. Quilliam (Ortho-McNeil Janssen); Michelle Richardson (Amgen, QualityMetric); Marisel Segarra-Newnham (Tibotec Therapeutics, USP, Annals of Pharmacotherapy); Jeffrey T. Sherer (Sturge-Weber Foundation); Evan Sisson (American Association of Diabetes Educators, University of Pittsburgh School of Pharmacy, Novartis Pharmaceuticals); Anne P. Spencer (ARCA biopharma); Sarah A. Spinler (Xcenda, Sanofi-aventis); Zachary A. Stacy (Sanofi-aventis, CV Therapeutics)

Honoraria: Nathan Clark (McMaster University, University of New Mexico, University of Colorado School of Pharmacy); Michael A. Crouch (The Medicines Co., Ortho-McNeil), Paul Dobesh (Sanofi-aventis); Michael Dorsch (Sanofi-aventis); Jeremy D. Flynn (The Medicines Co.); Kerry K. Pickworth (The Medicines Co.); Michelle Richardson (Amgen); Evan Sisson (Novartis Pharmaceuticals); Sarah A. Spinler (Sanofi-aventis, GlaxoSmithKline); Zachary A. Stacy (Sanofi-aventis)

Stock Ownership: Katherine H. Chessman (Procter & Gamble [stock owned by spouse or significant other]); Lisa C. Hutchison (Cardinal Health); Emilie Karpiuk (Cardinal Health); Michelle Richardson (TEI Biosciences [stock owned by spouse or significant other])

Nothing to Disclose: Adam J. Bursua, Benita Busch, Clarence Chant, Terri S. Cook, William E. Dager, Mary Beth Dowd, Sipi Garg, Kevin W. Hatton, Matthew K. Ito, Marianne McCollum, Mindi S. Miller, Kari L. Olson, Cynthia A. Sanoski, Ross T. Tsuyuki, Benjamin W. Van Tassell, Daniel M. Witt

Royalties: Lisa C. Hutchison (ASHP)

ROLE OF ACCP: ACCP developed the petition seeking recognition of Pharmacotherapy as a specialty of pharmacy and presented it to the Board of Pharmaceutical Specialties (BPS). As part of its mission to provide leadership, education, advocacy, and resources enabling clinical pharmacists to achieve excellence in practice and research, ACCP also helps pharmacotherapy specialists maintain their certification through PSAP. ACCP reports successful completion of PSAP examinations to BPS for recertification credit. Neither ACCP nor its agents, including the PSAP Editorial Board, authors, reviewers, or other staff, has knowledge of specific examination content, areas of emphasis, or any other information that would compromise the integrity of the examination process.


ROLE OF BPS: The Board of Pharmaceutical Specialties is an autonomous certification agency of the American Pharmacists Association. BPS is totally separate and distinct from ACCP. The Board, through its specialty councils, is responsible for specialty examination content, administration, scoring, and all other aspects of its certification programs. PSAP has been approved by BPS for use in BCPS recertification. Information about the BPS recertification process is available at www.bpsweb. org/recertification/general.cfm. Other questions regarding recertification should be directed to: Board of Pharmaceutical Specialties 2215 Constitution Avenue, NW Washington, DC 20037 (202) 429-7591 www.bpsweb.org

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Continuing Pharmacy Education and Program Instructions Continuing Pharmacy Education Credit: The American College of Clinical Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Subscribers to the Pharmacotherapy Self-Assessment Program, seventh edition (PSAP-VII), can earn 22.0 contact hours of continuing pharmacy education credit for successfully completing the Cardiology book. The Universal Program Numbers are: Cardiology I – 217-000-09-007-H01-P, 8.0 contact hours; Cardiology II – 217-000-09-008-H01-P, 6.5 contact hours; and Cardiology III – 217-000-09-009-H01-P, 7.5 contact hours.

To receive electronic access to the explained answers to the PSAP-VII questions without submitting a continuing pharmacy education post test, fill out the online waiver form for each test module you do not want to complete. By completing the waiver form for a module, you waive the opportunity to receive continuing pharmacy education credit for that module. After you submit a waiver for a post test, re-enter the online education center. You will be redirected to a PDF file that contains the answers for the module you waived. BCPS Recertification Continuing Education PSAP-VII post test modules are available for BCPS recertification credit only during the 3-month period after the book’s release. The first page of each print and online book lists the deadline for BCPS subscribers to submit online tests in order for the continuing pharmacy education credit to apply toward recertification.

To receive ACPE continuing pharmacy education credit for a PSAP-VII module, an online post test must be submitted for scoring. Continuing pharmacy education credit will be awarded for test scores of 50% and greater. Answers to each post test are available online to participants who complete the test. After submitting a PSAP-VII post test, reenter the online education center and click the link to view answers. You will see your test with correct and incorrect answers identified. You will also see a hyperlink to a PDF file with the correct answers and explanations for that test. Statements of continuing pharmacy education credit will be available online within 10 business days of receiving an ACPE test (see below for processing times for BCPS tests). The exception to the 10-day processing is the 3-month period after a book is released. Statements of ACPE credit will be available online after the BCPS tests are processed.

Tests submitted for BCPS recertification credit will be processed and results posted online within 60 days of the published test deadline. Only completed tests are eligible for credit; no partial or incomplete tests will be processed. The passing point for BCPS recertification is based on a statistical analysis of the examinations in each of the modules. If you receive a passing score, that information will be forwarded to the Board of Pharmaceutical Specialties (BPS), and an online statement of continuing pharmacy education/ BCPS recertification credit will be made available to you. Questions regarding the number of hours required for BCPS recertification should be directed to BPS at (202) 429-7591 or www.bpsweb.org.

Book 1 Post Test Directions Self-assessment questions are located at the end of each chapter. Each self-assessment question has four multiple-choice answer options. Please read each question carefully and select the one answer that is best or most correct for each question. Each book has two or more test modules. To submit your answers for the post test, go to www.accp.com and click on CE Center. Log in and select the link for the book (e.g., Cardiology) that contains the post test you wish to submit. The first screen will ask you to select the appropriate credit type (BCPS/ACPE or ACPE). We encourage you to SAVE or PRINT your responses to the post test before submitting the test.

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Director of Professional Development: Nancy M. Perrin, M.A., CAE Associate Director of Professional Development: Wafa Y. Dahdal, Pharm.D., BCPS (AQ Cardiology) Recertification Project Manager: Edward Alderman, B.S., B.A. Desktop Publisher/Graphic Designer: Jen DeYoe, B.F.A. Medical Editor: Kimma Sheldon, Ph.D., M.A. Information Technology Project Manager: Brent Paloutzian, A.A.S. For order information or questions, write or call: Pharmacotherapy Self-Assessment Program American College of Clinical Pharmacy 13000 W. 87th St. Parkway Lenexa, KS 66215-4530 Telephone: (913) 492-3311 Fax: (913) 492-4922 E-mail: [email protected]

Note The editors and publisher of PSAP recognize that the development of this volume of material offers many opportunities for error. Despite our best efforts, some errors may persist into print. Drug dosage schedules are, we believe, accurate and in accordance with current standards. Readers are advised, however, to check package inserts to be certain that the recommended dosages and contraindications are in agreement with the recommendations of PSAP. This is especially important for new, infrequently used, and highly toxic drugs.

Library of Congress Control Number: 2009942010 ISBN-13: 978-1-932658-44-6 (11-Volume Set) ISBN-13: 978-1-932658-45-3 (Book 1, Cardiology) Copyright © 2010 by the American College of Clinical Pharmacy. All rights reserved. This book is protected by copyright. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic or mechanical, including photocopy, without prior written permission of the American College of Clinical Pharmacy. Printed in the United States of America. To cite PSAP properly: Authors. Chapter name. In: Richardson M, Chant C, Cheng JWM, Chessman KH, Hume AL, Hutchison LC, et al, eds. Pharmacotherapy Self-Assessment Program, 7th ed. Book title. Lenexa, KS: American College of Clinical Pharmacy, year:page range.

Book 1 Table of Contents Illustrations in This Book PSAP-VII Editorial Board Welcome Acknowledgments Faculty Potential COI Disclosure Role of ACCP Role of BPS CE and Program Instructions Book 1 Post Test Directions Cardiology I Cardiology I Panel Cardiology I Subscriber Evaluation

iv v vi vi vii vii vii viii viii

Pediatric Screening and Treatment Quality Improvement—Pharmacist-Managed Programs Annotated Bibliography Self-Assessment Questions MANAGEMENT OF CHRONIC STABLE ANGINA By Paul P. Dobesh, Pharm.D., FCCP, BCPS (AQ Cardiology); and Zachary A. Stacy, Pharm.D., BCPS Introduction Pathophysiology Clinical Evaluation Clinical Presentation Physical Findings Diagnostic and Prognostic Testing Quality Patient Care Goals of Therapy Nonpharmacologic Treatments Pharmacologic Treatments Medical Therapy vs. PCI Pharmacotherapy with Elective PCI Monitoring Conclusion Annotated Bibliography Self-Assessment Questions

1 3 5

HYPERTENSION: cLINICAL pRACTICE uPDATES By Heath R. Jennings, Pharm.D., BCPS (AQ Cardiology); and Terri S. Cook, Pharm.D., BCPS Introduction 7 Overview 7 Evidence-Based Treatment 8 JNC 7 Guidelines 2003 8 AHA Scientific Statement 2007 8 ESC and ESH Guidelines 2007 12 CHEP 2008 and 2009 12 Changes Expected with the JNC 8 12 New Literature and Clinical Considerations 13 Special Patient Populations 13 Clinical Controversies 13 New Antihypertensive Therapies 14 Aliskiren 14 Nebivolol 14 Pipeline Agents 15 Additional Targets 15 Quality Improvement Programs 16 Home Blood Pressure Monitoring 16 The Pharmacist’s Role in Preventing Clinical Inertia 17 Annotated Bibliography 17 Self-Assessment Questions 21

43 43 44 44 44 44 45 45 45 46 48 49 57 57 57 61

VENOUS THROMBOEMBOLISM PREVENTION AND TREATMENT: eVIDENCE-bASED uPDATES By Nancy L. Shapiro, Pharm.D., BCPS; and Adam J. Bursua, Pharm.D., BCPS Introduction 65 VTE Prophylaxis 65 Formal Strategy to Address VTE Prevention 66 Risk Stratification 66 Moderate-Risk Groups 66 General Surgery 66 Acute Medical Illness 68 High-Risk Groups: Orthopedic Surgery 70 VTE Treatment 72 Initial Treatment Choices 72 Warfarin Intensity 73 Therapy Duration 74 Heparins in Special Populations 76 Malignancy 76 Obesity 76 Kidney Considerations 77 Heparin-Induced Thrombocytopenia 78 Diagnostic Controversies 78 Treatment Approach and Therapeutic Options 78 The Future of Anticoagulation 79 Genetic Screening/Warfarin Dosing 79 Emerging Therapies 79 The Role of the Pharmacist 82 Annotated Bibliography 82 Self-Assessment Questions 87

DYSLIPIDEMIAS: uPDATES AND nEW cONTROVERSIES By Evan Sisson, Pharm.D., MSHA, CDE; and Benjamin W. Van Tassell, Pharm.D., BCPS Introduction 25 Risk of Cardiovascular Disease 25 Novel and Emerging Risks 26 Risk Calculators 28 Risks and Benefits of Treatment 28 Nonprescription Therapy—Therapeutic Lifestyle Change 28 Prescription Therapy 29 Populations Deserving Special Risk Consideration 32 Acute Coronary Syndromes 32 Cardiometabolic Risk 32 Elderly and Stroke Prevention 34


34 35 35 39

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Cardiology II Cardiology II Panel Cardiology II Subscriber Evaluation

91 93 95

Perioperative Treatment of Patients Receiving VKAs Assessment of Bleeding Risk Assessment of Thromboembolic Risk During Interruption Recent ACCP Recommendations Emergency Reversal Management of Perioperative Bleeding Associated with VKAs Perioperative Treatment of Patients Receiving Antiplatelet Therapy Bleeding Risk Thromboembolic Risk During Antiplatelet Interruption ACCP and AHA/ACC Recommendations Management of Perioperative Bleeding Associated with Antiplatelet Agents Issues Unique to Cardiac Surgery Preoperative Considerations Intraoperative Anticoagulation Reversal of Anticoagulation After Separation from CPB Bleeding Associated with Cardiac Surgery Conclusion Annotated Bibliography Self-Assessment Questions

EVOLUTION OF ANTITHROMBOTIC THERAPY USED IN ACUTE CORONARY SYNDROMES By Sarah A. Spinler, Pharm.D., FCCP, FAHA, BCPS (AQ Cardiology) Introduction 97 Timeline for Antiplatelet Development 97 Timeline for Anticoagulant Development 98 General Overview of ACS Therapy 98 Newer Antiplatelet Therapies for ACS 98 Clopidogrel Loading Dose 98 Prasugrel 107 Other P2Y12 Antagonists 109 Newer Anticoagulants for ACS 111 Bivalirudin for STEMI 111 Rivaroxaban 111 Apixaban 112 Quality Patient Care 113 Quality Metrics vs. Quality Performance Measures 113 ACC/AHA 2008 STE and NSTE MI Performance Measures 113 Estimating Bleeding Risk: The CRUSADE Bleeding Risk Score 114 Conclusion 115 Annotated Bibliography 115 Self-Assessment Questions 121

Cardiology III Cardiology III Panel Cardiology III Subscriber Evaluation

ATRIAL AND VENTRICULAR ARRHYTHMIAS: eVOLVING PRACTICES By Cynthia A. Sanoski, Pharm.D., FCCP, BCPS Introduction 125 Atrial Fibrillation 125 Epidemiology 125 Pathophysiology 126 Therapeutic Goals 128 Pharmacologic Therapy 128 Nonpharmacologic Therapy 132 Treatment Plan 133 Ventricular Arrhythmias and Related Emergency Cardiovascular Care 135 Epidemiology 135 Therapeutic Goals 137 Pharmacologic Therapy 138 Nonpharmacologic Therapy 139 Treatment Plan 139 Annotated Bibliography 142 Self-Assessment Questions 147 PERIOPERATIVE MANAGEMENT OF ANTITHROMBOTIC THERAPY By Jeremy D. Flynn, Pharm.D., BCPS; and Kevin W. Hatton, M.D. Introduction Epidemiology Therapeutic Goals

Front Matter

154 154 155 155 156 157 159 159 159 160 161 162 162 162 163 165 165 165 169 173 175 177

CARDIOVASCULAR DISEASE IN WOMEN By Shannon W. Finks, Pharm.D., BCPS (AQ Cardiology) Introduction 179 Sex-Related Differences and Gender Bias 179 Sex-Related Risk of CVD 180 Risk Awareness 180 Risk Factors 180 Cardiovascular Risk Equations for Women 183 CVD Among Women 186 Disease Presentation 186 Disease Findings 186 Diagnostic Testing Challenges 187 Prognosis and Treatment Outcomes 187 Treatment Disparity Among Men and Women 188 Evidence-Based Treatment Guidelines 190 Sex-Specific Drug Therapy 191 Role of the Pharmacist 194 Conclusion 194 Annotated Bibliography 195 Self-Assessment Questions 201 ANTICOAGULATION MANAGEMENT IN PREGNANCY By Nathan P. Clark, Pharm.D., BCPS, CACP; and Mary Beth M. Dowd, Pharm.D., BCPS, CACP Introduction 205 Pathophysiology 205 Risk Factors for VTE During Pregnancy 206

153 153 154

ii


Thrombophilia Testing and Interpretation Presentation and Diagnosis of VTE Antithrombotic Drugs Pharmacokinetic Alterations in Antithrombotic Drugs During Pregnancy Risks Implications for Nursing Mothers Prevention of VTE Antenatal VTE Prophylaxis Postpartum VTE Prophylaxis Thromboprophylaxis for the Pregnant Patient with MHV Low-Molecular-Weight Heparin Unfractionated Heparin Warfarin Treatment Recommendations Treatment of VTE Recommended Antithrombotic Agents Thrombolysis and Vena Cava Interruption Obstetric Complications Treatment Recommendations Management of Antithrombotic Drugs at Delivery Role of the Pharmacist Conclusion Annotated Bibliography Self-Assessment Questions

206 206 208 208 208 209 209 210 211 212 212 213 213 213 213 213 214 214 214 215 216 216 216 221

Surrogate Outcomes Composite Outcomes Basic Data Interpretation Power and Sample Size Analysis Selection Survival Analyses Non-inferiority Trials Systematic Reviews and Meta-Analyses Annotated Bibliography Self-Assessment Questions

241 242 243 244 245 248 249 250 250 253

Reference Values for Common Laboratory Tests

258

EVALUATING DRUG-INDUCED Cardiovascular disease: A PHARMACOEPIDEMIOLOGIC PERSPECTIVE By Brian J. Quilliam, Ph.D., RPh; and Marilyn M. Barbour, Pharm.D., FCCP, BCPS Introduction 225 Epidemiology of Adverse Events 225 Necessity of Postmarketing Evaluation of Safety 226 Pharmacoepidemiology 226 Pharmacovigilance 226 History of Pharmacovigilance 226 Pharmacovigilance Methodology 227 Pharmacoepidemiology 230 Cohort Studies 230 Case-control Studies 230 Large, Simple Trials 231 Evaluating the Risk of MI Associated with TZDs: An Example of the Role of Observational Studies 232 Observational Studies Evaluating TZDs and MI 232 Causality: Weighing All Available Evidence 234 Conclusion 235 Annotated Bibliography 235 Self-Assessment Questions 237 Interpreting Data in Cardiovascular Disease Clinical Trials: A Biostatistical Toolbox By Ross T. Tsuyuki, BSPharm, Pharm.D., M.Sc., FCSHP, FACC; and Sipi Garg, M.Sc. Introduction 241 Types of Outcome Variables 241 Continuous and Discrete Variables 241


iii

Front Matter

Illustrations in this Book Factors contributing to cardiometabolic risk.

33

Treatment algorithm for the patient with stable angina.

47

Evaluation of the patient with acute coronary syndrome.

99

Initial pharmacotherapy for ST-segment elevation myocardial infarction.

101

Initial treatment of non–ST-segment elevation ACS.

102

Cardiovascular death, myocardial infarction, or stroke in the TRITON-TIMI 38 trial.

108

Major bleeding events in the TRITON-TIMI 38 trial.

108

Algorithm for the assessment and management of patients with significant postcardiac surgery hemorrhage.

164

Diagnostic algorithm for venous thromboembolism in pregnancy.

207

Antenatal thromboprophylaxis decision tree.

210

Postpartum thromboprophylaxis decision tree.

212

Possible relationships between surrogate outcomes and clinical outcomes.

242

Relationship between effect size and sample size at a constant power and α.

245

Relationship between sample size and power at a constant effect size and α.

246

Predicted probability of CRUSADE in-hospital major bleeding according to CRUSADE Bleeding Risk Score.

115

Scoring system for assessing the 10-year risk of atrial fibrillation. .

Relationship between event rate and sample size at a constant effect size, power, and α.

246

127

Treatment algorithm for pulseless ventricular tachycardia or ventricular fibrillation.

Types of dependent and independent variables and the analyses associated with them.

247

140

Treatment algorithm for asystole or pulseless electrical activity.

The cumulative incidence curve for mortality in the MERIT-HF trial.

248

142

Schematic diagram of a thromboelastography tracing.

Mortality curve from the Scandinavian Simvastatin Survival Study.

249

158

Front Matter

iv


Pharmacotherapy Self-Assessment Program Seventh Edition Editorial Board Aurora, Colorado Anne L. Hume, Pharm.D., FCCP, BCPS Professor of Pharmacy Department of Pharmacy Practice University of Rhode Island Kingston, Rhode Island Adjunct Professor of Family Medicine Alpert School of Medicine at Brown University Providence, Rhode Island

Michelle M. Richardson, Pharm.D., FCCP, BCPS (Chair) Special and Scientific Staff William B. Schwartz Division of Nephrology Tufts Medical Center Assistant Professor of Medicine Tufts University School of Medicine Boston, Massachusetts Katherine Hammond Chessman, Pharm.D., FCCP, BCPS, BCNSP (Vice Chair) Professor Department of Clinical Pharmacy and Outcome Sciences Pediatric Pharmacy Practice Residency Program Director South Carolina College of Pharmacy Medical University of South Carolina Campus Clinical Pharmacy Specialist Pediatrics/Pediatric Surgery MUSC Children’s Hospital Charleston, South Carolina

Lisa C. Hutchison, Pharm.D., MPH, FCCP, BCPS Associate Professor Pharmacy Practice University of Arkansas for Medical Sciences Little Rock, Arkansas Emilie L. Karpiuk, Pharm.D., BCPS, BCOP Oncology Pharmacist Department of Pharmacy Froedtert Hospital Milwaukee, Wisconsin

Clarence Chant, Pharm.D., FCCP, FCSHP, BCPS Clinical Pharmacy Specialist Critical Care/Research, Pharmacy Department St. Michael’s Hospital Assistant Professor Leslie Dan Faculty of Pharmacy University of Toronto Toronto, Ontario, Canada

Marianne McCollum, Ph.D., BSPharm, BCPS Assistant Dean for Assessment School of Pharmacy Rueckert-Hartman College for Health Professions Regis University Denver, Colorado Marisel Segarra-Newnham, Pharm.D., MPH, FCCP, BCPS Clinical Pharmacy Specialist, Infectious Diseases Patient Support Service Veterans Affairs Medical Center West Palm Beach, Florida Clinical Assistant Professor of Pharmacy Practice University of Florida College of Pharmacy Gainesville, Florida



Brian A. Hemstreet, Pharm.D., BCPS Associate Professor Director, Pharmaceutical Care Learning Center Department of Clinical Pharmacy University of Colorado Denver School of Pharmacy


v

Front Matter

Welcome from the Editorial Board The Editorial Board and ACCP Publications staff are deeply indebted to the dedicated authors and reviewers who make PSAP possible. The series is well known for its timeliness: with books released every 3 months over a 2.5-year period, it takes a major effort from many dedicated individuals to achieve the series’ mission. We gratefully acknowledge the contribution of these individuals to the publication and, ultimately, the education of our pharmacist readers.

On behalf of the Editorial Board, welcome to the seventh edition of the Pharmacotherapy Self-Assessment Program (PSAP-VII)! For almost two decades, PSAP has been the premier home study tool for pharmacists. We are pleased that you have chosen this edition as a resource for continuing pharmacy education and/or pharmacotherapy specialist recertification. As were our predecessors, the PSAP-VII Editorial Board is committed to providing readers with a high-quality educational series to enhance their skills as pharmacists and, ultimately, improve patient care.

PSAP is a work in progress, and the Editorial Board welcomes constructive feedback from subscribers. In fact, many of the changes in this edition are based on suggestions from readers such as you. Because we routinely evaluate and discuss reader commentary in an effort to continually improve the usefulness of PSAP, your opinions are very important. Constructive comments can be shared through the online evaluations or by contacting the Publications staff at ACCP, or any member of the Editorial Board.

Planning for each edition begins long before the first book is released, and we are very excited about the changes to PSAP-VII. Returning subscribers will immediately notice a new typeface, new table formatting, and a new baseline resources box intended to enhance the learning experience. We have also improved the format of the self-assessment questions, which now include the original question and response options with each explained answer; this will enhance the author’s explanation and make it easier for readers to continue learning after taking the test. With respect to book content, topics related to BPS Domain 2 (i.e., retrieval, generation, interpretation, and dissemination of knowledge in pharmacotherapy) and Domain 3 (i.e., health system-related pharmacotherapy) are integrated throughout all the PSAP-VII books. The Editorial Board believes this more closely reflects actual practice and will better relate Domain 2 and 3 topics to the clinical focus of each book.

Thank you again for choosing PSAP. It is our sincere hope this edition meets your educational needs and is a great addition to your professional library. Michelle M. Richardson, Pharm.D., FCCP, BCPS Chair, PSAP-VII Editorial Board

Acknowledgments The general format of PSAP is modeled after the American College of Physicians’ Medical Knowledge Self-Assessment Program (MK-SAP), currently entering its 15th edition. ACCP gratefully acknowledges the advice and guidance provided by the American College of Physicians in the development of PSAP.

Front Matter

ACCP and the PSAP Editorial Board also wish to express their appreciation to the authors and reviewers. The success of this unique pharmacotherapy self-assessment program is the direct result of the commitment of these outstanding clinical pharmacotherapy specialists.

vi


Disclosure of Potential Conflicts of Interest Grants: Kai I. Cheang (NIH NICHD); Judy W.M. Cheng (St. Jude’s Medical Research Center); Nathan Clark (Sanofi-aventis); Amy M. Franks (Pfizer); Brian A. Hemstreet (AstraZeneca); Anne L. Hume (AHRQ [two grants], HRSA); Lisa C. Hutchison (Boehringer Ingelheim, National Institutes of Health); Cynthia Jackevicius (ACCP, CIHR [two grants]); Brian J. Quilliam (Takeda Pharmaceuticals North America); Michelle Richardson (NIH NIDDK [two grants]); Nancy L. Shapiro (University of Illinois – Chicago Vahlteich Award); Anne P. Spencer (Pfizer)

Consultancies: Marilyn M. Barbour (New England Research Institute); Steven A. Baroletti (Sanofi-aventis); Michael A. Crouch (ARCA biopharma); Paul Dobesh (Sanofi-aventis, Eli Lilly, Inc., CV Therapeutics); Michael Dorsch (Merck); Shannon Willhite Finks (Novartis Pharmaceuticals); Jeremy D. Flynn (The Medicines Co., Novo Nordisk); Brian A. Hemstreet (Conexus Health); Lisa C. Hutchison (Arkansas Medicaid); Heath R. Jennings (American Heart Association); Lynette Moser (Michigan Department of Community Health); Kerry K. Pickworth (The Medicines Co., Merck, ARCA biopharma); Brian J. Quilliam (Ortho-McNeil Janssen); Michelle Richardson (Amgen, QualityMetric); Marisel Segarra-Newnham (Tibotec Therapeutics, USP, Annals of Pharmacotherapy); Jeffrey T. Sherer (Sturge-Weber Foundation); Evan Sisson (American Association of Diabetes Educators, University of Pittsburgh School of Pharmacy, Novartis Pharmaceuticals); Anne P. Spencer (ARCA biopharma); Sarah A. Spinler (Xcenda, Sanofi-aventis); Zachary A. Stacy (Sanofi-aventis, CV Therapeutics)

Honoraria: Nathan Clark (McMaster University, University of New Mexico, University of Colorado School of Pharmacy); Michael A. Crouch (The Medicines Co., Ortho-McNeil), Paul Dobesh (Sanofi-aventis); Michael Dorsch (Sanofi-aventis); Jeremy D. Flynn (The Medicines Co.); Kerry K. Pickworth (The Medicines Co.); Michelle Richardson (Amgen); Evan Sisson (Novartis Pharmaceuticals); Sarah A. Spinler (Sanofi-aventis, GlaxoSmithKline); Zachary A. Stacy (Sanofi-aventis)

Stock Ownership: Katherine H. Chessman (Procter & Gamble [stock owned by spouse or significant other]); Lisa C. Hutchison (Cardinal Health); Emilie Karpiuk (Cardinal Health); Michelle Richardson (TEI Biosciences [stock owned by spouse or significant other])

Nothing to Disclose: Adam J. Bursua, Benita Busch, Clarence Chant, Terri S. Cook, William E. Dager, Mary Beth Dowd, Sipi Garg, Kevin W. Hatton, Matthew K. Ito, Marianne McCollum, Mindi S. Miller, Kari L. Olson, Cynthia A. Sanoski, Ross T. Tsuyuki, Benjamin W. Van Tassell, Daniel M. Witt

Royalties: Lisa C. Hutchison (ASHP)

ROLE OF ACCP: ACCP developed the petition seeking recognition of Pharmacotherapy as a specialty of pharmacy and presented it to the Board of Pharmaceutical Specialties (BPS). As part of its mission to provide leadership, education, advocacy, and resources enabling clinical pharmacists to achieve excellence in practice and research, ACCP also helps pharmacotherapy specialists maintain their certification through PSAP. ACCP reports successful completion of PSAP examinations to BPS for recertification credit. Neither ACCP nor its agents, including the PSAP Editorial Board, authors, reviewers, or other staff, has knowledge of specific examination content, areas of emphasis, or any other information that would compromise the integrity of the examination process.


ROLE OF BPS: The Board of Pharmaceutical Specialties is an autonomous certification agency of the American Pharmacists Association. BPS is totally separate and distinct from ACCP. The Board, through its specialty councils, is responsible for specialty examination content, administration, scoring, and all other aspects of its certification programs. PSAP has been approved by BPS for use in BCPS recertification. Information about the BPS recertification process is available at www.bpsweb. org/recertification/general.cfm. Other questions regarding recertification should be directed to: Board of Pharmaceutical Specialties 2215 Constitution Avenue, NW Washington, DC 20037 (202) 429-7591 www.bpsweb.org

vii

Front Matter

Continuing Pharmacy Education and Program Instructions Continuing Pharmacy Education Credit: The American College of Clinical Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Subscribers to the Pharmacotherapy Self-Assessment Program, seventh edition (PSAP-VII), can earn 22.0 contact hours of continuing pharmacy education credit for successfully completing the Cardiology book. The Universal Program Numbers are: Cardiology I – 217-000-09-007-H01-P, 8.0 contact hours; Cardiology II – 217-000-09-008-H01-P, 6.5 contact hours; and Cardiology III – 217-000-09-009-H01-P, 7.5 contact hours.

To receive electronic access to the explained answers to the PSAP-VII questions without submitting a continuing pharmacy education post test, fill out the online waiver form for each test module you do not want to complete. By completing the waiver form for a module, you waive the opportunity to receive continuing pharmacy education credit for that module. After you submit a waiver for a post test, re-enter the online education center. You will be redirected to a PDF file that contains the answers for the module you waived. BCPS Recertification Continuing Education PSAP-VII post test modules are available for BCPS recertification credit only during the 3-month period after the book’s release. The first page of each print and online book lists the deadline for BCPS subscribers to submit online tests in order for the continuing pharmacy education credit to apply toward recertification.

To receive ACPE continuing pharmacy education credit for a PSAP-VII module, an online post test must be submitted for scoring. Continuing pharmacy education credit will be awarded for test scores of 50% and greater. Answers to each post test are available online to participants who complete the test. After submitting a PSAP-VII post test, reenter the online education center and click the link to view answers. You will see your test with correct and incorrect answers identified. You will also see a hyperlink to a PDF file with the correct answers and explanations for that test. Statements of continuing pharmacy education credit will be available online within 10 business days of receiving an ACPE test (see below for processing times for BCPS tests). The exception to the 10-day processing is the 3-month period after a book is released. Statements of ACPE credit will be available online after the BCPS tests are processed.

Tests submitted for BCPS recertification credit will be processed and results posted online within 60 days of the published test deadline. Only completed tests are eligible for credit; no partial or incomplete tests will be processed. The passing point for BCPS recertification is based on a statistical analysis of the examinations in each of the modules. If you receive a passing score, that information will be forwarded to the Board of Pharmaceutical Specialties (BPS), and an online statement of continuing pharmacy education/ BCPS recertification credit will be made available to you. Questions regarding the number of hours required for BCPS recertification should be directed to BPS at (202) 429-7591 or www.bpsweb.org.

Book 1 Post Test Directions Self-assessment questions are located at the end of each chapter. Each self-assessment question has four multiple-choice answer options. Please read each question carefully and select the one answer that is best or most correct for each question. Each book has two or more test modules. To submit your answers for the post test, go to www.accp.com and click on CE Center. Log in and select the link for the book (e.g., Cardiology) that contains the post test you wish to submit. The first screen will ask you to select the appropriate credit type (BCPS/ACPE or ACPE). We encourage you to SAVE or PRINT your responses to the post test before submitting the test.

Front Matter

viii


Cardiology I

Cardiology I Panel Editorial Board Liaison

Dyslipidemias: Updates and New Controversies


Authors Evan Sisson, Pharm.D., MSHA, CDE Assistant Professor Department of Pharmacotherapy and Outcomes Science VCU School of Pharmacy Virginia Commonwealth University Richmond, Virginia Benjamin W. Van Tassell, Pharm.D., BCPS Assistant Professor Department of Pharmacotherapy and Outcomes Science Virginia Commonwealth University Richmond, Virginia

Hypertension: Clinical Practice Updates Authors

Reviewers

Heath R. Jennings, Pharm.D., BCPS (AQ Cardiology) Director of Pharmacy and Acute Care Services Director of Graduate Pharmacy Education Department of Pharmaceutical Services University of Chicago Medical Center Associate Professor Chicago State University College of Pharmacy Adjunct Clinical Faculty University of Illinois at Chicago College of Pharmacy Chicago, Illinois

Benita E. Busch, Pharm.D., BCPS Oncology Pharmacist Department of Pharmacy Northside Hospital Atlanta, Georgia Matthew K. Ito, Pharm.D., FCCP, CLS, FNLA Professor of Pharmacy Practice Oregon State University Oregon Health and Science University College of Pharmacy Portland, Oregon

Terri S. Cook, Pharm.D., BCPS Clinical Pharmacy Specialist – Critical Care Department of Pharmacy VA Medical Center Lexington, Kentucky

Brian A. Hemstreet, Pharm.D., BCPS Associate Professor Director, Pharmaceutical Care Learning Center Department of Clinical Pharmacy University of Colorado Denver School of Pharmacy Aurora, Colorado

Reviewers Emilie L. Karpiuk, Pharm.D., BCPS, BCOP Oncology Pharmacist Department of Pharmacy Froedtert Hospital Milwaukee, Wisconsin

Management of Chronic Stable Angina Authors

Kari L. Olson, Pharm.D., BCPS (AQ Cardiology) Clinical Pharmacy Specialist Department of Pharmacy Kaiser Permanente Colorado Clinical Assistant Professor University of Colorado Denver School of Pharmacy Aurora, Colorado PSAP-VII • Cardiology

Paul P. Dobesh, Pharm.D., FCCP, BCPS (AQ Cardiology) Associate Professor Department of Pharmacy Practice College of Pharmacy University of Nebraska Medical Center Omaha, Nebraska 3

Cardiology I

Zachary A. Stacy, Pharm.D., BCPS Associate Professor of Pharmacy Practice Department of Pharmacy Practice St. Louis College of Pharmacy St. Louis, Missouri Pharmacotherapy Specialist Saint Luke’s Hospital Chesterfield, Missouri

Katherine Hammond Chessman, Pharm.D., FCCP, BCPS, BCNSP Professor Department of Clinical Pharmacy and Outcome Sciences Pediatric Pharmacy Practice Residency Program Director South Carolina College of Pharmacy Medical University of South Carolina Campus Clinical Pharmacy Specialist Pediatrics/Pediatric Surgery MUSC Children’s Hospital Charleston, South Carolina

Reviewers Michael A. Crouch, Pharm.D., FASHP, BCPS (AQ Cardiology) Professor and Chair Department of Pharmacy Practice South University School of Pharmacy Savannah, Georgia

The American College of Clinical Pharmacy and the authors thank the following individuals for their careful review of the Book 1, Cardiology I chapters: H. Gwen Bartlett, Pharm.D., BCPS Clinical Pharmacist II Department of Pharmacy St. Francis Health Center Topeka, Kansas

Lisa C. Hutchison, Pharm.D., MPH, FCCP, BCPS Associate Professor Pharmacy Practice University of Arkansas for Medical Sciences Little Rock, Arkansas

Julia Elenbaas, Pharm.D. Belton, Missouri

Venous Thromboembolism Prevention and Treatment: Evidence-Based Updates

Mary Lee, Pharm.D., FCCP, BCPS Vice President and Chief Academic Officer Pharmacy and Health Sciences Education Midwestern University Professor of Pharmacy Practice Midwestern University Chicago College of Pharmacy Downers Grove, Illinois

Authors Nancy L. Shapiro, Pharm.D., BCPS Clinical Associate Professor Operations Manager, Antithrombosis Clinic Director, PGY2 Ambulatory Care Pharmacy Residency Department of Pharmacy Practice University of Illinois at Chicago College of Pharmacy and Medical Center Chicago, Illinois Adam J. Bursua, Pharm.D., BCPS Clinical Assistant Professor Department of Pharmacy Practice University of Illinois College of Pharmacy Chicago, Illinois Reviewers Daniel M. Witt, Pharm.D., FCCP, BCPS, CACP Senior Manager of Clinical Pharmacy Services and Research Department of Pharmacy Kaiser Permanente Colorado Aurora, Colorado

Cardiology I

4


Subscriber Evaluation—Cardiology I 13. Evaluate patient risk of coronary heart disease (CHD) based on current National Cholesterol Education Program Adult Treatment Panel III guidelines. 14. Assess the impact of nontraditional and emerging risk factors for CHD (e.g., C-reactive protein, phospholipase A2, apolipoprotein B) on treatment decisions. 15. Evaluate the risks and benefits of specific lipid-lowering therapies based on current evidence. 16. Design an appropriate treatment plan, including goals of therapy and integration of nondrug therapy, for patients with dyslipidemia. 17. Design treatment strategies to optimize outcomes for special populations (e.g., patients at cardiometabolic risk, elderly, children).

As you take the post test for this module, also complete the accompanying evaluation of the material’s quality and usefulness and the achievement of learning objectives. Rate each item using this 5-point scale: • • • • •

Strongly agree Agree Neutral Disagree Strongly disagree

1. The educational content of the material presented was appropriate for a pharmacotherapy specialist. 2. The scope, depth, and relevance of the material presented were appropriate for a pharmacotherapy specialist. 3. The material presented was relevant and applicable to my practice. 4. The content of the module was objective and balanced. 5. The instructional materials were constructive for helping me learn and retain the information. 6. The learning objectives were adequately assessed by the self-assessment questions. 7. The self-assessment questions were written clearly.

Questions 18–23 apply to the learning objectives of Management of Chronic Stable Angina. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives: 18. Assess the clinical risk and presentation of a patient with chronic stable angina. 19. Given patient-specific information, develop a comprehensive therapeutic plan for a patient with chronic stable angina. 20. Resolve drug-drug interactions identified in the medical management of a patient with chronic stable angina. 21. Given patient-specific information, design a regimen to optimize revascularization pharmacotherapy. 22. Evaluate results of platelet function testing and develop a clinical plan for patients based on these results. 23. Plan appropriate monitoring for an individual patient’s anti-ischemic and antiplatelet therapy.

Questions 8–12 apply to the learning objectives of Hypertension: Clinical Practice Updates. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives: 8. Discuss differences in existing hypertension treatment recommendations and apply these recommendations to clinical practice. 9. Apply evidence from recently published landmark clinical studies in formulating evidence-based treatment plans for the care of patients with hypertension. 10. Assess changes in the treatment of antihypertensive disease and consider the impact of new literature on future treatment recommendations. 11. Evaluate the role of new agents in hypertension treatment. 12. Assess the role of the pharmacist and quality improvement programs for treatment of hypertension.

Questions 24–29 apply to the learning objectives of Venous Thromboembolism Prevention and Treatment: Evidence-Based Updates. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives: 24. Perform deep venous thromboembolism (VTE) risk stratification and design a therapeutic plan for VTE prophylaxis in hospitalized patients. 25. Based on current evidence, design an appropriate therapeutic regimen for VTE prophylaxis after major orthopedic surgery. 26. Design an appropriate plan for VTE prophylaxis and treatment in a patient with malignancy.

Questions 13–17 apply to the learning objectives of Dyslipidemias: Updates and New Controversies. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives:


5

Cardiology I

27. Based on current evidence, design an appropriate therapeutic regimen for the management of provoked and unprovoked VTE. 28. Justify an appropriate diagnostic approach and treatment plan for a patient with suspected or confirmed heparin-induced thrombocytopenia. 29. Distinguish the potential risks and benefits that new oral investigational anticoagulants may have compared with the vitamin K antagonist, warfarin. Questions 30–32 apply to the Cardiology I module. 30. How many minutes (total) did it take you to read all the chapters (learning objectives, text, tables/figures, and annotated bibliographies) for this module? 31. How many minutes (total) did it take you to answer all the questions for this module? 32. Do you have any comments on this module?

Cardiology I

6


Cardiology II Panel Editorial Board Liaison

Marisel Segarra-Newnham, Pharm.D., MPH, FCCP, BCPS Clinical Pharmacy Specialist, Infectious Diseases Patient Support Service Veterans Affairs Medical Center West Palm Beach, Florida Clinical Assistant Professor of Pharmacy Practice University of Florida College of Pharmacy Gainesville, Florida


Atrial and Ventricular Arrhythmias: Evolving Practices Author

Evolution of Antithrombotic Therapy Used in Acute Coronary Syndromes

Cynthia A. Sanoski, Pharm.D., FCCP, BCPS Department Chair Associate Professor Department of Pharmacy Practice Jefferson School of Pharmacy Thomas Jefferson University Philadelphia, Pennsylania

Author Sarah A. Spinler, Pharm.D., FCCP, FAHA, BCPS (AQ Cardiology) Professor of Clinical Pharmacy Department of Pharmacy Practice and Pharmacy Administration Philadelphia College of Pharmacy University of the Sciences in Philadelphia Philadelphia, Pennsylvania

Reviewers Steven A. Baroletti, Pharm.D., BCPS Clinical Practice Manager Department of Pharmacy Brigham and Women’s Hospital Boston, Massachusetts

Reviewers

Lynette Moser, Pharm.D. Clinical Assistant Professor Department of Pharmacy Practice Wayne State University Clinical Specialist – Cardiology Department of Pharmacy Services Harper University Hospital Detroit, Michigan

Michael P. Dorsch, Pharm.D., M.S., BCPS (AQ Cardiology) Clinical Pharmacist, Cardiology Adjunct Clinical Assistant Professor Department of Pharmacy and College of Pharmacy University of Michigan Ann Arbor, Michigan Kerry K. Pickworth, Pharm.D. Specialty Practice Pharmacist – Cardiology Associate Professor of Clinical Pharmacy Department of Pharmacy The Ohio State University Medical Center Columbus, Ohio



93

Cardiology II

Perioperative Management of Antithrombotic Therapy

Mary C. Gurnee, Pharm.D. Pharmacist Consultant Overland Park, Kansas

Authors

Mary Lee, Pharm.D., FCCP, BCPS Vice President and Chief Academic Officer Pharmacy and Health Sciences Education Midwestern University Professor of Pharmacy Practice Midwestern University Chicago College of Pharmacy Downers Grove, Illinois

Jeremy D. Flynn, Pharm.D., BCPS Clinical Pharmacist Specialist/Cardiothoracic Surgery Department of Pharmacy Services UK Healthcare Assistant Adjunct Professor Department of Pharmacy Practice and Science University of Kentucky College of Pharmacy Lexington, Kentucky Kevin W. Hatton, M.D. Assistant Professor Associate Residency Program Director Department of Anesthesiology University of Kentucky College of Medicine Lexington, Kentucky Reviewers William E. Dager, Pharm.D., FCCP, FCSHP, FCCM, BCSP Pharmacist Specialist University of California, Davis Medical Center Clinical Professor of Medicine UC Davis School of Medicine Sacramento, California Clinical Professor of Pharmacy UC San Francisco School of Pharmacy San Francisco, California Clinical Professor of Pharmacy Touro School of Pharmacy Vallejo, California Clarence Chant, Pharm.D., FCCP, FCSHP, BCPS Clinical Pharmacy Specialist Critical Care/Research, Pharmacy Department St. Michael’s Hospital Assistant Professor Leslie Dan Faculty of Pharmacy University of Toronto Toronto, Ontario, Canada The American College of Clinical Pharmacy and the authors thank the following individuals for their careful review of the Book 1, Cardiology II chapters: H. Gwen Bartlett, Pharm.D., BCPS Clinical Pharmacist II Department of Pharmacy St. Francis Health Center Topeka, Kansas

Cardiology II

94


Subscriber Evaluation—Cardiology II 13. Given a patient case, design a plan for improvement in quality care performance. 14. Given a patient case, estimate the patient’s risk of major bleeding and recommend therapies to reduce the patient’s bleeding risk.



Questions 15–21 apply to the learning objectives of Atrial and Ventricular Arrhythmias: Evolving Practices. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives:

1. The educational content of the materia presented was appropriate for a pharmacotherapy specialist. 2. The scope, depth, and relevance of the material presented were appropriate for a pharmacotherapy specialist. 3. The material presented was relevant and applicable to my practice. 4. The content of the module was objective and balanced. 5. The instructional materials were constructive for helping me learn and retain the information. 6. The learning objectives were adequately assessed by the self-assessment questions. 7. The self-assessment questions were written clearly.

15. Demonstrate an understanding of the most recent evidence regarding the epidemiology and pathophysiology of atrial fibrillation (AF). 16. Assess the role of statins, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and fish oil in the prevention of atrial or ventricular arrhythmias. 17. Using patient-specific information, design an appropriate treatment plan for the acute or chronic management of patients with AF based on the evidence and the most recent treatment guidelines. 18. Given a patient’s risk factor profile, justify appropriate selection of antithrombotic therapy in patients with AF. 19. Using patient-specific information, devise a pharmacotherapy treatment plan for patients with pulseless ventricular tachycardia, ventricular fibrillation, pulseless electrical activity, or asystole. 20. Analyze the role of implantable cardioverter-defibrillator therapy for the primary and secondary prevention of sudden cardiac death and develop a plan for reducing the frequency of appropriate or inappropriate shocks from these devices. 21. For each pharmacotherapy treatment plan developed for patients with atrial or ventricular arrhythmias, formulate a monitoring plan to assess efficacy as well as potential adverse effects and drug interactions.

Questions 8–14 apply to the learning objectives of Evolution of Antithrombotic Therapy Used in Acute Coronary Syndromes. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives: 8. Design an evidence-based treatment plan for a patient with ST-segment elevation myocardial infarction (STEMI). 9. Design an evidence-based treatment plan for a patient with non–ST-segment elevation (NSTE) acute coronary syndrome (ACS). 10. Justify the selection and timing of administration of 75-mg, 300-mg, 600-mg or 900-mg initial clopidogrel dose for a patient undergoing percutaneous coronary intervention (PCI) for NSTE ACS or STEMI or receiving fibrinolysis for STEMI. 11. Distinguish the efficacy and safety of prasugrel and clopidogrel for patients undergoing PCI. 12. Analyze the evidence for using rivaroxaban, apixaban, cangrelor, and ticagrelor in place of traditional antithrombotics for treating ACS. PSAP-VII • Cardiology

Questions 22–26 apply to the learning objectives of Perioperative Management of Antithrombotic Therapy. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives: 22. Evaluate risk factors that will influence the management of perioperative antithrombotic therapies for patients undergoing cardiac or noncardiac surgery. 95

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23. Apply recent guideline recommendations to design an appropriate perioperative anticoagulation regimen for patients requiring vitamin K antagonists related to anticoagulation who will undergo either cardiac or noncardiac surgery. 24. Apply recent guideline recommendations to design a care plan for patients with acute and chronic indications for antiplatelet therapy. 25. Develop a treatment plan to provide appropriate high-dose systemic anticoagulation necessitated by cardiopulmonary bypass during cardiac surgery. 26. Develop a treatment plan for the postoperative reversal of systemic anticoagulation provided during cardiac surgery and for postoperative surgical site bleeding associated with cardiac surgery. Questions 27–29 apply to the Cardiology II module. 27. How many minutes (total) did it take you to read all the chapters (learning objectives, text, tables/figures, and annotated bibliographies) for this module? 28. How many minutes (total) did it take you to answer all the questions for this module? 29. Do you have any comments on this module?

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Cardiology III Panel Editorial Board Liaison

Anticoagulation Management in Pregnancy


Authors Nathan P. Clark, Pharm.D., BCPS, CACP Clinical Pharmacy Supervisor Anticoagulation Service Kaiser Permanente Colorado Clinical Assistant Professor University of Colorado Denver School of Pharmacy Aurora, Colorado Mary Beth Dowd, Pharm.D., BCPS, CACP Clinical Pharmacy Supervisor Cardiac Risk Service Kaiser Permanente Colorado Aurora, Colorado

Cardiovascular Disease in Women Author Shannon W. Finks, Pharm.D., BCPS (AQ Cardiology) Associate Professor Department of Clinical Pharmacy University of Tennessee College of Pharmacy Clinical Pharmacy Specialist, Cardiology Department of Pharmacy VA Medical Center Memphis, Tennessee

Reviewers Amy M. Franks, Pharm.D. Associate Professor Department of Pharmacy Practice University of Arkansas for Medical Sciences College of Pharmacy Little Rock, Arkansas

Reviewers

Mindi S. Miller, Pharm.D., BCPS Clinical Associate Professor Department of Clinical and Administrative Pharmacy University of Georgia College of Pharmacy Athens, Georgia Clinical Pharmacist Emory Healthcare Atlanta, Georgia

Anne L. Hume, Pharm.D., FCCP, BCPS Professor of Pharmacy Department of Pharmacy Practice University of Rhode Island Kingston, Rhode Island Adjunct Professor of Family Medicine Alpert School of Medicine at Brown University Providence, Rhode Island

Michelle M. Richardson, Pharm.D., FCCP, BCPS (Chair) Special and Scientific Staff William B. Schwartz Division of Nephrology Tufts Medical Center Assistant Professor of Medicine Tufts University School of Medicine Boston, Massachusetts

Anne P. Spencer, Pharm.D., FCCP, BCPS (AQ Cardiology) Cardiovascular Care Pharmacy Specialist Roper Hospital Roper Saint Francis Healthcare Charleston, South Carolina


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Evaluating Drug-Induced CVD: A Pharmacoepidemiologic Perspective

Statistics: Study Design in Recent Cardiology Trials

Authors

Authors

Brian J. Quilliam, Ph.D., R.Ph. Associate Professor of Pharmacoepidemiology Department of Pharmacy Practice University of Rhode Island, College of Pharmacy Kingston, Rhode Island

Ross T. Tsuyuki, Pharm.D., BSPharm M.Sc., FCSHP, FACC Professor of Medicine (Cardiology) Director, EPICORE Centre/COMPRIS Department of Medicine Faculty of Medicine and Dentistry University of Alberta Edmonton, Alberta, Canada

Marilyn M. Barbour, Pharm.D., FCCP, BCPS Professor of Pharmacy Department of Pharmacy Practice University of Rhode Island Kingston, Rhode Island Adjunct Associate Professor of Medicine Alpert School of Medicine at Brown University Providence, Rhode Island

Sipi Garg, M.Sc. University of Alberta, EPICORE Centre Edmonton, Alberta, Canada Reviewers

Reviewers

Kai I. Cheang, Pharm.D., M.Sc., FCCP, BCPS Associate Professor Department of Pharmacy Virginia Commonwealth University Richmond, Virginia

Cynthia Jackevicius, Pharm.D., M.Sc., FCSHP, BCPS (AQ Cardiology) Associate Professor of Pharmacy Practice College of Pharmacy, Western University Pomona, California Clinical Pharmacy Specialist, Cardiology VA West Los Angeles Healthcare Center Los Angeles, California Adjunct Scientist Institute for Clinical Evaluative Sciences Toronto, Ontario, Canada

Marianne McCollum, Ph.D., BSPharm, BCPS Assistant Dean for Assessment School of Pharmacy Rueckert-Hartman College for Health Professions Regis University Denver, Colorado The American College of Clinical Pharmacy and the authors thank the following individuals for their careful review of the Book 1, Cardiology III chapters:


Dianne M. Brundage, Pharm.D., FCCP, BCPS, BCOP Oncology Clinical Pharmacy Specialist Park Nicollet Health Services Methodist Hospital Minneapolis, Minnesota Mary C. Gurnee, Pharm.D. Pharmacist Consultant Overland Park, Kansas Mary Lee, Pharm.D., FCCP, BCPS Vice President and Chief Academic Officer Pharmacy and Health Sciences Education Midwestern University Professor of Pharmacy Practice Midwestern University Chicago College of Pharmacy Downers Grove, Illinois

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Subscriber Evaluation—Cardiology III 16. Design an optimal pharmaceutical care plan for a woman with CVD.


Questions 17–24 apply to the learning objectives of Anticoagulation Management in Pregnancy. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives:


17. Distinguish the risk of thromboembolism in pregnancy based on an individual’s epidemiologic and medical background. 18. Analyze the physiological changes during pregnancy that predispose a woman to hypercoagulability and alter drug disposition. 19. Given a case scenario, evaluate the maternal and fetal risks of antithrombotic use during pregnancy and postpartum. 20. Develop a comprehensive antithrombotic regimen and monitoring strategy for a pregnant woman at risk of venous thromboembolism. 21. Develop a comprehensive antithrombotic regimen and monitoring strategy for a pregnant woman with a history of obstetric complications in the setting of thrombophilia. 22. Develop a comprehensive antithrombotic regimen and monitoring strategy for a pregnant woman presenting with acute deep venous thrombosis or pulmonary embolism. 23. Develop a comprehensive antithrombotic regimen and monitoring strategy for a pregnant woman with mechanical heart valve prosthesis. 24. Distinguish which female patients should undergo thrombophilia testing and evaluate the findings of such testing as it relates to pregnancy.

1. The educational content of the materia presented was appropriate for a pharmacotherapy specialist. 2. The scope, depth, and relevance of the material presented were appropriate for a pharmacotherapy specialist. 3. The material presented was relevant and applicable to my practice. 4. The content of the module was objective and balanced. 5. The instructional materials were constructive for helping me learn and retain the information. 6. The learning objectives were adequately assessed by the self-assessment questions. 7. The self-assessment questions were written clearly. Questions 8–13 apply to the learning objectives of Cardiovascular Disease in Women. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives: 8. Evaluate the impact of sex on morbidity and mortality from cardiovascular disease (CVD). 9. Evaluate cardiovascular risk factors to determine their relative importance in women versus men. 10. Assess the impact of gender-based biases on CVD morbidity and mortality in women. 11. Distinguish sex-based differences in cardiovascular pathophysiology, presentation, and diagnosis. 12. Formulate an opinion regarding CVD treatment disparities between men and women. 13. Apply knowledge of pharmacokinetic differences between men and women to minimize adverse drug events. 14. Apply current literature regarding treatment effectiveness in women who have coronary artery disease, with special consideration given to aspirin therapy. 15. Detect specific differences in evidence-based treatment guidelines between men and women. PSAP-VII • Cardiology

Questions 25–29 apply to the learning objectives of Evaluating Drug-Induced Cardiovascular Disease: A Pharmacoepidemiologic Perspective. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives: 25. Distinguish among available pharmacovigilance methodologies used in adverse event surveillance. 26. Evaluate the strengths of pharmacovigilance methodology to assess possible adverse events from cardiovascular drugs. 27. Estimate adverse event detection limits in pharmacoepidemiologic studies of cardiovascular drugs through application of knowledge regarding study design, sample size, and participant enrollment. 177

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28. Demonstrate an in-depth practical understanding of the merits and shortcomings of common pharmacoepidemiologic study designs used to assess adverse events identified through pharmacovigilance. 29. Assess a recent example of drug-induced cardiovascular disease in light of the study designs used in their discovery and form an educated opinion, considering all available evidence. Questions 30–36 apply to the learning objectives of Interpreting Data in Cardiovascular Disease Clinical Trials: A Biostatistical Toolbox. Use the scale above to indicate whether the chapter prepared you to accomplish each of the following learning objectives: 30. Distinguish among types of outcome variables and the appropriate statistical tools that can be used to interpret these data. 31. Evaluate the pros and cons of surrogate and composite end points in clinical trials. 32. Apply basic measures of effect size (i.e., absolute and relative risk reductions, and number needed to treat). 33. Explain the concepts of power and sample size and evaluate their impact on trial design and results interpretation. 34. Assess the use of regression and survival analysis in the interpretation of clinical trials. 35. Evaluate the use of non-inferiority designs in clinical trials. 36. Evaluate the use and role of systematic reviews and meta-analyses of clinical trials. Questions 37–39 apply to the Cardiology III module. 37. How many minutes (total) did it take you to read all the chapters (learning objectives, text, tables/figures, and annotated bibliographies) for this module? 38. How many minutes (total) did it take you to answer all the questions for this module? 39. Do you have any comments on this module?

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