Clinical pharmacy education, practice and research : clinical pharmacy, drug information, pharmacovigilance, pharmacoeconomics and clinical research

목차 (Table of Contents)

• CONTENTS
• List of Contributors = xvii
• Preface = xxi
• Acknowledgments = xxiii
• 1 Introduction to Clinical Practice, Research, and Pharmacy Education / Dixon Thomas ; Jennifer Marriott ; Rao Vadlamudi ; Benny Efendie ; Lucinda L. Maine
• Objective 1.1 Describe Salient Features of Clinical Practice of Pharmacists = 1
• Objective 1.2 Address Relevant Concepts in Pharmacy Education Leading to Clinical Practice = 3
• Objective 1.3 Outline How Research in Pharmacy Is Improving Patient Outcomes = 6
• Conclusion = 7
• Practice Questions = 7
• References = 8
• Answers to Practice Questions = 9
• Section Ⅰ General Clinical Pharmacy
• 2 Evolution of the Pharmacy Profession and Public Health / Balkrishna Khakurel ; Rishav Shrestha ; Sachita Joshi ; Dixon Thomas
• Objective 2.1 Outline Historical Developments in the Pharmacy Profession = 13
• Objective 2.2 Overview Eras of Pharmaceutical Industries and Their Jobs for Pharmacy Graduates = 17
• Comparison of Financial Volume of Pharmaceutical Industries With Other Industries = 18
• Career Opportunities for Pharmacy Graduates in Pharmaceutical Industries = 18
• Objective 2.3 Discuss Policies AND LAWS Governing the Pharmacy Profession and Public Health = 19
• World Health Organization = 19
• United States Drug Legislations = 20
• International Pharmaceutical Federation or Federation Internationale Pharmaceutique = 22
• International Patient Safety Goals = 23
• Objective 2.4 Detail an Overview of Public Health and Disease Prevention = 24
• Organizations Involved in International Public Health = 24
• Disease Prevention = 26
• Conclusion = 27
• Practice Questions = 28
• References = 28
• Answers to Practice Questions = 30
• 3 Clinical and Social Perspectives on Pharmacy Services / Anna Birna Almarsddttir ; Anne Gerd Granas ; Anna Bryndis Blondal
• Objective 3.1 Position Pharmacists in the Healthcare System = 31
• Objective 3.2 Describe the Patient Viewpoints on Clinical Pharmacy Services = 33
• Polypharmacy and Inappropriate Drug Use = 33
• Nonadherence to Pharmacotherapy-The Patients' Perspective on Taking Drugs = 33
• Objective 3.3 Highlight the Pharmacist Perspective on Clinical Pharmacy Services = 34
• Pharmaceutical Care-A Central Concept in Patient Care = 34
• Medication Reviews and Drug Therapy Problems = 34
• Cognitive Pharmaceutical Services = 35
• Objective 3.4 Describe the Institutional and Societal Viewpoints on Clinical Pharmacy Services = 35
• Barriers and Facilitators for Implementing Clinical Pharmacy Services = 37
• Understanding the Environment and Structure of Healthcare = 38
• Conclusion = 38
• Practice Questions = 38
• References = 38
• 4 Pharmacy Management / Johann Kruger ; Raj Vaidya ; Erick Sokn
• Objective 4.1 Outline the Major Principles in Managing a Pharmacy = 41
• Financial Management = 41
• Personnel Management = 45
• Regulatory Compliance = 48
• Objective 4.2 Overview the Purchase, Inventory Control, Storage, Drug Distribution, Compounding, and Disposal of Drugs and Related Products = 48
• Organization (Arrangement) of Products in a Hospital Pharmacy = 50
• Objective 4.3 Illustrate a Model Pharmacy and Detail the Facilities Required = 51
• Objective 4.4 Overview Pharmacy Practice Setting and Responsibilities of Professionals = 54
• Responsibilities of Personnel Involved in Pharmacy Operations = 55
• Objective 4.5 Explain Advantages and Limitations of Pharmacy Automation = 56
• Conclusion = 57
• Practice Questions = 57
• References = 57
• Answers to Practice Questions = 58
• 5 Rational Drug Use, Formulary Management, Pharmaceutical Care / Medication Therapy Management / Pharmacists' Patient Care Process / Seeba Zachariah ; Angela Hill ; Dixon Thomas ; Ola Ghaleb Al Ahdab ; Daniel Buffington
• Objective 5.1 Define Drug/Medicine, Medication, and Health Technology = 59
• Drug Names = 60
• Objective 5.2 Overview Rational Drug Use in Clinical Practice = 60
• Objective 5.3 Detail the Constitution and Functions of a Drug and Therapeutics Committee = 61
• Constitution of Drug and Therapeutics Committee = 62
• Functions of Drug and Therapeutics Committee = 62
• Objective 5.4 Discuss Essential Medicines Policy and Formulary Management = 63
• WHO Criteria for Selection of Essential Medicines = 63
• Objective 5.5 Explain Methods in Drug Use Evaluation (Drug Utilization Review) = 64
• Objective 5.6 Explain Methods to Standardize Pharmacy Education and Practice : Pharmaceutical Care, Medication Therapy Management, CAPE Educational Outcomes, Nanjing Statement, Pharmacists' Patient Care Process, and Entrustable Professional Activities = 65
• Pharmaceutical Care = 65
• Medication Therapy Management = 67
• Nanjing Statements = 70
• CAPE Educational Outcomes = 70
• Pharmacists' Patient Care Process = 71
• Core Entrustable Professional Activities = 73
• Conclusion = 75
• Practice Questions = 75
• References = 76
• Answers to Practice Questions = 77
• 6 Communication Skills and Patient History Interview / Shaun Wen Huey Lee ; Dixon Thomas ; Seeba Zachariah ; Jason C. Cooper
• Objective 6.1 Explain Why Communication Skills Are Essential for Pharmacists = 79
• Pharmacists' Communication Skills Relevant to Consumers = 80
• Pharmacists' Communication Skills Relevant to Other Healthcare Professionals = 80
• Objective 6.2 Detail the Elements of Professional Communication = 80
• Key Communication Skills = 81
• Objective 6.3 Identify Barriers to Communication and Suggest How to Overcome Them = 83
• Objective 6.4 Discuss the Characteristics and Process of the Patient History Interview = 85
• Involve the Patient in the Care Process = 85
• History Interview for Clinical Diagnosis = 85
• The Patient History Interview Should Be Ethical = 86
• The Information Collected Should Be Reliable = 86
• Conclusion = 88
• Practice Questions = 88
• References = 89
• Answers to Practice Questions = 89
• 7 Interpretation of Laboratory Data and General Physical Examination by Pharmacists / Seeba Zachariah ; Kiran Kumar ; Shaun Wen Huey Lee ; Wai Yee Choon ; Saba Naeem ; Christine Leong
• Objective 7.1 Describe Common Laboratory Tests and Interpret Their Clinical Significance to the Practice of Pharmacists = 91
• Electrolytes = 92
• Blood Gas = 92
• Blood Glucose = 93
• Hematology = 93
• Renal Function = 95
• Liver Function = 96
• Thyroid Function = 97
• Lipid Profile = 98
• Cardiac Enzymes = 100
• Objective 7.2 Discuss the Scope of General Physical Examination by Pharmacists = 100
• Context = 101
• Pharmacist-Patient Interaction = 101
• Prerequisites = 101
• Objective 7.3 Explain How to Measure and Interpret Vital Signs = 102
• Body Temperature = 102
• Peripheral Pulses = 102
• Respiration Rate = 102
• Blood Pressure = 103
• Objective 7.4 Perform a Detailed Head-To-Toe Physical Examination and Explain Possible Findings = 104
• Head and Neck = 104
• Eyes = 104
• Face = 104
• Oral Cavity = 104
• Neck = 105
• Upper Limbs and Hands = 105
• Lower Limbs = 106
• Conclusion = 106
• Practice Questions = 106
• References = 107
• Answers to Practice Questions = 108
• 8 Dispensing Process, Medication Reconciliation, Patient Counseling, and Medication Adherence / Ema Paulino ; Dixon Thomas ; Shaun Wen Huey Lee ; Jason C. Cooper
• Objective 8.1 List Steps in the Dispensing Process = 109
• Receive and Validate the Prescription = 110
• Assess and Review the Prescribed Drugs = 111
• Select / Prepare, Package, and Check Against the Original Prescription = 111
• Label Drugs = 112
• Supply and Provide Counseling = 112
• Record the Intervention = 113
• Objective 8.2 Detail Methods in Medication Reconciliation to Prevent Errors = 113
• Objective 8.3 Explain Approaches to Patient Counseling = 114
• Objective 8.4 Outline Strategies to Improve Medication Adherence = 116
• Conclusion = 118
• Practice Questions = 118
• References = 118
• Answers to Practice Questions = 120
• Section Ⅱ Drug Information
• 9 Drug Information Services and Sources of Information / Matthew P. Van Cuyk ; Jason C. Cooper ; James P. New
• Objective 9.1 Outline Features of Drug Information Centers and Types of Drug Information Services Provided in a Hospital = 123
• Drug Information Centers = 123
• Responding to Drug Information Questions = 124
• Formulary Management = 124
• Adverse Drug Reactions / Medication Errors = 126
• Education = 126
• Objective 9.2 Describe Applications of Common Sources of Drug Information = 126
• Tertiary References = 126
• Secondary References = 128
• Primary References = 136
• Drug Information Website Descriptions = 137
• Objective 9.3 Overview of Drug Information Quality on the Internet = 138
• Evaluation of Resources = 138
• Conclusion = 139
• Practice Questions = 140
• References = 140
• Answers to Practice Questions = 142
• 10 Medical Literature Evaluation and Biostatistics / Christopher S. Wisniewski ; Emily P. Jones ; Erin R. Weeda ; Nicole A. Pilch ; Mary Frances Picone
• Objective 10.1 Overview Medical Literature Evaluation and Common Features of Reputed Journals = 143
• Journals = 143
• Identifiers and Metrics = 144
• Research Reporting Guidelines = 145
• Objective 10.2 Explain How to Interpret and Evaluate a Typical Journal Article, Including the Common Biostatistics Methods = 146
• Title of the Article = 146
• Authors = 146
• Abstract = 147
• Introduction = 147
• Methods = 147
• Results = 155
• Discussion = 157
• Conclusion = 158
• Bibliography = 158
• Objective 10.3 Utilize Clinical Expertise to Identify the Overall Validity of a Given Clinical Trial = 158
• Conclusion = 159
• Practice Questions = 159
• References = 160
• Answers to Practice Questions = 162
• 11 Evidence-Based Practice: Use in Answering Queries and Developing Systematic Reviews / Emily Brennan ; Jason C. Cooper ; Amanda Davis
• Objective 11.1 Define Evidence-Based Practice and Explain Its Framework = 163
• Other Methods Used in EBP = 164
• Objective 11.2 Recognize and Employ the Steps for the Modified Systematic Approach When Answering Drug Information-Related Questions = 164
• Secure the Demographics of the Requester = 165
• Retrieving Necessary Background Information = 166
• Determining the True Informational Need and Categorizing the Ultimate Question = 166
• Developing a Sound Searching Strategy and Conducting a Thorough Search (Validate and Verify) = 168
• Evaluation, Analysis, and Synthesis of Gathered Information = 170
• Objective 11.3 Describe the Process of Preparing Systematic Reviews Using Evidence-Based Practice = 172
• Conclusion = 174
• Practice Exercise = 174
• References = 176
• 12 Clinical Guidelines for Decision-Making / Elangovan Gajraj ; Leeza Osipenko
• Objective 12.1 Overview the Rationale for the Use of Clinical Guidelines = 177
• Objective 12.2 Set the Framework for the Development of a Clinical Guideline = 179
• Before Developing a Guideline = 179
• Prioritization = 179
• Who Is Involved? = 180
• Managing Conflict of Interests = 181
• Objective 12.3 Introduce the Methodology of Clinical Guideline Development = 182
• Developing a Guideline = 182
• Definition and Purpose of Scope = 182
• Gathering Evidence = 184
• Developing Clinical Questions = 184
• Systematic Search for Evidence = 185
• Appraising Identified Research Evidence = 185
• From Evidence to Recommendations = 186
• Consultations = 187
• Publishing = 188
• Objective 12.4 Explain the process of implementation and update of a Clinical Guideline = 188
• Implementation = 188
• Reviewing and Updating Guidelines = 188
• Conclusion = 189
• References = 189
• Further Reading = 190
• 13 Drug Information Training for Pharmacists / Dixon Thomas ; Ivellise Costa De Sousa ; David J. Woods ; Ronald A. Herman ; Danial E. Baker
• Objective 13.1 Explain Why Pharmacists in Any Work Setting Require
• Well-Founded Drug Information Skills = 191
• Objective 13.2 Review Drug Information Training Strategies for Pharmacy Students = 192
• Objective 13.3 Categorize Drug Information Skills to Be Covered During Training = 193
• Objective 13.4 Plan a Week-Wise Follow-Up of Learning Objectives Achieved in Drug Information Training = 195
• Conclusion = 198
• References = 198
• Section Ⅲ Pharmacoepidemiology and Pharmacovigilance
• 14 Essentials of Pharmacoepidemiology / Douglas T. Steinke
• Objective 14.1 Outline Pharmacoepidemiology and Its Methodological Terminologies = 203
• Link to Pharmacoeconomic Studies = 204
• Methodological Terminology = 204
• Objective 14.2 Explain Study Designs Used in Pharmacoepidemiology Research = 206
• Ecological / Cross-Sectional Studies = 206
• Case-Control Studies = 206
• Measure of Association for a Case-Control Study = 207
• Cohort Studies = 208
• Measure of Association for a Cohort Study = 208
• Summary Comparison Tables of Study Designs = 209
• Data Used in Pharmacoepidemiological Research = 209
• Postmarket Surveillance = 210
• Pharmaceutical Policy Issues = 211
• Objective 14.3 Discuss How Pharmacoepidemiology Influences Health Improvement = 211
• Vaccination Services and Disease Prevention : an Example of Pharmaceutical Public Health = 212
• Decision Making = 212
• Determinants of Health = 212
• Conclusion = 213
• Practice Questions = 213
• References = 214
• Answers to Practice Questions = 214
• 15 Pharmacovigilance Systems / Dixon Thomas ; Christoph Klika
• Objective 15.1 Introduce the concepts pharmacovigilance, adverse drug event, and adverse drug reaction = 215
• Pharmacovigilance (WHO 2002) = 215
• Overview of Pharmacovigilance Systems = 216
• Poor Quality Product = 218
• Suboptimal Drug Use = 218
• Unidentified Factors = 218
• Objective 15.2 Describe the Pharmacovigilance Framework and the Roles of Different Stakeholders in Patient Safety = 219
• Patient / Carers = 219
• Healthcare Professionals = 219
• Manufacturers = 220
• Regulators = 220
• International Organizations and Healthcare Organizations = 220
• Objective 15.3 Explain How to Report Adverse Drug Events = 221
• Spontaneous Reporting on Adverse Drug Reactions = 222
• Mandatory Reporting = 223
• Conclusion = 223
• Practice Questions = 223
• References = 224
• Answers to Practice Questions = 225
• 16 Adverse Drug Events, Medication Errors, and Drug Interactions / Vincent W.L. Tsui ; Dixon Thomas ; Shuhui Tian ; Allen J. Vaida
• Objective 16.1 Classify and Detail Adverse Drug Events = 227
• Classification of Adverse Drug Reactions = 228
• Objective 16.2 Explain Methods for Prevention and Management of Adverse Drug Events = 229
• Preventability of Adverse Drug Events = 229
• Use of Signals = 230
• Causality Assessment of Adverse Drug Reactions = 231
• Objective 16.3 Classify and Detail Medication Errors = 232
• Types of Medication Errors = 232
• The Scope of the Problem = 232
• Categorization of Medication Errors = 233
• Objective 16.4 Explain Methods for Prevention and Management of Medication Errors = 234
• Common Causes of Medication Errors = 234
• Measures to Be Taken to Prevent Medication Errors = 234
• The Institute for Safe Medication Practices-Sharing and Learning From Errors = 234
• Objective 16.5 Classify and Detail Drug Interactions = 236
• Desirable Drug Interactions = 236
• Drug Interactions Precipitated by Agents Other Than Drugs = 236
• Pharmaceutical Drug Interactions (Incompatibilities) = 237
• Pharmacokinetic Drug Interactions = 237
• Pharmacodynamic Drug Interactions = 237
• Interindividual Variations = 238
• Objective 16.6 Explain Methods for Prevention and Management of Drug Interactions = 239
• Risk Ratings of Drug Interactions = 240
• Discontinuation = 240
• Therapy Modification = 240
• Monitoring Without Interventions = 241
• Balance of Strategies = 241
• Conclusion = 242
• Practice Questions = 242
• References = 243
• Answers to Practice Questions = 245
• Section Ⅳ Pharmacoeconomics and Outcomes Research
• 17 Market Access, Pharmaceutical Pricing, and Healthcare Costs / Dixon Thomas ; Denny John ; Nermeen Ashoush ; Federico Lega ; Hong Li
• Objective 17.1 Outline Market Access Policies by Pharmaceutical and Medical Technology Industries = 249
• Objective 17.2 Overview Pricing Practices of Pharmaceuticals = 251
• Supply and Demand Curves = 252
• Objective 17.3 Explain types of HealthCare Costs and their Estimation = 253
• Costing Terms = 253
• Cost Categorization = 254
• Perspective = 255
• Estimating Costs = 255
• Methods to Measure Indirect Costs = 256
• Time Adjustment for Cost = 257
• Conclusion = 257
• Practice Questions = 257
• References = 258
• Answers to Practice Questions = 259
• 18 Pharmacoeconomic Analyses and Modeling / Dixon Thomas ; Mickael Hiligsmann ; Denny John ; Ola Ghaleb Al Ahdab ; Hong Li
• Objective 18.1 Discuss the Purpose of Pharmacoeconomic Analyses = 261
• Burden of Disease and Affordability = 262
• Economic Evaluations Finding Value for Money Spent = 262
• Pharmacoeconomic Evaluation Purpose = 262
• Full Versus Partial Economic Evaluation = 262
• Levels of Application = 263
• Objective 18.2 Explain Pharmacoeconomic Analysis Approaches = 263
• Cost-of-Illness = 263
• Budget-Impact Analysis = 263
• Cost-Comparison Analysis = 265
• Cost-Minimization Analysis = 265
• Cost-Benefit Analysis = 266
• Cost-Consequence Analysis = 266
• Cost-Effectiveness Analysis = 266
• Cost-Utility Analysis = 268
• Perspectives in Pharmacoeconomic Analysis = 269
• Sensitivity Analysis in the Pharmacoeconomic Analysis = 269
• Discounting in Pharmacoeconomic Evaluations = 270
• Objective 18.3 Describe Common Pharmacoeconomic Modeling Methods = 270
• Decision Analyses = 271
• Markov Model = 272
• Conclusion = 273
• Practice Questions = 273
• References = 274
• Answers to Practice Questions = 275
• 19 Interpreting Pharmacoeconomic Findings / Piyameth Dilokthornsakul ; Dixon Thomas ; Lawrence Brown ; Nathorn Chaiyakunapruk
• Objective 19.1 Describe the Influence of Pharmacoeconomics in Healthcare = 277
• Objective 19.2 Explain How to Interpret Pharmacoeconomic Analysis Findings = 279
• Pharmacoeconomic Reporting Guidelines = 282
• Conclusion = 285
• Practice Questions = 285
• References = 286
• Answers to Practice Questions = 287
• 20 Outcomes Research / Erin R. Weecfa ; Nicole A. Pilch ; Lieven Annemans
• Objective 20.1 Define and Classify Outcomes Research = 289
• Characteristics of Outcomes Research = 289
• Economic, Clinical, and Humanistic Outcomes = 290
• Donabedian's Structure-Process-Outcome Model = 290
• Objective 20.2 Contrast Outcomes Research With Traditional Clinical Trial Research = 291
• Overlap Between Outcomes Reasearch and Clinical Trials = 291
• Objective 20.3 Define and Explain How to Measure Health-Related Quality of Life and Patient-Reported Outcomes = 293
• Defining Health-Related Quality of Life and Patient-Reported Outcomes = 294
• Distinction Between Health-Related Quality of Life and Patient-Reported Outcomes = 294
• Measuring Health-Related Quality of Life = 294
• Measuring Domain-Specific Patient-Reported Outcomes = 296
• Patient or Clinician, Who Should Fill a Questionnaire? = 296
• Objective 20.4 Generalize How Outcomes Research Is Gaining Importance in Clinical Practice = 297
• Conclusion = 298
• Practice Questions = 298
• References = 300
• Answers to Practice Questions = 301
• 21 Health Technology Assessment- Policy Objectives and Principles of System Design / David Dankd
• Objective 21.1 Overview of Health Technology Assessment From a Policy Perspective = 303
• Meaning and Purpose of Health Technology Assessment = 303
• Policy Objectives Related to Health Technology Assessment = 304
• Objective 21.2 Describe Different Paradigms in the Assessment of Health Technologies = 304
• Economic Evaluation = 305
• Comparative Assessment = 306
• Multidimensional Value Assessment Approaches = 307
• Objective 21.3 Describe a High-Level Health Technology Assessment Process = 308
• Objective 21.4 Explain Health Technology Assessment System Design in Current Practice = 309
• Conclusion = 310
• Practice Questions = 310
• References = 311
• Answers to Practice Questions = 312
• 22 NICE Guidance and Health Technology Assessment / Leeza Osipenko ; Elangovan Gajraj
• Objective 22.1 Overview of National Institute for Health and Care Excellence Guidance Development and Evidence-Based Practice = 313
• NICE Guidance = 315
• Objective 22.2 Explain the Purpose, Production, and Principles of Technology Appraisal Guidance = 315
• Technology Appraisals (TAs) = 315
• Methods = 317
• Types of Appraisals and Processes = 318
• Objective 22.3 Detail the NICE Technology Appraisal Committee Process and Decision-Making = 319
• Conclusion = 320
• References = 320
• Section Ⅴ Clinical Research
• 23 Clinical Trials / Gunasakaran Sambandan ; Adina Turcu-Stiolica
• Objective 23.1 Introduce Clinical Research Methods = 323
• Objective 23.2 Detail Methodological Aspects in Clinical Trials = 325
• Randomization = 326
• Blinding = 331
• Controls = 331
• Study Designs = 331
• Crossover Studies = 331
• Parallel Studies = 332
• Steady-State Studies = 332
• Basket and Umbrella Trials = 332
• Adaptive Study Design = 332
• Registry Trials = 332
• Objective 23.3 Explain the Phases of Clinical Trials = 332
• Phases of Clinical Trials = 332
• Phase 0 = 333
• Phase 1 = 333
• Phase 2-Therapeutic Exploratory Phase = 334
• Phase 3-Therapeutic Confirmatory Phase = 336
• Phase 4-Postmarketing Surveillance = 337
• Objective 23.4 Discuss the Role of Pharmacists and Newer Technologies in Clinical Research = 338
• Review of Protocol and Trial-Related Documents = 338
• Receipt, Storage, and Accountability of the Investigational Product = 338
• Dispensing of the Investigational Product = 338
• Return / Destruction of Investigational Products = 338
• Blinding / Unblinding Procedure of Codes = 339
• Conclusion = 340
• Practice Questions = 340
• Crossword Exercise = 341
• References = 342
• Answers to Practice Questions = 343
• Crossword Answers = 344
• 24 Ethics in Clinical Research / Nisha Rajendran ; Dixon Thomas ; S. Suresh Madhavan ; Ronald A. Herman
• Objective 24.1 Overview Untoward Drug Incidents That Influenced the Evolution of Ethics in Clinical Research = 345
• Tuskegee Syphilis Study (1932-72) = 345
• Elixir Sulfanilamide Disaster (1937) = 347
• Nuremberg Trials (Nazi Trials 1945-49) = 347
• Cutter Incident (1955) = 347
• Thalidomide Disaster (1962) = 347
• The Unfortunate Experiment (1960s-80s) = 348
• Other Major Issues Reported in Recent Times = 348
• Objective 24.2 Explain Salient Features of Laws and Guidelines in History to Counter Unethical Research = 348
• Food, Drug and Cosmetic Act (1938) = 348
• Nuremberg Code (1947) = 348
• Kefauver Harris Drug Amendment Act 1962 (Amendment to Federal Food, Drug and Cosmetic Act) = 349
• Declaration of Helsinki = 349
• Belmont Report (April 18, 1979) = 352
• International Council on Harmonization and Good Clinical Practice = 353
• Guidance From the Council for International Organization of Medical Sciences in Collaboration With the World Health Organization = 354
• Objective 24.3 Detail the Constitution and Process of Review by the Research Ethics Committee = 354
• Composition of the IEC / IRB = 354
• Registration of the IEC / IRB = 355
• Documents that Need to Be Submitted to the IEC / IRB for Approval = 355
• Communications and Functions of the IEC / IRB = 355
• Expedited Review Procedure of the IEC / IRB = 356
• Objective 24.4 Describe the Informed Consent Process in Clinical Research = 356
• Consent Process = 356
• Role of Legally Acceptable Representative = 357
• Responsibilities of the Legally Authorized Representative = 357
• What if the Legally Acceptable Representative is Illiterate? = 358
• Objective 24.5 Examples of Some Unethical Practices in Current Clinical Research = 358
• Conclusion = 360
• Practice Questions = 360
• Crossword Exercise = 361
• References = 362
• Answers to Practice Questions = 364
• Crossword Answers = 364
• 25 Stakeholders, Resources, and Documents in Clinical Research / Deepak C. Chilkoti
• Objective 25.1 Explain Responsibilities of Stakeholders in Clinical Research = 365
• Institutional Review Board/Independent Ethics Committee = 365
• Investigator = 366
• Responsibilities of the Investigator = 366
• Sponsor = 368
• Responsibilities of the Sponsor = 368
• Regulator = 371
• Contract Research Organization = 371
• Auditor = 371
• Clinical Research Coordinator = 371
• Clinical Research Associate = 371
• Data and Safety Monitoring Board (Independent Data-Monitoring Committee) = 372
• Participants (Subject / Trial Subject) = 372
• Objective 25.2 Overview of the Common Resources and Documents Used in Clinical Research = 372
• Documents in Clinical Trials = 373
• Conclusion = 377
• References = 377
• Section Ⅵ Pharmacy Education
• 26 Quality Assurance in Pharmacy Education / Dawn G. Zarembski ; Michael J. Rouse ; Peter H. Vlasses
• Objective 26.1 Describe Quality Assurance of Pharmacy Curricula in a Global Perspective = 381
• Pharmacy Education Planning = 381
• Framework-Based Quality Assurance Systems Development = 382
• Objective 26.2 Explain the Role of ACPE in Accreditation and Certification of Pharmacy Programs = 383
• Structure and Mission = 383
• Standards Development = 384
• Accreditation Process = 385
• Objective 26.3 Detail the Curriculum Mapping Process in Pharmacy Education = 385
• Conclusion = 386
• References = 386
• 27 Adult Learning Theories in Pharmacy Education / Kashelle Lockman ; Dixon Thomas ; Lilian H. Hill
• Objective 27.1 Outline the Concepts in Adult Learning Relevant to Pharmacy Education = 389
• Objective 27.2 Explain Applications of Adult Learning Principles in Pharmacy Education = 391
• Objective 27.3 Describe How to Write Learning Objectives in Pharmacy Education = 393
• Revised Bloom's Taxonomy = 394
• Conclusion = 396
• References = 396
• 28 What to Expect From a Pharmacist Preceptor / Susan S. Vos ; Mary E. Ray
• Objective 28.1 Differentiate the Roles of a Preceptor and Clarify the Terms Preceptor, Mentor, Faculty, Intern, and Resident = 399
• The Roles of a Preceptor = 400
• Objective 28.2 Describe the Qualities of Effective Preceptors and Responsibilities of Students = 401
• Qualities of Effective Preceptors = 401
• Receiving Effective Feedback = 403
• Objective 28.3 Detail How to Develop a Productive Student-Preceptor Relationship = 404
• Prior to the Experience = 404
• During the Experience = 405
• At the End of the Experience / Following the Experience = 405
• Ready for Practice = 405
• Conclusion = 406
• References = 406
• Section Ⅶ Pharmacokinetics/Pharmacogenomics/Nutrition
• 29 Clinical Pharmacokinetics / Mohammad Kowser Miah ; Imam Hussain Shaik ; Firuz Gamal Feturi ; Alshabi Ah ; Raman Venkataramanan
• Objective 29.1 Explain the Basic Concepts in Clinical Pharmacokinetics = 409
• Clinical Pharmacokinetics and Terminology = 409
• Pharmacokinetic Models = 416
• Objective 29.2 Discuss Factors Affecting Pharmacokinetics of a Drug = 417
• Absorption = 417
• Distribution = 418
• Metabolism = 418
• Excretion = 420
• Objective 29.3 Outline Pharmacometrics = 420
• Population Pharmacokinetic Modeling and Simulation = 420
• Application of Sparse or Limited Sampling in PopPK = 421
• Physiologically Based Pharmacokinetic Modeling and Simulation = 421
• Conclusion = 423
• Practice Questions = 423
• References = 424
• Answers to Practice Questions = 424
• 30 Therapeutic Drug Monitoring / Toluwalope Junaid ; Xuemei Wu ; Harisudhan Thanukrishnan ; Raman Venkataramanan
• Objective 30.1 Describe the Concept and Need for Therapeutic Drug Monitoring = 425
• Drug Dosing and Personalized Drug Therapy = 425
• Optimizing the Use of Medications : Therapeutic Drug Monitoring = 426
• Measurement of Systemic Drug Levels = 427
• Clinical Interpretation of Therapeutic Drug Monitoring Reports = 427
• Limitations of Therapeutic Drug Monitoring = 434
• Conclusion = 434
• References = 435
• 31 Pharmacogenomics and Precision Medicine / David F. Kisor ; Carrie Hoefer ; Brian S. Decker
• Objective 31.1 Define Terms and Explain Basic Concepts in Pharmacogenetics / Pharmacogenomics = 437
• Genetic Variations = 438
• Nomenclature = 439
• Pharmacogenomic Testing in Pharmacotherapy = 440
• Objective 31.2 Explain the Relationship of Pharmacogenomics With Pharmacokinetics and Pharmacodynamics = 440
• Example Drug-Gene Interactions = 441
• Objective 31.3 Describe Pharmacist Competencies in Genomics / Pharmacogenomics and Their Roles in Precision Medicine = 445
• Basic Genetic Concepts = 445
• Genetic and Disease = 446
• Pharmacogenetics / Pharmacogenomics = 446
• Ethical, Legal, and Social Implications = 446
• Growth and Future Direction of Pharmacogenomics = 447
• Conclusion = 447
• Practice Questions = 447
• References = 448
• Answers to Practice Questions = 451
• 32 TPN Primer for the Pharmacist: Approach to Nutrition Therapy / Mark Decerbo
• Objective 32.1 Explain the Need of Parenteral Nutrition = 453
• Determine if Parenteral Nutrition Needed = 453
• Assessing the Patient = 454
• Objective 32.2 Plan Administration, Calculation, and Preparation of Parenteral Nutrition = 455
• Protein = 456
• Carbohydrate = 456
• Fat = 456
• Micronutrients = 456
• Electrolytes = 457
• Parenteral Nutrition Preparation = 457
• Conclusion = 460
• Practice Questions = 460
• References = 460
• Answers to Practice Questions = 461
• Section Ⅷ Conclusion
• 33 Advanced Clinical Pharmacy Practitioner / Erick Sokn ; Sam Calabrese ; Douglas Scheckelhoff ; Dixon Thomas ; Jason A. Roberts
• Objective 33.1 Review the Outcomes of Pharmacist-Provided Interventions = 465
• Inpatient Practice = 465
• Ambulatory Practice = 466
• Community Pharmacy Practice = 466
• Objective 33.2 Overview Innovative Specialty Pharmacy Practice Models = 467
• Prescriptive Authority = 467
• Pharmacist Providers = 467
• Objective 33.3 Explain the Development of Competencies in Pharmacy Workforce Leadership = 467
• Vision = 468
• Communication Skills and Relationship Building = 468
• Emotional Intelligence = 469
• Challenge the Status Quo / Change Management = 469
• Resilience = 469
• Objective 33.4 Detail Continuing Education Needs of Pharmacists = 469
• Certificate Programs = 470
• Certification = 470
• Residency Training = 470
• Conclusion = 471
• References = 471
• Appendix Ⅰ = 473
• Appendix Ⅱ = 483
• Index = 507