The Clinical Practice of Drug Information

Title
......Page 2
Copyright......Page 3
Contents......Page 4
Preface......Page 16
About the editor......Page 18
Contributors......Page 20
Reviewers......Page 26
Chapter 1 Introduction to Drug Information Practice
......Page 28
History......Page 29
Practice Settings......Page 31
Pharmacy Curricular Instruction......Page 34
Residency Training......Page 35
Future Directions and Challenges......Page 36
References......Page 37
Chapter 2 The Systematic Approach to Responding to Drug Information Requests 
......Page 38
Receiving the Demographics of the Requestor......Page 39
Receiving the Background Information......Page 40
Receiving the Ultimate Question and Categorization......Page 43
Solicitation of Drug Information Requests Through Intermediaries......Page 44
Research......Page 45
Respond......Page 47
Record......Page 49
Continuous Quality Improvement......Page 54
Informal Drug Information Services......Page 55
Outcome Tracking......Page 56
References......Page 57
Chapter 3 Tertiary Sources of Information
......Page 58
AHFS® Drug Information (DI)™......Page 59
Drug Facts and Comparisons®
......Page 61
Clinical Drug Data......Page 62
Physicians’ Desk Reference......Page 63
Drug Interactions......Page 64
Adverse Drug Reactions......Page 67
Pregnancy and Lactation......Page 69
Pediatrics......Page 73
Compatibility and Stability......Page 75
Natural Products......Page 76
Foreign Drugs......Page 79
Other Specialty Areas......Page 80
Electronic Applications......Page 81
Sources for Mobile Applications and Digital Information
......Page 82
Summary......Page 84
References......Page 85
Chapter 4 Secondary Sources of Information
......Page 86
Search Strategy Issues......Page 87
Subheadings......Page 88
MEDLINE and PubMed......Page 89
Google Scholar......Page 91
Cochrane Library......Page 92
Other Specialty Resources......Page 93
Comparison of Secondary Resources......Page 94
Summary......Page 95
References......Page 96
Chapter 5 Primary Sources of Information
......Page 98
Introduction......Page 99
Advantages and Disadvantages of Primary Literature......Page 100
Journal Affiliations......Page 102
Impact Factor......Page 103
Publication in Peer-Reviewed Journals......Page 107
Title/Authors......Page 108
Methods......Page 109
References......Page 110
Summary......Page 111
References......Page 112
Chapter 6 Introduction to Clinical Study Design
......Page 114
Introduction......Page 116
Study Objectives......Page 117
Secondary Outcomes......Page 118
Safety Analyses......Page 119
Post-Hoc Analyses......Page 120
Precision and Accuracy......Page 121
Negative and Positive Predictive Values......Page 125
Sensitivity and Specificity......Page 126
Surrogate and Direct Outcomes......Page 128
Composite Outcomes......Page 129
Observational and Interventional (Experimental) Studies......Page 130
Parallel, Matched, and Crossover Studies......Page 131
Superiority, Equivalency, and Noninferiority Studies......Page 132
Populations and Sampling......Page 136
Probability (Random) Sampling......Page 137
Nonprobability (Nonrandom) Sampling......Page 138
Subject Criteria and Screening......Page 139
Study Groups and Subject Allocation......Page 140
Randomization Techniques......Page 141
Blinding......Page 142
Study Validity......Page 143
Internal and External Validity......Page 144
Principal Publications......Page 145
Standards of Care......Page 147
Special Populations......Page 148
Summary......Page 149
References......Page 151
Chapter 7 Research Study Design
......Page 152
Case Reports and Case Series......Page 153
Cross-Sectional Studies......Page 154
Observational Studies......Page 155
Interventional Studies and Randomized Controlled Trials......Page 160
Systematic Reviews and Meta-Analyses......Page 163
References......Page 164
Chapter 8 Descriptive Statistics
......Page 168
Variables: Dependent Versus Independent......Page 169
Scales of Measurement......Page 171
Measures of Central Tendency......Page 172
Normal Distribution......Page 173
Variance and Standard Deviation......Page 174
Range and Interquartile Range......Page 176
Display of Quantitative (Continuous) Data......Page 177
Summary......Page 178
References......Page 179
Chapter 9 Inferential Statistics 
......Page 180
Introduction......Page 181
Statistical Significance......Page 182
Clinical Significance......Page 183
Types of Data......Page 184
Confounding Variables......Page 185
Common Statistical Tests by Data Type......Page 186
Tests for Continuous Data......Page 187
Tests for Ordinal Data......Page 188
Tests for Nominal Data......Page 189
References......Page 190
Chapter 10 Epidemiology and Measures of Associated Risk
......Page 192
Introduction......Page 193
Measurement in Epidemiological Studies......Page 194
Incidence and Prevalence......Page 195
Interpreting Relative Risks, Odds Ratios, Hazard Ratios,and Absolute Risks......Page 196
Number Needed to Treat or Harm......Page 202
What Measure of Associated Risk Should Be Presented?......Page 203
Calculating Risk Measures......Page 206
References......Page 208
Chapter 11 Correlation and Regression
......Page 210
Correlation......Page 211
Regression......Page 217
Summary......Page 220
References......Page 221
Chapter 12 Analysis and Interpretation of Noninferiority Trials
......Page 222
Null and Alternative Hypotheses of Noninferiority Trials Are “Reversed”  from Superiority Trials
......Page 223
Reasons for Noninferiority Trial Design......Page 224
Confidence Intervals and Reference Points......Page 225
Establishing Margins of Clinically Significant Differences......Page 226
Interpretation of Results in Noninferiority Trials......Page 228
What Is the Effect of the Active Control Treatment?......Page 230
How Much Worse Can the Investigational Drug Be?......Page 231
Determining Noninferiority Margins in Trials That Report Absolute and Relative Risk Differences
......Page 232
Systematic Biases in Noninferiority Trials......Page 234
Summary......Page 237
References......Page 238
Chapter 13 Errors Related to Clinical Research
......Page 240
Introduction......Page 241
Types of Error in Clinical Research......Page 242
Biases in Clinical Research......Page 244
Participation (Nonresponse) Bias and the Volunteer Effect......Page 245
Admission Rate (Berkson) Bias......Page 246
Prevalence-Incidence (Neyman) Bias......Page 247
Medical Surveillance Bias......Page 249
Detection Bias......Page 250
Membership Bias......Page 251
Response Bias......Page 253
Recall Bias......Page 254
Attention Bias, the Hawthorne Effect, and the Placebo Effect......Page 255
Exposure Suspicion Bias......Page 257
Unmasking Bias and Mimicry Bias......Page 258
Missing Data Bias and Withdrawal Bias......Page 260
Migration (Contamination) Bias......Page 262
Compliance (Adherence) Bias......Page 264
Scale Degradation Bias......Page 266
Reference Bias......Page 267
Publication Bias......Page 268
Confounders in Clinical Research......Page 270
Alpha and p-Value......Page 271
Beta and Power......Page 272
Effect Size, Effect Variance, and Sample Size......Page 273
Relationships Between Biases, Confounders, and Chance......Page 275
Summary......Page 277
References......Page 278
Chapter 14 Evidence-Based Medicine
......Page 280
Introduction......Page 281
Practicing Evidence-Based Medicine......Page 283
Step 2: Find the Best Evidence......Page 285
Experimental Designs: Randomized Controlled Trials......Page 288
Observational Studies......Page 291
Comparative Effectiveness Research and Pragmatic Trials......Page 293
Trials That Review Other Trials......Page 294
Searching the Literature......Page 295
Step 2: Assess the Results......Page 298
Step 3: Assess Generalizability of the Results......Page 300
Step 4: Integrate Evidence with Clinical Judgment/Expertise and Patient Preferences......Page 301
Types of Guidelines and Guideline Development......Page 302
Evaluating Guidelines......Page 305
Incorporating Guidelines into Practice......Page 307
Barriers to Guideline Use......Page 308
Barriers to Evidence-Based Medicine......Page 309
Publication Bias......Page 311
The Future of Evidence-Based Medicine......Page 312
References......Page 313
Chapter 15 How to Prepare an Effective Journal Club
......Page 318
Introduction......Page 319
Professional Year 2 and 3 Students......Page 320
Professional Year 4 Students......Page 322
Drug Information Pharmacists and Educators......Page 323
Facilitator or Presenter......Page 324
Content Expert......Page 326
Classroom Setting......Page 327
Private Home, Restaurant, or Other Casual Setting......Page 328
Select an Article and Format for the Journal Club......Page 329
Historical Perspective Format......Page 330
Evaluate the Journal Club......Page 331
Summary......Page 335
References......Page 336
Chapter 16 Medication Safety
......Page 338
Introduction......Page 339
Medication Safety Terminology......Page 340
Why Errors Occur......Page 342
Human Error......Page 343
Systems Failures......Page 344
How Errors Are Detected......Page 345
Root Cause Analysis......Page 346
Risk Factors for Adverse Drug Events......Page 347
Medication-Related Factors......Page 348
Medication Use Process......Page 349
Role of Health Information Technology......Page 353
Interprofessional Teamwork......Page 354
Summary......Page 355
References......Page 356
Chapter 17 Medication Use Policy and Performance Assessment
......Page 358
How Medication Policies Are Developed and Written......Page 359
Drivers for Development of a Medication Use Policy......Page 362
Operational Performance Assessment: Logs, Checklists, and Tracers......Page 368
Clinical Performance Assessment: Medication Use Evaluation......Page 369
References......Page 375
Appendix 17-A IHI Model for Improvement......Page 380
Appendix 17-B Example MUE Template......Page 382
Appendix 17-C MUE Data Collection Form for Tapentadol......Page 384
Appendix 17-D Example of MUE Results......Page 388
Chapter 18 Formulary Management
......Page 394
What Is a Formulary?......Page 395
The History and Evolution of Formularies......Page 398
Governance of a Formulary System......Page 399
Membership......Page 400
Organization and Structure......Page 401
Product Selection/Request Process......Page 402
Product Review......Page 403
Application of Literature Evaluation Skills......Page 405
Pharmacoeconomic Evaluation......Page 406
Strategies for Formulary Management......Page 410
Role of Adverse Drug Reaction and Medication Error Surveillance and Reporting Programs
......Page 413
Medication Use Evaluations......Page 415
Procurement Challenges......Page 416
Effective Communication......Page 417
References......Page 418
Appendix 18-A Example of a Request to Change the Formulary......Page 422
Instructions......Page 13
Appendix 18-B Formulary Monograph Template......Page 428
Appendix 18-C Example of a Formulary Activity Checklist......Page 432
Appendix 18-D Example of Grading Levels of Evidence Worksheet
......Page 434
Chapter 19 Academic Detailing and Industry Relationships
......Page 436
Introduction......Page 437
Establishing an Academic Detailing Program......Page 438
Academic Detailing Programs on the State and Federal Levels......Page 440
The Current Pharmaceutical Industry Market......Page 442
The Governance of Pharmaceutical Industry Relationships......Page 444
Pharmaceutical Buying Contracts......Page 447
Pharmaceutical Industry Provision of Education......Page 448
Opportunities to Partner with the Pharmaceutical Industry to Improve Patient Care
......Page 449
References......Page 450
Chapter 20 Medical Writing and Peer Review
......Page 452
Introduction......Page 453
Writing a Research Paper: Tips for Success......Page 454
Parts of a Manuscript......Page 455
Methods......Page 456
Abstract and Keywords......Page 457
Ethical Issues in Medical Writing......Page 458
Selecting a Journal......Page 459
Manuscript Submission Process and Requirements......Page 461
Purpose of Article Peer Review......Page 464
Review Process......Page 465
Peer Reviewer Ethics......Page 467
References......Page 468
Chapter 21 Informatics and Clinical Decision Support
......Page 472
Introduction......Page 473
History of Informatics......Page 474
Meaningful Use......Page 475
Clinical Decision Support and Medication Decision Support Data
......Page 477
Summary......Page 478
References......Page 481
Chapter 22 Basic Principles of Pharmacoeconomics
......Page 482
Introduction......Page 483
Components of Economic Evaluations......Page 484
Types of Economic Evaluations......Page 488
Decision Analysis......Page 495
Sensitivity Analyses......Page 498
Health-Related Quality of Life......Page 499
Comparative Effectiveness Research......Page 501
Evaluating the Pharmacoeconomic Literature......Page 502
Future Challenges......Page 503
Summary......Page 504
References......Page 505
Glossary......Page 510
Index......Page 522