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A GUIDE FORPHARMACISTSthird edition
Editors
Patrick M. Malone, PharmD, FASHP Karen L. Kier, PhD, MSc, RPh
Professor of Pharmacy Practice Professor of Clinical Pharmacy
Assistant Dean Director, Drug Information
The University of Findlay Director, NTPD Program
School of Pharmacy College of Pharmacy
Findlay, Ohio Ohio Northern University
Ada, Ohio
John E. Stanovich, RPh
Assistant Professor of Clinical Pharmacy
Assistant Dean
College of Pharmacy
Ohio Northern University
Ada, Ohio
McGraw-HillMedical Publishing Division
New York • Chicago • San Francisco • Lisbon • London • Madrid • Mexico City • MilanNew Delhi • San Juan • Seoul • Singapore • Sydney • Toronto
Contents
Contributors xixPreface xxiiiAcknowledgments xxvi
Chapter One . Introduction to the Concept of Medicat ion Information ... 1Mary Lea Gora-Harper and Ann B. Amerson
Introduction 1The Beginning 2The Evolution 5
Drug Information—From Centers to Practitioners/6 • Factors Influencing theEvolution of the Pharmacist's Role as a Medication Information Provider/8 •Educating for the Need/17
Opportunities in Specialty Practice 18Contract Drug Information Center (Fee-for-Service)/18 • Medical Informaticsin a Health System/19 • Health Maintenance Organizations (HMOs)/Pharmacy Benefit Management Organizations (PBMs)/Managed CareOrganizations/19 • Poison Control/20 • Pharmaceutical Industry/21 •Academia/22 • Scientific Writing and Medical Communication/22
Summary and Direction for the Future 23
Chapter Two. Modified Systematic Approach to Answering Questions 29Craig F. Kirkwood and Karen L. Kier
Modified Systematic Approach 30Requestor Demographics/31 • Background Questions/31 • UltimateQuestion/Categorization of Question/32 • Search Strategy/33 •Data Evaluation, Analysis, and Synthesis/33 • Formulation and Provision ofResponse/34 • Follow-Up, Follow-Through, and Documentation/35
Vi CONTENTS
Conclusion 35Study Questions 36
Chapter Three. Formulating Effective Responses andRecommendations: A Structured Approach 39
Karim Anton Calis and Amy Heck SheehanAccepting Responsibility and Eliminating Barriers 40Identifying the Genuine Need 40Formulating the Response 43
Building a Database and Assessing Critical Factors/43 • Analysis andSynthesis/46 • Responses and Recommendations/46 • Follow-Up/47
Case Study 1 47Case Study 2 49Case Study 3 52Case Study 4 55Conclusion 58Study Questions 58
Chapter Four. Drug Information Resources 61
Kelly M. Shields and Elaine LustIntroduction 61Tertiary Resources 62General Product Information 66
AHFS Drug Information/66 • Clinical Pharmacology/66 • DRUGDEX® InformationSystem/66 • Drug Facts and Comparisons/66 • Drug InformationHandbook/67 • Handbook of Clinical Drug Data/67 • Handbook ofNonprescription Drugs: An Interactive Approach to Self-Care/67 •Physicians' Desk Reference/67 • USPDI Volumes I, II, and 111/68 •USP Dictionary of USAN and International Drug Names/68
Adverse Effects 68Meyler's Side Effects of Drugs/68
Availability of Dosage Forms 69American Drug Index/69 • Red Book/69
Compounding 69Allen's Compounded Formulations/69 • Extemporaneous Formulations/69 •Merck Index/69 • Remington: The Science and Practice of Pharmacy/70 •A Practical Guide to Contemporary Pharmacy Practice/70 • USP/NF/70
CONTENTS VM
Dietary Supplements 70
Natural Medicine Comprehensive Database/70 • Natural TherapeuticsPocket Guide/71 • Review of Natural Products/71 • The Complete GermanCommission E-Monographs/71 • PDR for Herbal Medicines/71 •Professional's Handbook of Complementary and Alternative Medicine/72
Dosage Recommendations 72Drug Prescribing in Renal Failure/72
Drug Interactions 72Hansten and Horn's Drug Interaction Analysis and Management/72 •Drug Interaction Facts/72 • DRUG-REAX/73 • Evaluations of DrugInteractions/73 • Drug Therapy Monitoring System/73 •Stockley's Drug Interactions/73
Foreign Drug Identification 73
European Drug Index/73 • Index Nominum: International Drug Directory/74 •Martindale: The Complete Drug Reference/74
Geriatric Dosage Recommendations 74Geriatric Dosage Handbook/74 • The Merck Manual of Geriatrics/74
Identification of Product 75Ident-a-Drug/75 • IDENTIDEXV75
Incompatibility and Stability 75Handbook on Injectable Drugs/75 • King Guide to Parenteral Admixtures/75 •Trissel's Stability of Compounded Formulations/76 • Trissel's™ 2 ClinicalPharmaceutics Database/76
Pediatric Dosage Recommendations 76The Harriet Lane Handbook/76 • Neofax/76 • Pediatric Dosage Handbook/76
Pharmacokinetics 77Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring/77 •
Basic Clinical Pharmacokinetics/77 • Clinical Pharmacokinetics:
Concepts and Applications/77
Pharmacology 77Goodman & Gilman's: The Pharmacological Basis of Therapeutics/77 •Basic & Clinical Pharmacology/77 • Principles of Pharmacology/78
Pharmacy Law 78Guide to Federal Pharmacy Law/78 • Pharmacy Practice and the Law/78
Teratogenicity/Lactation 78Drugs in Pregnancy and Lactation/78 • Medications and Mother's Milk:A Manual of Lactational Pharmacology/79 • REPRORISK®/79
viii CONTENTS
Therapy Evaluation/Drug of Choice 79Applied Therapeutics: The Clinical Use of Drugs/79 • Cecil Textbook ofMedicine/79 • Harrison's Principles of Internal Medicine/79 • The MerckManual of Diagnosis and Therapy/80 • Pharmacotherapy: A PathophysiologicApproach/80 • Textbook of Therapeutics/80
Toxicology 80Casarett & Doull's Toxicology: The Basic Science of Poisons/80 • Ellenhorn'sMedical Toxicology: Diagnosis and Treatment of Human Poisoning/80 •Goldfrank's Toxicologic Emergencies/'81 • POISINDEX®/81
Veterinary Medicine 81Compendium of Veterinary Products (CVP)/81 • Food and Drug Administration/Center for Veterinary Medicine Home Page/81 • The 5-Minute Veterinary Consultant:Canine and Feline/82 • Textbook of Veterinary Internal Medicine: Diseases of the Dogand Cat/82 • Veterinary Drug Handbook/82
References for PDA 83Secondary Literature 83
Anti-Infectives Today/86 • Biologic Abstracts/Biosis Previews/86 • CancerToday/86 • Cancerlit/86 • CINAHL®/87 • The Cochrane Database ofSystematic Reviews/87 • Current Contents/87 • EMBASE/87 • Google™Scholar/87 • Inpharma Weekly/88 • International PharmaceuticalAbstracts (IPA)/88 • Iowa Drug Information System/88 • JournalWatch/88 • LexisNexis/88 • MEDLINF®/89 • Paediatrics Today/89 •PharmacoEconomics and Outcomes News Weekly/89 • Reactions Weekly/89
Primary Literature 89Obtaining the Primary Literature 90Internet Resources 90Alternative Information Sources 92Consumer Health Information 93Conclusion 94Study Questions 95
Chapter Five. Electronic Information Management 103
Patrick M. Malone
Introduction 103Technology—The First Step 104Information via the Internet 106
The Present/106 • The Future/129
CONTENTS iX
Acknowledgment 131
Study Questions 131
Chapter Six. Controlled Clinical Trial Evaluation 139
Michael G. Kendrach and Maisha Kelly Freeman
Biomedical/Pharmacy Literature 141
Approach to Evaluating Research Studies (True Experiments) 145
Journal, Peer-Review, and Investigators 145
Clinical Trial Title 148
Abstract 148
Introduction 149
Methods 150Study Design/151 • Patient Inclusion/Exclusion Criteria/152 •Intervention and Control Groups/156 • Institutional Review Board(IRB)/Subject Consent/159 • Blinding/159 • Randomization/161 •Endpoints/163 • Follow-Up Schedule/Data Collection/Compliance/165 •Sample Size/166 • Statistical Analysis/168 • Types I and II Errors/PowerAnalysis/173
Results 176Subject Demographics/176 • Subject Dropouts/Compliance/177 • Endpointsand Safety/178 • Subgroup Analysis/180 • Ancillary versus AdjunctiveTherapies/182
Discussion/Conclusion 183
Clinical Trial Result Interpretation 185Statistical Significance versus Clinical Difference/185 • Assessing ClinicalDifference/186 • Confidence Intervals/188 • Interpreting Risks andNumbers-Needed-to-Treat/190 • "No Difference" Does Not Indicate"Equivalency"/193 • Assessing the Clinical Meaningfulness of the Results/193 •Standard of Care/194
Bibliography/References 195
Acknowledgments 195
Funding 196
Commentaries/Clinical Trial Critiques 197
Letters-to-the-Editor/199
Conclusion 199
Study Questions 200
X CONTENTS
Chapter Seven. Literature Evaluation II: Beyond the Basics 213Karen P. Norris, Carrie J. Johnson, H. Glenn Anderson, Jr., Patrick J. Bryant,Elizabeth A. Poole, Cydney E. McQueen, and Linda R. Young
Introduction 214Experimental Study Design 215
True Experiments—Beyond the Controlled Clinical Trial/216 • Stability Studies/In Vitro Studies/218 • Bioequivalence Studies/219 • Programmatic Research/222
Observational Study Design 222Cohort Studies/223 • Case-Control Studies/226 • Cross-SectionalStudies/231 • Case Studies, Case Reports, and Case Series/232
Survey Research 232Postmarketing Surveillance Studies 237Pulling It All Together: Organizing and Ranking Studies 238Review Articles 239
Narrative (Nonsystematic) Reviews/240 • Systematic Review—Qualitative/241 • Systematic Reviews—Quantitative (Meta-Analyses)/243
Practice Guidelines 246Health Outcomes Research 247
Quality-of-Life Measures/247
Dietary Supplement Medical Literature 252Standardization/252 • International Trials/253 • Duration/253 • TrialSize/253 • Lack of Evidence/254 • Other Special Considerations/254
Conclusion 254Study Questions 255Acknowledgment 256
Chapter Eight. Pharmacoeconomics 261James P. Wilson and Karen L Rascati
Pharmacoeconomics—What Is It and Why Do It? 262Relationship of Pharmacoeconomics to Outcomes Research 262Models of Pharmacoeconomic Analysis 263Assessment of Costs 263
Types of Costs/263 • Timing Adjustments for Costs/264Assessment of Outcomes 265
Cost-Minimization Analysis/265 • Cost-Benefit Analysis/266 •Cost-Effectiveness Analysis/269 • Cost-Utility Analysis/270
CONTENTS Xi
Performing an Economic Analysis 273Step 1: Define the Problem/274 • Step 2: Determine the Study's Perspective/274 •Step 3: Determine Specific Treatment Alternatives and Outcomes/274 •
Step 4: Select the Appropriate Pharmacoeconomic Method or Model/275 •Step 5: Measure Inputs and Outcomes/275 • Step 6: Identify the ResourcesNecessary to Conduct the Analysis/275 • Step 7: Establish the Probabilitiesfor the Outcomes of the Treatment Alternatives/276 • Step 8: Construct aDecision Tree/276 • Step 9: Conduct a Sensitivity Analysis/276 • Step 10:Present the Results/277
What Is Decision Analysis? 277
Steps in Decision Analysis/277
Steps in Reviewing Published Literature 281
Evaluation/283
Selected Pharmacoeconomics Websites 284
Conclusion 284
Study Questions 285
Chapter Nine. Evidence-Based Clinical Practice Guidelines 289
Kevin G. Moores
Introduction 289
Evidence-Based Practice and Clinical Practice Guidelines 291Guideline Development Methods 294
Select a Topic for Guideline Development/298 • Recruit AppropriateMultidisciplinary Membership for a Panel to be Involved in Development of theGuideline/299 • Define the Clinical Questions to be Addressed/302 • Determinethe Criteria for Evidence/303 • Conduct a Systematic Search for the QualijyingEvidence/304 • Perform a Systematic Evaluation and Grading of Hie Evidence/305 •Prepare a Synthesis of the Evidence/306 • Agree on Procedures for a ConsensusProcess, or Other Procedures for Making Recommendations, in the Absence ofHigher Levels of Evidence for Decision Making/308 • Formulate and GradeRecommendations Based on the Grade of Evidence and Balance of Benefits, Harms,and Costs of Treatment Options/308 • Draft the Guideline Document/309 •Conduct Peer-Review andPUot Testing of the Guideline/311 • Revise the Guidelineas Appropriate/312 • Create Tools for Implementation of the Guideline/312 •Establish a Plan for Follow-Up and Periodic Updating of the Guideline/313
Interpretation of Guideline Recommendations 313
Guideline Evaluation Tools 318
Xii CONTENTS
Implementation of Clinical Practice Guidelines 321Sources of Clinical Practice Guidelines 325
Conclusion 330Study Questions for Evidence-Based Clinical Practice Guidelines 330
Chapter Ten. Clinical Application of Statistical Analysis 339Karen L. Kier
Basic Concepts 340Populations and Samples/340 • Variables and Data/341
Descriptive and Inferential Statistic 343Descriptive Statistics/343 • Measures of Central Tendency/344 • Measures ofVariability/345 • Measures of Shape/346 • Ratios, Proportions, and Rates/347 •Incidence and Prevalence/347 • Relative Risk and Odds Ratio/348 •Sensitivity, Specificity, and Predictive Values/349 • Distributions/350 •
Statistical Inference 353Central Limit Theorem/353 • Parametric versus Nonparametric Testing/354 •Hypothesis Testing/355 • Errors/355 • Significance/356 • Statistical Tests/357• Comparing Two Groups/358 • Comparing More Than Two Groups/360• Describing the Relationship Between Two or More Variables/362 • OtherNonparametric Tests/367
Other Methods of Inference for Categorical Data 368Other Nonparametric Tests 369
Survival Analysis/369 • Multivariate Analysis/370 • Other Types of StudyDesign with Statistical Analysis/372
Conclusion 373Study Questions 373
Chapter Eleven. Professional Writing 375Patrick M. Malone
Introduction 375Steps in Writing 376
Preparing to Write/377 • General Rules of Writing/381 • Specific DocumentSections/384 • Submission of the Document/389 • Revision/390 • GalleyProofs/390
Referees 391
Specific Documents 391Newsletters and Websites/391 • Presentations/398
Conclusion *tr?
CONTENTS Xiii
Chapter Twelve. Legal Aspects of Drug Information Practice 411Martha M. Rumore
Tort Law 412
Incomplete Information/415 • Inappropriate Quality Information/418 •
Inappropriate Analysis/Dissemination of Information/420
Defenses to Negligence and Malpractice Protection 421Defenses for Individuals/422 • Defenses for Employers/423 • Protecting
Against Malpractice/424
Labeling and Advertising 426Direct-to-Consumer Drug Information and Erosion of the Learned
Intermediary Rule/427 • Doctrine of Drug Overpromotion/429 • Off Label
Use and Informed Consent/430
Liability Concerns for Internet Information 432Quality of Information/432 • Telemedicine and Cybermedicine/433 • Fraudand Abuse/435
Intellectual Property Rights 436
Copyright/436 • Digital Millennium Copyright Act/442
Privacy 443Health Insurance Portability Act of 1996/443 • Communication Privacy/445
Industry Support for Educational Activities 446
Guidelines and Guidance/447 • Relationship to Antikickback Statute/449
Conclusion 450
Study Questions 451
Chapter Thirteen. Ethical Aspects of Drug Information Practice 459
Linda K. Ohri
What Is Ethics and What Is Not 459
Ethical Dilemmas in Pharmacy Practice 460
Basics of Ethics Analysis 462Definitions Used in the Field of Ethics/462 • Overview of a Suggested
Process of Analysis to be Used When an Ethical Dilemma Arises/463 •An Annotated Listing of Rules and Principles (Action-Guides) Applied in
Medical Ethics Inquiry/468
Demonstration of the Process for Analyzing Ethical Dilemmas 470
Demonstration of Case Analysis/470
Resources for Use by Pharmacists Seeking to Learn More About
Medical Ethics 476
XiV CONTENTS
Structures That Support Ethical Decision-Making 477
Summary 479Study Questions 479
Chapter Fourteen. Pharmacy and Therapeutics Committee 483Patrick M. Malone, Mark A. Malesker, PaulJ. Nelson, and Nancy L Fagan
Introduction 483Organizational Background 485
Pharmacy Benefit Management P&T Committee Origin/488 • Pharmacy Supportof theP&T Committee/490 • Ad Hoc Committees/'495 • P&T CommitteeMeeting/496 • Formulary Management/498 • Policies and Procedures/510
Clinical Guidelines 513Standard Order Set Development 513Credentialing and Privileges 514Quality Improvement within the P&T Committee—Internal Audit 515
Medication Quality Assurance/515 • Adverse Drug Reactions/516 •Medication Error Incidents/516 • Illegible Handwriting, Transcription, andAbbreviations/516 • Timeliness/517 • Counterfeit Drug Products/517 •Safety Alert/518 • Product Shortages/519
Communication within an Organization 519Investigational Review Board Actions/519 • Cost, Budget, andForecasting/520 • Liaison with Other Elements of theOrganization/520
Conclusion 521Acknowledgment 522Study Questions 522
Chapter Fifteen. Drug Evaluation Monographs 533Patrick M. Malone, Mark A. Malesker, Nancy L Fagan, PaulJ. Nelsonand Linda K. Ohri
Introduction 533Summary Page/536 • Body of the Monograph/545
Conclusion 553
Chapter Sixteen. Quality Improvement and the Medication Use Process 557Mark A. Ninno and Sharon Davis Ninno
Quality Improvement 557Defining Quality/558 • Quality in Healthcare/562 • Quality and theJCAHO/565 • Standards/566 • Patient-Focused Care/567 •
CONTENTS XV
Organization-Focused Functions/567 • Structures with Functions/568 •Medication Management Standards/568 • Quality and Managed
Care/571
Drug Regimen Review and Drug Use Review 574Medication Use Evaluation/575 • The Medication Use Process/575 •
Medication Use Evaluation and the JCAHO/576
Quality in Drug Information 591
Conclusion 592
Study Questions 593
Chapter Seventeen. Medication Misadventures: Adverse Drug
Reactions and Medication Errors 599Philip J. Gregory
Adverse Drug Reactions 601Definitions/602 • Causality and Probability of Adverse Drug Reactions/603 •Classification/605 • Mechanism of Adverse Drug Reactions/605 • Reporting/606 •The FDA Reporting/606 • Dietary Supplements/608 • TheJCAHO and the ASHPGuidelines/609 • Implementing a Program/609 • Technology/611
Medication Errors 612Definitions/612 • Classification/614 • Error Type/614 • Outcome orSeverity/616 • Subclassifications/617 » Psychology of Medication Errors:Why Do Errors Occur?/617 • Medication Error Reporting/620 •Institutional Reporting/622 • National Reporting/622 • ErrorPrevention/624 • Practitioner Strategies/625 • Health SystemStrategies/626 • National Priority/628
Conclusion 630
Study Questions 631
Chapter Eighteen. Investigational Drugs 635
Bambi Grilley
Definitions 636
History of Drug Development Regulation in the United States 638
The Drug Approval Process 641
The Institutional Review Board 650
The Orphan Drug Act 651
Role of the Pharmacist 652
Conclusion 658
Study Questions 659
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