Drug Information: A Guide for Pharmacists, Sixth Edition

Patrick Malone, PharmD Director, Web-Based Pharmacy Pathway Creighton University School of Pharmacy Omaha, NE

Chapter One. Introduction to the Concept of Drug Information
Introduction
The Beginning
The Evolution
Opportunities in Drug Information Specialty Practice
Summary and Direction for the Future
Self-Assessment Questions
Chapter Two. Formulating an Effective Response: A Structured Approach
Introduction
Steps for Answering a Question
Formulating the Response
Conclusion
Self-Assessment Questions
Chapter Three. Drug Information Resources
Introduction
Types of Biomedical Resources
Tertiary Resources
Secondary Resources
Primary Resources
Alternative Resources
Conclusion
Self-Assessment Questions
Chapter Four. Drug Literature Evaluation I: Controlled Clinical Trial Evaluation
Introduction
Biomedical/Pharmacy Literature
Approach to Evaluating Research Studies (True Experiments)
Conclusion
Self-Assessment Questions
Chapter Five. Literature Evaluation II: Beyond the Basics
Introduction
Beyond the Basic Controlled Trial
N-of-1 Trials
Adaptive Clinical Trials
Stability Studies/In Vitro Studies
Bioequivalence Trials
Programmatic Research
Observational Study Design
Reports Without Control Group
Survey Research
Postmarketing Surveillance Studies
Review Articles
Practice Guidelines
Health Outcomes Research
Dietary Supplement Medical Literature
Getting to a Clinical Decision
Conclusion
Self-Assessment Questions
Abbreviations
Acknowledgments
Chapter Six. The Application of Statistical Analysis in the Biomedical Sciences
Introduction
Populations and Sampling
Variables and the Measurement of Data
Descriptive Statistics
Common Probability Distributions
Epidemiological Statistics
Types of Study Design
The Design and Analysis of Clinical Trials
Statistical Inference
Selecting the Appropriate Statistical Test
Introduction to Common Statistical Tests
Conclusion
Self-Assessment Questions
Chapter Seven. Pharmacoeconomics
Introduction
Pharmacoeconomics: What Is It and Why Do It?
Relationships of Pharmacoeconomics to Outcomes Research
Models of Pharmacoeconomic Analysis
Assessment of Costs
Assessment of Outcomes
Performing an Economic Analysis
What Is Decision Analysis?
Steps in Reviewing Published Literature
Selected Pharmacoeconomic Websites
Conclusion
Self-Assessment Questions
Chapter Eight. Evidence-Based Clinical Practice Guidelines
Introduction
Evidence-Based Medicine and Clinical Practice Guidelines
Guideline Development Methods
Guideline Evaluation Tools
Implementation of Clinical Practice Guidelines
Sources of Clinical Practice Guidelines
Conclusion
Self-Assessment Questions
Chapter Nine. Journal Clubs
Introduction
Conducting the Journal Club
Preparing the Presentation
Conclusion
Self-Assessment Questions
Chapter Ten. Legal Aspects of Drug Information Practice
Introduction
Tort Law
Defenses to Negligence and Malpractice Protection
Labeling and Advertising
Direct-to-Consumer (DTC) Drug Information
Off-Label Use and Informed Consent
Liability Concerns for Internet/Social Media Information
Fraud and Abuse
Intellectual Property Rights
Privacy
Industry Support for Educational Activities
Conclusion
Self-Assessment Questions
Chapter Eleven. Ethical Aspects of Drug Information Practice
Introduction
Basics of Ethics Analysis
Resources for Use by Professionals Seeking to Learn More about Medical Ethics, as Applied to Issues Involving Provision of Drug Information
Structures That Support Ethical Decision Making
Conclusion
Self-Assessment Questions
Chapter Twelve. Professional Communication of Drug Information
Introduction
Steps in Writing
Specific Documents
Conclusion
Self-Assessment Questions
Chapter Thirteen. Pharmacy and Therapeutics Committee
Introduction
Organizational Background
Pharmacy Support of the P&T Committee
P&T Committee Meeting
P&T Committee Functions
Communication Within an Organization
Conclusion
Study Questions
Self-Assessment Questions
Acknowledgment
Chapter Fourteen. Drug Evaluation Monographs
Introduction
Conclusion
Self-Assessment Questions
Acknowledgment
Chapter Fifteen. Drug Shortages and Counterfeit Drugs
Introduction
Drug Shortages
Counterfeit Drugs
Conclusion
Self-Assessment Questions
Chapter Sixteen. Quality Improvement and the Medication Use System
Introduction
The Changing Environment for Health Care Quality
Purpose of Measuring Quality
Quality Measures
Quality Improvement
Quality in Drug Information
Publication of Quality Improvement Studies
Conclusion
Self-Assessment Questions
Chapter Seventeen. Medication Misadventures I: Adverse Drug Reactions
Introduction
Impact of Adverse Drug Reactions
Definitions
Causality and Probability of Adverse Drug Reactions
Classification of Adverse Drug Reactions
Implementing a Program
The Role of Technology in Adverse Drug Reactions Surveillance
Reporting Adverse Drug Reactions
Future Approaches to Pharmacovigilance
Conclusion
Self-Assessment Questions
Chapter Eighteen. Medication Misadventures II: Medication and Patient Safety
Introduction
Definitions: Medication Errors, Adverse Drug Events, and Adverse Drug Reactions
The Impact of Errors on Patients and Health Care Systems
Identification and Reporting of Medication Errors and Adverse Drug Events
Classification of Error Types
Classifying Patient Outcomes
National Reporting
Managing an Event Reporting System
Types of Safety Event Analysis
To Err Is Human
System Error
A Just Culture—Not Shame and Blame
Risk Factors for Errors and Events
Health Professions Education
Best Practices for Error Prevention
Other Principles of Error Management
Putting It All Together
Conclusion: Safety as a Priority
Self-Assessment Questions
Chapter Nineteen. Policy, Procedure, and Guideline Development
Introduction
Regulatory Considerations
Practice Document Design and Organization
Factors Influencing Practice Document Development
Systematic Method for Practice Document Development and Maintenance
Conclusion
Self-Assessment Questions
Chapter Twenty. Project Management
Introduction
Projects, Programs, and Portfolios
Selecting Projects
Initiating a Project
Planning a Project
Executing a Project
Monitoring and Controlling a Project
Closing a Project
Conclusion
Self-Assessment Questions
Chapter Twenty-One. Investigational Drugs
Introduction
Definitions
History of Drug Development Regulation in the United States
The Drug Approval Process
The Orphan Drug Act
Institutional Review Board/Institutional Ethics Committee
Role of the Health Care Professional
Conclusion
Self-Assessment Questions
Chapter Twenty-Two. Pharmaceutical Industry and Regulatory Affairs
Introduction
Opportunities for Health Professionals within Industry
Regulation of Health Professionals in Industry
The Code on Interactions with Health Care Professionals
Fulfillment of MIRs
AE Reporting
Staying Connected with Pharmaceutical Industry
Anatomy of DHHS and FDA
Division of Drug Information
Opportunities within the FDA
Conclusion
Self-Assessment Questions
Chapter Twenty-Three. Assessing Drug Promotions
Introduction
Ethical Criteria for Medicinal Drug Promotion
Direct-to-Consumer Advertising (DTCA)
Promotions to Health Care Professionals
Conclusion
Self-Assessment Questions
Chapter Twenty-Four. Drug Information in Ambulatory Care
Introduction
Providing Drug Information in the Ambulatory Care Setting
Drug Information Responsibilities in Ambulatory Care
Conclusion
Self-Assessment Questions
Chapter Twenty-Five. Drug Information and Contemporary Community Pharmacy Practice
Introduction
Pharmacists as Drug Information Providers
Patient Sources of Drug Information
A New Model of Drug Information
Conclusion
Self-Assessment Questions
Chapter Twenty-Six. Pharmacy Informatics: Enabling Safe and Efficacious Medication Use
Introduction
Medication Use Process
Pharmacy Informatics
Order Entry (Prescribing Stage)
Order Verification (Transcribing Stage)
Dispensing
Administration
Monitoring
The Future: Informatics in the U.S. Health Care System
Conclusion
Self-Assessment Questions
Chapter Twenty-Seven. Drug Information Education and Training
Introduction
Drug Information in Pharmacy Curriculum
Postgraduate Training in Drug Information
Conclusion
Self-Assessment Questions
Appendices
Appendix 2–1 Example of Drug Information Consult Documentation Form
Appendix 2–2 Standard Questions for Obtaining Background Information from Requestors
Appendix 3–1 Performing a PubMed Search
Appendix 3–2 Selected Primary Literatures Sources
Appendix 4–1 Drug Literature Assessment Questions for Clinical Trials
Appendix 5–1 Beyond the Basics: Questions to Consider for Critique of Primary Literature
Appendix 8–1 Grade Evidence Profile: Antibiotics for Children with Acute Otitis Media
Appendix 11–1 Code of Ethics for Pharmacists
Appendix 12–1 Question Example
Appendix 12–2 Abstracts
Appendix 12–3 Bibliography
Appendix 13–1 Pharmacy and Therapeutics Committee Procedure
Appendix 13–2 Formulary Request Form
Appendix 13–3 P&T Committee Meeting Attributes
Appendix 13–4 Example P&T Committee Minutes
Appendix 13–5 Chairperson Skills
Appendix 13–6 Conflict of Interest Declaration
Appendix 14–1 Format for Drug Monograph
Appendix 14–2 Example Drug Monograph
Appendix 16–1 Tools Used in Quality Assurance
Appendix 16–2 Example of Criteria and Request for Approval
Appendix 16–3 Example of MUE Results
Appendix 16–4 Evaluation Form for Drug Information Response
Appendix 17–1 Kramer Questionnaire
Appendix 17–2 Naranjo Algorithm
Appendix 17–3 Jones Algorithm
Appendix 17–4 Liverpool ADR Causality Assessment Tool
Appendix 17–5 MedWatch Form
Appendix 19–1 Policy Example: High-Alert Medications
Appendix 20–1 Example of a Project Charter
Appendix 20–2 Stakeholder Matrix—IV Compounding Software Project
Appendix 20–3 Example PESTLE Analysis—IV Compounding Software Project
Appendix 20–4 Example Work Breakdown Structure (WBS)—IV Compounding Software Project
Appendix 21–1 Investigational New Drug Application
Appendix 21–2 Statement of Investigator
Appendix 21–3 Protocol Medication Economic Analysis
Appendix 21–4 Investigational Drug Accountability Record
Appendix 22–1 Response Letter Drug A—Incidence of Yellow Stripes
Glossary
Answers for Case Studies
Answers for Self-Assessment Questions
Index