دانلود کتاب Drug Information: A Guide for Pharmacists (Malone, Drug Information)

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Cover
Title Page
Copyright Page
Contents
Contributors
Preface
Chapter One. Introduction to the Concept of Drug Information
Introduction
The Beginning
The Evolution
Opportunities in Specialty Practice
Summary and Direction for the Future
Self-Assessment Questions
Chapter Two. Formulating Effective Responses and Recommendations: A Structured Approach
Introduction
Conclusion
Case Study 2–1
Case Study 2–2
Case Study 2–3
Case Study 2–4
Self-Assessment Questions
Chapter Three. Drug Information Resources
Introduction
Tertiary Resources
Case Study 3–1
Case Study 3–2
Case Study 3–3
Case Study 3–4
Secondary Literature
Case Study 3–5
Primary Literature
Alternative Resources
Case Study 3–6
Consumer Health Information
Conclusion
Case Study 3–7
Self-Assessment Questions
Chapter Four. Drug Literature Evaluation I: Controlled Clinical Trial Evaluation
Introduction
Biomedical/Pharmacy Literature
Approach to Evaluating Research Studies (True Experiments)
Case Study 4–1
Conclusion
Case Study 4–2
Case Study 4–3
Self-Assessment Questions
Chapter Five. Literature Evaluation II: Beyond the Basics
Introduction
Beyond the Basic Controlled Trial
Case Study 5–1: Noninferiority Trial Design
Case Study 5–2: Noninferiority Trial Design
Observational Study Design
Case Study 5–3: Cohort Study Design
Reports Without Control Group
Survey Research
Postmarketing Surveillance Studies
Review Articles
Case Study 5–4: Meta-Analysis
Practice Guidelines
Health Outcomes Research
Dietary Supplement Medical Literature
Case Study 5–5: Trials Testing Natural Products
Getting to a Clinical Decision
Conclusion
Self-Assessment Questions
Acknowledgments
Chapter Six. 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
Case Study 6–1
Selected Pharmacoeconomic Web Sites
Conclusion
Self-Assessment Questions
Chapter Seven. Evidence-Based Clinical Practice Guidelines
Introduction
Evidence-Based Medicine and Clinical Practice Guidelines
Guideline Development Methods
Case Study 7–1
Case Study 7–2
Case Study 7–3
Guideline Evaluation Tools
Implementation of Clinical Practice Guidelines
Case Study 7–4
Sources of Clinical Practice Guidelines
Conclusion
Self-Assessment Questions
Chapter Eight. 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
Case Study 8–1
The Design and Analysis of Clinical Trials
Statistical Inference
Selecting the Appropriate Statistical Test
Case Study 8–2
Statistical Tests
Conclusion
Self-Assessment Questions
Chapter Nine. Professional Writing
Introduction
Steps in Writing
Case Study 9–1
Specific Documents
Case Study 9–2
Case Study 9–3
Conclusion
Self-Assessment Questions
Chapter Ten. Legal Aspects of Drug Information Practice
Introduction
Tort Law
Case Study 10–1
Case Study 10–2
Defenses to Negligence and Malpractice Protection
Labeling and Advertising
Liability Concerns for Web 2.0 Information
Intellectual Property Rights
Case Study 10–3
Privacy
Case Study 10–4
Industry Support for Educational Activities
Conclusion
Self-Assessment Questions
Chapter Eleven. Ethical Aspects of Drug Information Practice
What Is Ethics and What Is Not
Ethical Dilemmas When Providing Drug Information
Basics of Ethics Analysis
Example Case 11–1
Example Case 11–2
Case Study 11–1
Case Study 11–2
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. Pharmacy and Therapeutics Committee
Introduction
Organizational Background
Pharmacy Support of the P&T Committee
Case Study 12–1
Case Study 12–2
Clinical Guidelines
Standard Order Set Development
Credentialing and Privileges
Quality Improvement Within the P&T Committee—Internal Audit
Case Study 12–3
Communication Within an Organization
Conclusion
Discussion Questions
Self-Assessment Questions
Acknowledgment
Chapter Thirteen. Drug Evaluation Monographs
Introduction
Drug Evaluation Monograph Sections
Conclusion
Case Study 13–1
Case Study 13–2
Self-Assessment Questions
Acknowledgments
Chapter Fourteen. Quality Improvement and the Medication Use System
Introduction
The Changing Environment for Health Care Quality
Purpose of Measuring Quality
Quality Improvement
Case Study 14–1
Case Study 14–2
Case Study 14–3
Quality in Drug Information
Conclusion
Self-Assessment Questions
Chapter Fifteen. Medication Misadventures I: Adverse Drug Reactions
Introduction to Adverse Drug Reactions
Causality and Probability of Adverse Drug Reactions
Case Study 15–1
Classification of Adverse Drug Reactions
Implementing a Program
Reporting Adverse Drug Reactions
Case Study 15–2
Future Approaches to Pharmacovigilance
Conclusion
Self-Assessment Questions
Chapter Sixteen. 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
Case Study 16–1
To Err Is Human
System Error
Case Study 16–2
A Just Culture—Not Shame and Blame
Case Study 16–3
Risk Factors for Errors and Events
Health Professions Education
Best Practices for Error Prevention
Other Principles of Error Management
Putting It All Together
Case Study 16–4
Conclusion: Safety as a Priority
Self-Assessment Questions
Chapter Seventeen. Investigational Drugs
Introduction
Definitions
History of Drug Development Regulation in the United States
The Drug Approval Process
Case Study 17–1
Case Study 17–2
The Orphan Drug Act
The Institutional Review Board
Case Study 17–3
Role of the Health Care Professional
Conclusion
Self-Assessment Questions
Chapter Eighteen. Policy Development, Project Design, and Implementation
Introduction
Policy Development
Project Design
Project Implementation
Project Closeout
Project Management
Conclusion
Case Study 18–1
Self-Assessment Questions
Chapter Nineteen. Drug Information in Ambulatory Care
Introduction
Why Focus on Drug Information Specifically in the Ambulatory Care Setting?
Providing Drug Information in the Ambulatory Setting
Drug Information Responsibilities in Ambulatory Care
Case Study 19–1
Patient Disposal of Unused Medications
Case Study 19–2
Providing Immunization Information
Quality-Assurance Considerations in Ambulatory Care
Case Study 19–3
Conclusion
Self-Assessment Questions
Chapter Twenty. Drug Information and Contemporary Community Pharmacy Practice
Introduction
Pharmacists as Drug Information Providers in the Community Setting
Current Patient Sources of Drug Information
Case Study 20–1
Case Study 20–2
Case Study 20–3
A New Model of Drug Information in the Community Pharmacy
Conclusion
Self-Assessment Questions
Chapter Twenty-One. Drug Information Education and Training
Introduction
Foundation Skill Development
Specialized Skill Development
Pursuing Specialty Training
Case Study 21–1
Conclusion
Self-Assessment Questions
Acknowledgments
Chapter Twenty-Two. Pharmaceutical Industry and Regulatory Agency Drug Information
Introduction
Opportunities for Health Professionals Within Industry
Regulation of Health Professionals in Industry
Case Study 22–1
Pharmaceutical Research and Manufacturers of America and the Code on Interactions with Health Care Professionals
Case Study 22–2
Fulfillment of Medical Information Requests
Case Study 22–3
Adverse Event Reporting
Case Study 22–4
Staying Connected with the Pharmaceutical Industry
Anatomy of Federal Agencies
Case Study 22–5
Case Study 22–6
Division of Drug Information at the FDA
Case Study 22–7
Opportunities Within FDA
Conclusion
Self-Assessment Questions
Chapter Twenty-Three. Assessing Drug Promotions
Introduction
WHO Ethical Criteria for Medicinal Drug Promotion
Direct-to-Consumer Advertising
Case Study 23–1
Promotions to Health Care Professionals
Case Study 23–2
Case Study 23–3
Case Study 23–4
Conclusion
Self-Assessment Questions
Chapter Twenty-Four. Pharmacy Informatics: Enabling Safe and Efficacious Medication Use
Introduction
Medication Use Process
Pharmacy Informatics
Order entry
Transcription
Dispensing
Administration
Monitoring
Case Study 24–1
The Future: Informatics in the U.S. Health Care System
Case Study 24–2
Interoperable Electronic Health Records
Case Study 24–3
Greater Emphasis on Security, Privacy, and Confidentiality of Protected Health Information
Conclusion
Self-Assessment Questions
Appendix 2–1 Drug Consultation Request Form
Appendix 2–2 Examples of Questions for Obtaining Background Information from Requestors
Appendix 3–1 Performing a PubMed Search
Appendix 3–2 Selected Primary Literatures Sources
Appendix 4–1 Questions for Assessing Clinical Trials
Appendix 5–1 Beyond the Basics: Questions to Consider for Critique of Primary Literature
Appendix 7–1 Grade Evidence Profile: Antibiotics for Children with Acute Otitis Media
Appendix 9–1 Question Example
Appendix 9–2 Abstracts
Appendix 9–3 Bibliography
Appendix 11–1 Code of Ethics for Pharmacists
Appendix 12–1 Pharmacy and Therapeutics Committee Procedure
Appendix 12–2 Formulary Request Form
Appendix 12–3 P&T Committee Meeting Attributes
Appendix 12–4 Example P&T Committee Minutes
Appendix 12–5 Chairperson Skills
Appendix 12–6 Conflict-of-Interest Declaration
Appendix 13–1 Format for Drug Monograph
Appendix 13–2 Example Drug Monograph
Appendix 14–1 Tools Used in Quality Assurance
Appendix 14–2 Example of Criteria and Request for Approval
Appendix 14–3 Example of MUE Results
Appendix 14–4 Evaluation Form for Drug Information Response
Appendix 15–1 Kramer Questionnaire
Appendix 15–2 Naranjo Algorithm
Appendix 15–3 Jones Algorithm
Appendix 15–4 MedWatch Form
Appendix 17–1 Investigational New Drug Application
Appendix 17–2 Statement of Investigator
Appendix 17–3 Protocol Medication Economic Analysis
Appendix 17–4 Investigational Drug Accountability Record
Appendix 18–1 Policy Example: High-Alert Medications
Appendix 18–2 Policy Example: Medication Shortages and Backorders
Appendix 22–1 Response Letter Drug A—Incidence of Yellow Stripes
Glossary
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Answers for Case Studies
Answers for Self-Assessment Questions
Index
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