Drug Information: A Guide for Pharmacists, 7th Edition

 

Description:

 

 

Everything pharmacists and pharmacy students need to know about drug information management Drug Information: A Guide for Pharmacists provides you with the tools you need to to research, interpret, evaluate, collate, and disseminate drug information in the most effective and efficient manner possible.

This trusted resource addresses essential topics such as formulating an effective response and recommendations for information, evaluation of drug literature, the application of statistical analysis in the biomedical sciences, medications and patient safety, investigational drugs, and more.

This updated seventh edition also addresses other important issues such as the legal and ethical considerations of providing information, how to respond to requests for information, and how to determine what information should be made available.

 

Table of Contents:

 

Chapter One.

Introduction to the Concept of Drug Information

Learning Objectives

Key Concepts

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

Learning Objectives

Key Concepts

Introduction

Steps for Answering a Question

Case Study 2–1

Case Study 2–2

Case Study 2–3

Formulating the Response

Case Study 2–4

Conclusion

Self-Assessment Questions

Chapter Three.

Drug Information Resources

Learning Objectives

Key Concepts

Introduction

Types of Biomedical Resources

Tertiary Resources

Case Study 3–1

Case Study 3–2

Case Study 3–3

Secondary Resources

Case Study 3–4

Primary Resources

Case Study 3–5

Alternative Resources

Case Study 3–6

Consumer Health Information

Staying Current

Reference Budget Considerations

Conclusion

Self-Assessment Questions

Chapter Four.

Drug Literature Evaluation I: Controlled Clinical Trial Evaluation

Learning Objectives

Key Concepts

Introduction

Biomedical/Pharmacy Literature

Approach to Evaluating Research Studies (True Experiments)

Case Study 4–1

Case Study 4–2

Specialized Types of Controlled Clinical Trials

Case Study 4–3

Conclusion

Self-Assessment Questions

Chapter Five.

Drug Literature Evaluation II: Beyond the Randomized Controlled Trial

Learning Objectives

Key Concepts

Introduction

Observational Studies

Case Study 5–1: Observational Study

Reviews

Case Study 5–2: Meta-Analysis

Other Study Designs

Natural Medicines Medical Literature

Case Study 5–3: Study Testing a Natural Medicine

Conclusion

Self-Assessment Questions

Chapter Six.

The Application of Statistical Analysis in the Biomedical Sciences

Learning Objectives

Key Concepts

Introduction

Populations and Sampling

Variables and the Measurement of Data

Descriptive Statistics

Common Probability Distributions

Epidemiological Statistics

Types of Study Design

Case Study 6–1

The Design and Analysis of Clinical Trials

Statistical Inference

Selecting the Appropriate Statistical Test

Case Study 6–2

Introduction to Common Statistical Tests

Case Study 6–3

Conclusion

Self-Assessment Questions

Chapter Seven.

Pharmacoeconomics

Learning Objectives

Key Concepts

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 7–1

Selected Pharmacoeconomic Websites

Conclusion

Self-Assessment Questions

Chapter Eight.

Evidence-Based Clinical Practice Guidelines

Learning Objectives

Key Concepts

Introduction

Evidence-Based Medicine and Clinical Practice Guidelines

Guideline Development Methods and Evaluation

Case Study 8–1

Case Study 8–2

Case Study 8–3

Guideline Evaluation Tools

Use of Clinical Practice Guidelines

Case Study 8–4

Sources of Clinical Practice Guidelines

Conclusion

Self-Assessment Questions

Chapter Nine.

Journal Clubs

Learning Objectives

Key Concepts

Introduction

Conducting Journal Clubs

Case Study 9–1

Preparing the Presentation

Case Study 9–2

Case Study 9–3

Conclusion

Self-Assessment Questions

Chapter Ten.

Peer Review

Learning Objectives

Key Concepts

Introduction

What Is Peer Review?

Criticisms and Variations of Peer Review

Reasons to Participate in Peer Review

Locating Peer Review Opportunities

Preparing for Peer Review

Case Study 10–1

Reasons to Decline a Peer Review Invitation

Case Study 10–2

Performing Peer Review

Case Study 10–3

Involving Learners in Peer Review

Conclusion

Self-Assessment Questions

Chapter Eleven.

Legal Aspects of Drug Information

Learning Objectives

Key Concepts

Introduction

Tort Law

Case Study 11–1

Case Study 11–2

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

Case Study 11–3

Privacy

Case Study 11–4

Industry Support for Educational Activities

Conclusion

Self-Assessment Questions

Chapter Twelve.

Ethical Aspects of Drug Information Practice

Learning Objectives

Key Concepts

Introduction

Basics of Ethics Analysis

Case Example 12–1 (Micro-Level Case)

Case Example 12–2 (Meso-Level Case)

Case Study 12–1 (Micro Level)

Case Study 12–2 (Micro Level)

Case Study 12–3 (Meso Level)

Case Study 12–4 (Macro Level)

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 Thirteen.

Professional Communication of Drug Information

Learning Objectives

Key Concepts

Introduction

Steps in Writing

Case Study 13–1

Specific Documents

Case Study 13–2

Case Study 13–3

Conclusion

Self-Assessment Questions

Chapter Fourteen.

Media Relations

Learning Objectives

Key Concepts

Introduction

Working with the Media

Case Study 14–1

Case Study 14–2

Case Study 14–3

Summary

Self-Assessment Questions

Chapter Fifteen.

Pharmacy and Therapeutics Committee

Learning Objectives

Key Concepts

Introduction

Case Study 15–1

Organizational Background

Pharmacy Support of the P&T Committee

P&T Committee Meeting

P&T Committee Functions

Case Study 15–2

Case Study 15–3

Communication within an Organization

Case Study 15–4

Conclusion

Study Questions

Self-Assessment Questions

Acknowledgment

Chapter Sixteen.

Drug Evaluation Monographs

Learning Objectives

Key Concepts

Introduction

Purpose of Drug Evaluation Monographs

Sources of Drug Monographs

Contents of the Drug Monograph

Importance of the Drug Monograph

Summary Page

Body of the Monograph

Distribution of Drug Formulary

Conclusion

Case Study 16–1

Case Study 16–2

Case Study 16–3

Case Study 16–4

Case Study 16–5

Case Study 16–6

Self-Assessment Questions

Acknowledgment

Chapter Seventeen.

Drug Shortages and Counterfeit Drugs

Learning Objectives

Key Concepts

Introduction

Drug Shortages

Case Study 17–1

Case Study 17–2

Case Study 17–3

Counterfeit Drugs

Conclusion

Self-Assessment Questions

Chapter Eighteen.

Quality Improvement and the Medication Use System

Learning Objectives

Key Concepts

Introduction

The Changing Environment for Health Care Quality

Case Study 18–1

Case Study 18–2

Purpose of Measuring Quality

Quality Measures

Quality Improvement

Case Study 18–3

Case Study 18–4

Case Study 18–5

Case Study 18–6

Quality in Drug Information

Publication of Quality Improvement Studies

Conclusion

Self-Assessment Questions

Chapter Nineteen.

Medication Safety I: Adverse Drug Reactions

Learning Objectives

Key Concepts

Introduction

Impact of Adverse Drug Reactions

Definitions

Causality and Probability of Adverse Drug Reactions

Case Study 19–1

Classification of Adverse Drug Reactions

Implementing a Program

The Role of Technology in ADR Surveillance

Reporting Adverse Drug Reactions

Case Study 19–2

Case Study 19–3

Future Approaches to Pharmacovigilance

Conclusion

Self-Assessment Questions

Chapter Twenty.

Medication Safety II: Medication Errors

Learning Objectives

Key Concepts

Introduction

Definitions: Medication Errors, Adverse Drug Events (ADES), and Adverse Drug Reactions (ADRS)

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

External Reporting

Managing an Event Reporting System

Human Error or System Error?

Case Study 20–1

Risk Factors for Errors and Events

Types of Safety Analyses

Case Study 20–2

Just Culture

Case Study 20–3

Key Organizations for Safety Best Practices

Case Study 20–4

Conclusion: Safety as a Priority

Self-Assessment Questions

Chapter Twenty-One.

Policy, Procedure, and Guideline Development

Learning Objectives

Key Concepts

Introduction

Regulatory Considerations

Practice Document Design and Organization

Factors Influencing Practice Document Development

Systematic Method for Practice Document Development and Maintenance

Case Study 21–1

Conclusion

Case Study 21–2

Self-Assessment Questions

Chapter Twenty-Two.

Project Management

Learning Objectives

Key Concepts

Introduction

Projects, Programs, and Portfolios

Selecting Projects

Initiating a Project

Planning a Project

Case Study 22–1

Executing a Project

Monitoring and Controlling a Project

Closing a Project

Conclusion

Self-Assessment Questions

Chapter Twenty-Three.

Investigational Drugs

Learning Objectives

Key Concepts

Introduction

History of Drug Development Regulation in the United States

The Drug Approval Process

Case Study 23–1

Case Study 23–2

The Orphan Drug Act

Institutional Review Board/Institutional Ethics Committee

Case Study 23–3

Role of the Health Care Professional

Conclusion

Self-Assessment Questions

Chapter Twenty-Four.

Regulatory Affairs and Pharmaceutical Industry

Learning Objectives

Key Concepts

Introduction

Anatomy of the Department of Health and Human Services and the Food and Drug Administration

Division of Drug Information

Case Study 24–1

Opportunities within the FDA

The Food and Drug Administration and the Pharmaceutical Industry

Medical Communications in the Pharmaceutical Industry

FDA Regulatory Oversight

Fulfillment of Medical Information Requests

Case Study 24–2

Required Safety Reporting to FDA

Case Study 24–3

Code on Interactions with Healthcare Professionals

Opportunities for Health Professionals within Industry

Conclusion

Self-Assessment Questions

Chapter Twenty-Five.

Assessing Drug Promotions

Learning Objectives

Key Concepts

Introduction

Ethical Criteria for Medicinal Drug Promotion

Direct-to-Consumer Advertising (DTCA)

Case Study 25–1

Promotions to Health Care Professionals

Case Study 25–2

Case Study 25–3

Case Study 25–4

Conclusion

Self-Assessment Questions

Chapter Twenty-Six.

Drug Information in Ambulatory Care

Learning Objectives

Key Concepts

Introduction

Providing Drug Information in the Ambulatory Care Setting

Drug Information Responsibilities in Ambulatory Care

Case Study 26–1

Case Study 26–2

Case Study 26–3

Case Study 26–4

Conclusion

Self-Assessment Questions

Chapter Twenty-Seven.

Drug Information and Contemporary Community Pharmacy Practice

Learning Objectives

Key Concepts

Introduction

Pharmacists as Drug Information Providers

Patient Sources of Drug Information

Case Study 27–1

Case Study 27–2

Case Study 27–3

A New Model of Drug Information

Conclusion

Self-Assessment Questions

Chapter Twenty-Eight.

Pharmacy Informatics I: Systems and Technology for Patient Care

Learning Objectives

Key Concepts

Introduction

Medication-Use Proces

Pharmacy Informatics

Order Entry (Prescribing Stage)

Case Study 28–1

Order Verification

Dispensing

Administration

Monitoring

Case Study 28–2

Case Study 28–3

The Future: Informatics in the U.

S.

Health Care System

Case Study 28–4

Case Study 28–5

Conclusion

Self-Assessment Questions

Chapter Twenty-Nine.

Pharmacy Informatics II: Big Data

Learning Objectives

Key Concepts

Introduction

Reporting and Analytics

Case Study 29–1

Big Data

Case Study 29–2

Artificial Intelligence

Conclusion

Self-Assessment Questions

Chapter Thirty.

Drug Information Education and Training

Learning Objectives

Key Concepts

Introduction

Drug Information in Pharmacy Curriculum

Case Study 30–1

Case Study 30–2

Postgraduate Training in Drug Information

Case Study 30–3

Pursuing Specialty Training

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 Drug Literature Assessment Questions for Other Study Designs

Appendix 8–1 Grade Evidence Profile: Antibiotics for Children with Acute Otitis Media

Appendix 12–1 Code of Ethics for Pharmacists

Appendix 13–1 Question Example

Appendix 13–2 Abstracts

Appendix 13–3 Bibliography

Appendix 15–1 Pharmacy and Therapeutics Committee Procedure

Appendix 15–2 Formulary Request Form

Appendix 15–3 P&T Committee Meeting Attributes

Appendix 15–4 Example P&T Committee Minutes

Appendix 15–5 Chairperson Skills

Appendix 15–6 Conflict of Interest Declaration

Appendix 16–1 Format for Drug Monograph

Appendix 16–2 Example Drug Monograph

Appendix 16–3 Biosimilar Monograph

Appendix 18–1 Tools Used in Quality Assurance

Appendix 18–2 Example of Criteria and Request for Approval

Appendix 18–3 Example of Medication Use Evaluation (MUE) Results

Appendix 18–4 Evaluation Form for Drug Information Response

Appendix 19–1 Kramer Questionnaire

Appendix 19–2 Naranjo Algorithm

Appendix 19–3 Jones Algorithm

Appendix 19–4 Liverpool ADR Causality Assessment Tool

Appendix 19–5 MedWatch Form

Appendix 21–1 Policy Example: High-Alert Medications

Appendix 22–1 Example of a Project Charter

Appendix 22–2 Stakeholder Matrix—IV Compounding Software Project

Appendix 22–3 Example PESTLE Analysis—IV Compounding Software Project

Appendix 22–4 Example Work Breakdown Structure (WBS)—IV Compounding Software Project

Appendix 24–1 Example REMS Template for Writing Participant Information

Appendix 24–2 Response Letter Drug A—Incidence of Yellow Stripes

Glossary

Case Study Answers

Abbreviations

Answers for Self-Assessment Questions

Index