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RN Pharmacology for Nursing 11th Edition Unknown

Pharmacology for Anaesthesia and Intensive Care 5th

Edition Tom Peck

Pharmacology: A Patient-Centered Nursing Process Approach

9th Edition Linda E. Mccuistion
Medical-Surgical Nursing: Concepts for Interprofessional
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 Contents
UNIT I 28 Opioid Analgesics, Opioid Antagonists, and
Nonopioid Centrally Acting Analgesics 260
INTRODUCTION 29 Pain Management in Patients with Cancer 286
1 Orientation to Pharmacology 1 30 Drugs for Headache 305
2 Application of Pharmacology in Nursing Practice 5
Psychotherapeutic Drugs
3 Drug Regulation, Development, Names, and
31 Antipsychotic Agents and Their Use in
Information 14
Schizophrenia 317
32 Antidepressants 339
UNIT II 33 Drugs for Bipolar Disorder 364
BASIC PRINCIPLES OF PHARMACOLOGY 34 Sedative-Hypnotic Drugs 373
35 Management of Anxiety Disorders 388
4 Pharmacokinetics 22
36 Central Nervous System Stimulants and
5 Pharmacodynamics 44
6 Drug Interactions 55 Attention-Deficit/Hyperactivity Disorder 395
7 Adverse Drug Reactions and Medication Errors 62 Drug Abuse
8 Individual Variation in Drug Responses 73 37 Drug Abuse I: Basic Considerations 406
38 Drug Abuse II: Alcohol 412
UNIT III 39 Drug Abuse III: Nicotine and Smoking 423
40 Drug Abuse IV: Major Drugs of Abuse Other Than
DRUG THERAPY ACROSS THE LIFE SPAN Alcohol and Nicotine 431
9 Drug Therapy During Pregnancy and
Breast-Feeding 81 UNIT VI
10 Drug Therapy in Pediatric Patients 88 DRUGS THAT AFFECT FLUID AND ELECTROLYTE
11 Drug Therapy in Geriatric Patients 92
BALANCE
41 Diuretics 447
UNIT IV
42 Agents Affecting the Volume and Ion Content of
PERIPHERAL NERVOUS SYSTEM DRUGS Body Fluids 459
Introduction
12 Basic Principles of Neuropharmacology 96 UNIT VII
13 Physiology of the Peripheral Nervous System 102 DRUGS THAT AFFECT THE HEART, BLOOD VESSELS,
Cholinergic Drugs AND BLOOD
14 Muscarinic Agonists and Antagonists 115 43 Review of Hemodynamics 464
15 Cholinesterase Inhibitors and Their Use in 44 Drugs Acting on the Renin-Angiotensin-Aldosterone
Myasthenia Gravis 127 System 470
16 Drugs That Block Nicotinic Cholinergic 45 Calcium Channel Blockers 485
Transmission: Neuromuscular Blocking 46 Vasodilators 494
Agents 134 47 Drugs for Hypertension 499
Adrenergic Drugs 48 Drugs for Heart Failure 517
17 Adrenergic Agonists 143 49 Antidysrhythmic Drugs 534
18 Adrenergic Antagonists 156 50 Prophylaxis of Atherosclerotic Cardiovascular
19 Indirect-Acting Antiadrenergic Agents 168 Disease: Drugs That Help Normalize Cholesterol
and Triglyceride Levels 556
UNIT V 51 Drugs for Angina Pectoris 581
52 Anticoagulant, Antiplatelet, and Thrombolytic
CENTRAL NERVOUS SYSTEM DRUGS Drugs 594
Introduction 53 Management of ST-Elevation Myocardial
20 Introduction to Central Nervous System Infarction 625
Pharmacology 173 54 Drugs for Hemophilia 632
Drugs for Neurodegenerative Disorders 55 Drugs for Deficiency Anemias 640
21 Drugs for Parkinson’s Disease 176 56 Hematopoietic Agents 655
22 Drugs for Alzheimer’s Disease 191
23 Drugs for Multiple Sclerosis 199 UNIT VIII
Neurologic Drugs DRUGS FOR ENDOCRINE DISORDERS
24 Drugs for Epilepsy 216 57 Drugs for Diabetes Mellitus 667
25 Drugs for Muscle Spasm and Spasticity 240 58 Drugs for Thyroid Disorders 703
Drugs for Pain 59 Drugs Related to Hypothalamic and Pituitary
26 Local Anesthetics 245 Function 715
27 General Anesthetics 251 60 Drugs for Disorders of the Adrenal Cortex 725
UNIT IX 85 Drugs That Weaken the Bacterial Cell Wall II:
WOMEN’S HEALTH Cephalosporins, Carbapenems, Vancomycin,
Telavancin, Aztreonam, and Fosfomycin 1025
61 Estrogens and Progestins: Basic Pharmacology and 86 Bacteriostatic Inhibitors of Protein Synthesis:
Noncontraceptive Applications 733 Tetracyclines, Macrolides, and Others 1037
62 Birth Control 751 87 Aminoglycosides: Bactericidal Inhibitors of Protein
63 Drug Therapy of Infertility 769 Synthesis 1050
64 Drugs That Affect Uterine Function 777 88 Sulfonamides and Trimethoprim 1058
89 Drug Therapy of Urinary Tract Infections 1066
UNIT X 90 Antimycobacterial Agents: Drugs for Tuberculosis,
MEN’S HEALTH Leprosy, and Mycobacterium avium Complex
65 Androgens 788
Infection 1071
66 Drugs for Erectile Dysfunction and Benign Prostatic
91 Miscellaneous Antibacterial Drugs:
Hyperplasia 796 Fluoroquinolones, Metronidazole, Daptomycin,
Rifampin, Rifaximin, Bacitracin, and
UNIT XI Polymyxins 1086
92 Antifungal Agents 1093
ANTIINFLAMMATORY, ANTIALLERGIC, AND 93 Antiviral Agents I: Drugs for Non-HIV Viral
IMMUNOLOGIC DRUGS Infections 1106
67 Review of the Immune System 806 94 Antiviral Agents II: Drugs for HIV Infection and
68 Childhood Immunization 817 Related Opportunistic Infections 1124
69 Immunosuppressants 834 95 Drug Therapy of Sexually Transmitted
70 Antihistamines 841 Diseases 1167
71 Cyclooxygenase Inhibitors: Nonsteroidal 96 Antiseptics and Disinfectants 1175
Antiinflammatory Drugs and Acetaminophen 849
72 Glucocorticoids in Nonendocrine Disorders 869 UNIT XVII
CHEMOTHERAPY OF PARASITIC DISEASES
UNIT XII 97 Anthelmintics 1182
DRUGS FOR BONE AND JOINT DISORDERS 98 Antiprotozoal Drugs I: Antimalarial Agents 1187
73 Drug Therapy of Rheumatoid Arthritis 879 99 Antiprotozoal Drugs II: Miscellaneous
74 Drug Therapy of Gout 891 Agents 1195
75 Drugs Affecting Calcium Levels and Bone 100 Ectoparasiticides 1201
Mineralization 896
UNIT XVIII
UNIT XIII CANCER CHEMOTHERAPY
RESPIRATORY TRACT DRUGS 101 Basic Principles of Cancer Chemotherapy 1206
76 Drugs for Asthma and Chronic Obstructive 102 Anticancer Drugs I: Cytotoxic Agents 1220
Pulmonary Disease 918 103 Anticancer Drugs II: Hormonal Agents, Targeted
77 Drugs for Allergic Rhinitis, Cough, and Colds 939 Drugs, and Other Noncytotoxic Anticancer
Drugs 1238
UNIT XIV
UNIT XIX
GASTROINTESTINAL DRUGS
MISCELLANEOUS DRUGS AND THERAPIES
78 Drugs for Peptic Ulcer Disease 947
79 Laxatives 963
104 Drugs for the Eye 1267
80 Other Gastrointestinal Drugs 971
105 Drugs for the Skin 1278
106 Drugs for the Ear 1296
UNIT XV 107 Additional Noteworthy Drugs 1302
108 Complementary and Alternative Therapy 1318
NUTRITION
81 Vitamins 987 UNIT XX
82 Drugs for Weight Loss 996 TOXICOLOGY
109 Management of Poisoning 1330
UNIT XVI
110 Potential Weapons of Biologic, Radiologic, and
CHEMOTHERAPY OF INFECTIOUS DISEASES Chemical Terrorism 1336
83 Basic Principles of Antimicrobial Therapy 1001
84 Drugs That Weaken the Bacterial Cell Wall I: APPENDIX
Penicillins 1015 Canadian Drug Information 1346
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Lehne’s Pharmacology
for Nursing Care
9th Edition

JACQUELINE ROSENJACK BURCHUM, DNSc, FNP-BC, CNE

Associate Professor, College of Nursing
Department of Advanced Practice and Doctoral Studies
University of Tennessee Health Science Center
Memphis, Tennessee

LAURA D. ROSENTHAL, RN, DNP, ACNP-BC

Assistant Professor, College of Nursing
Assistant Professor, School of Medicine
University of Colorado, Anschutz Medical Campus
Denver, Colorado

In consultation with

BETH OUTLAND JONES, PharmD

Clinical Pharmacist
Missouri Baptist Medical Center
St. Louis, Missouri

JOSHUA J. NEUMILLER, PharmD, CDE, FASCP

Assistant Professor of Pharmacotherapy
Washington State University
Spokane, Washington
3251 Riverport Lane
St. Louis, Missouri 63043

LEHNE’S PHARMACOLOGY FOR NURSING CARE, ED 9  ISBN: 978-0-323-32190-7

Copyright © 2016, 2013, 2010, 2007, 2004, 2001, 1998, 1994, 1990 by Saunders, an imprint of
Elsevier Inc.

All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any
means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval
system, without permission in writing from the publisher. Details on how to seek permission, further
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www.elsevier.com/permissions.

This book and the individual contributions contained in it are protected under copyright by the Publisher
(other than as may be noted herein).

Notices

Knowledge and best practice in this field are constantly changing. As new research and experience
broaden our understanding, changes in research methods, professional practices, or medical treatment may
become necessary.
Practitioners and researchers must always rely on their own experience and knowledge in evaluating
and using any information, methods, compounds, or experiments described herein. In using such
information or methods they should be mindful of their own safety and the safety of others, including
parties for whom they have a professional responsibility.
With respect to any drug or pharmaceutical products identified, readers are advised to check the most
current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be
administered, to verify the recommended dose or formula, the method and duration of administration, and
contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge
of their patients, to make diagnoses, to determine dosages and the best treatment for each individual
patient, and to take all appropriate safety precautions.
To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume
any liability for any injury and/or damage to persons or property as a matter of products liability,
negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas
contained in the material herein.

Library of Congress Cataloging-in-Publication Data

Burchum, Jacqueline Rosenjack, author.

Lehne’s pharmacology for nursing care / Jacqueline Rosenjack Burchum, Laura D. Rosenthal ;
in consultation with Beth Outland Jones, Joshua J. Neumiller.—Edition 9.
   p. ; cm.
Pharmacology for nursing care
Preceded by Pharmacology for nursing care / Richard A. Lehne ; in consultation with Linda A. Moore,
Leanna J. Crosby, Diane B. Hamilton. 8th ed. c2013.
Includes bibliographical references and index.
ISBN 978-0-323-32190-7 (pbk. : alk. paper)
I. Rosenthal, Laura D., author. II. Jones, Beth Outland, consultant. III. Neumiller, Joshua J.,
consultant. IV. Lehne, Richard A., 1943- Pharmacology for nursing care. Preceded by (work):
V. Title. VI. Title: Pharmacology for nursing care.
[DNLM: 1. Pharmacology—Nurses’ Instruction. 2. Drug Therapy—Nurses’ Instruction.
3. Pharmaceutical Preparations—Nurses’ Instruction. QV 4]
RM301
615'.1—dc23
   2014035140

Content Strategist: Jamie Randall

Content Development Manager: Billie Sharp
Senior Content Development Specialist: Jennifer Ehlers
Publishing Services Manager: Jeff Patterson
Senior Project Manager: Anne Konopka
Design Direction: Amy Buxton

Printed in China

Last digit is the print number: 9 8 7 6 5 4 3 2 1

To my mother, Jo Ann Hicks Cooper, who is the strongest yet most gentle person I know;
my husband, Tony Burchum, who is both my rock and my soft place to land;
and my son, Jade Charmagan, who is my pride, my joy,
and my constant source of inspiration.
JRB

For my husband, Ryan, who is my best friend and life companion.

Also, for my parents, John and Pat Dorman, for their endless love and support.
LDR
 About the Authors

Jacqueline Lee Rosenjack Laura Rosenthal, RN, DNP,

Burchum, DNSc, FNP-BC, ACNP-BC, has been a registered
CNE, earned the Bachelor of nurse since graduating with her
Science in Nursing degree from Bachelor of Science in nursing
Union University in Jackson, from the University of Michigan
Tennessee, and both the Masters in 2000. She completed her
of Science in Nursing and the Master of Science in nursing in
Doctor of Nursing Science 2006 at Case Western Reserve
degree from the University of University in Cleveland, Ohio.
Tennessee Health Science Center She finished her nursing educa-
(UTHSC) in Memphis, Tennes- tion at the University of Colo-
see. Dr. Burchum holds national rado, College of Nursing,
certification as a Family Nurse graduating with her Doctor of
Practitioner (FNP-BC) and Certi- Nursing Practice degree in 2011.
fied Nurse Educator (CNE). She is a faculty member in the Her background includes practice in acute care and inpatient
Department of Advanced Practice and Doctoral Studies of the medicine. While working as a nurse practitioner at the Uni-
College of Nursing at UTHSC. versity of Colorado Hospital, she assisted in developing one
As a nurse practitioner and researcher, Dr. Burchum’s of the first fellowships for advanced practice clinicians in
work has centered on addressing the needs of vulnerable hospital medicine.
populations with a special focus on immigrant and refugee Dr. Rosenthal serves as an assistant professor at the Uni-
populations. As an educator, Dr. Burchum has a special inter- versity of Colorado, College of Nursing, where she teaches
est in online teaching and program quality. She has received within the undergraduate and graduate programs. She received
awards for excellence in teaching from both student and pro- the Dean’s Award for Excellence in Teaching in 2013. She is
fessional organizations. She is a member of the American a member of the Allied Health Committee at The University
Nurses Association, the National League for Nursing, and of Colorado Hospital and remains an active member of Sigma
Sigma Theta Tau International Honor Society of Nursing. Theta Tau International Honor Society of Nursing. In her
In her spare time, Dr. Burchum enjoys hiking and piecing spare time, Dr. Rosenthal enjoys running, skiing, and foster-
quilts. ing retired greyhounds for Colorado Greyhound Adoption.

vi
 Contributors and Reviewers

CONTRIBUTOR TO TEXTBOOK

Joshua J. Neumiller, PharmD, CDE, FASCP

Assistant Professor of Pharmacotherapy
Washington State University
Spokane, Washington
Chapter 57

CONTRIBUTORS TO TEACHING AND LEARNING RESOURCES

Valerie O’Toole Baker, RN, MSN, ACNS, BC Tara McMillan-Queen, RN, MSN, ANP, GNP
Assistant Professor Faculty II
Villa Maria School of Nursing Mercy School of Nursing
Gannon University Charlotte, North Carolina
Erie, Pennsylvania Review Questions for the NCLEX® Examination
PowerPoint Collection
Kathryn Schartz, RN, MSN, CPNP
Nancy Haugen, PhD, RN Pediatric Nurse Practitioner
Associate Professor and ABSN Program Chair General Pediatrics, Medical Coordination Team
School of Nursing Children’s Mercy Hospital and Clinics
Samuel Merritt University Kansas City, Missouri
Oakland, California Test Bank
Pharmacology Online
Allison Terry, PhD, MSN, RN
Tiffany Jakubowski, BSN, RN Associate Professor of Nursing
Instructor Auburn University at Montgomery
School of Nursing Montgomery, Alabama
Front Range Community College Downloadable Key Points
Boulder, Colorado
Review Questions for the NCLEX® Examination Jennifer Yeager, PhD, RN, ANP-BC
Assistant Professor
Maria Lauer-Pfrommer, PhD, APN-C, CNE Department of Nursing
Assistant Professor Tarleton State University
College of Nursing Stephenville, Texas
Holy Family University Study Guide
Philadelphia, Pennsylvania
TEACH® for Nurses Lesson Plans

REVIEWERS

Beth Outland Jones, PharmD Jennifer Yeager, PhD, RN, ANP-BC

Clinical Pharmacist Assistant Professor
Missouri Baptist Medical Center Department of Nursing
St. Louis, Missouri Tarleton State University
Stephenville, Texas
Joshua J. Neumiller, PharmD, CDE, FASCP
Assistant Professor of Pharmacotherapy Nancy Haugen, PhD, RN
Washington State University Associate Professor and ABSN Program Chair
Spokane, Washington School of Nursing
Samuel Merritt University
Oakland, California

vii
 Preface

Pharmacology pervades all phases of nursing practice and these drugs is presented in a series of paragraphs describing
relates directly to patient care and education. Yet, despite its each drug in turn. When attempting to study from such a list,
importance, many students—and even some teachers—are you are likely to learn many drug names and little else; the
often uncomfortable with the subject. Why? Because tradi- important concept of similarity among family members is
tional texts have stressed memorizing rather than understand- easily lost. In this text, the family prototype—aspirin—is
ing. In this text, the guiding principle is to establish a basic discussed first and in depth. After this, the small ways in
understanding of drugs, after which secondary details can be which individual NSAIDs differ from aspirin are pointed out.
learned as needed. Not only is this approach more efficient than the traditional
This text has two major objectives: to help you, the nursing approach, it is also more effective, in that similarities among
student, establish a knowledge base in the basic science of family members are emphasized.
drugs, and to show you how that knowledge can be applied
in clinical practice. The methods by which these goals are
achieved are described below.
LARGE PRINT AND SMALL PRINT:
A WAY TO FOCUS ON ESSENTIALS
LAYING FOUNDATIONS IN
BASIC PRINCIPLES Pharmacology is exceptionally rich in detail. There are
many drug families, each with multiple members and
To understand drugs, you need a solid foundation in basic each member with its own catalogue of indications, con-
pharmacologic principles. To help you establish that founda- traindications, adverse effects, and drug interactions.
tion, the book has major chapters on the following topics: This abundance of detail confronts teachers with the dif-
basic principles that apply to all drugs (Chapters 4 through ficult question of what to teach, and students with the
8), basic principles of drug therapy across the life span equally difficult question of what to study. Attempting to
(Chapters 9 through 11), basic principles of neuropharmacol- answer these questions can frustrate teachers and students
ogy (Chapter 12), basic principles of antimicrobial therapy alike. Even worse, in the presence of myriad details, basic
(Chapter 83), and basic principles of cancer chemotherapy concepts can be obscured.
(Chapter 101). To help you focus on essentials, there are two sizes of
type. Large type is intended to say, “On your first expo-
sure to this topic, this is the core of information you
REVIEWING PHYSIOLOGY should learn.” Small type is intended to say, “Here is
AND PATHOPHYSIOLOGY additional information that you may want to learn after
mastering the material in large type.” As a rule, we
To understand the actions of a drug, it is useful to understand reserve large print for prototypes, basic principles of
the biologic systems that the drug influences. Accordingly, pharmacology, and reviews of physiology and patho-
for all major drug families, relevant physiology and patho- physiology. We use small print for secondary information
physiology are reviewed. In almost all cases, these reviews about the prototypes and for discussion of drugs that are
are presented at the beginning of each chapter, rather than not prototypes. This technique allows the book to contain
in a systems review at the beginning of a unit. This jux- a large body of detail without having that detail cloud the
taposition of pharmacology, physiology, and pathophysiol- big picture. Furthermore, because the technique high-
ogy is designed to help you understand how these topics lights essentials, it minimizes questions about what to
interrelate. teach and what to study.
The use of large and small print is especially valuable
for discussing adverse effects and drug interactions. Most
TEACHING THROUGH PROTOTYPES drugs are associated with many adverse effects and inter-
actions. As a rule, however, only a few of these are
Within each drug family, we can usually identify a proto- noteworthy. In traditional texts, practically all adverse
type—that is, a drug that embodies characteristics shared by effects and interactions are presented, creating long and
all members of the group. Because other family members are tedious lists. In this text, we use large print to highlight
similar to the prototype, to know the prototype is to know the the few adverse effects and interactions that are espe-
basic properties of all family members. cially characteristic; the rest are noted briefly in small
The benefits of teaching through prototypes can be appre- print. Rather than overwhelming you with long and for-
ciated with an example. Let’s consider the nonsteroidal anti- bidding lists, this text delineates a moderate body of
inflammatory drugs (NSAIDs), a family that includes aspirin, information that’s truly important, and thereby facilitates
ibuprofen [Motrin], naproxen [Aleve], celecoxib [Celebrex], comprehension.
and more than 20 other drugs. Traditionally, information on

viii
 PREFACE

current research. Canadian trade names have been updated

USING CLINICAL REALITY TO and continue to be identified by a maple-leaf icon.
PRIORITIZE CONTENT
This book contains two broad categories of information: phar- LEARNING SUPPLEMENTS FOR STUDENTS
macology (ie, basic science about drugs) and therapeutics (ie,
clinical use of drugs). To ensure that content is clinically • Online Evolve Resources accompany this edition and
relevant, we use evidence-based treatment guidelines as a include Downloadable Key Points, Review Questions
basis for deciding what to stress and what to play down. for the NCLEX® Examination, Unfolding Case Studies,
Unfortunately, clinical practice is a moving target: When and more. These resources are available at http://evolve.
effective new drugs are introduced, and when clinical trials elsevier.com/Lehne.
reveal new benefits or new risks of older drugs, the guidelines • Pharmacology Online for Lehne’s Pharmacology for
change—and so we have to work hard to keep this book Nursing Care, ninth edition, is a dynamic online course
current. Despite our best efforts, the book and clinical reality resource that includes interactive self-study modules, a
may not always agree: Some treatments discussed here will collection of interactive learning resources, and a media-
be considered inappropriate before the 10th edition comes rich library of supplemental resources.
out. Furthermore, in areas where controversy exists, the treat- • The Study Guide, which is keyed to the book, includes
ments discussed here may be considered inappropriate by study questions; critical thinking, prioritization, and dele-
some clinicians right now. gation questions; and case studies.

NURSING IMPLICATIONS: TEACHING SUPPLEMENTS

DEMONSTRATING THE APPLICATION OF FOR INSTRUCTORS
PHARMACOLOGY IN NURSING PRACTICE
• The Instructor Resources for the ninth edition are available
The principal reason for asking you to learn pharmacology online and include TEACH® for Nurses Lesson Plans, a
is to enhance your ability to provide patient care and educa- Test Bank, a PowerPoint Collection, and an Image
tion. To show you how pharmacologic knowledge can be Collection.
applied to nursing practice, nursing implications are inte-
grated into the body of each chapter. That is, as specific drugs
and drug families are discussed, the nursing implications WAYS TO USE THIS TEXTBOOK
inherent in the pharmacologic information are noted side-by-
side with the basic science. To facilitate access to nursing Thanks to its focus on essentials, this text is especially well
content, nursing implications are also summarized at the end suited to serve as the primary text for a course dedicated
of most chapters. These summaries serve to reinforce the specifically to pharmacology. In addition, the book’s focused
information presented in the chapter body. approach makes it a valuable resource for pharmacologic
In chapters that are especially brief or that address drugs instruction within an integrated curriculum and for self-
that are infrequently used, summaries of nursing implications directed learning by students, teachers, and practitioners.
have been omitted. However, even in these chapters, nursing How is this focus achieved? Four primary techniques are
implications are incorporated into the main chapter text. employed: (1) teaching through prototypes, (2) using standard
print for essential information and small print for second-
ary information, (3) limiting discussion of adverse effects
WHAT’S NEW IN THE BOOK? and drug interactions to information that matters most, and
(4) using evidence-based clinical guidelines to determine
Lehne’s Pharmacology for Nursing Care has been revised what content to stress. To reinforce the relationship between
cover to cover to ensure that the latest and most accurate pharmacologic knowledge and nursing practice, nursing
information is presented. Three new features have been added implications are integrated into each chapter. Also, to provide
to help promote our focus on the most useful, most critical rapid access to nursing content, nursing implications are
information for nursing students: summarized at the end of most chapters, using a nursing
process format. In addition, key points are listed at the
• Prototype Drugs: This content, which appeared in an end-
end of each chapter. As in previous editions, the ninth edition
of-book appendix in previous editions, has been moved
emphasizes conceptual material—reducing rote memori-
into the book’s chapters as a new, easy-to-find feature.
zation, promoting comprehension, and increasing reader
• Safety Alerts: This eye-catching new feature draws the
friendliness.
reader’s attention to important safety concerns related to
Pharmacology can be an unpopular subject due to the vast
contraindications, adverse effects, pregnancy categories,
and rapidly changing area of content. Often, nursing students
and more.
feel that pharmacology is one of the most difficult classes to
• Patient-Centered Care Across the Life Span: New tables
master. We hope that this book makes the subject of pharma-
in many chapters highlight care concerns for patients
cology easier and more enjoyable for you to understand by
throughout their lives, from infancy to older adulthood.
allowing you to focus on the most important, umbrella con-
In addition, the popular Special Interest Topics of past cepts of pharmacology as they relate to nursing care and the
editions have been thoroughly revised to allow for the most safety of patients.

ix
PREFACE

ACKNOWLEDGMENTS Finally, we would like to express our gratitude to Richard

A. Lehne for his dedication to this book for eight editions. We
We would like to acknowledge the support of our colleagues are honored to be able to continue his work.
at Elsevier, including Content Strategists Jamie Randall and
Lee Henderson, Senior Content Development Specialist Jacqueline Rosenjack Burchum
Jennifer Ehlers, and Senior Project Manager Anne Konopka. Laura D. Rosenthal
We also thank our reviewers, past and present, including
Beth Outland Jones, Joshua Neumiller, Jennifer Yeager,
Nancy Haugen, Alfred J. Rémillard, and Stephen M. Setter.

x
 CHAPTER

1 Orientation to Pharmacology

pharmacology includes knowledge of the history, sources, and

Four Basic Terms, p. 1
uses of drugs as well as knowledge of drug absorption, dis-
Properties of an Ideal Drug, p. 1 tribution, metabolism, and excretion. Because pharmacology
The Big Three: Effectiveness, Safety, and encompasses such a broad spectrum of information, it would
Selectivity, p. 1 be impossible to address the entire scope of pharmacology in
Additional Properties of an Ideal Drug, p. 2 this text. Consequently, we limit consideration to information
Because No Drug Is Ideal, p. 2 that is clinically relevant.
The Therapeutic Objective, p. 2 Clinical Pharmacology. Clinical pharmacology is defined
Factors That Determine the Intensity of Drug as the study of drugs in humans. This discipline includes the
Responses, p. 3 study of drugs in patients as well as in healthy volunteers
Administration, p. 3 (during new drug development). Because clinical pharmacol-
ogy encompasses all aspects of the interaction between drugs
Pharmacokinetics, p. 3
and people, and since our primary interest is the use of drugs
Pharmacodynamics, p. 3 to treat patients, clinical pharmacology includes some infor-
Sources of Individual Variation, p. 3 mation that is outside the scope of this text.
Key Points, p. 4 Therapeutics. Therapeutics, also known as pharmaco-
therapeutics, is defined as the use of drugs to diagnose,
prevent, or treat disease or to prevent pregnancy. Alterna-
By now, you’ve been hitting the books for many years, and tively, therapeutics can be defined simply as the medical use
have probably asked yourself, “What’s the purpose of all of drugs.
this education?” In the past your question may have lacked In this text, therapeutics is our principal concern. Accord-
a satisfying answer. Happily, now you have one: You’ve ingly, much of our discussion focuses on the basic science
spent most of your life in school so you could study that underlies the clinical use of drugs. This information is
pharmacology! intended to help you understand how drugs produce their
There’s good reason you haven’t approached pharmacol- effects—both therapeutic and adverse; the reasons for giving
ogy before now. Pharmacology is a science that draws on a particular drug to a particular patient; and the rationale
information from multiple disciplines, among them anatomy, underlying selection of dosage, route, and schedule of admin-
physiology, chemistry, microbiology, and psychology. Conse- istration. This information will also help you understand the
quently, before you could study pharmacology, you had to strategies employed to promote beneficial drug effects and to
become familiar with these other sciences. Now that you’ve minimize undesired effects. Armed with this knowledge, you
established the requisite knowledge base, you’re finally ready will be well prepared to provide drug-related patient care and
to learn about drugs. education. In addition, by making drugs less mysterious, this
knowledge should make working with drugs more comfort-
able, and perhaps even more satisfying.
FOUR BASIC TERMS
At this point, I’d like to define four basic terms: drug, phar- PROPERTIES OF AN IDEAL DRUG
macology, clinical pharmacology, and therapeutics. As we
consider these definitions, I will indicate the kinds of informa- If we were developing a new drug, we would want it to be
tion that we will and will not discuss in this text. the best drug possible. To approach perfection, our drug
Drug. A drug is defined as any chemical that can affect should have certain properties, such as effectiveness and
living processes. By this definition, virtually all chemicals can safety. In the discussion below, we consider these two char-
be considered drugs, since, when exposure is sufficiently acteristics as well as others that an ideal drug might have.
high, all chemicals will have some effect on life. Clearly, it is Please note, however, that the ideal medication exists in
beyond the scope of this text to address all compounds that theory only: In reality, there’s no such thing as a perfect drug.
fit the definition of a drug. Accordingly, rather than discussing The truth of this statement will become apparent as we con-
all drugs, we will focus primarily on drugs that have thera- sider the properties that an ideal drug should have.
peutic applications.
Pharmacology. Pharmacology can be defined as the
study of drugs and their interactions with living systems. The Big Three: Effectiveness, Safety,
Under this definition, pharmacology encompasses the study and Selectivity
of the physical and chemical properties of drugs as well The three most important characteristics that any drug can
as their biochemical and physiologic effects. In addition, have are effectiveness, safety, and selectivity.

1
CHAPTER 1 Orientation to Pharmacology

Effectiveness. An effective drug is one that elicits the dosing schedule that consists of one daily dose rather than
responses for which it is given. Effectiveness is the most several. Furthermore, whenever skin integrity is broken, as is
important property a drug can have. Regardless of its other the case when drugs are given by injection, there is a risk of
virtues, if a drug is not effective—that is, if it doesn’t do infection as well as injection-site pain and discomfort.
anything useful—there is no justification for giving it. Current Freedom from Drug Interactions. When a patient is
U.S. law requires that all new drugs be proved effective prior taking two or more drugs, those drugs can interact. These
to release for marketing. interactions may augment or reduce drug responses. For
Safety. A safe drug is defined as one that cannot produce example, respiratory depression caused by diazepam [Valium],
harmful effects—even if administered in very high doses and which is normally minimal, can be greatly intensified by
for a very long time. All drugs have the ability to cause injury, alcohol. Conversely, the antibacterial effects of tetracycline
especially with high doses and prolonged use. The chances of can be greatly reduced by taking the drug with iron or calcium
producing adverse effects can be reduced by proper drug supplements. Because of the potential for interaction among
selection and proper dosing. However, the risk of adverse drugs, when a patient is taking more than one agent, the pos-
effects can never be eliminated. The following examples illus- sible impact of drug interactions must be considered. An ideal
trate this point: drug would not interact with other agents. Unfortunately, few
medicines are devoid of significant interactions.
• Certain anticancer drugs (eg, cyclophosphamide, meth-
Low Cost. An ideal drug would be easy to afford. The
otrexate), at usual therapeutic doses, always increase
cost of drugs can be a substantial financial burden. As an
the risk of serious infection.
extreme example, treatment with adalimumab [Humira], a
• Opioid analgesics (eg, morphine, meperidine), at high
drug for rheumatoid arthritis and Crohn’s disease, can cost
therapeutic doses, can cause potentially fatal respiratory
$50,000 or more per year. More commonly, expense becomes
depression.
a significant factor when a medication must be taken chroni-
• Aspirin and related drugs, when taken chronically in
cally. For example, people with hypertension, arthritis, or
high therapeutic doses, can cause life-threatening gastric
diabetes may take medications every day for life. The cumula-
ulceration, perforation, and bleeding.
tive expense of such treatment can be huge—even for drugs
Clearly, drugs have both benefits and risks. This fact may of moderate price.
explain why the Greeks used the word pharmakon, which can Chemical Stability. Some drugs lose effectiveness during
be translated as both remedy and poison. storage. Others that may be stable on the shelf can rapidly
Selectivity. A selective drug is defined as one that elicits lose effectiveness when put into solution (eg, in preparation
only the response for which it is given. There is no such thing for infusion). These losses in efficacy result from chemical
as a wholly selective drug because all drugs cause side effects. instability. Because of chemical instability, stocks of certain
Common examples include the drowsiness that can be caused drugs must be periodically discarded. An ideal drug would
by many antihistamines; the peripheral edema that can be retain its activity indefinitely.
caused by calcium channel blockers; and the sexual dysfunc- Possession of a Simple Generic Name. Generic names
tion commonly caused by fluoxetine [Prozac] and related of drugs are usually complex, and hence difficult to remember
antidepressants. and pronounce. As a rule, the trade name for a drug is much
simpler than its generic name. Examples of drugs that have
complex generic names and simple trade names include acet-
Additional Properties of an Ideal Drug aminophen [Tylenol], ciprofloxacin [Cipro], and simvastatin
Reversible Action. For most drugs, it is important that [Zocor]. Since generic names are preferable to trade names
effects be reversible. That is, in most cases, we want drug (for reasons discussed in Chapter 3), an ideal drug should
actions to subside within an appropriate time. General anes- have a generic name that is easy to recall and pronounce.
thetics, for example, would be useless if patients never woke
up. Likewise, it is unlikely that oral contraceptives would find
wide acceptance if they caused permanent sterility. For a few Because No Drug Is Ideal
drugs, however, reversibility is not desirable. With antibiotics, From the preceding criteria for ideal drugs, we can see that
for example, we want toxicity to microbes to endure. available medications are not ideal. All drugs have the poten-
Predictability. It would be very helpful if, prior to drug tial to produce side effects. Drug responses may be difficult
administration, we could know with certainty just how a given to predict and may be altered by drug interactions. Drugs may
patient will respond. Unfortunately, since each patient is be expensive, unstable, and hard to administer. Because medi-
unique, the accuracy of predictions cannot be guaranteed. cations are not ideal, all members of the healthcare team must
Accordingly, to maximize the chances of eliciting desired exercise care to promote therapeutic effects and minimize
responses, we must tailor therapy to the individual. drug-induced harm.
Ease of Administration. An ideal drug should be simple
to administer: The route should be convenient, and the number
of doses per day should be low. Patients with diabetes, who THE THERAPEUTIC OBJECTIVE
must inject insulin multiple times a day, are not likely to judge
insulin ideal. Similarly, nurses who must set up and monitor The objective of drug therapy is to provide maximum benefit
IV infusions are unlikely to consider intravenous drugs ideal. with minimal harm. If drugs were ideal, we could achieve this
In addition to convenience, ease of administration has two objective with relative ease. However, because drugs are not
other benefits: (1) it can enhance patient adherence, and (2) it ideal, we must exercise skill and care if treatment is to result
can decrease risk. Patients are more likely to adhere to a in more good than harm. As detailed in Chapter 2, you have

2
 CHAPTER 1 Orientation to Pharmacology

Figure 1–1 ■ Factors that determine the intensity of drug responses.

a critical responsibility in achieving the therapeutic objective. dose, or at the wrong time; the patient may even be given the
To meet this responsibility, you must understand drugs. The wrong drug. These errors can be made by pharmacists, physi-
primary purpose of this text is to help you achieve that cians, and nurses. Any of these errors will detract from achiev-
understanding. ing the therapeutic objective. Medication errors are discussed
at length in Chapter 7.

FACTORS THAT DETERMINE THE Pharmacokinetics

INTENSITY OF DRUG RESPONSES
Pharmacokinetic processes determine how much of an admin-
Multiple factors determine how an individual will respond to istered dose gets to its sites of action. There are four major
a prescribed dose of a particular drug (Fig. 1–1). By under- pharmacokinetic processes: (1) drug absorption, (2) drug dis-
standing these factors, you will be able to think rationally tribution, (3) drug metabolism, and (4) drug excretion. Col-
about how drugs produce their effects. As a result, you will lectively, these processes can be thought of as the impact of
be able to contribute maximally to achieving the therapeutic the body on drugs. These pharmacokinetic processes are dis-
objective. cussed at length in Chapter 4.
Our ultimate concern when administering a drug is the
intensity of the response. Working our way up from the
bottom of Figure 1–1, we can see that the intensity of Pharmacodynamics
the response is determined by the concentration of a drug at Once a drug has reached its sites of action, pharmacodynamic
its sites of action. As the figure suggests, the primary deter- processes determine the nature and intensity of the response.
minant of this concentration is the administered dose. When Pharmacodynamics can be thought of as the impact of drugs
administration is performed correctly, the dose that was given on the body. In most cases, the initial step leading to a response
will bear a close relationship to the dose that was prescribed. is the binding of a drug to its receptor. This drug-receptor
The steps leading from prescribed dose to intensity of the interaction is followed by a sequence of events that ultimately
response are considered below. results in a response. As indicated in Figure 1–1, the patient’s
functional state can influence pharmacodynamic processes.
For example, a patient who has developed tolerance to mor-
Administration phine will respond less intensely to a particular dose than will
The drug dosage, route, and timing of administration are a patient who lacks tolerance. Placebo effects also help deter-
important determinants of drug responses. Accordingly, the mine the responses that a drug elicits. Pharmacodynamics is
prescriber will consider these variables with care. Unfortu- discussed at length in Chapter 5.
nately, drugs are not always taken or administered as pre-
scribed. The result may be toxicity (if the dosage is too high) or
treatment failure (if the dosage is too low). To help minimize Sources of Individual Variation
errors caused by poor adherence, you should give patients com- Characteristics unique to each patient can influence pharma-
plete instructions about their medication and how to take it. cokinetic and pharmacodynamic processes and, by doing so,
Medication errors made by hospital staff may result in a can help determine the patient’s response to a drug. As indi-
drug being administered by the wrong route, in the wrong cated in Figure 1–1, sources of individual variation include

3
CHAPTER 1 Orientation to Pharmacology

drug interactions; physiologic variables (eg, age, gender, drug reactions. Because individuals differ from one another,
weight); pathologic variables (especially diminished function no two patients will respond identically to the same drug
of the kidneys and liver, the major organs of drug elimina- regimen. Accordingly, to achieve the therapeutic objective,
tion); and genetic variables. Genetic factors can alter the we must tailor drug therapy to the individual. Individual varia-
metabolism of drugs and can predispose the patient to unique tion in drug responses is the subject of Chapter 8.

KEY POINTS
■ The most important properties of an ideal drug are effec- ■ Because all patients are unique, drug therapy must be
tiveness, safety, and selectivity. tailored to each individual.
■ If a drug is not effective, it should not be used.
■ Drugs have both benefits and risks. Please visit http://evolve.elsevier.com/Lehne for chapter-
■ There is no such thing as a wholly selective drug: All specific NCLEX® examination review questions.
drugs can cause side effects.
■ The objective of drug therapy is to provide maximum
benefit with minimum harm.

4
 CHAPTER

2 Application of Pharmacology
in Nursing Practice

the right dose by the right route at the right time. More
Evolution of Nursing Responsibilities Regarding recently, various other rights—right assessment, right docu-
Drugs, p. 5
mentation, right evaluation, the patient’s rights to education,
Application of Pharmacology in Patient Care, p. 6 and the patient’s right of refusal—have been recommended
Preadministration Assessment, p. 6 for inclusion. Clearly, the original five Rights and their sub-
Dosage and Administration, p. 6 sequent additions are important. However, although these
Evaluating and Promoting Therapeutic basics are vital, much more is required to achieve the thera-
Effects, p. 7 peutic objective. The Rights guarantee only that a drug will
Minimizing Adverse Effects, p. 7 be administered as prescribed. Correct administration, without
Minimizing Adverse Interactions, p. 7 additional interventions, cannot ensure that treatment will
Making PRN Decisions, p. 7
result in maximum benefit and minimum harm.
The limitations of the Rights can be illustrated with this
Managing Toxicity, p. 7 analogy: The nurse who sees his or her responsibility as being
Application of Pharmacology in Patient complete after correct drug administration would be like a
Education, p. 8 major league baseball pitcher who felt that his responsibility
Dosage and Administration, p. 8 was over once he had thrown the ball toward the batter. As
Promoting Therapeutic Effects, p. 8 the pitcher must be ready to respond to the consequences of
Minimizing Adverse Effects, p. 8 the interaction between ball and bat, you must be ready to
Minimizing Adverse Interactions, p. 9 respond to the consequences of the interaction between drug
Application of the Nursing Process in Drug and patient. Put another way, although both the nurse and the
Therapy, p. 9 pitcher have a clear obligation to deliver their objects in the
Review of the Nursing Process, p. 9
most appropriate fashion, proper delivery is only the begin-
ning of their responsibilities: Important events will take place
Applying the Nursing Process in Drug after the object is delivered, and these must be responded to.
Therapy, p. 9
Like the pitcher, the nurse can respond rapidly and effectively
Use of a Modified Nursing Process Format to only by anticipating what the possible reactions to the drug
Summarize Nursing Implications, p. 12 might be.
Key Points, p. 13 To anticipate possible reactions, both the nurse and the
pitcher require certain kinds of knowledge. Just as the pitcher
must understand the abilities of the opposing batter, you must
understand the patient and the disorder for which the patient
Our principal goal in this chapter is to answer the question is being treated. As the pitcher must know the most appropri-
“Why should a nursing student learn pharmacology?” By ate pitch (eg, fast ball, slider) to deliver in specific circum-
addressing this question, I want to give you some extra moti- stances, you must know what medications are appropriate for
vation to study. Why do I think you might need some motiva- the patient and must check to ensure that the ordered medica-
tion? Because pharmacology can be challenging and other tion is an appropriate medication. Conversely, as the pitcher
topics in nursing are often more alluring. Hopefully, when you must know what pitches not to throw at a particular batter,
complete the chapter, you will be convinced that understand- you must know what drugs are contraindicated for the patient.
ing drugs is essential for nursing practice, and that putting As the pitcher must know the most likely outcome after the
time and effort into learning about drugs will be a good ball and bat interact, you must know the probable conse-
investment. quences of the interaction between drug and patient.
Although this analogy is not perfect (the nurse and patient
are on the same team, whereas the pitcher and batter are not),
EVOLUTION OF NURSING it does help us appreciate that the nurse’s responsibility
RESPONSIBILITIES REGARDING DRUGS extends well beyond the Rights. Consequently, in addition to
the limited information needed to administer drugs in accor-
In the past, a nurse’s responsibility regarding medications dance with the Rights, you must acquire a broad base of
focused on the Five Rights of Drug Administration (the pharmacologic knowledge so as to contribute fully to achiev-
Rights)—namely, give the right drug to the right patient in ing the therapeutic objective.

5
CHAPTER 2 Application of Pharmacology in Nursing Practice

Nurses, together with healthcare providers and pharma- effectiveness of our drug. For example, if we plan to give a
cists, participate in a system of checks and balances designed drug to lower blood pressure, we must know the patient’s
to promote beneficial effects and minimize harm. Nurses are blood pressure prior to treatment. Similarly, if we are planning
especially important in this system because it is the nurse who to give a drug that can damage the liver, we need to assess
follows the patient’s status most closely. As a result, you are baseline liver function to evaluate this potential toxicity.
likely to be the first member of the healthcare team to observe Obviously, to collect appropriate baseline data, we must first
and evaluate drug responses, and to intervene if required. To know the effects that a drug is likely to produce.
observe and evaluate drug responses, and to intervene rapidly Identifying High-Risk Patients. Multiple factors can
and appropriately, you must know in advance the responses predispose an individual to adverse reactions from specific
that a medication is likely to elicit. Put another way, to provide drugs. Important predisposing factors are pathophysiology
professional care, you must understand drugs. The better your (especially liver and kidney impairment), genetic factors,
knowledge of pharmacology, the better you will be able to drug allergies, and life span considerations such as pregnancy,
anticipate drug responses and not simply react to them after advanced age, and extreme youth.
the fact. Patients with penicillin allergy provide a dramatic example
Within our system of checks and balances, the nurse has of those at risk: Giving penicillin to such a patient can be fatal.
an important role as patient advocate. It is your responsibility Accordingly, whenever treatment with penicillin is under con-
to detect mistakes made by pharmacists and prescribers. For sideration, we must determine if the patient has had an allergic
example, the prescriber may overlook potential drug interac- reaction to a penicillin in the past, and details about the type
tions, or may be unaware of alterations in the patient’s status of reaction. If there is a history of penicillin allergy, an alter-
that would preclude use of a particular drug, or may select the native antibiotic should be prescribed. If there is no effective
correct drug but may order an inappropriate dosage or route alternative, facilities for managing a severe reaction should
of administration. Because the nurse actually administers be in place before the drug is given.
drugs, the nurse is the last person to check medications before From the preceding example, we can see that, when plan-
they are given. Consequently, you are the patient’s last line ning drug therapy, we must identify patients who are at high
of defense against medication errors. It is ethically and legally risk of reacting adversely. To identify such patients, we use
unacceptable for you to administer a drug that is harmful to three principal tools: the patient history, physical examina-
the patient—even though the medication has been prescribed tion, and laboratory data. Of course, if identification is to be
by a licensed prescriber and dispensed by a licensed pharma- successful, you must know what to look for (ie, you must
cist. In serving as patient advocate, it is impossible to know know the factors that can increase the risk of severe reactions
too much about drugs. to the drug in question). Once the high-risk patient has been
identified, we can take steps to reduce the risk.

APPLICATION OF PHARMACOLOGY Dosage and Administration

IN PATIENT CARE
Earlier we noted the Rights of Drug Administration and
The two major areas in which you can apply pharmacologic agreed on their importance. Although you can implement the
knowledge are patient care and patient education. Patient Rights without a detailed knowledge of pharmacology, having
care is considered in this section. Patient education is con­ this knowledge can help reduce your contribution to medica-
sidered in the section that follows. In discussing the applica- tion errors. The following examples illustrate this point:
tions of pharmacology in patient care, we focus on seven
aspects of drug therapy: (1) preadministration assessment, • Certain drugs have more than one indication, and
(2) dosage and administration, (3) evaluating and promoting dosage may differ depending on which indication the
therapeutic effects, (4) minimizing adverse effects, (5) mini- drug is used for. Aspirin, for example, is given in low
mizing adverse interactions, (6) making “as needed” (PRN) doses to relieve pain and in high doses to suppress
decisions, and (7) managing toxicity. inflammation. If you don’t know about these differ-
ences, you might administer too much aspirin to the
patient with pain or too little to the patient with
Preadministration Assessment inflammation.
All drug therapy begins with assessment of the patient. • Many drugs can be administered by more than one
Assessment has three basic goals: (1) collecting baseline route, and dosage may differ depending upon the route
data needed to evaluate therapeutic and adverse responses, selected. Morphine, for example, may be administered
(2) identifying high-risk patients, and (3) assessing the by mouth or by injection (eg, subcutaneous, intramus-
patient’s capacity for self-care. The first two goals are highly cular, intravenous). Oral doses are generally much
specific for each drug. Accordingly, we cannot achieve these larger than injected doses. Accordingly, if a large dose
goals without understanding pharmacology. The third goal intended for oral use were to be mistakenly adminis-
applies generally to all drugs, and hence it does not usually tered by injection, the result could prove fatal. The
require specific knowledge of the drug you are about to give. nurse who understands the pharmacology of morphine
Preadministration assessment is discussed here and again is unlikely to make this error.
under Application of the Nursing Process in Drug Therapy. • Certain intravenous agents can cause severe local injury
Collecting Baseline Data. Baseline data are needed to if the drug extravasates (seeps into the tissues surround-
evaluate both therapeutic and adverse drug responses. Without ing the IV line). The infusion must be monitored closely,
these data, we would have no way of determining the and, if extravasation occurs, corrective steps must be

6
 CHAPTER 2 Application of Pharmacology in Nursing Practice

taken immediately. The nurse who doesn’t understand through weight reduction, smoking cessation, and sodium
these drugs will be unprepared to work with them restriction. As a nurse, you may provide these supportive
safely. measures directly, through patient education, or by coordinat-
• The following guidelines can help ensure correct ing the activities of other healthcare providers.
administration:
• Read the medication order carefully. If the order is
unclear, verify it with the prescriber. Minimizing Adverse Effects
• Verify the identity of the patient by comparing the name All drugs have the potential to produce undesired effects.
on the wristband with the name on the drug order or Common examples include gastric erosion caused by aspirin,
medication administration record. sedation caused by older antihistamines, hypoglycemia caused
• Read the medication label carefully. Verify the identity by insulin, and excessive fluid loss caused by diuretics. When
of the drug, the amount of drug (per tablet, volume of drugs are employed properly, the incidence and severity of
liquid, etc.), and its suitability for administration by the such events can be reduced. Measures to reduce adverse
intended route. events include identifying high-risk patients through the
• Verify dosage calculations. patient history, ensuring proper administration through patient
• Implement any special handling the drug may require. education, and teaching patients about activities that might
• Don’t administer any drug if you don’t understand the precipitate an adverse event.
reason for its use. When untoward effects cannot be avoided, discomfort and
injury can often be minimized by appropriate intervention.
Measures to minimize medication errors are discussed For example, timely administration of glucose will prevent
further in Chapter 7. brain damage from insulin-induced hypoglycemia. To help
reduce adverse effects, you must know the following about
the drugs you are working with:
Evaluating and Promoting • The major adverse effects the drug can produce
Therapeutic Effects • When these reactions are likely to occur
• Early signs that an adverse reaction is developing
Evaluating Therapeutic Responses. Evaluation is one
• Interventions that can minimize discomfort and harm
of the most important aspects of drug therapy. After all, this
is the process that tells us whether a drug is beneficial or is
causing harm. Because the nurse follows the patient’s status
most closely, the nurse is in the best position to evaluate Minimizing Adverse Interactions
therapeutic responses. When a patient is taking two or more drugs, those drugs may
To make an evaluation, you must know the rationale for interact with one another to diminish therapeutic effects or
treatment and the nature and time course of the intended intensify adverse effects. For example, the ability of oral
response. When desired responses do not occur, it may be contraceptives to protect against pregnancy can be reduced by
essential to identify the problem quickly, so that timely imple- concurrent therapy with carbamazepine (an antiseizure drug),
mentation of alternative therapy may be ordered. and the risk of thromboembolism from oral contraceptives can
When evaluating responses to a drug that has more than be increased by smoking cigarettes.
one application, you can do so only if you know the specific As a nurse, you can help reduce the incidence and intensity
indication for which the drug is being used. Nifedipine, for of adverse interactions in several ways. These include taking
example, is given for both hypertension and angina pectoris. a thorough drug history, advising the patient to avoid over-
When the drug is used for hypertension, you should monitor the-counter drugs that can interact with the prescribed medi-
for a reduction in blood pressure. In contrast, when this drug cation, monitoring for adverse interactions known to occur
is used for angina, you should monitor for a reduction in chest between the drugs the patient is taking, and being alert for
pain. Clearly, if you are to make the proper evaluation, you as-yet unknown interactions.
must understand the reason for drug use.
Promoting Patient Adherence. Adherence—also known
as compliance or concordance—may be defined as the extent Making PRN Decisions
to which a patient’s behavior coincides with medical advice. If A PRN medication order is one in which the nurse has discre-
we are to achieve the therapeutic objective, adherence is essen- tion regarding when to give a drug and, in some situations,
tial. Drugs that are self-administered in the wrong dose, by the how much drug to give. (PRN stands for pro re nata, a Latin
wrong route, or at the wrong time cannot produce maximum phrase meaning as needed.) PRN orders are common for
benefit—and may even prove harmful. Obviously, successful drugs that promote sleep, relieve pain, and reduce anxiety. To
therapy requires active and informed participation by the implement a PRN order rationally, you must know the reason
patient. By educating patients about the drugs they are taking, for drug use and be able to assess the patient’s medication
you can help elicit the required participation. needs. Clearly, the better your knowledge of pharmacology,
Implementing Nondrug Measures. Drug therapy can the better your PRN decisions are likely to be.
often be enhanced by nonpharmacologic measures. Examples
include (1) enhancing drug therapy of asthma through breath-
ing exercises, biofeedback, and emotional support; (2) enhanc- Managing Toxicity
ing drug therapy of arthritis through exercise, physical therapy, Some adverse drug reactions are extremely dangerous. Hence,
and rest; and (3) enhancing drug therapy of hypertension if toxicity is not diagnosed early and responded to quickly,

7
CHAPTER 2 Application of Pharmacology in Nursing Practice

irreversible injury or death can result. To minimize harm, you Some patients have difficulty remembering whether or not
must know the early signs of toxicity and the procedure for they have taken their medication. Possible causes include
toxicity management. mental illness, advanced age, and complex regimens. To facil-
itate accurate dosing, you can provide the patient with a pill
box that has separate compartments for each day of the week,
APPLICATION OF PHARMACOLOGY and then teach him or her to load the compartments weekly.
IN PATIENT EDUCATION To determine if they have taken their medicine, patients can
simply examine the box.
Very often, the nurse is responsible for educating patients Technique of Administration. Patients must be taught
about medications. In your role as educator, you must give how to administer their drugs. This is especially important for
the patient the following information: routes that may be unfamiliar (eg, sublingual for nitroglyc-
erin) and for techniques that can be difficult (eg, subcutaneous
• Drug name and therapeutic category (eg, penicillin:
injection of insulin). Patients taking oral medications may
antibiotic)
require special instructions. For example, some oral prepara-
• Dosage
tions must not be chewed or crushed; some should be taken
• Dosing schedule
with fluids; and some should be taken with meals, whereas
• Route and technique of administration
others should not. Careful attention must be paid to the patient
• Expected therapeutic response and when it should
who, because of disability (eg, visual or intellectual impair-
develop
ment, limited manual dexterity), may find self-medication
• Nondrug measures to enhance therapeutic responses
difficult.
• Duration of treatment
Duration of Drug Use. Just as patients must know when
• Method of drug storage
to take their medicine, they must know when to stop. In some
• Symptoms of major adverse effects, and measures to
cases (eg, treatment of acute pain), patients should discon-
minimize discomfort and harm
tinue drug use as soon as symptoms subside. In other cases
• Major adverse drug-drug and drug-food interactions
(eg, treatment of hypertension), patients should know that
• Whom to contact in the event of therapeutic failure,
therapy will probably continue lifelong. For some conditions
severe adverse reactions, or severe adverse interactions
(eg, gastric ulcers), medication may be prescribed for a spe-
To communicate this information effectively and accurately, cific time interval, after which the patient should return for
you must first understand it. That is, to be a good drug educa- reevaluation.
tor, you must know pharmacology. Drug Storage. Certain medications are chemically unsta-
In the following discussion, we consider the relationship ble and deteriorate rapidly if stored improperly. Patients
between patient education and the following aspects of drug who are using unstable drugs must be taught how to store
therapy: dosage and administration, promoting therapeutic them correctly (eg, under refrigeration, in a lightproof
effects, minimizing adverse effects, and minimizing adverse container). All drugs should be stored where children can’t
interactions. reach them.

Dosage and Administration Promoting Therapeutic Effects

Drug Name. The patient should know the name of the To participate fully in achieving the therapeutic objective,
medication he or she is taking. If the drug has been prescribed patients must know the nature and time course of expected
by trade name, the patient should be given its generic name, beneficial effects. With this knowledge, patients can help
too. This information will reduce the risk of overdose that can evaluate the success or failure of treatment. By recognizing
result when a patient fails to realize that two prescriptions that treatment failure, the informed patient will be able to seek
bear different names actually contain the same medicine. timely implementation of alternative therapy.
Dosage and Schedule of Administration. Patients With some drugs, such as those used to treat depression
must be told how much drug to take and when to take it. For and schizophrenia, beneficial effects are delayed, taking
some medications, dosage must be adjusted by the patient. several weeks to become maximal. Awareness that treatment
Insulin is a good example. For insulin therapy to be most may not produce immediate results allows the patient to have
beneficial, the patient must adjust doses to accommodate realistic expectations and helps reduce anxiety about thera-
changes in diet and subsequent glucose levels. peutic failure.
With PRN medications, the schedule of administration is As noted, nondrug measures can complement drug therapy.
not fixed. Rather, these drugs are taken as conditions require. For example, although drugs are useful in managing high
For example, some people with asthma experience exercise- cholesterol, exercise and diet are also important. Teaching the
induced bronchospasm. To minimize such attacks, they can patient about nondrug measures can greatly increase the
take supplementary medication prior to anticipated exertion. chances of success.
It is your responsibility to teach patients when PRN drugs
should be taken.
The patient should know what to do if a dose is missed. Minimizing Adverse Effects
With certain oral contraceptives, for example, if one dose is Knowledge of adverse drug effects will enable the patient to
missed, the omitted dose should be taken together with the avoid some adverse effects and minimize others through early
next scheduled dose. However, if three or more doses are detection. The following examples underscore the value of
missed, a new cycle of administration must be initiated. educating patients about the undesired effects of drugs:

8
 CHAPTER 2 Application of Pharmacology in Nursing Practice

• Insulin overdose can cause blood glucose levels to drop Analysis: Nursing Diagnoses. In this step, the nurse
precipitously. Early signs of hypoglycemia include analyzes information in the database to determine actual and
sweating and increased heart rate. The patient who has potential health problems. These problems may be physio-
been taught to recognize these early signs can respond logic, psychologic, or sociologic. Each problem is stated in
by ingesting glucose or other fast-acting carbohydrate- the form of a nursing diagnosis, which can be defined as an
rich foods, thereby restoring blood sugar to a safe actual or potential health problem that nurses are qualified and
level. In contrast, the patient who fails to recognize licensed to treat.
evolving hypoglycemia and does not ingest glucose or A complete nursing diagnosis consists of three statements:
similar substances may become comatose, and may (1) a statement of the patient’s actual or potential health
even die. problem; followed by (2) a statement of the problem’s prob-
• Many anticancer drugs predispose patients to acquiring able cause or risk factors; and (3) the signs, symptoms, or
serious infections. The patient who is aware of this pos- other evidence of the problem. (This third component is
sibility can take steps to avoid contagion (eg, avoiding omitted for potential problems.) Typically, the statements are
contact with people who have an infection, avoiding separated by the phrases related to and as evidenced by, as in
foods likely to contain pathogens). In addition, the this example of a drug-associated nursing diagnosis: “non-
informed patient is in a position to notify the prescriber compliance with the prescribed regimen [the problem] related
at the first sign that an infection is developing, thereby to complex medication administration schedule [the cause] as
allowing early treatment. In contrast, the patient who evidenced by missed drug doses and patient’s statement that
has not received adequate education is at increased risk the schedule is confusing [the evidence].”
of illness or death from an infectious disease. Planning. In the planning step, the nurse delineates spe-
• Some side effects, although benign, can be disturbing if cific interventions directed at solving or preventing the prob-
they occur without warning. For example, rifampin (a lems identified in analysis. The plan must be individualized
drug for tuberculosis) imparts a harmless red-orange for each patient. When creating a care plan, the nurse must
color to urine, sweat, saliva, and tears. Your patient will define goals, set priorities, identify nursing interventions, and
appreciate knowing about this in advance. establish criteria for evaluating success. In addition to nursing
interventions, the plan should include interventions performed
by other healthcare providers. Planning is an ongoing process
Minimizing Adverse Interactions that must be modified as new data are gathered.
Patient education can help avoid hazardous drug-drug and Implementation. Implementation begins with carrying
drug-food interactions. For example, phenelzine (an antide- out the interventions identified during planning. Some inter-
pressant) can cause dangerous elevations in blood pressure if ventions are collaborative while others are independent.
taken in combination with certain drugs (eg, amphetamines) Collaborative interventions require a healthcare provider’s
or certain foods (eg, figs, avocados, most cheeses). Accord- order, whereas independent interventions do not. In addition
ingly, it is essential that patients taking phenelzine be given to carrying out interventions, implementation involves coor-
specific and emphatic instructions regarding the drugs and dinating actions of other members of the healthcare team.
foods they must avoid. Implementation is completed by observing and documenting
the outcomes of treatment. Documentation should be thor-
ough and precise.
APPLICATION OF THE NURSING PROCESS Evaluation. This step is performed to determine the
IN DRUG THERAPY degree to which treatment has succeeded. Evaluation is
accomplished by analyzing the data collected following
The nursing process is a conceptual framework that nurses implementation. Evaluation should identify those interven-
employ to guide healthcare delivery. In this section we con- tions that should be continued, those that should be discon-
sider how the nursing process can be applied in drug therapy. tinued, and potential new interventions that might be
implemented. Evaluation completes the initial cycle of the
nursing process and provides the basis for beginning the
Review of the Nursing Process cycle anew.
Before discussing the nursing process as it applies to drug
therapy, we need to review the process itself. Since you are
probably familiar with the process already, this review is Applying the Nursing Process
brief. in Drug Therapy
In its simplest form, the nursing process can be viewed as Having reviewed the nursing process itself, we can now
a cyclic procedure that has five basic steps: (1) assessment, discuss the process as it pertains to drug therapy. Recall that
(2) analysis (including nursing diagnoses), (3) planning, the overall objective in drug therapy is to produce maximum
(4) implementation, and (5) evaluation. benefit with minimum harm.
Assessment. Assessment consists of collecting data
about the patient. These data are used to identify actual and Preadministration Assessment
potential health problems. The database established during Preadministration assessment establishes the baseline data
assessment provides a foundation for subsequent steps in the needed to tailor drug therapy to the individual. By identifying
process. Important methods of data collection are the patient the variables that can affect an individual’s responses to drugs,
interview, medical and drug-use histories, the physical exami- we can adapt treatment so as to maximize benefits and mini-
nation, observation of the patient, and laboratory tests. mize harm. Preadministration assessment has four basic goals:

9
CHAPTER 2 Application of Pharmacology in Nursing Practice

• Collection of baseline data needed to evaluate therapeu- being used, and practically any pathophysiologic condition.
tic effects These factors are discussed at length in Chapters 6
• Collection of baseline data needed to evaluate adverse through 11.
effects When identifying factors that put the patient at risk, you
• Identification of high-risk patients should distinguish between factors that put the patient at
• Assessment of the patient’s capacity for self-care extremely high risk versus factors that put the patient at mod-
erate or low risk. The terms contraindication and precaution
The first three goals are specific to the particular drug being are used for this distinction. A contraindication is defined as
used. Accordingly, to achieve these goals, you must know the a preexisting condition that precludes use of a particular drug
pharmacology of the drug under consideration. The fourth under all but the most critical of circumstances. For example,
goal applies more or less equally to all drugs—although this a previous severe allergic reaction to penicillin (which can be
goal may be more critical for some drugs than others. life threatening) would be a contraindication to using penicil-
Important methods of data collection include interviewing lin again—unless the patient has a life-threatening infection
the patient and family, observing the patient, performing a that cannot be effectively treated with another antibiotic. In
physical examination, checking results of laboratory tests, and this situation, where the patient will die if the drug isn’t
taking the patient’s medical and drug histories. The drug administered yet the patient may die if the drug is adminis-
history should include prescription drugs, over-the-counter tered, the provider may decide to give the penicillin along
drugs, herbal remedies, and drugs taken for nonmedical or with other drugs and measures to decrease the extent of the
recreational purposes (eg, alcohol, nicotine, caffeine, illicit allergic reaction. A precaution, by contrast, can be defined as
drugs). Prior adverse drug reactions should be noted, includ- a preexisting condition that significantly increases the risk of
ing drug allergies and idiosyncratic reactions (ie, reactions an adverse reaction to a particular drug, but not to a degree
unique to the individual). that is life threatening. For example, a previous mild allergic
Baseline Data Needed to Evaluate Therapeutic reaction to penicillin would constitute a precaution to using
Effects. Drugs are administered to achieve a desired response. this drug again. That is, the drug may be used, but greater than
To know if we have produced that response, we need to estab- normal caution must be exercised. Preferably, an alternative
lish baseline measurements of the parameter that therapy is drug would be selected.
directed at changing. For example, if we are giving a drug to Assessment of the Patient’s Capacity for Self-Care. If
lower blood pressure, we need to know what the patient’s drug therapy is to succeed, the outpatient must be willing and
blood pressure was prior to treatment. Without this informa- able to self-administer medication as prescribed. Accordingly,
tion, we have no basis for determining the effect of our drug. his or her capacity for self-care must be determined. If assess-
Baseline Data Needed to Evaluate Adverse Effects. ment reveals that the patient is incapable of self-medication,
All drugs have the ability to produce undesired effects. In alternative care must be arranged.
most cases, the adverse effects that a particular drug can Multiple factors can affect the capacity for self-care and
produce are known. In many cases, development of an adverse the probability of adhering to the prescribed regimen. Patients
effect will be completely obvious in the absence of any base- with reduced visual acuity or limited manual dexterity may
line data. For example, we don’t need special baseline data to be unable to self-medicate, especially if the technique for
know that hair loss following cancer chemotherapy was administration is complex. Patients with limited intellectual
caused by the drug. However, in other cases, baseline data are ability may be incapable of understanding or remembering
needed to determine whether or not an adverse effect has what they are supposed to do. Patients with severe mental
occurred. For example, some drugs can impair liver function. illness (eg, depression, schizophrenia) may lack the under-
To know if a drug has compromised liver function, we need standing or motivation needed to self-medicate. Some patients
to know the state of liver function before drug use. Without may lack the money to pay for drugs. Others may fail to take
this information, we can’t tell from later measurements medications as prescribed because of individual or cultural
whether liver dysfunction was preexisting or caused by attitudes toward drugs. For example, a common cause for
the drug. failed self-medication is a belief that the drug was simply not
Identification of High-Risk Patients. Because of indi- needed in the dosage prescribed. A thorough assessment will
vidual characteristics, a particular patient may be at high risk identify all of these factors, thereby enabling you to account
of experiencing an adverse response to a particular drug. Just for them when formulating nursing diagnoses and the patient
which individual characteristics will predispose a patient to care plan.
an adverse reaction depends on the drug under consideration.
For example, if a drug is eliminated from the body primarily Analysis and Nursing Diagnoses
by renal excretion, an individual with impaired kidney func- With respect to drug therapy, the analysis phase of the nursing
tion will be at risk of having this drug accumulate to a toxic process has three objectives. First, you must judge the appro-
level. Similarly, if a drug is eliminated by the liver, an indi- priateness of the prescribed regimen. Second, you must
vidual with impaired liver function will be at risk of having identify potential health problems that the drug might cause.
that drug accumulate to a toxic level. The message here is Third, you must determine the patient’s capacity for self-care.
that, to identify the patient at risk, you must know the phar- As the last link in the patient’s chain of defense against
macology of the drug to be administered. inappropriate drug therapy, you must analyze the data col-
Multiple factors can increase the patient’s risk of adverse lected during assessment to determine if the proposed treat-
reactions to a particular drug. Impaired liver and kidney func- ment has a reasonable likelihood of being effective and safe.
tion were just mentioned. Other factors include age, body This judgment is made by considering the medical diagnosis,
composition, pregnancy, diet, genetic heritage, other drugs the known actions of the prescribed drug, the patient’s prior

10
 CHAPTER 2 Application of Pharmacology in Nursing Practice

TABLE 2–1■ Examples of Nursing Diagnoses That Can Be Derived from Knowledge of Adverse

Drug Effects
Drug Adverse Effect Related Nursing Diagnosis
Amphetamine CNS stimulation Disturbed sleep pattern related to drug-induced CNS excitation
Aspirin Gastric erosion Pain related to aspirin-induced gastric erosion
Atropine Urinary retention Urinary retention related to drug therapy
Bethanechol Stimulation of GI smooth muscle Bowel incontinence related to drug-induced increase in bowel motility
Cyclophosphamide Reduction in white blood cell counts Risk for infection related to drug-induced neutropenia
Digoxin Dysrhythmias Ineffective tissue perfusion related to drug-induced cardiac dysrhythmias
Furosemide Excessive urine production Deficient fluid volume related to drug-induced diuresis
Gentamicin Damage to the eighth cranial nerve Disturbed sensory perception: hearing impairment related to drug therapy
Glucocorticoids Thinning of the skin Impaired skin integrity related to drug therapy
Haloperidol Involuntary movements Low self-esteem related to drug-induced involuntary movements
Propranolol Bradycardia Decreased cardiac output related to drug-induced bradycardia
Warfarin Bleeding Risk for injury related to drug-induced bleeding

CNS, central nervous system; GI, gastrointestinal.

responses to the drug, and the presence of contraindications planning will allow you to anticipate adverse effects—rather
to the drug. You should question the drug’s appropriateness if than react to them after the fact.
(1) the drug has no actions that are known to benefit individu- Defining Goals. In all cases, the goal of drug therapy is
als with the patient’s medical diagnosis, (2) the patient failed to produce maximum benefit with minimum harm. That is,
to respond to the drug in the past, (3) the patient had a serious we want to employ drugs in such a way as to maximize thera-
adverse reaction to the drug in the past, or (4) the patient has peutic responses while preventing or minimizing adverse
a condition or is using a drug that contraindicates the pre- reactions and interactions. The objective of planning is to
scribed drug. If any of these conditions apply, you should formulate ways to achieve this goal.
consult with the prescriber to determine if the drug should Setting Priorities. This requires knowledge of the drug
be given. under consideration and the patient’s unique characteristics—
Analysis must identify potential adverse effects and drug and even then, setting priorities can be difficult. Highest prior-
interactions. This is accomplished by integrating knowledge ity is given to life-threatening conditions (eg, anaphylactic
of the drug under consideration and the data collected during shock, ventricular fibrillation). These may be drug induced or
assessment. Knowledge of the drug itself will indicate adverse the result of disease. High priority is also given to reactions
effects that practically all patients are likely to experience. that cause severe, acute discomfort and to reactions that can
Data on the individual patient will indicate additional adverse result in long-term harm. Since we cannot manage all prob-
effects and interactions to which the particular patient is pre- lems simultaneously, less severe problems must wait until the
disposed. Once potential adverse effects and interactions have patient and care provider have the time and resources to
been identified, pertinent nursing diagnoses can be easily for- address them.
mulated. For example, if treatment is likely to cause respira- Identifying Interventions. The heart of planning is
tory depression, an appropriate nursing diagnosis would be identification of nursing interventions. These interventions
“risk for impaired gas exchange related to drug therapy.” can be divided into four major groups: (1) drug administra-
Table 2–1 presents additional examples of nursing diagnoses tion, (2) interventions to enhance therapeutic effects, (3) inter-
that can be readily derived from your knowledge of adverse ventions to minimize adverse effects and interactions, and
effects and interactions that treatment may cause. (4) patient education (which encompasses information in the
Analysis must characterize the patient’s capacity for self- first three groups).
care. The analysis should indicate potential impediments to When planning drug administration, you must consider
self-care (eg, visual impairment, reduced manual dexterity, dosage and route of administration as well as less obvious
impaired cognitive function, insufficient understanding of the factors, including timing of administration with respect to
prescribed regimen) so that these factors can be addressed in meals and with respect to administration of other drugs.
the care plan. To varying degrees, nearly all patients will be Timing with respect to side effects is also important. For
unfamiliar with self-medication and the drug regimen. Accord- example, if a drug causes sedation, it may be desirable to give
ingly, a nursing diagnosis applicable to almost every patient the drug at bedtime, rather than in the morning or during
is “knowledge deficit related to the drug regimen.” the day.
Nondrug measures can help promote therapeutic effects
Planning and should be included in the plan. For example, drug therapy
Planning consists of defining goals, establishing priorities, of hypertension can be combined with weight loss (in over-
identifying specific interventions, and establishing criteria for weight patients), salt restriction, and smoking cessation.
evaluating success. Good planning will allow you to promote Interventions to prevent or minimize adverse effects are of
beneficial drug effects. Of equal or greater importance, good obvious importance. When planning these interventions, you

11
CHAPTER 2 Application of Pharmacology in Nursing Practice

should distinguish between reactions that develop quickly and evaluating adherence include measurement of plasma drug
reactions that are delayed. A few drugs can cause severe levels, interviewing the patient, and counting pills. The evalu-
adverse reactions (eg, anaphylactic shock) shortly after ation should determine if the patient understands when to
administration. When planning to administer such a drug, you take medication, what dosage to take, and the technique of
should ensure that facilities for managing possible reactions administration.
are immediately available. Delayed reactions can often be Patient satisfaction with drug therapy increases quality of
minimized, if not avoided entirely. The plan should include life and promotes adherence. If the patient is dissatisfied, an
interventions to do so. otherwise effective regimen may not be taken as prescribed.
Well-planned patient education is central to success. The Factors that can cause dissatisfaction include unacceptable
plan should account for the patient’s capacity to learn, and it side effects, inconvenient dosing schedule, difficulty of
should address the following: technique of administration, administration, and high cost. When evaluation reveals dis-
dosage and timing, duration of treatment, method of drug satisfaction, an attempt should be made to alter the regimen
storage, measures to promote therapeutic effects, and mea- to make it more acceptable.
sures to minimize adverse effects. Patient education is dis-
cussed at length above.
Establishing Criteria for Evaluation. The need for Use of a Modified Nursing
objective criteria by which to measure desired drug responses
is obvious: Without such criteria we could not determine if Process Format to Summarize
our drug was doing anything useful. As a result, we would Nursing Implications
have no rational basis for making dosage adjustments or for Throughout this text, nursing implications are integrated into
deciding how long treatment should last. If the drug is to be the body of each chapter. The reason for integrating nursing
used on an outpatient basis, follow-up visits for evaluation information with basic science information is to reinforce the
should be planned. relationship between pharmacologic knowledge and nursing
practice. In addition to being integrated, nursing implications
Implementation are summarized at the end of most chapters under the heading
Implementation of the care plan in drug therapy has four “Summary of Major Nursing Implications.” The purpose of
major components: (1) drug administration, (2) patient educa- these summaries is to provide a concise and readily accessible
tion, (3) interventions to promote therapeutic effects, and reference on patient care and patient education related to
(4) interventions to minimize adverse effects. These critical specific drugs and drug families.
nursing activities are discussed at length in the previous The format employed for summarizing nursing implica-
section. tions reflects the nursing process (Table 2–2). Some headings
have been modified to accommodate the needs of pharmacol-
Evaluation ogy instruction and to keep the summaries concise. The com-
Over the course of drug therapy, the patient must be evaluated ponents of the format are as follows.
for (1) therapeutic responses, (2) adverse drug reactions Preadministration Assessment. This section summa-
and interactions, (3) adherence to the prescribed regimen, and rizes the information you should have before giving a drug.
(4) satisfaction with treatment. How frequently evaluations Each section begins by stating the reason for drug use. This
are performed depends on the expected time course of thera- is followed by a summary of the baseline data needed to
peutic and adverse effects. Like assessment, evaluation is evaluate therapeutic and adverse effects. After this, contrain-
based on laboratory tests, observation of the patient, physical dications and precautions are summarized, under the heading
examination, and patient interviews. The conclusions drawn Identifying High-Risk Patients.
during evaluation provide the basis for modifying nursing
interventions and the drug regimen.
Therapeutic responses are evaluated by comparing the
patient’s current status with the baseline data. To evaluate TABLE 2–2 ■ Modified Nursing Process Format

treatment, you must know the reason for drug use, the criteria Used for Summaries of Major Nursing
for success (as defined during planning), and the expected Implications
time course of responses (some drugs act within minutes, Preadministration Assessment
whereas others may take weeks to produce beneficial effects). Therapeutic Goal
The need to anticipate and evaluate adverse effects is self- Baseline Data
evident. To make these evaluations, you must know which Identifying High-Risk Patients
adverse effects are likely to occur, how they manifest, and Implementation: Administration
their probable time course. The method of monitoring is deter- Routes
mined by the expected effect. For example, if hypotension is Administration
expected, blood pressure is monitored; if constipation is
Implementation: Measures to Enhance Therapeutic Effects
expected, bowel function is monitored; and so on. Since some
Ongoing Evaluation and Interventions
adverse effects can be fatal in the absence of timely detection,
it is impossible to overemphasize the importance of monitor- Summary of Monitoring
ing and being prepared for rapid intervention. Evaluating Therapeutic Effects
Minimizing Adverse Effects
Evaluation of adherence is desirable in all patients—and Minimizing Adverse Interactions
is especially valuable when therapeutic failure occurs or Managing Toxicity
when adverse effects are unexpectedly severe. Methods of

12
 CHAPTER 2 Application of Pharmacology in Nursing Practice

Implementation: Administration. This section summa- Patient Education. This topic does not have a section
rizes routes of administration, guidelines for dosage adjust- of its own. Rather, patient education is integrated into the
ment, and special considerations in administration, such as other sections. That is, as we summarize the nursing implica-
timing with respect to meals, preparation of intravenous solu- tions that relate to a particular topic, such as drug administra-
tions, and unusual techniques of administration. tion or a specific adverse effect, patient education related
Implementation: Measures to Enhance Therapeutic to that topic is discussed concurrently. This integration is
Effects. This section addresses issues such as diet modifica- done to promote clarity and efficiency of communication.
tion, measures to increase comfort, and ways to promote To help this important information stand out, it appears in
adherence to the prescribed regimen. blue type.
Ongoing Evaluation and Interventions. This section What About Diagnosis and Planning? These headings
summarizes nursing implications that relate to both therapeu- are not used in the summaries. There are several reasons
tic and undesired drug responses. As indicated in Table 2–2, for the omission, the dominant one being efficiency of
the section has five subsections: (1) summary of monitoring, communication.
(2) evaluating therapeutic effects, (3) minimizing adverse Nursing diagnoses have been left out primarily because
effects, (4) minimizing adverse interactions, and (5) managing they are highly individualized. When caring for patients, you
toxicity. The monitoring section summarizes the physiologic will develop nursing diagnoses based on your analysis of
and psychologic parameters that must be monitored in order assessment data.
to evaluate therapeutic and adverse responses. The section on Planning has not been used as a heading for three
therapeutic effects summarizes criteria and procedures for reasons. First, planning applies primarily to the overall man-
evaluating therapeutic responses. The section on adverse agement of the disorder for which a particular drug is being
effects summarizes the major adverse reactions that should be used—and much less to the drug itself. Second, because
monitored for and presents interventions to minimize harm. planning is discussed at length and more appropriately in
The section on adverse interactions summarizes the major nonpharmacology nursing texts, such as those on medical-
drug interactions to be alert for and gives interventions to surgical nursing, there is no need to repeat this information
minimize them. The section on toxicity describes major here. Third, planning is reflected in interventions that are
symptoms of toxicity and treatment. implemented.

KEY POINTS
■ Nursing responsibilities with regard to drugs extend far ■ The analysis and diagnosis phase of treatment is directed
beyond the Rights of Drug Administration. at (1) judging the appropriateness of the prescribed
■ You are the patient’s last line of defense against medica- therapy, (2) identifying potential health problems treat-
tion errors. ment might cause, and (3) characterizing the patient’s
■ Your knowledge of pharmacology has a wide variety capacity for self-care.
of practical applications in patient care and patient ■ Planning is directed at (1) defining goals, (2) establishing
education. priorities, and (3) establishing criteria for evaluating
■ By applying your knowledge of pharmacology, you will success.
make a large contribution to achieving the therapeutic ■ In the evaluation stage, the objective is to evaluate
objective of maximum benefit with minimum harm. (1) therapeutic responses, (2) adverse reactions and inter-
■ Application of the nursing process in drug therapy is actions, (3) patient adherence, and (4) patient satisfaction
directed at individualizing treatment, which is critical to with treatment.
achieving the therapeutic objective.
■ The goal of preadministration assessment is to gather Please visit http://evolve.elsevier.com/Lehne for chapter-
data needed for (1) evaluation of therapeutic and adverse specific NCLEX® examination review questions.
effects, (2) identification of high-risk patients, and
(3) assessment of the patient’s capacity for self-care.

13
 CHAPTER

3 Drug Regulation, Development,

Names, and Information

In 1962, Congress passed the Harris-Kefauver Amend-

Landmark Drug Legislation, p. 14
ments to the Food, Drug and Cosmetic Act. This bill was
New Drug Development, p. 15 created in response to the thalidomide tragedy that occurred
The Randomized Controlled Trial, p. 15 in Europe in the early 1960s. Thalidomide is a sedative now
Stages of New Drug Development, p. 16 known to cause birth defects and fetal death. Because the drug
Limitations of the Testing Procedure, p. 16 was used widely by pregnant patients, thousands of infants
Exercising Discretion Regarding New Drugs, p. 17 were born with phocomelia, a rare birth defect characterized
Drug Names, p. 18 by the gross malformation or complete absence of arms or
legs. This tragedy was especially poignant in that it resulted
The Three Types of Drug Names, p. 18
from nonessential drug use: The women who took thalido-
Which Name to Use, Generic or Trade?, p. 18 mide could have managed their conditions without it. Tha-
Over-the-Counter Drugs, p. 20 lidomide was not a problem in the United States because the
Sources of Drug Information, p. 21 drug never received approval by the FDA.
Key Points, p. 21 Because of the European experience with thalidomide, the
Harris-Kefauver Amendments sought to strengthen all aspects
of drug regulation. A major provision of the bill required that
drugs be proved effective before marketing. Remarkably, this
In this chapter we complete our introduction to pharmacology was the first law to demand that drugs actually offer some
by considering five diverse but important topics. These are benefit. The new act also required that all drugs that had been
(1) drug regulation, (2) new drug development, (3) the annoy- introduced between 1932 and 1962 undergo testing for effec-
ing problem of drug names, (4) over-the-counter drugs, and tiveness; any drug that failed to prove useful would be with-
(5) sources of drug information. drawn. Lastly, the Harris-Kefauver Amendments established
rigorous procedures for testing new drugs. These procedures
are discussed below under New Drug Development.
LANDMARK DRUG LEGISLATION In 1970, Congress passed the Controlled Substances Act
(Title II of the Comprehensive Drug Abuse Prevention and
The history of drug legislation in the United States reflects an Control Act). This legislation set rules for the manufacture
evolution in our national posture toward regulating the phar- and distribution of drugs considered to have the potential for
maceutical industry. That posture has changed from one of abuse. One provision of the law defines five categories of
minimal control to one of extensive control. For the most part, controlled substances, referred to as Schedules I, II, III, IV,
increased regulation has been beneficial, resulting in safer and and V. Drugs in Schedule I have no accepted medical use in
more effective drugs. the United States and are deemed to have a high potential for
The first American law to regulate drugs was the Federal abuse. Examples include heroin, mescaline, and lysergic acid
Pure Food and Drug Act of 1906. This law set standards for diethylamide (LSD). Drugs in Schedules II through V have
drug quality and purity in addition to strength. It specifically accepted medical applications but also have a high potential
focused on product labeling and required that any variations for abuse. The abuse potential of these agents becomes pro-
from the standards be placed on the label. gressively less as we proceed from Schedule II to Schedule
The Food, Drug and Cosmetic Act, passed in 1938, was V. The Controlled Substances Act is discussed further in
the first legislation to address drug safety. The motivation Chapter 37.
behind the law was a tragedy in which more than 100 people In 1992, FDA regulations were changed to permit acceler-
died following use of a new medication. The lethal prepara- ated approval of drugs for acquired immunodeficiency syn-
tion contained sulfanilamide, an antibiotic, plus diethylene drome (AIDS) and cancer. Under these guidelines, a drug
glycol as a solubilizing agent. Tests showed that the solvent could be approved for marketing prior to completion of Phase
was the cause of death. (Diethylene glycol is commonly used III trials (see below), provided that rigorous follow-up studies
as automotive antifreeze.) To reduce the chances of another (Phase IV trials) were performed. The rationale for this change
such tragedy, Congress required that all new drugs undergo was that (1) medications are needed, even if their benefits
testing for safety. The results of these tests were to be reviewed may be marginal, and (2) the unknown risks associated with
by the Food and Drug Administration (FDA), and only early approval are balanced by the need for more effective
those drugs judged safe would receive FDA approval for drugs. Although accelerated approval seems like a good idea,
marketing. in actual practice, it has two significant drawbacks. First,

14
 CHAPTER 3 Drug Regulation, Development, Names, and Information

manufacturers often fail to conduct or complete the required include new safety information, and to restrict distribution of
follow-up studies. Second, if the follow-up studies—which a drug based on safety concerns. In addition, the FDA was
are more rigorous than the original—fail to confirm a clinical required to establish an active postmarketing risk surveillance
benefit, the guidelines have no clear mechanism for removing system, mandated to include 25 million patients by July 2010,
the drug from the market. and 100 million by July 2012. Because of the FDAAA,
The Prescription Drug User Fee Act (PDUFA), passed in adverse effects that were not discovered prior to drug approval
1992, was a response to complaints that the FDA takes too came to light much sooner than in the past, and the FDA now
long to review applications for new drugs. Under the Act, has the authority to take action (eg, limit distribution of a
drug sponsors pay the FDA fees that are used to fund addi- drug) if postmarketing information shows a drug to be less
tional reviewers. In return, the FDA must adhere to strict safe than previously understood.
review timetables. Because of the PDUFA, new drugs now In 2009, Congress passed the Family Smoking Prevention
reach the market much sooner than in the past. and Tobacco Control Act, which, at long last, allows the FDA
The Food and Drug Administration Modernization Act to regulate cigarettes, which are responsible for about one in
(FDAMA) of 1997—an extension of the Prescription Drug five deaths in the United States each year. Under the Act, the
User Fee Act—called for widespread changes in FDA regula- FDA was given the authority to strengthen advertising restric-
tions. Implementation is in progress. For health professionals, tions, including a prohibition on marketing to youth; require
four provisions of the act are of particular interest: revised and more prominent warning labels; require disclo-
sure of all ingredients in tobacco products and restrict harmful
• The fast-track system created for AIDS drugs and
additives; and monitor nicotine yields and mandate gradual
cancer drugs now includes drugs for other serious and
reduction of nicotine to nonaddictive levels.
life-threatening illnesses.
• Manufacturers who plan to stop making a drug must
inform patients at least 6 months in advance, thereby
giving them time to find another source. NEW DRUG DEVELOPMENT
• A clinical trial database was required for drugs directed
The development and testing of new drugs is an expensive
at serious or life-threatening illnesses. These data allow
and lengthy process, requiring 10 to 15 years for completion.
clinicians and patients to make informed decisions
Of the thousands of compounds that undergo testing, only a
about using experimental drugs.
few enter clinical trials, and of these, only 1 in 5 gains
• Drug companies can now give prescribers journal arti-
approval. Because of this high failure rate, the cost of devel-
cles and certain other information regarding off-label
oping a new drug can exceed $1.2 billion.
uses of drugs. (An off-label use is a use that has not
Rigorous procedures for testing have been established so
been evaluated by the FDA.) Before the new act, clini-
that newly released drugs might be both safe and effective.
cians were allowed to prescribe a drug for an off-label
Unfortunately, although testing can determine effectiveness,
use, but the manufacturer was not allowed to promote
it cannot guarantee that a new drug will be safe: Significant
the drug for that use—even if promotion was limited to
adverse effects may evade detection during testing, only to
providing potentially helpful information, including
become apparent after a new drug has been released for
reprints of journal articles. In return for being allowed
general use.
to give prescribers information regarding off-label uses,
manufacturers must promise to do research to support
the claims made in the articles. The Randomized Controlled Trial
Two laws—the Best Pharmaceuticals for Children Act Randomized controlled trials (RCTs) are the most reliable
(BPCA), passed in 2002, and the Pediatric Research Equity way to objectively assess drug therapies. RCTs have three
Act (PREA) of 2003—were designed to promote much- distinguishing features: use of controls, randomization, and
needed research on drug efficacy and safety in children. The blinding. All three serve to minimize the influence of personal
BPCA offers a 6-month patent extension to manufacturers bias on the results.
who evaluate a drug already on the market for its safety, Use of Controls. When a new drug is under development,
efficacy, and dosage in children. The PREA gives the FDA we want to know how it compares with a standard drug used
the power, for the first time, to require drug companies to for the same disorder, or perhaps how it compares with no
conduct pediatric clinical trials on new medications that might treatment at all. To make these comparisons, some subjects in
be used by children. (In the past, drugs were not tested in the RCT are given the new drug and some are given either
children, so there is a general lack of reliable information (1) a standard treatment or (2) a placebo (ie, an inactive com-
upon which to base therapeutic decisions.) pound formulated to look like the experimental drug). Sub-
In 2007, Congress passed the FDA Amendments Act jects receiving either the standard drug or the placebo are
(FDAAA), the most important legislation on drug safety since referred to as controls. Controls are important because they
the Harris-Kefauver Amendments of 1962. The FDAAA help us determine if the new treatment is more (or less) effec-
expands the mission of the FDA to include rigorous oversight tive than standard treatments, or at least if the new treatment
of drug safety after a drug has been approved. (Prior to this is better (or worse) than no treatment at all. Likewise, controls
act, the FDA focused on drug efficacy and safety prior to allow us to compare the safety of the new drug with that of
approval, but had limited resources and authority to address the old drug, a placebo, or both.
drug safety after a drug was released for marketing.) Under Randomization. In an RCT, subjects are randomly
the new law, the FDA has the legal authority to require post- assigned to either the control group or the experimental group
marketing safety studies, to order changes in a drug’s label to (ie, the group receiving the new drug). The purpose of

15
CHAPTER 3 Drug Regulation, Development, Names, and Information

randomization is to prevent allocation bias, which results

TABLE 3–1 ■ Steps in New Drug Development
when subjects in the experimental group are different from
those in the control group. For example, in the absence of Preclinical Testing (in animals)
randomization, researchers could load the experimental group Toxicity
with patients who have mild disease and load the control Pharmacokinetics
group with patients who have severe disease. In this case, any Possible Useful Effects
differences in outcome may well be due to the severity of the
disease rather than differences in treatment. And even if
Investigational New Drug (IND) Status
researchers try to avoid bias by purposely assigning subjects
who appear similar to both groups, allocation bias can result
from unknown factors that can influence outcome. By assign- Clinical Testing (in humans)
ing subjects randomly to the control and experimental groups, Phase I
all factors—known and unknown, important and unimportant— Subjects: healthy volunteers
should be equally represented in both groups. As a result, the Tests: metabolism, pharmacokinetics, and biologic effects
influences of these factors on outcome should tend to cancel Phase II
each other out, leaving differences in the treatments as the Subjects: patients
best explanation for any differences in outcome. Tests: therapeutic utility and dosage range
Blinding. A blinded study is one in which the people Phase III
involved do not know to which group—control or Subjects: patients
experimental—individual subjects have been randomized. If Tests: safety and effectiveness
only the subjects have been “blinded,” the trial is referred to Conditional Approval of New Drug Application (NDA)
as single blind. If the researchers as well as the subjects are
kept in the dark, the trial is referred to as double blind. Of the Phase IV: Postmarketing Surveillance
two, double-blind trials are more objective. Blinding is
accomplished by administering the experimental drug and the
control compound (either placebo or comparison drug) in
identical formulations (eg, green capsules, purple pills) that Phases II and III. In these trials, drugs are tested in
bear a numeric code. At the end of the study, the code is patients. The objective is to determine therapeutic effects,
accessed to reveal which subjects were controls and which dosage range, safety, and effectiveness. During Phase II and
received the experimental drug. When subjects and research- Phase III trials, 500 to 5000 patients receive the drug, and
ers are not blinded, their preconceptions about the benefits only a few hundred take it for more than 3 to 6 months. Upon
and risks of the new drug can readily bias the results. Hence, completing Phase III, the drug manufacturer applies to the
blinding is done to minimize the impact of personal bias. FDA for conditional approval of a New Drug Application. If
conditional approval is granted, Phase IV may begin.
Phase IV: Postmarketing Surveillance. In Phase IV, the
Stages of New Drug Development new drug is released for general use, permitting observation
The testing of new drugs has two principal steps: preclinical of its effects in a large population. Thanks to the FDAAA of
testing and clinical testing. Preclinical tests are performed in 2007, postmarketing surveillance is now much more effective
animals. Clinical tests are done in humans. The steps in drug than in the past.
development are shown in Table 3–1.
Preclinical Testing Limitations of the Testing Procedure
Preclinical testing is required before a new drug may be It is important for nurses and other healthcare professionals
tested in humans. During preclinical testing, drugs are evalu- to appreciate the limitations of the drug development process.
ated for toxicities, pharmacokinetic properties, and poten- Two problems are of particular concern. First, until recently,
tially useful biologic effects. Preclinical tests may take 1 to 5 information on drug use in women and children has been
years. When sufficient preclinical data have been gathered, limited. Second, new drugs are likely to have adverse effects
the drug developer may apply to the FDA for permission to that were not detected during clinical trials.
begin testing in humans. If the application is approved, the
drug is awarded Investigational New Drug status and clinical Limited Information on Women and Children
trials may begin. Women. Until recently, very little drug testing was done
in women. In almost all cases, women of child-bearing age
Clinical Testing were excluded from early clinical trials out of concern for
Clinical trials occur in four phases and may take 2 to 10 years fetal safety. Unfortunately, FDA policy took this concern to
to complete. The first three phases are done before a new drug an extreme, effectively barring all women of child-bearing
is marketed. The fourth is done after marketing has begun. age from Phase I and Phase II trials—even if the women were
Phase I. Phase I trials are usually conducted in healthy not pregnant and were using adequate birth control. The only
volunteers. However, if a drug is likely to have severe side women allowed to participate in early clinical trials were
effects, as many anticancer drugs do, the trial is done in vol- those with a life-threatening illness that might respond to the
unteer patients who have the disease under consideration. drug under study.
Phase I testing has three goals: evaluating drug metabolism, Because of limited drug testing in women, we don’t know
pharmacokinetics, and biologic effects. with precision how women will respond to most drugs. We

16
 CHAPTER 3 Drug Regulation, Development, Names, and Information

TABLE 3–2 ■ Drugs That Were Withdrawn from the U.S. Market for Safety Reasons
Year Introduced/ Months on
Drug Indication Year Withdrawn the Market Reason for Withdrawal
Peginesatide [Omontys] Anemia 2012/2013 12 Life-threatening reactions
Rotigotine* [Neupro] Parkinson’s disease 2007/2008 10 Patch formulation delivered erratic dosages
Natalizumab† [Tysabri] Multiple sclerosis 2004/2005 3 Progressive multifocal leukoencephalopathy
Rapacuronium [Raplon] Neuromuscular blockade 1999/2001 19 Bronchospasm, unexplained fatalities
Alosetron† [Lotronex] Irritable bowel syndrome 2000/2000 9 Ischemic colitis, severe constipation; deaths
have occurred
Troglitazone [Rezulin] Type 2 diabetes 1999/2000 12 Fatal liver failure
Grepafloxacin [Raxar] Infection 1997/1999 19 Severe cardiovascular events, including
seven deaths
Bromfenac [Duract] Acute pain 1997/1998 11 Severe hepatic failure
Mibefradil [Posicor] Hypertension, angina pectoris 1997/1998 11 Inhibits drug metabolism, causing toxic
accumulation of many drugs
Dexfenfluramine [Redux] Obesity 1996/1997 16 Valvular heart disease

*Note that rotigotine was withdrawn because the formulation was unsafe, not because the drug itself is inherently dangerous.
†
Alosetron and natalizumab were returned to the market in 2002 and 2006, respectively. These two drugs and one other—tegaserod [Zelnorm]—are
the only drugs the Food and Drug Administration has ever reapproved after withdrawing them for safety reasons. With all three drugs, risk
management guidelines must be followed.

don’t know if beneficial effects in women will be equivalent selected, they do not represent the full spectrum of individuals
to those seen in men. Nor do we know if adverse effects will who will eventually take the drug; and (3) patients in trials
be equivalent to those in men. We don’t know how timing of take the drug for a relatively short time. Because of these
drug administration with respect to the menstrual cycle will unavoidable limitations in the testing process, effects that
affect beneficial and adverse responses. We don’t know if occur infrequently, effects that take a long time to develop,
drug disposition (absorption, distribution, metabolism, and and effects that occur only in certain types of patients can go
excretion) will be the same in women as in men. Furthermore, undetected. Hence, despite our best efforts, when a new drug
of the drugs that might be used to treat a particular illness, we is released, it may well have adverse effects of which we are
don’t know if the drugs that are most effective in men will as yet unaware. In fact, about half of the drugs that reach the
also be most effective in women. Lastly, we don’t know about market have serious adverse effects that were not detected
the safety of drug use during pregnancy. until after they were released for general use.
During the 1990s, the FDA issued a series of guidelines The hidden dangers in new drugs are shown in Table 3–2,
mandating participation of women (and minorities) in trials which presents information on 10 drugs that were withdrawn
of new drugs. In addition, the FDA revoked a 1977 guideline from the U.S. market soon after receiving FDA approval. In
that barred women from most trials. Because of these changes, all cases, the reason for withdrawal was a serious adverse
the proportion of women in trials of most new drugs now effect that went undetected in clinical trials. Admittedly, only
equals the proportion of women in the population. The data a few hidden adverse effects are as severe as the ones in the
generated since the implementation of the new guidelines table. Hence, most do not necessitate drug withdrawal. None-
have been reassuring: Most gender-related effects have been theless, the drugs in the table should serve as a strong warning
limited to pharmacokinetics. More importantly, for most about the unknown dangers that a new drug may harbor.
drugs, gender has shown little impact on efficacy, safety, or Because adverse effects may go undetected, when caring
dosage. However, although the new guidelines are an impor- for a patient who is prescribed a new drug, you should be
tant step forward, even with them, it will take a long time to especially watchful for previously unreported drug reactions.
close the gender gap in our knowledge of drugs. If a patient taking a new drug begins to show unusual symp-
Children. Until recently, children, like women, had been toms, it is prudent to suspect that the new drug may be the
excluded from clinical trials. As a result, information on cause—even though the symptoms are not yet mentioned in
dosage, therapeutic responses, and adverse effects in children the literature.
has been limited. As noted previously, the FDA can now force
drug companies to conduct clinical trials in children. However,
it will still be a long time before we have the information Exercising Discretion Regarding
needed to use drugs safely and effectively in young patients. New Drugs
When thinking about prescribing a new drug, clinicians would
Failure to Detect All Adverse Effects do well to follow this guideline: Be neither the first to adopt
Premarketing clinical trials cannot detect all adverse effects the new nor the last to abandon the old. Recall that the thera-
before a new drug is released. There are three reasons why: peutic objective is to produce maximum benefit with minimum
(1) during clinical trials, a relatively small number of patients harm. To achieve this objective, we must balance the potential
are given the drug; (2) because these patients are carefully benefits of a drug against its inherent risks. As a rule, new

17
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