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Pharmacological
Aspects of
Nursing Care
Sixth Edition
Barry S. Reiss, B.S., M.S., Ph.D.
Mary E. Evans, B.S.Ed., M.S.N.,
Ph.D., R.N., F.A.A.N.
Revised by
Bonita E. Broyles, R.N.,
B.S.N., Ed.D.
Revised by
Bonita E. Broyles, R.N., B.S.N., Ed.D.
COPYRIGHT © 2002 by Delmar, a division of Thomson For permission to use material from this text or product,
Learning, Inc. contact us by
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Library of Congress Cataloging-in-Publication Data:
For more information contact Delmar,
Reiss, Barry S., 1944–
3 Columbia Circle, PO Box 15015,
Pharmacological aspects of nursing care / Barry S. Reiss,
Albany, NY 12212-5015.
Mary E. Evans; revised by Bonita Broyles.—6th ed.
p. cm.
Or find us on the World Wide Web at http://www.delmar.com
Includes bibliographical references and index.
ISBN 0-7668-0502-6 (alk. paper)
ALL RIGHTS RESERVED. No part of this work covered by the
1. Pharmacology. 2. Hemotherapy. 3. Drugs. 4. Nursing.
copyright hereon may be reproduced or used in any form or
I. Evans, Mary E., 1942– II. Broyles, Bonita E. III. Title.
by any means—graphic, electronic, or mechanical, including
photocopying, recording, taping, Web distribution or infor- RM300. R43 2001
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The Publisher makes no representation or warranties of any kind, including but not limited to, the warranties of fitness for
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CONTENTS
List of Tables (Text) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
List of Tables (Appendices) . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
iii
iv CONTENTS
Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 871
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 899
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 925
LIST OF TABLES (TEXT)
table 1–1 Controlled Substances Schedules . . . . . . . . . . . . . . . . . ........ 13
2–1 Abbreviations Commonly Found in Drug Orders . . . . . ........ 37
2–2 Some Commonly Used Approximate Weight
and Measure Equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
2–3 Types of Syringes in Common Use . . . . . . . . . . . . . . . . . . . . . . . . 40
2–4 Common Routes of Drug Administration . . . . . . . . . . . . . . . . . . . 42
2–5 Administration of Oral Medications . . . . . . . . . . . . . . . . . . . . . . . 46
2–6 Selection of Needles for Injection . . . . . . . . . . . . . . . . . . . . . . . . . 48
4–1 Amount/Dosage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
4–2 Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
4–3 Routes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
4–4 Special Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
4–5 Times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
4–6 Values of Single Roman Numbers . . . . . . . . . . . . . . . . . . . . . . . . . 80
4–7 Metric Prefixes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
4–8 Common Metric Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
4–9 Liquid Measure in the Apothecary System . . . . . . . . . . . . . . . . . . 84
4–10 Apothecary Notation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
5–1 Classification of Pediatric Clients . . . . . . . . . . . . . . . . . . . . . . . . . 94
5–2 Guidelines for the Administration of Oral and
Parenteral Medications to Young Children . . . . . . . . . . . . . . . . . . 99
7–1 Penicillins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
7–2 Cephalosporins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
7–3 Tetracyclines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
7–4 Macrolides/Erythromycins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
7–5 Aminoglycosides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
7–6 Other Antibacterial Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
7–7 Sulfonamide Products for Systemic Use . . . . . . . . . . . . . . . . . . . . . 150
7–8 Lab Test Interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
7–9 Antitubercular Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
7–10 Antiviral Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
7–11 Antiviral Drug Interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
8–1 Drugs Used in the Treatment of Malaria . . . . . . . . . . . . . . . . . . . . 188
8–2 Drugs of Choice for the Treatment of Intestinal
Parasitic Worm Infestations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
9–1 Commonly Used Antiseptics and Disinfectants . . . . . . . . . . . . . . . 202
10–1 Receptor Activity Related to Some Analgesic Drugs . . . . . . . . . . . 219
10–2 Opioid Analgesics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
10–3 Equianalgesic Doses of Opioid Analgesics . . . . . . . . . . . . . . . . . . . 224
10–4 Opioid Antagonists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
10–5 Nonopioid Analgesics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
10–6 Some Popular Opioid Analgesic Combination Products . . . . . . . . 228
10–7 Drug Products Used to Treat Migraine Headaches . . . . . . . . . . . . . 230
10–8 Drug Products Used for PCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
11–1 Changes in Body Function During Stages
and Planes of Anesthesia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
11–2 General Anesthetics Administered by Inhalation . . . . . . . . . . . . . 252
11–3 General Anesthetics Administered by Injection . . . . . . . . . . . . . . . 254
11–4 Drugs Used as Adjuncts to General Anesthesia . . . . . . . . . . . . . . . 256
11–5 Common Types of Regional Anesthesia . . . . . . . . . . . . . . . . . . . . . 258
11–6 Regional Anesthetic Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
x
LIST OF TABLES/TEXT xi
xiii
PREFACE
introduction This new full-color edition of Pharmacological Aspects of Nursing Care pre-
sents vital information on more than 1,100 pharmacologic agents. In the
most comprehensive edition to date, this text remains easy to understand,
well-organized, and logical in its discussion of nursing responsibilities related
to pharmacology—making it a vital text for all nursing students. The use of
full color will stimulate the reader and make this sometimes difficult to
understand content an exciting learning experience.
The nurse’s role in the assessment, diagnosis, planning, implementation,
and evaluation of clients receiving drug therapies is a vital and growing func-
tion of nursing. Additionally, the role of educating clients about their drug
therapies is a critical component in obtaining the client’s cooperation in the
therapies.
To function therapeutically and successfully in these roles, the nurse must
understand:
the fundamental principles of drug action,
the principles and methods of drug administration,
the accurate calculating of drug dosages,
the special considerations of drug therapy for pediatric and geriatric
clients,
the application of specific drugs in the treatment of health alterations,
normal and adverse responses by the client to drug therapy, and
the appropriate nursing interventions to achieve the desired goals of
drug therapy.
In addition, the nurse must be able to assess a client’s response to a drug
therapy to provide feedback about its effectiveness. To ensure that these
client goals are met, the framework of the nursing process is used to guide
the learner in this new edition.
organization The text begins with an introduction to drugs and drug therapies, including
of text a brief history of pharmacology, sources of drugs and dosage forms, drug
legislation, principles of drug action, pharmacokinetic factors in drug ther-
apy, and drug interactions and incompatibilities. A discussion follows of the
principles and methods of drug administration, with emphasis on the impli-
cations for nursing care. A review of dosage calculations is included. Specific
drug therapy considerations for pediatric clients and geriatric clients are pre-
sented in separate chapters to highlight the special concerns for these groups
of clients.
The remainder of the text is organized according to the major drug classi-
fications, identified either by their clinical use or by the body system they
affect. For each classification of drugs discussed in the text, the underlying
pharmacological principles of drug action and the specific uses in clinical
practice are explained. This is followed by “Applying the Nursing Process,”
which contains assessment, pertinent nursing diagnoses, planning/goals,
implementation, and evaluation.
features and New Activity Software CD-ROM is packaged free with every book!
benefits The activity software contains over 500 questions in a game format
that enables students to study and test their knowledge in an inter-
active and stimulating learning environment.
xiv
PREFACE xv
about the Dr. Broyles began in nursing in 1968 working as a student nursing assistant
author while pursuing her Bachelor of Science degree in Nursing from Ohio State
University in Columbus, OH. She was graduated with her B.S.N. in 1970 and
spent the next 13 years staffing and teaching in obstetrics and gynecology.
From 1972 to 1976, she taught in the Associate Degree Nursing Education
PREFACE xvii
acknowledgments The author wishes to express her appreciation to all who contributed to the
development of this sixth edition. Without the love, support, encourage-
ment and watchful eye of my husband, Roger, this project would not have
come to completion. In addition to my husband, Mike and Jeff are such
supporters for my writing.
The author also wishes to thank Mr. James W. Bevill, the Director of
Nursing Education at Piedmont Community College, for recommending me
for this project and for his expertise and support during the writing of this
edition.
The Piedmont Community College Associate Degree Nursing Classes of
2001 and 2002 served as inspiration and offered many suggestions from
students’ perspectives to help make this revision of the text a work of heart.
The author wishes to thank the people at Delmar Thomson Learning, espe-
cially Marah Bellegarde, Cathy Esperti, Matthew Kane, and Shelley Esposito
for the opportunity to work on this project and for their constant support,
encouragement, and gentle reminders of the time frame of the writing of this
sixth edition.
The author wishes to thank Barry S. Reiss and Mary E. Evans for such a
wonderful manuscript to revise. The author has used this text in her nursing
classes since its first edition. This text was originally designed as a student-
friendly pharmacology text and the author has attempted to build on that
and the professional style of Dr. Reiss and Dr. Evans.
Finally, the author wishes to thank the reviewers for their wonderful com-
ments and suggestions, many of which were used in this sixth edition.
Having been a book reviewer for 5 years, the author appreciates the time and
effort of the reviewers as they shared their expertise to help make this edition
such a success.
reviewers Nicholas R. Blanchard, PharmD, MEd Lou Ann Boose, RN, BSN, MSN
Professor of Pharmacy Assistant Professor of Nursing
Washington State University Harrisburg Area Community College
Spokane, WA Harrisburg, PA
xviii PREFACE
OBJECTIVES
After studying this chapter, the student will be able to:
Describe the scope of the science of pharmacology
Identify drug sources and provide an example of each
Identify the properties of each of the following dosage forms:
tablets • capsules • troches • suppositories • solutions • suspensions
• emulsions • semisolid dosage forms (ointments, creams, and gels)
• transdermal patches • parenterals (ampules, vials, prefilled syringes)
Compare the significance of the chemical name, generic name, and brand
name of a drug
Discuss the meaning of each part of a “product insert” and a “patient
package insert (PPI)”
Identify the component parts of a written prescription order
Identify the meaning of common abbreviations used in prescription orders
Identify the significance of each controlled substance schedule as defined in
the Controlled Substances Act of 1970 (Title II of the Comprehensive Drug
Abuse Prevention and Controlled Substances Act of 1970)
Describe Canadian drug legislation
Briefly describe the review process employed by the FDA in evaluating the
safety and effectiveness of nonprescription drug products
Identify the significance of each of the four phases involved in the clinical
testing of a new drug
Describe the FDA Medical Products Reporting Program
Describe the role of the nurse in the clinical testing of a new drug
Identify the unique characteristics of each of the following drug information
sources:
AHFS Drug Information • Physicians’ Desk Reference • Drug Facts and
Comparisons • Handbook of Nonprescription Drugs
Discuss the significance of the following terms in the measurement of drug
concentrations in the body:
minimum effective concentration (MEC) • minimum toxic concentration
(MTC) • plateau or steady-rate concentration • peak concentration
• trough concentration
Discuss the significance of the term “bioequivalent” as it pertains to a drug
product
Compare the actions of agonist, partial agonist, and specific antagonist drugs
Differentiate among each of the following adverse drug reactions:
side effect • toxic effect • allergic reaction • idiosyncratic reaction
• teratogenic effect
2
DRUGS/AGENTS AND FACTORS AFFECTING THEIR ACTION 3
A
drug can be broadly described as any chem- Pharmacotherapeutics
ical substance that affects living systems
Study of how drugs may best be used in the
by changing their structure or function.
treatment of illnesses
Pharmacology is the science concerned with the
Study of which drug would be most or least
history, sources, and physical and chemical prop-
appropriate to use for a specific disease, what
erties of drugs, as well as the ways in which drugs
dose would be required, etc.
affect living systems. Because of the complex nature
of this science, various subdivisions of pharmacol-
ogy have evolved.
Pharmacognosy
Study of drugs derived from herbal and other
Pharmacology natural sources
By studying the compositions of natural sub-
Study of history, sources, and physical and
stances and how the body reacts to them, one
chemical properties of drugs
gains better knowledge for developing syn-
Also includes how drugs affect living systems
thetic versions.
Pharmacodynamics
Toxicology
Study of the biochemical and physiological
Study of poisons and poisonings
effects of drugs
As almost all drugs are capable of being toxic
Study of drugs’ mechanisms of action
under some circumstances, this deals with
the toxic effects of substances on the living
Pharmacokinetics organism.
Study of the absorption, distribution, bio-
transformation (metabolism), and excretion
of drugs
HISTORY
Each of these factors is related to the concen- The treatment and prevention of disease is as
tration of the drug and/or its chemical by- old as the history of man since it has always been
products in various body sites as well as the considered as important to survival as the need for
time required for these drug concentrations to food and shelter. In early civilizations, disease was
develop and/or change. viewed with great superstition. Prevention and
4 CHAPTER 1
treatment of illness were, therefore, often directed Lister and Semmelweis first introduced the use
to driving away evil spirits and invoking magical of antiseptics to prevent infection during surgery.
powers. To enhance the mystical treatment of dis- With Ehrlich’s discovery of antibiotics and Banting
ease, primitive cultures began to experiment with and Best’s discovery of insulin, the golden age of
the plants that grew around them. This led to the pharmacology was ushered in. This culminated in
discovery of the first medicinal agents, some of the development of literally thousands of drugs
which (alcohol, opium, etc.) are still used today. during the twentieth century. Collectively, these
Even agents used as poisons to coat the tips of drugs have altered the practice of medicine and
arrows and spears of ancient warriors (e.g., curare) saved millions of human lives.
are still used medicinally.
Ancient Egypt is often credited as being the
cradle of pharmacology. Egyptian medical sources,
SOURCES OF DRUGS
such as the Ebers Papyrus, which were written over Drugs may be derived from a number of differ-
3,000 years ago, listed over seven hundred differ- ent sources. Some are derived from natural sources.
ent remedies used to treat specific ailments. These For example, insulin can be extracted from the
were probably the earliest documents devoted pancreas of animals, attapulgite suspension (e.g.,
entirely to medicine. Hippocrates, in the fourth Kaopectate) is derived from natural clays, while
century BC, declared in Greece that knowledge some bulk-forming laxatives (e.g., Metamucil),
about health and disease could only come through cardiac drugs (e.g., digitoxin) and cancer
the study of natural laws. This resulted in the first chemotherapeutic agents (e.g., vincristine) are
systematic dissections of the human body done to derived from plants.
study the functions of specific organs. Some drugs are produced semisynthetically. For
In the first century, Dioscorides prepared De example, many antimicrobial agents are prepared
Materica Medica, which scientifically described six by chemically modifying substances that are avail-
hundred different plants and classified them, for able from a natural source. Likewise, some human
the first time, by substance rather than by the dis- insulin products are prepared by chemically mod-
ease they were intended to treat. This work ifying animal insulin so it has precisely the same
remained the main source of pharmaceutical chemical structure as human insulin.
knowledge until the sixteenth century. At that The vast majority of drugs currently in use are
time, Paracelsus, a Swiss scientist, first advocated entirely prepared by synthetic means; i.e., they are
the use of single drugs, rather than mixtures or formed by chemical reactions in a laboratory (e.g.,
potions, as a means of treating diseases. He Synthroid). Such agents are synthesized after
believed that the dosage of single drugs could be determination of how the chemical structure of a
regulated more precisely than that of complex compound relates to its pharmacological proper-
mixtures and recognized the dangers of giving too ties. Because synthetic drugs are produced in the
much or too little medicine to a specific client. He laboratory, it is often possible to create com-
wrote, “all things are poisons, for there is nothing pounds that have greater purity than those which
without poisonous qualities. It is only the dose are naturally derived.
which makes a thing a poison.” For his contribu- The most exciting advances in the development
tions Paracelsus is often considered to be the of new drugs have been in the area of biotechnol-
father of pharmacology. ogy. Biotechnology involves the manipulation of
It was not until the seventeenth century that proteins to permit the large-scale industrial pro-
the English physiologist William Harvey first duction of complex natural substances (e.g., hor-
began to explain how drugs exert their beneficial mones) or genetically altered biological sub-
or harmful effects. He first demonstrated the cir- stances. It is a science that uses discoveries derived
culation of blood in the body and introduced a from molecular biology, recombinant DNA tech-
new way of administering drugs— intravenously. nology, genetic engineering, immunology, and
In the two hundred years that followed Harvey’s pharmacology.
work, drug products of greater purity gradually In pharmacology, the greatest potential for
evolved. Using these purified drugs two French applying biotechnology is in gene splicing. This
physiologists, Francois Magendie and Claude involves the genetic manipulation of nonpatho-
Bernard, in the nineteenth century, demonstrated genic, rapidly growing bacteria, such as E. coli, to
that certain drugs work at specific sites of action enable them to manufacture complex biological
within the body. compounds that would be extremely difficult or
DRUGS/AGENTS AND FACTORS AFFECTING THEIR ACTION 5
costly to prepare by conventional means. The the introduction of biotechnology products will
process of gene splicing involves the inoculation be common and their benefits to humans almost
of such E. coli organisms with plasmids. Plasmids too great to measure.
are circular DNA molecules that carry a few genes
the bacterium can perpetuate and duplicate in
addition to its own chromosomes (Figure 1–1).
Currently, hundreds of different biotechnology
DRUG USES
products are in various stages of development Drugs may be helpful to both the healthy and
(i.e., are in Phase I, II, or III of testing). Products the sick. Drugs have six major uses.
already approved include human insulin, human The most common drug use is symptomatic
tissue plasminogen activator, human growth hor- treatment. Many drugs are used to relieve dis-
mone, and hepatitis B vaccine. The first decade of ease symptoms (e.g., aspirin to relieve fever
the new millenium promises to be a time when and headache).
Gene splicing
A. B. C. D.
E. F. G.
I.
H.
Preventive drugs help the body avoid disease such dosage forms with antacids, milk, or other
(e.g., hepatitis vaccine for serum hepatitis B). alkaline substances, as these may cause the coating
Diagnostic drugs (e.g., radiopaque dyes) help to dissolve in the stomach rather than in the small
the physician determine whether a disease is intestine. Enteric-coated tablets should never be
present. crushed or chewed.
Curative drugs (e.g., antibiotics) eliminate the Timed or Sustained-Release Tablets. Many
disease. different technologies exist for permitting drugs to
Health maintenance drugs (e.g., insulin) help be released from tablets in a controlled fashion.
keep the body functioning normally. For example, some tablets (e.g., Slow-K®) have
Contraceptive drugs (e.g., oral contraceptives) crystals of potassium chloride embedded in a wax
prevent pregnancy. matrix. When these tablets come in contact with
gastric fluid, the fluid causes small amounts of the
dissolved drug to leak through the channels in
DOSAGE FORMS the wax matrix and promotes gradual release of
the drug over several hours. This helps reduce the
Drugs are capable of being transported into the
irritating effect of the drug on the GI lining.
human body in a variety of ways. Rarely are they
Controlled release of potassium chloride and
administered in their pure chemical form, but
other drugs is also accomplished by preparing
rather in a formulation designed to maximize the
tablet products that contain a microencapsulated
stability and usefulness of the medication. Such
drug, i.e., small drug particles coated with a poly-
formulations or dosage forms may be simple solu-
mer coating. When the tablet disintegrates, the
tions of the drug in water and some may be more
microencapsulated drug particles are released.
complex combinations. Some of the most com-
Depending on the thickness of the polymer coat-
mon dosage forms are in the next sections.
ing, the particles release the drug over varying
periods. Osmotic pumps have also been employed
Tablets in providing a controlled release feature from
The tablet is the most popular dosage form and some tablets. Osmotic pumps are polymer-coated
usually the easiest to administer. Almost all tablets tablets that allow water to enter into the tablet
now used in the United States are “compressed” from the gastric fluid. As the drug dissolves within
tablets. They have been formed by compressing a the tablet, it forms an osmotic gradient that forces
mixture of pure drug(s) with inactive components drug solution out of a laser-drilled hole on the
that serve to add bulk, shape, weight, and/or other tablet surface. This mechanism permits a slow and
properties to the tablet. Compressed tablets are steady drug release over a number of hours.
usually manufactured commercially since costly Some tablets contain different layers or have
equipment is required to form them. cores that separate different drugs that might be
Most tablets contain a disintegrating agent in
their formulation. Usually this is cornstarch. The
disintegrating agent swells when it comes into
contact with fluid in the stomach and causes the A. Scored Tablet
tablet to break apart into smaller particles, which B. Layered Tablet
dissolve rapidly and release the active drug. Many
tablets are scored to facilitate convenient division
into halves or even quarters (Figure 1–2A). Unscored
tablets are difficult to break evenly. Some are
D. Soft Gelatin Capsules
coated with a substance which prevents the tablet
from dissolving in the stomach but permits it to
dissolve in the small intestine. Such tablets are
enteric-coated (ec) and are designed to carry drugs
that could irritate the stomach or be chemically C. Hard Gelatin Capsules E. Sustained-Release Capsules
destroyed by the acid environment of the stom-
Figure 1–2 Solid Dosage Forms. (From Physicians Drug
ach. Since the coating of enteric-coated tablets is
Reference (2001). Montvale, NJ: Medical Economics. Courtesy of
designed to dissolve in a neutral or alkaline pH Medical Economics.)
environment, it is important to avoid administering
DRUGS/AGENTS AND FACTORS AFFECTING THEIR ACTION 7
Capsules Solutions
A capsule is a dosage form in which a drug A solution is a clear liquid preparation that
is enclosed in either a hard or soft soluble shell, contains one or more solvents, usually water, and
usually made of gelatin. When the capsule one or more dissolved components, or solutes.
is administered orally, the shell generally dis- When used orally, solutions are often flavored
solves in the stomach within 10 to 20 minutes, and colored to make them more appealing to the
releasing its contents. Hard gelatin capsules (e.g., client. Solutions offer the advantage of easy admin-
Temazepam) consist of two parts that slide istration, particularly for pediatric and geriatric
together to enclose the powdered medicinal con- clients, as well as the ability to infinitely vary the
tents (Figure 1–2C). They may be commercially dose administered.
manufactured or they may be prepared by the Syrups are sweetened solutions that are often
pharmacist to contain a precise medicinal formu- used to mask the unpleasant taste of certain drugs.
lation. If necessary, they may be opened by the Syrups are also given for their soothing effect.
nurse for administration in food, liquids, or tube Sugar-free syrups are available for diabetics. Elixirs
feedings. To discourage tampering, some capsules are also solutions, but contain a solvent mixture of
are now manufactured to make it impossible to alcohol and water as well as other components.
separate the two parts of the capsule without They are often employed as vehicles in order to
destroying its integrity. dissolve drugs that do not dissolve in water alone.
Soft gelatin capsules (e.g., Colace) are usually Tinctures are solutions that contain alcohol as the
designed to encapsulate medicinal liquids (Figure primary solvent but which may contain some
1–2D). They are only prepared by commercial water as well. Because tinctures are available for
manufacturers and are completely sealed. Some internal and external use, they should be stored
capsule products contain small drug-impregnated separately from other liquid medication. Careful
beads designed to release drug(s) at different rates label checks should be made before administering
while they pass through the gastrointestinal tract, them.
thereby producing a sustained-release action Solutions are used in a wide variety of medicinal
(Figure 1–2E). applications. Most are given orally, but some are
administered by other routes. Solutions used for
injection (parenteral administration) or in the eye
Troches (ophthalmic use) must be sterile and should be
Troches, or lozenges, are solid dosage forms that nonirritating to body tissues. When administered
are generally disc shaped and should be dissolved intravenously, the solution must also be free of
slowly in the mouth. They are often designed to solid particulate matter.
release medication that exerts an antiseptic or A douche solution is one intended to be used in
anesthetic effect on the tissues of the oral cavity or cleansing a body part or cavity, usually the vagina.
throat (e.g., zinc lozenges). It is often prepared by diluting a liquid concentrate
8 CHAPTER 1
or soluble powder with water to make a solution of matological disorders. Some may be greasy and
an appropriate strength. insoluble in water (e.g., petrolatum and most oint-
Unless they are prepared and stored carefully, ments), while others (e.g., creams and gels) usually
most solutions are subject to contamination by are not greasy and are easily washed from the skin
bacteria, molds or other microorganisms, as well with water. Selection of the appropriate base to use
as by dust. If they are not kept in tightly capped for topically applied drugs is based upon such
containers, the solvent of most solutions will factors as:
evaporate, leaving behind a more concentrated the desired rate of drug release from the base
drug solution. whether to retain or remove moisture at the
site of drug application
how stable the drug(s) is (are) in the base
Suspensions The student is referred to Chapter 40 for a more
Suspensions are liquid dosage forms that con- detailed discussion of dermatological products.
tain solid drug particles that are suspended in a Topical Patches. Within the last few years,
suitable liquid medium. Most suspensions are several dosage forms have been developed that
administered orally although some are applied to permit topical drugs to pass through the skin and
the skin as lotions or liniments or administered by into the bloodstream where they exert systemic
injection. Note: Suspensions should never be effects. Nitroglycerin, a drug used primarily in the
administered intravenously. Magmas are suspen- treatment of angina pectoris, is available in an
sions which contain relatively large drug particles ointment dosage form which releases the drug
(e.g., milk of magnesia). All suspensions must be gradually through the skin and into the blood-
shaken thoroughly immediately prior to adminis- stream. A number of drugs, e.g., nitroglycerin, estro-
tration in order to assure dosage uniformity each gen, clonidine, fentanyl, scopolamine, and
time the product is used. nicotine are available in patchlike devices known
as transdermal therapeutic systems (Figure 1–3).
Most of these consist of a reservoir that contains
Emulsions the drug, a water-resistant surface covering, a thin
Emulsions are dispersions of fine droplets of membrane which lies between the drug and the
an oil in water or water in oil. Those which skin, and an adhesive area which permits the
contain an oil dispersed in water are primarily secure application of the system to the skin. Once
used orally. By dispersing a medicinal oil (e.g., applied, the drug slowly passes from the reservoir
castor oil or mineral oil) in water that contains through the membrane into the skin. The drug
flavoring agents, the objectionable taste and/or then is absorbed into blood vessels within the skin
odor of the oil can be masked. Some sterile emul- and is carried to other parts of the body. The stu-
sions containing vegetable oils dispersed in water dent is referred to Chapter 29 for a more detailed
are used intravenously as an injectable nutrient discussion of the use of nitroglycerin ointment
source. and transdermal therapeutic systems.
Emulsions containing water droplets dispersed
in oil are used primarily for topical application to
the skin. The oily vehicle may provide a useful
protective action for damaged skin while the water
droplets may carry dissolved medicinal agents to
the application site. Emulsions must be shaken
thoroughly just prior to their use since the oil and
water phases, as well as solids which may be sus-
pended in some emulsion products, may tend to
separate upon standing.
Implants
KEY NURSING IMPLICATIONS 1–1
Drugs may be administered for extended peri-
ods of time, sometimes as long as five years, by General Guidelines for Drug Administration
administering them in small flexible capsules 1. Enteric-coated tablets should not be
made of a Silastic polymer. These capsules are sur- administered with antacids, milk, or other
gically implanted subdermally, often in the upper alkaline substances because enteric-coated
arm region. When the action of the drug is to agents require the acid environment of
be discontinued or when new implants need to be the stomach to be effective.
inserted, the old implants are surgically removed. 2. Enteric-coated tablets should not be
An example of such a system is Norplant, a prod- crushed before administration because
uct that releases contraceptive doses of progestin crushing will alter absorption.
for up to a 5-year period. 3. For appropriate absorption, some tablets
are to be chewed or dissolved under the
Parenteral Products tongue (sl-sublingual) or in the inner lin-
Several different ways are used to package sterile ing of the cheek (bc-buccal), rather than
solutions or suspensions intended for use as an being swallowed whole.
injection. Ampules are sterile, sealed, glass or 4. Suspensions and emulsions must be
plastic containers containing a single liquid dose. shaken thoroughly immediately before
Vials are either single- or multiple-dose glass or use because the separation that occurs
plastic containers that are sealed with a rubber after standing for a short period will alter
diaphragm. Prefilled syringes containing a single the dosage if used in the separated form.
dose also are available. 5. Suspensions are never administered
intravenously.
DRUG NAMES 6. Solutions administered parenterally or in
the eye must be sterile to prevent caus-
By the time a drug becomes available for com- ing infection, and those administered
mercial distribution in the United States, it already intravenously must be sterile and free of
has several names. During its earliest stages of particulate matter that could serve as an
development, the first name which is likely to be embolus.
applied is the chemical name. This is a systemati- 7. Proper storage of solutions is very
cally derived name which identifies the chemical important to prevent contamination
structure of the drug. Since the chemical name is and evaporation.
often quite complex, a code designation is some-
8. The skin integrity should be assessed for
times chosen for the drug during this early period
rashes or open areas before applying top-
of its development. This merely represents a tem-
ical medications, as these conditions will
porary name, which is generally discarded once a
alter the absorption time of the medication.
drug becomes commercially available. Investiga-
tional drugs, those that are not yet commercially 9. Transdermal therapeutic systems or
available but are undergoing experimental study, patches permit drugs to pass through the
are often labeled only with this code designation. skin into the bloodstream. Therefore, the
Once a drug is to be marketed, a relatively sim- nurse must be very careful when apply-
ple generic, or nonproprietary name, is assigned to ing them to prevent self-medication.
the drug by the U.S. Adopted Names (USAN) 10. A previous transdermal patch should be
Council. This name is meant to be easier to pro- removed before the next dosage patch is
nounce and remember than the chemical name. applied.
Yet it reflects some important pharmacological or 11. Proper disposal of transdermal patches is
chemical characteristic of the drug. Attention is important, so children do not apply used
also given to selecting a name unlikely to be con- patches to themselves and so that house
fused with the names of other drugs. pets will not chew them.
When a drug appears to be ready for commercial
distribution, it may be assigned a brand (or trade) From DeLaune & Ladner (1998)
name. This name, which is usually followed with
10 CHAPTER 1
the superscript ®, is registered by the U.S. Patent required that all drugs marketed in the United
Office, is approved by the U.S. Food and Drug States meet minimal standards of strength, purity,
Administration (FDA), and is permitted to be used and quality. The act also established the U.S.
only by the company which has registered the drug. Pharmacopoeia (USP) and the National Formulary
The brand, or trade, name is usually short and one (NF) as the official legal standards for drugs in the
that is easy to recall. It often does not refer to the United States.
drug alone but to the entire formulation in which In 1938 the Federal Food, Drug and Cosmetic
the drug is contained. When a drug is manufac- Act added the requirement that a drug be shown
tured by different companies, each company must to be safe before it could be distributed in inter-
market the drug under its own trade, or brand, state commerce. An amendment to this act,
name. An example of some of the names currently known as the Durham-Humphrey Amendment,
used for a single drug are listed below: was enacted in 1952. It required that certain drugs
Chemical Name: 7-chloro-2-methylamino-5-phenyl- be classified as legend drugs, i.e., that they be
3H- 1,4- benzodiazepine 4-oxide hydrochloride labeled with the legend “Caution—Federal law
Nonproprietary, or Generic, Name: chlordiazepox- prohibits dispensing without prescription.” It also
ide hydrochloride specified that all other drugs approved for use be
Brand Name: Librium considered nonprescription drugs. These could be
Once a manufacturer’s patent for a drug has sold directly to the consumer without the need for
expired (usually 17 years from the date it was first a prescription.
registered), other companies are free to market the In 1962, this act was again amended by the
drug under their own trademarked name or under Kefauver-Harris Amendment. It added the require-
the generic name of the drug. Considerable ment that both prescription and nonprescription
controversy has raged regarding the therapeutic drugs be shown to be effective as well as safe. This
equivalence, or bioequivalence, of products con- was followed in 1970 by the Comprehensive Drug
taining the same dose of a specific drug but in a Abuse Prevention and Control Act (also known
different formulation. This debate has been fur- as the Controlled Substance Act), which further
ther intensified by the recognition that vast price classified drugs according to their potential for
differences may exist between competing brand causing abuse. It also regulated the manufacture
name products, as well as those sold under the and distribution of drugs considered capable of
drug’s generic name. In some instances, different causing dependence.
products containing identical drugs and drug As a result of these federal statutes all drugs may
doses have been shown to produce significantly be classified into one of four categories:
different pharmacological responses, even in the prescription or legend drugs
same client. In other cases, no significant differ- nonprescription or over-the-counter (OTC)
ence in response is noted when such competing drugs
products are administered. It has become evident, investigational drugs
therefore, that no generalization can be made illicit, or “street,” drugs
regarding the therapeutic effectiveness of compet-
ing drug products containing the same dose of a
drug. Careful assessment must be made of the
Prescription Drugs
client’s response when the source of a client’s drug Prescription drugs are those that have on their
product is changed, in order to immediately rec- labels the prescription legend described previously.
ognize any variation that may occur. Before such drugs can be marketed in the United
States, the manufacturer must file a New Drug
Application (NDA) with the U.S. Food and Drug
CLASSIFICATION OF DRUGS Administration (FDA). This action must include a
Up to the beginning of the twentieth century, detailed description of the drug, its toxicity, and
no federal controls existed for the protection of the results of all experimental clinical trials of the
consumers who used drugs. After a number of cat- drug in clients. Only if the FDA determines that
astrophic incidents in which deaths resulted from the drug has been proven to be safe and effective
the use of adulterated drugs, the first federal and that the claims made for the drug by the man-
statute controlling the manufacture of drugs ufacturer are supported by scientific data, is the
was passed—the Food and Drug Act of 1906. It drug approved for general distribution.
DRUGS/AGENTS AND FACTORS AFFECTING THEIR ACTION 11
Drugs introduced after the 1962 Kefauver-Harris as well as other information required by the laws
Amendment were subjected to particularly close of different states. In addition, prescriptions usu-
scrutiny and were rated systematically by experts ally contain the component parts:
assembled by the FDA. This rating process was part descriptive client information (e.g., name,
of a project known as the Drug Efficacy Study address, age, or birth date)
Implementation (DESI). Drugs that were desig- the date on which the prescription was writ-
nated as being “ineffective” were removed from ten by the prescriber
the market, while those classified as being “pos- the RX symbol
sibly effective” or “probably effective” required name and dosage strength of the prescribed
reformulation or retesting to remain on the mar- medication
ket. All newly introduced products must be shown dispensing instructions for the pharmacist
to be effective prior to marketing. (e.g., “Dispense 100 tablets” or “Compound
Prescription drugs may be prescribed by physi- 40 capsules”)
cians, dentists, veterinarians, or other legally auth- directions for the client, or signa (often abbre-
orized health practitioners as part of their specific viated sig. or Sig.), which the pharmacist will
practice; that is, physicians may only prescribe place on the prescription label
drugs intended for human use, veterinarians only refill and/or specialized labeling instructions
for animal use, etc. The usual method employed in (e.g., “Refill 5 times” or “Do not label”)
transmitting the prescriber’s wishes to the phar- the prescriber’s signature, address, and tele-
macist who will compound and/or dispense the phone number
medication is the prescription order. It should be noted that by convention some
Prescription Forms. The prescription is an parts of the prescription order may be written in
order for medication (or other forms of therapy) Latin. More commonly, abbreviations are used for
which specifies precisely the name of the drug and these terms. Detailed lists are in Chapter 2, which
the dosage regimen to be used by the client for deals with drug administration, and in Chapter 4.
whom it is written (Figure 1–4). Most prescriptions Medication orders intended for hospital or other
are written on printed forms, which may be institutional inpatients are generally written by
imprinted with the prescriber’s name and address, the prescriber on a form known as the “Physician’s
Order Sheet.” The design of this form may vary
widely from institution to institution or even
within the same institution (Figure 1–5). Usually
Jane Doeseckle
Name _________________________________ 36
Age ______ when the prescriber writes an order on such a
form, one or more duplicate copies are simultane-
15 Celtic Ave. , Exam City, NY
Address _____________________________ 7/ 5 / xx
Date _______ ously made. These may be sent to the pharmacy,
This prescription will be filled generically unless physician the client records department, and/or to other
signs on line stating "Dispense as written". areas of the institution.
Storage of Medications. All personnel
responsible for the storage of medication must be
aware of the necessity for keeping them in secure
areas away from the general flow of traffic in the
institution. In addition, proper control of the
environment is essential. Most medications may
be safely stored at normal room temperature.
Some, however, require refrigeration or must even
be kept frozen to maintain their potency. Every
_____________ ______________ effort must be made to assess the storage require-
Dispense as Written Substitution Permissible ments of each medication stored at the nursing
Frank Giacobbe, M.D. 120 Madison Road Center, NY station and to discard medications that have been
DEA # AG7241893 432-2341
Ph. No. _____________ improperly stored for even brief periods. Most
medications have an expiration date printed on
Figure 1–4 This prescription has been completed and signed
their label. This indicates the length of time the
by the physician. preparation will remain stable when stored under
recommended conditions. When the date is shown
12 CHAPTER 1
as a month and year (e.g., June 2004), expiration at temperature extremes (e.g., in a hot automobile
refers to the last day of the month indicated. during summer months) may dramatically lose
Beyond the expiration date, the manufacturer their potency, regardless of the expiration date on
cannot guarantee full drug potency or stability the label.
and the product should be discarded. Note: A number of medications are classified as
Medications that are stored for even brief periods controlled substances. These are agents that have
J. Physician, M.D.
None Known
Client, Mary Q.
Diabetes
#3-11316-7
5' 5" 130 lb.
been identified by various governmental bodies as sibilities include the maintenance of secure stor-
having the ability to cause physical and/or psy- age conditions for these drugs. This often includes
chological dependence. Controlled substances are the use of double-locked storage cabinets as well as
classified in five different categories, or schedules, keeping accurate records of the disposition of all
under the Controlled Substances Act of 1970. doses of controlled substances received and/or used
Table 1–1 describes the characteristics of each during each shift.
schedule. In most institutions, orders for controlled sub-
The prescribing, dispensing, manufacturing, stances must be renewed every 48 hours for the
administration, and storage of controlled substances order to remain valid. The nurse has the responsi-
are subject to considerably greater governmental bility for carefully assessing the progress of clients
control than the use of conventional prescription receiving controlled substances in order to deter-
drugs. Procedures to be followed in virtually every mine the development of physical and/or psycho-
step from the manufacture to the administration logical dependency or the possible abuse of the
of these agents are precisely defined by law. In medication.
handling such agents, the nurse has both special
legal and ethical responsibilities. The legal respon-
Nonprescription Drugs
Drugs that may be legally acquired by the client
TABLE 1–1 without a prescription order are known as non-
prescription, or OTC drugs. Such agents are con-
Controlled Substances Schedules sidered to be relatively safe for the layperson to use
when taken according to directions provided by
SCHEDULE I the manufacturer and when given to treat condi-
Drugs in Schedule I have a high potential for abuse and tions for which they are intended. In 1972, after
no accepted medical use in the United States, e.g., years of relatively little control of drugs sold with-
heroin, LSD. out a prescription, the FDA began reviewing each
class of OTC drugs (i.e., antacids, laxatives, etc.) to
SCHEDULE II
Drugs in Schedule II also have a high potential for abuse,
establish the safety and efficacy of the ingredients.
but do have a currently accepted medical use in the This was accomplished by the appointment of
United States. It has been determined that abuse of a expert panels by the FDA. Each of these panels was
drug included in this schedule may lead to a severe to review a specific category of OTC drug prod-
psychological or physical dependence, e.g., meperidine, ucts. Upon completing this review, the panel was
morphine, cocaine, oxycodone, Ritalin. to designate each ingredient used in the products
as being in one of three categories. Agents placed
SCHEDULE III
in Category I were those recognized as being safe
Schedule III drugs have accepted medical uses in the
United States, but they have a lower potential for abuse and effective for the therapeutic uses claimed
than drugs in Schedules I and II, e.g., Tylenol with for them. Those in Category II were not recog-
codeine, hydrocodone. nized as being safe and effective, while those in
Category III were agents for which additional data
SCHEDULE IV were required to establish safety and/or efficacy.
These drugs have a low potential for abuse relative to Based upon the recommendations made by these
Schedule III drugs. Abuse of Schedule IV drugs may lead
panels, many OTC products have been removed
to limited physical or psychological dependence as
compared to Schedule III drugs, e.g., Librium, Valium. from the market or have been reformulated to
gain acceptance. As a result of the FDA’s review
SCHEDULE V of OTC products and their ingredients, many
Schedule V drugs have the lowest abuse potential of ingredients previously available only by prescrip-
the controlled substances. They consist of preparations tion can now be sold as OTC products. These
containing limited quantities of certain narcotic drugs include many ingredients used to treat colds and
generally used for antitussive and antidiarrheal properties,
allergies, certain strengths of hydrocortisone
e.g., Lomotil, Robitussin A–C.
topical products, ibuprofen and naproxen in cer-
tain strengths, some topical antifungal products,
Source: Controlled Substances Act of 1970, Title II of
Comprehensive Drug Abuse Prevention and Controlled drugs used to reduce acid secretion in the stom-
Substances Act of 1970. ach, and some fluoride dental rinse products. It is
14 CHAPTER 1
likely that more products will have their status and that the drug will be administered only
changed from prescription to OTC in the next to volunteers or clients who have been
several years. fully informed of the nature of the study
Even though a prescription order is not required and from whom an informed written consent
for their purchase, OTC medications are capable of has been obtained. Consent forms must be
producing considerable toxicity, if they are not read and signed by clients and witnesses
used in accordance with their labeled directions (Figure 1–6).
and/or if they are used in combination with other protocols that clearly define how the drug is to
OTC drugs or prescription drugs the client may be be administered to experimental subjects (i.e.,
using. Many OTC drugs should not be used in the in what doses, by what route, for how long,
presence of certain medical conditions. It is essen- etc.). Protocols include what specific observa-
tial, therefore, that the nurse make every attempt tions or determinations will be made during
to assist the client in identifying health problems the trial.
that can be safely treated with OTC medication Clinical studies performed on human subjects
and in selecting safe and effective products. The prior to the marketing of a drug are usually
pharmacist is an excellent resource for informa- divided into four phases. Phase I is devoted to the
tion concerning the appropriate use of OTC evaluation of the drug in normal human volun-
medication. The client should be encouraged to teers to determine if the drug is toxic and how it is
communicate with a pharmacist about any OTC metabolized and excreted. Phase II involves a
drug needs. more detailed evaluation of the drug in normal
Once the client begins self-medication with an subjects, and initial trials in relatively small num-
OTC product, it is essential that continuous evalu- bers of subjects who have the disease state for
ation of the response to the medication be made which the drug is intended to be used. The next
to identify the development of any adverse effects. phase, Phase III, consists of broad clinical trials
This includes adverse effects resulting from inter- designed to evaluate the usefulness of the drug in
action with prescription drugs. It is equally impor- treating the disease for which it is claimed to be
tant to avoid the masking of symptoms (e.g., effective. Phase IV involves postmarketing surveil-
cough, pain, or fever) that could be the result of a lance of the drug product’s activity. During this
serious underlying disorder. phase, prescribers are encouraged to submit to the
manufacturer and/or the FDA experience reports
based on their clinical use of the product. This per-
Investigational Drugs mits the detection of problems with the use of the
In order to fulfill the requirements of the FDA, product that would only be evident on widespread
a manufacturer who wishes to market a new drug use in many diverse clients.
must perform a wide array of animal studies and The nurse is generally most involved in Phase
carry out clinical testing of the drug in human III of the clinical trial and may be responsible for
subjects. To accomplish this, the manufacturer administering investigational drugs to clients. In
must file a “Notice of Claimed Investigational doing so, it is essential that the clinical protocol to
Exemption for a New Drug” (IND) with the FDA. be followed be readily available for inspection and
This is a complex form, which must include: that the proper method of drug administration
all known information regarding the chemical, and client evaluation be understood completely
biological, pharmacological, and toxicological before initiating therapy. In some states, only per-
properties of the new agent sons identified in the clinical protocol as inves-
precise details of how the drug is manufac- tigators may administer the medication and/or
tured and how it must be stored to preserve its obtain informed consent from a subject. The nurse
stability should, therefore, be familiar with the laws defin-
the name and qualifications of each investiga- ing the extent to which a nurse may participate in
tor who will participate in the clinical trial the testing of investigational drugs.
a signed statement from each investigator The personal response of the subject in whom
indicating awareness of the nature of the an investigational drug is being used may vary
drug to be studied, as well as assurances that considerably. Some clients may have unrealistic
the investigator or an appointed agent will expectations of a drug’s usefulness, perhaps believ-
adequately supervise every aspect of the study ing that it must be better than existing forms of
DRUGS/AGENTS AND FACTORS AFFECTING THEIR ACTION 15
Memorial Hospital
Hometown, New York
PERMISSION FOR CLINICAL INVESTIGATION
Patient Form
3. I have (have not) been made aware of certain risks, possible consequences and discomfort
associated with these extraordinary procedures which are: _________________________
________________________________________________________________________
________________________________________________________________________
4. I understand that no guarantee or assurance has been made as to the results that may
obtained although I have (have not) been advised of the possibility that certain benefits may
be expected such as: ______________________________________________________
________________________________________________________________________
5. I have (have not) had explained to me alternative procedures that may be advantageous
and they include the following: ______________________________________________
______________________________________________________________________
6. I have (have not) received an offer to answer any inquires concerning the procedures
involved ____________________________________________________________
7. I have (have not) had explained to me all medical terminology in connection with this study
______________________________________________________________________
8. I understand that it is in the intent of the principal investigator to maintain the confidentiality
of records identifying subjects in this study. The Food and Drug Administration, however,
may possibly inspect the records to monitor compliance with published federal regulations.
9. I understand that I may withdraw this consent and discontinue participation in this study at
any time, without prejudice to my care, by informing Dr. ______________________ of my
desire to withdraw. __________ Yes, I understand __________ No, I do not understand
10. I understand that Department of Health and Human Services regulations require the
Memorial Hospital to inform me of any provisions to provide for medical treatment for any
physical injury which may occur as a result of this study. In the connection, I understand
that the Memorial Hospital does not have a formal pan or program to provide for the cost
of medical treatment or compensation for any physical injury which occurs as a result of this
study and for which they do not have legal liability. However, in the unlikely event that I am
Injured as a result of my participation, I understand that I should promptly inform
Dr. ____________________________________________________________________
SIGNED _______________________________________________________________
RELATIONSHIP _________________________________________________________
ADDRESS _____________________________________________________________
______________________________________________________________________
DATED ________________________________________________________________
Figure 1–6 Example of forms that must be signed before a client participates in a clinical investigation. The upper form is read
and signed by the client, the lower by the witness. A member of the study staff fills in the blanks before submitting the form for
clients and witnesses to sign.
16 CHAPTER 1
therapy because it is “new.” Others may partici- (1) drugs which are not legal for sale under any
pate in a trial with some reluctance, because they circumstances in the United States (e.g., heroin) or
believe that they are being used as a “guinea pig.” (2) drugs which may be sold legally under certain
Understanding these feelings and assisting the circumstances (e.g., with a prescription order)
client to deal with them are important for all those but which have been manufactured illegally or
involved in the clinical study. Only subjects who diverted or stolen from normal channels of distri-
have signed informed consent forms should bution. Illicit drugs usually are used for nonmed-
receive investigational drugs. They should fully ical purposes, generally to alter mood or feeling.
understand the potential hazards associated with The student is referred to Chapter 41 for a de-
the intended therapy. In addition, as volunteers, tailed discussion of illicit drugs and substance abuse.
subjects who are part of the study may withdraw
from a program at any time.
The student is referred to Chapter 39 for a dis- CANADIAN DRUG LEGISLATION
cussion of nursing actions related to the clinical
In Canada the Health Protection Branch of the
use of investigational drugs.
Department of Health and Welfare is responsible
for monitoring the potency, purity, and safety of
The FDA Medical Products Reporting
Canadian drug products. This is done through the
Program administration and enforcement of two federal acts.
The FDA Medical Products Reporting Program The Food and Drug Act includes legislation
(MedWatch) is an Internet site for health profes- about prescription, nonprescription, and con-
sionals and consumers to voluntarily report “adverse trolled drugs. Examples of controlled drugs include
events and product problems with medications barbiturates and amphetamines, which must be
(drugs and biologics, except vaccines), medical carefully monitored to prevent indiscriminate use.
devices (including in vitro diagnostics), special Controlled drugs are potentially addicting and
nutritional products (dietary supplements, infant subject to more stringent controls than ordinary
formulas, medical foods) and other FDA-regulated prescription drugs.
medical products” (Food and Drug Administration, The Narcotic Control Act governs the manufac-
1994). The Internet site http://www.fda.gov/med- ture and distribution of narcotics, e.g., morphine,
watch provides MedWatch FDA form 3500 with codeine, meperidine. As with controlled drugs,
instructions for completing form and submitting it these drugs also require a prescription, because
to the FDA. The FDA MedWatch program can also dependency is a potential outcome from narcotic
be contacted through their toll-free telephone use. In addition, automatic stop order policies are
number (800-FDA-1088). MedWatch was estab- in place in most agencies. The nurse must become
lished to provide a comprehensive product prob- familiar with these policies and know when
lem reporting system. he/she can be in legal possession of a narcotic.
The Drug Product Problem Reporting Program Narcotics and controlled drugs are stored under
(DPPR) established in 1971 by the USP was the pri- double-lock and key. Records are maintained to
mary reporting system for identifying and improv- ensure accountability for every dose administered.
ing defective and potentially unsafe drug prod-
ucts; however, it ceased to operate in August,
2000. At the time of the DPPR’s inception, it was DRUG INFORMATION RESOURCES
the only nationally operated program focused on
The nurse, as well as other health professionals
surveillance of medical products, providing the
who may prescribe, dispense, or administer med-
FDA with information about drug products that
ication, requires reliable and current drug infor-
could endanger the public health. The USP con-
mation. Such a need is heightened when one
tinues to operate the USP Medication Errors
considers the constant dynamic changes in phar-
Reporting Program and MedMARx ® as a part of
macology. Dozens of new drug products are
the SP Practitioners’ Reporting Network.
released every year. Although textbooks of phar-
macology may be useful as sources of information
Illicit Drugs regarding basic pharmacological principles, they
Illicit agents, or “street” drugs, are those which quickly become outdated and do not always meet
are used and/or distributed illegally. They may be: the varied needs of the working health practitioner.
DRUGS/AGENTS AND FACTORS AFFECTING THEIR ACTION 17
In an institution, the most readily available of the content and relative cost of competing
source of drug information may be the institu- products.
tion’s drug formulary. This is a continually revised The Handbook of Nonprescription Drugs, pub-
compilation of drugs and drug products available lished by the American Pharmaceutical Associa-
for use in an institution. The formulary serves to tion, is perhaps the most valuable resource for
provide prescribers within the institution with a information regarding nonprescription medica-
selection of useful and economical drugs from tion. Each of its chapters is devoted to a discussion
which to choose. It also limits the number of of a different class of nonprescription drugs and
duplicative drug products that must be stocked. includes a review of the diseases treatable by self-
For example, a formulary may only list one oral medication, as well as the content of competing
product for the treatment of cough, even though nonprescription products used for the treatment
dozens may be available commercially. of the same conditions.
The AHFS Drug Information (2001), published Drug Interactions is a guide to drug–drug inter-
by the American Society of Hospital Pharmacists, actions, herbal–drug interactions, and the effects
is a reference that is sometimes available at a nurs- of drugs on clinical laboratory tests. Information
ing station. This publication, which is published on the mechanism, if known, of each listed drug
annually and updated quarterly, lists a variety of interaction, its clinical significance and how it
information about almost all drugs in current use may best be managed is presented.
in the United States. While the preceding references are the most
The Physicians’ Desk Reference (2001) or PDR, as popular, there are many others which may be of
it is often called, is an annual publication prima- use to the nurse. These include nursing journals,
rily intended for use by prescribers. It contains textbooks, periodicals, and other reference sources,
several types of drug information, each of which as well as the product information which may
is identified by color-coded pages. Drugs are listed accompany the drug package.
by generic and brand names, as well as by manu- With the rapid explosion of scientific literature
facturer. A product information section contains related to drug action has come the need for rapid
virtually the same information provided with the retrieval of this drug information. This has been
original drug package. The PDR also contains a accomplished by the development of several com-
useful product identification section of color puter services which permit the user to identify
photographs of more than 1000 commercially journal articles on a given drug-related topic from
available tablets, capsules, and other dosage forms. literally hundreds of different journals. Once the
This section makes the PDR perhaps the best appropriate articles have been identified, hard
source for identifying unknown drug products by copies or summaries of the actual articles can be
their appearance. The usefulness of this publica- accessed directly without the need for maintain-
tion is somewhat limited, since many drugs, drug ing a large journal library. Systems that use such
products, and nursing data with implications are data retrieval techniques are frequently available
not included. in hospital pharmacies or in health profession
The American Drug Index (2000) is a work pub- school libraries.
lished annually that lists basic drug information, The pharmacist is often the best resource for
i.e., generic and brand names, manufacturers, drug information both in the institution and in
uses, dosages, and dosage form availability. It pro- the community. In addition to a background of
vides little pharmacological information. education and experience, the pharmacist has
Facts and Comparisons (2001) is a highly useful access to the most complete and current library of
reference available in an annual bound version, drug information literature available.
as well as in looseleaf and computer versions.
The looseleaf form is updated monthly. Facts
and Comparisons lists a variety of information
including the actions, indications, interactions,
warnings, contraindications, precautions, adverse
THE PRODUCT INSERT
reactions, dosage, and important prescribing A product insert is a detailed description of
and client information for each drug. Informa- a drug product that is required to be included in
tion about related drugs is presented in a tabular the package of all legend drug products sold in the
form, permitting easy comparisons to be made United States. The contents of the product insert
18 CHAPTER 1
Figure 1–7 Kefzol label with portion of the accompanying package insert.
must be approved by the FDA before the drug can in the product. It may include information
be marketed. The insert must be periodically about the appearance of the drug, its solubility,
updated to represent the current information chemical formula and structure, and melting
available about the drug. Most product inserts point. Inactive ingredients may also be listed in
contain similar information about the drug prod- this section.
uct (Figure 1–7). The following is a description of Clinical Pharmacology. This describes the
the meaning of the categories that are often part mechanism of action of the active drug in the
of the Product Insert: human body.
Brand Name. This is the name, approved by Indications and Usage. The indication is a
the Federal government, which the manufacturer description of the illnesses for which the drug is
may exclusively use to call the product. It is always approved for use. The usage describes how and for
followed by the superscript ® symbol. how long the drug is generally used.
Generic Name. This is the name, approved by Contraindications. This describes the situa-
the Federal government, which is commonly used tions when the drug product should not be used,
to describe the active drug(s) in the product. The e.g., if the client is hypersensitive to any compo-
name may be used by anyone. nents in the product.
Description. This section describes the physi- Warnings. These are situations in which there
cal and chemical properties of the active drug is a threat of imminent and serious danger if the
DRUGS/AGENTS AND FACTORS AFFECTING THEIR ACTION 19
exert a systemic effect, such drugs may need to be Rectal absorption of drugs after administration
administered parenterally. of a medicated enema or suppository tends to be
Drugs may be administered and absorbed unpredictable. This route is therefore generally
through tissues which lie under the tongue (sub- reserved for instances in which the use of more
lingual administration), on the surface of the reliable routes of administration is not feasible, for
tongue (translingual administration), or in the example in cases of severe nausea and vomiting
inner lining of the cheeks (buccal, or transmucosal or when a localized drug action is desired in the
administration). These routes may be appropriate rectum or lower colon.
for the administration of some drugs, to protect
them from chemical decomposition which might Distribution
occur in the stomach or the liver (the first-pass
Drug distribution is the process by which a drug
effect) if the drug were given orally. Nitroglycerin,
is carried from its site of absorption to its site of
a drug used in treating the cardiovascular condi-
action. When a drug enters the bloodstream, it is
tion angina pectoris, is an example of a drug which
carried most rapidly to those organs having an
may be administered by these routes. If given
extensive blood supply, such as the heart, liver,
orally, nitroglycerin is absorbed and transported to
kidneys, and brain. Areas with less extensive blood
the liver. There it may be destroyed before it can
supply, like muscle, skin, and fat, receive the drug
reach its site of action, the coronary arteries.
more slowly.
However, when the drug is administered sublin-
The physical and chemical characteristics of a
gually, translingually, or by the transmucosal
drug usually determine precisely how the drug will
route, it is absorbed into blood vessels, which carry
be distributed. Those drugs which are highly solu-
it directly to the heart. This permits a pharma-
ble in fatty tissue (e.g., some general anesthetics)
cological response to occur before the drug is
may accumulate rapidly in fat. In some cases, fat
destroyed in the liver.
may act as a reservoir for such drugs, slowly releas-
When drugs are administered by injection (i.e.,
ing the drug back into the bloodstream, thereby
parenterally) other than by the intravenous route,
prolonging its effect and delaying its elimination.
they may also undergo an absorption process
A number of drugs are capable of being bound
before reaching the body fluids which will trans-
to plasma proteins, particularly albumin (Figure
port them to their site of action. For example,
1–9). While in this bound state, the drug is inca-
when a drug is administered under the skin (i.e.,
pable of eliciting a pharmacological effect. In most
subcutaneously), its absorption into the circula-
cases, however, an equilibrium is established
tory system is slower than if it were injected into a
between the concentration of bound and unbound
muscle. This is because muscles are better supplied
drug. This permits bound drug to be released from
with blood vessels than subcutaneous tissue.
its binding sites when plasma concentrations of
Absorption of drugs from either subcutaneous or
unbound drug diminish. When two drugs are
intramuscular injection sites may be increased by
administered that are both capable of being
application of heat and/or massage to the area.
protein bound, they may compete for the same
These actions will increase blood flow to the site.
binding sites. Displacement of one bound drug
Absorption of drugs from such injection sites may
by another may increase the observed pharmaco-
be reduced by the application of cold packs or
logical response to the displaced drug since more
compresses to the area and/or by the injection of
a vasoconstrictor drug such as epinephrine into the
site. This local injection may be desirable to limit
the action of a drug to a particular region of the D D D D D
D
body (e.g., when administering regional anes-
D
thetic drugs). Some drugs intended for subcuta- D Protein
D D
neous or intramuscular injection may be formu-
lated as a suspension of a poorly soluble form of
the drug in water or an oily vehicle. Such dosage
forms, often referred to as depot injections, are
intended to provide sustained drug action by Figure 1–9 Drug molecules that are bound to protein (D) are
pharmacologically inactive, while those that are unbound
D
permitting the drug to be absorbed slowly from are active.
its site of injection.
24 CHAPTER 1
may be circulating in the blood in the active, immature livers which do not yet secrete adequate
unbound state. An example of this drug interac- levels of microsomal enzymes. The capacity of the
tion occurs when aspirin and warfarin (an oral liver to metabolize drugs may also decline with
anticoagulant) are used together. The aspirin increasing age or in the presence of hepatic dam-
displaces the warfarin from its binding sites, age (e.g., that caused by chronic alcohol inges-
resulting in an increased anticoagulant effect and tion). This is due to the diminished production of
greater chance of hemorrhage. For this reason, metabolizing enzymes. If doses of drugs normally
close client monitoring is essential in clients using metabolized by the liver are not reduced in situa-
two drugs capable of competing for binding sites tions where the liver’s capacity to metabolize
in order to identify the emergence of an enhanced drugs is impaired, the drugs may accumulate in
or diminished drug response. the body and produce toxicity.
be partially reabsorbed through the wall of the amount remaining after 8 hours = 25%
tubule back into the bloodstream, thereby delay- amount remaining after 12 hours = 12.5%
ing its complete elimination from the body. Some amount remaining after 16 hours = 6.25%
drugs (e.g., penicillin) may be eliminated by being
Note that as each 4-hour interval (one half-life)
secreted directly through the walls of the tubule,
elapses, the drug concentration in the body is fur-
i.e., by tubular secretion. This is generally a more
ther reduced by 50% of what it was at the begin-
rapid process than glomerular filtration and
ning of the interval. This process would continue
results in the rapid elimination of such drugs.
until the entire dose of the drug was eliminated.
Attempts have been made to prolong the action of
Another means of describing drug action is by
certain drugs eliminated by tubular secretion by
the use of a graphic depiction of the plasma con-
developing drugs which would block the tubular
centration of the drug versus time (Figure 1–11).
secretion process. One such drug, probenecid
On this graph, the zero point on the “time” axis
(Benemid), an antigout drug, is sometimes admin-
represents the time at which the drug is first
istered with penicillins or other tubular-secreted
administered. With an orally administered dose,
drugs to prolong their action in the body.
the drug concentration in the plasma increases
The pH of the urine may affect the rate of drug
from a zero level as the drug is absorbed into the
excretion by changing the chemical form of a drug
plasma from the gastrointestinal tract. This rise
to one which can be more readily excreted or to
continues until the elimination rate of the drug is
one which can be reabsorbed back into the circu-
equivalent to its rate of absorption. This point is
latory system. Drugs which are weak acids, e.g.,
known as the peak plasma level of the drug, that is,
barbiturates, penicillins, and other drugs that are
the highest plasma level achieved by the adminis-
available as sodium or potassium salts, tend to be
tration of a single dose of the drug. The time
better excreted if the urine is less acid, as this will
elapsed from the time of administration to the
increase the proportion of drug which is in the
time that the peak plasma level is reached is
ionized, water soluble form. Weak bases, e.g., mor-
known as the “time to peak” and is important in
phine, atropine, and other drugs that are available
making clinical judgments about the use of a drug.
as sulfate, hydrochloride, or nitrate salts, are better
From the peak plasma level the concentration
excreted if the urine is more acidic.
declines since the amount of drug being elimi-
The efficiency with which drugs and/or metabo-
nated exceeds the amount being absorbed.
lites are excreted by the kidneys often diminishes
When a drug is administered by rapid intra-
in persons of advancing age. This may necessitate
venous (bolus) injection, the plasma level versus
a reduction in dose and/or fewer drug administra-
tions in elderly clients to prevent the accumula-
tion of toxic concentrations of drugs or active
metabolites. This may also be the case in clients
with renal impairment caused by disease (e.g.,
nephritis) or by the administration of nephrotoxic
drugs (e.g., aminoglycoside antibiotics).
Drug concentration in plasma
Minimum effective
concentration (MEC)
10
0
4 12 20 28
Time (hours)
DRUG INTERACTIONS
Figure 1–14 Use of Nomogram. In the example, a child who
weighs 15 kilograms and is about 92 centimeters in height has A drug interaction occurs when the pharmaco-
a body surface area of 0.60 square meters. (From Nelson logical effects of one drug are potentiated or
Textbook of Pediatrics (16th ed.), by R. E. Behrman, R. M. diminished by another drug. If the administration
Kleigman and A. M. Arvin, 2000, Philadelphia: Saunders.
Copyright 2000 by Saunders. Reprinted with permission.)
of two or more drugs produces a pharmacological
response which is greater than that which would
be expected by the individual effects of each drug
placebo effect —By definition, a placebo is a together, the drugs are said to be acting synergisti-
dosage form which contains no pharmacolog- cally. If one drug diminishes the action of another,
ically active ingredient. A placebo effect is one it is said to act antagonistically.
elicited by the administration of virtually Drug interactions may be desirable or undesir-
any drug, whether it is pharmacologically able. For example, the use of a central nervous
active or inert. The effect results from a vari- system stimulant such as caffeine with an antihis-
ety of factors, including the relationship of tamine that may cause drowsiness as one of
the client with those providing treatment, its side effects may be a useful drug interaction;
belief in the ultimate success of their therapy, the caffeine acts only to counteract the unwanted
and the client’s cultural and ethnic back- side effect of the antihistamine without altering
ground, as well as many other factors. In treat- its intended pharmacological action. The use
ing subjective symptoms such as pain or of an antacid with the antibiotic tetracycline
anxiety, the placebo response may be as would be likely to result in an undesirable
important as the actual pharmacological drug interaction, however, since the antacid may
actions produced by potent drugs. It is essen- form a chemical complex with the tetracycline,
DRUGS/AGENTS AND FACTORS AFFECTING THEIR ACTION 29
thereby rendering it incapable of being absorbed Before combining two drug solutions, every
into the bloodstream. attempt must be made to ascertain the stability
Drug interactions may occur at any step in and safety of the mixture. This can best be accom-
the passage of a drug through the body—during plished by consulting with the pharmacist and/or
its liberation, absorption, distribution, biotrans- by referring to a compatibility chart.
formation, or excretion. Interactions may also
take place at the receptor site of a drug by inter-
fering with the ability of the drug to combine with HERBALS/BOTANICAL MEDICINE
the receptor to produce a pharmacological effect.
In most cases, however, drug interactions simply Herbals
involve the overlapping of similar pharma- Herbal medicine has been used since prehistoric
cological effects (e.g., central nervous system times and is used today by up to 80% of the
depression) to produce an excessive drug response world’s population. It involves the use of natural
(potentiation) or the opposite pharmacological plant substances to prevent and treat disease. The
activity (e.g., the use of a drug intended to con- latter part of the 1990s and into the twenty-first
strict the pupil of the eye with one which dilates century has seen an increased use of herbal
the pupil). supplements by people believing these substances
Drugs may also interact with foods, laboratory can prevent and cure disease. Historically, herbal
test substances, and environmental pollutants. medicine has been associated with the Chinese
The body of knowledge involving the interaction and frequently is used in conjunction with acu-
of drugs with other drugs or substances has puncture (Sinclair, 1998). Currently, herbals are
grown rapidly. Many reference sources dealing sold in nutrition stores, major drug chains, as well
with drug interactions have been published. as discount retail stores wherever vitamins are sold.
The student is referred to the listings at the end In a study done at the Harvard School of
of this chapter for readings dealing with drug Medicine, Brigham and Women’s Hospital in
interactions. Boston (Sinclair, 1998), researchers concluded that
The student is also referred to Appendix 5, “alternative medicine use is common in the pre-
which summarizes many of the most clinically sig- operative period.” They found 22% of presurgical
nificant drug interactions. In addition, through- clients reported the use of herbal remedies with
out this text, references are made to those 51% using vitamins (Tsen, 2000). Women and
drug interactions that may be appropriate to each clients aged 40–60 years old were the most likely
chapter. to use herbals. Among the most commonly used
herbals included echinacea, gingko biloba, St.
John’s wort, garlic, and ginseng.
PHYSICAL AND CHEMICAL Of primary concern to health care professionals
is that herbals are not regulated by the FDA
INCOMPATIBILITIES and, thus, their safety and efficacy has not been
Since all drugs are chemical compounds, they reliably established. The FDA does, however, have
are all capable of reacting chemically with other an Office of Special Nutritionals in its Center for
substances. This often becomes most evident Food Safety and Applied Nutrition that places
when two or more drugs are combined in prepar- adverse herbal product effects reported to the FDA
ing solutions for parenteral administration. In in its database. The Internet site for this informa-
some cases (but not always), when an incompati- tion is http://vm.cfsan.fda.gov. Many scientific
bility exists, some change in appearance of the studies have focused on herbal medicine, and
mixture provides outward evidence that an the results are available on numerous Internet
unwanted chemical reaction is occurring or has sites devoted to alternative medicine. WebMD
occurred. It may appear as precipitate formation, (www.webmd.com) presents herbal information
color change, or gas evolution. Note: Under no at its site. The Alternative Medicine Foundation
circumstances should such a mixture be adminis- (www.herbmed.org) provides information con-
tered to the client until the safety of the adminis- cerning more than 120 herbs, from achillea to zizi-
tration can be assured. Generally, the mixture phus, including human clinical studies, traditional
is discarded. and folk use, adverse effects, and contraindications
30 CHAPTER 1
for the use of herbals. All information cited in this Nursing Implications
section can be referenced through this web site.
The Herb Research Foundation (www.herbs.org) Because of the increased use of herbal medicine
is a nonprofit research and education organization in our society, nurses need to be sure to address
founded and “dedicated to improving world this matter during the assessment of all clients.
health through the informed use of herbs.” Its web Two important facts health care professionals need
site focuses on media outreach and education pro- to remember are: (1) herbals are not regulated by
grams around the world. the FDA and (2) herbals, like drugs, are chemicals
Herbal treatment claims range from the treat- and, consequently, chemically have an influence
ment and prevention of heart disease to adjuncts on the body. Nurses need to be familiar with
to cancer prevention and therapy. Some of the herbals in common use, and should ask clients if
herbs and their uses are familiar to many people, they use herbals, what herbals they use and how
such as aloe vera, garlic, gingko, and echinacea. often, and assess the clients’ knowledge of why
Aloe vera’s most common use is in the treatment they are taking these supplements. The nurse also
of superficial skin burns. Aloe vera is a common needs to assess the clients for the presence of
ingredient in numerous hand lotions. In addition, potential adverse effects associated with the use
aloe vera plants are familiar sights in homes. of specific herbals. Reporting the information
Garlic (allium sliva) and ginseng are consis- received to the physician is an important nursing
tently among the biggest selling herbal supple- action, as herbals can influence the pharmaco-
ments. Garlic is said to possess antimicrobial, anti- therapeutics of medical treatment.
thrombitic, antitumor, antilipidemic, antiarthritic,
and hypoglycemic qualities (Herbal Companion
to AHFS DI, 2001). In studies as current as the year
2000, including a study at the University of
Kuwait, the use of garlic and onions in the treat-
ment and prevention of cardiovascular disease and CRITICAL THINKING EXERCISES
cancer is “an area of considerable investigation 1. Identify the significance of each of the follow-
and interest” (www.herbmed.org). ing as they pertain to the use of drugs in the
Astrogalus (locoweed), according to researchers United States:
in 1998 who reviewed Chinese medicine (Sinclair, • Food and Drug Act of 1906
1998), showed immunopotentiating effects. • Federal Food, Drug and Cosmetic Act of 1938
They also reported their review indicated astro- • Durham-Humphrey Amendment of 1952
galus as a potential adjunct for cancer therapy • the Controlled Substance Act of 1970
(www.herbmed.org). 2. Describe the significance of the term “bio-
One of the most popular herbals today is equivalent” as it applies to a comparison of
ginkgo. It has been advertised as a prevention and two drugs.
treatment for dementia. Studies have reported that 3. Define the term “pharmacotherapeutics” and
use of ginkgo caused from moderate to no effect on give an example of a drug and its use.
clients with mild to severe dementia. It also claims 4. Discuss the history of the prevention and
to help treat depression. In addition, it has been treatment of disease as it applies to pharma-
studied relative to claims that it can treat sexual cology.
dysfunction. It has been shown to alter blood coag- 5. Contact a state and/or local substance abuse
ulation because of its platelet-activating antagonist agency to determine what materials are avail-
qualities. Studies focusing on the adverse effects of able for secondary school students.
ginkgo have shown an association between sub- 6. Contact a hospital pharmacist to determine
arachnoid hemorrhage and bilateral subdural which drugs are routinely monitored using
hematomas and the long-term use of ginkgo biloba. plasma drug levels and how the data is used to
Echinacea was the subject of numerous studies establish client dosages.
in the year 2000. One such study indicated its pos- 7. Visit a pharmacy and determine the costs of
itive effect when used with garlic to prevent and 25 brand-name products and compare them
treat the flu. Other articles have stated that the use to the costs of generic equivalents of thatdrug.
of echinacea for atherosclerosis treatment “lacks 8. Discuss why brand-name drugs are more
clinical validation” (www.herbmed.org). expensive than generic products, including
DRUGS/AGENTS AND FACTORS AFFECTING THEIR ACTION 31
such factors as the costs incurred in the inves- DeLaune, S. C., & Ladner, P. K. (1998). Fundamentals
tigational process, pharmaceutical company of nursing: Standards & practice. Albany, NY:
profits, etc. Delmar Thomson Learning.
Drug facts and comparisons. (1999). St. Louis: Facts
and Comparisons.
Edwards, J. (1997). Guarding against adverse drug
DRUG INFORMATION SOURCES events. American Journal of Nursing, 97(5), 26–31.
AHFS Drug Information. Published by American FDA. (1994). FDA launches MEDWATCH program:
Society of Hospital Pharmacists, 4630 Mont- Monitoring adverse drug reactions, NP News, 2,
gomery Ave., Washington, DC 20014 1, 4.
Physicians’ Desk Reference. Published by Medical McEvoy, G. (Ed.). (2001). AHFS Drug information, 2001.
Economics Company, 680 Kinderkamack Rd., Washington, DC: American Society of Health-
Oradell, NJ 07649 System Pharmacists.
The American Drug Index. Edited by Norman F. Billups. Medical Letter on Drugs and Therapeutics. (1999). New
Published by Lippincott/Harper Company, Rochelle, NY: Medical Letter.
Keystone Industrial Park, Scranton, PA 18512 PDR for nonprescription drugs and dietary supplements.
The Modern Drug Encyclopedia and Therapeutic Index. (2001). Albany, NY: Thomson Healthcare.
Edited by Gonzales and Lewis. Published by Yorke Physicians’ Desk Reference 55 (2001). Albany, NY:
Medical Books, 666 Fifth Avenue, New York, NY Thomson Healthcare.
10103 Pirmohamed, M. et al. (1996). The role of active
Facts and Comparisons. Published by Facts and Com- metabolites in drug toxicity. Drug Safety, 11,
parisons Division, J.B. Lippincott Co., 111 West 114–144.
Port Plaza, St. Louis, MO 63141 Shuster, J. (1997). Looking out for adverse drug reac-
tions. Nursing 97, 27(11), 34–39.
Sinclair, S. (1998). Chinese herbs: A clinical review of
Astragalus, Ligusticum, and Schizandrae.
BIBLIOGRAPHY Alternative Medicine Review, 3, 338–344.
American Society of Health-System Pharmacists (2001). Stockley, I. H. (1999). Drug interactions: A source book
Herbal companion to AHFS DI, 2001. Washington, of adverse interactions, their mechanisms, clinical
DC: Author. importance and management (5th ed.) UK:
Anderson, P. O. (1998). Handbook of critical drug data Pharmaceutical Press.
(8th ed.). Hamilton, IL: Drug Intelligence. Tsen, L. C. (2000). Alternative medicine use in presur-
Barone, M. A. (Ed.). (1996). The Harriet Lane handbook gical patients. Anesthesiology, 93(1), 148–151.
(14th ed.). St. Louis: Mosby. U.S. Department of Justice: Drug Enforcement
Billups, N. F. & Billups, S. M. (2001). American drug Administration: Controlled Substance Act:
index 2001. St. Louis: Facts–Comparisons, Inc. www.usdoj.gov/dea/briefingbook/page9
Other documents randomly have
different content
If we wish that on the morrow of the cataclysm of war the
sufferings of martyred countries, the sacrifices of victorious nations,
and also the expiation of guilty people will engender a better
humanity, justice must strike those guilty of the enterprise of
barbarism from which we have just escaped. The reign of justice is
the most exact expression of the great human hope. Your decision
can mark a decisive stage in its difficult pursuit.
Undoubtedly even today, this justice and this punishment have
become possible only because, as a first condition, free peoples
emerged victorious from the conflict. This is actually the link
between the force of the victors and the guilt of the vanquished
leaders who appear before Your High Tribunal.
But this link signifies nothing else but the revelation of the
wisdom of nations that justice, in order to impose itself effectively
and constantly upon individuals and upon nations, must have force
at its disposal. The common will to put force in the service of justice
inspires our nations and commands our whole civilization.
This resolution is brilliantly confirmed today in a judicial case
where the facts are examined scrupulously in all their aspects, the
penal nature of the offense rigorously established, the competency
of the Tribunal incontestable, the rights of the defense intact, total
publicity insured.
Your judgment pronounced under these conditions can serve as a
foundation for the moral uplift of the German people, first stage in
its integration into the community of free countries. Without your
judgment, history might incur the risk of repeating itself, crime
would become epic, and the National Socialist enterprise a last
Wagnerian tragedy; and new Pan-Germanists would soon say to the
Germans:
“Hitler and his companions were wrong because they finally
failed, but we must begin again some day, on other
foundations, the extraordinary adventure of Germanism.”
After your judgment, if only we know how to enlighten this
people and watch over their first steps on the road to liberty,
National Socialism will be inscribed permanently in their history as
the crime of crimes which could lead it only to material and moral
perdition, as the doctrine which they should forever avoid with
horror and scorn in order to remain faithful or rather become once
more faithful to the great norms of common civilization.
The eminent international jurist and noble European, Politis, in
his posthumous book entitled International Ethics reminds us that,
like all ethical rules, those which should govern international
relations will never be definitely established unless all peoples
succeed in convincing themselves that there is definitely a greater
profit to be gained by observing them than by transgressing them.
That is why your judgment can contribute to the enlightenment of
the German people and of all peoples.
Your judgment must be inscribed as a decisive act in the history
of international law in order to prepare the establishment of a true
international society excluding recourse to war and enlisting force
permanently in the service of the justice of nations; it will be one of
the foundations of this peaceful order to which nations aspire on the
morrow of this frightful torment. The need for justice of the
martyred peoples will be satisfied, and their sufferings will not have
been useless to the progress of mankind.
THE PRESIDENT: M. De Menthon, would you prefer to continue
the case on behalf of France this afternoon, or would you prefer to
adjourn?
M. DE MENTHON: We are at the disposal of the Court.
THE PRESIDENT: Well then, if that is so, then I think we better
go on until 5 o’clock.
M. DE MENTHON: It might be preferable to adjourn, because M.
Faure’s brief which is going to be presented will last at least an hour.
Perhaps it is better to adjourn until tomorrow morning. However, we
will remain at the disposal of the Court.
THE PRESIDENT: When you said that the proof which will now be
presented would take an hour, do you mean by that that it is an
introductory statement or is it a part of the main case which you are
presenting?
M. DE MENTHON: Your Honor, it is part of the general case.
THE PRESIDENT: Would it not be possible then to go on until 5
o’clock?
M. DE MENTHON: Yes, quite so.
M. EDGAR FAURE (Deputy Chief Prosecutor for the French
Republic): Mr. President and Your Honor, I propose to submit to the
Tribunal an introduction dealing with the first and the second part of
the French case.
The first part relates to forced labor; the second part to economic
looting. These two over-all questions are complementary to each
other and form a whole. Manpower on the one hand and material
property on the other constitute the two aspects of the riches of a
country and the living conditions in that country. Measures taken
with regard to the one necessarily react on the other, and it is
understandable that in the occupied countries German policy with
regard to manpower and economic property was inspired from the
very beginning by common directing principles.
For this reason the French Prosecution has deemed it logical to
submit successively to the Tribunal those two briefs corresponding to
the letters “H” and “E” of the third Count of the Indictment. My
present purpose is to define these initial directives covering the
German procedure in regard to manpower and to material in the
occupied territories.
When the Germans occupied the territories of Denmark, Norway,
Holland, Belgium, Luxembourg, and part of continental France, they
thereby assumed a material power of constraint with regard to the
inhabitants and a material power of acquisition with regard to its
property. They thus had in fact the possibility of utilizing these dual
resources on behalf of the war effort.
On the other hand, legally they were confronted with precise
rules of international law relating to the occupation of territories by
the military forces of a belligerent state. These rules very strictly
limit the rights of the occupant, who may requisition property and
services solely for the needs of the army of occupation. I here allude
to the regulation annexed to the Convention concerning the Laws
and Customs of War signed at The Hague on 18 October 1907,
Section III, and in particular to the Articles 46, 47, 49, 52, and 53. If
it please the Tribunal, I shall merely cite the paragraph of Article 52
which defines in a perfectly exact manner the lawful conditions of
requisition of persons and property:
“Requisitions in kind and of services may be demanded of
communities or of inhabitants only for the needs of the
army of occupation. They will be proportionate to the
resources of the country and of such a nature that they do
not imply for the population the obligation of taking part in
war operations against their native country.”
These various articles must, moreover, be considered in the
general spirit defined in the preamble of the Convention, from which
I take the liberty of reading the last paragraph to the Tribunal:
“Until such time as a more complete code of the laws of
war can be enacted, the High Contracting Parties deem it
opportune to state that in cases not included in the
regulations adopted by them, populations and belligerents
remain under the safeguard and direction of the principles
of the law of nations derived from the established usages
among civilized nations, the laws of humanity, and the
requirements of public conscience.”
From this point of view it is very evident that the total
exploitation of the resources of occupied countries for the benefit of
the enemy’s war economy is absolutely contrary to the law of
nations and to the requirements of public conscience.
Germany signed the Hague Convention and it must be pointed
out that she made no reservations at that time except with regard to
Article 44, which relates to the supply of information to the
belligerents. She made no reservation with regard to the articles
which we have cited nor with regard to the preamble. These articles
and the preamble, moreover, reiterate the corresponding text of the
previous Hague Convention of 28 July 1899.
German official ratifications of the Conventions were given on 4
September 1900 and 27 November 1909. I have purposely recalled
these well-known facts in order to emphasize that the Germans
could not fail to recognize the constant principles of international law
to which they subscribed on two occasions, long before their defeat
in 1918 and consequently outside the alleged pressure to which they
referred in regard to the Treaty of Versailles.
While on this subject of juridical theory, may I point out that in
the arrangement signed at Versailles on 28 June 1919 in connection
with the military occupation of the territories of the Rhine, reference
is made in Article 6 to the Hague Convention in the following terms:
“The right of requisition in kind and in services as
formulated by the Hague Convention of 1907 will be
exercised by the allied and associate armies of occupation.”
Thus, the governing principles of the rights of requisition by the
occupiers is confirmed by a third international agreement subscribed
to by Germany, who in regard to the occupation of her own territory
is here the beneficiary of this limitation.
What, then, will the conduct of the Germans be like, in view of
this factual situation, which involves power and temptation, and in
view of this legal situation which involves a limitation?
The Tribunal is already aware, by virtue of the general
presentation of the American Prosecution, that the conduct of the
Germans was to profit by the fact and to ignore the law.
The Germans systematically violated international rules and the
law of nations, as far as we are concerned, both by forced labor and
by spoliation. Detailed illustrations of these acts in the Western
countries will be laid before you in the briefs which will follow my
own. For my part I propose to concentrate for a moment on the
actual concepts which the Germans had from the outset. In this
connection I shall submit to the Tribunal three complementary
propositions.
First Proposition: From the very beginning of the occupation, the
Germans decided, in the interests of their war effort, to seize in any
way possible all the resources, both material and human, of the
occupied countries. Their plan was not to take any account of legal
limitations. It is not under the spur of occasional necessity that they
subsequently perpetrated their illicit acts, but in pursuance of a
deliberate intention.
Second Proposition: However, the Germans took pains to mask
their real intentions; they did not make known that they rejected
international juridical rules. On the contrary, they gave assurance
that they would respect them. The reasons for this camouflage are
easy to understand. The Germans were anxious from the beginning
to spare public opinion in the occupied territory. Brutal proceedings
would have aroused immediate resistance which would have
hampered their actions. They also wished to deceive world opinion,
and more particularly American public opinion, since the United
States of America had at that time not yet entered the war.
The third proposition which I lay before the Tribunal results from
the first two. As the Germans contemplated achieving their aims and
masking their intentions, they were of necessity bound to organize a
system of irregular means, while maintaining an appearance of
legality. The complexity and the technical character of the
proceedings they used enabled them easily to conceal the real state
of affairs from the uninitiated or the merely uninformed. These
disguised means proved, in fact, just as efficient and perhaps even
more so than would have been brutal seizure. They moreover
enabled the Germans to have recourse to such brutal action the day
they deemed that this would yield them more advantages than
inconvenience.
We are of the opinion that this analysis of the German intentions
is of interest to the Tribunal for, on the one hand, it demonstrates
that the illicit acts were premeditated and that their authors were
aware of their reprehensible character; and on the other hand, it
enables one to understand the scope and extent of these acts,
despite the precautions taken to mask them.
The evidence which the Prosecution will submit to the Tribunal
refers chiefly to the second and third propositions, for as regards the
first, that is to say, the criminal intention and premeditation, it is
demonstrated by the discrepancy between the facade and reality.
I say in the first place that the Germans at the time of the
occupation made a pretense of observing the rules of international
law. Here is, by way of example, a proclamation to the French
population, signed by the Commander-in-Chief of the German Army.
This is a public document which is reproduced in the Official Journal,
containing the decrees issued by the military governor for French
occupied territories, Number 1 dated 4 July 1940. I submit to the
Tribunal this document, which will bear Number RF-1 of the French
documentation; and from it I cite merely the following sentence:
“The troops have received the order to treat the population
with regard and to respect private property provided the
population remains calm.”
The Germans proceeded in identical manner in all the occupied
countries. I also submit to the Tribunal the text of the same
proclamation, dated 10 May 1940, which was published in the
Official Journal of the Commander-in-Chief in Belgium and in the
north of France, Number 1, Page 1, under the title “Proclamation to
the Population of Belgium.” The German text, as well as the Flemish
text, bear the more complete title, “Proclamation to the Population
of Holland and Belgium.” In view of the identical nature of these
texts, this copy may be considered as Document Number RF-1 (bis)
of the French documentation.
I now submit another proclamation entitled, “To the Inhabitants
of Occupied Countries!” dated 10 May 1940, and signed “The
Commander-in-Chief of the Army Group.” This is likewise published
in the Official Journal of German ordinances. This will be Document
Number RF-2 of the French documentation. I will cite the first two
paragraphs:
“The Commander-in-Chief of the German Army has given
me authority to announce the following:
“I. The German Army guarantees the inhabitants full
personal security and the safeguard of their property. Those
who behave peacefully and quietly have nothing to fear.”
I also quote passages from Paragraphs V, VI, and VII:
“V. The administrative authorities of the state, communities,
the police, and schools shall continue their activities. They
therefore remain at the service of their own population. . . .
“VI. All enterprises, businesses, and banks will continue
their work in the interest of the population. . . .
“VII. Producers of goods of prime necessity, as well as
merchants, shall continue their activities and place their
goods at the disposal of the public.”
The passages which I have just quoted are not the literal
reproduction of international conventions, but they reflect their
spirit. Repetition of the terms, “at the service of the population,” “in
the interest of the population,” “at the disposal of the public” must
necessarily be construed as an especially firm assurance that the
resources of the country and its manpower will be preserved for that
country and not diverted in favor of the German war effort.
We pass now Document under Number RF-2 (bis) to the next of
the same proclamations signed by the Commander-in-Chief of the
Army Group and published in the Official Journal of the Commander-
in-Chief in Belgium, numbered as above, Page 3.
Finally, on 22 June 1940, an armistice convention was signed
between the representatives of the German Government and the
representatives of the de facto authority which was at that time
assuming the Government of France. This convention is likewise a
public document. It will be submitted to the Tribunal at a later stage
as the first document of the economic case. At this stage I merely
wish to cite a sentence of Paragraph 3, which reads as follows: “In
the occupied districts of France the German Reich exercises all the
rights of an occupying power.”
This constitutes then a very definite reference to international
law. Moreover, the German plenipotentiaries gave in this respect
complementary oral assurances. On this matter I submit to the
Tribunal, in the form of French Exhibit Number RF-3 (Document RF-
3), an extract from the deposition made by Ambassador Leon Noel in
the course of proceedings before the French High Court of Justice.
This extract is reproduced from a book entitled Transcript in extenso
of the Sessions of the Trial of Marshal Pétain, printed in Paris in 1945
at the printing office of the official journals and constitutes a
document admissible as evidence in accordance with the Charter of
the Tribunal, Article 21. This is the statement of M. Leon Noel, which
I desire to cite to the Tribunal. M. Leon Noel was a member of the
French Armistice Delegation.
THE PRESIDENT: Are you going to present this document to us?
M. FAURE: This document is presented to the Tribunal. We have
given to the Tribunal the transcript of the proceedings, and in the
book of documents the Tribunal will find the excerpt I am now
quoting.
THE PRESIDENT: We are not in possession of it at present. I do
not know where it is.
M. FAURE: I think that possibly this document was handed to the
Secretariat of the Tribunal rather late, but it will be here
immediately. May it please the Tribunal, I merely intend to read a
short extract from this document today.
THE PRESIDENT: We will have it tomorrow, I hope?
M. FAURE: Certainly, Mr. President.
[Quoting.] “I have also obtained a certain number of replies
from German generals which I believe could have been
subsequently used—from General Jodl, who in the month of
May last signed at Reims the unconditional surrender of
Germany and from General (subsequently Marshal) Keitel,
who a few weeks later was to sign in Berlin the ratification
of this surrender. In this way I led them to declare in the
most categorical manner that in no event would they
interfere with administration, that the rights which they
claimed for themselves under the convention were purely
and simply those which in similar circumstances
international law and international usage concede to
occupation armies, that is to say, those indispensable for
the maintenance of security, transportation, and the food
supply needs of these armies.”
These assertions and promises on the part of the Germans were
therefore formal. Now, even at that time, they were not sincere.
Indeed, not only did the Germans subsequently violate them, but
from the very beginning they organized a system whereby they were
enabled to accomplish these violations in the most efficacious
manner and at the same time in a manner which enabled them to
some extent to mask them.
As far as economy and labor are concerned, this German system
comes from a very simple idea. It consisted in supervising
production at its beginning and its end. On the one hand, the
Germans embarked immediately upon the general requisitioning of
all raw materials and all goods in the occupied countries.
Thenceforth, it would depend upon them to supply, or not to supply,
raw material to the national industry. They were thus in a position to
develop one branch of production rather than another, to favor
certain undertakings, and, inversely, to oblige other undertakings to
close down. As events and opportunities demanded, they organized
this appropriation of raw materials, principally with a view to
facilitating their distribution in their own interest but the principle
was continuously maintained. They thus held, as it were, the key of
entrance to production. On the other hand, they also held the exit
key, that is to say, of finance. By securing the financial means in the
form of the money of an occupied country, the Germans were able
to purchase products and to acquire, under the pretense of legality,
the output of the economic activity of the country. In point of fact,
the Germans obtained for themselves from the outset such
considerable financial means that they were easily able to absorb the
entire productive capacity of each country.
If the Tribunal finds it suitable, I will interrupt at this point.
[The Tribunal adjourned until 18 January 1946 at 1000 hours.]
THIRTY-SEVENTH DAY
Friday, 18 January 1946
Morning Session
M. FAURE: Mr. President, Your Honors. At yesterday’s session I
explained to the Tribunal the principles of the provisions made by
the Germans to ensure the seizure of raw materials and the control
of finance in the occupied countries.
These provisions will be demonstrated by numerous documents
which will be presented to the Tribunal in the course of the
presentation of the case on economic spoliation and forced labor. I
shall not quote these documents at this moment since, as I pointed
out yesterday, the purpose of my introduction is limited to the initial
concepts of the Germans in these matters. I shall cite only one
document, which reveals the true intentions of the Germans in the
very first period. This document bears our Document Number RF-3
(bis), and I offer it in evidence to the Tribunal.
It relates particularly to Norway. It consists of a photostatic copy,
certified, of a transcript of a conference held in Oslo, 21 November
1940, under the presidency of the Reich Commissioner. I would point
out to the Tribunal that we submit this document as being
particularly significant, because Norway is a country which was
occupied at a very early date by the Germans. The date of 21
November 1940, which you see, refers to the very earliest period of
the German occupation, and moreover, in the text of the conference,
allusion is made to the situation of the 7 months preceding.
You will find there the exact psychology of the occupation as it
existed in this period of April 1940 to November 1940, that is to say,
at the time, or even before, when the Germans, while invading other
countries, made the reassuring proclamations which I read to the
Tribunal yesterday.
There were 40 personages present at the conference, of whom
State Secretary Dr. Landfried represented the Reich Ministry of
Economics. This is how the Reich Commissioner expresses himself:
“Today’s conference is the continuation of a conference
which was held in Berlin. On this occasion I should like, first
of all, to stress and establish definitely that the
collaboration between the Wehrmacht and the Reich
Commissioner is exemplary. I must protest against the idea
that the Wehrmacht carried out its financial task here in a
muddled and irresponsible manner. We must also take into
account the particular circumstances which then prevailed
in Norway and which still partially prevail.
“Certain tasks were fixed by the Führer which were to be
carried out within a given time.
“At the conference in Berlin the following points were
settled, which we can take as a basis of today’s conference.
There is no doubt that the country of Norway was utilized
for the execution of the tasks of the Wehrmacht during the
last 7 months in such a way that a further drain on the
country without some compensation is no longer possible in
view of the future tasks of the Wehrmacht.
“I considered it from the beginning my obvious duty in my
capacity as Reich Commissioner to devote my activities to
mobilizing all the economic and material forces of the
country for the purposes of the Wehrmacht and not to call
on the resources of the Reich as long as I am in a position
to organize such resources in the country.”
I will stop quoting the words of the Reich Commissioner at this
point, and now I shall cite the terms of the reply of Dr. Landfried,
which you will find a little lower down in the document:
“I am very glad to be able to state that we have succeeded
here in Norway . . . in mobilizing the economic forces of
Norway for German needs to an extent which it has not
been possible to attain in all the other occupied countries. I
must thank you especially in the name of the Minister of
Economics for having succeeded in inducing the
Norwegians to achieve the greatest possible results.”
I think the Tribunal will have observed the series of expressions
which are used in this document and which are quite characteristic.
The Reich Commissioner says that from the very beginning, his duty
was to mobilize all the economic and material forces of the country
for the purposes of the Wehrmacht, and Dr. Landfried answers that
they succeeded in mobilizing the economic forces to an extent which
it has not been possible to attain in all the other occupied territories.
Thus we see that Dr. Landfried does not say that the Germans
had, in Norway, a particular concept of occupation and that in the
other countries they used a different procedure; he says that it was
not possible to do as well in the other countries. The only limitation
he recognizes is a limit of fact and opportunity, which will soon be
overcome, but in no wise a limitation of law. The idea of a legal
limitation never enters his mind, any more than it comes to the mind
of any of the 40 personages present.
It is not here a question of an opinion or initiative of a regional
administrative authority, but rather of the official doctrine of the
Reich Cabinet and the High Command, since 40 high officials were
present at this conference, and especially the representative of the
Minister for Economy.
I should like to stress at this point that this German doctrine and
these German methods for the mobilization of the resources of the
occupied countries necessarily extend to the labor of the inhabitants.
I said yesterday that the Germans ensured for themselves from
the very beginning the two keys of production. By that very fact they
had within their power the working capital and the manpower. It
depended on their decision whether labor worked or did not work,
whether there should or should not be unemployment. This explains
in a general way why the Germans took such brutal measures as the
displacement and the mobilization of workers only after a certain
time.
In the first period, that is to say, as long as there existed in the
occupied countries stocks and raw materials, it was more in the
interests of the Germans to utilize labor locally, at least to a great
extent. This labor permitted them to produce for their benefit, with
the wealth of these countries, finished products which they seized.
Thus, besides the moral advantage of safeguarding appearances,
they avoided the initial transportation of raw materials. The
consideration of transport difficulties was always very important in
the German war economy.
But when after a time, which was more or less long, the occupied
countries were impoverished in their raw materials and really ruined,
then the Germans no longer had any interest in permitting labor to
work on the spot. They would, indeed, have had to furnish the raw
materials themselves, and consequently that would involve double
transportation—that of raw material in one direction and that of the
finished products in the other direction. At that moment it became
more advantageous for them to export workmen. This consideration
coincided, moreover, with the needs resulting from the economic
situation of Germany at that time and with political considerations.
On this question of the use of labor, I shall read to the Tribunal a
few sentences of a document which I offer under Document Number
RF-4. It is therefore the document following that from which I have
just read. The note which you will find in the document book
reproduces the sentences from an article which appeared in the
newspaper Pariser Zeitung on 17 July 1942.
I offer at the same time to the Tribunal a certified photostatic
copy of the page of the newspaper, which is from the collection of
the Bibliothèque Nationale. This article is signed by Dr. Michel, who
was the Chief of the Economic Administration in France. Its title is
“Two Years of Controlled Economy in France.” It is then an article
written for the purpose of German propaganda since it appeared in a
German newspaper which published one page in French in Paris.
Naturally I wish to point out to the Tribunal that we in no way accept
all the ideas which are presented in this article, but we should like to
point out several sentences of Dr. Michel’s as revealing the same sort
of procedure about which I was speaking just now, which consisted
of utilizing labor, first on the spot, as long as there was raw material,
and then deporting that labor to Germany:
“In order to utilize the productive forces of French industry,
the Reich began by transferring to France its orders for
industrial articles for the war effort.
“One single figure is sufficient to show the success of this
transfer of German orders: The value of the transactions to
date is expressed in a figure surpassing hundreds of
thousands of millions of francs. New blood is circulating in
the veins of French economy, which is working to the
utmost of its capacity. . . .”
Some sentences in the original are omitted here, as they are of
no interest, and I would like to read the following sentence:
“As the stocks of raw materials tended to diminish on
account of the length of the war, the recruitment of
available French labor began.”
Dr. Michel uses here elegant ways of expressing himself, which
cover the reality, that is to say, the beginning of the transfer of
workmen at the moment when raw materials, which the Germans
had appropriated from the beginning, had begun to be exhausted.
The conclusion which I would now like to give to my statement is
the following: That the Germans have always considered labor,
human labor, as a factor for their use. This attitude existed even
before the official institution of compulsory labor, of which we will
speak to you presently.
For Germans the work of others has always been compulsory and
for their profit, and it was meant to remain so even after the end of
the war.
It is this last point that I should like to emphasize, for it shows
the extent and the gravity of the German conception and of the
German projects. I shall quote in relation to this a document which
will bear the Number RF-5 in our document book. Here is the
document, which I submit to the Tribunal. It is a work published in
French in Berlin in 1943, by Dr. Friedrich Didier, entitled Workers for
Europe. It was issued by the central publishing house of the National
Socialist Party. It begins with a preface by the Defendant Sauckel,
whose facsimile signature is printed.
I shall quote to the Tribunal a paragraph from this work, which is
the last page in my document book. It is Document Number RF-5
and this sentence is found on Page 23. I quote:
“A great percentage of foreign workers will remain, even
after victory, in our territory, in order to complete then—
having been trained in construction work—what the
outbreak of war had prevented, and to carry out those
planned projects which up to now had remained
unrealized.”
Thus, in a work of propaganda, consequently written with great
prudence and with intent to seduce, we nevertheless find this main
admission by the Germans, that they intended to keep, even after
the war, the workers of other countries in order to insure the
greatness of Germany without any limitation of aim or time. Hence it
is a matter of a policy of perpetual exploitation.
If it please the Tribunal, my introduction having come to an end,
M. Herzog will present the brief relating to forced labor in France.
M. JACQUES B. HERZOG (Assistant Prosecutor for the French
Republic): Mr. President and Your Honors.
The National Socialist doctrine, by the pre-eminence which it
gives to the idea of the State, by the contempt in which it holds
individuals and personal rights, contains a conception of work which
agrees with the principles of its general philosophy.
For it, work is not one of the forms of the manifestation of
individual personalities; it is a duty imposed by the community on its
members.
“The relationship of labor, according to National Socialist ideas,” a
German writer has said, “is not a simple judicial relationship between
the worker and his employer; it is a living phenomenon in which the
worker becomes a cog in the National Socialist machine for collective
production.” The conception of compulsory labor is thus, for National
Socialism, necessarily complementary to the conception of work
itself.
Compulsory labor service was first of all imposed on the German
people. German labor service was instituted by a law of 26 June
1935 which bears Hitler’s signature and that of the Defendant Frick,
Minister of the Interior. This law was published in the
Reichsgesetzblatt, Part I, Page 769. I submit it to the Tribunal as
Exhibit Number RF-6 (Document Number 1389-PS).
From 1939 the mobilization of workers was added to the
compulsory labor service. Decrees were promulgated to that effect
by the Defendant Göring in his capacity as Delegate for the Four
Year Plan. I do not stress this point; it arises from the conspiracy
entered into by the accused to commit their Crimes against Peace,
and which my American colleagues have already brought to the
attention of the Tribunal. I merely point out that the mobilization of
workers was applicable to foreigners resident in German territory,
because I find in this fact the proof that the principle of compulsory
recruitment of foreign workers existed prior to the war. Far from
being the spontaneous result of the needs of German war industry,
the compulsory recruitment of foreign workers is the putting into
practice of a concerted policy. I lay before the Tribunal a document
which proves this. It is Document C-2 of the French classification,
which I offer as Exhibit Number RF-7. This is a memorandum of the
High Command of the German Armed Forces of 1 October 1938.
This memorandum, drawn up in anticipation of the invasion of
Czechoslovakia, contains a classification of violations possible under
international law. In connection with each violation appears the
explanation which the High Command of the Armed Forces thinks it
possible to give. The document appears in the form of a list in four
columns. In the first is a statement of the violations of international
law; the second gives a concrete example; the third contains the
point of view of international law on the one hand and, on the other
hand, the conclusions which can be drawn from it; the fourth column
is reserved for the explanation of the Propaganda Ministry.
I read the passage which deals with the forced labor of civilians
and prisoners of war, which is found on Page 6 of the German
original, Page 7 of the French translation:
“Use of prisoners of war and civilians for war work,
(construction of roads, digging trenches, making munitions,
employment in transport, et cetera).”
Second column:
“Captured Czech soldiers or Czech civilians are ordered to
construct roads or to load munitions.”
The third column:
“Article 31 of an agreement signed 27 July 1939 concerning
the treatment of prisoners of war forbids their use in tasks
directly related to war measures. Compulsion to do such
work is in every case contrary to international law. The use
of prisoners of war as well as civilians is allowed for road
construction but forbidden for the manufacture of
munitions.”
Last column:
“The use of these measures may be based on war needs or
on the declaration that the enemy has acted in the same
way first.”
The compulsory recruitment of foreign workers is thus in
accordance with National Socialist doctrine, one of the elements of
the policy of German domination. Hitler himself recognized this on
several occasions. I quote in this connection his speech of 9
November 1941 which was printed in the Völkischer Beobachter of
10 November 1941, Number 314, Page 4, which I submit to the
Tribunal under Document Number RF-8. I read the extract of this
discourse, Columns 1 and 2, and the first paragraph below, in the
German original:
“The territory which now works for us contains more than
250 million men, but the territory in Europe which works
indirectly for this battle includes now more than 350 million.
“As far as German territory is concerned, the territory
occupied by us and that which we have taken under our
administration, there is no doubt that we shall succeed in
harnessing every man for this work.”
The recruitment of foreign workers thus proceeds in a systematic
manner. It constitutes the putting into practice of the political
principles as applied to the territories occupied by Germany. These
principles, the concrete development of which in other departments
of German criminal activity will be pointed out to you by my
colleagues, are essentially of two kinds: employment of all active
forces of the occupied or dominated territories; extermination of all
their non-productive forces.
These are the two reasons which the defendants gave in
justification for the establishment of the recruitment of foreign
workers. There are many documents to this effect; I confine myself
to the most explicit.
The justification for the recruitment of foreign workers, because
of the necessity of including the peoples of the enslaved states in
the German war effort, is primarily a result of the explanatory
statement of the decree of 21 March 1942, appointing the Defendant
Sauckel as Plenipotentiary for Allocation of Labor. The decree was
published in the Reichsgesetzblatt, 1942, Part I, Page 179. I submit
it and will read its complete text to the Tribunal, as Document
Number RF-9.
“The decree of the Führer concerning the creation of a
Plenipotentiary for Allocation of Labor, dated 21 March
1942.
“The assurance of the required manpower for the whole
war economy, and in particular for the armament industry,
necessitates a uniform direction, meeting the needs of the
war economy, of all available labor, including hired
foreigners and prisoners of war, as well as the mobilization
of all unused labor still in the Greater German Reich,
including the Protectorate as well as the Government
General and the occupied territories.
“This mission will be accomplished by Reichsstatthalter and
Gauleiter Fritz Sauckel in the capacity of Plenipotentiary
General for Allocation of Labor. In this capacity he is directly
responsible to the Delegate for the Four Year Plan.”
I would like to point out here that the Defendant Sauckel
developed the same theme at the Congress of Gauleiter and
Reichsleiter held 5 and 6 February 1943 at Posen. He expressed
himself in plain terms: He justified compulsory recruitment on the
basis of National Socialist philosophy and on the basis of the
necessity of drawing all the European peoples into the struggle
carried on by Germany. His speech constitutes Document 1739-PS. I
submit it under Exhibit Number RF-10, and I request the Court to
take judicial notice of it and to accept the following passages in
evidence against the Defendant Sauckel. First, Page 5 of the German
text, fourth paragraph—this is found on the first page of the French
translation:
“The remarkable violence of the war forces me to mobilize,
in the name of the Führer, many millions of foreigners for
labor for the entire German war economy and to urge them
to effect the maximum production. The purpose of this
utilization is to assure in the field of labor the war material
necessary in the struggle for the preservation of the life and
liberty, in the first place, of our own people, and also for
the preservation of our Western culture for those peoples
who, in contrast to the parasitical Jews and plutocrats,
possess the honest will and strength to shape their life by
their own work and effort.
“This is the vast difference between the work which was
exacted through the Treaty of Versailles and the Dawes and
Young Plans at one time—which took the form of slavery
and tribute to the might and supremacy of Jewry—and the
use of labor which I, as a National Socialist, have the honor
to prepare and to carry out as a contribution by Germany in
the fight for her liberty and for that of her allies.”
The compulsory recruitment of foreign workers did not have as
its only object the maintenance of the level of German industrial
production. There was also the conscious desire to weaken the
human potential of the occupied countries.
The idea of extermination by work was familiar to the theorists of
National Socialism and to the leaders of Germany. It constituted one
of the bases of the policy of domination of the invaded territories. I
lay before the Court the proof that the National Socialist conspirators
envisaged the destruction by work of whole ethnical groups. A
discussion which took place on 14 September 1942 between
Goebbels and Thierack is significant. It constitutes Document 682-
PS, which I submit to the Tribunal under Exhibit Number RF-11, from
which I take the following passage:
“Concerning the extermination of asocial elements, Doctor
Goebbels is of the opinion that the following groups must
be exterminated: All Jews and gypsies; Poles who have to
serve 3 or 4 years penal servitude; Czechoslovakians and
Germans who have been condemned to death or hard labor
for life or placed in protective custody. The idea of
extermination by work is best.”
The idea of extermination by work was not applied to ethnical
groups alone, the disappearance of which was desired by the
defendants; it also led to the employment of foreign labor in the
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