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  Knowledge and best practice in this field are constantly changing. As new research and experience
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                                                                vi
                      Contributors and Reviewers
CONTRIBUTOR TO TEXTBOOK
Valerie O’Toole Baker, RN, MSN, ACNS, BC            Tara McMillan-Queen, RN, MSN, ANP, GNP
Assistant Professor                                 Faculty II
Villa Maria School of Nursing                       Mercy School of Nursing
Gannon University                                   Charlotte, North Carolina
Erie, Pennsylvania                                  Review Questions for the NCLEX® Examination
PowerPoint Collection
                                                    Kathryn Schartz, RN, MSN, CPNP
Nancy Haugen, PhD, RN                               Pediatric Nurse Practitioner
Associate Professor and ABSN Program Chair          General Pediatrics, Medical Coordination Team
School of Nursing                                   Children’s Mercy Hospital and Clinics
Samuel Merritt University                           Kansas City, Missouri
Oakland, California                                 Test Bank
Pharmacology Online
                                                    Allison Terry, PhD, MSN, RN
Tiffany Jakubowski, BSN, RN                         Associate Professor of Nursing
Instructor                                          Auburn University at Montgomery
School of Nursing                                   Montgomery, Alabama
Front Range Community College                       Downloadable Key Points
Boulder, Colorado
Review Questions for the NCLEX® Examination         Jennifer Yeager, PhD, RN, ANP-BC
                                                    Assistant Professor
Maria Lauer-Pfrommer, PhD, APN-C, CNE               Department of Nursing
Assistant Professor                                 Tarleton State University
College of Nursing                                  Stephenville, Texas
Holy Family University                              Study Guide
Philadelphia, Pennsylvania
TEACH® for Nurses Lesson Plans
REVIEWERS
                                              vii
                                                        Preface
Pharmacology pervades all phases of nursing practice and                  these drugs is presented in a series of paragraphs describing
relates directly to patient care and education. Yet, despite its          each drug in turn. When attempting to study from such a list,
importance, many students—and even some teachers—are                      you are likely to learn many drug names and little else; the
often uncomfortable with the subject. Why? Because tradi-                 important concept of similarity among family members is
tional texts have stressed memorizing rather than understand-             easily lost. In this text, the family prototype—aspirin—is
ing. In this text, the guiding principle is to establish a basic          discussed first and in depth. After this, the small ways in
understanding of drugs, after which secondary details can be              which individual NSAIDs differ from aspirin are pointed out.
learned as needed.                                                        Not only is this approach more efficient than the traditional
   This text has two major objectives: to help you, the nursing           approach, it is also more effective, in that similarities among
student, establish a knowledge base in the basic science of               family members are emphasized.
drugs, and to show you how that knowledge can be applied
in clinical practice. The methods by which these goals are
achieved are described below.
                                                                            LARGE PRINT AND SMALL PRINT:
                                                                            A WAY TO FOCUS ON ESSENTIALS
LAYING FOUNDATIONS IN
BASIC PRINCIPLES                                                            Pharmacology is exceptionally rich in detail. There are
                                                                            many drug families, each with multiple members and
To understand drugs, you need a solid foundation in basic                   each member with its own catalogue of indications, con-
pharmacologic principles. To help you establish that founda-                traindications, adverse effects, and drug interactions.
tion, the book has major chapters on the following topics:                  This abundance of detail confronts teachers with the dif-
basic principles that apply to all drugs (Chapters 4 through                ficult question of what to teach, and students with the
8), basic principles of drug therapy across the life span                   equally difficult question of what to study. Attempting to
(Chapters 9 through 11), basic principles of neuropharmacol-                answer these questions can frustrate teachers and students
ogy (Chapter 12), basic principles of antimicrobial therapy                 alike. Even worse, in the presence of myriad details, basic
(Chapter 83), and basic principles of cancer chemotherapy                   concepts can be obscured.
(Chapter 101).                                                                  To help you focus on essentials, there are two sizes of
                                                                            type. Large type is intended to say, “On your first expo-
                                                                            sure to this topic, this is the core of information you
REVIEWING PHYSIOLOGY                                                        should learn.” Small type is intended to say, “Here is
AND PATHOPHYSIOLOGY                                                         additional information that you may want to learn after
                                                                            mastering the material in large type.” As a rule, we
To understand the actions of a drug, it is useful to understand             reserve large print for prototypes, basic principles of
the biologic systems that the drug influences. Accordingly,                 pharmacology, and reviews of physiology and patho-
for all major drug families, relevant physiology and patho-                 physiology. We use small print for secondary information
physiology are reviewed. In almost all cases, these reviews                 about the prototypes and for discussion of drugs that are
are presented at the beginning of each chapter, rather than                 not prototypes. This technique allows the book to contain
in a systems review at the beginning of a unit. This jux-                   a large body of detail without having that detail cloud the
taposition of pharmacology, physiology, and pathophysiol-                   big picture. Furthermore, because the technique high-
ogy is designed to help you understand how these topics                     lights essentials, it minimizes questions about what to
interrelate.                                                                teach and what to study.
                                                                                The use of large and small print is especially valuable
                                                                            for discussing adverse effects and drug interactions. Most
TEACHING THROUGH PROTOTYPES                                                 drugs are associated with many adverse effects and inter-
                                                                            actions. As a rule, however, only a few of these are
Within each drug family, we can usually identify a proto-                   noteworthy. In traditional texts, practically all adverse
type—that is, a drug that embodies characteristics shared by                effects and interactions are presented, creating long and
all members of the group. Because other family members are                  tedious lists. In this text, we use large print to highlight
similar to the prototype, to know the prototype is to know the              the few adverse effects and interactions that are espe-
basic properties of all family members.                                     cially characteristic; the rest are noted briefly in small
    The benefits of teaching through prototypes can be appre-               print. Rather than overwhelming you with long and for-
ciated with an example. Let’s consider the nonsteroidal anti-               bidding lists, this text delineates a moderate body of
inflammatory drugs (NSAIDs), a family that includes aspirin,                information that’s truly important, and thereby facilitates
ibuprofen [Motrin], naproxen [Aleve], celecoxib [Celebrex],                 comprehension.
and more than 20 other drugs. Traditionally, information on
                                                                   viii
                                                                                                                            PREFACE
                                                                   ix
PREFACE
                                                               x
 CHAPTER
1 Orientation to Pharmacology
                                                                    1
CHAPTER 1      Orientation to Pharmacology
    Effectiveness. An effective drug is one that elicits the            dosing schedule that consists of one daily dose rather than
responses for which it is given. Effectiveness is the most              several. Furthermore, whenever skin integrity is broken, as is
important property a drug can have. Regardless of its other             the case when drugs are given by injection, there is a risk of
virtues, if a drug is not effective—that is, if it doesn’t do           infection as well as injection-site pain and discomfort.
anything useful—there is no justification for giving it. Current           Freedom from Drug Interactions. When a patient is
U.S. law requires that all new drugs be proved effective prior          taking two or more drugs, those drugs can interact. These
to release for marketing.                                               interactions may augment or reduce drug responses. For
    Safety. A safe drug is defined as one that cannot produce           example, respiratory depression caused by diazepam [Valium],
harmful effects—even if administered in very high doses and             which is normally minimal, can be greatly intensified by
for a very long time. All drugs have the ability to cause injury,       alcohol. Conversely, the antibacterial effects of tetracycline
especially with high doses and prolonged use. The chances of            can be greatly reduced by taking the drug with iron or calcium
producing adverse effects can be reduced by proper drug                 supplements. Because of the potential for interaction among
selection and proper dosing. However, the risk of adverse               drugs, when a patient is taking more than one agent, the pos-
effects can never be eliminated. The following examples illus-          sible impact of drug interactions must be considered. An ideal
trate this point:                                                       drug would not interact with other agents. Unfortunately, few
                                                                        medicines are devoid of significant interactions.
   • Certain anticancer drugs (eg, cyclophosphamide, meth-
                                                                           Low Cost. An ideal drug would be easy to afford. The
     otrexate), at usual therapeutic doses, always increase
                                                                        cost of drugs can be a substantial financial burden. As an
     the risk of serious infection.
                                                                        extreme example, treatment with adalimumab [Humira], a
   • Opioid analgesics (eg, morphine, meperidine), at high
                                                                        drug for rheumatoid arthritis and Crohn’s disease, can cost
     therapeutic doses, can cause potentially fatal respiratory
                                                                        $50,000 or more per year. More commonly, expense becomes
     depression.
                                                                        a significant factor when a medication must be taken chroni-
   • Aspirin and related drugs, when taken chronically in
                                                                        cally. For example, people with hypertension, arthritis, or
     high therapeutic doses, can cause life-threatening gastric
                                                                        diabetes may take medications every day for life. The cumula-
     ulceration, perforation, and bleeding.
                                                                        tive expense of such treatment can be huge—even for drugs
   Clearly, drugs have both benefits and risks. This fact may           of moderate price.
explain why the Greeks used the word pharmakon, which can                  Chemical Stability. Some drugs lose effectiveness during
be translated as both remedy and poison.                                storage. Others that may be stable on the shelf can rapidly
   Selectivity. A selective drug is defined as one that elicits         lose effectiveness when put into solution (eg, in preparation
only the response for which it is given. There is no such thing         for infusion). These losses in efficacy result from chemical
as a wholly selective drug because all drugs cause side effects.        instability. Because of chemical instability, stocks of certain
Common examples include the drowsiness that can be caused               drugs must be periodically discarded. An ideal drug would
by many antihistamines; the peripheral edema that can be                retain its activity indefinitely.
caused by calcium channel blockers; and the sexual dysfunc-                Possession of a Simple Generic Name. Generic names
tion commonly caused by fluoxetine [Prozac] and related                 of drugs are usually complex, and hence difficult to remember
antidepressants.                                                        and pronounce. As a rule, the trade name for a drug is much
                                                                        simpler than its generic name. Examples of drugs that have
                                                                        complex generic names and simple trade names include acet-
Additional Properties of an Ideal Drug                                  aminophen [Tylenol], ciprofloxacin [Cipro], and simvastatin
    Reversible Action. For most drugs, it is important that             [Zocor]. Since generic names are preferable to trade names
effects be reversible. That is, in most cases, we want drug             (for reasons discussed in Chapter 3), an ideal drug should
actions to subside within an appropriate time. General anes-            have a generic name that is easy to recall and pronounce.
thetics, for example, would be useless if patients never woke
up. Likewise, it is unlikely that oral contraceptives would find
wide acceptance if they caused permanent sterility. For a few           Because No Drug Is Ideal
drugs, however, reversibility is not desirable. With antibiotics,       From the preceding criteria for ideal drugs, we can see that
for example, we want toxicity to microbes to endure.                    available medications are not ideal. All drugs have the poten-
    Predictability. It would be very helpful if, prior to drug          tial to produce side effects. Drug responses may be difficult
administration, we could know with certainty just how a given           to predict and may be altered by drug interactions. Drugs may
patient will respond. Unfortunately, since each patient is              be expensive, unstable, and hard to administer. Because medi-
unique, the accuracy of predictions cannot be guaranteed.               cations are not ideal, all members of the healthcare team must
Accordingly, to maximize the chances of eliciting desired               exercise care to promote therapeutic effects and minimize
responses, we must tailor therapy to the individual.                    drug-induced harm.
    Ease of Administration. An ideal drug should be simple
to administer: The route should be convenient, and the number
of doses per day should be low. Patients with diabetes, who             THE THERAPEUTIC OBJECTIVE
must inject insulin multiple times a day, are not likely to judge
insulin ideal. Similarly, nurses who must set up and monitor            The objective of drug therapy is to provide maximum benefit
IV infusions are unlikely to consider intravenous drugs ideal.          with minimal harm. If drugs were ideal, we could achieve this
    In addition to convenience, ease of administration has two          objective with relative ease. However, because drugs are not
other benefits: (1) it can enhance patient adherence, and (2) it        ideal, we must exercise skill and care if treatment is to result
can decrease risk. Patients are more likely to adhere to a              in more good than harm. As detailed in Chapter 2, you have
                                                                    2
                                                                                            CHAPTER 1       Orientation to Pharmacology
a critical responsibility in achieving the therapeutic objective.        dose, or at the wrong time; the patient may even be given the
To meet this responsibility, you must understand drugs. The              wrong drug. These errors can be made by pharmacists, physi-
primary purpose of this text is to help you achieve that                 cians, and nurses. Any of these errors will detract from achiev-
understanding.                                                           ing the therapeutic objective. Medication errors are discussed
                                                                         at length in Chapter 7.
                                                                     3
CHAPTER 1      Orientation to Pharmacology
drug interactions; physiologic variables (eg, age, gender,           drug reactions. Because individuals differ from one another,
weight); pathologic variables (especially diminished function        no two patients will respond identically to the same drug
of the kidneys and liver, the major organs of drug elimina-          regimen. Accordingly, to achieve the therapeutic objective,
tion); and genetic variables. Genetic factors can alter the          we must tailor drug therapy to the individual. Individual varia-
metabolism of drugs and can predispose the patient to unique         tion in drug responses is the subject of Chapter 8.
                                                      KEY POINTS
 ■   The most important properties of an ideal drug are effec-       ■   Because all patients are unique, drug therapy must be
     tiveness, safety, and selectivity.                                  tailored to each individual.
 ■   If a drug is not effective, it should not be used.
 ■   Drugs have both benefits and risks.                             Please visit http://evolve.elsevier.com/Lehne for chapter-
 ■   There is no such thing as a wholly selective drug: All          specific NCLEX® examination review questions.
     drugs can cause side effects.
 ■   The objective of drug therapy is to provide maximum
     benefit with minimum harm.
                                                                 4
 CHAPTER
        2                     Application of Pharmacology
                              in Nursing Practice
                                                                     the right dose by the right route at the right time. More
 Evolution of Nursing Responsibilities Regarding                     recently, various other rights—right assessment, right docu-
   Drugs, p. 5
                                                                     mentation, right evaluation, the patient’s rights to education,
 Application of Pharmacology in Patient Care, p. 6                   and the patient’s right of refusal—have been recommended
   Preadministration Assessment, p. 6                                for inclusion. Clearly, the original five Rights and their sub-
   Dosage and Administration, p. 6                                   sequent additions are important. However, although these
   Evaluating and Promoting Therapeutic                              basics are vital, much more is required to achieve the thera-
      Effects, p. 7                                                  peutic objective. The Rights guarantee only that a drug will
   Minimizing Adverse Effects, p. 7                                  be administered as prescribed. Correct administration, without
   Minimizing Adverse Interactions, p. 7                             additional interventions, cannot ensure that treatment will
   Making PRN Decisions, p. 7
                                                                     result in maximum benefit and minimum harm.
                                                                         The limitations of the Rights can be illustrated with this
   Managing Toxicity, p. 7                                           analogy: The nurse who sees his or her responsibility as being
 Application of Pharmacology in Patient                              complete after correct drug administration would be like a
   Education, p. 8                                                   major league baseball pitcher who felt that his responsibility
   Dosage and Administration, p. 8                                   was over once he had thrown the ball toward the batter. As
   Promoting Therapeutic Effects, p. 8                               the pitcher must be ready to respond to the consequences of
   Minimizing Adverse Effects, p. 8                                  the interaction between ball and bat, you must be ready to
   Minimizing Adverse Interactions, p. 9                             respond to the consequences of the interaction between drug
 Application of the Nursing Process in Drug                          and patient. Put another way, although both the nurse and the
   Therapy, p. 9                                                     pitcher have a clear obligation to deliver their objects in the
   Review of the Nursing Process, p. 9
                                                                     most appropriate fashion, proper delivery is only the begin-
                                                                     ning of their responsibilities: Important events will take place
   Applying the Nursing Process in Drug                              after the object is delivered, and these must be responded to.
      Therapy, p. 9
                                                                     Like the pitcher, the nurse can respond rapidly and effectively
   Use of a Modified Nursing Process Format to                       only by anticipating what the possible reactions to the drug
      Summarize Nursing Implications, p. 12                          might be.
 Key Points, p. 13                                                       To anticipate possible reactions, both the nurse and the
                                                                     pitcher require certain kinds of knowledge. Just as the pitcher
                                                                     must understand the abilities of the opposing batter, you must
                                                                     understand the patient and the disorder for which the patient
Our principal goal in this chapter is to answer the question         is being treated. As the pitcher must know the most appropri-
“Why should a nursing student learn pharmacology?” By                ate pitch (eg, fast ball, slider) to deliver in specific circum-
addressing this question, I want to give you some extra moti-        stances, you must know what medications are appropriate for
vation to study. Why do I think you might need some motiva-          the patient and must check to ensure that the ordered medica-
tion? Because pharmacology can be challenging and other              tion is an appropriate medication. Conversely, as the pitcher
topics in nursing are often more alluring. Hopefully, when you       must know what pitches not to throw at a particular batter,
complete the chapter, you will be convinced that understand-         you must know what drugs are contraindicated for the patient.
ing drugs is essential for nursing practice, and that putting        As the pitcher must know the most likely outcome after the
time and effort into learning about drugs will be a good             ball and bat interact, you must know the probable conse-
investment.                                                          quences of the interaction between drug and patient.
                                                                         Although this analogy is not perfect (the nurse and patient
                                                                     are on the same team, whereas the pitcher and batter are not),
EVOLUTION OF NURSING                                                 it does help us appreciate that the nurse’s responsibility
RESPONSIBILITIES REGARDING DRUGS                                     extends well beyond the Rights. Consequently, in addition to
                                                                     the limited information needed to administer drugs in accor-
In the past, a nurse’s responsibility regarding medications          dance with the Rights, you must acquire a broad base of
focused on the Five Rights of Drug Administration (the               pharmacologic knowledge so as to contribute fully to achiev-
Rights)—namely, give the right drug to the right patient in          ing the therapeutic objective.
                                                                 5
CHAPTER 2      Application of Pharmacology in Nursing Practice
   Nurses, together with healthcare providers and pharma-                effectiveness of our drug. For example, if we plan to give a
cists, participate in a system of checks and balances designed           drug to lower blood pressure, we must know the patient’s
to promote beneficial effects and minimize harm. Nurses are              blood pressure prior to treatment. Similarly, if we are planning
especially important in this system because it is the nurse who          to give a drug that can damage the liver, we need to assess
follows the patient’s status most closely. As a result, you are          baseline liver function to evaluate this potential toxicity.
likely to be the first member of the healthcare team to observe          Obviously, to collect appropriate baseline data, we must first
and evaluate drug responses, and to intervene if required. To            know the effects that a drug is likely to produce.
observe and evaluate drug responses, and to intervene rapidly                Identifying High-Risk Patients. Multiple factors can
and appropriately, you must know in advance the responses                predispose an individual to adverse reactions from specific
that a medication is likely to elicit. Put another way, to provide       drugs. Important predisposing factors are pathophysiology
professional care, you must understand drugs. The better your            (especially liver and kidney impairment), genetic factors,
knowledge of pharmacology, the better you will be able to                drug allergies, and life span considerations such as pregnancy,
anticipate drug responses and not simply react to them after             advanced age, and extreme youth.
the fact.                                                                    Patients with penicillin allergy provide a dramatic example
   Within our system of checks and balances, the nurse has               of those at risk: Giving penicillin to such a patient can be fatal.
an important role as patient advocate. It is your responsibility         Accordingly, whenever treatment with penicillin is under con-
to detect mistakes made by pharmacists and prescribers. For              sideration, we must determine if the patient has had an allergic
example, the prescriber may overlook potential drug interac-             reaction to a penicillin in the past, and details about the type
tions, or may be unaware of alterations in the patient’s status          of reaction. If there is a history of penicillin allergy, an alter-
that would preclude use of a particular drug, or may select the          native antibiotic should be prescribed. If there is no effective
correct drug but may order an inappropriate dosage or route              alternative, facilities for managing a severe reaction should
of administration. Because the nurse actually administers                be in place before the drug is given.
drugs, the nurse is the last person to check medications before              From the preceding example, we can see that, when plan-
they are given. Consequently, you are the patient’s last line            ning drug therapy, we must identify patients who are at high
of defense against medication errors. It is ethically and legally        risk of reacting adversely. To identify such patients, we use
unacceptable for you to administer a drug that is harmful to             three principal tools: the patient history, physical examina-
the patient—even though the medication has been prescribed               tion, and laboratory data. Of course, if identification is to be
by a licensed prescriber and dispensed by a licensed pharma-             successful, you must know what to look for (ie, you must
cist. In serving as patient advocate, it is impossible to know           know the factors that can increase the risk of severe reactions
too much about drugs.                                                    to the drug in question). Once the high-risk patient has been
                                                                         identified, we can take steps to reduce the risk.
                                                                     6
                                                                          CHAPTER 2     Application of Pharmacology in Nursing Practice
       taken immediately. The nurse who doesn’t understand                through weight reduction, smoking cessation, and sodium
       these drugs will be unprepared to work with them                   restriction. As a nurse, you may provide these supportive
       safely.                                                            measures directly, through patient education, or by coordinat-
   •   The following guidelines can help ensure correct                   ing the activities of other healthcare providers.
       administration:
   •   Read the medication order carefully. If the order is
       unclear, verify it with the prescriber.                            Minimizing Adverse Effects
   •   Verify the identity of the patient by comparing the name           All drugs have the potential to produce undesired effects.
       on the wristband with the name on the drug order or                Common examples include gastric erosion caused by aspirin,
       medication administration record.                                  sedation caused by older antihistamines, hypoglycemia caused
   •   Read the medication label carefully. Verify the identity           by insulin, and excessive fluid loss caused by diuretics. When
       of the drug, the amount of drug (per tablet, volume of             drugs are employed properly, the incidence and severity of
       liquid, etc.), and its suitability for administration by the       such events can be reduced. Measures to reduce adverse
       intended route.                                                    events include identifying high-risk patients through the
   •   Verify dosage calculations.                                        patient history, ensuring proper administration through patient
   •   Implement any special handling the drug may require.               education, and teaching patients about activities that might
   •   Don’t administer any drug if you don’t understand the              precipitate an adverse event.
       reason for its use.                                                   When untoward effects cannot be avoided, discomfort and
                                                                          injury can often be minimized by appropriate intervention.
   Measures to minimize medication errors are discussed                   For example, timely administration of glucose will prevent
further in Chapter 7.                                                     brain damage from insulin-induced hypoglycemia. To help
                                                                          reduce adverse effects, you must know the following about
                                                                          the drugs you are working with:
Evaluating and Promoting                                                     •   The major adverse effects the drug can produce
Therapeutic Effects                                                          •   When these reactions are likely to occur
                                                                             •   Early signs that an adverse reaction is developing
    Evaluating Therapeutic Responses. Evaluation is one
                                                                             •   Interventions that can minimize discomfort and harm
of the most important aspects of drug therapy. After all, this
is the process that tells us whether a drug is beneficial or is
causing harm. Because the nurse follows the patient’s status
most closely, the nurse is in the best position to evaluate               Minimizing Adverse Interactions
therapeutic responses.                                                    When a patient is taking two or more drugs, those drugs may
    To make an evaluation, you must know the rationale for                interact with one another to diminish therapeutic effects or
treatment and the nature and time course of the intended                  intensify adverse effects. For example, the ability of oral
response. When desired responses do not occur, it may be                  contraceptives to protect against pregnancy can be reduced by
essential to identify the problem quickly, so that timely imple-          concurrent therapy with carbamazepine (an antiseizure drug),
mentation of alternative therapy may be ordered.                          and the risk of thromboembolism from oral contraceptives can
    When evaluating responses to a drug that has more than                be increased by smoking cigarettes.
one application, you can do so only if you know the specific                 As a nurse, you can help reduce the incidence and intensity
indication for which the drug is being used. Nifedipine, for              of adverse interactions in several ways. These include taking
example, is given for both hypertension and angina pectoris.              a thorough drug history, advising the patient to avoid over-
When the drug is used for hypertension, you should monitor                the-counter drugs that can interact with the prescribed medi-
for a reduction in blood pressure. In contrast, when this drug            cation, monitoring for adverse interactions known to occur
is used for angina, you should monitor for a reduction in chest           between the drugs the patient is taking, and being alert for
pain. Clearly, if you are to make the proper evaluation, you              as-yet unknown interactions.
must understand the reason for drug use.
    Promoting Patient Adherence. Adherence—also known
as compliance or concordance—may be defined as the extent                 Making PRN Decisions
to which a patient’s behavior coincides with medical advice. If           A PRN medication order is one in which the nurse has discre-
we are to achieve the therapeutic objective, adherence is essen-          tion regarding when to give a drug and, in some situations,
tial. Drugs that are self-administered in the wrong dose, by the          how much drug to give. (PRN stands for pro re nata, a Latin
wrong route, or at the wrong time cannot produce maximum                  phrase meaning as needed.) PRN orders are common for
benefit—and may even prove harmful. Obviously, successful                 drugs that promote sleep, relieve pain, and reduce anxiety. To
therapy requires active and informed participation by the                 implement a PRN order rationally, you must know the reason
patient. By educating patients about the drugs they are taking,           for drug use and be able to assess the patient’s medication
you can help elicit the required participation.                           needs. Clearly, the better your knowledge of pharmacology,
    Implementing Nondrug Measures. Drug therapy can                       the better your PRN decisions are likely to be.
often be enhanced by nonpharmacologic measures. Examples
include (1) enhancing drug therapy of asthma through breath-
ing exercises, biofeedback, and emotional support; (2) enhanc-            Managing Toxicity
ing drug therapy of arthritis through exercise, physical therapy,         Some adverse drug reactions are extremely dangerous. Hence,
and rest; and (3) enhancing drug therapy of hypertension                  if toxicity is not diagnosed early and responded to quickly,
                                                                      7
CHAPTER 2      Application of Pharmacology in Nursing Practice
irreversible injury or death can result. To minimize harm, you               Some patients have difficulty remembering whether or not
must know the early signs of toxicity and the procedure for              they have taken their medication. Possible causes include
toxicity management.                                                     mental illness, advanced age, and complex regimens. To facil-
                                                                         itate accurate dosing, you can provide the patient with a pill
                                                                         box that has separate compartments for each day of the week,
APPLICATION OF PHARMACOLOGY                                              and then teach him or her to load the compartments weekly.
IN PATIENT EDUCATION                                                     To determine if they have taken their medicine, patients can
                                                                         simply examine the box.
Very often, the nurse is responsible for educating patients                  Technique of Administration. Patients must be taught
about medications. In your role as educator, you must give               how to administer their drugs. This is especially important for
the patient the following information:                                   routes that may be unfamiliar (eg, sublingual for nitroglyc-
                                                                         erin) and for techniques that can be difficult (eg, subcutaneous
   • Drug name and therapeutic category (eg, penicillin:
                                                                         injection of insulin). Patients taking oral medications may
     antibiotic)
                                                                         require special instructions. For example, some oral prepara-
   • Dosage
                                                                         tions must not be chewed or crushed; some should be taken
   • Dosing schedule
                                                                         with fluids; and some should be taken with meals, whereas
   • Route and technique of administration
                                                                         others should not. Careful attention must be paid to the patient
   • Expected therapeutic response and when it should
                                                                         who, because of disability (eg, visual or intellectual impair-
     develop
                                                                         ment, limited manual dexterity), may find self-medication
   • Nondrug measures to enhance therapeutic responses
                                                                         difficult.
   • Duration of treatment
                                                                             Duration of Drug Use. Just as patients must know when
   • Method of drug storage
                                                                         to take their medicine, they must know when to stop. In some
   • Symptoms of major adverse effects, and measures to
                                                                         cases (eg, treatment of acute pain), patients should discon-
     minimize discomfort and harm
                                                                         tinue drug use as soon as symptoms subside. In other cases
   • Major adverse drug-drug and drug-food interactions
                                                                         (eg, treatment of hypertension), patients should know that
   • Whom to contact in the event of therapeutic failure,
                                                                         therapy will probably continue lifelong. For some conditions
     severe adverse reactions, or severe adverse interactions
                                                                         (eg, gastric ulcers), medication may be prescribed for a spe-
To communicate this information effectively and accurately,              cific time interval, after which the patient should return for
you must first understand it. That is, to be a good drug educa-          reevaluation.
tor, you must know pharmacology.                                             Drug Storage. Certain medications are chemically unsta-
    In the following discussion, we consider the relationship            ble and deteriorate rapidly if stored improperly. Patients
between patient education and the following aspects of drug              who are using unstable drugs must be taught how to store
therapy: dosage and administration, promoting therapeutic                them correctly (eg, under refrigeration, in a lightproof
effects, minimizing adverse effects, and minimizing adverse              container). All drugs should be stored where children can’t
interactions.                                                            reach them.
                                                                     8
                                                                       CHAPTER 2     Application of Pharmacology in Nursing Practice
   • Insulin overdose can cause blood glucose levels to drop               Analysis: Nursing Diagnoses. In this step, the nurse
     precipitously. Early signs of hypoglycemia include                analyzes information in the database to determine actual and
     sweating and increased heart rate. The patient who has            potential health problems. These problems may be physio-
     been taught to recognize these early signs can respond            logic, psychologic, or sociologic. Each problem is stated in
     by ingesting glucose or other fast-acting carbohydrate-           the form of a nursing diagnosis, which can be defined as an
     rich foods, thereby restoring blood sugar to a safe               actual or potential health problem that nurses are qualified and
     level. In contrast, the patient who fails to recognize            licensed to treat.
     evolving hypoglycemia and does not ingest glucose or                  A complete nursing diagnosis consists of three statements:
     similar substances may become comatose, and may                   (1) a statement of the patient’s actual or potential health
     even die.                                                         problem; followed by (2) a statement of the problem’s prob-
   • Many anticancer drugs predispose patients to acquiring            able cause or risk factors; and (3) the signs, symptoms, or
     serious infections. The patient who is aware of this pos-         other evidence of the problem. (This third component is
     sibility can take steps to avoid contagion (eg, avoiding          omitted for potential problems.) Typically, the statements are
     contact with people who have an infection, avoiding               separated by the phrases related to and as evidenced by, as in
     foods likely to contain pathogens). In addition, the              this example of a drug-associated nursing diagnosis: “non-
     informed patient is in a position to notify the prescriber        compliance with the prescribed regimen [the problem] related
     at the first sign that an infection is developing, thereby        to complex medication administration schedule [the cause] as
     allowing early treatment. In contrast, the patient who            evidenced by missed drug doses and patient’s statement that
     has not received adequate education is at increased risk          the schedule is confusing [the evidence].”
     of illness or death from an infectious disease.                       Planning. In the planning step, the nurse delineates spe-
   • Some side effects, although benign, can be disturbing if          cific interventions directed at solving or preventing the prob-
     they occur without warning. For example, rifampin (a              lems identified in analysis. The plan must be individualized
     drug for tuberculosis) imparts a harmless red-orange              for each patient. When creating a care plan, the nurse must
     color to urine, sweat, saliva, and tears. Your patient will       define goals, set priorities, identify nursing interventions, and
     appreciate knowing about this in advance.                         establish criteria for evaluating success. In addition to nursing
                                                                       interventions, the plan should include interventions performed
                                                                       by other healthcare providers. Planning is an ongoing process
Minimizing Adverse Interactions                                        that must be modified as new data are gathered.
Patient education can help avoid hazardous drug-drug and                   Implementation. Implementation begins with carrying
drug-food interactions. For example, phenelzine (an antide-            out the interventions identified during planning. Some inter-
pressant) can cause dangerous elevations in blood pressure if          ventions are collaborative while others are independent.
taken in combination with certain drugs (eg, amphetamines)             Collaborative interventions require a healthcare provider’s
or certain foods (eg, figs, avocados, most cheeses). Accord-           order, whereas independent interventions do not. In addition
ingly, it is essential that patients taking phenelzine be given        to carrying out interventions, implementation involves coor-
specific and emphatic instructions regarding the drugs and             dinating actions of other members of the healthcare team.
foods they must avoid.                                                 Implementation is completed by observing and documenting
                                                                       the outcomes of treatment. Documentation should be thor-
                                                                       ough and precise.
APPLICATION OF THE NURSING PROCESS                                         Evaluation. This step is performed to determine the
IN DRUG THERAPY                                                        degree to which treatment has succeeded. Evaluation is
                                                                       accomplished by analyzing the data collected following
The nursing process is a conceptual framework that nurses              implementation. Evaluation should identify those interven-
employ to guide healthcare delivery. In this section we con-           tions that should be continued, those that should be discon-
sider how the nursing process can be applied in drug therapy.          tinued, and potential new interventions that might be
                                                                       implemented. Evaluation completes the initial cycle of the
                                                                       nursing process and provides the basis for beginning the
Review of the Nursing Process                                          cycle anew.
Before discussing the nursing process as it applies to drug
therapy, we need to review the process itself. Since you are
probably familiar with the process already, this review is             Applying the Nursing Process
brief.                                                                 in Drug Therapy
   In its simplest form, the nursing process can be viewed as          Having reviewed the nursing process itself, we can now
a cyclic procedure that has five basic steps: (1) assessment,          discuss the process as it pertains to drug therapy. Recall that
(2) analysis (including nursing diagnoses), (3) planning,              the overall objective in drug therapy is to produce maximum
(4) implementation, and (5) evaluation.                                benefit with minimum harm.
   Assessment. Assessment consists of collecting data
about the patient. These data are used to identify actual and          Preadministration Assessment
potential health problems. The database established during             Preadministration assessment establishes the baseline data
assessment provides a foundation for subsequent steps in the           needed to tailor drug therapy to the individual. By identifying
process. Important methods of data collection are the patient          the variables that can affect an individual’s responses to drugs,
interview, medical and drug-use histories, the physical exami-         we can adapt treatment so as to maximize benefits and mini-
nation, observation of the patient, and laboratory tests.              mize harm. Preadministration assessment has four basic goals:
                                                                   9
CHAPTER 2      Application of Pharmacology in Nursing Practice
   • Collection of baseline data needed to evaluate therapeu-             being used, and practically any pathophysiologic condition.
     tic effects                                                          These factors are discussed at length in Chapters 6
   • Collection of baseline data needed to evaluate adverse               through 11.
     effects                                                                  When identifying factors that put the patient at risk, you
   • Identification of high-risk patients                                 should distinguish between factors that put the patient at
   • Assessment of the patient’s capacity for self-care                   extremely high risk versus factors that put the patient at mod-
                                                                          erate or low risk. The terms contraindication and precaution
   The first three goals are specific to the particular drug being        are used for this distinction. A contraindication is defined as
used. Accordingly, to achieve these goals, you must know the              a preexisting condition that precludes use of a particular drug
pharmacology of the drug under consideration. The fourth                  under all but the most critical of circumstances. For example,
goal applies more or less equally to all drugs—although this              a previous severe allergic reaction to penicillin (which can be
goal may be more critical for some drugs than others.                     life threatening) would be a contraindication to using penicil-
   Important methods of data collection include interviewing              lin again—unless the patient has a life-threatening infection
the patient and family, observing the patient, performing a               that cannot be effectively treated with another antibiotic. In
physical examination, checking results of laboratory tests, and           this situation, where the patient will die if the drug isn’t
taking the patient’s medical and drug histories. The drug                 administered yet the patient may die if the drug is adminis-
history should include prescription drugs, over-the-counter               tered, the provider may decide to give the penicillin along
drugs, herbal remedies, and drugs taken for nonmedical or                 with other drugs and measures to decrease the extent of the
recreational purposes (eg, alcohol, nicotine, caffeine, illicit           allergic reaction. A precaution, by contrast, can be defined as
drugs). Prior adverse drug reactions should be noted, includ-             a preexisting condition that significantly increases the risk of
ing drug allergies and idiosyncratic reactions (ie, reactions             an adverse reaction to a particular drug, but not to a degree
unique to the individual).                                                that is life threatening. For example, a previous mild allergic
   Baseline Data Needed to Evaluate Therapeutic                           reaction to penicillin would constitute a precaution to using
Effects. Drugs are administered to achieve a desired response.            this drug again. That is, the drug may be used, but greater than
To know if we have produced that response, we need to estab-              normal caution must be exercised. Preferably, an alternative
lish baseline measurements of the parameter that therapy is               drug would be selected.
directed at changing. For example, if we are giving a drug to                 Assessment of the Patient’s Capacity for Self-Care. If
lower blood pressure, we need to know what the patient’s                  drug therapy is to succeed, the outpatient must be willing and
blood pressure was prior to treatment. Without this informa-              able to self-administer medication as prescribed. Accordingly,
tion, we have no basis for determining the effect of our drug.            his or her capacity for self-care must be determined. If assess-
   Baseline Data Needed to Evaluate Adverse Effects.                      ment reveals that the patient is incapable of self-medication,
All drugs have the ability to produce undesired effects. In               alternative care must be arranged.
most cases, the adverse effects that a particular drug can                    Multiple factors can affect the capacity for self-care and
produce are known. In many cases, development of an adverse               the probability of adhering to the prescribed regimen. Patients
effect will be completely obvious in the absence of any base-             with reduced visual acuity or limited manual dexterity may
line data. For example, we don’t need special baseline data to            be unable to self-medicate, especially if the technique for
know that hair loss following cancer chemotherapy was                     administration is complex. Patients with limited intellectual
caused by the drug. However, in other cases, baseline data are            ability may be incapable of understanding or remembering
needed to determine whether or not an adverse effect has                  what they are supposed to do. Patients with severe mental
occurred. For example, some drugs can impair liver function.              illness (eg, depression, schizophrenia) may lack the under-
To know if a drug has compromised liver function, we need                 standing or motivation needed to self-medicate. Some patients
to know the state of liver function before drug use. Without              may lack the money to pay for drugs. Others may fail to take
this information, we can’t tell from later measurements                   medications as prescribed because of individual or cultural
whether liver dysfunction was preexisting or caused by                    attitudes toward drugs. For example, a common cause for
the drug.                                                                 failed self-medication is a belief that the drug was simply not
   Identification of High-Risk Patients. Because of indi-                 needed in the dosage prescribed. A thorough assessment will
vidual characteristics, a particular patient may be at high risk          identify all of these factors, thereby enabling you to account
of experiencing an adverse response to a particular drug. Just            for them when formulating nursing diagnoses and the patient
which individual characteristics will predispose a patient to             care plan.
an adverse reaction depends on the drug under consideration.
For example, if a drug is eliminated from the body primarily              Analysis and Nursing Diagnoses
by renal excretion, an individual with impaired kidney func-              With respect to drug therapy, the analysis phase of the nursing
tion will be at risk of having this drug accumulate to a toxic            process has three objectives. First, you must judge the appro-
level. Similarly, if a drug is eliminated by the liver, an indi-          priateness of the prescribed regimen. Second, you must
vidual with impaired liver function will be at risk of having             identify potential health problems that the drug might cause.
that drug accumulate to a toxic level. The message here is                Third, you must determine the patient’s capacity for self-care.
that, to identify the patient at risk, you must know the phar-               As the last link in the patient’s chain of defense against
macology of the drug to be administered.                                  inappropriate drug therapy, you must analyze the data col-
   Multiple factors can increase the patient’s risk of adverse            lected during assessment to determine if the proposed treat-
reactions to a particular drug. Impaired liver and kidney func-           ment has a reasonable likelihood of being effective and safe.
tion were just mentioned. Other factors include age, body                 This judgment is made by considering the medical diagnosis,
composition, pregnancy, diet, genetic heritage, other drugs               the known actions of the prescribed drug, the patient’s prior
                                                                     10
                                                                       CHAPTER 2        Application of Pharmacology in Nursing Practice
TABLE 2–1■ Examples of Nursing Diagnoses That Can Be Derived from Knowledge of Adverse
 Drug Effects
 Drug                       Adverse Effect                          Related Nursing Diagnosis
 Amphetamine                CNS stimulation                         Disturbed sleep pattern related to drug-induced CNS excitation
 Aspirin                    Gastric erosion                         Pain related to aspirin-induced gastric erosion
 Atropine                   Urinary retention                       Urinary retention related to drug therapy
 Bethanechol                Stimulation of GI smooth muscle         Bowel incontinence related to drug-induced increase in bowel motility
 Cyclophosphamide           Reduction in white blood cell counts    Risk for infection related to drug-induced neutropenia
 Digoxin                    Dysrhythmias                            Ineffective tissue perfusion related to drug-induced cardiac dysrhythmias
 Furosemide                 Excessive urine production              Deficient fluid volume related to drug-induced diuresis
 Gentamicin                 Damage to the eighth cranial nerve      Disturbed sensory perception: hearing impairment related to drug therapy
 Glucocorticoids            Thinning of the skin                    Impaired skin integrity related to drug therapy
 Haloperidol                Involuntary movements                   Low self-esteem related to drug-induced involuntary movements
 Propranolol                Bradycardia                             Decreased cardiac output related to drug-induced bradycardia
 Warfarin                   Bleeding                                Risk for injury related to drug-induced bleeding
responses to the drug, and the presence of contraindications             planning will allow you to anticipate adverse effects—rather
to the drug. You should question the drug’s appropriateness if           than react to them after the fact.
(1) the drug has no actions that are known to benefit individu-              Defining Goals. In all cases, the goal of drug therapy is
als with the patient’s medical diagnosis, (2) the patient failed         to produce maximum benefit with minimum harm. That is,
to respond to the drug in the past, (3) the patient had a serious        we want to employ drugs in such a way as to maximize thera-
adverse reaction to the drug in the past, or (4) the patient has         peutic responses while preventing or minimizing adverse
a condition or is using a drug that contraindicates the pre-             reactions and interactions. The objective of planning is to
scribed drug. If any of these conditions apply, you should               formulate ways to achieve this goal.
consult with the prescriber to determine if the drug should                  Setting Priorities. This requires knowledge of the drug
be given.                                                                under consideration and the patient’s unique characteristics—
    Analysis must identify potential adverse effects and drug            and even then, setting priorities can be difficult. Highest prior-
interactions. This is accomplished by integrating knowledge              ity is given to life-threatening conditions (eg, anaphylactic
of the drug under consideration and the data collected during            shock, ventricular fibrillation). These may be drug induced or
assessment. Knowledge of the drug itself will indicate adverse           the result of disease. High priority is also given to reactions
effects that practically all patients are likely to experience.          that cause severe, acute discomfort and to reactions that can
Data on the individual patient will indicate additional adverse          result in long-term harm. Since we cannot manage all prob-
effects and interactions to which the particular patient is pre-         lems simultaneously, less severe problems must wait until the
disposed. Once potential adverse effects and interactions have           patient and care provider have the time and resources to
been identified, pertinent nursing diagnoses can be easily for-          address them.
mulated. For example, if treatment is likely to cause respira-               Identifying Interventions. The heart of planning is
tory depression, an appropriate nursing diagnosis would be               identification of nursing interventions. These interventions
“risk for impaired gas exchange related to drug therapy.”                can be divided into four major groups: (1) drug administra-
Table 2–1 presents additional examples of nursing diagnoses              tion, (2) interventions to enhance therapeutic effects, (3) inter-
that can be readily derived from your knowledge of adverse               ventions to minimize adverse effects and interactions, and
effects and interactions that treatment may cause.                       (4) patient education (which encompasses information in the
    Analysis must characterize the patient’s capacity for self-          first three groups).
care. The analysis should indicate potential impediments to                  When planning drug administration, you must consider
self-care (eg, visual impairment, reduced manual dexterity,              dosage and route of administration as well as less obvious
impaired cognitive function, insufficient understanding of the           factors, including timing of administration with respect to
prescribed regimen) so that these factors can be addressed in            meals and with respect to administration of other drugs.
the care plan. To varying degrees, nearly all patients will be           Timing with respect to side effects is also important. For
unfamiliar with self-medication and the drug regimen. Accord-            example, if a drug causes sedation, it may be desirable to give
ingly, a nursing diagnosis applicable to almost every patient            the drug at bedtime, rather than in the morning or during
is “knowledge deficit related to the drug regimen.”                      the day.
                                                                             Nondrug measures can help promote therapeutic effects
Planning                                                                 and should be included in the plan. For example, drug therapy
Planning consists of defining goals, establishing priorities,            of hypertension can be combined with weight loss (in over-
identifying specific interventions, and establishing criteria for        weight patients), salt restriction, and smoking cessation.
evaluating success. Good planning will allow you to promote                  Interventions to prevent or minimize adverse effects are of
beneficial drug effects. Of equal or greater importance, good            obvious importance. When planning these interventions, you
                                                                    11
CHAPTER 2      Application of Pharmacology in Nursing Practice
should distinguish between reactions that develop quickly and           evaluating adherence include measurement of plasma drug
reactions that are delayed. A few drugs can cause severe                levels, interviewing the patient, and counting pills. The evalu-
adverse reactions (eg, anaphylactic shock) shortly after                ation should determine if the patient understands when to
administration. When planning to administer such a drug, you            take medication, what dosage to take, and the technique of
should ensure that facilities for managing possible reactions           administration.
are immediately available. Delayed reactions can often be                   Patient satisfaction with drug therapy increases quality of
minimized, if not avoided entirely. The plan should include             life and promotes adherence. If the patient is dissatisfied, an
interventions to do so.                                                 otherwise effective regimen may not be taken as prescribed.
   Well-planned patient education is central to success. The            Factors that can cause dissatisfaction include unacceptable
plan should account for the patient’s capacity to learn, and it         side effects, inconvenient dosing schedule, difficulty of
should address the following: technique of administration,              administration, and high cost. When evaluation reveals dis-
dosage and timing, duration of treatment, method of drug                satisfaction, an attempt should be made to alter the regimen
storage, measures to promote therapeutic effects, and mea-              to make it more acceptable.
sures to minimize adverse effects. Patient education is dis-
cussed at length above.
   Establishing Criteria for Evaluation. The need for                   Use of a Modified Nursing
objective criteria by which to measure desired drug responses
is obvious: Without such criteria we could not determine if             Process Format to Summarize
our drug was doing anything useful. As a result, we would               Nursing Implications
have no rational basis for making dosage adjustments or for             Throughout this text, nursing implications are integrated into
deciding how long treatment should last. If the drug is to be           the body of each chapter. The reason for integrating nursing
used on an outpatient basis, follow-up visits for evaluation            information with basic science information is to reinforce the
should be planned.                                                      relationship between pharmacologic knowledge and nursing
                                                                        practice. In addition to being integrated, nursing implications
Implementation                                                          are summarized at the end of most chapters under the heading
Implementation of the care plan in drug therapy has four                “Summary of Major Nursing Implications.” The purpose of
major components: (1) drug administration, (2) patient educa-           these summaries is to provide a concise and readily accessible
tion, (3) interventions to promote therapeutic effects, and             reference on patient care and patient education related to
(4) interventions to minimize adverse effects. These critical           specific drugs and drug families.
nursing activities are discussed at length in the previous                 The format employed for summarizing nursing implica-
section.                                                                tions reflects the nursing process (Table 2–2). Some headings
                                                                        have been modified to accommodate the needs of pharmacol-
Evaluation                                                              ogy instruction and to keep the summaries concise. The com-
Over the course of drug therapy, the patient must be evaluated          ponents of the format are as follows.
for (1) therapeutic responses, (2) adverse drug reactions                  Preadministration Assessment. This section summa-
and interactions, (3) adherence to the prescribed regimen, and          rizes the information you should have before giving a drug.
(4) satisfaction with treatment. How frequently evaluations             Each section begins by stating the reason for drug use. This
are performed depends on the expected time course of thera-             is followed by a summary of the baseline data needed to
peutic and adverse effects. Like assessment, evaluation is              evaluate therapeutic and adverse effects. After this, contrain-
based on laboratory tests, observation of the patient, physical         dications and precautions are summarized, under the heading
examination, and patient interviews. The conclusions drawn              Identifying High-Risk Patients.
during evaluation provide the basis for modifying nursing
interventions and the drug regimen.
    Therapeutic responses are evaluated by comparing the
patient’s current status with the baseline data. To evaluate             TABLE 2–2 ■ Modified Nursing Process Format
treatment, you must know the reason for drug use, the criteria           Used for Summaries of Major Nursing
for success (as defined during planning), and the expected               Implications
time course of responses (some drugs act within minutes,                 Preadministration Assessment
whereas others may take weeks to produce beneficial effects).            Therapeutic Goal
    The need to anticipate and evaluate adverse effects is self-         Baseline Data
evident. To make these evaluations, you must know which                  Identifying High-Risk Patients
adverse effects are likely to occur, how they manifest, and              Implementation: Administration
their probable time course. The method of monitoring is deter-           Routes
mined by the expected effect. For example, if hypotension is             Administration
expected, blood pressure is monitored; if constipation is
                                                                         Implementation: Measures to Enhance Therapeutic Effects
expected, bowel function is monitored; and so on. Since some
                                                                         Ongoing Evaluation and Interventions
adverse effects can be fatal in the absence of timely detection,
it is impossible to overemphasize the importance of monitor-             Summary of Monitoring
ing and being prepared for rapid intervention.                           Evaluating Therapeutic Effects
                                                                         Minimizing Adverse Effects
    Evaluation of adherence is desirable in all patients—and             Minimizing Adverse Interactions
is especially valuable when therapeutic failure occurs or                Managing Toxicity
when adverse effects are unexpectedly severe. Methods of
                                                                   12
                                                                    CHAPTER 2          Application of Pharmacology in Nursing Practice
   Implementation: Administration. This section summa-                     Patient Education. This topic does not have a section
rizes routes of administration, guidelines for dosage adjust-           of its own. Rather, patient education is integrated into the
ment, and special considerations in administration, such as             other sections. That is, as we summarize the nursing implica-
timing with respect to meals, preparation of intravenous solu-          tions that relate to a particular topic, such as drug administra-
tions, and unusual techniques of administration.                        tion or a specific adverse effect, patient education related
   Implementation: Measures to Enhance Therapeutic                      to that topic is discussed concurrently. This integration is
Effects. This section addresses issues such as diet modifica-           done to promote clarity and efficiency of communication.
tion, measures to increase comfort, and ways to promote                 To help this important information stand out, it appears in
adherence to the prescribed regimen.                                    blue type.
    Ongoing Evaluation and Interventions. This section                     What About Diagnosis and Planning? These headings
summarizes nursing implications that relate to both therapeu-           are not used in the summaries. There are several reasons
tic and undesired drug responses. As indicated in Table 2–2,            for the omission, the dominant one being efficiency of
the section has five subsections: (1) summary of monitoring,            communication.
(2) evaluating therapeutic effects, (3) minimizing adverse                 Nursing diagnoses have been left out primarily because
effects, (4) minimizing adverse interactions, and (5) managing          they are highly individualized. When caring for patients, you
toxicity. The monitoring section summarizes the physiologic             will develop nursing diagnoses based on your analysis of
and psychologic parameters that must be monitored in order              assessment data.
to evaluate therapeutic and adverse responses. The section on              Planning has not been used as a heading for three
therapeutic effects summarizes criteria and procedures for              reasons. First, planning applies primarily to the overall man-
evaluating therapeutic responses. The section on adverse                agement of the disorder for which a particular drug is being
effects summarizes the major adverse reactions that should be           used—and much less to the drug itself. Second, because
monitored for and presents interventions to minimize harm.              planning is discussed at length and more appropriately in
The section on adverse interactions summarizes the major                nonpharmacology nursing texts, such as those on medical-
drug interactions to be alert for and gives interventions to            surgical nursing, there is no need to repeat this information
minimize them. The section on toxicity describes major                  here. Third, planning is reflected in interventions that are
symptoms of toxicity and treatment.                                     implemented.
                                                        KEY POINTS
 ■   Nursing responsibilities with regard to drugs extend far           ■   The analysis and diagnosis phase of treatment is directed
     beyond the Rights of Drug Administration.                              at (1) judging the appropriateness of the prescribed
 ■   You are the patient’s last line of defense against medica-             therapy, (2) identifying potential health problems treat-
     tion errors.                                                           ment might cause, and (3) characterizing the patient’s
 ■   Your knowledge of pharmacology has a wide variety                      capacity for self-care.
     of practical applications in patient care and patient              ■   Planning is directed at (1) defining goals, (2) establishing
     education.                                                             priorities, and (3) establishing criteria for evaluating
 ■   By applying your knowledge of pharmacology, you will                   success.
     make a large contribution to achieving the therapeutic             ■   In the evaluation stage, the objective is to evaluate
     objective of maximum benefit with minimum harm.                        (1) therapeutic responses, (2) adverse reactions and inter-
 ■   Application of the nursing process in drug therapy is                  actions, (3) patient adherence, and (4) patient satisfaction
     directed at individualizing treatment, which is critical to            with treatment.
     achieving the therapeutic objective.
 ■   The goal of preadministration assessment is to gather              Please visit http://evolve.elsevier.com/Lehne for chapter-
     data needed for (1) evaluation of therapeutic and adverse          specific NCLEX® examination review questions.
     effects, (2) identification of high-risk patients, and
     (3) assessment of the patient’s capacity for self-care.
                                                                   13
 CHAPTER
                                                                     14
                                                          CHAPTER 3         Drug Regulation, Development, Names, and Information
manufacturers often fail to conduct or complete the required           include new safety information, and to restrict distribution of
follow-up studies. Second, if the follow-up studies—which              a drug based on safety concerns. In addition, the FDA was
are more rigorous than the original—fail to confirm a clinical         required to establish an active postmarketing risk surveillance
benefit, the guidelines have no clear mechanism for removing           system, mandated to include 25 million patients by July 2010,
the drug from the market.                                              and 100 million by July 2012. Because of the FDAAA,
   The Prescription Drug User Fee Act (PDUFA), passed in               adverse effects that were not discovered prior to drug approval
1992, was a response to complaints that the FDA takes too              came to light much sooner than in the past, and the FDA now
long to review applications for new drugs. Under the Act,              has the authority to take action (eg, limit distribution of a
drug sponsors pay the FDA fees that are used to fund addi-             drug) if postmarketing information shows a drug to be less
tional reviewers. In return, the FDA must adhere to strict             safe than previously understood.
review timetables. Because of the PDUFA, new drugs now                    In 2009, Congress passed the Family Smoking Prevention
reach the market much sooner than in the past.                         and Tobacco Control Act, which, at long last, allows the FDA
   The Food and Drug Administration Modernization Act                  to regulate cigarettes, which are responsible for about one in
(FDAMA) of 1997—an extension of the Prescription Drug                  five deaths in the United States each year. Under the Act, the
User Fee Act—called for widespread changes in FDA regula-              FDA was given the authority to strengthen advertising restric-
tions. Implementation is in progress. For health professionals,        tions, including a prohibition on marketing to youth; require
four provisions of the act are of particular interest:                 revised and more prominent warning labels; require disclo-
                                                                       sure of all ingredients in tobacco products and restrict harmful
   • The fast-track system created for AIDS drugs and
                                                                       additives; and monitor nicotine yields and mandate gradual
     cancer drugs now includes drugs for other serious and
                                                                       reduction of nicotine to nonaddictive levels.
     life-threatening illnesses.
   • Manufacturers who plan to stop making a drug must
     inform patients at least 6 months in advance, thereby
     giving them time to find another source.                          NEW DRUG DEVELOPMENT
   • A clinical trial database was required for drugs directed
                                                                       The development and testing of new drugs is an expensive
     at serious or life-threatening illnesses. These data allow
                                                                       and lengthy process, requiring 10 to 15 years for completion.
     clinicians and patients to make informed decisions
                                                                       Of the thousands of compounds that undergo testing, only a
     about using experimental drugs.
                                                                       few enter clinical trials, and of these, only 1 in 5 gains
   • Drug companies can now give prescribers journal arti-
                                                                       approval. Because of this high failure rate, the cost of devel-
     cles and certain other information regarding off-label
                                                                       oping a new drug can exceed $1.2 billion.
     uses of drugs. (An off-label use is a use that has not
                                                                           Rigorous procedures for testing have been established so
     been evaluated by the FDA.) Before the new act, clini-
                                                                       that newly released drugs might be both safe and effective.
     cians were allowed to prescribe a drug for an off-label
                                                                       Unfortunately, although testing can determine effectiveness,
     use, but the manufacturer was not allowed to promote
                                                                       it cannot guarantee that a new drug will be safe: Significant
     the drug for that use—even if promotion was limited to
                                                                       adverse effects may evade detection during testing, only to
     providing potentially helpful information, including
                                                                       become apparent after a new drug has been released for
     reprints of journal articles. In return for being allowed
                                                                       general use.
     to give prescribers information regarding off-label uses,
     manufacturers must promise to do research to support
     the claims made in the articles.                                  The Randomized Controlled Trial
    Two laws—the Best Pharmaceuticals for Children Act                 Randomized controlled trials (RCTs) are the most reliable
(BPCA), passed in 2002, and the Pediatric Research Equity              way to objectively assess drug therapies. RCTs have three
Act (PREA) of 2003—were designed to promote much-                      distinguishing features: use of controls, randomization, and
needed research on drug efficacy and safety in children. The           blinding. All three serve to minimize the influence of personal
BPCA offers a 6-month patent extension to manufacturers                bias on the results.
who evaluate a drug already on the market for its safety,                  Use of Controls. When a new drug is under development,
efficacy, and dosage in children. The PREA gives the FDA               we want to know how it compares with a standard drug used
the power, for the first time, to require drug companies to            for the same disorder, or perhaps how it compares with no
conduct pediatric clinical trials on new medications that might        treatment at all. To make these comparisons, some subjects in
be used by children. (In the past, drugs were not tested in            the RCT are given the new drug and some are given either
children, so there is a general lack of reliable information           (1) a standard treatment or (2) a placebo (ie, an inactive com-
upon which to base therapeutic decisions.)                             pound formulated to look like the experimental drug). Sub-
    In 2007, Congress passed the FDA Amendments Act                    jects receiving either the standard drug or the placebo are
(FDAAA), the most important legislation on drug safety since           referred to as controls. Controls are important because they
the Harris-Kefauver Amendments of 1962. The FDAAA                      help us determine if the new treatment is more (or less) effec-
expands the mission of the FDA to include rigorous oversight           tive than standard treatments, or at least if the new treatment
of drug safety after a drug has been approved. (Prior to this          is better (or worse) than no treatment at all. Likewise, controls
act, the FDA focused on drug efficacy and safety prior to              allow us to compare the safety of the new drug with that of
approval, but had limited resources and authority to address           the old drug, a placebo, or both.
drug safety after a drug was released for marketing.) Under                Randomization. In an RCT, subjects are randomly
the new law, the FDA has the legal authority to require post-          assigned to either the control group or the experimental group
marketing safety studies, to order changes in a drug’s label to        (ie, the group receiving the new drug). The purpose of
                                                                  15
CHAPTER 3      Drug Regulation, Development, Names, and Information
                                                                     16
                                                               CHAPTER 3         Drug Regulation, Development, Names, and Information
    TABLE 3–2    ■   Drugs That Were Withdrawn from the U.S. Market for Safety Reasons
                                                              Year Introduced/     Months on
    Drug                      Indication                      Year Withdrawn       the Market   Reason for Withdrawal
    Peginesatide [Omontys]    Anemia                             2012/2013             12       Life-threatening reactions
    Rotigotine* [Neupro]      Parkinson’s disease                2007/2008             10       Patch formulation delivered erratic dosages
    Natalizumab† [Tysabri]    Multiple sclerosis                 2004/2005              3       Progressive multifocal leukoencephalopathy
    Rapacuronium [Raplon]     Neuromuscular blockade             1999/2001             19       Bronchospasm, unexplained fatalities
    Alosetron† [Lotronex]     Irritable bowel syndrome           2000/2000              9       Ischemic colitis, severe constipation; deaths
                                                                                                   have occurred
    Troglitazone [Rezulin]    Type 2 diabetes                    1999/2000             12       Fatal liver failure
    Grepafloxacin [Raxar]     Infection                          1997/1999             19       Severe cardiovascular events, including
                                                                                                  seven deaths
    Bromfenac [Duract]        Acute pain                         1997/1998             11       Severe hepatic failure
    Mibefradil [Posicor]      Hypertension, angina pectoris      1997/1998             11       Inhibits drug metabolism, causing toxic
                                                                                                  accumulation of many drugs
    Dexfenfluramine [Redux]   Obesity                            1996/1997             16       Valvular heart disease
*Note that rotigotine was withdrawn because the formulation was unsafe, not because the drug itself is inherently dangerous.
†
 Alosetron and natalizumab were returned to the market in 2002 and 2006, respectively. These two drugs and one other—tegaserod [Zelnorm]—are
the only drugs the Food and Drug Administration has ever reapproved after withdrawing them for safety reasons. With all three drugs, risk
management guidelines must be followed.
don’t know if beneficial effects in women will be equivalent             selected, they do not represent the full spectrum of individuals
to those seen in men. Nor do we know if adverse effects will             who will eventually take the drug; and (3) patients in trials
be equivalent to those in men. We don’t know how timing of               take the drug for a relatively short time. Because of these
drug administration with respect to the menstrual cycle will             unavoidable limitations in the testing process, effects that
affect beneficial and adverse responses. We don’t know if                occur infrequently, effects that take a long time to develop,
drug disposition (absorption, distribution, metabolism, and              and effects that occur only in certain types of patients can go
excretion) will be the same in women as in men. Furthermore,             undetected. Hence, despite our best efforts, when a new drug
of the drugs that might be used to treat a particular illness, we        is released, it may well have adverse effects of which we are
don’t know if the drugs that are most effective in men will              as yet unaware. In fact, about half of the drugs that reach the
also be most effective in women. Lastly, we don’t know about             market have serious adverse effects that were not detected
the safety of drug use during pregnancy.                                 until after they were released for general use.
    During the 1990s, the FDA issued a series of guidelines                  The hidden dangers in new drugs are shown in Table 3–2,
mandating participation of women (and minorities) in trials              which presents information on 10 drugs that were withdrawn
of new drugs. In addition, the FDA revoked a 1977 guideline              from the U.S. market soon after receiving FDA approval. In
that barred women from most trials. Because of these changes,            all cases, the reason for withdrawal was a serious adverse
the proportion of women in trials of most new drugs now                  effect that went undetected in clinical trials. Admittedly, only
equals the proportion of women in the population. The data               a few hidden adverse effects are as severe as the ones in the
generated since the implementation of the new guidelines                 table. Hence, most do not necessitate drug withdrawal. None-
have been reassuring: Most gender-related effects have been              theless, the drugs in the table should serve as a strong warning
limited to pharmacokinetics. More importantly, for most                  about the unknown dangers that a new drug may harbor.
drugs, gender has shown little impact on efficacy, safety, or                Because adverse effects may go undetected, when caring
dosage. However, although the new guidelines are an impor-               for a patient who is prescribed a new drug, you should be
tant step forward, even with them, it will take a long time to           especially watchful for previously unreported drug reactions.
close the gender gap in our knowledge of drugs.                          If a patient taking a new drug begins to show unusual symp-
    Children. Until recently, children, like women, had been             toms, it is prudent to suspect that the new drug may be the
excluded from clinical trials. As a result, information on               cause—even though the symptoms are not yet mentioned in
dosage, therapeutic responses, and adverse effects in children           the literature.
has been limited. As noted previously, the FDA can now force
drug companies to conduct clinical trials in children. However,
it will still be a long time before we have the information              Exercising Discretion Regarding
needed to use drugs safely and effectively in young patients.            New Drugs
                                                                         When thinking about prescribing a new drug, clinicians would
Failure to Detect All Adverse Effects                                    do well to follow this guideline: Be neither the first to adopt
Premarketing clinical trials cannot detect all adverse effects           the new nor the last to abandon the old. Recall that the thera-
before a new drug is released. There are three reasons why:              peutic objective is to produce maximum benefit with minimum
(1) during clinical trials, a relatively small number of patients        harm. To achieve this objective, we must balance the potential
are given the drug; (2) because these patients are carefully             benefits of a drug against its inherent risks. As a rule, new
                                                                    17
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