Drug

Development
and Ethical
Considerations
u US Food and Drug Administration (FDA) is
responsible for the approval of new drugs.
u Critical Path Initiative, a national strategy to
drive innovation in the scientific processes
through which medical products are
developed, evaluated, and manufactured.
u FDA requires pre clinical trials to determine
drug’s toxicity, genotoxicity, and
pharmacologic effects through in vitro and in
vivo animal testing in lab.
u Genotoxicity, ability of a compound to
damage genetic information in a cell, in
addition to drug absorption, distribution,
metabolism, and excretion.
 I. CORE ETHICAL PRINCIPLES
u Threecore ethical principles are
relevant to research involving human
subjects:
uRespect for persons
uInformed Consent
uBeneficence
uRisk-Benefit Ratio
uJustice
RESPECT FOR PERSONS
u Patients should be treated as
independent persons who are
capable of making decisions in
their own best interests. Patients
with diminished decision-making
capacity are entitled in protection.
u When making health care
decisions, patients should be made
aware of alternatives available to
them as well as the consequences
that stem from those alternatives
u Autonomy is an integral part of
respect for persons
INFORMED CONSENT
u It is a mutual sharing of
information, a process of
communication.
u It expresses respect for
persons.
u It gains the patient’s active
involvement in their care.
u It respects the patient’s right
to self-determination.
 Informed Consent Checklist: Basic
Elements
• A statement that the • Identification of any • A disclosure of
study involves experimental appropriate
research procedures alternative
procedures or courses
• An explanation of the • A description of any
of treatment, if any,
purposes of the reasonably
that may be
research foreseeable risks or
advantageous to the
discomforts to the
• The expected subject
subject
duration of the
• A statement
subject’s • A description of any
describing the extent,
participation benefits to the subject
if any, to which
or to others that may
• A description of the confidentiality of
reasonably be
procedures to be records identifying
expected from the
followed the subject will be
research
maintained
• For research that involves • a statement that participation
minimal risk, an explanation as is voluntary, refusal to
to whether any compensation participate will involve no
will be paid and whether any penalty or loss of benefits to
medical treatments are which the subject is otherwise
available if injury occurs, and if entitled, and the subject may
so, what the treatments consist discontinue participation at
of or where further information any time without penalty or loss
may be obtained of benefits to which the subject
• Research, Rights or Injury: An is otherwise entitled
explanation of whom to
contact for answers to
pertinent questions about the
research and the research
subjects’ rights and whom to
contact in the event of a
research-related injury to the
subject
BENEFICENCE
u Beneficence is the duty to protect research subjects from harm. It
involves assessing potential risks and possible benefits and ensuring
the benefits are greater than the risk.

Risk-Benefit Ratio
u The risk-benefit ratio is one of the most complex problems faced by
the researcher. All possible consequences of a clinical study must
be analyzed and balanced against the inherent risks and the
anticipated benefits.
u Physical, psychological and social risks must be identified and
weighed against the benefits.
JUSTICE

u Justice requires that the selection of research

subjects be fair. Research must be conducted
so that the distribution of benefits and burdens
are equitable
II. Human
Clinical
Experimentation

The Drug
approval
process
 III. Nursing Process: Patient-
Centered Collaborative Care
Clinical Research
Assessment Planning

• Identify patients who are eligible • Have a process in place to identify

persons who are eligible to participate in
to participate in or who are a clinical research or to identify
participating in clinical research. participants actively participating in
clinical research studies.
• Assess response to the study agent
and identify adverse events (an • Have a process in place to facilitate
unfavorable or unintended sign, education and informed consent of
eligible study participants.
symptom, or disease that was not
present at the time of study • Plan educational programming for staff
enrollment and is associated with who provide direct care to study
participants
the treatment or procedure.
• Plan participant care to ensure integrity
and compliance with study protocol.
Nursing Interventions Evaluation
• Support the process of informed consent • Determine if the potential
in a culturally competent manner.
participant understands what it
• Provide an interpreter if necessary. means to participate in the study
• Provide enough time for the person to by asking open-ended questions.
read the consent and ask questions.
• Monitor response to the study
• Serve as a witness to informed consent. agent or other interventions.
• After reviewing the study protocol,
administer study agent(s). • Determine whether participants
understand how to take their study
• Accurately document all participant agents, what to do if they miss a
care, assessment findings and study
agent administration. dose, how to store the study agent
and when to call their health care
• Accurately and safely collect provider.
biospecimens.
• Act as advocate, educator, and
collaborator in the research process.
• Ensure safe care.
• Ensure integrity of study data.
• Communicate clearly.
IV. Federal Legislation
u 1912: The Sherley Amendment u 1996: Health Insurance Portability
and Accountability Act
u 1914: The Harrison Narcotic Act
u 1997: The Food and Drug
u 1938: The Federal Food, Drug and Administration Modernization Act
Cosmetic Act
u 2002: Best Pharmaceuticals for
u 1951: Durham-Humphrey
Children Act
Amendment
u 2003: Pediatric Research Equity
u 1962: Kefauver-Harris Amendment Act
to the 1938 Act
u 2007: Food and Drug
u 1965: Drug Abuse Control
Administration Amendments Act
Amendments
u 2010: Patient Protection and
u 1970: The Comprehensive Drug
Affordable Care Act
Abuse Prevention and Control Act
u 2012: Food and Drug
u 1983: The Orphan Drug Act Administration Safety and
u 1994: Dietary Supplement Health Innovation Act (FDASIA)
and Education Act
V. Nurse Practice Acts

u Nurses cannot prescribe or administer drugs without a health care

provider’s order.
u Nurses are responsible for knowing their state’s law and
administrative code.
u Nurses who administer a drug without a licensed health care
provider’s order are in violation of the Nurse Practice Act and can
have their license revoked.
u In a civil court, the nurse can be prosecuted for giving the wrong
drug or dosage, or giving the drug by the wrong route.
 VI. Drug Names
u The chemical name describes the drug’s chemical structure.
u The generic name is the official, nonproprietary name for the drug; this
name is not owned by any drug company and is universally accepted.
u The brand (trade) name, also known as the proprietary name, is chosen
by the drug company and is usually a registered trademark.
u If the generic drug is found to be bioequivalent to the brand-name drug,
the generic drug is considered therapeutically equivalent and is given an
“A” rating.
u If there is less than a 20% variance in drug absorption, distribution,
metabolism, and excretion, a generic drug is considered equivalent to
the brand-name drug.
Sources of drugs

— plants(digoxin),
— animals (insulin), and
— synthetic chemicals (meperidine)
— Most of the drugs used today are
synthetic and are associated with
fewer allergic reactions
Digitalis purpurea
VI. Drug Names
VI. Drug Names
 VII. Over-the-
u
Counter Drugs
In 2002, the FDA standardized OTC labeling to
provide consumers with better information and to
describe the benefits and risks associated with
taking OTC drugs. It is an important nursing
responsibility to ensure that patients are able to
read and understand OTC labels. All OTC drugs
must have labels that provide the following
information in this specific order:
u The product’s active ingredients, including
the amount in each dosage unit
u The purpose of the product
u The uses (indications) for the product
u Specific warnings, including when the
product should not be used under any
circumstances, substances or activities to
avoid, side effects that could occur, and
when it is appropriate to consult with a
doctor or pharmacist
u Dosage instructions that include when, how,
and how often to take the product
u The product’s inactive ingredients and
important information to help consumers
avoid ingredients that may cause an allergic
reaction
u Be guided with the use of SAFER before taking any medication.
u Speak up
Ask questions
Find the facts
Evaluate your choices
Read labels
The Label Also Tells You...
u The expiration date, when applicable (date after which you should
not use the product).
u Lot or batch code (manufacturer information to help identify the
product).
u Name and address of manufacturer, packer, or distributor.
u Net quantity of contents (how much of the product is in each
package).
u What to do if an overdose occurs.
VIII. Drug Resources
u American Hospital Formulary
Service (AHFS) Drug Information
u United States Pharmacopeia – Drug
Information (USP-DI)
u Medical Letter
u Prescriber’s Letter
u MedlinePlus
u The Handbook of Nonprescription
Drugs
u MIMS
u PNDF
 Practice Question #1 23

The nurse identifies the act that provides for the privacy
of patient health information as the

A. Drug Regulation Reform Act.

B. Drug Relations Act.
C. Food and Drug Administration Modernization Act.
D. Health Insurance Portability and Accountability Act.
 Practice Question #2 24

The nurse identifies the primary purpose of federal

legislation in drug standards as

A. preventing overcharging for drugs.

B. controlling efforts in drug research.
C. ensuring public safety.
D. moderating effective drug usage.
 Practice Question #3 25

Which situation regarding controlled substances requires the supervising RN

to intervene?

A. The staff keeps a separate controlled-substances record for

all required information.
B. Controlled substances are locked away from patients, and all
staff members have keys for necessary access.
C. Opioids are kept under double lock to limit access to them.
D. All discarded or wasted controlled substances are
countersigned.
 Practice Question #4 26

A nurse is to administer a dose of furosemide (Lasix).

The nurse is aware that Lasix is the ________ for the
drug.

A. generic name
B. chemical name
C. nonproprietary name
D. brand name
Chapter 2
PHARMACOKINETICS,
PHARMACODYNAMICS,
AND PHARMACOGENETICS
Pharmaceutic Phase

u The study of how various drug forms influence

pharmacokinetic and pharmacodynamic
activities;concerned with the disintegration of the dosage
form or dissolution of the drug in the body
u Considerations:
u Acidity of GI tract
u Enteric coatings
u Sustained-release medications
u Food
Drug Phases 29

u Pharmacokinetic phase (what the body does

to a drug)
u Absorption
u Distribution
u Metabolism
u Excretion
u Pharmacodynamic phase
u Receptor binding
u Postreceptor effects
u Chemical reaction
Pharmacokinetics 30

u Drug absorption
u Drug movement from GI tract into
bloodstream
u Disintegration
u Breakdown of oral drug form into
small particles
u Dissolution
u Process of combining small drug
particles with liquid to form a solution
 31
Pharmacokinetics (Cont.)
u Absorption methods
u Passive transport
u Diffusion
u Facilitated diffusion

u Active transport
u Requires energy and carrier substance
(enzyme)
u Pinocytosis
u Cell carries drug across membrane by
engulfing drug particles.
Pharmacokinetics (Cont.)
32
Pharmacokinetics 33
u Factors affecting absorption
u Blood circulation
u Pain, stress
u Food texture, fat content,
temperature
u pH
u Route of administration
u Drug movement from GI
tract to liver
u Via portal vein
u First pass effect
u Bioavailability
 Pharmacokinetics (Cont.) 34

uFactors affecting bioavailability

uDrug form
uRoute of administration
uGastric mucosa and motility
uAdministration with food and
other drugs
uChanges in liver metabolism
Pharmacokinetics:
Absorption
Routes
uA drug’s route of
administration affects the rate
and extent of absorption of
that drug.
u Enteral
u Parenteral
u Topical
Pharmacokinetics: Absorption
Enteral Route
u Drug is absorbed into the
systemic circulation
through the oral or gastric
mucosa, the small intestine,
or rectum.
u Oral
u Sublingual
u Buccal
u Rectal
 Routes of Drug Delivery
Parenteral Inhaled
(IV)
Oral

Transdermal
Parenteral
Topical (SC, IM)

Rectal
Pharmacokinetics:
Absorption
Parenteral Route
u Intravenous*
u Intramuscular
u Subcutaneous
u Intradermal
u Intrathecal/spinal
u Intraarticular/ Intraosseous
*Fastest delivery into the blood
circulation
Pharmacokinetics:
Absorption
Topical Route
u Skin (including transdermal
patches)
u Eyes
u Ears
u Nose
u Lungs (inhalation)
u Vagina
Distribution
u Processby which drug becomes available
to body fluids and tissues
Pharmacokinetics (Cont.) 41

uDrug distribution
uProteinbinding
uFree drugs
uVolume of drug distribution
(Vd)
Factors that affect distribution

Protein-binding

u Many drugs bind to proteins in the bloodstream

-Albumin is the main protein to bind with drugs
-Drugs bound to proteins are not available for use
*called protein bound
-Drugs not bound to protein are available to act at
the intended site of action and exert their effects
*called free drug
Pharmacokinetics (Cont.) 43
 44
Water soluble vs. fat soluble
u Water soluble u Fatsoluble drugs
drugs
are distributed to
tend to stay in the the tissues more
bloodstream and quickly
have slow
absorption into the
tissues.
 Pharmacokinetics (Cont.)
45
u Distribution

Drug movement across the blood-brain barrier.

 46

u Blood-brain barrier
-network of capillaries that
makes it more difficult for drugs to pass
through--will allow some fat soluble
drugs to pass through
u Placental barrier
-in general whatever mom
gets the fetus gets
 Pharmacokinetics (Cont.)
47
u Distribution

Drug crossing the placenta.

Pharmacokinetics (Cont.) 48
u Drug metabolism
(biotransformation)
u Half-life (t½)
u Loading dose
u Drug excretion (elimination)
u Kidneys
u Creatinine clearance
u BUN
u Glomerular filtration rate

u Liver (bile)
u Feces
u Lungs
u Saliva, sweat, breast milk
Metabolism

u Liver is the primary site of metabolism

u Most drugs converted to inactive water
soluble metabolites to aid with renal
excretion
u Some converted to active metabolites
u Half-life (t½) – time it takes for ½ of drug
concentration to be eliminated
First-Pass Effect
The metabolism of a drug and its
passage
from the liver into the circulation.
u A drug given via the oral route may be
extensively metabolized by the liver before
reaching the systemic circulation (high first-
pass effect).
u The same drug—given IV—bypasses the
liver, preventing the first-pass effect from
taking place, and more drug reaches the
circulation.
First-Pass Effect

u Routes that bypass the liver:

u Sublingual Transdermal
u Buccal Vaginal
u Rectal* Intramuscular
u Intravenous Subcutaneous
u Intranasal Inhalation
*Rectal route undergoes a higher degree of
first-pass effects than the other routes listed.
Excretion

u Kidneys primarily responsible

u Can also occur through: sweat,
breast milk, bile, feces, saliva, lungs,
etc
u Influenced by:
uUrinepH
uCreatinine clearance (CLcr)
Pharmacodynamic Phase
u Study of drug concentration and is effect to the body
u What the drug does to the body

u Primary effects – desired effects

u Secondary effects – may be desirable or
undesirable
u Dose Response – dose needed to
produce desired response
u Maximal efficacy – maximum drug effect
 Pharmacodynamics 54

A positive change in a physiologic system is called a

THERAPEUTIC EFFECT

This is the goal of drug therapy

Pharmacodynamics:
Mechanisms of Action
The ways by which drugs can
produce therapeutic effects:
u Once the drug is at the site of action, it can
modify the rate (increase or decrease) at
which the cells or tissues function.
u A drug cannot make a cell or tissue perform
a function it was not designed to perform.
Pharmacodynamics (Cont.) 56

uDrug response
relationship
uPotency
uTherapeutic index
Pharmacodynamics (Cont.) 57
Pharmacodynamics (Cont.) 58
u Onset
u Time it takes for drug to reach minimum effective
concentration.
u Peak
u Highest concentration in blood
u Duration
u Length of time taken for a drug to exert a therapeutic
effect.
u Trough level
u lowest plasma concentration of a drug
u Loading Dose
u large initial administration to achieve minimum effective
concentration of a drug
59
Pharmacodynamics (Cont.) 60

uTherapeutic drug
monitoring
uPeak drug level
uTrough drug level
Pharmacodynamics (Cont.) 61

u Receptor theory
uDrugs bind to
receptors
uTo activate
receptor
uTo produce a
response
uTo inactivate a
receptor
 Pharmacodynamics 62
a) Receptor interactions

u Key in a lock

u Drug binds to a specific site on the

cell (called a receptor site) and
modifies the function of the cell
u This is the way many drugs work
u How strong a drug binds to the
receptor site is called the AFFINITY
for that binding site
Pharmacodynamics (Cont.) 63

uAgonists
uActivatereceptors
uProduce desired response

uAntagonists
uPrevent receptor activation
uBlock response
Pharmacodynamics (Cont.) 64
Pharmacodynamics (Cont.) 65

uFour receptor families

uCell membrane–embedded
enzymes
uLigand-gated ion channels
uG protein–coupled receptor
systems
uTranscription factors
66
Pharmacodynamics (Cont.)
67

Cholinergic receptors are located in the

bladder, heart, blood vessels, stomach,
bronchi, and eyes.
Pharmacodynamics (Cont.)
68

Epinephrine affects three different receptors: alpha1, beta1, and beta2.

Pharmacodynamics 69

b) Enzyme interactions

u The drug alters the enzymes necessary for a certain body function

The Ace Inhibitor class of blood pressure medicines are an

example of drugs that exert their action by altering enzyme
pathways
Pharmacodynamics 70

c) Non-specific interactions

ualter the cell structure

ualter some crucial cell process

Antibiotics are an example of drugs that alter the cell

wall or alter the internal function of the bacterial cell
Pharmacodynamics (Cont.)
71

uMechanisms of drug action

uStimulation/Depression
uReplacement
uIrritation
uCytotoxic action/
Antimicrobial action
uModification of immune status
Therapeutic Index

u Safety margin of the drug

u Low or narrow = greater danger of toxicity
u Example: Digoxin (0.5 – 2.0ng/ml)
Pharmacodynamics (Cont.) 73

u Side effects
uSecondary drug effects
u Adverse reactions
uMore severe than side
effects
uUndesirable effects
u Drug toxicity
uDrug level exceeds
therapeutic range
 Pharmacogenetics 74

u Biologic variations
u Studyof genetic factors influencing individual
response
u Tolerance
u Decreased drug responsiveness over time
u Tachyphylaxis
u Acute, rapid decrease in drug responsiveness
regardless of time
u Placebo effect
u Drugresponse not attributed to chemical drug
properties
Pharmacodynamics 75

u Drug interactions
uAltered drug effect due to interaction
with another drug
u Pharmacokinetic interactions
uChanges occurring in absorption,
distribution, metabolism, and excretion
Pharmacodynamic Interactions 76

u Additive
u Sum of effects of two drugs
u Synergistic
u Effect
is much greater than effects of either
drug alone.
u Antagonistic
u One drug reduces or blocks effect of other
drug.
Pharmacodynamics 77

u Drug-nutrient interactions
u Food may increase, decrease, or delay
drug response.
u Drug-laboratory interactions
u Drugs may cause misinterpretation of test
results.
u Drug-induced photosensitivity
u Skin reaction caused by sunlight exposure.
Pharmacologic Principles 78

4) Pharmacotherapeutics

The use of drugs and the

clinical indications for drugs to
prevent and treat diseases
 Pharmacotherapeutics
79
q Acute therapy-------- stroke, heart attack

q Maintenance therapy--- hypertension, hyperlipidemia,

q Supplemental/replacement therapy----insulin, iron, thyroid

q Palliative therapy--- high dose opioids for cancer patients,

q Supportive therapy—fluid and electrolytes, volume

expanders

q Prophylactic therapy--- antibibiotics before surgery

q Empiric therapy– experience shows it works- no evidence-

Pharmacotherapeutics 80

Therapeutic Drug Monitoring

u Certain drugs need close monitoring of blood levels

during administration

u They have a potential to become toxic--

some can become toxic at very low blood levels
Pharmacotherapeutics: Monitoring

Iatrogenic Responses

Unintentional adverse effects that are treatment-induced

u Dermatologic

u Renal damage

u Blood dyscrasias

u Hepatic toxicity
 Toxicology
Drug Related Effects
82

q Teratogenic
drugs or chemicals that result fetal defects
Accutane

q Mutagenic
drugs or chemicals that cause permanent changes in the genetic
composition
may pose a genotoxic hazard to hospital personnel or
family
members caring for the patient.

q Carcinogenic
drugs, chemicals etc. that cause cancer
Tobacco
Tamoxifen
 83
Practice Question #1

A patient has liver and kidney disease. He is

given a medication with a half-life of 30
hours. The nurse expects the duration of this
medication to

A. increase.
B. decrease.
C. remain unchanged.
D. dissipate.
 Practice Question #2 84

When assessing older adults and those with

renal dysfunction, the nurse knows that
creatinine clearance is usually

A. substantially increased.
B. slightly increased.
C. decreased.
D. in the normal range.
Practice Question #3 85

u A patient sustains significant burns to the skin and is experiencing

fluid shift associated with edema in the fluid overload phase. The
nurse would anticipate that this will interfere most with which phase
of pharmacodynamics?

A. Absorption
B. Distribution
C. Metabolism
D. Excretion
Practice Question #4 86

Which nursing actions would be most appropriate

for ensuring patient safety with a medication that
has a low therapeutic index?

A. Monitoring a patient’s urine output

B. Assessing vital signs hourly
C. Maintaining strict isolation precautions
D. Monitoring serum peak and trough levels
 Practice Question #5 87

Most drugs are metabolized in the

A. kidney.
B. small intestine.
C. liver.
D. brain.
Chapter 3
CULTURAL CONSIDERATIONS
 89
Cultural Considerations
u Ethnomedicine
u Study of ways in which people in different cultures
conceptualize health and illness.
u Traditional healers can include priests, herbalists, midwives,
etc.
u Ethnopharmacology
u Study of ethnic groups and their use of drugs
u Culture
u Shared learned beliefs and behaviors by a group
u Pharmacogenetics
u Study of inherited genetic differences affecting individual
responses to drugs
Cultural 90
Considerations
(Cont.)
u Transcultural nursing
u Provides culturally
competent care.
u Nurses need to be sensitive
to beliefs and practices of
different cultural groups.
u Complementary health
practices
u Alternative health practices
 Cultural Considerations 91

(Cont.)
u Transcultural Assessment Model
u Developed by Giger and Davidhizar in 1998
u Assumes that all cultures have six phenomena:
u Communication

u Space
u Social organization
u Time

u Environmental control
u Biologic variations
Cultural Considerations
92
(Cont.)
 93
Cultural Considerations
u Communication
u Occurs verbally and nonverbally
u Nurses
must be alert to different types of
communication styles.
u Use translators whenever possible.
u Do not assume understanding when patient is being
polite or nodding.
u All cultures have prescribed norms for greetings.
 94
Cultural Considerations
u Space
u Amount of space around a person’s body is an important
psychological consideration.
u Americans often desire much personal space.
u Major challenges include
u use of touch.
u protection of modesty.
u Communities particularly sensitive to touch
u Muslim, Orthodox Jewish, Amish, Roma
u Ask patient about preferences.
 Cultural Considerations 95

u Social organization
u Families are basic social units.
u Include family whenever appropriate.
u Time
u Perception of time is shaped by culture and
situation.
u Some cultures are primarily present-oriented;
others are past-oriented or future-oriented.
 96
Cultural Considerations

u Environmental control
Ø Concept of nature may include
otherworldly forces and beings (e.g., spirits).
Ø Traditional healers
Ø Spiritual advisors
u Biologic variations
u The Genographic Project
Ø Human Genome Project
 Cultural Considerations: 97
Nursing Process
u Assessment
u Assess cultural background and preferences.
u Planning
u Collaborate with patient to meet health care needs.
u Nursing interventions
u Incorporate nonharmful traditional practices with
conventional prescriptive therapies when appropriate.
u Use appropriate translators when needed.
u Allow patient adequate time with family and group
members.
 Cultural Considerations: 98

Nursing Process (Cont.)

u Patient teaching
uInvolvefamily or group members in
teaching about prescriptive therapies.
u Evaluation
uEvaluate understanding and outcomes of
prescriptive therapies.
 Practice Question #1 99

Timeliness for appointments may be

especially important for some members of
which ethnocultural group?

A. Filipino
B. Native American
C. European American
D. African American
 Practice Question #2
100

Pharmacogenetic research has found that some African

Americans

A. are less responsive to beta blockers than are

European Americans.
B. are more responsive to beta blockers than are
European Americans.
C. experience fewer toxic side effects with
psychotropic medications than do European
Americans.
D. experience fewer toxic side effects with
antidepressant medications than do European
Americans.
 Practice Question #3 101

The patient’s culture may influence the patient’s

attentiveness to time. This may be of special
concern to nurses when they teach patient about

A. the routes of medication administration.

B. the schedule of medication dosing.
C. the anticipated side effects.
D. the anticipated therapeutic effects.
 Practice Question #4 102

A nurse is aware that some drug responses are

unique to an individual due to social, cultural, and
biological phenomena. This is an example of

A. biological variations.
B. Giger Model.
C. ethnopharmacology.
D. pharmacogenetics.
Chapter 5
PEDIATRIC CONSIDERATIONS
Pediatric Pharmacology 104

u Limited research
uResearch risk
uObtaining informed consent
uDrug labeling and dosing instructions
uPediatric Research Equity Act in 2012
uRequires study of pediatric drug use
 Pediatric Pharmacokinetics 105

u Absorption
u Influencing factors
u Child’s age, health status, weight, route of administration
u Nutritional habits, physical maturity, hormonal differences
u Hydration, underlying disease, GI disorders
u Route of administration
u Gastric acidity, emptying, motility, surface area, enzyme levels, intestinal flora
u IM/subQ
u Peripheral perfusion
u Effectiveness of circulation
u Topical
u Children’s skin is thin and porous.
Pediatric Pharmacokinetics (Cont.) 106
u Distribution
u Influencing factors
u Body fluid composition
u Neonates and infants have 75% water.
u Body tissue composition
u Neonates and infants have less body fat.
u Protein-binding capability
u Neonates and infants have less albumin and fewer protein
receptor sites.
u Effectiveness of barriers
u Skin
u Blood-brain barrier
Pediatric Pharmacokinetics (Cont.) 107

u Metabolism
uInfluencing factors
uMaturational level of child
uLiver metabolism
uHigher metabolic rate
Pediatric Pharmacokinetics (Cont.) 108

uExcretion
uKidneys
uInfants have decreased
urenal blood flow.
uglomerular filtration rate.
urenal tubular function.
Pediatric Pharmacodynamics 109

u Mechanisms of action and effect of a drug on

the body
u Includes the onset, peak, and duration of
effect of a medication.
u Intensity of therapeutic effects and adverse
effects
Nursing Implications 110

u Pediatric drug dosing and monitoring

u Monitoring for therapeutic effects and adverse
reactions
u Calculations
u Pediatric drug administration
u Considering developmental and cognitive differences
u Differentiating developmental from chronologic age
u Maintainingsafety while ensuring comfort
u Family-centered care
Nursing Implications (Cont.) 111

u Pediatric drug administration

u Teaching is directed toward family or caregivers and patients.
u Side effects may be difficult to evaluate.
u Assess pediatric patient for ability to understand the reason for drug.
u Consider level of knowledge, developmental age, cultural factors, anxiety level,
when communicating with pediatric patient and family.
Nursing Implications (Cont.) 112

u Pediatric drug administration

u Atraumatic care
u Oral administration
u Subcutaneous, intramuscular, and intravenous
u Eutectic mixture of local anesthetics
u Decreasing pain and anxiety
u Distraction, diversion, relaxation
u Creative imagery
Nursing Implications (Cont.) 113

uPediatric drug administration

uIntravenous sites
uBasic rules
uHonesty, respect
uAge-appropriate teaching and
explanations
uPositive reinforcement
Adolescent Considerations 114

u Considerations for adolescents

u Need individualized care specific to
developmental stage
u Physical changes
u Cognitive level and abilities
u Social, reasoning, and decision-making skill
development
u Emotional factors
u Independence from parents
u Self-care behaviors
u Impact of chronic illness
Nursing Process: Family-Centered 115
Collaborative Care
u Assessment
u Age, weight, height
u Developmental age
u Health status
u Allergy history
u Nutritional/hydration status
u Cognitive level
u Family/child understanding
u History of drug use
Nursing Process: Family-Centered 116
Collaborative Care (Cont.)
uPotential nursing diagnoses
uKnowledge, deficient
uHealth maintenance, ineffective
uKnowledge, readiness
uInjury, risk for
Nursing Process: Family-Centered 117
Collaborative Care (Cont.)
u Planning
u Child,
family members, and caregivers will
recognize the need for drug administration.
u Child, family members, and caregivers will
incorporate the drug treatment regimen into
their lifestyle.
u Child,
family members, and caregivers will
demonstrate safe drug administration practices.
Nursing Process: Family-Centered 118
Collaborative Care (Cont.)
u Nursing interventions
u Assistpatient, family, and caregivers to use
appropriate follow-up resources and support.
u Follow all rights of safe drug administration.
u Help patient, family, and caregivers to manage
complex drug schedules.
u Use educational strategies that are interactive
and engaging for the pediatric patient.
Nursing Process: Family-Centered 119
Collaborative Care (Cont.)
u Evaluation
uDetermine child’s physiologic and
psychological response.
uDetermine family member’s knowledge
concerning drug, dose, administration
schedule, and side effects.
uDetermine therapeutic and adverse effects
of drug(s).
 Practice Question #1 120

Children have higher metabolic rates than adults. The

nurse realizes that this affects administration of
medication for pain in children in all of the following
ways except

A. higher requirement for medication.

B. increased dosage.
C. decreased frequency.
D. increased frequency.
 Practice Question #2 121

Although adolescents have physical appearance and organ

structure and function similar to that of adults, the nurse
understands that their bodies continue to grow, requiring
the nurse to follow increased vigilance in monitoring what?

A. Therapeutic and toxic drug levels

B. Side effects of medications
C. Route of medication administration
D. Frequency of medication administration
 Practice Question #3 122

A toddler requires an oral medication. It is most

appropriate for the nurse to administer the oral
medication

A. in a nipple.
B. dipped in a pacifier.
C. via an oral syringe.
D. mixed with formula in a bottle.
 Practice Question #4 123

Drug calculations for children are based on which

factors? (Select all that apply.)

A. Sex
B. Age
C. Weight
D. Height
Chapter 6
GERIATRIC CONSIDERATIONS
Geriatric Considerations 125

u Aging population
u Physiologic changes
u Reduction in total body water and lean body
mass
u Reduction in kidney mass and function
u Reduction in liver mass and function
u Reduction in physiologic processes that
maintain equilibrium
Geriatric Considerations (Cont.) 126

uPharmacokinetics
uAbsorption
uDistribution
uMetabolism
uExcretion
Geriatric Considerations (Cont.) 127

u Pharmacodynamics
u Age-relatedchanges in the central nervous system
and cardiovascular system
u Changes in the number of drug receptors
u Changes in the sensitivity of receptors to drugs
u Compensatory response to physiologic changes is
decreased.
Nursing Implications: Older Adult Drug 128
Dosing and Monitoring
u Polypharmacy
u Riskfactors
u Pharmacotherapy
u Beers criteria for potential inappropriate drug
use
u Renal dosing of drugs
u Drug-drug interactions
u Provide safety information
Nursing Implications: Older Adult Drug 129
Dosing and Monitoring (Cont.)
uAdverse drug events
uAdverse reactions
uMedication errors
uTherapeutic failures
uAdverse drug withdrawal events
uOverdoses
Nursing Implications: Older Adult Drug 130
Dosing and Monitoring (Cont.)
u Adherence
u Patient may not fully understand drug regimen.
u Nonadherence may cause underdosing.
u Nonadherence may cause overdosing.
u Barriers to effective drug use by the older adult
u Medication education extremely important
Health Teaching 131
With the Older Adult
u Have patient’s senses as sharp as possible.
u Wearing clean eyeglasses.
u Make sure that functional hearing aids are in place.
u Speak in tones such that patient can hear.
u Face patient when speaking.
u Limit distractions.
u Treat patient with respect.
u Expect that the patient can learn.
u Use large print and bright colors in teaching aids.
Health Teaching 132
With the Older Adult (Cont.)
u Review all medications at each visit.
u Advise patient to complete vial of life.
u Instruct patient to take the list of all drugs
taken to all health appointments.
u Encourage a simple dosing schedule.
Health Teaching 133
With the Older Adult (Cont.)
u With onset of confusion or disorientation,
suspect recently prescribed
medication(s).
u Encourage the patient to report if the new
drug is not improving the condition for
which it was prescribed.
u Consider use of memory aids.
Nursing Process: Patient-Centered 134
Collaborative Care
u Assessment
uAssess for sensory and cognitive barriers.
uAssess laboratory results.
uDiscern whether patient lives alone, with or
without social support, and if assistance is
needed with medications, including costs
or transportation.
Nursing Process: Patient-Centered 135
Collaborative Care (Cont.)
uNursing diagnoses
uIneffective health maintenance
related to lack of or alteration in
communication skills
uKnowledge, deficient related to
cognitive limitation
Nursing Process: Patient-Centered 136
Collaborative Care (Cont.)
uPlanning
uPatient will collaborate with health care
providers to develop a therapeutic
regimen that is congruent with health
goals and lifestyle.
uPatient will list resources that can be
used for more information and support.
Nursing Process: Patient-Centered 137
Collaborative Care (Cont.)
u Nursing interventions
u Monitor laboratory results.
u Observe the patient for adverse reactions when multiple drugs are taken.
u Recognize a change in usual behavior or an increase in confusion.
u Remind patient and family to tell pharmacist about OTC preparations that the
patient is taking.
u Advise patient and family to request non-childproof caps.
u Evaluation
 Practice Question #1 138

When administering medications to the older adult

population, the nurse is aware that the physiologic
changes of aging that can affect drug activity include all
of the following except

A. increased fat-to-water ratio.

B. decreased liver enzyme production.
C. loss of nephrons.
D. increased gastrointestinal blood flow.
 Practice Question #2 139

Adverse reactions and drug interactions occur

frequently in older adults due to all of the following
except

A. consumption of numerous drugs owing to multiple chronic

illnesses.
B. drugs ordered by several health care providers.
C. increased incidence of allergic responses.
D. self-medication with OTC preparations.
 Practice Question #3 140

Older adults are at risk for taking many medications

together. This is known as

A. tachyphylaxis.
B. drug interaction.
C. polypharmacy.
D. tolerance.
 Practice Question #4 141

Which is a physiologic change seen in the older adult

that has an effect on drug administration?

A. Lower (acidic) gastric secretions

B. Increased first-pass effect through the liver
C. Increased glomerular filtration rate
D. Lower cardiac output
 Practice Question #5 142

When assessing older adults’ renal function, which

laboratory value will the nurse monitor?

A. Liver enzymes
B. Serum electrolytes
C. Complete blood count
D. Blood urea nitrogen and creatinine