Chapter 4
Cultural, Legal, and Ethical
Considerations
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Audience Response System
Question #1
Which racial group is predicted to be nearly one in
three U.S. residents in 2050?
A. African American
B. Asian
C. Hispanic
D. White
NOTE: No input is required to proceed.
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Answer to System Question #1
ANS: C
It is predicted that by 2050, nearly one third of the U.S.
population will be Hispanic. The non-Hispanic, single-race
white population is projected to be only slightly larger in
2050. The African-American population is projected to
increase from 41 million (about 14%) to about 66 million (or
15%) by 2050. The Asian population is projected to
increase from 15 million to about 40 million, rising from a
current 5.1% to 9.2% of the total population.
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3
Ethnopharmacology
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
Body of knowledge for understanding the
specific impact of cultural factors on patient drug
response
Lack of clarity in terms: race, ethnicity, and
culture
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4
Cultural Considerations
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Pharmacogenomics: study of how certain
genetic traits affect drug response
Drug polymorphism
Adherence with therapy
Environmental and economic considerations
Pharmacokinetics
Pharmacodynamics
Varying drug responses in different racial or
ethnic groups
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Cultural Considerations (Cont.)
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Health beliefs and practices
Barriers to adequate health care for the
culturally diverse U.S. patient population
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Language, poverty, access, pride, and beliefs
regarding medical practices
Medications may have a different meaning to different
cultures.
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Cultural Assessment
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Languages spoken: need for interpreter
Health beliefs and practices
Past uses of medicine
Herbal treatments, folk remedies, and home
remedies
Over-the-counter drugs and treatment
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Cultural Assessment (Cont.)
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Usual response to illness
Responsiveness to medical treatment
Religious practices and beliefs
Support from the patient’s cultural community
Dietary habits
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Audience Response System
Question #2
Which of the following statements regarding African
Americans’ responses to antihypertensive medication
therapy is true?
A. African Americans respond better to diuretics than to
beta blockers.
B. African Americans do not respond to diltiazem.
C. Single-drug therapy is effective for African Americans.
D. Hypertension is uncommon in the African-American
population.
NOTE: No input is required to proceed.
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Answer to System Question #2
ANS: A
African Americans respond less effectively to beta
blockers. African Americans respond best to
calcium channel blockers, especially diltiazem.
African Americans respond less effectively to
single-drug therapy.
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10
Legal Considerations



Food and Drug Administration (FDA)
Drug Enforcement Agency (DEA)
Individual state laws
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HIPAA

Health Insurance Portability and Accountability
Act (HIPAA)

1996
 Maintain privacy regarding protected health
information
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12
New Drug Development
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Food and Drug Administration (FDA): primary
purpose of the FDA is to protect patients and
ensure drug effectiveness.
Dietary Supplement Health and Education Act of
1994
National Center for Complementary and
Alternative Medicine of 1998
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New Drug Development (Cont.)
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Expedited drug approval process
U.S. FDA drug approval process
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Preclinical testing
Clinical studies
Investigational drug studies
Expedited drug approval
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U.S. FDA Drug Approval Process
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Informed consent
Investigational new drug study
Preclinical investigational drug studies
Clinical phases of investigational drug studies
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Phase I
Phase II
Phase III
Phase IV
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U.S. FDA Drug Approval Process (Cont.)

Black box warning
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

Class I
Class II
Class III
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Audience Response System
Question #3
A research group is conducting an investigational drug study on a
promising new drug for osteoporosis. It has been difficult to find
research participants who meet the criteria. Just before the
conclusion of the study, four participants approach the researchers
and express their desire to withdraw from the study. What is the
researcher’s priority intervention?
A.
B.
C.
D.
Inform them that they waited too long to withdraw from the study.
Explore with them the reasons for withdrawing from the study.
Acknowledge that they can withdraw at any time from the study.
Request that they try to remain with the study until it is
completed.
NOTE: No input is required to proceed.
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Answer to System Question #3
ANS: C
The researcher may try to find the reasons for
withdrawal and request that the participants try to
remain with the study, but the individuals must
know that their participation is truly voluntary and
that they can quit the study at any time.
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Legal Considerations Related to Drug
Therapy and Nursing Practice
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State and federal legislation
Nurse practice acts
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Scope of nursing practice
Expanded nursing roles
Educational requirements
Standards of care
Minimally safe nursing practice
Differences between nursing and medical practice
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Legal Considerations Related to Drug
Therapy and Nursing Practice (Cont.)
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Guidelines from professional nursing groups
American Nurses Association (ANA)
Institutional policies and procedures; state and
federal hospital licensing
Specific Nurse Practice Acts
Standards of Practice
HIPPA
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Ethical Terms Related to Nursing
Practice
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Autonomy
Beneficence
Autonomy
Confidentiality
Justice
Nonmaleficence
Veracity
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Audience Response System
Question #4
A nurse does not notice that a patient’s IV site is swollen,
red, painful, and warm to touch nor that the IV has quit
infusing properly. What ethical principle does this involve?
A.
B.
C.
D.
Breach of duty
Duty
Causation
Damage
NOTE: No input is required to proceed.
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Answer to System Question #4
ANS: A
Refer to Teamwork and Collaboration: Legal and
Ethical Principles: Elements of Liability for Nursing
Malpractice box on page 58 in the textbook.
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Legal and Ethical Principles: Elements
of Liability for Nursing Malpractice


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
Duty
Breach of duty
Causation
Damage
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Ethical Considerations

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ANA Code of Ethics for Nurses
International Council of Nurses Code of Ethics
for Nurses
Placebos
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Audience Response System
Question #5
A nurse has been asked to participate in an elective
procedure that violates the nurse’s personal ethical
principles. What is the nurse’s best action?
A.
B.
C.
D.
Refuse to participate.
Ask to switch assignments with another nurse.
Speak to the manager or supervisor.
Perform the procedure.
NOTE: No input is required to proceed.
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Answer to System Question #5
ANS: C
The nurse has a right to refuse to participate in any
treatment or aspect of patient care that violates the
nurse’s personal ethical principles. However, this
should be done without deserting the patient. The
matter should be discussed with the manager or
supervisor so that a change in assignment can be
approved.
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