Transcript Pharmacology and the Nursing Process, 4th ed. Lilley/Harrington

Chapter 4
Cultural, Legal, and Ethical
Considerations
Copyright © 2014 by Mosby, an imprint of Elsevier Inc.
Classroom Response Question
Which racial group is predicted to be nearly one in three
U.S. residents in 2050?
A.
B.
C.
D.
African American
Asian
Hispanic
White
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Cultural Considerations
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Influence of ethnicity on genetics and drug
response
Drug polymorphism
Compliance level with therapy
Environmental and economic considerations
Barriers to adequate health care for culturally
diverse
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Cultural Assessment
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Languages spoken
Health beliefs and practices
Past uses of medicine
Herbal treatments, folk remedies, home
remedies
Over-the-counter drugs and treatment
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Cultural Assessment (cont’d)
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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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U.S. Drug Legislation
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1906: Federal Food and Drugs Act
1912: Sherley Amendment (to the Federal Food
and Drug Act of 1906)
1914: Harrison Narcotic Act
1938: Federal Food, Drug, and Cosmetic Act
(revision of 1906 act)
1951: Durham-Humphrey Amendment (to the
1938 act)
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U.S. Drug Legislation (cont’d)
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1962: Kefauver-Harris Amendments (to the 1938
act)
1970: Controlled Substances Act
1983: Orphan Drug Act
1996: Health Insurance Portability and
Accountability Act (HIPAA)
2003: Medicare Prescription Drug, Improvement,
and Modernization Act
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New Drug Development
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Investigational new drug (IND) application
Informed consent
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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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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Classroom Response Question
A research group is conducting an investigational drug study on a
promising new drug for osteoporosis. It has been difficult to find
research subjects who meet the criteria. Just before the
conclusion of the study, four subjects approach the researchers
and express their desire to withdraw from the study. The
researcher should first
A. inform them that they waited too long to withdraw from the
study.
B. explore with them the reasons for withdrawing from the study.
C. acknowledge that they can withdraw at any time from the
study.
D. request that they try to remain with the study until it is
completed.
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Legal Nursing Considerations
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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 Nursing Considerations
(cont’d)
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Guidelines from professional nursing groups
Institutional policies and procedures, state and
federal hospital licensing
Case law or common law
HIPAA
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Ethical Considerations
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American Nurses Association (ANA) Code of
Ethics for Nurses
International Council of Nurses (ICN) Code of
Ethics for Nurses
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Classroom Response Question
A nurse has been asked to participate in an
elective procedure that violates the nurse’s
personal ethical principles. The nurse should
A. refuse to participate.
B. ask to switch assignments with another nurse.
C. speak to the manager or supervisor.
D. perform the procedure.
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