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.African American B.Asian C.Hispanic D.White 2Copyright © 2014 by Mosby, an imprint of Elsevier Inc.

Cultural Considerations  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 Copyright © 2014 by Mosby, an imprint of Elsevier Inc.3

Cultural Assessment 4Copyright © 2014 by Mosby, an imprint of Elsevier Inc.  Languages spoken  Health beliefs and practices  Past uses of medicine  Herbal treatments, folk remedies, home remedies  Over-the-counter drugs and treatment

Cultural Assessment (cont’d) 5Copyright © 2014 by Mosby, an imprint of Elsevier Inc.  Usual response to illness  Responsiveness to medical treatment  Religious practices and beliefs  Support from the patient’s cultural community  Dietary habits

U.S. Drug Legislation 6Copyright © 2014 by Mosby, an imprint of Elsevier Inc.  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)

U.S. Drug Legislation (cont’d) 7Copyright © 2014 by Mosby, an imprint of Elsevier Inc.  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

New Drug Development 8Copyright © 2014 by Mosby, an imprint of Elsevier Inc.  Investigational new drug (IND) application  Informed consent  U.S. FDA drug approval process  Preclinical testing  Clinical studies  Investigational drug studies  Expedited drug approval

U.S. FDA Drug Approval Process 9Copyright © 2014 by Mosby, an imprint of Elsevier Inc.  Preclinical investigational drug studies  Clinical phases of investigational drug studies  Phase I  Phase II  Phase III  Phase IV

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. Copyright © 2014 by Mosby, an imprint of Elsevier Inc.10

Legal Nursing Considerations 11Copyright © 2014 by Mosby, an imprint of Elsevier Inc.  State and federal legislation  Nurse practice acts  Scope of nursing practice  Expanded nursing roles  Educational requirements  Standards of care  Minimally safe nursing practice  Differences between nursing and medical practice

Legal Nursing Considerations (cont’d)  Guidelines from professional nursing groups  Institutional policies and procedures, state and federal hospital licensing  Case law or common law  HIPAA Copyright © 2014 by Mosby, an imprint of Elsevier Inc.12

Ethical Considerations 13Copyright © 2014 by Mosby, an imprint of Elsevier Inc.  American Nurses Association (ANA) Code of Ethics for Nurses  International Council of Nurses (ICN) Code of Ethics for Nurses

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. 14Copyright © 2014 by Mosby, an imprint of Elsevier Inc.