Cultural, Legal, and Ethical Considerations 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? African American Asian Hispanic White Correct answer: C Rationale: 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. Copyright © 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.

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

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

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

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

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

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

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 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. Correct answer: C Rationale: The researcher may try to find the reasons for withdrawal and request that they 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. Copyright © 2014 by Mosby, an imprint of Elsevier Inc. Elsevier items and derived items © 2009, 2005, 2001 by Saunders, an imprint of Elsevier Inc.

Legal Nursing Considerations 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 Copyright © 2014 by Mosby, an imprint of Elsevier Inc.

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.

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

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 refuse to participate. ask to switch assignments with another nurse. speak to the manager or supervisor. perform the procedure. Correct answer: C Rationale: 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. Copyright © 2014 by Mosby, an imprint of Elsevier Inc. Elsevier items and derived items © 2009, 2005, 2001 by Saunders, an imprint of Elsevier Inc.