Chapter 2 Drug Development & Ethical Considerations

Question 1

U.S. Food and Drug Administration (FDA)

Answer 1

Designed to promote and protect the public’s health

Responsible for new drug approval and monitoring drug safety after they reach the market

Question 2

Core Ethical Principles

Answer 2

Respect for persons
Beneficence
Justice

Question 3

Respect for persons

Answer 3

Treated as individual
Autonomy
Informed consent

Question 4

Beneficence

Answer 4

Duty to protect subjects from harm
Risk-benefit ratio
IRB

Question 5

Justice

Answer 5

Selection of research subjects be fair

Distribution of benefits and burdens is equitable

Question 6

Phases of Pharmaceutical Research

Answer 6

Preclinical trials
Human clinical experimentation
Phase I
Phase II
Phase III
Phase IV

Clinical research study design
Independent variable
Dependent variable
Extraneous variables
Experimental group, control group, placebo

Question 7

American Nurses Association

Answer 7

Code of Ethics
Guide for carrying out nursing responsibilities
Adopted in 1950; Revised in 2015
9 Provisions included
The Nurse’s role in clinical research
Responsible for patient safety
Responsible for integrity of research protocol

Question 8

Drug Development and Ethical Considerations

Answer 8

Nurse Practice Acts
Different per state
Canadian Drug Regulation
Health Products and Food Branch (HPFB)
Review drugs for safety, efficacy, and quality prior to drug approval.
1996: Controlled Drugs and Substances Act
2012: Safe Streets and Communities

Question 9

Nursing Interventions for Controlled Substances

Answer 9

Account for all controlled drugs.
Keep a special controlled-substance record for required information.
Countersign all discarded or wasted medications; wastage must be witnessed.
Ensure that documentation and drugs on hand match.
Keep all controlled drugs in locked storage area.
Medications may also be administered via an automated dispensing cabinet with bioidentical identifiers used for access.
The American Nurses Association (ANA) recognizes nurse drug diversion and recommends that all states have a peer-to-peer assistance program for addicted nurses. Reporting is mandatory if suspected or known diversion occurs.

Question 10

Drug Names

Answer 10

Chemical names-Drug’s chemical structure
Generic names-Official, nonproprietary, not owned by any drug company
Brand/trade names
-Chosen by drug company
-Registered trademark

Question 11

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.

Answer 11

D

Question 12

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.

Answer 12

C

Question 13

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.

Answer 13

B