Ch 2 Drug Development

What are the three major ethical principles discussed in the chapter?

Respect for persons, beneficence, and justice.

What does respect for persons mean?

Respecting an individual's autonomy and right to make decisions about their own care.

What does beneficence mean?

Acting for the benefit and well-being of the patient.

What does justice mean?

Providing fair and equal treatment

What are preclinical trials?

Research conducted before a drug is tested in humans.

What are the phases of human clinical drug trials?

Phase I, Phase II, Phase III, and Phase IV

What is the general purpose of Phase I clinical trials?

To initially evaluate a drug in humans, including safety and how the body responds to it.

What is the general purpose of Phase II clinical trials?

To evaluate effectiveness and continue assessing safety in people with the condition being treated.

What is the general purpose of Phase III clinical trials?

To further evaluate effectiveness and safety in a larger population.

What is Phase IV research?

Postmarketing research conducted after a drug is approved and available to the public.

What are independent and dependent variables in research?

The independent variable is what the researcher changes or controls; the dependent variable is what is measured as the outcome

What is the purpose of the ANA Code of Ethics?

To guide nurses' responsibilities and ethical obligations while providing quality nursing care.

When was the ANA Code of Ethics adopted and when was it revised?

It was adopted in 1950 and revised in 2015.

What are two major responsibilities of a nurse involved in clinical research?

Protecting patient safety and maintaining the integrity of the research protocol

What does the nurse do when recognizing cues in clinical research?

Identifies patients who may be eligible for the study.

What should the nurse consider when analyzing and prioritizing research participants' needs?

Patient safety and needs such as health teaching.

What is the nurse's role in maintaining research protocol integrity?

Providing participant care according to the protocol and maintaining compliance with study requirements

What should the nurse do when obtaining informed consent?

Provide culturally competent information and ensure the participant understands the study before consenting.

What documentation is especially important during clinical research?

Accurate documentation of care, assessments, and administration of the study agent.

What roles can a nurse have during clinical research?

Advocate, educator, collaborator, and provider of safe patient care.

What is the primary purpose of federal drug legislation?

To ensure public safety.

What did HIPAA address?

Privacy and protection of patients' health information

What is the Sherley Amendment of 1912 associated with?

Federal regulation related to drug labeling/claims and preventing misleading drug information.

What did the Federal Food, Drug, and Cosmetic Act of 1938 establish?

Stronger federal regulation of drugs and food to protect public safety.

What did the Comprehensive Drug Abuse Prevention and Control Act of 1970 address?

Controlled substances and their regulation

What did the Dietary Supplement Health and Education Act of 1994 address?

Regulation of dietary supplements.

What did the Patient Protection and Affordable Care Act of 2010 address?

Major healthcare reform.

What is a counterfeit drug?

A drug that may contain incorrect, insufficient, or no active ingredients, contaminants/impurities, or fake packaging.

What should nurses teach patients about counterfeit drugs?

How to recognize potential problems and the importance of obtaining medications from reliable sources.

What are the three types of drug names?

Chemical name, generic/nonproprietary name, and brand/trade name.

What is the generic name of a drug?

The standardized, nonproprietary name of the drug.

What is an OTC drug?

A medication that can be obtained without a prescription and is considered appropriate for use without direct supervision of a healthcare professional.

Why did the FDA standardize OTC drug labeling?

To provide consumers with better information about medication benefits and risks.

What are examples of reliable drug information resources?

American Hospital Formulary Service Drug Information, USP Drug Information, Medical Letter, Prescriber's Letter, MedlinePlus, Handbook of Nonprescription Drugs, and credible internet sources.

A medication is labeled “furosemide.” Is this its brand or generic name?

Generic/nonproprietary name.

A hospital allows all staff members to have keys to a controlled-substance storage area. Should the nurse be concerned?

Yes. Access to controlled substances should be restricted to authorized personnel.