Chapter 1 Drug Development and Ethical Considerations

U.S. Food and Drug Administration (FDA)

The agency in the U.S. federal government that has the power to approve and disapprove new drugs.

Critical Path Initiative

a national strategy "to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured

Respect for Person

an ethical principle that incorporates two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection

Autonomy

the right to self-determination

When do patients have the right to refuse to participate in a research study?

They may refuse at any time and withdraw from study anytime without penalty.

Informed consent

an ethical principle that research participants be told enough to enable them to choose whether they wish to participate

Dimensions of Informed Consent

-It is a mutual sharing of information, a process of communication
-It expresses respect for the person
-It gains the patient's active involvement in their care
-It respects the patient's right to self-determination

Beneficence

duty to protect research subjects from harm.

Risk-Benefit Ratio

analysis of whether the research is important enough to warrant placing participants at risk All possible consequences of a clinical study must be analyzed and balanced against the inherent risks and the anticipated benefits.

Justice

requires the selection of research subjects be fair

Good Clinical Practice (GCP) Consolidated Guideline

an international and ethical scientifc quality standard for designing, conducting, monitoring, auditing, recording, analyzing, and reporting clinical research.

What are the guidelines for Good Clinical Practice (GCP)?

-Design
-Conduct
-Performance
-Monitoring
-Auditing
-Recording
-Analysis
-Reporting

Genotoxicity

the ability of a compound to damage genetic information in a cell

Phase I Clinical Trial

test new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II Clinical Trial

The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety

Phase III Clinical Trial

The drug or treatment is given to largegroups of people to confirm its effectiveness, monitor side effects, compare it to commonly use treatements, and collect information that will allow the drug or treatment to be used safely.

Phase IV Clinical Trial

Studies are done after the drug or treatment has been marketed to gather information and to assess any side effects associated with long-term use.

Experimental Group

receive the experimental intervention or treatment

Control Group

Do not receive the experimental intervention or treatment and provide a baseline against which to measure the effects of the treatment. Serve as comparison group when treatment results are evaluated

Independent Variable

the treatment (such as with a drug)

Dependent Variable

outcome (such as the clinical effect)

American Nurse Association (ANA)

defines nursing as the protection, promotion, and optimization of health and abilities; prevention of illness and injury; alleviation of suffering through diagnoses and treatment of human response; and advocacy in the care of individuals, families, commun

Experimental Design

A design in which researchers manipulate an independent variable and measure a dependent variable to determine a cause-and-effect relationship.

What are characteristics of an experimental design?

-different groups of subjects who receive treatment and a control group who receives no treatment, and alternative treatment or a combination of both.
-randomly assigns subjects to treatment or control groups
-Answers questions about drug safety and effic

Placebo

pharmacologically inactive substance

Nursing Responsibilities in Clinical Research

-recruiting and assessment of study subjects
-understanding of research protocol
-validity and reliability of measurement instruments
-communication and teamwork
-knowledge of HIPAA requirements
-staff education
-budget negotiations
-ongoing resource for

United States Pharmacopeia (USP)

authoritative list of drugs, formulas, and preparations that sets a standard for drug manufacturing and dispensing

United States Pharacopeia and the National Formulary (USP-NF)

the authoritative source for drug standards (dosage, forms, drug substances, excipients, biologics, compounded preparations, and dietary supplements that is published annually.

Pure Food and Drug Act

1906-first American law to regulate drugs. Require that all medications be free of impure products

Medwatch Program

This voluntary program encourages nurses and other health care professionals to report when a medication, product, or medical event causes serious harm to a patient.

Nurse Practice Act

law established to regulate nursing practice

Sherley Amendment (1912)

prohibited fraudulent therapeutic claims on drug labels. (Mrs. Winslow's Soothing Syrup for colic that contained morphine and cause infant death)

Federal Food, Drug, and Cosmetic Act of 1938

Ensures the safety of food, drugs & cosmetics sold within U.S. borders. Requires drug labels to include accurate information, detailed information on adverse effects, can prevent marketing drug FDA deems dangerous

Durham-Humphrey Amendment of 1952

Defined 2 specific drug categories for medications legend (prescription) and over the counter (OTC)

Kefauver-Harris Amendment of 1962

� Also known as the "Drug Efficacy Amendment".
� Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .
� Required drug advertising to be more closely regulated and disclose accurate information about

Comprehensive Drug Abuse Prevention and Control Act of 1970

law is a consolidation of numerous laws regulating the manufacturing and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances. It was created to remedy

The 1970 Drug Abuse Prevention and Control Act stated that Nurses must:

1. Verify Order
2. Account for all controlled medications
3. Maintain log
4. Document wasted and discarded medications
5. Timely documentation after administration
6. Keep locked stage and double lock narcotics
7. Peer to peer program for addicted nurses

Dietary Supplement Health and Education Act of 1994

defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices.

Health Insurance Portability and Accountability Act (HIPAA)

Privacy of patient health information and right to access. Created primarily to modernize the flow of healthcare information, stiuplate how personally identifiable information maintained by the healthcare and healthcare insurance industries should be prot

FDA Modernization Act of 1997

1. Review and use of new drug is accelerated
2. Ok to test drugs on children before manufacturing
3. Clinical trial data necessary for experimental drug use from serious to life threatening health conditions
4. Drug company required to provide information