Study Guide for Exam #1 N 224 Winter/2025
1. Review important points about nurse practitioner prescribing authority
Nurse practitioner - The Board of Nursing regulates practice- Five states have joint oversight.
27 states, the District of Columbia, and Guam, APRNs are totally autonomous.
BENEFITS OF APRN prescribers:
•Lifestyle and chronic disease management
•Consideration of herbal therapies
•Nutrition counseling
•Education
*Holistic approach to care
•Culturally specific and sensitive
•Education is tailored to patient preferences
KNOWLEDGE CHECK
Which of the following is the best strategy to enhance medication adherence?
A.Provide written education material
B.Explain in detail how the drug works
C.Communicate clearly at a 6th-grade level
D.Tell the patients to take the drug as prescribed
Barriers to medication adherence include which of the following?
A.Real or perceived adverse reactions
B.Trust in the provider
C.Remembering to take the medication
D. Belief in the effectiveness of the medication
, 2. Know the different functions of the US Food and Drug Administration (FDA)
The FDA regulates:
•Standardization of nomenclature
•Approval process of new drugs or new indications
•Official labeling
•Surveillance of adverse drug events
•Methods of manufacture and distribution
•Medical and electronic devices
•Advertising of prescription drugs
The FDA regulates what goes on a label
•Labeling on over-the-counter (OTC) drugs
•Package insert in prescription drugs
•Physicians’ Desk Reference – official labeling
3. Know the different stages of clinical trials for a new drug required by FDA
Clinical research – phases of investigational drug testing before approval:
‒Phase I
‒Phase II
‒Phase III
Postapproval research
-Phase IV studies to detect adverse events
KNOWLEDGE CHECK!!
Drugs approved by the U.S. Food and Drug Administration (FDA) must be both safe and
effective and are screened by pharmacologists specializing in various aspects of drug
toxicity.
The FDA requires drug companies to conduct clinical trials for any new drug. The phase
III
clinical trial will:
1. Establish biological effects, as well as safe dosages and pharmacokinetics in a small number
, of healthy patients
2. Compare the new medication to standard therapy in a large number of patients studied in
population across the country.
3. Use new drugs to treat disease in a small number of patients and establish the potential of
the drug to improve patient outcomes
4. Set up potential marketing goals and outcomes using large number of patients outside the
United States
4. Review the process to apply for a new investigational drug application to FDA
Drug Price Competition and Patent Term Restoration Act of 1984
-Expanded the number of generic drugs suitable for an abbreviated new drug application
(ANDA)
Preclinical research must be conducted: phase I, II, III for new drug application.
Expedited new drug approval
•Priority review
•Breakthrough therapy
•Accelerated approval
•Fast track
Postapproval research
•Phase IV studies to detect adverse events
•Data submitted through MedWatch
KNOWLEDGE CHECK!!
An investigational new drug is filed with the U.S. Food and Drug Administration:
1. When the manufacturer has completed phase III trials
2. When a new drug is discovered
3. Prior to animal testing of any new drug entity
4. Prior to human testing of any new drug entity
5. Review what is a “pain medication contract”
Medication agreements
•Incorporate into treatment plan
1. Review important points about nurse practitioner prescribing authority
Nurse practitioner - The Board of Nursing regulates practice- Five states have joint oversight.
27 states, the District of Columbia, and Guam, APRNs are totally autonomous.
BENEFITS OF APRN prescribers:
•Lifestyle and chronic disease management
•Consideration of herbal therapies
•Nutrition counseling
•Education
*Holistic approach to care
•Culturally specific and sensitive
•Education is tailored to patient preferences
KNOWLEDGE CHECK
Which of the following is the best strategy to enhance medication adherence?
A.Provide written education material
B.Explain in detail how the drug works
C.Communicate clearly at a 6th-grade level
D.Tell the patients to take the drug as prescribed
Barriers to medication adherence include which of the following?
A.Real or perceived adverse reactions
B.Trust in the provider
C.Remembering to take the medication
D. Belief in the effectiveness of the medication
, 2. Know the different functions of the US Food and Drug Administration (FDA)
The FDA regulates:
•Standardization of nomenclature
•Approval process of new drugs or new indications
•Official labeling
•Surveillance of adverse drug events
•Methods of manufacture and distribution
•Medical and electronic devices
•Advertising of prescription drugs
The FDA regulates what goes on a label
•Labeling on over-the-counter (OTC) drugs
•Package insert in prescription drugs
•Physicians’ Desk Reference – official labeling
3. Know the different stages of clinical trials for a new drug required by FDA
Clinical research – phases of investigational drug testing before approval:
‒Phase I
‒Phase II
‒Phase III
Postapproval research
-Phase IV studies to detect adverse events
KNOWLEDGE CHECK!!
Drugs approved by the U.S. Food and Drug Administration (FDA) must be both safe and
effective and are screened by pharmacologists specializing in various aspects of drug
toxicity.
The FDA requires drug companies to conduct clinical trials for any new drug. The phase
III
clinical trial will:
1. Establish biological effects, as well as safe dosages and pharmacokinetics in a small number
, of healthy patients
2. Compare the new medication to standard therapy in a large number of patients studied in
population across the country.
3. Use new drugs to treat disease in a small number of patients and establish the potential of
the drug to improve patient outcomes
4. Set up potential marketing goals and outcomes using large number of patients outside the
United States
4. Review the process to apply for a new investigational drug application to FDA
Drug Price Competition and Patent Term Restoration Act of 1984
-Expanded the number of generic drugs suitable for an abbreviated new drug application
(ANDA)
Preclinical research must be conducted: phase I, II, III for new drug application.
Expedited new drug approval
•Priority review
•Breakthrough therapy
•Accelerated approval
•Fast track
Postapproval research
•Phase IV studies to detect adverse events
•Data submitted through MedWatch
KNOWLEDGE CHECK!!
An investigational new drug is filed with the U.S. Food and Drug Administration:
1. When the manufacturer has completed phase III trials
2. When a new drug is discovered
3. Prior to animal testing of any new drug entity
4. Prior to human testing of any new drug entity
5. Review what is a “pain medication contract”
Medication agreements
•Incorporate into treatment plan
