Week 3 Flashcards
What are the three core ethical principles for drug research?
- Respect for persons
- Beneficence
- Justice
What are the two main aspects of the ethical principle “Respect for Persons”
- Autonomy
- Informed consent
What is Autonomy?
The right for self-determination
What is informed consent?
The patient should only consent if they have been completely informed of the risks and benefits.
- Provider Explains
- RN is advocate
What is Beneficence?
- Protecting the patient from harm
- Assessing the potential risks and making sure they are outweighed by the benefits
The Ethical principle of justice ensures that ____
the selection of participants in a drug study are selected in a fair manner
What is the purpose of pre-clinical trials?
To determine a drugs toxic and pharmacological effects
How many phases of Human Clinical drug experimentation are there?
4
What occurs during a phase 1 drug trial?
-New drug tested on small number to evaluate safety and determine safe dose range and side effects
What occurs during phase 2 drug trials
-Larger group to test effectiveness and eval safety
What occurs during phase 3 drug trials?
-Larger group to compare drug to other treatments and to continue to assess for safety, effectivness, and side effects
What occurs during phase 4 drug trials?
-occurs after drug is on market. Assesses long term use
According to the ADA code of ethics, what is the nurses responsibility during drug research?
They are responsible for the safety of the patient and integrity of the research protocol
For a drug to be included in the US pharmacopoeia they must meet _____
Standards set by the FDA
What categories of standards do drugs need to meet in order to be included in the national formulary?
7
- Therapeutic use
- Patient safety
- Quality
- Purity
- Strength
- Packaging safety
- Dosage form
What is the primary purpose of federal legislation in regard to drug approval
The ensure safety
-Protects from impure, toxic, ineffective, or untested drugs.
The nurse practice act states that
Nurses generally can not prescribe or administer drugs without a HCP’s order
What are the most common counterfeit drugs?
- HTN
- Antibiotics
- Chemo
- HIV/AIDs
- ED
What is the nurses role in protecting patients from counterfeit drugs?
To educate a patient to recognize and report differences in taste/apperance/packaging
Educate patient to pay attention to labels and to buy med’s from legitimate agencies
What are the three types of drug names?
- Chemical
- Generic
- Trade/Brand
What is a chemical drug name?
The actual chemical structure of the drug
What is a generic drug name?
The official name that is not owned by the drug company
What is a trade/brand drug name?
A name chosen by the drug company that is a registered trademark
Generic drugs are required to?
3 things
- Be approved by the FDA
- Be equivalent to the brand name
- Contain the same active ingredients as brand name
Does a generic drug need to have identical effectiveness to the brand name drug to be considered equivalent?
no. They are allowed a 20% variance in pharmacokinetic effects
