Exam One Flashcards
What is the National Institutes of Health (NIH) Revitalization Act?
Ensures women and minorities are included in clinical research
What is Pre-Clinical Drug Testing and what does it study?
- Performed on animals or human cells/tissues (outside of the body)
- Studies toxic/pharmacological effects of drugs
What is informed consent and what does it include?
HINT: PECIVC
- The right to be informed, participate voluntarily, and without coercion
- Includes purpose of the study, what is expected of patient, and potential consequences of the study
Define autonomy
Right to make decisions for oneself
List the core ethical principals
- Respect for persons
- Beneficence
- Justice
Define beneficence
- Duty to protect research subjects from harm
- Ensuring benefits of the clinical study are greater than the risks
Define non-maleficence
HINT: Beneficence = Non-Maleficence
The act of “do no harm”
What is risk-benefit ratio and who determines it?
- Risks of a clinical study must be balanced with the anticipated benefits
- Determined by the Institutional Review Board (IRB)
Who/What is in-vitro testing performed on?
Human cells or tissues (outside of the body)
Who/What is in-vivo testing performed on?
Whole, living organisms (i.e. animals)
In-Vitro and In-Vivo testing are a part of what?
Pre-clinical drug testing
What is the Best Pharmaceuticals for Children Act?
Requires that drugs marketed for children be tested on children for safety and effectiveness
What is the Pediatric Research Equity Act?
- Recognizes a child’s response to drugs are not solely affected by size and weight
- Notes that “children are not just small adults”
What is the purpose of Phase 1 Drug Research? Who is it conducted on?
- Tests for safety of the drug (i.e. safe dosage ranges and side affects)
- Conducted on 20-100 healthy individuals with no underlying health conditions
What is the purpose of Phase 2 Drug Research? Who is it conducted on?
- Tests for effectiveness of the drug
- Conducted on 100-300 people who currently have the condition the drug is meant to treat
What is the purpose of Phase 3 Drug Research? Who is it conducted on?
- Tests for effectiveness compared to marketed drugs that treat the same condition
- Conducted on large groups of >1000
- Involves double-blind, randomized trials
What is the purpose of Phase 4 Drug Research? Who is it conducted on?
- Tests the drug after approved for marketing for long term affects and safety
- Can be prescribed and marketed to various populations
What is the importance of randomized controlled trials?
- Most reliable way to evaluate drug therapy
- Ensures differences in outcome result from drug treatment, NOT differences in subjects
- Prevents bias and promotes fairness
What is a double blind study?
Neither the researcher or research subject know who is receiving experimental treatment
What is an experimental group?
A group that receives the drug/treatment being tested
What is a control group?
A group that receives no drug, a different drug, placebo, or the same drug at a different dose, frequency, or route
What is the American Nurses Association Code of Ethics?
- States the nurses primary ethical duty is to care for the patient
- Last revision addressed ethical considerations regarding social media, electronic health records, and expanding the nursing role in clinical research
What is the United States Pharmacopeia and National Formulary?
- Authoritative source for drug standards in the US
- Drugs included have met high standards of quality and safety
- Initials “USP” will follow the official drug name to denote global recognition
Nurse accountability for controlled substances includes?
- Verify orders before administering drug
- Account for all controlled drugs
- Maintain log of controlled substances
- Document all discarded drugs, witnessed by another nurse
- Timely documentation of drug administration
- Document patient response
- Keep all controlled drugs in locked storage container and double lock narcotics
- Mandatory reporting of suspected or known drug diversion
What is a Schedule I controlled substance? Give examples.
- Not safe or accepted for medical use
- Highest abuse/addiction potential
- Examples: heroin, LSD, peyote, crack cocaine, PCP
What is a Schedule II controlled substance? Give examples.
- Safe and accepted for medical use
- High abuse/addiction potential
- Examples: cocaine, morphine, oxycodone, methadone, fentanyl
What is a Schedule III controlled substance? Give examples.
- Less risk of abuse/addiction than Schedule II drugs
- Examples: acetaminophen with codeine, ketamine, anabolic steroids, testosterone
What is a Schedule IV controlled substance? Give examples.
- Less risk of abuse/addiction than Schedule I, II, or III drugs
- Examples: diazepam, lorazepam, tramadol, zolpidem
What is a Schedule V controlled substance? Give examples.
- Lowest potential for abuse
- Contain limited quantities of narcotics
- Examples: cough preparations with <200mg of codeine per 100mL (Robitussin AC, phenergan with codeine, pregabalin)
What are chemical drug names?
- Describes the chemical structures of drugs
- Not commonly used
What are generic drug names?
- Official, nonproprietary, universal drug name
- Not owned by any drug company
- Only one name for each drug
- No trademark, lowercase first letter
- Same active ingredients as brand name drugs
- May have different inert ingredients than brand name drug
- Requires FDA approval
- Example: acetaminophen, ibuprofen
What are trade/brand drug names?
- Name owned by a drug company
- Uppercase first letter, trademark follows name
- Easier to spell and pronounce
- Example: Tylenol, Advil
What are the responsibilities of the FDA?
Ensure drugs are labeled correctly, effective for marketed condition, and safe
What is ‘Respect for Persons’?
Patients should be allowed to make their own decisions
What is an example of fairness?
When performing a drug study, if one group is receiving substantial benefits, stop study and allow all people of study to use the drug
What are counterfeit drugs?
- May contain wrong ingredients
- May have insufficient amount of active ingredients
- May have no active ingredients
- May contain impurities and contaminants
- May be distributed in fake packaging
What is the nurses role in regards to counterfeit drugs?
Educate the patient!
What is The Sherley Amendment?
- Prohibits false therapeutic claims on drug labels
- Mrs. Winslow’s Soothing Syrup, advertised to treat colic and teething, resulted in infant deaths because it contained morphine
What is The Federal Food, Drug, and Cosmetic Act?
- Requires FDA to ensure a drug is safe before marketing
- Requires FDA to ensure drugs are tested for harmful effects
- Requires FDA to ensure drugs are labeled with correct information, including adverse effects
What is the Comprehensive Drug Abuse Prevention and Control Act?
- Designed to lower problems of drug abuse by incorporating:
1) promotion and research into prevention and treatment of abuse
2) strengthening enforcement of authority
3) establishing treatment and rehabilitation facilities
4) creating schedules for drugs based on addictive tendencies
What is the Dietary Supplement and Education Act?
- Classified dietary supplements as food
- Enforced labeling requirements for FDA
- Authorized FDA to promote safe manufacturing practices
What is the Health Insurance Portability and Accountability Act (HIPAA)?
- Protects workers health insurance when they change or lose jobs
- Sets privacy standards for individuals health information
What is the Food and Drug Administration Safety and Innovation Act?
-Enhances safety of the global drug supply chains
What is pharmacogenetics and what does it do?
- How people respond to drug therapy related to their genetic makeup
- Studies how patients genome affects drug response
- Helps individualize optimal drug treatment regimes
- Helps decrease drug reaction
- Promotes drug regime adherence
- Reduces costs of healthcare
Pharmacogenetics is the same as what?
Pharmagonetics
What type of patients may benefit from pharmacogenetics?
- Those taking multiple prescription drugs
- Those not responding to current therapy
- Those having adverse drug reactions
- Those taking black box warning drugs
Is pharmacogenetic testing available for every drug?
No
What legal and ethical considerations should be made regarding pharmacogenetics, specifically autonomy?
- Patient may change their mind about genetic testing
- Patient may consent or refuse genetic testing
Define justice.
Equal and fair treatment for all
What are the four phases of pharmacokinetics?
- Absorption
- Distribution
- Metabolism
- Excretion
What is pharmacokinetics?
Body acting on the drug
What is pharmacodynamics?
Drug acting on the body
What are the three phases of pharmacodynamics?
- Receptor binding
- Post-receptor effects
- Chemical reaction
What is drug absorption?
Drug movement from the GI tract into the bloodstream
What does drug absorption require?
- Disintegration
- Dissolution
What is disintegration?
Breakdown of oral drugs into small particles
What is dissolution?
- Process of combining small drug particles with liquid to form a solution
- Not required if drug is already in liquid form
What are the different methods of absorption?
- Passive transport
- Active transport
- Pinocytosis
What is the most common, cheapest, and easiest route to administer drugs?
Enteral (oral)
What drug resists disintegration in the gastric acid of the stomach? Where is this drug absorbed?
- Enteric Coated (EC) drugs
- Small intestine
What factors affect drug absorption?
- Blood flow, pain, stress, gastric pH
- Food texture, fat content, temperature
- Route of administration
What factors cause minimal drug absorption?
-Decreased blood flow (i.e. shock or extreme decrease in blood pressure)
Which route of drug administration has the fastest onset of action?
IV
Which route of drug administration is slowed, depending on blood flow to the area?
Subcutaneous (SubQ)
Which route of drug administration has a slow onset and is unpredictable?
Oral
Which drug route is slower than IV, but faster than Subcutaneous?
IM
Passive transport occurs through what?
- Diffusion
- Facilitated Diffusion
What is diffusion?
Movement across a cell membrane from an area of higher concentration to an area of lower concentration
What is facilitated diffusion?
Movement across a cell membrane from an area of higher concentration to an area of lower concentration using a carrier protein
Which transport route does not require energy?
Passive transport
What is active transport?
- The movement of a drug across a concentration gradient
- Requires a carrier protein or enzyme
Which transport route requires energy?
Active transport
What is pinocytosis?
A cell carries the drug across the membrane by engulfing the drug particles
What organ metabolizes most drugs?
Liver
What is first pass affect, or first pass metabolism?
When the liver metabolizes a drug to an inactive form and it is excreted, reducing the amount of active drug available to exert a pharmacological effect