Exam One Flashcards
1
Q
What is the National Institutes of Health (NIH) Revitalization Act?
A
Ensures women and minorities are included in clinical research
2
Q
What is Pre-Clinical Drug Testing and what does it study?
A
- Performed on animals or human cells/tissues (outside of the body)
- Studies toxic/pharmacological effects of drugs
3
Q
What is informed consent and what does it include?
HINT: PECIVC
A
- 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
4
Q
Define autonomy
A
Right to make decisions for oneself
5
Q
List the core ethical principals
A
- Respect for persons
- Beneficence
- Justice
6
Q
Define beneficence
A
- Duty to protect research subjects from harm
- Ensuring benefits of the clinical study are greater than the risks
7
Q
Define non-maleficence
HINT: Beneficence = Non-Maleficence
A
The act of “do no harm”
8
Q
What is risk-benefit ratio and who determines it?
A
- Risks of a clinical study must be balanced with the anticipated benefits
- Determined by the Institutional Review Board (IRB)
9
Q
Who/What is in-vitro testing performed on?
A
Human cells or tissues (outside of the body)
10
Q
Who/What is in-vivo testing performed on?
A
Whole, living organisms (i.e. animals)
11
Q
In-Vitro and In-Vivo testing are a part of what?
A
Pre-clinical drug testing
12
Q
What is the Best Pharmaceuticals for Children Act?
A
Requires that drugs marketed for children be tested on children for safety and effectiveness
13
Q
What is the Pediatric Research Equity Act?
A
- Recognizes a child’s response to drugs are not solely affected by size and weight
- Notes that “children are not just small adults”
14
Q
What is the purpose of Phase 1 Drug Research? Who is it conducted on?
A
- 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
15
Q
What is the purpose of Phase 2 Drug Research? Who is it conducted on?
A
- Tests for effectiveness of the drug
- Conducted on 100-300 people who currently have the condition the drug is meant to treat
16
Q
What is the purpose of Phase 3 Drug Research? Who is it conducted on?
A
- Tests for effectiveness compared to marketed drugs that treat the same condition
- Conducted on large groups of >1000
- Involves double-blind, randomized trials
17
Q
What is the purpose of Phase 4 Drug Research? Who is it conducted on?
A
- Tests the drug after approved for marketing for long term affects and safety
- Can be prescribed and marketed to various populations
18
Q
What is the importance of randomized controlled trials?
A
- Most reliable way to evaluate drug therapy
- Ensures differences in outcome result from drug treatment, NOT differences in subjects
- Prevents bias and promotes fairness
19
Q
What is a double blind study?
A
Neither the researcher or research subject know who is receiving experimental treatment
20
Q
What is an experimental group?
A
A group that receives the drug/treatment being tested
21
Q
What is a control group?
A
A group that receives no drug, a different drug, placebo, or the same drug at a different dose, frequency, or route
22
Q
What is the American Nurses Association Code of Ethics?
A
- 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
23
Q
What is the United States Pharmacopeia and National Formulary?
A
- 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
24
Q
Nurse accountability for controlled substances includes?
A
- 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
25
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
26
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
27
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
28
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
29
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)
30
What are chemical drug names?
- Describes the chemical structures of drugs
| - Not commonly used
31
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
32
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
33
What are the responsibilities of the FDA?
Ensure drugs are labeled correctly, effective for marketed condition, and safe
34
What is 'Respect for Persons'?
Patients should be allowed to make their own decisions
35
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
36
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
37
What is the nurses role in regards to counterfeit drugs?
Educate the patient!
38
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
39
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
40
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
41
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
42
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
43
What is the Food and Drug Administration Safety and Innovation Act?
-Enhances safety of the global drug supply chains
44
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
45
Pharmacogenetics is the same as what?
Pharmagonetics
46
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
47
Is pharmacogenetic testing available for every drug?
No
48
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
49
Define justice.
Equal and fair treatment for all
50
What are the four phases of pharmacokinetics?
- Absorption
- Distribution
- Metabolism
- Excretion
51
What is pharmacokinetics?
Body acting on the drug
52
What is pharmacodynamics?
Drug acting on the body
53
What are the three phases of pharmacodynamics?
- Receptor binding
- Post-receptor effects
- Chemical reaction
54
What is drug absorption?
Drug movement from the GI tract into the bloodstream
55
What does drug absorption require?
- Disintegration
| - Dissolution
56
What is disintegration?
Breakdown of oral drugs into small particles
57
What is dissolution?
- Process of combining small drug particles with liquid to form a solution
- Not required if drug is already in liquid form
58
What are the different methods of absorption?
- Passive transport
- Active transport
- Pinocytosis
59
What is the most common, cheapest, and easiest route to administer drugs?
Enteral (oral)
60
What drug resists disintegration in the gastric acid of the stomach? Where is this drug absorbed?
- Enteric Coated (EC) drugs
| - Small intestine
61
What factors affect drug absorption?
- Blood flow, pain, stress, gastric pH
- Food texture, fat content, temperature
- Route of administration
62
What factors cause minimal drug absorption?
-Decreased blood flow (i.e. shock or extreme decrease in blood pressure)
63
Which route of drug administration has the fastest onset of action?
IV
64
Which route of drug administration is slowed, depending on blood flow to the area?
Subcutaneous (SubQ)
65
Which route of drug administration has a slow onset and is unpredictable?
Oral
66
Which drug route is slower than IV, but faster than Subcutaneous?
IM
67
Passive transport occurs through what?
- Diffusion
| - Facilitated Diffusion
68
What is diffusion?
Movement across a cell membrane from an area of higher concentration to an area of lower concentration
69
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
70
Which transport route does not require energy?
Passive transport
71
What is active transport?
- The movement of a drug across a concentration gradient
| - Requires a carrier protein or enzyme
72
Which transport route requires energy?
Active transport
73
What is pinocytosis?
A cell carries the drug across the membrane by engulfing the drug particles
74
What organ metabolizes most drugs?
Liver
75
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
76
What is bioavailability?
Percentage of the administered drug that reaches systemic circulation
77
Drugs move from the GI tract to the liver via the what?
Portal vein
78
What factors affect bioavailability?
- Absorption
- First pass affect
- Drug form
- Route of administration
- Gastric mucosa and motility
- Administration with food or other drugs
- Changes in liver metabolism
79
Decreased liver function increases what?
Bioavailability
80
What is drug distribution?
Movement of drug from circulation to body fluids and tissues
81
What factors influence drug distribution?
- Protein binding
- Free drugs
- Blood brain barrier (BBB)
82
As drugs are distributed in the plasma, many bind with what?
Plasma proteins
83
What happens to a drug if it binds to a protein?
- It is unable to affect the rest of the body/interact with tissue receptors
- Becomes inactive
84
What is a free drug?
- Portion of a drug that is not bound to protein
| - Able to exit blood vessels and reach a site of action resulting in a pharmacological effect
85
What is the blood brain barrier? What is its purpose?
- Blood vessels of the brain, made of special endothelial lining, compressed tightly together
- Protects the brain from foreign substances
86
What drugs are able to cross the blood brain barrier?
- Highly-lipid soluble drugs
| - Drugs with low molecular weight (benzodiazepines)
87
Drug metabolism is also known as what?
Biotransformation
88
What is drug metabolism? Where does it occur?
- Process of the body chemically changing drug into a form that can be excreted
- Occurs primarily in the liver
89
If the liver function is decreased, what happens to the drug effects?
Increase
90
What is prodrug? Why is it used?
HINT: Codeine and Morphine
- Biologically inactive compound which is metabolized inside the body to produce an active drug
- Improves drug delivery, decrease toxicity, targets specific cells/tissues
91
What is a half-life?
Period of time required for concentration or amount of drug in body to be reduce by one-half
92
What affects a drugs half-life?
- Metabolism
| - Elimination
93
What does the half-life help determine?
Dosing intervals
94
If liver and kidney function is decreased, the half-life will do what?
Increase
95
Long half-life equals _____ frequent dosing.
Less
96
Short half-life equals _____ frequent dosing.
More
97
What is a steady state?
When the amount of drug administered equals the amount of drug eliminated
98
Steady state requires how many half-lives?
Four (4)
99
What is a loading dose? Give an example.
- Large initial dose or series of doses to rapidly achieve therapeutic concentration and steady state
- Example: Z-pac
100
Name the different ways that drugs are excreted? What is the main route of drug excretion?
- Kidney (Main route)
- Liver
- Lungs
- Saliva, sweat, and breastmilk
101
How are drugs excreted from the liver?
Through bile
102
How are drugs excreted through the lungs?
Exhalation
103
Liver dysfunction leads to what?
Decreased metabolism
104
Kidney dysfunction leads to what?
Decreased excretion
105
Urine pH will affect what phase of pharmacokinetics?
Excretion
106
Acidic urine promotes the elimination of what drugs?
Alkalotic (Basic)
107
Alkaline urine promotes the elimination of what drugs?
Acidic
108
What drug is excreted rapidly in alkaline urine?
Salicylic acid (Aspirin)
109
What tests determine renal function?
- Creatinine
| - BUN
110
What is a primary effect?
Desirable response
111
What is a secondary effect?
Desirable or undesirable response
112
What is potency?
Amount of drug needed to initiate a physiological response
113
What is high potency?
High therapeutic response at a low dosage
114
What is low potency?
Low therapeutic response at a low dosage
115
What is maximal efficacy?
No matter how much drug you take it will not work
116
What is the difference between therapeutic dose and toxic dose known as?
Therapeutic index
117
What medications have a narrow therapeutic index?
- Warfarin
- Digoxin
- Phenytoin
118
Define onset.
Time it takes drug to reach minimum effective concentration
119
Define peak.
When drug reaches highest concentration in blood
120
What is minimum effective concentration?
Minimum amount of drug necessary to produce an effect on body
121
What is duration?
Length of time taken for a drug to exert a therapeutic effect
122
What are peak and trough drug levels? What are they monitored for?
- Rate of drug absorption and rate of drug excretion
| - Monitor for drugs with small therapeutic index
123
Which level is more commonly monitored, peak or trough? When do we draw this level?
- Trough
| - Right before the next drug dose is scheduled to be administered
124
What is the peak time of an IV drug?
30-60 minutes
125
What is the peak time of an oral drug?
2-3 hours
126
What is the receptor theory?
-Drugs bind to receptors to activate or inactivate them
127
Activating a receptor does what?
Produces a response
128
Inactivating a receptor does what?
Blocks a response
129
What is the role of agonists?
Activate receptors to produce a desire response
130
What is the role of antagonists?
Prevent receptor activation and block the response
131
Describe nonspecific drugs?
Affect different sites of the same receptor
132
Describe nonselective drugs?
Affected different receptors
133
What is an example of a nonspecific drug?
Bethanechol
134
What is an example of a nonselective drug?
Epinephrine
135
What is drug tolerance?
Decreased response to drug, requiring an increase in dosage to get desired affect
136
What is tachyphylaxis?
When a drug suddenly stops working after one or several doses
137
What is a side effect?
- Predictable and often mild
| - Secondary drug effect
138
What is an adverse reaction?
- Unexpected and undesirable reaction to drug
- More severe than side effects
- Can occur at normal dosage
139
What is drug toxicity?
- Drug level exceeds therapeutic range
| - Over accumulation of drug
140
Who is at risk for drug interactions? Who is at the highest risk?
- Chronic health
- Patients taking multiple medications
- Patients taking different dietary supplements/herbs
- Patients who see more than 1 HCP
- Patient who use multiple pharmacies
- Older adults (highest risk)
141
What are drug interactions?
When one drug affects another
142
What percentage of older adults take 5 or more different medications?
20%
143
What factors affect changes in absorption?
- Increase or decrease in gastric emptying time
- Changes in gastric pH
- Formation of drug complexes
144
What happens if the production of hepatic enzymes are induced?
Drug is metabolized more quickly
145
What happens if the production of hepatic enzymes are inhibited?
Drug is metabolized more slowly
146
What are impotent inhibitors that increase toxicity?
- Alcohol
- Food
- Diet
- Grapefruit juice
147
When two or more drugs are excreted through the same route, they do what?
Fight
148
What is an additive interaction? Give an example.
- Sum of effects of two drugs
| - Hydralazine and nitro (cause vasodilation and low blood pressure)
149
What is a synergistic interaction? Give an example.
- Effect is much greater than effects of either drug alone
| - Amoxicillin and Coagulonate (antibiotics)
150
What is an antagonistic interaction?
- One drug reduces or blocks effects of other drug
| - Desirable nalaxone and protamine sulfate
151
What occurs during a drug-nutrient interaction?
Food may increase, decrease or delay drug response
152
What is an example of a drug-nutrient interaction?
MAOI's taken with tyramine-rich foods such as cheese, wine, organ meats, beer, yogurt, sour cream, bananas can result in hypertensive crisis
153
What occurs during a drug-laboratory interaction?
-Drugs may cause misinterpretation of drug results
154
What is drug-induced photosensitivity?
- Skin reaction caused by sunlight exposure
| - Can be avoided
155
What drug treats leukemia?
Mercaptopurine
156
What drug treats colon cancer and small lung cancer?
- Irinotecan
| - Want to eliminate if you have genetic variation
157
What drug treats HIV and affects 10% of the public with its life threatening effects?
Abacavir
158
What drug is a vitamin K antagonist, anticoagulant, increases the risk of bleeding, and is not widely used?
Warfarin
159
What drug class does codeine and tramadol fall under? Some people also lack the enzyme to convert this drug for pain control.
- Opoids
| - Mostly affects Asians, Middle Easterns, and Caucasians
160
What drug is an anti-analytic, increases immune response and can cause the development of Steven Johnson syndrome?
Carbamazepine
161
What should you do as part of the assessment for the nursing process of pharmacogenetics?
- Assess family history back three generations
| - Determine side effects/adverse effects to drug therapy
162
What are the nursing interventions of pharmacogenetics?
- Refer identified patients to genetic counseling as needed
- Guide patients in the implications and uses of genetic results
- Ensure patient knows to report genetic findings to all HCP's
163
What are botanicals?
Additive substances that come from plants
164
What is an herb?
Any plant used for culinary or medicinal purposes
165
What is phytomedicine?
A type of medicine that focuses on the therapeutic value of plants
166
What did the Dietary Supplement Health and Education Act (DSHEA) do?
It is a US federal act that defined dietary supplements
167
What is the Current Good Manufacturing Practices (CGMPs)?
US Food and Drug Administration standards requiring that package labels give the quality and strength of all contents and that products be free of contaminants or impurities
168
What is Astralagus used for? What type of reaction can occur?
- Used to boost the immune system and limit the effects of cold and flu symptoms
- May interact with drugs that alter immune function such as cyclosporine
169
What is Chamomile used for? What type of reaction can occur?
- Used to treat sleeplessness, anxiety, and stomach ailments -Often used as a tea
- Allergic reactions may occur in those allergic to ragweed.
170
What is Cinnamon used for? What type of reaction can occur?
- Used to treat bronchitis, GI problems, anorexia, and diabetes
- May decrease blood clotting.
171
What is Echinacea used for?
- Used for colds, flu, and infections
| - Stimulates the immune system.
172
What is Garlic used for? What type of reaction can occur?
- Used to lower cholesterol, decrease blood pressure, and reduce heart disease
- Reduces blood clotting, risk for bleeding
173
What is Ginkgo used for? What type of reaction can occur?
Used for asthma, bronchitis, fatigue, tinnitus, memory impairment, intermittent claudication, sexual dysfunction, and multiple sclerosis
-Increases bleeding risk
174
What is Ginseng used for? What type of reaction can occur?
- Used to boost the immune system, increase wellbeing, and stamina
- Also used to treat erectile dysfunction, hepatitis C, menopausal symptoms, and to lower glucose and blood pressure
- May cause hypoglycemia in diabetic patients
175
What is Hawthorn used for? What type of reaction can occur?
- Used for heart disease, digestive issues, and kidney disease
- May interact with multiple drugs including those for erectile dysfunction, nitrates, and antihypertensives
176
What is Licorice used for? What type of reaction can occur?
- Used to treat stomach ulcers, bronchitis, sore throat, and viral hepatitis
- May elevate BP, cause water retention, and lower potassium levels
177
What is Kava Kava used for? What type of reaction can occur?
- Used to aid relaxation and treat anxiety
| - May cause liver damage, especially when taken with alcohol
178
What is Milk Thistle used for? What type of reaction can occur?
- Used to treat cirrhosis, chronic hepatitis, gall bladder disorders, elevated cholesterol, and type 2 diabetes
- May cause allergic reaction in those allergic to ragweed
- May also cause hypoglycemia
179
What is Peppermint used for?
-Used to treat nausea, indigestion, IBS, cold symptoms, headaches, and muscle and nerve pain
180
What is Saw Palmetto used for?
-Used to treat BPH, chronic pelvic pain, decreased libido, migraine, and hair loss
181
What is St. John's Wort used for? What type of reaction can occur?
- Used to treat mental disorders, nerve pain, sleep disorders, malaria, and wounds
- Has many drug interactions, like those that affect serotonin levels
182
What is Turmeric used for? What type of reaction can occur?
- Used for heartburn, stomach ulcers, gallstones, inflammation, and cancer
- Need to avoid in those with gallbladder disease
183
What is Valerian used for?
-Used for insomnia, anxiety, headaches, depression, irregular heart beat, and tremors
184
When does the liver form enzymes?
When liver function is decreased
185
List the different plasma proteins.
- Albumin
- Lipoproteins
- Alpha-1-acid-glycoprotein (AGP)
186
How does drug move throughout the body?
- GI Tract
- Portal Vein
- Liver
- Body
187
What drug is given to treat salicylic acid toxicity in the body?
IV administration of sodium bicarbonate
188
What three mechanisms affect drug-drug interaction?
- Absorption
- Metabolism
- Excretion
189
What education should you provide to patients taking herbal supplements?
- Consult with HCP before taking
- Report all herbal products to HCP
- Inform HCP of any allergies associated with herbal products
- Use caution if pregnant/breastfeeding
- Do not take more than the recommended dose
- Follow label instructions
- Do not give to young children/infants
- May contain multiple compounds not listed on the label
