Why aren't all adverse side effects detected in Phase III studies?

Limited patient numbers don't uncover all side effects

An adverse drug reaction is:

Unintended drug actions resulting from lack of specificity of drug action

What is a therapeutic window?

Range of dose that produces a therapeutic response

When can an ANDA be filed by a generic manufacturer?

After patent on brand name expires

Identify issues with absorption in pediatrics -- Oral medications

GI Motility, Low Bioavailability

A measure of the dose required to produce an effect or response

Identify issues with absorption in Geriatrics

Decreased gastric acid secretion and GI Motility, Malabsorption, Bowel resections, Antacid usage, Decreased small intestine surface area

Identify some issue with geriatric distribution

Decreased Albumin, Increased body fat

Which of these affects the drug crossing membranes during distribution?

Fat or wtaer solubility, pH, Size, Protein binding

Identify some issue with pediatric metabolism

Hepatic enzyme function not optimal, Slowed metabolism results in half life error

Identify some issue with Geriatric metabolism

Severe nutritional deficiencies, Decreased hepatic blood flow

Identify issues with absorption in pediatrics - Transdermal

Increased rate of absorption, Skin Thickness

Where or what the drug/chemical binds to in the body

Receptor, Protein, Enzyme, Nucleic Acid

Choosing wisely includes the following concepts...

Encourage comprehensive med review, Reduce waste in health care and avoid risks associated with treatment, Consumer reports partnership

What is a therapeutic index?

LD 50/ED 50 -- Margin of Safety

Identify some pharmacologic changes associated with aging

Maximal Breathing Capacity, Glomerular Filtration, Cariac Index

Which of these are possible factors that influence oral absorption?

Hepatic blood flow, Bioavailability, Drug formulation - ie SR, ER, GI Motility

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Pharmacology - Exam 1 -- Part 1

88 termsStudBud Administration12 plays

Lectures 1-3

Flashcards88 cardsFPractice quizPHost liveL

Questions 88

Answers

1
Goal is to get water-soluble products excreted by the body...
Metabolism - phase 1
Metabolism - Phase II
2
Why aren't all adverse side effects detected in Phase III studies?
More placebo is given at this time and actual numbers are not accurate
Limited resources don't assist with patient account of side effects
Limited patient numbers don't uncover all side effects
Limited funds at that point in trials
3
An adverse drug reaction is:
The quantity to be administered at one time
How well a person feels after the administration of a drug
Unintended drug actions resulting from lack of specificity of drug action
Desirable response to a drug
4
Study of biochemical/physiologic effects of drugs on body -- What the drugs to do the body.
Pharmacodynamics
Affinity
Pharmacokinetics
Mechanism of Action
5
What is a therapeutic window?
A window to look out of
Margin of safety
Range of dose that produces a therapeutic response
Medication that has an anaphylactic effect
6
Using medications that are non-essential for treating a medical problem is a risk factor for...
ADR's
Hospitalization
Overmedication
Polypharmacy
7
Dose required for 50% of patients to have a response -- median effective dose
ED 50
TD 50
DD 50
LD 50
8
When can an ANDA be filed by a generic manufacturer?
After Phase IV
After phase II
After patent on brand name expires
During phase I
9
Identify issues with absorption in pediatrics -- Oral medications
Increased rate of drug half life depletion
Increased chances of Excretion
GI Motility
Low Bioavailability
10
Uptake of drug by the body into circulatory system
Distribution
Metabolism
Excretion
Absorption
11
The process of taking medication away that is not needed
Prescription elimination
Prescription minimizing
Prescription adherence measures
Deprescribing
12
Potency is...
dose that produces death in one half ofthe subjects.
A measure of the dose required to produce an effect or response
what the body does to the drug
maximal intensity of effect or responsethat can be produced by a drug.
13
Large scale clinical trials, compared to “gold standard” treatments “Post marketing surveillance”
Phase III
Phase IV
Phase II
Phase I
14
Identify issues with absorption in Geriatrics
Decreased gastric acid secretion and GI Motility
Malabsorption, Bowel resections, Antacid usage
Low Bioavailability
Decreased small intestine surface area
15
Adrenergic, Dopaminergic, Serotonin, Cholinergic, Nicotinic, Angiotensin --These are all examples of what?
Therapeutic Supplements
Receptors
Drugs
Agonists
16
Identify some issue with geriatric elimination
Changes in renal function
Decreased water absorption rate
Decreased bowel response
May have shorter elimination half-lives
17
Drug is on the market -- Ongoing surveillance continues for therapeutic use/safety-- ADR Profile may change
Surveillance Option
Post Marketing
FDA Review
Marketing Analysis
18
Interaction of drug with site of action in the body
Affinity
Receptor
Intrinsic Activity
MOA
19
Uptake of drug by the body into circulatory system
Absorption
Excretion
Distribution
Metabolism
20
Identify some issue with geriatric distribution
Decreased Albumin
Increased body fat
decreased protein binding
Increased body water
21
Identify issues with absorption in pediatrics - IM/SC route
Decreased Muscle Mass
Increased error risk
All of the above
Increased solubility rate
22
Can be faxed/phoned, no original copy needs to go to pharmacy, Can be e-prescribed
Schedule III
Schedule IV
Schedule IV
All of the above
23
Pediatric patients have:
Decreased total body water
Unchanged total body water
Increased total body water
body water fluctuates and is complex to calculate dosing
24
More than one prescriber, More than one pharmacy, Non/over compliance, Increased age, Use of OTC, expired meds leads to?
Polypharmacy
ADR's
Hospitalization
Overmedication
25
Which of these affects the drug crossing membranes during distribution?
Enteric coating
Size of drug
Fat or wtaer solubility, pH, Size
Protein binding
26
Used as an estimation of glomerular filtration for those drugs which are renally filtered
Creatinine Clearance
Glomerular filtration index
Clearance
Serum creatinine
27
N-4 hydroxyphenol acetamide
Generic Name
Formulary Name
Chemical Name
Brand Name
28
When it comes to absorption and pediatrics, which group is higher at risk?
Infants
Neonates
All of the above
Children
29
State law can be ____ restrictive than federal law – but not ____ restrictive
Less, More
More, Less
30
Use of medications in doses or for time periods longer than are known to be effective is a risk factor for...
Overmedication
Hospitalization
ADR's
Polypharmacy
31
Maximal response of a drug
Therapeutic Dose
ED 50
Efficacy
Potency
32
Identify some issue with pediatric metabolism
Decreased liver function levels
Hepatic enzyme function not optimal
Low Kidney response
Slowed metabolism results in half life error
33
Commercial/ trade name
Formulary Name
Chemical Name
Generic Name
Brand Name
34
Identify some issue with Geriatric metabolism
Severe nutritional deficiencies
Decreased liver function levels
Low Kidney response
Decreased hepatic blood flow
35
Ability of drug to activate its receptor upon binding
Affinity
MOA
Agonist
Intrinsic Activity
36
Equivalence of a generic drug should not differ by greater than ___
20%
15%
25%
10%
37
Chemical that blocks the effects of an agonist (Affinity but no intrinsic activity -competitive/non-competitive subtype)
Antagonist
Anti therapeutic Drug
Partial Agonist
Agonist
38
The NDA is filed after which clinical trial phase?
Phase III
Phase IV
Phase II
Phase I
39
Use of several medications at the same time
Polypharmacy
ADR's
Overmedication
Hospitalization
40
Identify issues with absorption in pediatrics - Transdermal
Increased error risk
Increased rate of absorption
All of the above
Skin Thickness
41
Movement of drugs throughout the body after entering the circulation
Metabolism
Excretion
Distribution
Absorption
42
Where or what the drug/chemical binds to in the body
Receptor
Protein
Enzyme
Nucleic Acid
43
Elimination is the combination of?
Metabolism and Distrubution
Excretion and Absorption
Metabolism and excretion
Distribution and Excretion
44
Cannot be faxed/phoned under usual circumstances, Emergencies OK for hospice or nursing home pt's, Can be e-prescribed
Schedule III
All of the above
Schedule I
Schedule II
45
Where does CYP450 primarily breakdown certain drugs?
Liver
Large Intestine
Kidneys
Stomach
46
Choosing wisely includes the following concepts...
Encourage comprehensive med review
Reduce waste in health care and avoid risks associated with treatment
Consumer reports partnership
Let the patient help write their prescription
47
What is a therapeutic index?
When the animal begins to feel relaxed after a drug
Range of doses
The amount of a drug being administered
LD 50/ED 50 -- Margin of Safety
48
Which Metabolism phase results in inactive metabolites and is more predictable for elderly patients?
Metabolism - Phase II
Metabolism - Phase I
49
Identify some pharmacologic changes associated with aging
Increased water absorption
Maximal Breathing Capacity
Glomerular Filtration
Cariac Index
50
CYP has over ___ different enzymes, but __ are responsible for nearly 90% of all drug metabolism.
75, 11
50, 6
60, 5
50, 9
51
Which of these are possible factors that influence oral absorption?
Hepatic blood flow
Bioavailability
Drug formulation - ie SR, ER
GI Motility
52
Pharmacology of undesirable effects of these drugs in the human host/other biological systems.
Therapeutics
Pharmacology
Toxicology
Side Effects
53
Phase I reactions during the Metabolism phase include?
CYP450
Secretion
CYP3A4
Kidney metabolites
54
Dose that kills 50% of the animals that get it -- lethal dose/median toxic dose
DD 50
TD 50
LD 50
ED 50
55
Extended study of large # of pt's, Define therapeutic use, Identify side effects, Study drug interaction
Phase I
Phase IV
Phase II
Phase III
56
Volume of plasma cleared of a medication per unit of time
Zero Order
First Order
Clearance
Rate of elimination
57
Lower abuse potential (APAP with codeine)
Schedule I
Schedule III
Schedule V
Schedule IV
58
What is the acronym used to help choose a drug for your patient?
SAFE
DOSE
PHARM
STEPS
59
A drug that binds to a receptor, but does not achieve 100% response (affinity & moderate intrinsic activity)
Ineffective dose
Agonist
Antagonist
Partial Agonist
60
Identify some issue with pediatric distribution
May displace bilirubin
Increased body water
Very Little fat content
decreased protein binding
61
What is NDA?
Normal Drug Agreement
Normal Drug Application
New Drug Agreement
New Drug Application
62
Actual drug name; an easier form of chemical name
Generic Name
Brand Name
Formulary Name
Chemical Name
63
What should you never put on a prescription?
The medication Purpose
Your DEA number
"Take as Directed"
The route of administration
64
Does not involve CYP450 Enzyme, Drugs are metabolized by conjugative chemical reactions
Metabolism Phase I
Metabolism Phase II
Therapeutic Doses
LD 50
65
Ratio of the amount of drug in body to its concentration in blood -- how widely the drug is distributed in the body
Distribution Ratio
Distribution Circulation
Volume Trafficking
Vd
66
A drug that binds to a receptor and exerts an effect (biologic response) (Affinity and high intrinsic activity)
Antagonist
Agonist
Partial Agonist
Effective Therapeutic Dose
67
The use of drugs to prevent, diagnose and manage a disease
Toxicology
Therapeutics
Pharmacology
Generic Formulary
68
Identify factors that contribute to poor medical adherence in the pediatric population
Working parents
Medication administration - can't swallow pills
Tolerance
School medication policies
69
Strength of attraction between drug and its receptor
MOA
Affinity
Agonist
Intrinsic Activity
70
Expanded study in patients with disease to show drug has clinical utility-- Randomized controlled trials with placebo
Phase III
Phase IV
Phase I
Phase II
71
Lower abuse potential -- (benzodiazepines, zolpidem, etc.)
Schedule IV
Schedule I
Schedule V
Schedule II
72
Define IND(A)
Investigatory Necessary Documentation Application
Investigational New Drug Application
Investigation needing Disclosures Application
Investigational Normal Drug Application
73
Include the following on a prescription: RX, Sig, Medication purpose
False
True
74
Illicit drugs not available for legal consumer use (heroin, LSD, etc.)
Schedule I
Schedule IV
Schedule III
Schedule II
75
Diphenoxylate with atropine Acetaminophen with codeine elixir -- In some states these do not require a prescription
Schedule IV
Schedule II
Schedule I
Schedule V
76
What is ANDA?
Abbreviated Normal Drug Agreement
Assisted New Drug Application
Abbreviated New Drug Application
Apparent New Drug Agreement
77
Legit drugs with high abuse potential (cocaine, codeine, morphine, oxycodone, amphetamines, fentanyl, hydrocodone/APAP)
Schedule IV
Schedule I
Schedule II
Schedule III
78
Who is always a good resource for identifying drug interactions?
Physician Assistant
Pharmacist
Dermatologist
Gynocologist
79
A measure of how long it takes for 1/2 of the drug to be eliminated from the body
Elimination Rate
TD 50
Elimination Index
Half Life
80
You can get refills on a Schedule II prescription
True
False
81
What is first pass effect?
initial metabolism of drug in Rectum before it reach bldstrm
initial metabolism of drug in stomach before it reach bldstrm
initial metabolism of drug in Kidneys before it reach bldstrm
initial metabolism of drug in liver before it reach bldstrm
82
All drugs are capable of side effects
False
True
83
A substance used in the prevention, diagnosis, treatment of disease.
Toxicology
Therapeutics
Personal Formulary
Drug
84
initial clinical study in small groups to determine safety, ADRs, dosage Dose/response studies
Phase II
Phase I
Phase III
Phase IV
85
Use of drugs and the method of their administration in the treatment of disease
Therapeutics
Personal Formulary
Toxicology
Pharmacology
86
Define pharmacokinetics
study of drugs including their composition
relationship between absorption, distribution, metabolism & excretion
what drug does to the body
what the body does to the drug
87
Identify some issue with pediatric elimination
Decreased water absorption rate
Decreased bowel response
Decreased Glomerular Filtration rate until 3-5 months
May have shorter elimination half-lives
88
A drug with a _______ therapeutic index is more dangerous?
Smaller
Wider
Narrow
Bigger

Pharmacology - Exam 1 -- Part 1 Flashcards | StudBud