NURP 424 Pharm Exam 1 Questions and Answers Graded A+
Considerations when prescribing: - Answers I: Indication
C: contraindication
P: precautions or interactions
C: cost/compliance
E: efficacy
A: adverse effects
D: dose/duration/directions
Drug approval process: Phase I - Answers Phase I: safety and safe dosage- how the drug is tolerated at
different doses- does not determine efficacy; studies the pharmacokinetics of the drug
(After the preclinical animal testing phase)
Drug Approval Process: Phase II - Answers Phase II: determine dosage and efficacy; determine short-
term risks
Drug Approval Process: Phase III - Answers Phase III: controlled and uncontrolled clinical trials of safety
and efficacy in multiple settings; submit a new drug application (NDA) to the FDA
-Is it better than current treatment?
Drug Approval Process: Post Market - Answers Phase IV or Post market research: has no fixed duration,
further report adverse events
DEA Controlled Drug Schedules: Schedule 1 - Answers - No accepted medical use
-No legal use permitted
- For registered research facilities only
Heroin, LSD, mescaline, peyote, marijuana*(state to state)
DEA Controlled Drug Schedules: Schedule 2 - Answers -No refills permitted (only 30 day supply)
-No phone orders unless you have a written one within 7 days
-E-prescribe is OK
- expires in 72hrs id not filled
Narcotics, stimulants, depressants (phenobarbital, secobarbital)
,DEA Controlled Drug Schedules: Schedule 3 - Answers -must be rewritten after 6 months or five refills
-phone and fax OK
Some narcotics (Percocet, hydrocodone) Some stimulants (benzphetamine, chlorpheniramine,
diethylpropion)
Anabolic steroids, testosterone
DEA Controlled Drug Schedules: Schedule 4 - Answers -same as schedule 3, penalties for illegal
possessions are different
-low potential for abuse per DEA
pentazocine, phentermine, benzos, meprobamate
DEA Controlled Drug Schedules: Schedule 5 - Answers - same as all prescription drugs
-may be dispensed without prescription unless regulated by the state
loperamide, cough meds, pregabalin
Adverse Drug Reactions: Pharmacological - Answers - majority of adverse reactions
-predictable
-dose-related
-85-90% of ADRs
(Hypotension from antihypertensives)
Adverse Drug Reactions: Idiosyncratic - Answers -unpredictable
-Not dose-related
(Stevens-Johnson syndrome from lamictal or ibuprofen)
Immune-Mediated ADR: Type 1 - Answers -igE mediated, immediate type
-previously sensitize person
-hypersensitivity like atopic dermatitis, hives, angioedema or anaphylaxis
Immune-Mediated ADR: Type 2 - Answers - antibody-dependent cytotoxicity
- "autoimmune response"
- improvement with removal of drug
, - HIT or hemolytic anemia, neutropenia
Immune-Mediated ADR: Type 3 - Answers -immune complex hypersensitivity (Arthus reaction to tetanus
vaccine)
- "serum sickness"
-Aggregates of antigens and IgG create insoluble immune complexes in blood vessels which can take a
week to occur and cause vasculitis
- arthralgia, fever, swollen lymph nodes, and splenomegaly
-involvement of tissue
Immune-Mediated ADR: Type 4 - Answers -cell-mediated or delayed hypersensitivity
- Usually occurs more than 12 hours after exposure to the allergen, with a maximal reaction time
between 48 and 72 hrs
-Ex. drug rash, eosinophilia, and systemic syndrome (DRESS), Stevens Johnsons, contact dermatitis
Time-Related ADR - Answers -Rapid: during or immediately following admin
-First-dose: occur immediately after the first dose
-Immediate: within one hour of exposure
-Delayed: one hour after exposure
-Early: occur early in treatment and generally resolves with continued treatment as tolerance is
developed
-intermediate: occur after repeated exposure to med
-Late: occur after prolonged exposure to an offending agent
Delayed: occur at variable points in time after exposure or even after stopping the drug
Severity of ADRs - Answers -Mild: typically can be managed by dose reduction, discontinuation, or may
subside as tolerance builds
-Moderate: often requires discontinuation and minimal medical intervention. Typically does not cause
permanent harm to the patient
Severe: may be life-threatening and result is hospitalization, birth defects, or even death; intensive
medical intervention necessary
ADR Risk Factors - Answers -Genetics
Considerations when prescribing: - Answers I: Indication
C: contraindication
P: precautions or interactions
C: cost/compliance
E: efficacy
A: adverse effects
D: dose/duration/directions
Drug approval process: Phase I - Answers Phase I: safety and safe dosage- how the drug is tolerated at
different doses- does not determine efficacy; studies the pharmacokinetics of the drug
(After the preclinical animal testing phase)
Drug Approval Process: Phase II - Answers Phase II: determine dosage and efficacy; determine short-
term risks
Drug Approval Process: Phase III - Answers Phase III: controlled and uncontrolled clinical trials of safety
and efficacy in multiple settings; submit a new drug application (NDA) to the FDA
-Is it better than current treatment?
Drug Approval Process: Post Market - Answers Phase IV or Post market research: has no fixed duration,
further report adverse events
DEA Controlled Drug Schedules: Schedule 1 - Answers - No accepted medical use
-No legal use permitted
- For registered research facilities only
Heroin, LSD, mescaline, peyote, marijuana*(state to state)
DEA Controlled Drug Schedules: Schedule 2 - Answers -No refills permitted (only 30 day supply)
-No phone orders unless you have a written one within 7 days
-E-prescribe is OK
- expires in 72hrs id not filled
Narcotics, stimulants, depressants (phenobarbital, secobarbital)
,DEA Controlled Drug Schedules: Schedule 3 - Answers -must be rewritten after 6 months or five refills
-phone and fax OK
Some narcotics (Percocet, hydrocodone) Some stimulants (benzphetamine, chlorpheniramine,
diethylpropion)
Anabolic steroids, testosterone
DEA Controlled Drug Schedules: Schedule 4 - Answers -same as schedule 3, penalties for illegal
possessions are different
-low potential for abuse per DEA
pentazocine, phentermine, benzos, meprobamate
DEA Controlled Drug Schedules: Schedule 5 - Answers - same as all prescription drugs
-may be dispensed without prescription unless regulated by the state
loperamide, cough meds, pregabalin
Adverse Drug Reactions: Pharmacological - Answers - majority of adverse reactions
-predictable
-dose-related
-85-90% of ADRs
(Hypotension from antihypertensives)
Adverse Drug Reactions: Idiosyncratic - Answers -unpredictable
-Not dose-related
(Stevens-Johnson syndrome from lamictal or ibuprofen)
Immune-Mediated ADR: Type 1 - Answers -igE mediated, immediate type
-previously sensitize person
-hypersensitivity like atopic dermatitis, hives, angioedema or anaphylaxis
Immune-Mediated ADR: Type 2 - Answers - antibody-dependent cytotoxicity
- "autoimmune response"
- improvement with removal of drug
, - HIT or hemolytic anemia, neutropenia
Immune-Mediated ADR: Type 3 - Answers -immune complex hypersensitivity (Arthus reaction to tetanus
vaccine)
- "serum sickness"
-Aggregates of antigens and IgG create insoluble immune complexes in blood vessels which can take a
week to occur and cause vasculitis
- arthralgia, fever, swollen lymph nodes, and splenomegaly
-involvement of tissue
Immune-Mediated ADR: Type 4 - Answers -cell-mediated or delayed hypersensitivity
- Usually occurs more than 12 hours after exposure to the allergen, with a maximal reaction time
between 48 and 72 hrs
-Ex. drug rash, eosinophilia, and systemic syndrome (DRESS), Stevens Johnsons, contact dermatitis
Time-Related ADR - Answers -Rapid: during or immediately following admin
-First-dose: occur immediately after the first dose
-Immediate: within one hour of exposure
-Delayed: one hour after exposure
-Early: occur early in treatment and generally resolves with continued treatment as tolerance is
developed
-intermediate: occur after repeated exposure to med
-Late: occur after prolonged exposure to an offending agent
Delayed: occur at variable points in time after exposure or even after stopping the drug
Severity of ADRs - Answers -Mild: typically can be managed by dose reduction, discontinuation, or may
subside as tolerance builds
-Moderate: often requires discontinuation and minimal medical intervention. Typically does not cause
permanent harm to the patient
Severe: may be life-threatening and result is hospitalization, birth defects, or even death; intensive
medical intervention necessary
ADR Risk Factors - Answers -Genetics
