NURP 424 Pharm Exam 1 Questions And Answers
With Verified Study Solutions
Considerations when prescribing: ANS 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 ANS 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 ANS Phase II: determine dosage and efficacy; determine short-
term risks
Drug Approval Process: Phase III ANS 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 ANS Phase IV or Post market research: has no fixed
duration, further report adverse events
DEA Controlled Drug Schedules: Schedule 1 ANS - 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 ANS -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 ANS -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 ANS -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 ANS - same as all prescription drugs
-may be dispensed without prescription unless regulated by the state
loperamide, cough meds, pregabalin
Adverse Drug Reactions: Pharmacological ANS - majority of adverse reactions
-predictable
-dose-related
-85-90% of ADRs
(Hypotension from antihypertensives)
Adverse Drug Reactions: Idiosyncratic ANS -unpredictable
, -Not dose-related
(Stevens-Johnson syndrome from lamictal or ibuprofen)
Immune-Mediated ADR: Type 1 ANS -igE mediated, immediate type
-previously sensitize person
-hypersensitivity like atopic dermatitis, hives, angioedema or anaphylaxis
Immune-Mediated ADR: Type 2 ANS - antibody-dependent cytotoxicity
- "autoimmune response"
- improvement with removal of drug
- HIT or hemolytic anemia, neutropenia
Immune-Mediated ADR: Type 3 ANS -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 ANS -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 ANS -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
With Verified Study Solutions
Considerations when prescribing: ANS 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 ANS 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 ANS Phase II: determine dosage and efficacy; determine short-
term risks
Drug Approval Process: Phase III ANS 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 ANS Phase IV or Post market research: has no fixed
duration, further report adverse events
DEA Controlled Drug Schedules: Schedule 1 ANS - 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 ANS -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 ANS -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 ANS -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 ANS - same as all prescription drugs
-may be dispensed without prescription unless regulated by the state
loperamide, cough meds, pregabalin
Adverse Drug Reactions: Pharmacological ANS - majority of adverse reactions
-predictable
-dose-related
-85-90% of ADRs
(Hypotension from antihypertensives)
Adverse Drug Reactions: Idiosyncratic ANS -unpredictable
, -Not dose-related
(Stevens-Johnson syndrome from lamictal or ibuprofen)
Immune-Mediated ADR: Type 1 ANS -igE mediated, immediate type
-previously sensitize person
-hypersensitivity like atopic dermatitis, hives, angioedema or anaphylaxis
Immune-Mediated ADR: Type 2 ANS - antibody-dependent cytotoxicity
- "autoimmune response"
- improvement with removal of drug
- HIT or hemolytic anemia, neutropenia
Immune-Mediated ADR: Type 3 ANS -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 ANS -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 ANS -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
