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