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