CPJE LAW -1: Questions With Proven Solutions
Save
Terms in this set (241)
CS _______ Require a one-inch Red "C" -3-5
on the lower right corner of the Rx if - NOT electronic system
filed along with the non-CS Rx (so
they can be easily identified)
Poison Prevention Packaging Act of Oral (only) Rx meds in child-resistant safety
1970 containers
Child-resistant safety containers - NTG SL tab
except (4) - Colestipol powder
- Erythormycin granules for oral susp
- OC in manu's memory-aid dispenser pkg
"Preemption Doctrine" when there's conflict btw Fed and State
- Fed > State
unless state is more strict
- state cannot make laws that are less strict than fed
Ca CE requirement (3) - 30H/2yrs
- 2 of 30H of CE must be on Law/Ethics from counsel
provided by board
- record 4 yrs
REMS meaning - pharm manu may restrict access to med that show
serious SE/teratogenic/abuse potential for app
prescribing and minimize risk
REMS programs require registration of - pt
______/_______/______ by calling the - prescriber
program before dispensing - pharmacy
,REMS medications (8) -Bosentan (Tracleer)
-Subutex & Suboxone
-Clozapine (Clozaril)
-Isotretinoin (Accutance)
-Natalizumab (Tysabri)
-Zyprexa Relprevv
-Sod oxybate (Xyrem)
-Thalidomide (Thalomid)
Bosentan (Tracleer) - Hepatotox/Teratogenic
REMS med/Safety - Prescriber/Pt
concern/Enrollment/Program details - Liver fx and Preg q1mo
Subutex & Suboxone - Abuse potential
REMS med/Safety - prescriber
concern/Enrollment/Program details - special DEA# (opioid dependence)
Clozapine (Clozaril) -neuropentia & aplastic anemia
REMS med/Safety -prescriber/pharmacy
concern/Enrollment/Program details -Clozaril National Registry -> WBC q2-4wks
Isotretinoin (Accutane) -teratogenic
REMS med/Safety - prescriber/pt/pharmacy
concern/Enrollment/Program details -iPLEDGE -> 2 preg tests + 2 Birth control
Natalizumab (Tysabri) -PML
REMS med/Safety -prescriber/pt/pharmacy
concern/Enrollment/Program details -complete pre-infusion pt checklist
Zyprexa Relprevv -post-inj delirium/sedation
REMS med/Safety -prescriber/pt/pharmacy
concern/Enrollment/Program details -Pt care program
Sod oxybate (Xyrem) -narcolepsy
REMS med/Safety -overuse, abuse, addiction potential
concern/Enrollment/Program details -prescriber/pt
-distribution to pt
,Thalidomide (Thalomid) -teratogenic
REMS med/Safety -prescriber/pt/pharmacy
concern/Enrollment/Program details -STEPS program -> Rx has authorization#
RECALL meaning: remove a product from the market by a firm's own
initiative by FDA request or FDA order under
statuatory authority
Class I RECALL: reasonable probability of serious AE consequences
or death
Class II RECALL: may cause temporary or reversible AE (serious AE
remote)
Class III RECALL NOT likely to cause AE consequences
Market withdrawal firm removes product from the market and/or
corrects a minor violation (ex. tampering)
Medical Device safety alert unreasonable risk of substantial harm
sometimes considered recalls
CA BOP agency authorized to enact rules and regs pertaining
to the practice of pharmacy
Pharmacy Board Inspector -not required to be an Rph
-inspects any site drugs or devices are cmpded
stored dispensed or sold including vet retailers,
physician office
-may issue order of abatement or request sth to be
corrected
-any person with a citation may appeal to Board in
writing within 30 days
BOP notified within 30 days
-change of
owndership/address/name/PIC/phar
macy permit/theft/diversion/drug loss
, BOP notified within 14 days
-licensed employee is found
chemically/mentally/physically
impaired
BOP notified within 30 days
-CS losses
DEA notified within immediately
-CS losses
BOP notified within 14 days
- if cause is theft/diversion/self-
use/loss of CS
BOP notified within immediately
Bankruptcy/Insolvency/Receivership
BOP notified within 10 days
-pharmacy closure a transfer of drugs
notice
"Closed-Down" pharmacy def: 1 day/wk during any 120 day (4 mo) period
pharmacy no longer engaged in
ordinary activity for at least ___________
during any ___________ period
Board may issue a temporary permit 180 days (6 mo)
for ____________ during a transfer of
ownership in order for the pharmacy
to cont its oeprations
Time Limit Requirements in Keeping of
Pharmacy Records
Save
Terms in this set (241)
CS _______ Require a one-inch Red "C" -3-5
on the lower right corner of the Rx if - NOT electronic system
filed along with the non-CS Rx (so
they can be easily identified)
Poison Prevention Packaging Act of Oral (only) Rx meds in child-resistant safety
1970 containers
Child-resistant safety containers - NTG SL tab
except (4) - Colestipol powder
- Erythormycin granules for oral susp
- OC in manu's memory-aid dispenser pkg
"Preemption Doctrine" when there's conflict btw Fed and State
- Fed > State
unless state is more strict
- state cannot make laws that are less strict than fed
Ca CE requirement (3) - 30H/2yrs
- 2 of 30H of CE must be on Law/Ethics from counsel
provided by board
- record 4 yrs
REMS meaning - pharm manu may restrict access to med that show
serious SE/teratogenic/abuse potential for app
prescribing and minimize risk
REMS programs require registration of - pt
______/_______/______ by calling the - prescriber
program before dispensing - pharmacy
,REMS medications (8) -Bosentan (Tracleer)
-Subutex & Suboxone
-Clozapine (Clozaril)
-Isotretinoin (Accutance)
-Natalizumab (Tysabri)
-Zyprexa Relprevv
-Sod oxybate (Xyrem)
-Thalidomide (Thalomid)
Bosentan (Tracleer) - Hepatotox/Teratogenic
REMS med/Safety - Prescriber/Pt
concern/Enrollment/Program details - Liver fx and Preg q1mo
Subutex & Suboxone - Abuse potential
REMS med/Safety - prescriber
concern/Enrollment/Program details - special DEA# (opioid dependence)
Clozapine (Clozaril) -neuropentia & aplastic anemia
REMS med/Safety -prescriber/pharmacy
concern/Enrollment/Program details -Clozaril National Registry -> WBC q2-4wks
Isotretinoin (Accutane) -teratogenic
REMS med/Safety - prescriber/pt/pharmacy
concern/Enrollment/Program details -iPLEDGE -> 2 preg tests + 2 Birth control
Natalizumab (Tysabri) -PML
REMS med/Safety -prescriber/pt/pharmacy
concern/Enrollment/Program details -complete pre-infusion pt checklist
Zyprexa Relprevv -post-inj delirium/sedation
REMS med/Safety -prescriber/pt/pharmacy
concern/Enrollment/Program details -Pt care program
Sod oxybate (Xyrem) -narcolepsy
REMS med/Safety -overuse, abuse, addiction potential
concern/Enrollment/Program details -prescriber/pt
-distribution to pt
,Thalidomide (Thalomid) -teratogenic
REMS med/Safety -prescriber/pt/pharmacy
concern/Enrollment/Program details -STEPS program -> Rx has authorization#
RECALL meaning: remove a product from the market by a firm's own
initiative by FDA request or FDA order under
statuatory authority
Class I RECALL: reasonable probability of serious AE consequences
or death
Class II RECALL: may cause temporary or reversible AE (serious AE
remote)
Class III RECALL NOT likely to cause AE consequences
Market withdrawal firm removes product from the market and/or
corrects a minor violation (ex. tampering)
Medical Device safety alert unreasonable risk of substantial harm
sometimes considered recalls
CA BOP agency authorized to enact rules and regs pertaining
to the practice of pharmacy
Pharmacy Board Inspector -not required to be an Rph
-inspects any site drugs or devices are cmpded
stored dispensed or sold including vet retailers,
physician office
-may issue order of abatement or request sth to be
corrected
-any person with a citation may appeal to Board in
writing within 30 days
BOP notified within 30 days
-change of
owndership/address/name/PIC/phar
macy permit/theft/diversion/drug loss
, BOP notified within 14 days
-licensed employee is found
chemically/mentally/physically
impaired
BOP notified within 30 days
-CS losses
DEA notified within immediately
-CS losses
BOP notified within 14 days
- if cause is theft/diversion/self-
use/loss of CS
BOP notified within immediately
Bankruptcy/Insolvency/Receivership
BOP notified within 10 days
-pharmacy closure a transfer of drugs
notice
"Closed-Down" pharmacy def: 1 day/wk during any 120 day (4 mo) period
pharmacy no longer engaged in
ordinary activity for at least ___________
during any ___________ period
Board may issue a temporary permit 180 days (6 mo)
for ____________ during a transfer of
ownership in order for the pharmacy
to cont its oeprations
Time Limit Requirements in Keeping of
Pharmacy Records
