2
Alabama MPJE Exam with precise detailed answers || || || || || ||
Pure Food and Drug Act (1906) aka Wiley Law - ✔✔Prohibits adulteration and misbranding
|| || || || || || || || || || || || ||
Food, Drug and Cosmetic Act (1938) - ✔✔-New drug could not be marketed unless safe
|| || || || || || || || || || || || || ||
-Required manufacturer label to have directions for use and warnings about habit forming
|| || || || || || || || || || || || ||
drugs
Durham-Humphrey Amendment (1951) - ✔✔-Established prescription and OTC drug || || || || || || || || ||
categories
-Allowed for oral prescriptions
|| || ||
-Allowed for refills || ||
Manufacturer label on Rx drugs after Durham-Humphrey Amendment - ✔✔-Not required
|| || || || || || || || || || ||
to have directions for use
|| || || ||
-"Caution: Federal law prohibits dispensing w/o a prescription"
|| || || || || || ||
Kefauver-Harris Amendment (1962) - ✔✔-New drug could not be marketed unless effective
|| || || || || || || || || || ||
-Informed consent ||
-FDA allowed to regulate prescription drug advertising
|| || || || || ||
-Reporting of ADRs || ||
-GMPs
Who regulates OTC drug advertising? - ✔✔FTC
|| || || || || ||
,2
Hatch-Waxman Amendment - ✔✔-Generics only have to submit abbreviated NDA
|| || || || || || || || || ||
(ANDA): bioequivalence, not safety and efficacy
|| || || || ||
-Gives incentives to brand manufacturers by giving 5 more years of patent protection (up to
|| || || || || || || || || || || || || || ||
22 years)
||
Reverse distributor - ✔✔Distributor registered with the DEA to destroy drugs
|| || || || || || || || || ||
# of DEA registrations: owner of two pharmacies - ✔✔2
|| || || || || || || || ||
# of DEA registrations: hospital with inpatient satellites - ✔✔1
|| || || || || || || || ||
# of DEA registrations: hospital with outpatient pharmacy down the street - ✔✔2
|| || || || || || || || || || || ||
# of DEA registrations: pharmacy with nursing home business - ✔✔2
|| || || || || || || || || ||
# of DEA registrations: consultant pharmacist - ✔✔0
|| || || || || || ||
# of DEA registrations: pharmacy that does coop buying - ✔✔2
|| || || || || || || || || ||
# of DEA registrations: pharmacy that provides methadone - ✔✔1
|| || || || || || || || ||
Explain DEA number - ✔✔First letter: A,B,F for providers; M for midlevel; R for distributor
|| || || || || || || || || || || || || ||
Second letter: Last name or 9
|| || || || ||
Number: 6 digits plus check digit || || || || ||
Who can use the hospital DEA number and internal code to prescribe? - ✔✔Any employee
|| || || || || || || || || || || || || || ||
authorized to prescribe || ||
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Explain the check digit in the DEA number? - ✔✔a) Add 1,3,5
|| || || || || || || || || || ||
b) Add 2,4,6 and multiply by 2
|| || || || || ||
c) Add (a) and (b)
|| || || ||
d) Last digit in the sum is the check digit
|| || || || || || || || ||
What two things should a pharmacist look for when deciding whether or not to fill a
|| || || || || || || || || || || || || || || ||
prescription? - ✔✔Physician-patient relationship and scope of practice
|| || || || || || ||
What information must be on a prescription for a controlled substance? - ✔✔1. Patient
|| || || || || || || || || || || || || ||
name
2. Patient address
|| ||
3. Date written
|| ||
4. Drug, quantity, directions
|| || ||
5. Physician signature
|| ||
6. Physician address
|| ||
7. Physician DEA number
|| || ||
What act developed office based narcotic maintenance programs (buprenorphine rather
|| || || || || || || || || ||
than methadone)? - ✔✔Drug Addiction Treatment Act (DATA)
|| || || || || || ||
T/F: Methadone prescriptions not written in multiple daily doses should be assumed for
|| || || || || || || || || || || || ||
maintenance of addiction and only dispensed by MMPs - ✔✔True || || || || || || || || ||
T/F: A pharmacy may use a computer to store records of C3-5 - ✔✔True
|| || || || || || || || || || || || ||
Computerized refill history must include - ✔✔-Drug name || || || || || || ||
, 2
-Date of refill || ||
-Quantity dispensed ||
-Total number of refills (pills) dispensed to date
|| || || || || || ||
-Pharmacist identifier ||
Computer generated prescription/refill information must be maintained for ___ - ✔✔2
|| || || || || || || || || || ||
years after the dispensing date
|| || || ||
What must the pharmacist write on the printout of the day's CS refills? - ✔✔Signature and
|| || || || || || || || || || || || || || || ||
date (by each pharmacist that dispensed)
|| || || || ||
Refill printout must be provided to each pharmacy that uses the computer system within
|| || || || || || || || || || || || || ||
___ of the refill being dispensed - ✔✔72 hours
|| || || || || || || ||
Printout of refill data must include - ✔✔-Patient name and address
|| || || || || || || || || ||
-Prescriber name ||
-Pharmacist ID ||
-Prescription number ||
-Date dispensed ||
-Quantity dispensed ||
A centralized pharmacy must be capable of giving refill printouts to a requesting pharmacy
|| || || || || || || || || || || || || ||
within ____ - ✔✔48 hours || || || ||
T/F: C2 prescriptions must be written and manually signed - ✔✔True
|| || || || || || || || || ||
When do C2 prescriptions expire? - ✔✔Never
|| || || || || ||
Alabama MPJE Exam with precise detailed answers || || || || || ||
Pure Food and Drug Act (1906) aka Wiley Law - ✔✔Prohibits adulteration and misbranding
|| || || || || || || || || || || || ||
Food, Drug and Cosmetic Act (1938) - ✔✔-New drug could not be marketed unless safe
|| || || || || || || || || || || || || ||
-Required manufacturer label to have directions for use and warnings about habit forming
|| || || || || || || || || || || || ||
drugs
Durham-Humphrey Amendment (1951) - ✔✔-Established prescription and OTC drug || || || || || || || || ||
categories
-Allowed for oral prescriptions
|| || ||
-Allowed for refills || ||
Manufacturer label on Rx drugs after Durham-Humphrey Amendment - ✔✔-Not required
|| || || || || || || || || || ||
to have directions for use
|| || || ||
-"Caution: Federal law prohibits dispensing w/o a prescription"
|| || || || || || ||
Kefauver-Harris Amendment (1962) - ✔✔-New drug could not be marketed unless effective
|| || || || || || || || || || ||
-Informed consent ||
-FDA allowed to regulate prescription drug advertising
|| || || || || ||
-Reporting of ADRs || ||
-GMPs
Who regulates OTC drug advertising? - ✔✔FTC
|| || || || || ||
,2
Hatch-Waxman Amendment - ✔✔-Generics only have to submit abbreviated NDA
|| || || || || || || || || ||
(ANDA): bioequivalence, not safety and efficacy
|| || || || ||
-Gives incentives to brand manufacturers by giving 5 more years of patent protection (up to
|| || || || || || || || || || || || || || ||
22 years)
||
Reverse distributor - ✔✔Distributor registered with the DEA to destroy drugs
|| || || || || || || || || ||
# of DEA registrations: owner of two pharmacies - ✔✔2
|| || || || || || || || ||
# of DEA registrations: hospital with inpatient satellites - ✔✔1
|| || || || || || || || ||
# of DEA registrations: hospital with outpatient pharmacy down the street - ✔✔2
|| || || || || || || || || || || ||
# of DEA registrations: pharmacy with nursing home business - ✔✔2
|| || || || || || || || || ||
# of DEA registrations: consultant pharmacist - ✔✔0
|| || || || || || ||
# of DEA registrations: pharmacy that does coop buying - ✔✔2
|| || || || || || || || || ||
# of DEA registrations: pharmacy that provides methadone - ✔✔1
|| || || || || || || || ||
Explain DEA number - ✔✔First letter: A,B,F for providers; M for midlevel; R for distributor
|| || || || || || || || || || || || || ||
Second letter: Last name or 9
|| || || || ||
Number: 6 digits plus check digit || || || || ||
Who can use the hospital DEA number and internal code to prescribe? - ✔✔Any employee
|| || || || || || || || || || || || || || ||
authorized to prescribe || ||
,2
Explain the check digit in the DEA number? - ✔✔a) Add 1,3,5
|| || || || || || || || || || ||
b) Add 2,4,6 and multiply by 2
|| || || || || ||
c) Add (a) and (b)
|| || || ||
d) Last digit in the sum is the check digit
|| || || || || || || || ||
What two things should a pharmacist look for when deciding whether or not to fill a
|| || || || || || || || || || || || || || || ||
prescription? - ✔✔Physician-patient relationship and scope of practice
|| || || || || || ||
What information must be on a prescription for a controlled substance? - ✔✔1. Patient
|| || || || || || || || || || || || || ||
name
2. Patient address
|| ||
3. Date written
|| ||
4. Drug, quantity, directions
|| || ||
5. Physician signature
|| ||
6. Physician address
|| ||
7. Physician DEA number
|| || ||
What act developed office based narcotic maintenance programs (buprenorphine rather
|| || || || || || || || || ||
than methadone)? - ✔✔Drug Addiction Treatment Act (DATA)
|| || || || || || ||
T/F: Methadone prescriptions not written in multiple daily doses should be assumed for
|| || || || || || || || || || || || ||
maintenance of addiction and only dispensed by MMPs - ✔✔True || || || || || || || || ||
T/F: A pharmacy may use a computer to store records of C3-5 - ✔✔True
|| || || || || || || || || || || || ||
Computerized refill history must include - ✔✔-Drug name || || || || || || ||
, 2
-Date of refill || ||
-Quantity dispensed ||
-Total number of refills (pills) dispensed to date
|| || || || || || ||
-Pharmacist identifier ||
Computer generated prescription/refill information must be maintained for ___ - ✔✔2
|| || || || || || || || || || ||
years after the dispensing date
|| || || ||
What must the pharmacist write on the printout of the day's CS refills? - ✔✔Signature and
|| || || || || || || || || || || || || || || ||
date (by each pharmacist that dispensed)
|| || || || ||
Refill printout must be provided to each pharmacy that uses the computer system within
|| || || || || || || || || || || || || ||
___ of the refill being dispensed - ✔✔72 hours
|| || || || || || || ||
Printout of refill data must include - ✔✔-Patient name and address
|| || || || || || || || || ||
-Prescriber name ||
-Pharmacist ID ||
-Prescription number ||
-Date dispensed ||
-Quantity dispensed ||
A centralized pharmacy must be capable of giving refill printouts to a requesting pharmacy
|| || || || || || || || || || || || || ||
within ____ - ✔✔48 hours || || || ||
T/F: C2 prescriptions must be written and manually signed - ✔✔True
|| || || || || || || || || ||
When do C2 prescriptions expire? - ✔✔Never
|| || || || || ||
