Alabama MPJE Exam with precise detailed answers

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Alabama MPJE Exam with precise detailed answers || || || || || ||




Pure Food and Drug Act (1906) aka Wiley Law - ✔✔Prohibits adulteration and misbranding
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Food, Drug and Cosmetic Act (1938) - ✔✔-New drug could not be marketed unless safe
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-Required manufacturer label to have directions for use and warnings about habit forming
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drugs



Durham-Humphrey Amendment (1951) - ✔✔-Established prescription and OTC drug || || || || || || || || ||




categories

-Allowed for oral prescriptions
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-Allowed for refills || ||




Manufacturer label on Rx drugs after Durham-Humphrey Amendment - ✔✔-Not required
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to have directions for use
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-"Caution: Federal law prohibits dispensing w/o a prescription"
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Kefauver-Harris Amendment (1962) - ✔✔-New drug could not be marketed unless effective
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-Informed consent ||




-FDA allowed to regulate prescription drug advertising
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-Reporting of ADRs || ||




-GMPs



Who regulates OTC drug advertising? - ✔✔FTC
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Hatch-Waxman Amendment - ✔✔-Generics only have to submit abbreviated NDA
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(ANDA): bioequivalence, not safety and efficacy
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-Gives incentives to brand manufacturers by giving 5 more years of patent protection (up to
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22 years)
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Reverse distributor - ✔✔Distributor registered with the DEA to destroy drugs
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# of DEA registrations: owner of two pharmacies - ✔✔2
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# of DEA registrations: hospital with inpatient satellites - ✔✔1
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# of DEA registrations: hospital with outpatient pharmacy down the street - ✔✔2
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# of DEA registrations: pharmacy with nursing home business - ✔✔2
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# of DEA registrations: consultant pharmacist - ✔✔0
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# of DEA registrations: pharmacy that does coop buying - ✔✔2
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# of DEA registrations: pharmacy that provides methadone - ✔✔1
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Explain DEA number - ✔✔First letter: A,B,F for providers; M for midlevel; R for distributor
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Second letter: Last name or 9
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Number: 6 digits plus check digit || || || || ||




Who can use the hospital DEA number and internal code to prescribe? - ✔✔Any employee
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authorized to prescribe || ||

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Explain the check digit in the DEA number? - ✔✔a) Add 1,3,5
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b) Add 2,4,6 and multiply by 2
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c) Add (a) and (b)
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d) Last digit in the sum is the check digit
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What two things should a pharmacist look for when deciding whether or not to fill a
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prescription? - ✔✔Physician-patient relationship and scope of practice
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What information must be on a prescription for a controlled substance? - ✔✔1. Patient
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name

2. Patient address
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3. Date written
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4. Drug, quantity, directions
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5. Physician signature
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6. Physician address
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7. Physician DEA number
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What act developed office based narcotic maintenance programs (buprenorphine rather
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than methadone)? - ✔✔Drug Addiction Treatment Act (DATA)
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T/F: Methadone prescriptions not written in multiple daily doses should be assumed for
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maintenance of addiction and only dispensed by MMPs - ✔✔True || || || || || || || || ||




T/F: A pharmacy may use a computer to store records of C3-5 - ✔✔True
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Computerized refill history must include - ✔✔-Drug name || || || || || || ||

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-Date of refill || ||




-Quantity dispensed ||




-Total number of refills (pills) dispensed to date
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-Pharmacist identifier ||




Computer generated prescription/refill information must be maintained for ___ - ✔✔2
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years after the dispensing date
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What must the pharmacist write on the printout of the day's CS refills? - ✔✔Signature and
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date (by each pharmacist that dispensed)
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Refill printout must be provided to each pharmacy that uses the computer system within
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___ of the refill being dispensed - ✔✔72 hours
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Printout of refill data must include - ✔✔-Patient name and address
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-Prescriber name ||




-Pharmacist ID ||




-Prescription number ||




-Date dispensed ||




-Quantity dispensed ||




A centralized pharmacy must be capable of giving refill printouts to a requesting pharmacy
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within ____ - ✔✔48 hours || || || ||




T/F: C2 prescriptions must be written and manually signed - ✔✔True
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When do C2 prescriptions expire? - ✔✔Never
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