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Alabama MPJE | Questions and answers 100% correct solutions | Graded A+2, Exams of Medicine

Alabama MPJE | Questions and answers 100% correct solutions | Graded A+2

Typology: Exams

2024/2025

Available from 03/11/2025

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Alabama MPJE | Questions and answers
100% correct solutions | Graded A+2
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
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Download Alabama MPJE | Questions and answers 100% correct solutions | Graded A+2 and more Exams Medicine in PDF only on Docsity!

Alabama MPJE | Questions and answers

100% correct solutions | Graded A+ 2

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

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

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

-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

T/F: Oral orders for C2 prescriptions are allowed in emergency situations ✔✔if it is for long term care facility, hospice, patient receiving home health services and the amount is only for 72 hours AND physician furnishes written rx for the amount given within 7 days.

Can a pharmacist fill a faxed C2 prescription? ✔✔Yes, they may fill it but they may not dispense it until a hard copy is presented.

Under what circumstances can a faxed C2 serve as an original? ✔✔-Home infusion for pain (direct parenteral administration of a narcotic)

-LTCF

-Medicare certified hospice (must note hospice on Rx)

What additional information is required for a faxed C2? ✔✔-Signature of sender (nurse)

-Pharmacist verifies sender

What are the rules for partial dispensing of C2s? (Not LTCF or terminal illness) ✔✔1. May only partial if the pharmacy doesn't have adequate supply

  1. Remainder may be dispensed within 72 hours
  2. If the remainder is not dispensed within 72 hours the prescriber must be notified

What are the rules for partial dispensing of C2s in a LTCF or terminal illness? ✔✔1. Must note "LTCF patient" or "terminally ill"

  1. Note date filled, quantity dispensed, quantity remaining and ID of pharmacist
  2. Valid for 60 days from the date of issue

What are the requirements for partially dispensing a C3-5? ✔✔1. Must write quantity and initials on prescription

  1. Rx still expires after 6 months from issue

Important aspects of electronic prescribing ✔✔Authentication (are who they say they are), Nonrepudiation (cannot deny signing), Integrity (not changed following signature)

T/F: A C2 can be prescribed electronically ✔✔True

What is two factor credentialing used for? ✔✔Electronic signing of prescriptions and approval of control access

What are three things that may be used in two factor credentialing? ✔✔-Something you know

-Something you have

-Something you are

Can an electronic prescription be faxed or printed? ✔✔-May NOT be faxed

-May be printed if

(a) for copy only (b) if transmission failed (must indicate attempt)

How do internet pharmacies register with the DEA? ✔✔The actual physical location that orders, stores and dispenses must be registered (not the internet)

Ryan Haight Act ✔✔Prohibits dispensing of controlled substances via the internet without a valid prescription

At what quantity does an internet pharmacy have reporting responsibilities? ✔✔ 100 prescriptions/month or 5,000 units/month of controlled substances

Can a NP write for a controlled substance? ✔✔Yes with QACSC, LPSP certificates

Can a PA write for a controlled substance? ✔✔Yes with QACSC, LPSP certificates

When can someone ship a CS to someone in another country? ✔✔Only if they have an export license

What is the maximum amount of ephedrine/pseudoephedrine that may be sold in 30 days? ✔✔7. grams

DSHEA prohibits regulation by the FDA unless ✔✔Proving unsafe (note: NDA requires the manufacturer to prove safety; DSHEA requires the FDA to prove safety if a problem arises)

Suppose the wrong expiration date is printed on a bottle (misbranded) and the company decides to recall the product. What type of recall is this? ✔✔Category 3

The Poison Prevention Act is intended for what demographic? ✔✔Children 5 years old and younger

What bottles must have child resistant containers (CRCs)? ✔✔-Household products

-Almost all prescription drugs (definitely controlled substances)

-Some OTC drugs

-Rx to OTC switches

Who sets the standards for child resistant packaging? ✔✔Consumer Products Safety Commission

Explain the child resistant packaging test ✔✔-80% of a group of children should not be able to gain entry in 10 minutes

-90% of adults should be able to open it once in 5 minutes and open and close in one minute

List exemptions to the PPA ✔✔-Topical products/inhalers/those not intended for oral administration

-SL Nitroglycerin

-Oral contraceptives

-Powdered cholestyramine

-Potassium in unit dose forms (not regular bottles)

-Methylprednisolone in packages containing <84 mg

T/F: Reconstituted ABX must be in CPC ✔✔True

T/F: Drugs given for in-house use have to be in CPC ✔✔False

Which OTCs must have CRCs? ✔✔1. Aspirin and NSAIDs

  1. Acetaminophen
  2. Lidocaine, Dibucaine
  3. Minoxidil
  4. Methyl salicylate
  5. Methyl alcohol
  6. Ethylene glycol
  7. Hydrocarbons and solvents
  8. NaOH, KOH
  9. Iron >250 mg elemental/package
  10. Diphenhydramine >66 mg/package

If a product contains cyanide, is it adulterated or misbranded? ✔✔Both

Name 4 items that are excluded from tamper resistant packaging ✔✔1. Dentrifices

  1. Dermatologicals

Acknowledgements of Privacy Practice (or attempt to obtain it) must be kept for ✔✔6 years from the date signed or the last date the patient was treated (whichever is later)

Are pharmacies required to shred Rx vials? ✔✔No

Under what circumstance can PHI be released to law enforcement? ✔✔Written request with patient name

active investigation

signature of someone from the police department

Who is responsible for scheduling drugs in Alabama? ✔✔State Board of Health (not Board of Pharmacy)

determines what an immediate precursor is ✔✔State Board of Health

T/F: Under the CSA of Alabama, a pharmacy is considered a practitioner ✔✔True

If a CS is reclassified federally, the state board has (time) to follow suit ✔✔30 days

How often must people renew their CS license? ✔✔Every 2 years

If denied CS registration, when must the applicant appear before the certifying board? ✔✔Within 30 days of the order to show cause was served

T/F: If someone already has a CS license, they can't be denied renewal without a hearing. So they would be granted one and then appear before the board or they would be given the order at least 30 days

before their license were to expire. ✔✔True

T/F: A first time applicant for a CS license must be given a license before a hearing ✔✔False

T/F: If a license is revoked in Alabama, it can never be earned again ✔✔True

T/F: The board may limit revocation or suspension of a license to a particular controlled substance

✔✔True

When may the board suspend a registration without an order to show cause? ✔✔If there is an imminent danger to public health

What form should be used if one pharmacy sells a C2 to another? ✔✔ 222

T/F: C2 prescriptions can be in the same stack as other CS prescriptions ✔✔FALSE- this is an ALABAMA law. Correct other slides PRN

When may an oral prescription for a C2 be valid? What rules are associated with this? ✔✔1. If emergency for LTCF, hospice or home health

  1. Maximum of 72 hour supply
  2. Must obtain hard copy from prescriber within 7 days

If someone who owns a pharmacy dies, the next of kin has (time) to find a new owner ✔✔30 days

If there is a theft in Alabama, who must be notified? ✔✔1. DEA Field Office

  1. State Board of Pharmacy

Where do forms 106 go in Alabama? ✔✔1. Stays at pharmacy

  1. Goes to State Board
  2. Go to DEA Field office (one of which is the original)

What day is inventory taken in Alabama ✔✔1/15 (or other approved date)

Record of inventory must include ✔✔1. Date

  1. Signature
  2. Whether inventory was taken as of opening or as of closing

If you are a backup pharmacy and a pharmacy faxes you a prescription for a C2 for a LTCF patient, can

you fill it? ✔✔No, because the pharmacy is not an agent

Can a pharmacist change the date to be filled? ✔✔No

What is the purpose of the Federal Register? ✔✔To give citizens access to rules the government is considering passing

What is the difference between the Federal Register and Code of Federal Regulations? ✔✔Federal Register is daily and Code is annually

The effective date for notice of a proposed rule is NO LESS THAN after publishing ✔✔60 days

Which schedule of drugs has the highest abuse potential? ✔✔ 1

Who schedules drugs federally? ✔✔Attorney General (not the DEA)

T/F: A state can classify a schedule 2 federal drug as schedule 3 ✔✔False. A state can go harsher, but not more lenient

provides a scientific and medical evaluation of a drug and recommends a schedule to the Attorney General. This is typically binding but may be overridden if there is an imminent hazard to public safety.

✔✔Secretary of the Department of Health and Human Services

When transferring a business, a CS inventory should be taken when? ✔✔The day of transfer

T/F: The attorney general can revoke DEA registration if an entitiy has been excluded from participation in Medicaid or Medicare ✔✔True

If you are selling your practice, you must notify the DEA at least the date of transfer ✔✔14 days BEFORE

What three entities are EXEMPT from DEA registration so that they may prescribe, dispense and

administer CS but not purchase them? ✔✔-Members of armed forces

-Public Health Service

-Bureau of Prisons

DEA form 224B ✔✔Register multiple pharmacies in a chain

The DEA requires schedule 2-5 drugs to be kept in ✔✔A LOCKED drawer or dispersed through noncontrol stock

Who can use a faxed Rx like an original? ✔✔Longterm care facilities, home infusion practices, hospice patients

What can be changed on an C2 Rx by a pharmacist? ✔✔-Patient address

-Dose form, strength, quantity- consult MD

-Directions for use- consult MD

-Issue date- consult MD

What activities require separate DEA registration? ✔✔Manufacturing

Distributing

Dispensing

Research on C

Research on C2-

Narcotic treatment programs

Chemical analysis

Importing

Exporting

What is the definition of dispense? ✔✔Give to ultimate user (not office use)

What is a pharmacy? ✔✔Any place that has medicine or whose title implies it has medicine

What is the difference between a prescription and an order? ✔✔An order is administered directly

How many years are required for a pharmacy degree? ✔✔ 5

When is a state drug inspector allowed to inspect drugs? ✔✔During business hours

Which violations does the state drug inspector have to report? ✔✔ALL

When does the state drug inspector allowed to inspect records (including patient files)? ✔✔When there is a specific complaint and inspection is approved by the board

If you are going to carry drugs around for your job, what is the requirement? ✔✔They must be in an unbroken package