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Alabama MPJE | Questions and answers
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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
with
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
- Remainder may be dispensed within 72 hours
- 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"
- Note date filled, quantity dispensed, quantity remaining and ID of pharmacist
- 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
- 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
- Acetaminophen
- Lidocaine, Dibucaine
- Minoxidil
- Methyl salicylate
- Methyl alcohol
- Ethylene glycol
- Hydrocarbons and solvents
- NaOH, KOH
- Iron >250 mg elemental/package
- 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
- 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
- Maximum of 72 hour supply
- 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
- State Board of Pharmacy Where do forms 106 go in Alabama? ✔✔1. Stays at pharmacy
- Goes to State Board
- 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
- Signature
- 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
