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Nebraska MPJE Questions and Answers
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What legistation was created for the provisions for the fast track review of some NDA submissions to expedite approval of new drugs used to treat life-threatening conditions? ✔✔Food and Drug Administration (FDA) Modernization Act 1997
What legistation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? ✔✔FDA modernization act 1997
What act reduced the cose of orphan drugs? ✔✔Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs? ✔✔Pure Food and Drug Act 1906
What act required tha active ingredients be placed on the label of a drug's packaging and that drugs couldn't fall below purity levels established by the USP or National Formulary? ✔✔Pure food and drug act 1906
What amendment defined two categories - legend and OTC ✔✔Durham-humphrey 1951
What amendment mandated there must be "adequate directions for use" on the manufacturer's label for OTC's ✔✔Durham-Humphrey 1951
What amendment declared that all new drugs marketed in the U.S. had to be shown to be safe and effective ✔✔Kefauver-Harris 1962
What act was passed to correct the problem of diversion from the normal distribution channels. Prohibits drug from being re-imported into the U.S. Except by the manufacturer of said drugs. ✔✔Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution records? ✔✔Prescription Drug Marketing Act 1987
What act prohibits sale, purchase, or trade of any drug which was purchased by a public or private hospital or other health care entity? ✔✔Prescription Drug Marketing Act 1987
What act prohibits the sale, purchase, or trade of any drug sample or drug coupon redeemable for a drug product? ✔✔Prescription Drug Marketing Act 1987
What information is reported under the Parkinson's disease registry ✔✔Report shall include the name, address, and socical security number of the person for whom the drugs were prescribed and the name and address of the prescribing physician
How long must a pharmacy maintain inventory records ✔✔5 years
Within how many days should a copy of the initial CS inventory, annual inventory, and/or CS inventory take pursuant to change in PIC be forwarded to the Department? ✔✔Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department ✔✔Pharmacy license, pharmacy's DEA registration, all unused DEA 222 Forms
If CS inventory is transferred to another pharmacy, how long must those transfer records be maintained? ✔✔2 years
How often does a consult pharmacist have to physically be in the public health clinic? ✔✔ 30 days
May a pharmacy intern transfer CS? ✔✔Yes
May a pharmacy intern conduct DUR? ✔✔Yes
May a pharmacy intern oversee technicians? ✔✔No
May a technician receive an oral medication order? ✔✔No
May a technician Drug Product Select? ✔✔No
May a technician counsel or provide any professional consultations? ✔✔No
May a technician clarify a medical order? ✔✔No
Can supervision and/or verification be fulfilled via real-time audiovisual cmmunication? ✔✔Yes, for verification only if patient is resident of a facility
If a licensed practitioner provides written requiests for prescription drug samples, for how long must the manufacturer keep the request and who is responsible for the annual inventory of the samples? ✔✔3 years; sales representatives are responsible for prescription drug samples, including the annual inventory
What is proper refrigeration temperatures ✔✔36 to 46'F or 2 to 8'C
What is the proper freezer temperatures ✔✔-4 to 14'F or -20 to -10'C
What is the proper room temperature? ✔✔46 to 59'F or 8 to 15'C
A pharmacy must register as a wholesale drug distributor if it distributes more than: ✔✔5% gross dollar value of the total prescription drug sales revenue in a 12month period
Define long-term detox treatment ✔✔30 to 180 days
Define maintenance treatment ✔✔> 21 days
Define short term detox treatment ✔✔< 30 days
What act enables qualifying physicians to receive a waiver from the special registration requirements in the Controlled Substance Act for the provision of medication-assisted opioid therapy ✔✔Drug Addiction Treatment Act 2000 (DATA 2000)
May an optometrist prescribe C2's? ✔✔Yes but only topical ophthalmics
May a prescriber prescribe controlled substances to themselves? ✔✔No
Can an APRN dispense samples? ✔✔Yes, but not a APRN-CNS (clinical nurse specialist) they have no prescribing authority
May a midwife (APRN-CNM) prescribe C2's? ✔✔Only for up to 72 hours for pain only
When is the name of the prescriber (supervisor of PA) required to be on the label of a prescription written by a Physician's Assistant? ✔✔When required for reimbursement purposes
What schedule is Ephedrine? ✔✔C
According to federal law how much C5 containing opium can a Pharmacist sell within 48 hrs? ✔✔Not more than 240mL/8oz. Or 48 dosage units
According to federal law how much C5, other than opium containing, can be sold by a Pharmacist in 48 hrs? ✔✔Not more than 120mL/4oz or 24 dosage units
What are legal letters for the first letter in a prescriber's DEA number? ✔✔A, B, F, G, M
Prescription quantity for residents of LTCF must be ____ days, unless otherwise limited by the prescriber ✔✔60 days
If a RPh enters a practice agreement with a licensed medical practitioner to provide pharmaceutical care according to written protocols, how often must the agreement be reviewed, signed, and dated? ✔✔Every 12 months
A chart order in a hospital must contain? ✔✔Patient Name, Date of order, Drug name, strength, and sig, and prescriber's name
How long must a poison registry be maintained? ✔✔2 years from the last entry
When refilling a prescription that was initially dispensed in a threaded child-resistant container, the RPh must always replace: ✔✔The plastic closure
The labeling requirements do not apply when no more than how many days supply of a C2 is dispensed at one time for an institutionalized patient? ✔✔7 day supply
The labeling requirements do not apply when no more than how many days supply of a C through 5 may be dispensed at one time for an institutionalized patient? ✔✔34 day supply or 100 dosage units
Filing systems for prescription hard-copies? ✔✔2 file system - C2 in one drawer and C3 through non-controlled in another (C3-5 must be marked with a red C)
3 file system
When a prescriber writes "do not label" on the original written prescription, what isn't placed on the dispensing label? ✔✔Drug name
When a prescription is written for an animal which of the following should be on the label: (A) name of animal, (B) species of animal, (C) name of owner ✔✔Species of animal and name of owner
List the requirements of Unit-Dose packaging system ✔✔(1) contains individually sealed doses, (2) May or may not attach the sealed doses to each other by placement in a card, (3) May not contain doses for greater than 14 days, (4) non-reusable
How long must a cancer drug repository logbook be maintained? ✔✔5 years
In accordance with Nebraska Pharmacy Law a RPh may accept return of the dispensed drug or device when? ✔✔Device is defective/malfunctioning, collected for the purpose of disposal, in response to a recall
How long should record of Form 41 be maintained? ✔✔5 years
Theft occurs at your pharmacy, what should you do? ✔✔Complete a DEA Form 106 (send org. To DEA, keep copy for pharmacy, and send copy to NE Department) and contact local law enforcement
What should be on the exterior of an e-kit box? ✔✔"Emergencies only"; listings of drugs: name, strength, quantity, route, and expiration; name, address, and telephone of pharmacy
What are the restrictions on the contents of an e-kit? ✔✔Can not contain multi dose vials, no more than 10 CS drugs, and no more than 50 total drugs
What information shall be on repackaged containers ✔✔Manufacturer, lot #, drug name, strength, dosage form, NDC, route, and expiration on a typewritten label
How often shall a e-kit be inspected by a RPh? ✔✔Once every 30 days and after reported use (must be inspected by a pharmacist)
How long shall record of inspection and delivery of e-kit be maintained? ✔✔5 years
Delegated dispensing permit, worker qualifications? ✔✔At least 18 y/o, earned high school diploma or equivalent, completed training, demonstrated proficiency
Requirements of a RPh, due to OBRA 90? ✔✔DUR (prospective and retrospective [medicaid]), Offer to Counsel, Maintain patient profile
Minimum required to maintain patient profile? ✔✔Name, address, telephone#, don, gender, significant medical history (allergies), RPh comments relevant to drug therapy
When is counseling not required? ✔✔Patient is in facility, refused by patient/caregiver, counseling may hurt patient-practitioner relationship, prescriber specifies to be "contacted prior to counseling"
Drugs required to have PPI ✔✔Statins, accurate, oral contraceptives, estrogenic substances
When should PPI be included? ✔✔Ambulatory: initial fill and every refill
Institutions: prior to first fill and every 30 days
Who dispenses PPI? ✔✔Hospital pharmacy, LTCF, doctors
Failure to distribute a PPI is considered? ✔✔Misbranding
Common drugs that require a medguide? ✔✔Antidepressants (SSRI), ADHD, NSAIDs, Fluoroquinolones, Thiazolidinedions
Who is required to dispense medguides? ✔✔Dispensers to outpatients
What Form or Program is used by healthcare providers and consumers for voluntary reporting of ADR ✔✔FDA Form 3500 or MedWatch
Does a RPh have to be the one to make the "offer for counseling"? ✔✔No, but it has to be verbally offered by a pharmacy staff member
What act protects against intential contamination of OTCs? ✔✔Federal Anti-Tampering Act 1982
Are OTC labels required to have Lot# and Exp date? ✔✔No
How long must NOPP be maintained? ✔✔6 years from date of signature or last date of RX dispensed
Are there an requirements for future NOPP signatures? ✔✔No
Does the date of initial filling and quantity dispensed need to be on the prescription hard-copy? ✔✔Yes
Is it a requirement for a C2 hard copy to have the pharmacist or practitioner filing the prescription write the date of filling and his/her signature on the face of the prescription? ✔✔No, this requirement was repealed by Nebraska statue 28-
What is the intention of HIPPA ✔✔To ensure the safety and security of each patient's health related information
How often is a CS inventory required via Federal Law? ✔✔Beinnial
How often is a CS inventory required in Nebraska? ✔✔Annual
For how long should records of inventory count be maintained? ✔✔5 years
In Nebraska, can the count of any CS be estimated? ✔✔No
How shall CS be stored in a pharmacy? ✔✔C1 must be stored in a locked cabinet; C2 through 5 can be stored in a locked cabinet or stored throughout the pharmacy's noncontrolled inventory
T/F the prescription inventory and prescription records of the pharmacy must be maintained in a secure location when there is no pharmacist on the premises. ✔✔True
Every record of CS shall be kept for a period of ________ from the date of transaction recorded. ✔✔5 years
A central record keeping location must be capable of sending the printout to the pharmacy within? ✔✔48 hours
Are pharmacy licenses transferable to different locations or owners ✔✔no
