Nebraska MPJE; 176 Questions with 100% Correct Answers

Nebraska MPJE | 176 Questions with 100% Correct Answers 2022/2023 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? Correct Answer: 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? Correct Answer: FDA modernization act 1997 What act reduced the cose of orphan drugs? Correct Answer: Orphan drug act 1983 What act prohibited the adulteration or misbranding of food and drugs? Correct Answer: 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? Correct Answer: Pure food and drug act 1906 What amendment defined two categories - legend and OTC Correct Answer: Durham-humphrey 1951 What amendment mandated there must be "adequate directions for use" on the manufacturer's label for OTC's Correct Answer: Durham-Humphrey 1951 What amendment declared that all new drugs marketed in the U.S. had to be shown to be safe and effective Correct Answer: 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. Correct Answer: Prescription Drug Marketing Act 1987 What act requires proper storage of drugs and maintenance of appropriate distribution records? Correct Answer: 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? Correct Answer: 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? Correct Answer: Prescription Drug Marketing Act 1987 To be PIC what are the hourly requirements they must physically work in a pharmacy? Correct Answer: majority of the hours per week that the pharmacy is open averaged over a 12 - month period or 30 hours per week Who must submit the Pharmacy Quality Assurance Report and when? Correct Answer: PIC and Annually Who submits the Parkinson's Disease Registry Act to the Department semiannually? Correct Answer: PIC Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy closes? Correct Answer: Department of Health and Human Services Within how many days should the department be notified that a pharmacy is closing? Correct Answer: 30 days prior Within how many days should the department be notified of the disposition/sale of inventory, prescription records, etc due to pharmacy closing? Correct Answer: 15 days When shold the department be notified of a change in PIC? Correct Answer: Immediately What information is reported under the Parkinson's disease registry Correct Answer: 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 Correct Answer: 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? Correct Answer: Within 30 days after completion In the event of a pharmacy closing what documents must be returned to the Department Correct Answer: 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? Correct Answer: 2 years How often does a consult pharmacist have to physically be in the public health clinic? Correct Answer: 30 days May a pharmacy intern transfer CS? Correct Answer: Yes May a pharmacy intern conduct DUR? Correct Answer: Yes May a pharmacy intern oversee technicians? Correct Answer: No May a technician receive an oral medication order? Correct Answer: No May a technician Drug Product Select? Correct Answer: No May a technician counsel or provide any professional consultations? Correct Answer: No May a technician clarify a medical order? Correct Answer: No Can supervision and/or verification be fulfilled via real-time audiovisual cmmunication? Correct Answer: Yes, for verification only if patient is resident of a facility Requirements to be a pharmacy technician Correct Answer: Must be at least 18 years old, have met the educational requirements of a high school diploma, never been convicted of any nonalcohol, drug-related misdemeanor/felony, fulfill training requirements within the first 30 days of employment, apply for registration w/in 30 days of being hired Supervision Ratio Correct Answer: 2 technicians : 1 RPh 3 interns : 1 RPh 2 technicians and 1 intern : 1 RPh Are interns receiving their experiential training applied to the supervision ratios Correct Answer: No May retail pharmacies receive starter packs? Correct Answer: Yes, they are not considered samples and are intended for initiation of drug therpy for a patient. Also not labeled as a sample Possession of prescription drug samples by retail pharmacies would be considered ________ ___________ by the FDA. Correct Answer: Drug diversion When may institutional pharmacies receive prescription drug samples? Correct Answer: Licensed prescriber requested (disposition precisely recorded and stored separately from normal drug stock) 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? Correct Answer: 3 years; sales representatives are responsible for prescription drug samples, including the annual inventory What is proper refrigeration temperatures Correct Answer: 36 to 46'F or 2 to 8'C What is the proper freezer temperatures Correct Answer: -4 to 14'F or -20 to -10'C What is the proper room temperature? Correct Answer: 46 to 59'F or 8 to 15'C A pharmacy must register as a wholesale drug distributor if it distributes more than: Correct Answer: 5% gross dollar value of the total prescription drug sales revenue in a 12month period Define long-term detox treatment Correct Answer: 30 to 180 days Define maintenance treatment Correct Answer: 21 days Define short term detox treatment Correct Answer: 30 days