Download NEBRASKA MPJE QUESTIONS WITH CORRECT ANSWERS and more Exams Medicine in PDF only on Docsity!
NEBRASKA MPJE QUESTIONS WITH CORRECT
ANSWERS
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 To be PIC what are the hourly requirements they must physically work in a pharmacy? 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? PIC and Annually
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 Requirements to be a pharmacy technician 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 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 No May retail pharmacies receive starter packs? 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. Drug diversion When may institutional pharmacies receive prescription drug samples?
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 How can a pharmacist verify a prescriber is allowed to prescribe suboxone? Confirm prescriber has been granted a waiver via SAMHSA website/phone, Check DEA# for leading letter "X" What part of an RX may a pharmacist never change? Patient name, drug name, Dr. Name/signature Who should be contacted in the event that the pharmacist does not receive a cover script for an emerency verbal within 7 days of the oral C2 order? The dea
What schedule is glutathione? C What schedule is oxandrolone (Oxandrin)? C What schedule is phendimetrazine? C What schedule is be petaling (didrex)? C 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
5 years What is the purposes of drug product select? To provide for the drug product selection of equivalent drug products and promote the greatest possible use of such products What does Bioequivalent mean? Same dosage form of identical active ingredients in identical amounts What does Chemically equivalent mean? Contain amounts of the identical therapeutically active ingredients in the identical strength, quantity, and dosage form and meet present compendial standards When can a RPh not product select? Patient or caregiver instructs not to, Prescriber specifies on phone or writes NDPS, DAW, or BMN How many times may a prescription be transferred? Once, unless they share a real-time online database Who can conduct controlled and non-controlled transfers? RPh or Intern 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
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 should a ephedrine, pseudoephedrine, phenylpropanolamin logbook be maintained? 2 years When doesn't a logbook or ID for the sale ephedrine need to be used? Single sales < 60mg Nebraska requires electronic transmission for the sale of methamphetamine precursor, what information is required? Name, age, address of the person purchasing; name and quantity of product; date and time of purchase; name/initials of seller; type and number of ID... Must be 18 to purchase or sell May the attorney general grant a waiver exempting a seller from complying with the electronic submission for the sale of methamphetamine precursor? Yes
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 How old must you be to get credentialed in Nebraska? 19 What is the composition of the Nebraska Board of Pharmacy 5 members; 4 pharmacists (at least one of whose practices w/in a hospital) and 1 public member How long can a board member serve?
They are appointed for a term of 5 years. They can not serve for more than 2 consecutive terms Qualifications for a pharmacy inspector Only a licensed pharmacist can be appointed by the department with approval of the board Requirements to become a licensed pharmacist in Nebraska (1) Graduated from pharmacy program (2) Pass licensure exam (MPJE and NAPLEX) (3) Meet one of the following requirements to demonstrate competency: (a) within the last 3 years, passed RPh exam (b) active practice of pharmacy in another state for a least 1 year within the 3 years immediately preceding the application (c) has become board certified in a specialty recognized by the board w/in 7 years (d) duly licensed as a RPh in another state, OR (e) completed continuing competency in pharmacy approved by the board (4) be good moral character and at least 21 y/o (Federal, 19y/o NE) What is a TEP? Temporary Education Permit - issued to pharmacy grad not licensed yet as a pharmacist, but is "serving in a supervised educational program" Requirements for TEP No less that 21 y/o, good moral character, graduate of pharmacy May a graduate with a TEP engage in pharmacy outside of the assigned training program? No
Under what circumstances of change should a licensee notify the Department? Change in PIC, Owner, Location, Pharmacy Name, Change in scope/type of services, change in environment, licensee dies When there is a new owner but the location stays the same, what must occur? Apply for pharmacy license, but no additional inspection When there is a change in location, what must occur? Apply for new pharmacy license and inspection According to Nebraska Pharmacy Law, the PHarmacy Quality Assurance Report is due when? One year from the date of the initial on-site inspection, and annually thereafter Must report incompetence, negligence, or unprofessional conduct to the department within _______ days of occurence 30 days If in the same profession, it is mandatory to report what? First-hand knowledge of negligence, unprofessional conduct, practicing while impaired by substance, or violated regulatory provisions governing the practice of pharmacy If in different profession, it is mandatory to report what? First-hand knowledge of negligence or practicing impaired When is it mandatory for a credential holder report him/herself? Lost privileges/employment or disciplined for reportable behavior Had adverse judgement/settlement arising out of a professional liability claim Been convicted of a misdemeanor Loss membership/discipline from a professional organization
Mandatory reporting, exceptiosn Spouse, pharmacist interns, practitioner treating credential holder, or when a credential holder who is chemically impaired enters the licensee assistance program How often does the department require an out of state mail order ophthalmic provider to provide the registration to dispense contact lenses to Nebraska residents? Annually Mail service pharmacy license requirements Must comply with the laws in the state where it's located and Nebraska laws; requires a pharmacist who is licensed in Nebraska When is a CLIA (clinical laboratory improvement act) waiver required? Pharmacy must obtain a CLIA waiver if a pharmacist pricks a patient's finger for a blood glucose test For how long is a CLIA waiver valid? 2 years What act seizes any adulterated/Misbranding food, drug, or cosmetic with court approval, approves new drug entities, and drug package insert labeling? Food, Drug, and Cosmetic Act What act didn't allow marketing until the product was proven safe? FDCA 1938 What act made manufacturers prove effectiveness and safety of drug before marketing? Kefauver-Harris 1962
