Download Nebraska MPJE-------------------------Nebraska MPJE and more Exams Advanced Education in PDF only on Docsity!
Nebraska MPJE
What legislation 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 legislation 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 case 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
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 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 - correct answer Drug Addiction Treatment Act 2000 (DATA 2000) May an optometrist prescribe C2's? - correct answer Yes but only topical ophthalmics May a prescriber prescribe controlled substances to themselves? - correct answer No Can an APRN dispense samples? - correct answer Yes, but not a APRN-CNS (clinical nurse specialist) they have no prescribing authority May a midwife (APRN-CNM) prescribe C2's? - correct answer Only for up to 72 hours for pain only
What are legal letters for the first letter in a prescriber's DEA number? - correct answer A, B, F, G, M Prescription quantity for residents of LTCF must be ____ days, unless otherwise limited by the prescriber - correct answer 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? - correct answer Every 12 months A chart order in a hospital must contain? - correct answer Patient Name, Date of order, Drug name, strength, and sig, and prescriber's name How long must a poison registry be maintained? - correct answer 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: - correct answer 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? - correct answer 7 day supply The labeling requirements do not apply when no more than how many days supply of a C3 through 5 may be dispensed at one time for an institutionalized patient? - correct answer 34 day supply or 100 dosage units Filing systems for prescription hard-copies? - correct answer 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 How long should prescription hard-copies be maintained? - correct answer 5 years
What is the purposes of drug product select? - correct answer To provide for the drug product selection of equivalent drug products and promote the greatest possible use of such products What does Bioequivalent mean? - correct answer Same dosage form of identical active ingredients in identical amounts What does Chemically equivalent mean? - correct answer 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? - correct answer Patient or caregiver instructs not to, Prescriber specifies on phone or writes NDPS, DAW, or BMN How many times may a prescription be transferred? - correct answer Once, unless they share a real-time online database Who can conduct controlled and non-controlled transfers? - correct answer RPh or Intern When a prescriber writes "do not label" on the original written prescription, what isn't placed on the dispensing label? - correct answer 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 - correct answer Species of animal and name of owner List the requirements of Unit-Dose packaging system - correct answer (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? - correct answer 5 years
The licensee must notify the Department in writing by e-mail, fax, or postal within how much time of any change in environment which will adversely affect the potency, efficacy, safety, or security of the drugs, devices, or biological a in the pharmacy (accident, natural disaster, interruption in utility services)? - correct answer 24 hours The pharmacy must establish and implement disaster preparedness plans and procedures that address: - correct answer (1) How the pharmacy will provide storage of drugs at proper temp (2) how the pharmacy will provide disposal of drugs in quality affected (3) how the pharmacy will secure the drugs from the public (4) how the pharmacy will maintain patient and inventory records What drugs are allowed on a public health clinic's formulary? - correct answer Contraception, STD, and vaginal infections Delegated dispensing permit, worker qualifications? - correct answer At least 18 y/o, earned high school diploma or equivalent, completed training, demonstrated proficiency Requirements of a RPh, due to OBRA 90? - correct answer DUR (prospective and retrospective [medicaid]), Offer to Counsel, Maintain patient profile Minimum required to maintain patient profile? - correct answer Name, address, telephone#, don, gender, significant medical history (allergies), RPh comments relevant to drug therapy When is counseling not required? - correct answer 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 - correct answer Statins, accurate, oral contraceptives, estrogenic substances When should PPI be included? - correct answer Ambulatory: initial fill and every refill
Institutions: prior to first fill and every 30 days Who dispenses PPI? - correct answer Hospital pharmacy, LTCF, doctors Failure to distribute a PPI is considered? - correct answer Misbranding Common drugs that require a medguide? - correct answer Antidepressants (SSRI), ADHD, NSAIDs, Fluoroquinolones, Thiazolidinedions Who is required to dispense medguides? - correct answer Dispensers to outpatients What Form or Program is used by healthcare providers and consumers for voluntary reporting of ADR - correct answer FDA Form 3500 or MedWatch Does a RPh have to be the one to make the "offer for counseling"? - correct answer No, but it has to be verbally offered by a pharmacy staff member What act protects against intential contamination of OTCs? - correct answer Federal Anti-Tampering Act 1982 Are OTC labels required to have Lot# and Exp date? - correct answer No How long should a ephedrine, pseudoephedrine, phenylpropanolamin logbook be maintained? - correct answer 2 years When doesn't a logbook or ID for the sale ephedrine need to be used? - correct answer Single sales < 60mg Nebraska requires electronic transmission for the sale of methamphetamine precursor, what information is required? - correct answer 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
How shall CS be stored in a pharmacy? - correct answer 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. - correct answer True Every record of CS shall be kept for a period of ________ from the date of transaction recorded. - correct answer 5 years A central record keeping location must be capable of sending the printout to the pharmacy within? - correct answer 48 hours Are pharmacy licenses transferable to different locations or owners - correct answer no How old must you be to get credentialed in Nebraska? - correct answer 19 What is the composition of the Nebraska Board of Pharmacy - correct answer 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? - correct answer They are appointed for a term of 5 years. They can not serve for more than 2 consecutive terms Qualifications for a pharmacy inspector - correct answer Only a licensed pharmacist can be appointed by the department with approval of the board Requirements to become a licensed pharmacist in Nebraska - correct answer (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? - correct answer Temporary Education Permit - issued to pharmacy grad not licensed yet as a pharmacist, but is "serving in a supervised educational program" Requirements for TEP - correct answer 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? - correct answer No Can a holder of a TEP supervise and/or verify work of an intern or tech? - correct answer No What is the duration of a TEP? - correct answer 1 year, but can be renewed for no more than 5 years When does a Nebraska pharmacist license expire? - correct answer January 1 of each even-numbered years CE requirements - correct answer 30 hours within 24 months (exceptions: served in armed forces during credentialing period, or was first credentialed within the period immediately preceding the renewal date) Approved providers of CE - correct answer ACPE, NE council of continuing pharmacy education, Others demonstrating same quality standards as ACPE, OR Nebraska approves Physician CME Category 1, as well
When is it mandatory for a credential holder report him/herself? - correct answer 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 - correct answer 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? - correct answer Annually Mail service pharmacy license requirements - correct answer 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? - correct answer 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? - correct answer 2 years What act seizes any adulterated/Misbranding food, drug, or cosmetic with court approval, approves new drug entities, and drug package insert labeling? - correct answer Food, Drug, and Cosmetic Act What act didn't allow marketing until the product was proven safe? - correct answer FDCA 1938 What act made manufacturers prove effectiveness and safety of drug before marketing? - correct answer Kefauver-Harris 1962
What act gave the FDA authority to regulate RX drug advertisments - correct answer Kefauver-Harris 1962 What act required informed consent in clinical investigations - correct answer Kefauver-Harris 1962 What act is responsible for the creation of GMP - correct answer Kefauver-Harris 1962 What act gave clarification on compounding by pharmacies, state regulated? - correct answer FDA modernization act 1997 What act encouraged research for new uses of drugs - correct answer FDA modernization act 1997 What act created provision to fast track some NDA - correct answer FDA modernization act 1997 What act revised the legend requirement to "RX Only" - correct answer FDA modernization act 1997 Describe Phase 1 clinical testing - correct answer 20-80 healthy volunteers Drug properties; safety in humans Evaluate drug toxicology, pharmacokinetics and pharmacological properties; Describe Phase 2 clinical testing - correct answer 100-300 volunteers Drug effectiveness and dosing Describe Phase 3 clinical testing - correct answer 1000-5000 volunteers Drug effectiveness compared to control group
