Nevada MPJE Questions With Complete Solutions.

Nevada MPJE Questions With Complete Solutions. True or false: "take as directed" does not fulfill the directions for use requirements for controlled substances. true. Controlled Rx must clearly specify dosage, frequency, and manner in which the drug is to be taken. How often must practitioners or other people who dispense controlled substances obtain registration from the DEA? every 2 years True or false: an agent or employee of a registered dispenser is not required to register with the DEA. True, so long as they are acting in the usual course of their business/employment. True or false: a common or contract carrier or warehouseman does not need registration with the DEA. True. Which of the following activities requires separate registration with the DEA? (1) manufacturing. (2) distributing. (3) dispensing, prescribing, conducting research. (4) conducting chemical analysis. they all do. A separate registration for each of these activities is required. True or false: a person who engages in more than one group of independent activities must obtain a separate registration for each group of activities. TRUE. True or false: a separate registration is required for each place of business or professional practice where controlled substances are manufactured, distributed, used in research or scientific investigation, prescribed or dispensed. TRUE True or false: a warehouse that stores controlled substances requires a separate registration. FALSE. True or false: a practitioner's office where controlled substances are prescribed but not stored or dispensed still requires a separate registration. FALSE. If they are only prescribed, and not stored/dispensed/administered, the location does not require registration. True or false: a practitioner's office where controlled substances are stored does not require a separate registration. FALSE - if controlled substances are being stored, they require separate registration. What items are required on the certificate of registration? (1) name of registrant. (2) address of registrant. (3) registration number (DEA#) of registrant). (4) activity authorized (is it dispensing, research, etc). (5) the schedules of the controlled substances which the registrant is authorized to handle. For a practitioner who dispenses controlled substances for use by his patients outside of his presence, what record-keeping is required? (1) name of the patient. (2) address, unless readily available (then indicated). (3) date of dispensing. (4) name of the prescribing practitioner and classification of license. (5) DEA #. (6) initials of the dispensing practitioner if the dispensing is different from the prescribing. (7) directions for use. (8) signature of the prescribing practitioner. True or false: a practitioner may dispense controlled drugs to a patient only after he has issues a written RX that allows the patient to have it filled at another location of the patient's choosing. TRUE True or false: an individual practitioner may dispense a controlled substance (2-4) for his own personal use. FALSE - they may not. Exception: medical emergency. Can pharmacists use oral authorization to dispense CII medications? YES, but only in emergency situations. The quantity prescribed/dispensed must be limited to the amount adequate to treat the patient during the emergency period. Any quantity beyond this requires a written prescription. What are the requirements for dispending a CII in an emergency situation? Reduce the oral authorization to writing immediately. RX must contain all information required of controlled medications, except the signature of the prescriber. Write on the face of the RX "authorization for emergency dispensing" and date or oral order. Make reasonable effort to confirm validity of registered practitioner if they are personally unknown to the pharmacist. A written prescription must be received, either by person or by mail, within 72 hours (if by mail, then post-marked by 72 hours). Attach this written rx to the oral authorization. If the written RX is not received, the pharmacist must notify the board of the prescribers' failure to deliver. True or false: an individual practitioner may issue a prescription order in order to obtain controlled substances for the purpose of general dispensing to patients. FALSE - they should be filling out an order form - prescribers cannot write an RX to a pharmacy with "for office use," for example. Can a prescription for a narcotic be given to a patient who is dependent with the sole purpose of extending their dependence on the medication? ONLY if they are in an authorized investigation in the development of a program for rehabilitating narcotic addicts. True or false: the prescribing of narcotic's to a person dependent on a narcotic for the purpose of continuining his dependence is persmissible as long as that patient is in a authorized clinical investigation in the development of a program for rehabilitating narcotic addicts. FALSE - narcotics may be administered or dispensed directly - but they cannot be prescribed! (this is unsafe for the patient, who should be supervised while taking medication they are dependent upon) What schedules of controlled medications can be accepted through fax? C3-5. C2s can be accepted via fax in only 3 circumstances: (1) compounded for direct administration, (2) for a patient in a LTCF, or (3) for a patient in hospice-care (or is "terminally ill") What items must be included in an written prescription? (nor oral or electronic) for the prescriber: (1) name, (2) address - unless readily available, (3) signature, (4) type of license, (5) DEA#. For the patient: (1) name of the patient, (2) address, unless readily available, (3) name, strength, quantity of drug, (4) directions for use, (5) date issued What items can be changed on a CII prescription? strength of drug, quantity of drug, directions for use, and the date the RX was issued. All changes require prescribing practitioner approval. Note the date and time of change, and the reason for the change. Which items can NOT be changed on a CII prescription? name of the patient, name of the drug, signature of the prescribing practitioner. Can a prescription blank contain more than one CII medication? YES. If it's being filled immediately, the prescription can contain multiple CIIs, other controlled medications, or non-controlled medications. They just have to be filed appropriately. (make copies, reference the original rx/C2 on the copies) Can a pharmacist return a written C2 prescription? yes, only if the medication has not already been dispensed. If the medication has been dispensed, the pharmacist shall not return the rx to the patient. Can multiple drugs be on a single prescription blank if the medication is issued for future use? NO. any C2 with "do not fill before" or some version thereof must be alone on that prescription blank. When must a C2 prescription for future use be tendered? within 14 days of the future date indicated (on or before the 14th day). True or false: the date indicated on a C2 for future use must not be later than 4 months after the date on which the prescription is written. FALSE - no later than THREE months. True or false: for C2s with future fill date; "no combination of prescriptions for the same medication may exceed a 90-day supply based on the date indicated." TRUE. Are pharmacists allowed to dispense a partial fill on C2 medications? YES. If the pharmacist is unable to supply the full quantity, you can fill a partial quantity - note the quantity dispensed on the RX. The remaining quantity must be filled within 72 hours. If the remainder cannot be filled within 72 hours, the pharmacist must notify the prescriber. No further quantity may be supplied beyond the 72-hour period without a new prescription. How long is a C2 prescription valid for after a partial fill? if it's a regular patient, the remainder must be filled within 72 hours. For patients in LTCF or hospice/terminally-ill, the prescription is valid for 60 days after its written date unless the rx is terminated earlier by d/c of the medication. Can C-3 to 5 be partially filled by the pharmacist? What counts as a full refill? YES, schedule 3 to 5 can be partially filled. A patient will not receive a full refill until the entire quantity of the first prescription has been dispensed. Example: patient has RX for Xanax 2 mg, # 60. Patient can pick up #20. It will not count as a "full" fill until the patient picks up a total of 60. Up to how long can C3-5 rxs be partially filled or refilled? no more than 6 months after the date it was originally written. If a pharmacist is hired as a new pharmacy manager, when must they conduct a controlled inventory by? within 48 hours, with the preceding pharmacist. Both must sign the inventory. How often must an inventory of controlled substances be conducted? Biennially (every 2 years). "on any date which is within 2 years of the date on which the previous biennial inventory was conducted." Which records must be maintained in regards to the sale of controlled substances to a practitioner? DEA 22 form for all controlled substances (2-5), plus, a certificate placed on the written order, signed by the pharmacist filling the order and the person receiving the order and specifying the date the order was filled and any deletion or change in the order. If a DEA 222 form is lost or stolen, who and when must the pharmacist notify? notify the DEA immediately upon discovery of loss or theft. What are the requirements to sell/dispense a controlled medication that by law does not require a prescription? (1) dispensing only by the pharmacist/intern. (2) no more than 60ml or 2oz in any 48-hr period. (3) purchaser is at least 21 yo. (4) validate the ID/age of the purchaser if unknown to the pharmacist. (5) maintain a log book . (6) the medication is not required by law to have a prescription. What items must be contained in the log book for selling non-prescription controlled medications? (1) name and address of the purchaser, (2) name and quantity of drug sold, (3) date of each purchase, (4) initials/name of pharmacist who dispensed the medication What are the requirements in dispensing Paregoric? Paregoric is camphorated tincture of opium, used for GI issues. Can dispense is (1) it has been mixed with at least 3 oz of non-narcotic medication/mixture, (2) contains no more than 1 oz total paregoric. True or false: a practitioner may prescribe or administer controlled substances (C2s) for himself, his spouse, or his children if it's in the usual course of his professional practice. FALSE - only in cases of emergency. How long does a pharmacist have to notify the DEA and Board of Pharmacy of any loss or theft of controlled substances? within 10 days after the date of discovery of the theft or loss. What items are required in the log book for the sale of precursors to methamphetamines? (1) name of the product sold, (2) quantity of the product sold, (3) name and address of the purchaser, (4) date and time of the sale How long must records for the sale of precursors to methamphetamine be maintained? at least 2 years. What is the max of pseudoephedrine product that can be purchased in a single day? 30 days? 3.6 grams per day. 9 grams per 30 days. What are the elements of negligence? duty owed, breach of duty, causation and damage. All four elements required to prove legal liability. What is the difference between a prescription drug and an OTC drug? Prescription drugs are intended for human use, but are generally not safe unless taken under the supervision of a practitioner. OTC medications are generally seen as safe, must be manufactured using current GMPs, and have adequate directions for use for the lay-person. What is the difference between an NDA and an ANDA? NDA is a new drug application. Typically reserved for new chemical entities, or new indications/dosage forms/routes of administration, etc of already known chemical entities. These require safety and efficacy data for the FDA to give pre-marketing approval. And ANDA = abbreviated new drug application. These are used for generics of brand name medications who's patent just ran out. Safety/efficacy studies not generally required, but bioequivalency studies are needed. What is an SNDA? Supplemental new drug application. An application process for previously FDA approved drug products that want to request a change to the production of the drug, manufacturing process, or to the labeling of the drug. What is an OTC monograph? a regulation specifying the conditions (dosage, indications) under which specific active ingredients and combinations may be formulated in OTC drug products without prior FDA approval. What is an NDC? national drug code - it identifies all drug products, is required on all OTC and prescription drug labels. A drug with an NDC does not mean is has an approved NDA. First section = manufacturer. 2nd section = drug product. 3rd section = packaging. What is the difference between adulteration and misbranding? Adulteration is concerned with the physical conditions of drugs or devices and the environment of their manufacture. Misbranding is concerned with the representations made by the manufacturer concerning the drug or device. Misbranding or adulteration: does not bear generic name in type not less than ½ size of the trade or brand name? misbranding Misbranding or adulteration: does not bear adequate directions for use. misbranding Misbranding or adulteration: label fails to state name and place of business of manufacturer and accurate statement of quantity. misbranding Misbranding or adulteration: does not bear caution: warning, may be habit forming, if the substance is habit forming. misbranding Misbranding or adulteration: prepared, packed, or held in unsanitary conditions adulteration Misbranding or adulteration: manufactured not in conformance with GMP. adulterated Misbranding or adulteration: contains unsafe color additive. adulteration Misbranding or adulteration: OTC drug not packaged in tamper-resistant packaging. Adulteration Misbranding or adulteration: subject to deterioration and label does not warn