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Federal MPJE Practice Questions with
Complete Answers
what law prohibits the distribution of food and drugs that are misbranded or adulterated? ✔✔Pure Food and Drug Act
What is the system that can be used as an electronic substitute for DEA Form 222 when ordering Schedule II controlled substances? ✔✔Controlled Substance Ordering System (CSOS)
What agency is responsible for the federal Controlled Substances Act (CSA)? ✔✔the DEA
A pharmacist wants to know if generic warfarin tablets are bioequivalent to brand name Coumadin tablets. Where can this information be found? ✔✔The Orange Book
When a pharmacy submits a DEA Form 222 (single sheet) to purchase Schedule II controlled substances, who keeps the original copy of the DEA Form 222? ✔✔the supplier
Which DEA form must be completed and submitted to the DEA upon discovering a theft or significant loss of controlled substances? ✔✔DEA Form 106
What is the first application that must be submitted to the FDA before a drug can be administered to humans in order to start testing? ✔✔Investigational New Drug Application (IND)
Which phase of a clinical trial is first used to determine the efficacy of a drug? ✔✔Phase II
What Act regulates the sale and recordkeeping requirements for prescription drug samples? ✔✔Prescription Drug Marketing Act
A manufacturer has a drug that is currently on the market, but they want to change the way the drug is produced. What type of application must be submitted to the FDA in order to request approval for this change? ✔✔Prior Approval Supplement (PAS)
Which FDA expedited review program is intended for drugs that treat serious conditions and fill an unmet medical need? ✔✔Fast track
Which of the following is a Schedule II controlled substance? ✔✔pentobarbital
A prescription for lorazepam can be refilled a maximum of how many times within a six-month period? ✔✔five
Which of the following is NOT required on the manufacturer's drug container label for an oral drug product? ✔✔directions for administration
A water-containing oral formulation that is compounded from commercially available drug products has a maximum beyond-use-date (BUD) of ___ when refrigerated. ✔✔14 days
Which of the following is a mid-level practitioner? ✔✔Optometrist
Durable Medical Equipment (DME) must meet which standards? ✔✔It can withstand repeated use
Appropriate for use in the home
It is primarily for a medical purpose
Federal investigations into thefts and robberies may take place per the Controlled Substances Registrant Protection Act (CSRPA) if the incident meets which of the following conditions? ✔✔It will cost $500 or more to replace controlled substances
An employee suffers from significant injuries or death
What Act set the requirement that patients must be offered counseling on dispensed medications? ✔✔OBRA 90
Under the iPledge Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, what is the maximum number of refills that may be authorized on a prescription? ✔✔0 refills
In which situation would it be illegal for a pharmacy to compound drugs? ✔✔Dosage forms are sold only to other pharmacies and not physician offices
What DEA form is necessary to purchase or transfer Schedule II controlled substances? ✔✔DEA Form 222
Re-importation of medications is only legal if performed by the: ✔✔original manufacturer
What law requires drugs to be proven effective (as well as safe) before being marketed? ✔✔Kefauver-Harris Amendment
Which DEA registration form is used for pharmacies to register with the DEA to possess and dispense controlled substances? ✔✔DEA Form 224
What information is required to be included in the transaction report transmitted from a manufacturer to a pharmacy when the pharmacy purchases bulk bottles of a medication? ✔✔transaction information
transaction history
transaction statement
A pharmacist receives an urgent notification from a manufacturing company for a recall of a specific medication because it may cause serious adverse health issues or death. What type of drug recall is this? ✔✔Class I
What Act requires health care facilities to report death or injuries caused by or suspected to have been caused by a medical device to the FDA or the manufacturer? ✔✔Safe Medical Device Act
An example of a misbranded manufacturer's container of a drug would be: ✔✔there is no quantity of the contents listed on the container
Which of the following is TRUE regarding the stocking and dispensing of methadone at retail pharmacies? ✔✔methadone may be stocked at a retail pharmacy, but may only be dispensed as an analgesic
According to the FDA, a drug is considered to be an orphan drug if it is for rare diseases or conditions that impact fewer than how many people in the US? ✔✔200,
Which of the following ingredients has special labeling requirements if it is included in a product? ✔✔FD&C Yellow No. 5
In which case(s) is it appropriate to receive a faxed prescription for a Schedule II controlled substance? ✔✔Patient is a resident of a long-term care facility
Patient is enrolled in hospice program
A manufacturer of a prescription-only drug wants to reclassify the drug as an OTC drug. What is one of the forms that may be submitted to the FDA when requesting reclassification of a prescription-only drug to an OTC? ✔✔New Drug Application (NDA)
You are a pharmacist that suspects a fake controlled substance prescription was called into your pharmacy. You use the numbers in the provided DEA to verify if it is a true DEA number. It is indeed not a true DEA number because the last number is incorrect. The DEA number is BS5927683. What would be the correct last digit of the DEA number if it was accurate? ✔✔The number should be 1.
To check:
add together the first, third, and fifth numbers
add together the second, fourth, and sixth numbers. multiply this number by 2.
add the numbers together from steps 1 and 2.
the last digit of the number you get from step 3 is the last number of the DEA number. It should be a 1 in this case.
Which of the following prescriptions would likely be out of the scope of practice for a dentist? ✔✔Atorvastatin
Who is authorized to sign a DEA 222 Form at a community pharmacy? ✔✔The pharmacist who signed the most recent application for renewal of the pharmacy's DEA registration or someone authorized under a power of attorney
OTC drug advertising is regulated by the: ✔✔Federal Trade Commission (FTC)
A pharmacy may keep which of the following records at a central location other than the location registered with the DEA? ✔✔Controlled substance shipping and financial records
Acetaminophen with codeine (Tylenol #3) is classified under which controlled substance schedule? ✔✔Schedule III
A patient is admitted to a hospital and does not remember the names of the medication that she takes at home. The hospital pharmacist calls the patient's outpatient pharmacy to obtain a list of medications. Which of the following statements is true? ✔✔This is not a HIPAA violation because the information is being given to the hospital for treatment purposes
A warning stating "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" is required on the label on which of the following prescriptions? ✔✔Schedule II-IV
Which of the following medications requires REMS monitoring? ✔✔Clozapine (Clozaril)
A DEA Form 41 is used to document which of the following? ✔✔on-site destruction of controlled substances
What Act set the requirement for tamper-evident packaging for some OTC products in order to avoid risk of contamination? ✔✔Federal Anti-Tampering Act
Drugs that have a high potential for abuse and severe potential for dependence with no currently accepted medical use in the US are classified as: ✔✔Schedule I
Which of the following is NOT required to be included on a manufacturer's container of an OTC medication? ✔✔Poison Control Center phone number
A nursing home patient who is prescribed an estrogen-containing product must be given a Patient Package Insert (PPI): ✔✔prior to the first administration and every 30 days thereafter
For how long is a DEA registration for possession of controlled substances valid? ✔✔36 months
Which of the following statements is/are TRUE regarding DEA Form 222? ✔✔Executed copies of DEA Form 222 must be maintained separately from all other records
On the DEA Form 222, only 1 item may be entered on each numbered line
An independent community pharmacy wants to start offering refill reminders to patients in the form of a postcard mailed to the patient's house. The fee for this service would be $2 per month. Which of the following is TRUE regarding this service? ✔✔There are no barriers to offering this service and the pharmacy can proceed as planned
The expiration date on a bottle of metformin purchased from a manufacturer by a pharmacy is listed as 3/19. What is the expiration date of the drug? ✔✔March 31, 2019
A prospective drug utilization review (DUR) consists of reviewing all of the following aspects of a prescription EXCEPT for: ✔✔compliance with prescription labeling
Which of the following statements is required on an OTC package of acetaminophen tablets under the Federal Hazardous Substances Act? ✔✔"Keep out of reach of children"
Which of the following is a valid method of ordering Schedule III medications from a supplier to restock a pharmacy's bulk medication supply? ✔✔sending an online order to the supplier with no additional form sent
Which of the following products is NOT required to be in tamper-evident packaging for retail sale? ✔✔benzocaine/menthol lozenges
A pharmacist may call a prescriber and receive verbal permission to change all of the following on a Schedule II prescription EXCEPT: ✔✔drug name
A patient requests a copy of her prescription records from a community pharmacy. Within what time period must the pharmacy provide this information? ✔✔30 days
Which of the following drugs has a REMS program due to a high frequency of birth defects? ✔✔Thalidomide
Which law requires new drugs to be proven safe and effective before approval? ✔✔Kefauver- Harris Amendment
Anabolic steroids are classified under which controlled substance schedule under federal law? ✔✔Schedule III
Which act or amendment created the separation of drugs into two different categories, prescription (legend) and OTC? ✔✔Durham-Humphrey Amendment
A patient picks up a prescription for Xarelto at a community pharmacy, but returns later in the day concerned that the prescription was filled with generic rivaroxaban. The pharmacist explains that the prescription was filled with the generic form of the medication because it was cheaper than using the brand name product. According to the pharmacist's drug reference, the two products have an FDA equivalency rating of AB. What is the proper interpretation of this code? ✔✔the products may have actual or potential bioequivalence issues, but there is adequate evidence to use them interchangeably
DEA registration is NOT required for which of the following situations? ✔✔A nurse who is working in a physician's office where controlled substances are prescribed
A pharmacist who regularly dispenses controlled substances at a community pharmacy
A patient who picks up a prescription for a newly prescribed controlled substance
The FDA may require a Medication Guide be issued with certain prescriptions for which reasons? ✔✔When a drug has serious risks relative to benefits
When patient adherence is crucial
When drug info can prevent serious adverse effects
Which of the following can be determined from the National Drug Code (NDC) number on a medication bottle? ✔✔Manufacturer
Specific drug
Package
Which of the following is/are NOT required to be packaged in a child-resistant container? ✔✔A container of 30 sublingual nitroglycerin tablets
A methylprednisolone dose pack containing 21 tablets that are 4mg each
An albuterol inhaler
Prescription records must be kept for a minimum of ___ based on federal law. ✔✔2 years
In the event of a breach of unsecured protected health information (PHI) at a retail pharmacy affecting approximately 900 patients, who must be notified? ✔✔Prominent local media outlets
Affected patients
US Secretary of Health and Human Services
To comply with Centers for Medicare and Medicaid Services (CMS) requirements, how often must a pharmacist conduct a Drug Regimen Review for long-term care patients? ✔✔at least once a month
