Final Exam - Random Multiple Choice Flashcards
(31 cards)
As a citizen of the state of Indiana, Dr. Ades is represented by each of the following in either the federal or state government. (SELECT ALL THAT APPLY)
a. two US senators
b. one Indiana state representative
c. two Indiana state senators
d. one US representative
a. two US senators
b. one Indiana state representative
d. one US representative
What differentiates a DESI drug from a new drug?
a. New drugs must partner with generic manufacturers for future cost savings.
b. DESI drugs had to prove they would make money before being marketed.
c. DESI drugs were grandfathered onto the market, and new drugs must go through clinical trials.
d. New drugs must show efficacy, and DESI drugs were assumed to be effective due to length on the market.
e. DESI drugs only had to prove efficacy in trials, and new drugs must prove safety and efficacy.
e. DESI drugs only had to prove efficacy in trials, and new drugs must prove safety and efficacy.
Which of the following pieces of information must always be included on a prescription label to ensure that the product is exempted from misbranding? (SELECT ALL THAT APPLY)
a. The name of the patient
b. The prescription number
c. The name of the dispenser
d. The address of the prescriber
e. Directions for use
b. The prescription number
c. The name of the dispenser
Select all of the following products that are NOT required to be dispensed in special packaging. (SELECT ALL THAT APPLY)
a. Lotrisone twice daily for seven days and no waiver in place.
b. Mebendazole twice daily for three days (600 mg total) and no waiver in place.
c. Latuda daily for 30 days and no waiver in place.
d. Aricept daily for 30 days and a patient blanket waiver in place.
e. Intuniv daily for 90 days and a prescriber waiver in place for Kapvay.
a, b, d
Under the HIPAA Privacy Rule a covered entity must disclose protected health information
a. To the individual receiving care
b. To HHS when it is undertaking an investigation
c. For public interest and benefit activities
d. For treatment, payment, and healthcare operations
b. To HHS when it is undertaking an investigation
Which of the following is considered identifiable information when not combined with other identifiers? (SELECT ALL THAT APPLY)
a. Medical record number
b. Patient name
c. Patient state of residence
d. Patient insurance identification number
a. Medical record number
b. Patient name
d. Patient insurance identification number
Select all of the following prescriptions that can be sent to the pharmacy by fax and the fax used as the original. (SELECT ALL THAT APPLY)
a. lorazepam for a patient in a long-term care facility.
b. lisdexamfetamine for a patient in hospice care.
c. dexmethylphenidate for a patient in a long-term care facility.
d. Roxanol for a patient in hospice care.
e. tramadol for a patient in an outpatient setting.
a, c, d, e
A prescription for Tylenol #3 with codeine is sent to a pharmacy, which does not have the full amount in stock. A partial fill is initiated by the pharmacy for this prescription. When must the remainder of the prescription be ready for pick up?
a. 72 hours from the date filled
b. 7 days from the date written
c. 30 days from the date filled
d. 60 days from the date written
e. 6 months from the date written
e. 6 months from the date written
(CIII drug)
Identify which of the following products pharmacists may independently prescribe in Indiana (SELECT ALL THAT APPLY)
a. Estrace
b. Freestyle Test Strips
c. Loestrin
d. EpiPen
e. Normal Saline for Wound Irrigation
b. Freestyle Test Strips
c. Loestrin
e. Normal Saline for Wound Irrigation
Which category of pharmacy permit does not have to file an application with the board if they intend to have a pharmacy department closed while the licensed area is open
a. Category I
b. Category II
c. Category III
d. All of the above must file an application if the pharmacy department is to be closed while the licensed area is open.
b. Category II
In March 2023, a pharmacist repackages a product for their institution. The product is a nonprescription capsule that expires in May 2024. The pharmacist repackages the product in a non-child-resistant prescription vial. The pharmacist places several items on the label, including a beyond-use date of March 2024, but fails to list tamper-evident information. This drug is:
a. adulterated
b. misbranded
c. both
d. neither
d. neither
According to the Drug Supply Chain Security Act (DSCSA), companies must notify the Food and Drug Administration within seven days of finding an inappropriate product in the drug supply chain.
a. True
b. False
b. False
A company manufactured a cyanocobalamin injection. During manufacture, the sterile product was contaminated with animal hair. Patients who received the contaminated product had hypersensitivity reactions, and several patients passed away. The company does not want to go through the hassle of removing the product from the market. At this time, the FDA cannot mandate a recall; instead, they can request that the company recalls the product unless they take them to court.
a. True
b. False
a. True
A company is marketing a new dietary supplement. The dietary supplement is marketed to prevent COVID-19 and contains the disclaimer “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” on the label. They notified the FDA of the product four weeks after starting marketing. Which requirement of the Dietary Supplement Health and Education Act did this company violate in marketing their product?
a. The company failed to notify the FDA of marketing the product in the appropriate time frame.
b. The company claimed the dietary supplement impacted a disease.
c. The company failed to label the product with the required disclaimer.
d. The company claimed the dietary supplement impacted a nutrient deficiency without evidence for the claim.
e. The company failed to prove the dietary supplement was safe and effective before marketing.
b. The company claimed the dietary supplement impacted a disease.
A company is developing a new device. The company is only required to register with the FDA and follow current good manufacturing practices when manufacturing the device. If nothing else is required for this device, select all of the following classes or subclasses this device may be classified under.
a. class I
b. class II
c. class III
d. custom
e. restricted
f. banned
a. class I
A location is filling Ortho-Cyclen for a patient. Determine if a patient package insert is required to be dispensed for this medication and, if so, select all locations that would be required to dispense the PPI.
a. Patient receiving the product from a retail pharmacy while attending university.
b. A PPI would not be required to be dispensed with this product.
c. Patient receiving the product from a long-term care facility pharmacy while living in an assisted living facility.
d. Patient receiving the product from a hospital pharmacy while in the hospital.
e. Patient receiving the product from an ambulatory clinic after completing their yearly visit.
a, c, d, e
The FDA recently received reports about a drug product through MedWatch. They notified the manufacturer of the reports, and the manufacturer issued a voluntary class III recall. A pharmacist did not see the recall notice and dispensed the medication to a patient. This pharmacist:
a. proceeded legally; drugs under a class III recall may still be dispensed.
b. violated the law; class III recalls are the most serious, where death or serious harm may occur, and drugs cannot be dispensed until the FDA reviews the recall.
c. proceeded legally; drugs under voluntary recalls may still be dispensed until the Food and Drug Administration issues a mandatory recall.
d. violated the law; drugs cannot be dispensed after being recalled.
d. violated the law; drugs cannot be dispensed after being recalled.
A company manufactures a device. Before marketing, the company was required to perform clinical trials on the product to prove the safety and efficacy of the device for the intended conditions. While the device was marketed for a few years, the Food and Drug Administration recently noted that the device could no longer be marketed due to safety concerns. If nothing else is known or required for this device, which classes or subclasses would the device be classified under? (SELECT ALL THAT APPLY)
a. class I
b. class II
c. class III
d. custom
e. restricted
f. banned
c. class III
f. banned
An over-the-counter product was manufactured with foil over the top of the bottle to alert individuals if a product was opened. However, it was manufactured without notices on the product about the covering over the top of the bottle. This causes the drug to be adulterated.
a. True
b. False
b. False
Which of the following is an accurate statement about the Poison Prevention Packaging Act?
a. Special packaging that meets required standards will keep all children under the age of four from accessing a covered product.
b. Certain oral OTC products are manufactured in special packaging because pharmacists do not review the product before a patient purchases it.
c. The Consumer Product Safety Commission requires pharmacies to send documentation of all waivers.
d. All oral products must be dispensed in child-resistant containers.
e. Products intended for inhalation must always be dispensed in special packaging.
b. Certain oral OTC products are manufactured in special packaging because pharmacists do not review the product before a patient purchases it.
Which of the following actions may an agent complete after being given agency? (SELECT ALL THAT APPLY)
a. Verify the quantity of a Fiorinal prescription after reviewing notes in the chart.
b. Provide their opinion on the practitioner’s intended directions.
c. Decide the drug a patient needs for their symptoms.
d. Call in a cephalexin prescription for the provider.
e. Fax a Focalin prescription to the pharmacy.
a. Verify the quantity of a Fiorinal prescription after reviewing notes in the chart.
d. Call in a cephalexin prescription for the provider.
e. Fax a Focalin prescription to the pharmacy.
Which of the following items are considered labeling? (SELECT ALL THAT APPLY)
a. MedWatch phone number on a medication cap.
b. Package insert.
c. Medication guide.
d. Healthcare professional-focused advertising.
e. Prescription label.
all of the above
A pharmacist is checking in a controlled substance order. They pick up a bottle of a schedule III controlled substance. When picking up the product, they note the bottle does not weigh anything, and there is no sound of tablets inside. They take off the bottle top and see that the product is sealed with foil and shows no signs of tampering. This situation must be reported on a DEA 106.
a. True
b. False
b. False
A prescriber is interested in obtaining triazolam for use in their office before procedures. They write a prescription for four bottles of 10 tablets with the patient’s name as Office Use and directions to dispense as needed in the office. The pharmacist who received the prescription evaluated the prescription for red flags and found no issues but did not call the provider. They dispensed the prescription. This pharmacist:
a. violated the law; prescribers cannot write prescriptions for office use and must purchase the medication on an invoice.
b. proceeded legally.
c. violated the law; prescriptions for office use must list the patient names the product will be used for in the directions.
d. violated the law; prescriptions for office use are limited to no more than ten tablets.
e. violated the law; pharmacists must call providers to verify all controlled substance prescriptions before dispensing.
a. violated the law; prescribers cannot write prescriptions for office use and must purchase the medication on an invoice.
