Federal Law Quizzes

A prescription written for Ritalin (CII) for a child, can legally have how many refills on it? A) 0 B) 3 C) 2 D) 1

A) 0

A prescription written for Ativan (CIV) for a patient, can legally have up to how many refills on it? A) 5 B) 4 C) 2 D) 0

A) 5

A prescription written for Ativan (CIV) for a patient, would expire, at the latest, how long after its issuance date? A) 6 months B) 1 month C) federal law is silent on this topic D) 3 months

A) 6 months

Which of the listed information below is NOT required on the pharmacy label of a controlled substance medication when dispensed to the patient? I. Address of pharmacy II. Address of patient III. Address of prescriber A) II and III only B) I and II only C) I only D) I, II, and III

A) II and III only

Which statement regarding OBRA 90 is accurate? A) It recognized pharmacists go above the role of dispensing and can positively impact drug therapy outcomes B) Its impact on the daily practice of pharmacy very minimal C) It created our current professional practice reimbursement model which includes pharmacists receiving payment for counseling D) It decreased liability concerns for pharmacists as it limited their overall practice role

A) It recognized pharmacists go above the role of dispensing and can positively impact drug therapy outcomes

A prescription written for Soma (CIV) for a chronic pain patient, could be written for what maximum quantity at one time? A) federal law is silent on this topic B) 3 month supply C) 1 month supply D) 2 month supply

A) federal law is silent on this topic

The FDA Drug Facts Panel applies to the: A) manufacturer label of OTC medications B) pharmacy provided patient package inserts C) manufacturer package insert of prescription medications D) manufacturer label of prescription medications

A) manufacturer label of OTC medications

Dr. Brian Gold is a family physician. Which of the below would be an appropriate first character for Dr. Gold's DEA registration number? A) M B) F C) 2 D) 9 E) P

B) F

Which statement regarding HIPAA is FALSE? A) In general, marketing activities by pharmacies directed towards patients will require written patient authorization B) HHS/OCR has determined that pharmacies must obtain prior written authorization to send patients refill reminders C) Patients have a right to request and obtain their PHI on file at the pharmacy D) A pharmacy can use and disclose a patient's PHI without prior written consent when consulting with other health care providers regarding the patient's treatment

B) HHS/OCR has determined that pharmacies must obtain prior written authorization to send patients refill reminders

As a community pharmacist you dispensed Drug Z to a patient. Drug Z is on the FDA MedGuide list. You provided the patient with the written Consumer Medication Information (CMI) when you dispensed the drug but not the MedGuide. In addition, the patient was harmed by the drug and claimed that you since you failed to give them the Medication Guide this contributed to their harm. Which statement(s) is/are correct? I. You can be found for misbranding the product by the FDA because you failed to give the MedGuide. II. You will be shielded from any claims of harm by the patient because the CMI contains the same information as the MedGuide. III. Failure to distribute a MedGuide cannot be used by a patient as a reason to claim harm as there can be no association between the two. A) II and III only B) I only C) I and II only D) I, II, and III

B) I only

A patient asks to obtain a partial fill of 10 tablets of her Oxycodone (CII) prescription that was electronically prescribed by her physician to the pharmacy. The physician prescribed 30 tablets, but she isn't sure she will need all of those for her acute condition. If the prescriber issued the prescription today (March 1, 2023), what would be the last day she would be able to obtain any remaining amount left on the prescription? A) The patient won't be able to obtain any remaining tablets unless she is in a resident in a LTCF or a terminally ill patient B) March 31, 2023 C) The patient would only be able to obtain a partial fill if the pharmacy did not have an adequate supply of the medication D) March 4, 2023

B) March 31, 2023

A dietary supplement wants to state on one of its product's label that the product "helps decrease the amount of acne lesions". Would this statement be ok to use? A) Yes, as long as the company puts on the label the FDA did not approve the product B) No, the company would want to reword the statement to be less misleading C) Yes, because the company is permitted to do this under DSHEA D) No, any type of statement is prohibited unless approved by the FDA in advance

B) No, the company would want to reword the statement to be less misleading

Drug Regimen Reviews (DRRs) in LTCFs have to be completed by a pharmacist for each resident at a minimum once every: A) 60 days B) month C) 2 weeks D) week

B) month

A family doctor, Dr. Best, calls in a prescription today for Mr. Smith. He asks you (the pharmacist) to make sure that Mr. Smith has this prescription and all of his future prescriptions dispensed in non-safety cap containers as he has really bad arthritis and is having a hard time opening his medication containers. The prescriber tells you Mr. Smith has no small kids at home. How would you respond to the prescriber? A) "Absolutely Dr. Best, I will put that request in Mr. Smith's profile for him immediately." B) "I'm sorry Dr. Best, but this is not an appropriate request to make on behalf of Mr. Smith, and any requests for non-safety caps will have to come from the patient." C) "Dr. Best, I would be happy to do this for Mr. Smith for the prescription you are calling in today (and any refills on it), but if he would like all future prescriptions to have non safety caps, he will need to request that from us." D) "I'd

C) "Dr. Best, I would be happy to do this for Mr. Smith for the prescription you are calling in today (and any refills on it), but if he would like all future prescriptions to have non safety caps, he will need to request that from us."

A pharmacy gets a phone call from a dentist's office that would like to purchase a 100 size bottle of Ativan (CIV) to use for patients prior to certain procedures. What would be an appropriate reply? A) "You will have to purchase it through a registered distributor, sorry" B) "Sorry, I can't do this for you, please send each patient in with a prescription for the Ativan prior to their procedure" C) "No problem, I can sell you a bottle and write up an invoice to document the sale" D) "Sure, I can do this, just write 'for office use' on one of your prescription pads and I can sell it to you that way"

C) "No problem, I can sell you a bottle and write up an invoice to document the sale"

A pharmacy would have to register with the DEA every how many years? A) 4 B) 2 C) 3 D) 5 E) 1

C) 3

Major violations of the Food Drug and Cosmetic Act (FDCA) include: I. Misbranding a drug product II. Adulteration of a drug product III. Improperly counseling of a patient. A) I only B) I, II, and III only C) I and II only D) II and III only

C) I and II only

Which of the below are Prospective Drug Use Review (ProDUR) components under OBRA 90? I. Screening of prescriptions II. Pharmacist documentation III. Educational programs A) I only B) I, II, and III C) I and II only D) II and III only

C) I and II only

A prescription written for Ritalin (CII) for a child, would expire how soon after its issuance date? A) 1 month B) 3 months C) federal law is silent on the topic D) 6 months

C) federal law is silent on the topic

You are a pharmacist at a local chain pharmacy. When are you required to provide your "Notice of Privacy Practices" to patients? A) once every 6 months B) everytime you provide services C) first day services are provided and when requested D) once a year

C) first day services are provided and when requested

Compared to drug products, at what level does the FDA regulate dietary supplements? A) the same as drug products B) more than drug products C) less than drug products D) not at all compared to drug products

C) less than drug products

Dr. Smith calls and asks if your pharmacy can make a compounded medication (2 creams mixed together) that he can keep at the office and use prior to some office procedures that they perform a few times a week. What would be an appropriate reply (assuming you are not registered as any type of compounding pharmacy)? A) "I'd be happy to do this for you, but we would first have to sign a contract recognizing that I am a distributor to your office." B) "I can, but only if you write the name of your medical practice on a prescription pad, e.g. 'Berk County Family Medicine', I could then use this as an appropriate record." C) "Yes, I can do this for you as long as it is non-sterile products and it is under a one month supply at a time." D) "I'm sorry I am unable to assist you with this request."

D) "I'm sorry I am unable to assist you with this request."

NDC codes are how many digits? A) 9 B) 11 C) 8 D) 10

D) 10 DON'T CONFUSE THIS WITH BILLING NDC WHICH IS 11 DIGITS LONG!!!!

Which statement about the Orange Book is correct? A) It rates which biosimilars can be interchanged B)It is a federal law used to determine which products can substituted for reference products C) It lists NDCs of drugs products to provide an easily identifiable database D) It is a reference to help determine bioequivalence of medications

D) It is a reference to help determine bioequivalence of medications

As pharmacists (or future pharmacists), MedWatch requires us to do what? A) take required continued education credits on patient safety B) report adverse side effects patients tell us about C) Be an individual member, or part of a corporate membership, of one national patient safety organization (e.g. ISMP) D) Provide patients with the MedWatch number

D) Provide patients with the MedWatch number B is also correct because we can report the adverse effects if we wanted... it would be wrong if it said we are required to do so

A resident physician from a local hospital wrote a prescription for Xanax (CIV) for a patient as she got discharged from the hospital. The patient brings this prescription to your community pharmacy to have filled and dispensed by you (the pharmacist). The DEA # on the prescription is the hospitals with a code of 461 after it. Can you dispense this prescription? A) No, unless another prescriber with their own DEA number co-signed the prescription as well B) Yes, but only after you obtained the attending physician's DEA number C) No, the resident is not permitted to prescribe outpatient prescriptions D) Yes, you would use the hospital DEA number and the resident's internal code

D) Yes, you would use the hospital DEA number and the resident's internal code

A physician that intends to prescribe controlled substances would register with the DEA as a: A) manufacturer B) exporter C) distributor D) dispenser

D) dispenser

Which of the listed below is NOT a required element on an ISSUED written controlled substance prescription by the prescribing practitioner? A) directions for use of medication B) date of issuance C) address of patient D) quantity prescribed (prescriber must write number out)

D) quantity prescribed (prescriber must write number out)

If a pharmacist wanted to determine which practitioners could prescribe medications, which would be the proper resource to refer to? A) All of the resources listed would provide the necessary information. B) FDA regulations C) federal law D) state law

D) state law

The expiration date on a manufacturer's label is determined by: A) FDA and/or USP guidance B) federal law C) state law D) the manufacturer (based on tests)

D) the manufacturer (based on tests)

Which Schedule of controlled substances are considered to have NO approved medical use in the United States? A) II B) III C) IV D) V E) I

E) I

Jane Smith is a Nurse Practitioner in your state that has authority to prescribe controlled substances. Which of the below would be an appropriate first character for her DEA registration number? A) B B) G C) A D) F E) M

E) M

( True or False) To become qualified to treat patients with opioid use disorder (addiction) and prescribe buprenorphine products in the community setting, prescribers must obtain a special DEA "X" number.

False

(True or False) Pharmacists are permitted to dispense methadone in the community setting for both pain and addiction, but if its for addiction they must meet specific documentation requirements.

False