PTCE Pharmacy Law and Regulations 5

Question 1

Which of the following describes a 'narrow therapeutic index' (NTI) drug from a legal/regulatory standpoint?

Accepted Answer

A drug where small changes in dose or blood level can cause serious adverse effects or therapeutic failure

Answer

A drug that requires a triplicate prescription

Answer

A drug classified as Schedule II by the DEA

Answer

A drug approved only for hospital use

Question 2

Under federal law, a DEA Form 222 must be completed to order which class of controlled substances?

Accepted Answer

Schedule I and II only

Answer

Schedule III and IV only

Answer

All Schedules I through V

Answer

Schedule II through IV

Question 3

A patient opts out of child-resistant packaging for their prescription. What documentation is required?

Accepted Answer

A signed waiver from the patient or their caregiver on file

Answer

A physician's written order

Answer

DEA approval for the exemption

Answer

No documentation is needed — verbal opt-out is sufficient

Question 4

Which federal agency oversees the National Provider Identifier (NPI) system?

Accepted Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

DEA

Answer

FDA

Answer

State Board of Pharmacy

Question 5

Under the Omnibus Budget Reconciliation Act (OBRA '90), pharmacists are required to offer counseling to:

Accepted Answer

Medicaid patients only

Answer

All patients regardless of insurance status

Answer

Medicare Part D patients only

Answer

Patients picking up controlled substances only

Question 6

A prescription label for a controlled substance dispensed to a patient must include which of the following by federal law?

Accepted Answer

The transfer warning 'Caution: Federal law prohibits transfer of this drug to any person other than the patient for whom it was prescribed'

Answer

The prescriber's DEA number printed in full

Answer

The drug's DEA schedule number in Roman numerals

Answer

The patient's date of birth

Question 7

The FDA's 'black box warning' (boxed warning) is BEST described as:

Accepted Answer

The strongest warning the FDA requires, indicating serious or life-threatening risks

Answer

A voluntary manufacturer advisory for minor side effects

Answer

A DEA restriction placed on Schedule II medications

Answer

A state-level warning mandated by the Board of Pharmacy