Compliance and Ethics Flashcards
7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Compliance and Ethics flashcards as text
Which of the following correctly describes the difference between 'promotion' and 'education' in pharmaceutical industry standards?
Answer: Promotion is branded and intended to influence prescribing; education is independent, balanced, and not controlled by the company
Promotion is company-controlled messaging intended to drive prescribing, while independent medical education (CME) is not controlled by industry and must be unbiased.
A representative is asked to submit expense reports that include meals coded under 'office supplies' to avoid scrutiny. This practice is:
Answer: A violation of company policy and potentially constitutes fraud
Falsifying expense report categories constitutes expense fraud and violates company policy, ethical standards, and potentially federal law.
Under the Prescription Drug Marketing Act (PDMA), pharmaceutical samples must be:
Answer: Distributed only to licensed practitioners and carefully documented
PDMA requires that drug samples be given only to licensed practitioners and that companies maintain strict chain-of-custody records for all samples.
What is the primary purpose of a 'Corrective Action Plan' (CAP) in pharmaceutical compliance?
Answer: To document a structured response to identified compliance deficiencies and prevent recurrence
A CAP is a proactive, documented plan that identifies the root cause of a compliance gap and outlines steps to correct and prevent recurrence.
A physician who serves on an advisory board for a pharmaceutical company and also prescribes that company's drugs is at risk of a conflict of interest. The appropriate safeguard is:
Answer: Full disclosure of the financial relationship and independent prescribing decisions
Disclosure of financial relationships and maintaining independent clinical judgment are the standard safeguards for physician-industry conflicts of interest.
Which agency is primarily responsible for enforcing violations of the Anti-Kickback Statute in the pharmaceutical industry?
Answer: The Department of Justice (DOJ) and Office of Inspector General (OIG)
The DOJ and OIG have primary jurisdiction over Anti-Kickback Statute enforcement, often working with the FBI and state attorneys general.
A sales representative who is aware of a serious adverse event involving their company's drug must report it to their company's pharmacovigilance department within what timeframe, according to standard industry practice?
Answer: Within 15 calendar days for serious and unexpected adverse events
FDA regulations require expedited reporting of serious and unexpected adverse drug reactions within 15 calendar days of when the company becomes aware.