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
Under the PhRMA Code on Interactions with Healthcare Professionals, which of the following gifts is permissible for a pharmaceutical sales representative to provide?
Answer: Educational materials of minimal value that benefit patients
The PhRMA Code permits educational materials of minimal value that primarily benefit patients, while purely personal gifts are prohibited.
A sales representative learns that a competitor is engaging in off-label promotion. What is the ethically correct action?
Answer: Report the concern through the company's internal compliance hotline
Representatives should report compliance concerns through their company's internal compliance hotline or legal department as the primary appropriate channel.
Which federal law specifically prohibits pharmaceutical companies from paying physicians to prescribe their drugs, including indirect payments disguised as 'consulting fees'?
Answer: The Anti-Kickback Statute
The Anti-Kickback Statute prohibits any remuneration intended to induce or reward referrals or prescriptions for federally reimbursed healthcare services.
When a pharmaceutical representative discusses a drug's side effect profile with a physician, they must ensure the information is:
Answer: Balanced, fair, and consistent with the FDA-approved labeling
Representatives must present balanced, fair, and accurate information consistent with the FDA-approved prescribing information, including risks and side effects.
A representative notices that a physician seems to be prescribing a medication for an off-label use that could harm patients. The best course of action is to:
Answer: Alert the company's medical affairs or compliance department
Patient safety concerns should be escalated to the company's medical affairs or compliance team, who can engage appropriately with the healthcare provider.
The Sunshine Act (Open Payments Program) requires pharmaceutical manufacturers to report payments to physicians exceeding what threshold per transaction?
Answer: $10 per transaction or $100 in aggregate annually
The Sunshine Act requires reporting of payments of $10 or more per transaction, or $100 or more in aggregate per year, to covered recipients.
Which of the following best describes the concept of 'fair market value' in pharmaceutical compliance?
Answer: The price at which a product or service would be exchanged between unrelated parties with no obligation to buy or sell
Fair market value refers to the arm's-length price between unrelated parties with no compulsion, used to ensure payments to physicians are not disguised kickbacks.