CNPR Compliance and Ethics 2 — Questions and Answers
Question 1: Under the PhRMA Code on Interactions with Healthcare Professionals, which of the following gifts is permissible for a pharmaceutical sales representative to provide?
- A branded pen valued at $15
- Educational materials of minimal value that benefit patients (Correct answer)
- A gift card to a restaurant for a physician's personal use
- Sports tickets for the physician and a guest
Correct 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.
Question 2: A sales representative learns that a competitor is engaging in off-label promotion. What is the ethically correct action?
- Report it anonymously to the FDA MedWatch program
- Use the information to undermine the competitor's credibility with physicians
- Report the concern through the company's internal compliance hotline (Correct answer)
- Ignore the issue since it does not involve their own company
Correct 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.
Question 3: Which federal law specifically prohibits pharmaceutical companies from paying physicians to prescribe their drugs, including indirect payments disguised as 'consulting fees'?
- The Federal Food, Drug, and Cosmetic Act
- The Anti-Kickback Statute (Correct answer)
- The Stark Law
- The Controlled Substances Act
Correct 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.
Question 4: When a pharmaceutical representative discusses a drug's side effect profile with a physician, they must ensure the information is:
- Focused only on benefits to encourage prescribing
- Balanced, fair, and consistent with the FDA-approved labeling (Correct answer)
- Limited to what the physician specifically requests
- Positive enough to differentiate from competitors
Correct 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.
Question 5: 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:
- Provide additional off-label data to support the physician's decision
- Alert the company's medical affairs or compliance department (Correct answer)
- Ignore the situation to preserve the business relationship
- Discuss the matter openly with other physicians in the practice
Correct 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.
Question 6: The Sunshine Act (Open Payments Program) requires pharmaceutical manufacturers to report payments to physicians exceeding what threshold per transaction?
- $0 — all payments must be reported regardless of amount
- $10 per transaction or $100 in aggregate annually (Correct answer)
- $25 per transaction
- $100 per transaction or $500 in aggregate annually
Correct 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.
Question 7: Which of the following best describes the concept of 'fair market value' in pharmaceutical compliance?
- The amount a company can afford to pay based on its sales budget
- The price at which a product or service would be exchanged between unrelated parties with no obligation to buy or sell (Correct answer)
- The cost of a service as determined by industry average salary surveys only
- The price set by the compliance department for speaker bureau payments
Correct 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.
CNPR Compliance and Ethics 2
Under the PhRMA Code on Interactions with Healthcare Professionals, which of the following gifts is permissible for a pharmaceutical sales representative to provide?