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
A pharmaceutical representative is asked by a physician about a drug's use in a pediatric population, but the drug is only approved for adults. The representative should:
Answer: Decline to discuss it and refer the physician to the company's medical information department
Off-label inquiries should be referred to the company's medical information or medical affairs team, who can respond appropriately within regulatory bounds.
Under the False Claims Act, a whistleblower (relator) who exposes pharmaceutical fraud against the government may receive what percentage of the government's recovery?
Answer: 15–30%
Under the False Claims Act's qui tam provisions, relators are entitled to 15–30% of the government's recovery, depending on their contribution to the case.
Which of the following is an example of an acceptable educational grant in the pharmaceutical industry?
Answer: An unrestricted grant to a medical school to fund an independent CME program
Unrestricted educational grants to independent medical organizations for legitimate CME programs are permissible, as the company does not control the content.
Which regulation requires pharmaceutical companies to maintain records of all promotional materials and submit them to the FDA at the time of first use?
Answer: 21 CFR Part 202
21 CFR Part 202 governs prescription drug advertising and requires companies to submit promotional materials to FDA's Office of Prescription Drug Promotion (OPDP) at first use.
A healthcare provider requests a 'speaker honorarium' for a dinner program but wants to invite fewer than 5 attendees. The representative should:
Answer: Require a minimum attendance that justifies an educational program format
Speaker programs must have a legitimate educational purpose, which typically requires a reasonable minimum audience; events with very few attendees may not meet this standard.
The CNPR certification demonstrates that a pharmaceutical representative has mastered knowledge of:
Answer: Physiology, pharmacology, and federal regulations governing pharmaceutical sales
The CNPR certification covers physiology, pharmacology, diseases/conditions, and federal regulations relevant to ethical pharmaceutical sales.
Which of the following describes a 'nominal value' item that may still be provided to healthcare professionals under the PhRMA Code?
Answer: Pens, notepads, and other items worth less than $10 per item that primarily benefit patients
The PhRMA Code permits items of minimal value (under $10) that primarily benefit patients, such as patient education materials, but not personal gifts.