CNPR Regulatory Compliance & Ethical Standards 2

Question 1

Under the Prescription Drug Marketing Act (PDMA), which activity is strictly prohibited for pharmaceutical sales representatives?

Accepted Answer

Reselling or trading prescription drug samples

Answer

PDMA prohibits the sale, purchase, or trading of prescription drug samples, as samples must be distributed only to licensed practitioners for patient use.

Question 2

The PhRMA Code on Interactions with Healthcare Professionals limits the value of educational items a representative may provide to a healthcare professional to:

Accepted Answer

$25 or less

Answer

The PhRMA Code restricts educational items or practice-related items to those worth $25 or less and that are directly beneficial to patient care.

Question 3

A pharmaceutical rep is asked by a physician about using a drug at a dose higher than what is listed in the FDA-approved labeling. The rep should:

Accepted Answer

Decline to discuss and refer the physician to medical affairs for an unsolicited inquiry

Answer

Off-label promotion is prohibited; reps should direct unsolicited off-label questions to the medical affairs team who can respond appropriately.

Question 4

Which federal law requires pharmaceutical manufacturers to track and record all sample distributions made by their sales representatives?

Accepted Answer

Prescription Drug Marketing Act (PDMA)

Answer

PDMA requires manufacturers to maintain detailed records of all sample distributions, including recipient signatures and quantities, to prevent diversion.

Question 5

When a pharmaceutical sales rep receives a report of a serious adverse event from a healthcare provider during a sales call, the rep's first obligation is to:

Accepted Answer

Document and report the event to the company's pharmacovigilance department promptly

Answer

FDA regulations require manufacturers to collect and submit serious adverse event reports; reps are the frontline reporters and must escalate immediately.

(CNPR) Certified National Pharmaceutical Representative Practice Test

(CNPR) Certified National Pharmaceutical Representative Practice Test

CNPR Regulatory Compliance & Ethical Standards 2