CNPR Regulatory Compliance & Ethical Standards 3

Question 1

Which organization publishes the voluntary code of conduct most widely adopted by US pharmaceutical companies for interactions with healthcare professionals?

Accepted Answer

Pharmaceutical Research and Manufacturers of America (PhRMA)

Answer

PhRMA publishes the 'Code on Interactions with Healthcare Professionals,' which sets voluntary ethical standards for pharmaceutical marketing practices.

Question 2

Under HIPAA, when a pharmaceutical representative visits a physician's office and overhears protected health information about a patient, the rep must:

Accepted Answer

Treat the information as strictly confidential and not use or disclose it

Answer

HIPAA protects patient health information; even incidentally overheard PHI must not be used or disclosed by pharmaceutical representatives.

Question 3

A pharmaceutical company's medical science liaison (MSL) differs from a sales representative primarily because MSLs are permitted to:

Accepted Answer

Engage in reactive scientific exchange with KOLs about unpublished data within company guidelines

Answer

MSLs operate in a medical/scientific rather than commercial capacity and can respond to unsolicited off-label inquiries, unlike sales representatives.

Question 4

Which document must a physician sign each time a pharmaceutical sales representative leaves drug samples at an office?

Accepted Answer

A sample receipt acknowledgment required by PDMA

Answer

PDMA requires that a licensed practitioner sign a receipt for each sample delivery, which manufacturers must retain as part of their sample accountability records.

Question 5

The concept of 'fair balance' in pharmaceutical promotion requires that promotional materials:

Accepted Answer

Include risk information in a comparable manner to efficacy claims

Answer

FDA requires that promotional materials present a fair balance of information about risks and benefits so that the net impression is not misleading.

(CNPR) Certified National Pharmaceutical Representative Practice Test

(CNPR) Certified National Pharmaceutical Representative Practice Test

CNPR Regulatory Compliance & Ethical Standards 3