Practice Test Geeks(CNPR) Certified National Pharmaceutical Representative Practice Test
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Regulatory Compliance & Ethical Standards 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 Regulatory Compliance & Ethical Standards flashcards as text

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

    Answer: Pharmaceutical Research and Manufacturers of America (PhRMA)

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

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

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

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

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

    Answer: Engage in reactive scientific exchange with KOLs about unpublished data within company guidelines

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

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

    Answer: A sample receipt acknowledgment required by PDMA

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

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

    Answer: Include risk information in a comparable manner to efficacy claims

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

  6. Corporate integrity agreements (CIAs) are typically entered into between pharmaceutical companies and which federal entity following a compliance violation?

    Answer: Office of Inspector General (OIG) of the Department of Health and Human Services

    The OIG negotiates CIAs with companies as an alternative to exclusion from federal healthcare programs, requiring enhanced compliance oversight.

  7. A sales representative is offered a large speaking fee by a hospital to present about their product. According to PhRMA guidelines, this arrangement raises concerns primarily because:

    Answer: Speaking fees to reps can be seen as disguised payments for prescribing activity

    PhRMA guidelines caution that payments to sales representatives for speaking engagements can appear to reward prescribing behavior rather than reflect legitimate educational value.