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Chapter 22. Pharmaceutical Industry and Regulatory Agency Drug Information

Which of the following is a department within the medical division of a company that employs HPs?

a. Research and Development

b. Medical Information

c. Epidemiology

d. Biometrics

Which of the following best describes an appropriate lifecycle of a medical information request?

a. Inquiry solicited by representative, standard response letter verbally communicated

b. Inquiry solicited by representative, package insert information verbally communicated

c. Inquiry submitted by practitioner, package insert information verbally communicated

d. Inquiry submitted by representative, opinion of industry health professional verbally communicated

Identify which of the following is not a typical component of a standard response letter.

a. Outline

b. Opening

c. Signature

d. Closing

Which of the following departments may be involved in approving a standard response letter?

a. Medical Publications

b. Marketing

c. Medical Information

d. Metrics

HPs are regulated in industry in which of the following ways?

a. Externally by the Food and Drug Administration

b. Externally by Food and Drug Administration Amendments Act

c. Internally by standard operating procedures

d. All of the above

Identify which interaction between the pharmaceutical industry and HPs is unacceptable according to PhRMA's Code on Interactions with Health Care Professionals.

a. An industry representative stops by a clinician's office to invite them to an upcoming industry-sponsored continuing medical education event.

b. An industry representative makes an appointment with a practitioner to discuss a newly approved indication for BESTDRUGEVER®.

c. An industry representative drops off a basket of BESTDRUGEVER® pens, mugs, and coffee to a health professional's office.

d. An industry representative refers a health professional to contact their medical information department to discuss an off-label use.

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