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Chapter 22. Pharmaceutical Industry and Regulatory Agency Drug Information

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

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a. Research and Development

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b. Medical Information

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c. Epidemiology

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d. Biometrics

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

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

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

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

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

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

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a. Outline

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b. Opening

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c. Signature

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d. Closing

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

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a. Medical Publications

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b. Marketing

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c. Medical Information

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d. Metrics

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

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a. Externally by the Food and Drug Administration

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b. Externally by Food and Drug Administration Amendments Act

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c. Internally by standard operating procedures

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d. All of the above

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

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

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

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

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

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