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Learning Objectives

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After completing this chapter, the reader will be able to

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  • Define drug promotions.

  • List World Health Organization (WHO) recommendations for appropriate drug promotions.

  • Describe the role of the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP).

  • Determine whether a piece of direct-to-consumer advertising (DTCA) has been cited in FDA warning letters to companies.

  • Describe the allowed content for a specific type of DTCA.

  • Evaluate a given piece of DTCA based on FDA and Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines.

  • Report a drug promotion concern using the Bad Ad program.

  • Evaluate the appropriateness of a piece of drug promotion designed for a health care professional.

  • List system and individual strategies that may be used to combat proliferation of misinformation in drug promotions.

  • Identify logical fallacies used in drug promotion, when given an interaction with a pharmaceutical industry representative.

  • Describe the goals and design of academic detailing programs.

  • Describe the clinical, economic, and humanistic effects of academic detailing.

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Key Concepts

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  1. Drug promotion is defined by the World Health Organization (WHO) as material or information provided by drug manufacturers with the ultimate goal of increasing prescribing or purchasing of medications.

  2. The FDA currently recognizes and outlines appropriate content for three types of direct-to-consumer advertising (DTCA): help-seeking ads, reminder ads, and product claim ads.

  3. The following information should be considered when validating appropriateness of DTCA: balance of risk and benefit information and inclusion of a brief summary of the risks listed in the labeling, a statement encouraging patients to seek information from their physicians, and references to other sources to find the full prescribing information.

  4. Drug promotion to health care professionals makes up the majority of drug promotions activity in terms of financial expenditure on the part of the pharmaceutical industry; this information can be effective in eliciting changes in prescribing behavior.

  5. All health care professionals, including pharmacists, should arm themselves using strategies of information mastery and vigilance for flawed reasoning when interacting with pharmaceutical sales representatives.

  6. Health care professionals are encouraged to report drug promotion violations to the FDA’s Bad Ad program.

  7. Academic detailing programs, often led by pharmacists, are designed to combat pharmaceutical industry detailing by providing evidence-based information in the form of one-on-one or small group interactions between a clinician and prescribers.

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Introduction

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Drug promotion is defined by the World Health Organization (WHO) as material or information provided by drug manufacturers with the ultimate goal of increasing prescribing or purchasing of medications. Every year, the pharmaceutical industry spends billions of dollars advertising their medications to the public and to health care professionals.1-11 In 2012, about $27 billion was spent on drug promotion in the United States (U.S.) alone.12 The channels companies use to promote their products include medical journals, newspapers, radio, television, magazines, Web sites, social media, search engine marketing, distributed promotional materials, billboards, direct mailings, ...

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