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Learning Objectives
After completing this chapter, the reader will be able to:
Define drug promotions.
List recommendations by the World Health Organization (WHO) for appropriate drug promotions.
Describe the role of the U.S. 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 Manufacturer’s Association (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 systematic 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
Drug promotion is defined by the WHO as material or information provided by drug manufacturers with the ultimate goal of increasing prescribing or purchasing of medications.
The FDA currently recognizes and outlines appropriate content for three types of direct-to-consumer advertising (DTCA): help-seeking advertisements, reminder advertisements, and product claim advertisements/full product promotions.
The following information should be considered when validating appropriateness of DTCA: (1) balance of risk and benefit information and inclusion of a brief summary of the risks listed in the labeling, (2) a statement encouraging patients to seek information from their physician, and (3) references to other sources to find the full prescribing information.
Drug promotion to health care professionals makes up the majority of drug promotions activity in terms of financial expenditure on the part of pharmaceutical industry; this information can be effective in eliciting changes in prescribing behavior.
All health care professionals, including pharmacists, should arm themselves using strategies of information mastery and vigilance for potentially flawed reasoning when interacting with pharmaceutical sales representatives.
Health care professionals are encouraged to report drug promotion violations to the FDA’s Bad Ad program.
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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Drug promotion is defined by the WHO as material or information provided by drug manufacturers with the ultimate goal of increasing prescribing or purchasing of medications. Each year, the pharmaceutical industry spends billions of dollars on advertising their medications to the public and to health care professionals.1–10 Annual spending on marketing of prescription drugs, health services, disease awareness campaigns, and laboratory testing increased from $17.7 billion in 1997 to $29.9 billion in 2016.11 In 2017, AbbVie’s Humira®, Pfizer’s Lyrica®, and Pfizer’s Xeljanz® spent the most on measured media advertising ($410 ...