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Risk Management
Comprehension Testing for OTC Drug Labels
  by Louis A. Morris, Pharmaceutical Executive, May 2004

or many products, it is necessary to ensure that labels are understandable so that consumers can use the product safely and effectively. For pharmaceutical products, however, the development of a comprehensible label can influence whether the product may be sold
directly to consumers as an over-the-counter (OTC) drug or whether it must be dispensed by a pharmacist as a prescription (Rx) drug. The distinction between these two product categories is based on both the potential for harm and the ability of the consumer to use the product safely and effectively.

A drug is appropriate for Rx status if, because of the potential for toxicity or other harmful effects, it cannot be used safely unless such use is supervised by a person who is licensed to make diagnostic and usage decisions--usually a physician (Food, Drug and Cosmetic Act, Section 503 (B)). Proper diagnostic and usage decisions are, in turn, based on the adequacy of the product labeling. Both OTC and Rx drugs are deemed misbranded (an illegal act) unless their labeling bears adequate directions for use. However, adequate directions for laypersons might be different than adequate directions for licensed prescribers.

Adequate directions enable a layperson to use an OTC drug safely for its intended purposes (21 CFR 201.5). For OTC labeling to be clear and truthful (and not false or misleading), it must contain directions, warnings, and information on intended uses and side effects and be presented in such a manner "as to render the label likely to be understood by ordinary consumers, including individuals with low comprehension ability, as assessed under customary conditions of purchase and use" (21 CFR 330.10 (a)(4)(v)).

As a practical matter, most newly approved chemical entities initially are marketed as Rx-only products and usually remain Rx-only products. However, marketers can apply to switch certain products from Rx to OTC status. In recent years, there have been many Rx-to-OTC drugs approved, including those that treat heartburn, aid smoking cessation, induce hair restoration, and relieve seasonal nasal allergies (Juhl 1997). To approve a switch, the Food and Drug Administration (FDA) must determine if the product has a favorable benefit-to-risk profile and if it can and will be used safely and effectively at an OTC dosage level in an OTC environment (i.e., without direct supervision of a prescribing health care professional). Recently, the FDA has requested that applicants for new Rx-to-OTC products present evidence of (1) label comprehension and (2) the product's "actual use" in a simulated OTC environment by the intended target population.

Evidence regarding label comprehension has been provided in the form of label comprehension tests. Recently, Friedman, Romeo, and Hilton (1997) published a label comprehension study that provides an example of this methodology. Comprehension tests often are similar to advertising-copy tests, in particular, to forced-exposure "communication tests" (Stewart 1995). Recruited subjects are shown a proposed OTC drug label or a control label and are asked questions that measure their understanding of the material. Research participants might be asked additional questions about product use or behavioral intentions. Evidence of actual use has been provided in the form of simulation studies, in which recruited subjects are provided an opportunity to purchase and/or use the product and behavioral outcomes are tracked.

In this article, we discuss several issues involved in testing OTC product labels to determine comprehensibility to "ordinary individuals." The article is divided into four sections. First, we discuss the goals of comprehension testing; second, some general methodological issues; third, the target audience; and fourth, the testing environment and context. In each of these sections, we address conceptual and operational concerns and then review areas in need of further research and debate. Unfortunately, most OTC label comprehension tests are not publicly available. These tests usually are submitted to the FDA in support of a new drug application to switch a product from Rx to OTC status. They are considered trade secrets and are not releasable by the FDA to the public. However, a few examples of specific design considerations or questions posed in these tests have been discussed at FDA advisory committee hearings, and several of these are cited in this article. We address other issues in the development and review of comprehension tests in general terms.

The FDA has used comprehension-testing results in its reviews of most recent Rx-to-OTC candidate drugs. However, comprehension-testing methodology is still in its earliest stage of development. During this initial phase, the FDA and the nonprescription drug industry have experimented with a variety of testing methods. Results from these tests can help analysts understand consumers' interpretations of labeling information. However, the subjective nature of such testing makes the results particularly sensitive to the reactivity of research methods (e.g., questionnaire wording) and other biases. In this article, we seek to identify controversies in comprehension testing and thereby encourage debate and further development of new approaches to this research methodology.

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