The Drug Facts Box: Providing Consumers with Simple Tabular Data on Drug Benefit and Harm

Schwartz, Lisa M.; Woloshin, Steven; Welch, H. Gilbert

doi:10.1177/0272989x07306786

Cited by 104 publications

(96 citation statements)

References 9 publications

(7 reference statements)

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“…Based on a series of studies, we are confident that most can (42)(43)(44)(45)(46). The first study (n = 203) tested consumer comprehension of the benefit portion of the box: for example, 97% were able to correctly read percentages from the data table (45).…”

Section: How To Do Bettermentioning

confidence: 99%

“…The first study (n = 203) tested consumer comprehension of the benefit portion of the box: for example, 97% were able to correctly read percentages from the data table (45). The second study (n = 274) tested a full box for the drug Tamoxifen for preventing first breast cancers (42). This more complex table included nine rows and two columns of data.…”

Section: How To Do Bettermentioning

confidence: 99%

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The Drug Facts Box: Improving the communication of prescription drug information

Schwartz

Woloshin

2013

Proc. Natl. Acad. Sci. U.S.A.

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Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label—the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing—may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and “spinning” unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies—including national randomized trials—demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3–5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.

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Section: How To Do Bettermentioning

confidence: 99%

Section: How To Do Bettermentioning

confidence: 99%

The Drug Facts Box: Improving the communication of prescription drug information

Schwartz

Woloshin

2013

Proc. Natl. Acad. Sci. U.S.A.

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“…9 Therefore, it is simple for consumers to read, understand, and form their own gist about the benefit information. On the other hand, risk information is usually presented in smaller font sizes that can be easily ignored, 10 composed of long lists where it is difficult to recognize clinically important and unimportant information, 11 and is often missing key pieces of information such as numeric descriptors for the incidence level of each side effect. 6 The format in which risk information is presented makes it overwhelming for consumers to comprehend.…”

Section: Introductionmentioning

confidence: 99%

Exploring Strategies to Enhance the Presentation of Information in Print DTCA to Improve Consumers’ Recall of Information

Hwang

Hsu

2017

Iip

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“…12 However, the extensive evaluation of tamoxifen treatment revealed small but significant side effects such as endometrial cancer, blood clots and the development of acquired resistance. 13 More than that, many current breast cancer chemotherapy treatments are often associated with severe side effects, and according to statistics, up to approximate 50% of patients with ER-positive tumors either initially do not respond or become resistant to these drugs. 14 Thus contributing to a significant obstacle towards breast cancer treatment.…”

Section: Introductionmentioning

confidence: 99%

3-Acyl-5-hydroxybenzofuran derivatives as potential anti-estrogen breast cancer agents: A combined experimental and theoretical investigation

et al. 2013

Bioorganic & Medicinal Chemistry Letters

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The Drug Facts Box: Providing Consumers with Simple Tabular Data on Drug Benefit and Harm

Abstract: Most participants--even those with lower formal educational attainment--were able to understand and use the tabular data.

Cited by 104 publications

References 9 publications

The Drug Facts Box: Improving the communication of prescription drug information

The Drug Facts Box: Improving the communication of prescription drug information

Exploring Strategies to Enhance the Presentation of Information in Print DTCA to Improve Consumers’ Recall of Information

3-Acyl-5-hydroxybenzofuran derivatives as potential anti-estrogen breast cancer agents: A combined experimental and theoretical investigation

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