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The Prescription Drug Facts Box: Helping Doctors and Patients Make Wise Choices

The views expressed herein do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

People need accurate, understandable information to make wise decisions about medical care. Yet much of what they receive is marketing designed to generate enthusiasm for new products by highlighting benefit and minimizing harm. Balanced data promoting informed decision making about medical interventions--including the decision to forgo them--is far less common.

Problems with Drug Information

Direct-to-consumer (DTC) advertising for prescription drugs is the most prominent example of how medical interventions are marketed to the public. Industry spent more than $5 billion on these ads in 2007--more than twice the total U.S. Food and Drug Administration (FDA) budget. Although proponents claim they serve an education purpose, the ads generally fail to relate the most fundamental information consumers need: how well the drug works. Not surprisingly, consumers tend to overestimate treatment efficacy.

DTC advertisements are only one way that patients learn about medications. Theoretically, prescribing physicians summarize drug benefits and harms, although this probably does not occur often in practice. When they fill their prescriptions, patients may receive a variety of information sheets, patient package inserts, or medication guides. A recent FDA survey found, unfortunately, that these information sheets (which provide instructions about use, but rarely if ever quantify benefit and harm) are often illegible and hard to understand. Even the most complete prescribing information--the prescription drug label--written by industry and approved by the FDA can be incomplete and biased.¹

A Practical Idea: The Drug Facts Box

To clearly communicate prescription drug benefits and harms, we developed a single page, standardized format called the "prescription drug facts" box (see example). The box is modeled on FDA's nutrition facts box, a format already familiar to consumers. Data for drug boxes would come from the studies used in FDA's drug approval process. Ideally, boxes would be written by FDA's reviewers during the drug approval process. The reviewers, independent experts with complete access to the relevant published and unpublished data, could ensure that everyone knows what FDA knew at the time of approval.

Drug facts boxes could serve a variety of purposes including: an executive summary of the FDA review documents, a replacement for the current "brief summary" (the FDA required, small print 2nd page) on direct-to-consumer drug ads, and as standalone information sheets for doctors and patients. The approach could easily be used for devices and surgical procedures as well.

Does the Drug Box Help?

We have published a number of studies, including two national randomized trials, showing that consumers want the information in the drug box, understand it, and can use it.^2,3 Most importantly, the box helps consumers make better decisions about prescription drugs. For example, we randomized 231 consumers to see either standard drug advertisements or ads with drug facts boxes for two medications used to treat heartburn. The drugs were selected so that they had similar side effect profiles, but one clearly outperformed the other. We found that the drug box group was more than twice as likely as the standard ad group to choose the better drug: 68 percent vs. 31 percent, p < 0.001.

The Drug Box and FDA Policy

In a pilot project, we have shown that FDA reviewers can create drug boxes. We worked with 10 FDA medical reviewers who iteratively drafted, critiqued, and revised boxes for a variety of drugs. To develop a transparent, replicable process for creating drug facts boxes, we also developed a handbook to guide subsequent production of drug boxes.

Earlier this year, the FDA's Risk Communication Advisory Committee voted unanimously in a non-binding recommendation that FDA "should adopt the Drug Facts Box format as its standard for communicating essential information about pharmaceuticals" in the drug label, advertisements, and other consumer materials. Most recently, Senators Reed (RI) and Mikulski (MD) introduced legislation (S. 1142, the Informed Health Care Decision Making Act, May 21, 2009) calling on the Secretary of the Department of Health and Human Services to review the evidence supporting the drug facts box, and if satisfied that the box would improve health care decision making by clinicians and patients and consumers, to "promulgate regulations as necessary to implement such format." The legislation has been incorporated into the Senate's health care reform bill, the "Patient Protection and Affordable Care Act" now under consideration.

Helping patients make informed decisions is fundamental to good medical practice and has long been a VA priority. Drug facts boxes--ideally produced by the FDA--would help inform decisions about prescription drug by providing doctors and patients with access to key information about drug benefits and harms in an understandable format.

References

1. Schwartz LM, Woloshin S. Lost in Transmission-- FDA Drug Information that Never Reaches Clinicians. New England Journal of Medicine 2009; 361: 1717-20.
2. Schwartz L, Woloshin S, Welch HG. Using aDrug Facts Box to Communicate Drug Benefits and Harms: Two Randomized Trials. Annals of Internal Medicine 2009;150:516-27.
3. Schwartz LM, Woloshin S, Welch HG. The Drug Facts Box: Providing Consumers with Simple TabularData onDrug Benefit and Harm. Medical Decision Making 2007; 27(5):655.