FDA Poised To Overhaul Distribution Of Consumer Medical Information

FDA appears poised to begin an overhaul of the dissemination of consumer drug information.

The recent Risk Communication Advisory Committee meeting Feb. 26 and 27 endorsed a concept that the agency has been considering - a single document in lieu of the numerous leaflets, including MedGuides, that patients often receive at the pharmacy.

"We were anxious to hear from them that we ought to adopt a single standard document for communicating the essential information to consumers," Deborah Henderson, director of CDER's Office of Executive Programs, said in an interview.

FDA convened the panel to discuss the different types of prescription drug information currently available to patients, review a recently completed survey gauging their effectiveness and discuss next steps for assuring that consumers receive useful written information with their prescriptions.

"I think it's quite clear that the current system is a failure," panel member Christine Bruhn, University of California-Davis, said.

Committee members agreed that the new document should take the shape of a Drug Facts Box, which would be similar to the nutrition table found on food packaging, and include quantitative summaries of risks and benefits for the drug along with use and precaution information.

Current System "Cumbersome At Best"

The agency said it believes its authority to reformat consumer drug information was triggered when a report by the National Association of Boards of Pharmacy found that Consumer Medication Information was not being delivered to a pre-specified percentage of patients with their prescriptions (¹ (Also see "FDA Risk Communication Advisory Cmte. Will Assess Pharmacy Leaflets’ Utility" - Pink Sheet, 22 Dec, 2008.), p. 5).

The results underscored the great variability from pharmacy to pharmacy in the content and quality of CMI distributed. While the quality of the leaflets has increased since 2001, information about the use of medications and how effectiveness and safety should be monitored is lacking, the study says.

Ultimately, the study stresses the ongoing need for more uniform, "user-friendly," concise and clinically relevant written medication information.

Currently, in addition to a Consumer Medication Information, patients may also receive Patient Package Information, which is required for some drugs and considered part of the approved labeling, as well as Medication Guides, required for drugs the agency considers to be a serious and significant health concern.

In some cases, patients leave the pharmacy with three packets of information, which critics say is not only duplicative, but also intimidating and confusing. As the study shows, however, even with an overload of information, patients are still not getting the information they need.

"I think we whole-heartedly agree that the current system for providing information to consumers about their medicine is cumbersome at best," said Henderson.

For pharmacists, the overhaul might come as a welcome relief from a distribution system they often find as vexing as patients feel it is. But for drug manufacturers and the firms that currently produce consumer medical information, a single FDA-approved document would create high-stakes negotiations with the agency about what should appear about each drug.

While the agency has not determined what specific regulatory authority it would need, FDA's Director of Risk Communication, Office of Policy and Planning, Nancy Ostrove said at the advisory committee meeting that under the law setting up the evaluation of CMI, if the goals are not met, FDA must step in to fix it.

Options Abound

There have already been numerous recommendations to FDA as to how to reformat consumer information for drugs. The two leading proposals are the "single document solution" and a Drug Facts Box.

A ² citizen petition, backed by eight pharmacy and consumer organizations, requests an FDA-approved "single patient document" in concise, plain language that can be used in lieu of CMIs, PPIs and MedGuides.

The petition, submitted June 30, 2008, argues that the present "jumble of documents" provided to patients "ill-serves" those looking for the "essential information to take a prescription drug safely and effectively."

In the petition, the document is proposed as being "voluntary" for pharmacists, something the committee members unanimously disagreed with. By being voluntary, pharmacists could decide whether to dispense the document or continue to distribute the relevant CMIs, PPIs and MedGuides.

The second proposal, which committee members were smitten with, is a Drug Facts Box. The idea is not new (³ (Also see "FDA Drug Risk Communication Should Include Drug Benefit Info, PhRMA Says" - Pink Sheet, 19 Dec, 2005.), p. 28), but a recently published study in the Annals of Internal Medicine shows promising results from an FDA pilot program.

The facts box, while formatted like nutritional labeling or the OTC drug facts table, would quantify outcomes with and without the drug. In the published study of two trials, for example, 70 percent of the drug box group correctly identified one drug as being "a lot more effective" than another, compared to 8 percent of the control group.

Overall, the studies showed that the drug facts box improved U.S. consumers' knowledge of prescription drug benefits and side effects and resulted in better choices between drugs for current symptoms, as well as corrected the overestimation of benefit in the prevention setting.

"I'm just delighted that you've gathered so much good research to support it. I'm eager and ready to see it go into practice," patient advocate Musa Mayer said at the committee meeting.

Henderson said that the agency's next step is to reconvene the investigators in the study with decision-makers and policymakers within FDA to decipher the practical aspects of working with the box.

"Now it's incumbent upon us; the ball is in the agency's court to reassemble," she said, noting that the agency is "very interested" in looking at where the box might be applicable. A "one document solution" could also incorporate a drug facts box in its design.

Emphasis On Social Science of Communication

One area FDA was looking forward to hearing about, which Henderson said they did not hear as much about as they would like, is the current state of social science research regarding different forms of communication: What types of communication are most effective? When is the best time to communicate with patients about risks? What specific aspects of communication would patients react to the most?

The committee members, while not providing the social science background the agency was looking for, also agreed it was an important point.

The members voted that FDA-approved and required communications be subject to rigorous empirical evaluation of their effectiveness, and that the agency should establish performance standards for the effectiveness of the standard document, defined in terms of individuals who have received it. Finally, members voted that FDA should conduct a systems analysis of the dissemination processes by which the standard document reaches consumers at times relevant to their decision-making about adoption and use.

Still A Long Road Ahead

FDA said it does not have a timeline for when revisions might be made - that will depend on what the agency actually decides to do. Even though Ostrove stressed at the meeting "a real sense of urgency," Henderson noted that a consumer medication piece is "not an emergency for us."

There are many challenges involved in actually implementing a new document policy. If the agency decides to go ahead with a single patient document in lieu of CMIs, PPIs and MedGuides, for example, it will have to do some heavy regulatory lifting to repeal the current rules that require those documents (⁴ (Also see "Pharmacy Leaflets Become Focus For Patient Safety; IoM, FDA Finalize Standards" - Pink Sheet, 24 Jul, 2006.), p. 13). The central role that MedGuides play in FDA's new safety powers could also complicate the overhaul efforts (⁵ (Also see "MedGuide Requirements Need To Be Overhauled, Pharmacy Groups Tell FDA" - Pink Sheet, 25 Aug, 2008.), p. 9).

"Depending on where we go will depend on how long it takes, but we feel a real urgency in the agency to seize the day," said Ostrove.

There are also questions surrounding the comprehensibility of even the newly proposed documents. Proposals for formats available in different languages were made on behalf of non-English speaking patients. For illiterate and lower-education patients, pictographs were suggested to complement writing.

Indeed, the committee voted that FDA should identify populations for which the standard document is inadequate, and should address their needs. FDA noted, though, that there is no requirement that labeling be written in any other language except for English.

"It's just very clear to me how crucial this effort must be to have a single source of really comprehensive, clear, understandable, unbiased risk benefit information," said Mayer. "It seems to me that FDA might be able to find some ways to seize the regulatory authority to once and for all make this happen and not leave this up to manufacturers and outside developers."

- Lauren Smith ([email protected])