Simpler drug packaging doesn't increase patient compliance

Clear communication about a medication's pluses and minuses leads more patients to comprehend what a pharmaceutical can do for them, but this greater understanding may not translate into better compliance, according to a pair of recently published studies.

"It's disappointing, but not that surprising. There's probably a lot of work to do systematically to really improve adherence," said Ruth Parker, MD, professor of medicine at Emory University School of Medicine in Atlanta. She also is a member of the Institute of Medicine's Roundtable on Health Literacy.

Target's "ClearRx" prescription bottle was designed with color-coded rings and easy-to-read instructions to help patients better follow their medication regimens. Launched in May 2005, its effectiveness is the object of study.

Advocates for improving the ability of patients to understand their health care needs have long complained that prescription drug labels are written at too high a reading level and lack consistency. Retailer Target's "ClearRx" prescription bottle with color-coded rings and easy-to-read instructions received much praise when it was launched in May 2005.

But a study published online Feb. 27 in the Journal of General Internal Medicine found that this packaging did not make it more likely that patients would follow care plans.

"This is not to suggest that the Target redesign is not good. I think it's great," said William Shrank, MD, lead author and assistant professor of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School in Boston. "This study says that simple interventions probably are not going to fix nonadherence."

Researchers analyzed data from two large health plans, comparing 23,745 patients with chronic conditions filling their prescriptions at Target with 162,368 who got their drugs from other pharmacies. No relevant difference was found between the two groups.

Experts and the authors said expecting the redesign to impact adherence is likely asking too much. But many hope this packaging will improve safe use and outcomes, and research is ongoing to determine if evidence supports that idea.

Adherence is viewed as a much tougher problem. Assessing it also is challenging, and the claims data used in the study will not reveal changes beyond how often the prescription was refilled. "Adherence is hard to measure," said Dr. Parker, who is part of a team developing new warning labels for Target. "That's not to say that the change in the design didn't impact some very important outcomes. Maybe it impacted safety or patients are taking their drugs according to the directions for use?"

Target responded that the redesigned bottle was not carried out to impact adherence but probably has made a difference in whether patients take their medications correctly.

The American Medical Association recognizes poor health literacy as a barrier to good medical care, although it does not have a position on what drug labels should look like. The AMA Foundation also has several health literacy programs.

Box it up

Meanwhile, another study, this one in the April 21 Annals of Internal Medicine, indicated that a clearly laid-out "drug facts box" would lead to better understanding of the risks and benefits of various medications.

"What we're saying is let everyone know what the Food and Drug Administration knows and package it in a way that makes it accessible to everybody," said Steven Woloshin, MD, associate professor of medicine at the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H., and the VA Outcomes Group in White River Junction, Vt.

Researchers created a table quantifying possible outcomes if a patient did or did not take a drug. The information was then added to direct-to-consumer advertising for pharmaceuticals used to treat heartburn or to prevent cardiovascular events. Modeled on the nutrition information boxes on food labels, it was presented to a nationally representative sample of adults selected through random-digit telephone dialing. The drug facts box replaced a page of tiny text that accompanies most print drug ads, and increased people's ability to understand which drug was more effective, how the side-effect profiles compared, and how much benefit they could expect from the drug.

An accompanying Annals editorial called for more innovative ways to present complex data and a "national system of balanced, evidence-based, and user-friendly drug-information."

"Patients are bombarded with information that is hard to read, understand and interpret on the label itself and in direct-to-consumer advertising. Patients really have to overcome big barriers to figure out how to take their medications appropriately," said Dr. Shrank, one of the authors of the editorial.

To that end, the FDA's Risk Communication Advisory Committee in February considered whether this drug facts box should be used by the agency to communicate essential prescription drug information, along with several other possibilities. The panel was positive about the configuration and recommended that, if adopted, the boxes should go through a rigorous evaluation process.

A spokesman for Pharmaceutical Research and Manufacturers of America, a trade association representing the industry, said the organization "is committed to a fair balance of risk and benefit information in all direct-to-consumer advertising." The organization issued its latest guidelines on the subject Dec. 10, 2008.

DTC advertising of prescription drugs and devices is a contentious issue among physicians and has been debated many times at AMA meetings. The Association considers acceptable only those ads that are indication-specific and enhance consumer education about both the product and the relevant medical condition. Ads also should convey clear, accurate responsible health messages by providing objective information about the benefits and risks.