Consumer medication information falls short, UF researchers say

Two University of Florida pharmacy faculty members will tell a U.S. Food and Drug Administration panel this week that the information that accompanies prescription medicine often does not follow FDA format and content recommendations.

Consumers should be able to easily recognize essential information in the drug handouts, and the fonts should be relatively large and readable. All these factors affect the quality and accessibility of the instructions and other information consumers need to safely take their prescription medicines.

Almut Winterstein, Ph.D.

Almut Winterstein, Ph.D.

But much of this information does not comply with FDA guidelines for formatting and content, according to Carole Kimberlin, Ph.D., a professor of pharmaceutical outcomes and policy, and Almut Winterstein, Ph.D., an assistant professor of pharmaceutical outcomes and policy.

The FDA does not have regulatory authority over such information, so it varies from one pharmacy to the next — even for the same medications. The information comes from private companies that collect and format the data for pharmacies to distribute.

"In the late '90s, the FDA was on the verge of implementing regulations that they had generated (about) content and the format of consumer medication information that was given to patients when they got prescriptions filled," Kimberlin said. "Congress stopped that regulation from going into effect and said that they would leave it to the private-sector efforts but charge the FDA with evaluating how well the private sector was doing."

In 2001, the FDA funded a study by University of Wisconsin researchers that sent trained shoppers to pharmacies across the country to fill prescriptions for specific medications. Pamphlets of information handed out with the drugs were then evaluated by a group of experts according to FDA standards for factors such as the comprehensiveness of the information and its format. Non-experts also evaluated the documents for consumer usefulness.

Kimberlin and Winterstein conducted a similar study in 2008, also with FDA funding, and compared their results with the previous ones. The researchers will present their findings today and Friday at a public hearing before the FDA's Risk Communication Advisory Committee.

Carole Kimberlin, Ph.D.

Carole Kimberlin, Ph.D.

"What we found was that there was more content, more pieces of information included in most of the information leaflets that were given to patients," said Kimberlin, "but that the formatting, the reading level, the font size, how easy it is to read in terms of the spacing between lines — all of the formatting that would make it more readable and interpretable did not improve at all."

Even with the additionalinformation, some pamphlets did not include all the vital contentrecommended by the FDA.

Researchers examined the information handed out with prescriptions of the heart medication lisinopril at 365 pharmacies and with prescriptions of the diabetes drug metformin at 364 pharmacies. Twenty-two pharmacies did not distribute any information on the medications aside from bottle labeling. Individual leaflets were assigned points indicating their adherence to predetermined criteria. Those receiving less than 60 percent of the total possible points were deemed not helpful for patients. Out of pharmacies that did hand out leaflets of information, the mean quality score for lisinopril information was 62 percent, while the mean quality score for metformin information was 59 percent.

In addition, Winterstein said the increase in information doesn't mean it is useful to patients or easily understood, and it may actually hinder comprehension in the long run. For some patients, she emphasized, knowing how to properly use their medications can be a matter of life or death.

"I think this is more a philosophical issue of how much do you want the government to regulate certain things," Winterstein said. "A private company will only put as much effort financially into this as requested or required. I mean some of these leaflets are really bad, to say the least."

She said she hopes the research will prompt policy change on the issue.

"The reality is our research shows that after this has been in the private domain for a decade now, it really is not up to what is needed," she said. "So from that perspective, I think the FDA has a good chance right now that people will agree that having a more prescriptive system would probably be better."

Lucinda Maine, executive vice president of the American Association of Colleges of Pharmacy, said the findings are important and detailed.

"Very few studies approach this question at the level of specificity and detail that the 2001 and 2008 studies have used," said Maine, who was not involved in the research.