Patients Say Drug Leaflets Are Hard To Read, Understand

Main Category: Compliance
Also Included In: Pharma Industry / Biotech Industry;  Public Health
Article Date: 02 Apr 2007 - 0:00 PDT

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Patients report that leaflets provided with prescription drugs do not meet their needs, according to a new systematic review. Instead, poor layout and complex language often hinder communication.

Review studies confirm that written drug information does not improve patient understanding of their medications. Many people would like information that better helps them evaluate potential benefits and harms of a drug treatment.

"If you're going to have safe and effective medicines use, then we need to give patients the tools to do that job," says lead author D.K. Raynor, Ph.D., of the University of Leeds in England.

The reviewers emphasize that patients want written information in addition to not instead of spoken instructions from their health care professionals.

According to the Partnership for Clear Health Communication, nearly half of all American adults have difficulty understanding and using health information.

In fact, the organization says, literacy skills are a stronger predictor of an individual's health status than age, income, employment status, education level or racial/ethnic group.

The review is published in the latest issue of Health Technology Assessment, the international journal series of the Health Technology Assessment programme, part of the National Institute for Health Research in the United Kingdom.

The authors reviewed 70 quantitative and qualitative studies carried out in the United Kingdom, Europe, Australia and the United States. They also conducted two patient workshops and delved into texts on information design to identify best practices.

The studies varied considerably in setting and timing, and reporting of interventions and methodological quality was often poor, the review authors say. For this reason, the experts detailed their findings in a nearly 200-page monograph rather than pooling the data for statistical analysis.

One key finding was an apparent dichotomy between prescriber and patient views of the fundamental purpose of drug leaflets, the authors say.

Some providers see increasing treatment compliance as a primary function. In contrast, patients say an informed decision not to take a medicine is also an acceptable result.

"Patients see the role of written medical information as guiding them in terms of which medicine is right for them and, if they take the medicine, how best they can use it," Raynor said. To that end, patients would also like to see more balance between benefit and harm information.

Current drug information focuses too heavily on warnings and adverse effects of the medication, Raynor said. "Patients also need to know how it might benefit them and how likely it is to benefit them."

Exactly how to convey the likelihood of benefits and harms most clearly remains in question. Verbal descriptors like "rare" or "common" are too vague, according to the review.

Yet, more scientific terminology like percentages or "numbers needed to treat" can also confuse the lay public. More research is needed in how best to communicate probability data to consumers, the reviewers say.

Raynor said that studies showed that poor layout of drug leaflets is a particular problem in the United States: "The information can be very dense, and the headings can be very indistinct. It can be very difficult to navigate."

To help drug companies produce more user-friendly consumer information, the authors reviewed six texts recommended by experts in information design to identify best practices. Recommendations include.

-- Use short, familiar words and short sentences.

-- Use short headings that stand out.

-- Use the largest possible type size.

-- Leave plenty of white space.

-- Use bullet points to organize lists.

"That's probably one of the most important parts of the review," Raynor said.

"This resource can help make leaflets in the way that patients find them useful."

In 2005, the European Union took an important step forward by requiring pharmaceutical companies to test their leaflets on patients before they begin marketing a product.

"Some [European] companies have started to realize how important the leaflets are," Raynor said. "Changing them and making them more valued for patients really is in their interests."

One U.S. company that is following suit is Pfizer, Inc.

"We moved all of our patient education materials around our brand down to the sixth-grade reading level," said Barbara DeBuono, M.D., the company's senior medical advisor for public health. She is also board chair at the Partnership for Clear Health Communication.

"Health literacy is not only the ability to read and understand information, but to act on the information," DeBuono added. "There's nothing more de-motivating for a patient than to find the information confusing, unintelligible and inaccessible."

The review authors call for more robust, patient-focused research on improving content, delivery and layout of written drug information. They add that none of the studies in the current review covered Web-based medicines information, which will surely be an emerging field of study in the future.

Raynor DK, et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technology Assessment 11(5), 2007.

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