FDA guide spells out what is useful Rx info for patients

How much written drug information is enough for consumers? Is there such a thing as too much information?

That's what the Food & Drug Administration set out to answer in its new guidance, Useful Written Consumer Medication Information, released in July. The guidance is designed to assist pharmacists and private vendors in developing more practical and comprehensible consumer medication information (CMI). The guidelines comply with Public Law 104-180, enacted in 1996, which set down a requirement that by 2006, "95% of all patients receiving new prescriptions would receive useful written patient information with their prescriptions." If the FDA finds that the 95% goal is not reached through measures implemented by pharmacies on their own, the agency could then mandate specific steps for the industry to take.

The driving force behind the development of the CMI guidelines was concern amongst pharmaceutical manufacturers, prescription drug wholesalers, drug information database companies, and others that there were parts of the FDA action plan that weren't clear, explained Paul Seligman, M.D., MPH, associate director for safety policy and communication at the Center for Drug Evaluation & Research (CDER) and a contributor to the new guidelines.

Information overload, however, is a concern of some pharmacists. "In our view, useful does not necessarily mean longer," said John Coster, Ph.D., VP of policy and programs for the National Association of Chain Drug Stores. "We have some concerns about the length of the information that will result if everything in that guidance is included. At some point, you have to balance length with usefulness, and we're already concerned that patients may be getting too much information that they're just not reading. Once you get beyond a page or so, you start losing patients in terms of their ability to want to read and to comprehend. If they have questions, they need to ask their physician or their pharmacist."

Overall, however, Coster said the guidelines serve a useful purpose for pharmacists in fulfilling the need to educate their customers and he is hopeful that the 95% compliance goal will be met. "All pharmacy operators and pharmacists need to look at what they are producing and measure it against the guidance to determine how they can make their information better and more useful to patients," he said. "Let's hope that we can all work toward achieving this [95%] goal without having any further FDA regulations."

While patients may not read everything they are given about their prescriptions, Seligman feels it's better to err on the side of giving too much information instead of too little or information that is vague. "Given the complexity of medicine these days, it's important for consumers to have something physically in their hands that they can have as a reference," he said. "It's hard to deliver all of that information in one sitting in a doctor's office or across the pharmacy counter, so we think CMI is important to have. My hope is that we will exceed the Congressional goal this year in that every patient who picks up a prescription will get something that's clear, accurate, and useful."

For a complete copy of the CMI guidelines and examples of how to present this type of written drug information using the guidelines, log onto http://www.fda.gov/cber/guidelines.htm or call 1-(800) 835-4709.

Consumer medication information at a glance

According to the Food & Drug Administration, consumer medication information (CMI) is "written information about prescription drugs developed by organizations or individuals other than a drug's manufacturer intended for distribution to consumers at the time of drug dispensing."