FDA Study Finds Consumer Prescription Information Needs Improvement

A recent FDA study found that the information leaflets consumers receive at pharmacies when they have new prescriptions filled need to be more consistent in quality and easier to understand.

These leaflets, called Consumer Medical Information or CMI, contain information about the drug and how to properly and safely use it.  CMI is different from the professional package inserts that are aimed at health care professionals and is also different from the Medication Guides and Patient Package Inserts which are legally required to accompany certain medicines, such as oral contraceptives.  All of these are authored by the drug companies and then reviewed by the FDA.  CMI is the information that the pharmacy prints out and either staples to or places inside the bag with the prescription.  Pharmacies buy it from special publishing companies, who write it using the professional inserts as a guide.  But the final published form it takes, which is sometimes altered further by the pharmacy companies themselves, is not reviewed by the FDA, and varies widely from pharmacy to pharmacy.   Pharmacies distribute it at the strong suggestion of the FDA, but are not legally required to do so.

In 1996, Congress issued a mandate that by 2006, consumer medical information that is considered to be “useful” should be distributed with new prescriptions at least 95% of the time, under a voluntary system.  Congress defined the information as being “useful” if it is scientifically accurate and is unbiased, meaning it contains no sales messages, is easy to read and understand, and contains specific information including the drug’s name, its approved uses, and medical situations when it should not be used, as well as instructions for using it properly, safely, and effectively, the most common and most serious adverse side effects to watch for, and encouragement to consult health care professionals in the event of adverse reactions or with any questions.

In 2001, the FDA conducted a study to see how close pharmacies were coming to meeting the 2006 goal.  The results from the recent 2008 study were compared with results from the 2001 study.  The 2008 study found that about 94% of consumers receive some form of CMI, but that only a little under 75% of it meets the minimum standards for being considered useful.  This is up from 2001, but falls short of the 95% goal, prompting the director of FDA’s Center for Drug Evaluation and Research, Janet Woodcock, MD, to say that “The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely.”  She went on to say, “We need to work with pharmacy operators, manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive, and more effective solution.”

The study was conducted at the University of Florida by the National Boards of Pharmacy, and sponsored by the FDA.  Professional shoppers were used, trained to portray consumers who had just been diagnosed with either diabetes or high blood pressure.  They visited a variety of pharmacies on a random list, in 41 states, and filled new prescriptions for either lisinopril or metformin, which are commonly prescribed for those conditions.

The CMI the shoppers collected were reviewed and graded on how well they met a list of criteria, which were based on Congress’s definition of usefulness.  There were two panels of graders, one an expert panel made up of pharmacists, pharmacy educators, and drug information specialists, and the other a panel of consumers.  If the CMI scored at least 60% of the points possible on the two evaluation forms used by the two panels, it was considered to have met the minimum threshold for being useful.

One of the lowest scoring areas in both the 2001 and 2008 studies was legibility and comprehensibility, which involves issues like print size, line spacing, formatting, and generally being easy to understand.  Only about 8% of the CMI scored the minimum number of points in this area in 2008.  There was no improvement since 2001.

The FDA Risk Communication Advisory Committee will hold a meeting about the results of the study on February 26 and 27, 2009.  In the meantime, the FDA seeks comments from pharmacy and health care professionals, and from the general public as well.  At http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-S-0627, you may read either the full study or a summary and leave your comments.