Problems with the content and format of consumer medical information distributed with prescription drugs at retail pharmacies are the primary barriers to providing appropriate information to patients, a recent evaluation suggests. The reading level and length of CMI were also cited as shortcomings.
Problems with the content and format of consumer medical information (CMI) distributed with prescription drugs at retail pharmacies are the primary barriers to providing appropriate information to patients, a recent evaluation suggests. The reading level and length of CMI were also cited as shortcomings.
Although the content and format of CMI are not subject to FDA regulation, the agency is required to evaluate progress toward a goal requiring that 95% of prescription drugs were to be accompanied by "useful" CMI by 2006, according to Almut Winterstein, PhD, lead author of a study that appeared recently in Archives of Internal Medicine. Dr. Winterstein is an associate professor, Pharmaceutical Outcomes and Policy, College of Pharmacy, and Epidemiology and Biostatistics, College of Public Health and Health Professions, University of Florida, Gainesville.
This research evaluated the percentage of dispensed medications accompanied by written CMI and the percentage of CMI that adhered to the criteria for content and formatting provided in an FDA guidance document.
The CMI was obtained through a national sample of retail pharmacies in the United States. Trained professional shoppers filled prescriptions for lisinopril at 365 pharmacies and for metformin at 364 pharmacies; 94% of the pharmacies provided CMI in leaflets ranging from 33 to 2,482 words. A mean of 60.2% of the criteria for useful CMI was met for lisinopril and 57.7% for metformin prescriptions.
The study found that leaflets were often overloaded with content that included information about the medication, text on the disease itself, advertisements, coupons, and regulatory information. To accommodate page limits, poor formatting choices were often made concerning font size, line spacing, lack of bullet points or text boxes for emphasis, and lack of white space, all of which decreased readability. Most of the evaluated leaflets scored poorly on these criteria.
In addition, many of the leaflets omitted required information such as a complete list of absolute contraindications or specific directions that would enable patients to handle problems, Dr. Winterstein said.
One solution for improving the quality of CMI could be the equivalent of the "quick start guide" often packaged with consumer electronics. Such a document could provide just the essentials, such as how to take the drug, the key side effects, and the most critical contraindications. A separate, longer document or link to a website could provide consumers with additional information.
CMI, by default, is generalized and won't always contain facts pertinent to a particular patient's situation, such as off-label use, said David Zimmerman, PharmD, FASCP, a pharmacy consultant in the Detroit area. "It's good that it's there, but it needs to be improved, " he said. Ideally, one-on-one counseling could fill that gap, but it isn't always provided because of time and staffing constraints.
Editor's note: According to a recent FDA press statement, the agency has determined that the current system is not adequate to ensure that patients receive essential medication information that is needed to use drugs safely. FDA is proposing that medication information leaflets be streamlined into a single, FDA-approved Patient Medication Information sheet that would be given to the patient the first time a prescription is filled and for subsequent refills. But before anything happens, FDA is asking consumers for feedback at a Sept. 27-28 hearing at FDA offices in Silver Spring, Md. Complete details about the hearing are posted at FDA CMI meeting.