There are wide variations in the quality of leaflets that accompany new prescriptions and let consumers know about correct dosage and the associated benefits and risks, according to a 50-page study released on Tuesday and sponsored by FDA, the Wall Street Journal reports. While FDA has authority over a medication`s label and inserts, it is not authorized to regulate the leaflets. FDA previously attempted to set standards on the quality of the information contained in the leaflets, but Congress passed legislation that restricted the agency from regulating the information.
For the study, researchers from the National Association of Boards of Pharmacy
and University of Florida College of Pharmacy examined the leaflets pharmacies gave to customers with new prescriptions for the blood pressure medication lisinopril or the diabetes treatment metformin. Researchers obtained the leaflets from 365 pharmacies in 41 states. The study updates research conducted in 2001.
Most of the leaflets included information on approved uses for the medication and directions for proper use. According to the study, one-quarter of the leaflets did not meet minimum standards for information; for example, about two-thirds of the leaflets failed to clearly indicate general dosing information and 40% did not include dosing instructions specifically written for the patient, the study found.
Three percent of the leaflets for lisinopril and 18% for metformin advised patients to stop taking the treatments if they experienced side effects, and most of the leaflets suggested contacting a physician. Some of the leaflets also included data not related to the medications, such as marketing information for vitamins, which could distract patients from essential information, according to the study`s authors. They noted that 6% of the pharmacies did not provide any written information with new prescriptions.
According to the study authors, the variation in leaflet quality is related to the companies providing the safety data and pharmacies deciding how to distribute that information.
FDA officials said the study findings show that pharmaceutical companies, pharmacies and drug-safety data providers need to do more to improve the information patients receive. In a statement, Janet Woodcock, director of FDA`s Center for Drug Evaluation and Research, said, "Consumers are not getting the information they need consistently enough to promote the safe and effective use of prescription medicines."
Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said, "It appears that the editing the pharmacies are doing is causing the problems," adding, "We need to get a message to pharmacies about that so patients get the appropriate information in formats they can understand."
FDA has established a Web site for public comment on the issue and plans to conduct an advisory committee meeting in early 2009, the Journal reports (Rockoff, Wall Street Journal, 12/17).
The study is available online (.pdf).
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