Drug Information Leaflets Too Lengthy, Complicated

The information leaflets that patients receive at pharmacies along with their prescriptions differ significantly in content, and can be difficult for people to read and understand, according to research published in the Archives of Internal Medicine.

Currently, the material found in leaflets distributed by pharmacies is not regulated by the FDA, and no standard approach exists for generating content. Private publishing companies provide the content for the leaflets, and then pharmacies—or their software vendors—determine the formatting of the leaflets, and can select what drug information to include or leave out. Therefore, leaflet information about the same drug, provided by the same publisher, can vary widely from pharmacy to pharmacy, according to Carole L. Kimberlin, PhD, and colleagues from the University of Florida, Gainesville.

In the study, they found a “large variances” among leaflets for two common drugs, the blood-pressure drug lisinopril and the diabetes medication metformin, which are dispensed at 365 US retail pharmacies. The leaflets ranged in word count from 33 to 2,482 words, with more than 1,000-word differences among those meeting higher than 80% of the content criteria. However, although the longer leaflets provided more information, few came close to meeting all of the FDA standards, according to an online report, noting that just 3% of lisinopril prescriptions and just 1% of metformin scripts came with leaflets that met at least 80% of the “usefulness criteria” the researchers adapted from the FDA standards.

Kimberlin and colleagues also found that that chain pharmacies had better adherence to content criteria than did independent stores, with mean differences of 22.1% for lisinopril and 21.1% for metformin.

They concluded that although distribution of medication information through pharmacies “seems effective, the content, format, reading level, and excessive length of CMI are disconcerting. Private sector initiatives to provide useful CMI have failed.” Further research, they say, “is needed on effective information selection and presentation in terms of effects on comprehension, retention, and appropriate patient actions to derive optimal drug benefit.”