The content, formatting, and word count of leaflets pharmacies hand out with medicines are inconsistent and should be subject to FDA guidance, researchers say.
Among written instructions given out with prescriptions of lisinopril (Prinivil, Zestril) and metformin (Fortamet, Glucophage, Glumetza, Riomet), about half failed to include directions on use and raised questions about comprehensibility, Almut G. Winterstein, PhD, of the University of Florida, and colleagues reported in the Aug. 9/23 issue of Archives of Internal Medicine.
“Private sector initiatives to provide useful [consumer medication information] have failed,” they wrote. “Research is needed on effective information selection and presentation in terms of effects on comprehension, retention, and appropriate patient actions to derive optimal drug benefit.”
The FDA regulates label information and guides that accompany drugs with safety concerns but not the content and format of consumer medication information (CMI) documents. The agency does, however, have a set of eight standards for CMI leaflets:
•State drug name and indication
•List contraindications
•Include directions about use
•Note precautions and potential harms
•List symptoms of possible adverse reactions
•Include general information and encourage patients to ask questions
•Be scientifically accurate
•Be comprehensible and legible
To assess the consistency of these documents, “professional shoppers” filled prescriptions for lisinopril and metformin in a national sample of 365 independent and chain pharmacies.
About 6% of pharmacies didn’t provide any written leaflets with these medications.
A mean of 60.2% and 57.7% of the criteria for useful consumer medical information were met for lisinopril and metformin prescriptions, respectively.
However, 14% and 16% of leaflets, respectively, were of low quality overall, the researchers said.
There were many shortcomings with regard to the “directions about use” standard — found in 53.4% and 45.6% of lisinopril and metformin prescriptions, respectively.
Comprehensibility and legibility were also of concern in 43.8% and 42.6% of prescriptions for these two drugs, respectively.
The standard that had the best compliance was the one regarding scientific accuracy, the researchers said.
Leaflets ranged from 33 to 2,482 words, with more than 1,000-word differences among those meeting the highest quality of content. This suggests “large variations in conciseness,” the researchers wrote.
For the 92 lisinopril leaflets that met more than 80% of the content quality criteria, the mean word count was 1,523.
Less than a third of leaflets used font size of 10 points or larger. Only 10% of lisinopril and 6% of metformin leaflets were written at or below an eighth-grade reading level.
The researchers also noted that chain pharmacies had better adherence to content criteria than did independent stores.
The study was limited because it can’t be generalized to other settings, including mail-order outlets.
Still, the researchers concluded that the “usefulness of CMI ultimately depends on meeting the needs of patients for information that facilitates the understanding and management of their therapies.”
source: Archives of Internal Medicine