CMI ... TMI?

According to a new study in the Archives of Internal Medicine (Winterstein AG, et al "Evaluation of consumer medical information dispensed in retail pharmacies" Arch Intern Med 2010; 170(15): 1317-13240), The content, formatting, and word count of leaflets pharmacies hand out with medicines leave much to be desired and should be subject to FDA guidance.

Among written instructions given out with sample prescriptions about half failed to include directions on use and raised questions about comprehensibility. "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 in a national sample of 365 independent and chain pharmacies.

Leaflets for the same product 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. Less than a third of leaflets used font size of 10 points or larger. Only 10% of leaflets were written at or below an eighth-grade reading level. About 6% of pharmacies didn't provide any written leaflets.

The researchers also noted that chain pharmacies had better adherence to content criteria than did independent stores.

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."

While “more guidance” isn’t always the answer, the FDA should step up to the plate as this is squarely a “safe use” issue.  Helping patients (aka: “consumers”) use medicines as they are intended is the best way to make drugs “safer.”

Knowledge is Power.