Image via WikipediaThe 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
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