Q: I always get a couple of pages of printed information about my medicine every time I get it refilled, but the print is so tiny I can barely make out the name of my pills at the top. There’s so many side effects listed, if I read them all I would be too scared to take it. What’s the point?
The Food and Drug Administration (FDA) wants consumers like you to know certain important facts about your medicines to help you take them safely. Written information is considered one of the best ways to give out information because it’s something you can hold in your hand and look at, not just hear once at your doctor’s appointment or at your pharmacy, forgotten by the time you get home. Written information goes with you to where you store and take your medicines.
The printed sheet given to you along with your medicine is called a consumer medication information sheet, or CMI. Although the FDA has published guidelines about what type of information should be included in a CMI, it doesn’t directly regulate or enforce any of them, relying instead on private companies to hire people to write the information for each medicine.
If you think the print on your information sheet or CMI seems small, you are not alone! The first thing most people notice about their CMI is how microscopically small the type is. The bigger issue is, how USEFUL is it to you? Did you actually stop and read your CMI? Even more important, though, is was it worth reading? Did it make sense to you?
The FDA is very concerned about how useful CMIs are. In a study published in 2010 by the University of Florida College of Pharmacy, professional shoppers filled prescriptions for two common medications in a sampling of 365 pharmacies across the country. The CMIs they collected were tracked and compared to recommended guidelines set out by the FDA.
This particular study found that getting a CMI sheet was nearly universal: 94% of the pharmacies in the study dispensed one with each prescription. The quality of the information was less consistent, with less than 50% of the CMIs provided by the pharmacies considered as meeting the guidelines for being easy to read or understand. Some leaflets gave only a few sentences of information, while others covering the same medicine went on for several pages.
According to FDA guidelines about CMIs, they should include 8 criteria: the drug name and what it’s used for; any contraindications and what to do about them; specific directions about how to use it, monitor your progress and get the most benefit; any special precautions and how to avoid harm while using it; include symptoms of serious or frequent side effects and what to do if they happen; encourage you to ask questions; be up to date and scientifically accurate; be easily understandable and legible.
What do you do with your CMI? Do you stop, sit down and read it word for word, look it over quickly as you scan for useful tidbits, or do you just pitch it directly into your trash? A significantly improved one-page CMI may be on its way to you soon.
In April 2013, Catalina Health announced the results of a pilot of a redesigned one-page patient handout based on a prototype recently developed by the FDA. The new one-page sheet, also called a Patient Medication Information sheet or PMI, was developed through a collaborative workgroup including the FDA, the Medical Cognition Laboratory at Duke University, 2 medical schools, a pharmacy school, 3 pharmaceutical manufacturers, the Regenstrief Center for Healthcare Effectiveness Research, and Catalina Health. The new format PMI has separate boxes for key topics such as “Uses,” “Important Safety Information,” “How to Take,” “Get emergency help if you have,” and “Possible side effects.”
The new PMI was piloted by a major retail pharmacy chain in California and Michigan for 3 medications over an 8-week period in late 2012. Over 90 per cent of customers surveyed found the new PMI useful and readable. Catalina Health plans expansion into Phase 2 of the project later this year.
