Millions of people take daily or weekly medications for a variety of health concerns. As we all know, each prescription we get comes with a leaflet or other print-out from the pharmacy that explains what the drug is, how it is to be taken, what the side effects are, etc. The National Institute of Health and Reuters Health are reporting a new study that raises serious questions as to how useful and effective these leaflets actually are.
Dr. Carole Kimberlin and her colleagues at the University of Florida, Gainesville, studied product leaflets on two common medications: lisinopril (a blood-pressure medication sold as Prinivil and Zestril) and metformin (a diabetes drug sold as Glucophage and Fortamet). The study found a “great deal of variance” among the various leaflets, including substantial differences in word count, content, and readability. The reason for these variances? Unlike prescription labels, which are subject to strict FDA regulation, the leaflets provided by pharmacies are not. The FDA only provides recommendations for leaflets. Private publishing companies actually provide the content for leaflets and the pharmacy then decides what information to put on its leaflet, as well as the format of the leaflet.
The differences found by Dr. Kimberlin were striking. Word counts on leaflets for the same medication ranged from 30 words to 2,500, with a corresponding difference in the amount of drug content contained on each leaflet. Only three percent of leaflets for the drug lisinopril met at least 80% of the FDA’s recommendations of usefulness criteria. Only one leaflet for metformin met this same criteria. The study also found lacking the amount of information related to drug interactions, i.e., how the medication may react to other drugs the patient is taking.
While the differences in content were significant, the study found that even greater differences existed in readability. It is up to each pharmacy to format its leaflets so there can be large differences in the size of type, the spacing of the text, and general visual clutter – including store ads or coupons. All of this can make deciphering these leaflets even more difficult.
In general, Kimberlin told Reuters Health, the biggest shortcoming was in the leaflets’ readability. On average, leaflets from all pharmacies met less than half of the criteria for “comprehensibility/legibility.” For example, Kimberlin said, the content should be written at sixth- to eighth-grade reading level, but only 10 percent of lisinopril and 6 percent of metformin leaflets met that standard.
The bottom line – carefully read the product leaflet that comes with your prescription. And if you have any concern about the drug’s usage, side-effects, drug interactions, etc., be sure to talk to your pharmacist or doctor directly. You may not be able to rely on the information contained in the product leaflet.