Sunday, July 14, 2024

Drug information sheets – why you get them

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Q: I always get a sheet of printed information with every new prescription and refill. I usually throw them away without reading them because the print is too small. Why do I get these?

The Food and Drug Administration (FDA) wants you to be informed about important facts about your medicines so you can take them safely. Each time a pharmacist dispenses a new or refilled prescription, he or she is REQUIRED to provide written information about every one of your medicines. They are also expected to ensure that you have received it, so you get these either folded inside the bag containing your pill bottles or stapled to the outside.

Written information is considered one of the most reliable ways to give you essential information about your medicines. Instead of only hearing it once from your doctor or pharmacist, which you may forget by the time you arrive home, with printed information, you can read it at your own pace. Written communication can also be stored where you take your medicines in case you have a future question about one of your medicines.

There are 3 types of printed consumer information given out with prescription medicines: consumer medication information sheets (CMIs), Medication Guides (MedGuides), and Patient Package Inserts (PPIs).

Every time you get a new or refilled medicine, you are supposed to receive a consumer medication information sheet or CMI. Each CMI is computer-generated and designed to travel home with you, either stapled to or placed inside the bag holding your prescription. Although the FDA has published guidelines about what types of information they feel should be included in a CMI, they don’t directly regulate or control what form a CMI takes.

The FDA recommends specific elements that they prefer pharmacies to use in their CMI handouts. However, each pharmacy retains the choice of which of those elements they will use. For example, the CMI you receive for your blood pressure medicine at one pharmacy may look different from the CMI for the same drug from another drugstore. Some leaflets give only a few sentences of information, while others covering the same medicine can go on for several pages. One reason for this variation is how the printers used by each pharmacy limit the length and format of their CMI printouts. Whichever form they take, what most people consistently notice about their CMI is how small the print seems.

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 nationwide. 94% of the pharmacies in the study dispensed a CMI with each drug. However, fewer than 50% of the CMIs provided were considered easy to read or understand.

A collaborative workgroup, including the FDA and other stakeholders, has been developing and promoting an easier-to-read format for medication information called a Patient Medication Information sheet (PMI). PMIs use bold print, bigger fonts, and much more white space.

Here are the 4 types of written information for consumers about medications:

1.           Consumer Medication Information sheets (CMIs)

CMIs are required by the FDA to be given out with every new prescription and refill. According to FDA guidelines, a CMI 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, how to monitor your progress and get the most benefit; any special precautions and how to avoid harm while using it; symptoms of severe or frequent side effects and what to do if they happen; and encouragement to ask questions. The information must be up to date and scientifically accurate, easily understandable and legible, and have print large enough to read easily by most people.

2.           Patient Medication Information sheets (PMIs)

PMIs are CMIs that are easier to read. They have larger fonts and more white space. PMIs usually include separate boxes or bubbles for crucial topics such as "Uses," "Important Safety Information," "How to Take," "Get emergency help if you have," and "Possible side effects." 

3.           Medication Guides (MedGuides)

MedGuides are specialized information sheets describing how to reduce the risk of taking certain medicines known to have serious adverse reactions. MedGuides explain what side effects to watch out for. Non-steroidal anti-inflammatory drugs, blood thinners, and antidepressants are examples of drugs with MedGuides.

4.           Patient Package Inserts (PPIs)

PPIs are similar to MedGuides but from the manufacturer. PPIs are required for products containing estrogens, like birth control pills, patches, and vaginal creams.

Dr. Louise Achey, Doctor of Pharmacy, is a 43-year veteran of pharmacology and author of Why Dogs Can’t Eat Chocolate: How Medicines Work and How YOU Can Take Them Safely. Get clear answers to your medication questions at her website and blog, TheMedicationInsider.com.

Ó2023 Louise Achey

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