Medication package inserts: Reading them can save lives

"For risks and side effects, read the package insert and ask your doctor or pharmacist." This version of the more than three-decade-old warning is quite new; gender-neutral language, to the detriment of pharmacists, has only been introduced since the end of 2023. It can be read and heard after every commercial at a record pace. Advertising is constantly being carried out, tailored to the target group and season, between magazines about the lives of the poor, the middle class, and the rich. Here's a remedy for dizziness, here a few vitamins and nutritional supplements, there's a cream for a twinge in the knee. These are all over-the-counter products; prescription drugs are not permitted to be advertised.

Either way. Inside each package is a neatly folded leaflet containing some information that could be vital in extreme cases, such as dosage and side effects, which a degree in medicine or pharmacy would greatly assist in understanding. Alternatively , Dr. Google and colleagues can help. Just one example: According to the package insert, taking the prescription painkiller Novaminsulfon Lichtenstein can lead to skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, agranulocytosis, and asthma attacks. How often this occurs—occasionally, rarely, or very rarely—is also noted.

Reading can save lives. But such documents are not a pleasure to read, which is why the small print is often ignored. No study is needed for this; critical self-examination is sufficient. The mail-order company Mycare.de examined the package inserts of 50 medications that, according to it, were most frequently prescribed in Germany in 2022, measured by daily doses, and determined the readability index (LIX). This index determines the linguistic difficulty based on word and sentence length. Texts with a score below 30 are considered very easy, according to the website of the Berlin School Portal , among others. The average score for fiction is 40 to 50, non-fiction books with a score of 50 to 60 are considered difficult, and specialist books with a score above 60 are considered very difficult.

According to Mycare.de, the average value for the package inserts was 47.04. According to the calculations, the painkiller Ibu-Lysin from Ratiopharm performed worst in terms of language, with a LIX of 53.68: 4,093 words and 503 sentences. Allopurinol, used to treat elevated uric acid levels, from the Indian supplier Indoco, achieved the lowest score, i.e., the most linguistically understandable: LIX 41.41, 2,159 words, and 461 sentences. Short words; only 37 percent of the words had more than six letters. For Ibu-Lysin, the figure was around 46 percent. The text of the package inserts is "linguistically complex, difficult to access, and often difficult for laypeople to understand," according to Mycare.de. “Many patients would already be helped if the font were larger or if there were color highlights,” says Martin Schulze, a pharmacist and head of pharmaceutical customer service at Mycare.de.

Package inserts leave little room for poetry. What a package insert should look like and what it must contain is regulated by EU Directive 2001/83/EC, which was implemented into national law by Section 11 of the Medicines Act . It is a comprehensive list of tasks. For example, the name of the medication, the name and address of the pharmaceutical company, dosage, side effects and a request to report any suspected side effects to a doctor or pharmacist. The Federal Institute for Drugs and Medical Devices (Bfarm) maintains a reporting page for side effects. The Bfarm is responsible, among other things, for the approval of medications. There are a number of guidelines on how to implement the EU directive, including a guide to readability. The readability index for the guidelines is not available.