Drug leaflet: Information about side effects confuses patients

Drug leaflet: Information about side effects confuses patients

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Study: patient information leaflet on drug side effects confuses patients

A recent study has shown that the descriptions of side effects in the package leaflets of medicines are often incomprehensible to patients. And although, according to the researchers, a small addition could help.

Read the package insert correctly

Regardless of whether it is a pain reliever, cholesterol or blood pressure lowering: Before taking medication, the package insert should always be read correctly, in order to inform yourself about the correct intake and possible side effects. However, studies have shown that this drug leaflet leads to uncertainty in many patients. Even some doctors are increasingly overwhelmed by it. But a small addition on the package insert could help, as a study now shows.

Important information about the right medication

The medication package insert contains important information about the correct intake and possible side effects.

However, many patients cannot correctly assess this information because there is no comparative information on how often undesirable symptoms, which are listed as side effects, occur with and without medication.

Such comparative information is currently not to be found on package inserts in Germany or in other European countries, reports the Max Planck Institute for Educational Research (MPIB) in Berlin in a communication.

An online study by the MPIB and the University of Hamburg with around 400 laypersons has now shown that a small addition to the package insert could contribute to a better understanding.

The study results were published in the specialist journal "PLOS ONE".

Even doctors and pharmacists are wrong

"Very few people are aware that there is no causal connection between the symptoms listed as side effects and the medication they are taking," says lead author Viktoria Mühlbauer, pharmacist and doctoral candidate at the University of Hamburg.

"An early study shows that even doctors and pharmacists mistakenly believe that the listed side effects are caused by the respective drug in the abovementioned frequency," said the expert.

The aim of the study with 392 participants was to investigate whether alternative information leaflets with supplemented comparative information reduce misinterpretations.

For this purpose, the scientists showed the test subjects one of four leaflets, which all listed the same four symptoms (side effects).

Three of the four package inserts were alternative versions that listed the corresponding frequency of the symptoms both with and without medication and also provided explanations of the causality between the occurrence of the symptoms and the use of medication.

The fourth leaflet used in the study corresponded to the standard leaflet currently used in practice. As usual, this only provided information on the frequency of symptoms when taking medication.

Danger to patient and drug safety

In the subsequent survey, those who had read an alternative package insert scored particularly well.

While only two to three percent of the participants were able to correctly answer questions about causal frequency using the standard package insert, the figure for the alternative formats was up to 82 percent.

The alternative package inserts therefore led to fewer misinterpretations.

"The fact that information formats are still used in our healthcare system, which confuses patients and practicing doctors, is an overall problem that endangers patient and drug safety," says senior author Odette Wegwarth, research assistant in the "Adaptive Rationality" research area at the MPIB.

There is now a well-founded study on which information formats support patients and doctors in understanding the benefits and harms of medical interventions and which do not.

"What we need to put this knowledge into practice is the will and effort of everyone involved in healthcare," said Wegwarth. (ad)

Author and source information

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