Package insert: Doctors increasingly overwhelmed

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A survey shows that doctors and pharmacists often misunderstand the leaflet

Doctors and pharmacists also often misunderstand the information leaflet for medication, according to the latest survey by a research team from the Institute for Medical Biometry and Statistics at the University of Lübeck. As reported by the “Deutsche Ärzteblatt”, the scientists led by Prof. Dr. Andreas Ziegler and Prof. Inke R. König checked the knowledge of doctors and pharmacists about the frequency of the side effects on the package insert. If you ask your doctor or pharmacist about the risks and side effects of medication, you may receive an inadequate answer. "Even the experts misinterpret the formulations on the package leaflets for medications regarding the frequency of side effects," reports the "Deutsche Ärzteblatt".

The study, which was developed in cooperation with the University Medical Center Schleswig-Holstein, shows that many doctors and pharmacists have considerable difficulties in correctly interpreting the information on the frequency of side effects on the package inserts. The terms used, such as "frequently", "occasionally" and "rarely" are actually assigned clear values ​​by definition by the Federal Institute for Drugs and Medical Devices (BfArM), but many pharmacists and doctors are not familiar with this definition. In the current survey, they often tended to overestimate the risk of side effects.

Only four out of a hundred respondents correctly interpret “common” side effects. A total of 600 doctors, 200 pharmacists and 200 lawyers were asked about the frequency of side effects in the package insert. "The questioning among doctors was limited to the fields of anesthesia and internal medicine, since the use of medicines is very common in these areas," write the study authors. Respondents were asked to indicate what it means when a drug is likely to have “common”, “uncommon” or “rare” side effects. According to Prof. Ziegler, only four out of a hundred physicians surveyed were able to correctly assign the meaning of the term “frequently” in connection with side effects. According to the researchers, “is for the term frequently the range is from one percent to ten percent, but the doctors indicated an average frequency of 60 percent. ”They were not aware of the correct numerical interpretations given by the BfArM.

Pharmacists, medical professionals and lawyers misinterpret frequency data Comparable results would have been shown in all examined groups. "Both the participants in the medical, pharmaceutical and legal professions mostly assigned the frequency information in the package leaflets of medicinal products incorrectly," added Ziegler and König. According to the researchers, the interpretations by doctors rarely matched the specifications. For example, only 3.5 percent of those surveyed correctly interpreted the term “frequently”; the term “occasionally” only applied to 0.3 percent of medical professionals and the term “rarely” to 0.9 percent. "The results were similar in the pharmaceutical and legal groups (agreement for frequently at 5.8 percent and 0.7 percent, for occasionally at 1.9 percent and zero percent for Rare 1.9 percent and 0.7 percent), ”the scientists report. Overall, the pharmacists performed best.

New information on side effects risk required According to the researchers, the result of the survey is extremely questionable. "If experts overestimate the risk of side effects, how must the patient first be," emphasized Prof. Ziegler. An overestimation of the risks of side effects results in “that patients are more likely to forego medication”, at worst with far-reaching consequences for the success of the therapy. The available results suggest that the problem may be even more far-reaching than previously thought, "because even those whose job it is to provide information about the likelihood of side effects overestimate them," the researchers said. In their opinion, the definitions of the terms according to the BfArM are not suitable for everyday use and instead information such as "One or every 100 patients experience this or that side effect" should be given instead.

No revision of the frequency information in sight The press spokesman for the Federal Institute for Drugs and Medical Devices Maik Pommer said to the “Deutsches Ärzteblatt”: “We want to inform consumers about all possible risks, and we have agreed on the form at hand.” A revision is therefore obviously not being considered, even if the current study has confirmed the results of previous studies from Great Britain, which have already indicated the weaknesses of such a frequency statement. (fp)

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