Leaflet Doctors increasingly overwhelmed

A survey shows that doctors and pharmacists often misunderstand the leaflets

18/10/2013

Doctors and pharmacists also often misunderstand medication leaflets, according to a recent survey by a research team from the Institute for Medical Biometry and Statistics at the University of Lübeck. As the „German Medical Journal“ reported, the scientists around Prof. Dr. Andreas Ziegler and Prof. Dr. med. Inke R. König reviewed the knowledge of physicians and pharmacists on the frequency of side effects on the leaflet. Therefore, anyone who asks their doctor or pharmacist about the risks and side effects of medication may receive an inadequate answer. „The formulations on the leaflets of drugs to the frequency of side effects are often misinterpreted even by experts“, reports that „German Medical Journal“.

The study, which was developed in cooperation with the University Hospital Schleswig-Holstein, shows that many physicians and pharmacists have considerable difficulty in correctly interpreting the information on the frequency of side effects on the package leaflets. Although the terms used are like „frequently“, „occasionally“ and „Rare“ By definition, by the Federal Institute for Drugs and Medical Devices (BfArM) actually assigned unique values, but many pharmacists and medical professionals, this definition is not common. In the current survey, they often tended to overestimate the risk of side effects.

Only four out of a hundred interviewees interpret „frequent“ Side effects right
A total of 600 physicians, 200 pharmacists and 200 lawyers were asked about the frequency of side effects in the leaflet. „For physicians, the survey was limited to the fields of anesthesia and internal medicine, because in these areas the handling of medicines is very common“, write the study authors. Respondents should state what it means when taking a drug „frequently”, „occasionally” or „Rare” with side effects is to be expected. According to Prof. Ziegler, only four out of every hundred physicians surveyed were able to understand the meaning of the term „frequently“ correctly associate with side effects. According to the researchers „is for the term frequently the range is defined as one percent to ten percent, but the physicians reported an average frequency of 60 percent.“ They were not aware of the correct numerical interpretations given by the BfArM.

Pharmacists, physicians and lawyers interpret frequency data incorrectly
Comparable results have been shown in all groups studied. „ Both the participants in the medical and the pharmaceutical and legal professions usually misclassified the frequency information in the leaflets of medicinal products“, so Ziegler and King continue. According to the researchers, the interpretations by doctors rarely agree with the guidelines. Only 3.5 percent of respondents would have the term „frequently“ correctly interpreted, in the designation „occasionally“ This was true for just 0.3 percent of physicians and for the term „Rare“ to 0.9 percent. „The results were similar in the pharmaceutical and legal group (agreement for frequently at 5.8 percent and 0.7 percent, for occasionally at 1.9 percent and zero percent for Rare at 1.9 percent and at 0.7 percent)“, the scientists continue to report. Overall, therefore, the pharmacists have performed best.

New claims of side effects risk required
According to the researchers, the survey results are extremely questionable. „If experts are already overestimating the risk of side effects, how must it first be the patient”, emphasized Prof. Ziegler. An overestimation of the risks of side effects result, „that patients are more likely to do without a drug“, at worst, with far-reaching consequences for the success of therapy. The results suggest that the problem may be more far-reaching than previously thought, „because even those whose job it is to inform about the probabilities of side effects overestimate them“, so the statement of the researchers. According to her, the definitions of terms according to the BfArM are not suitable for everyday use and should instead contain information such as „In one in 100 patients, this or that side effect occurs” respectively.

No revision of the frequency indication in sight
Compared to the „German Medical Journal“ said the press secretary of the Federal Institute for Drugs and Medical Devices Maik Pommer meanwhile: „We want to inform the consumers about all conceivable risks, to this one has agreed on the present form.” A revision is therefore apparently not considered, even if the current study, the results of previous investigations from the United Kingdom have been confirmed, which have already pointed to the weaknesses of such a frequency indication. (Fp)