Uncertainty due to package insert

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Package inserts unsettle the patients

The information leaflet for the medicinal products leads to uncertainty among the patients rather than being perceived as helpful information, according to the results of a current survey by
Federal Association of German Pharmacists' Associations (ABDA).

The Federal Association of German Pharmacists' Associations (ABDA) asked 3,300 German citizens about their experiences with the information leaflet and found that the majority of them found the explanations too complicated and detailed. In addition, the described side effects frighten many respondents and lead to patient uncertainty, according to the result of the ABDA survey.

One in two is unsettled by the package leaflet In the current survey, 58 percent of the 3,300 respondents indicated that they find the package leaflet of the medicines too complicated and detailed. In addition, the information is often incomprehensible and difficult to read due to the particularly small print format, according to the assessment of every second study participant. In addition, 37 percent of the test subjects stated that the package insert frightened them. Among the study participants over the age of 65, 49 percent of those questioned felt scared by the package insert. ABDA Vice President Friedemann Schmidt therefore explained that in the event of possible uncertainties caused by "the long list of possible side effects", those affected should definitely "speak to a doctor or pharmacist". The side effects described are often frightening for the patients, but according to the experts, possible imponderables can be discussed in a counseling interview much more precisely than on a package insert in the small print. In any case, a consultation is "better than not taking medication or stopping treatment prematurely," warned the ABDA Vice President.

Information on the side effects is often confusing According to Friedemann Schmidt, the criticism of the patients is also due to the fact that the manufacturers must state all known side effects, including their frequency. However, the information on the patient information leaflets, such as "frequently" or "occasionally", would differ from general language use, so that this could already lead to confusion among the patients. Because the statement “frequently” means according to the ABDA vice president with regard to side effects that out of a hundred patients at most nine developed corresponding symptoms. Side effects that are given as "rare" can only be seen in one out of a thousand users, explains Schmidt. As the problem is well known to medical professionals and pharmacists, the ABDA and the National Association of Statutory Health Insurance Physicians (KBV) presented a comprehensive concept for the future in spring 2011, with the aim of reducing patient uncertainty and improving drug therapy safety (AMTS). As a possible measure, it is suggested, among other things, that doctors should not determine the drugs directly in the future, but only active ingredients and the general conditions for their use (amount, dosage form). The pharmacists would then choose the right preparations for the patient. (fp)

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Photo credit: Jens Goetzke / pixelio.de

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