THE HEALTHCARE SYSTEM IN GERMANY: COMPREHENSIBLE PACKAGE INSERTS TO COME SOON?
FRANKFURT and MAIN, Germany, March 29 /PRNewswire/ -- "Instructions for the elaboration of package inserts"(A) are to make essential drug information more comprehensible to patients. The instructions worked out by the Association of the German Pharmaceutical Industry (BPI) and the German Federal Health Agency (BGA) are now available. They take into account new requirements on patient information as laid down in EC directives. These requirements have to be incorporated in the German Drug Law (AMG). BPI hopes that this will be done soon so that current package inserts can be replaced by a new and generally more understandable form. The instructions contain several patient-friendlyo?rdings. BPI highly values a straightforward structure, the absence of technical terms as well as short and unequivocal phrases, giving clear instructions to patients. In order to directly address patients, headings are to be kept in a simple style and expressed in the form of questions. Furthermore, every point is again explained separately in a standard text. Examples: -- Interactions: What other medicinal products influence the effect of /../?... Please note that this information may also be relevant to medicinal products administered some time ago. -- Contraindicactions: When should /../ not be administered? Please seek medical advice whether you may administer /../ if the following information is not applicable to you at present but was applicable at any time in the past. -- Side effects: What side effects can occur in the administration of /../... Side effects are classified using the criteria of frequency and seriousness... The estimated frequency is currently broken down as follows: Frequent (more than 10 percent approx.), occasional (1 percent to 10 percent approx.), rare (less than 1 percent approx.) and isolated cases. (A) German: "Anleitung zur Gestaltung von Packungsbeilagen" -0- 3/29/93 /CONTACT: Elke Peters for BPI, in Frankfurt, 69-2556-1220/
CO: Association of the German Pharmaceutical Industry ST: IN: HEA SU:
LR -- NY029 -- 0410 03/29/93 10:21 EST
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|Date:||Mar 29, 1993|
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