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[Drugs and patient information. Writing of instructions]
M Auriche1, M Courtand, G Danan
1Laboratoires Hoechst, France.
Abstract:
The main accusation against package inserts is that they are not understood by the patients: the vocabulary used is uncommon and the information is not always relevant. A recent European directive on package inserts for drugs concerning human use specifies the items that must be mentioned. Following this directive and regarding patient interest, a presentation for notices is proposed in which the subject headings are presented as questions and the text is a guide to drug practical use to provide the elements of surveillance. A summarized version added to this detailed notice for the convenience of the patient is also proposed, which should be translated into the language of each European Community's member state.