[Drugs and patient information. Writing of instructions].
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.
Auriche
M
M
Laboratoires Hoechst, France.
Courtand
M
M
Danan
G
G
Elmalem
J
J
Loupi
E
E
Vaissere
J
J
D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D005062:European Union; D005602:France; D006801:Humans; D007880:Legislation, Drug; D010353:Patient Education as Topic
Médicaments et information aux patients. Rédaction des notices.