French summaries of product characteristics: content in relation to therapeutic monitoring of psychotropic drugs.

Details

Serval ID
serval:BIB_DBA70501F744
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
French summaries of product characteristics: content in relation to therapeutic monitoring of psychotropic drugs.
Journal
Fundamental & clinical pharmacology
Author(s)
Rougemont M., Ulrich S., Hiemke C., Corruble E., Baumann P.
ISSN
1472-8206 (Electronic)
ISSN-L
0767-3981
Publication state
Published
Issued date
06/2010
Peer-reviewed
Oui
Volume
24
Number
3
Pages
377-384
Language
english
Notes
Publication types: Comparative Study ; Journal Article
Publication Status: ppublish
Abstract
The prescription information (summary of product characteristics, SPC) is compiled by the pharmaceutical industry as required by the national regulatory authorities. They vary in their content about the properties of drugs and about the usefulness of therapeutic drug monitoring (TDM) in the blood of patients. Based on a previous study carried out in Germany, the degree of agreement of French SPC for 59 psychotropic drugs with the existing medico-scientific evidence in the area of TDM was examined using a recently developed instrument. A summary score of SPC content (SPCC) related to TDM (SPCC(TDM)) has been calculated and compared with the level of recommendation of TDM of the AGNP-TDM expert group consensus guidelines for TDM in psychiatry [AGNP: Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (Association for neuropsychopharmacology and pharmacopsychiatry)]. Among the antidepressants, antipsychotics, tranquillizers/hypnotic agents and mood stabilizers, the highest SPCC(TDM) scores in the French SPC were reached for imipramine (16), haloperidol (6), clonazepam (8) and lithium (23), respectively. Results were similar to those obtained from the analysis of German SPC, and considerable disagreement was found between the information on TDM in SPC and existing medico-scientific evidence, albeit less in the case of mood stabilizers. Taking into account the recommendations of the AGNP-TDM expert group guidelines, there is a deficit in the French SPC concerning TDM-relevant information. An amelioration of this situation could help to improve the clinical practice of TDM of psychotropic drugs, as the SPC is a widely used tool.

Keywords
Drug Labeling/methods, Drug Labeling/standards, Drug Monitoring/methods, Drug Monitoring/standards, France, Humans, Mental Disorders/drug therapy, Mental Disorders/psychology, Practice Guidelines as Topic/standards, Psychotropic Drugs/standards, Psychotropic Drugs/therapeutic use
Pubmed
Web of science
Create date
05/07/2010 15:30
Last modification date
20/08/2019 17:00
Usage data