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

Détails

ID Serval
serval:BIB_DBA70501F744
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Institution
Titre
French summaries of product characteristics: content in relation to therapeutic monitoring of psychotropic drugs.
Périodique
Fundamental & clinical pharmacology
Auteur⸱e⸱s
Rougemont M., Ulrich S., Hiemke C., Corruble E., Baumann P.
ISSN
1472-8206 (Electronic)
ISSN-L
0767-3981
Statut éditorial
Publié
Date de publication
06/2010
Peer-reviewed
Oui
Volume
24
Numéro
3
Pages
377-384
Langue
anglais
Notes
Publication types: Comparative Study ; Journal Article
Publication Status: ppublish
Résumé
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.

Mots-clé
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
Création de la notice
05/07/2010 15:30
Dernière modification de la notice
20/08/2019 17:00
Données d'usage