title: French summaries of product characteristics: content in relation to therapeutic monitoring of psychotropic drugs.
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.
authors.affiliation: Department of Psychiatry, Bicêtre Hospital, Assistance Publique - Hôpitaux de Paris, 78 rue du Général Leclerc, 94275 Le Kremlin Bicêtre, France. mrougemont@hotmail.com
authors.forename: Michael
authors.initials: M
authors.lastname: Rougemont
authors.forename: Sven
authors.initials: S
authors.lastname: Ulrich
authors.forename: Christoph
authors.initials: C
authors.lastname: Hiemke
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Corruble
authors.forename: Pierre
authors.initials: P
authors.lastname: Baumann
mesh_terms: D004348:Drug Labeling / Q000379:methods / Q000592:standards*; D016903:Drug Monitoring / Q000379:methods / Q000592:standards*; D005602:France; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy / Q000523:psychology; D017410:Practice Guidelines as Topic / Q000592:standards; D011619:Psychotropic Drugs / Q000592:standards* / Q000627:therapeutic use*
chemical_list: D011619:Psychotropic Drugs