title: [Developing a terminology in the French language for clinical practice and research in drug safety].
abstract: While several attempts have been made to clarify the English terminology of drug-related iatrogeny, a consensus has still not been reached in the French language. We set up a multidisciplinary task force to propose a terminology that differs from the one used in pharmacovigilance and risk management. We prefer the term "adverse drug event" (ADE) over "adverse drug reaction", and recommend avoiding the term "adverse event", which is too general. We propose to classify ADEs as "direct drug effect" or "drug involvement in a multifactorial pathological condition", taking into account the close relationship commonly found between drug and non-drug etiologies of a pathology. The consistent association between the notions "error" and "preventability" is also questionable, and we suggest assessing the "ameliorability" of ADEs rather than their "preventability". "Misuse" (i.e., the non-respect by the patient of the drug label) must be distinguished from "off-label use or substance abuse".
authors.affiliation: Service de pharmacie, Hôpital du Valais, Sion, Suisse.
authors.forename: Lucien
authors.initials: L
authors.lastname: Roulet
authors.affiliation: Medqual, CHU de Nantes, Nantes, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Ballereau
authors.affiliation: Service de pharmacologie clinique, CHU de Toulouse, Toulouse, France.
authors.forename: Maryse
authors.initials: M
authors.lastname: Lapeyre-Mestre
authors.affiliation: Service de médecine intensive, Hôpital du Valais, Sion, Suisse.
authors.forename: Muriel
authors.initials: M
authors.lastname: Joris-Frasseren
authors.affiliation: Service des maladies infectieuses et tropicales, CHU de Nantes, Nantes, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Asseray
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification*; D006801:Humans; D007049:Iatrogenic Disease; D007802:Language; D008508:Medication Errors / Q000145:classification; D056687:Off-Label Use; D060735:Pharmacovigilance; D012308:Risk Management; D009626:Terminology as Topic