title: Off-label prescriptions: how to identify them, frame them, announce them and monitor them in practice?
abstract: Following the Mediator crisis and the passage of the Health and Safety Law of December 2011, off-label prescriptions are a real concern shared by all those involved in healthcare system. Off-label, in the strictest sense of the term, is defined as all prescriptions that do not correspond to the summary of product characteristics (SPC), particularly those that fail to comply with the indications and dosage regimens defined by the marketing authorization (MA) for clear safety reasons. There are various rasons for off-label prescriptions, both conscious and unconscious. They are intended to respond to unmet medical needs, the needs of poorly studied populations or not studied at all in trials, but in relation to whom it is reasonable to extrapolate that MA would be given (common-sense prescriptions) and, additionally, to urgent public health needs (such as baclofen, pregnant women, and HIV drugs). All these prescriptions would deserve to be studied for a potential MA. However, there are off-label prescriptions that need to be restricted or even penalized in the case of compassionate prescriptions or unjustified prescriptions or prescriptions not based on any scientific grounds. Off-label prescriptions are not easy to track down because if the prescriber has to write "off-label" on his prescription, then clearly, in practice, he will only do so in exceptional cases. Neither the pharmacists who dispense the drug nor the Social Security that reimburses it, have access to the diagnosis (or targeted indication). Thus, in order to identify the off-label prescription, we must be able to cross reference the available databases (such as pharmacovigilance database, medicalized information system program [programme de médicalisation des systèmes d'information, PMSI], hospital drug formularies, general sample of beneficiaries [échantillon généraliste de bénéficiaires, EGB] or national inter-regional Health Insurance Information System [système national d'informations inter-régions d'Assurance maladie, SNIIRAM], sales data, and data from market surveys). The shared computerized patient file may resolve this problem. The temporary use recommendation (TUR) proposed by the Drug Safety Law will only partially deal with this problem for recently marketed molecules. This temporary and exceptional mechanism will authorize a recognized off-label prescription, which may be reimbursed and monitored for 3 years. These TURs will only concern a small portion of "off-label" drugs having yet a positive risk/benefit ratio (conditional MA) but this is far from matching with majority of off-label prescriptions. As such, and in order to improve the use of drugs, it is important to propose a control system for all "off-label" prescriptions with a dedicated committee: the "off-label" committee which would determine the frame of the "off-label" prescriptions.
authors: Service de Médecine interne, Assitance Publique - Hôpitaux de Paris, Hôtel Dieu, Paris, France.
authors: Claire
authors: C
authors: Le Jeunne
authors: Nathalie
authors: N
authors: Billon
authors: Anne
authors: A
authors: Dandon
authors: Driss
authors: D
authors: Berdaï
authors: Yolande
authors: Y
authors: Adgibi
authors: Jean-François
authors: JF
authors: Bergmann
authors: Régis
authors: R
authors: Bordet
authors: Anne
authors: A
authors: Carpentier
authors: Emmanuelle
authors: E
authors: Cohn
authors: Soizic
authors: S
authors: Courcier
authors: Danièle
authors: D
authors: Girault
authors: Sylvia
authors: S
authors: Goni
authors: Pascale
authors: P
authors: Jolliet
authors: François
authors: F
authors: Liard
authors: Sonia
authors: S
authors: Prot-Labarthe
authors: Tabassome
authors: T
authors: Simon
authors: Christine
authors: C
authors: Vernotte
authors: Jérémie
authors: J
authors: Westerloppe
mesh_terms: D004348:Drug Labeling / Q000379:methods / Q000592:standards; D016903:Drug Monitoring / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D011307:Drug Prescriptions / Q000592:standards / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D056687:Off-Label Use / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians' / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D011247:Pregnancy