Off-label voorschrijven: medisch handelen en motieven van huisartsen

Huisarts en Wetenschap, jaargang 2007, nummer 5:193-197


Jochemsen HM, Gijsen R, Caspers PWJ. Off-label prescribing: medical practice and motives of general practitioners. Huisarts Wet 2007;50(5):193-7. Background Prescribing medication for an indication or indications other than those listed on the manufacturer’s label (off-label prescribing) can often be considered acceptable or even desirable. Prescribing drugs without a scientific basis can, however, sometimes increase the risks of side-effects for patients and lead to unnecessary healthcare costs. It is not known how general practitioners (GPs) behave as regards off-label prescribing. Aim We examined the off-label awareness of GPs, their motives for prescribing off-label, and their behaviour when prescribing off-label. In addition we investigated the need for instruments that can increase GPs’ awareness about off-label prescribing. Methods A questionnaire was sent to 800 GPs in the Netherlands. We asked them to respond with regard to actual cases and to judge their own medical behaviour with respect to off-label prescribing. Results There were 464 respondents to the questionnaire plus 13 uncompleted questionnaires returned by individuals no longer working as GPs (response rate: 59%). The results showed that 100% of all GPs prescribe off-label, the most frequently reported motive being that the effectiveness of the medication in question was described in medical guidelines, guidebooks, and/or scientific literature. However, motives based on a tendency to experiment did also occur. Almost half of the GPs indicated that they regularly do not know whether a prescription is approved for a specific indication. If they are aware of this, they do not always inform their patients (27% seldom or never). Half of the GPs seldom or never ask for informed consent. Personal evaluation of the off-label prescriptions is limited and sharing information with colleagues is very uncommon. The GPs agreed on the instruments we proposed: information in their electronic prescription system, counselling sessions for local groups of GPs and pharmacists about off-label prescribing and a countrywide registration system to collect individual experiences of GPs systematically. Conclusions The most frequently reported motives for off-label prescribing are considered to be in accordance with the opinions of the government and the scientific organisation of GPs. The motive that the effectiveness is described in medical guidelines is also in accordance with forthcoming legislation. Nevertheless, shortcomings were revealed in several fields of medical performance. The development of new instruments would make it easier for GPs to prescribe in a more aware fashion and would help increase the knowledge about off-label prescriptions.