off-label-use

'The Medicines Evaluation Board (MEB) and Dutch Health Care Inspectorate (IGZ) realise that in isolated cases physicians prescribe medicinal products "off-label". The MEB and IGZ do not object to the off-label prescription of medicinal products so long as this takes place in a responsible manner. Off-label use means the prescription of a medicinal product for an indication for which the product is not registered. However, if a physician cannot justify the off-label prescription of a medicinal product then MEB and IGZ disapprove of this. Off-label use can therefore be applied correctly or incorrectly.

Correct off-label use is the prescription of a medicinal product for an indication for which scientific evidence already exists, but that has not (yet) been assessed by MEB. Some uses of a medicinal product are not stated in the summary of product characteristics and package leaflet, as these had not yet been (fully) investigated when the application was submitted to MEB. Study data for these indications are therefore not included in the authorisation file at that time. The MEB cannot yet approve these indications and they cannot be stated in the summary of product characteristics and package leaflet. There may sometimes be signs that medicinal products are also useful for unauthorised indications. Information about this would then have been published in scientific literature. Sometimes a physician is obliged to prescribe a medicinal product off-label, as no other alternative is available for some patients. The physician must decide to prescribe a medicinal product off-label if this is the best possible treatment for the patient concerned. However, the physician must inform the patient that it concerns an off-label medicinal product and explain the pros and cons of the treatment.

Incorrect off-label use is the prescription of a medicinal product outside of the approved indication and for which there is no medical or scientific evidence. Another example of incorrect use is the failure to inform the patient adequately if an off-label medicinal product is prescribed.

MEB and IGZ provide as much information as possible to medical professionals about possible off-label uses of medicinal products. This information is provided and kept up-to-date, so that professionals know when off-label use is no longer applicable to certain medicinal products. For instance, when a manufacturer has requested authorisation for a particular indication, but this indication was refused by the MEB, because the health risks outweighed the benefits. This indication is then not listed in the summary of product characteristics, but doctors may continue off-label use of the medicinal product, because the scientific literature was initially favourable. MEB and IGZ also collect information about the adverse affects of medicinal products, equally in the case of off-label use, so that prescribers can take these into account. IGZ inspects the professional practice and care provided by physicians. If incorrect off-label use is detected, the physician will be spoken to about this and, if necessary, disciplinary measures will be taken.'