In the case of off-label use, a medicine is prescribed for an indication, age group or use for which the product is not registered. Health care providers may prescribe products off-label under certain conditions. The registered indications are available in the MEB Medicines Information Bank.
What is off-label use?
The MEB assesses the efficacy and risks of all medicines that are authorised in the Netherlands. The indication is awarded based on a positive balance between efficacy and risks. This indication is listed in the patient information leaflet and in the Summary of Product Characteristics (SmPC) for healthcare providers. In the case of off-label use, the patient receives a medicine that:
- is not indicated for that condition
- is not indicated for a specific administration method or dosage
- is not authorised for that group of patients
Companies have not (yet) applied for a marketing authorisation for off-label use. This means that the MEB has not assessed the risks and the efficacy of this treatment or method of administration. It may also be the case that an application for marketing authorisation has been submitted, but that the MEB has decided not to grant a marketing authorisation.
When is off-label use permitted?
Off-label use is permitted under the following legal conditions:
- You must always discuss the off-label use with the patient and the pharmacist in advance. In this discussion, you will explain the effect and the risks.
- The treatment method is recorded in a treatment guideline.
- An authorised treatment or authorised medicine is not available.
Do you as a doctor prescribe medicines that the pharmacist makes himself? Then this is always off-label use.
The conditions are described in more detail in the guideline about off-label use by the KNMG and the guideline about off-label use of the Zorginstituut Nederland.
Discuss off-label use with the patient
Do you want to prescribe a product off-label? Always discuss the following with the patient:
- why you think that this medicine is best for the patient
- why you think that it is best to use this product off-label
- what the risks are
- how you want the patient to use this medicine
- whether the medicine is suitable for the patient, for example if the patient belongs to a vulnerable group