3. Off-label use
1. Off-label use
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In some regions, for example in the US, the Summary of Product Characteristics (SmPC) is called ‘label’, therefore the term ‘off-label’. There is no definition on the term ‘off-label use’ of medicines in the EU legislation, but off-label use is commonly understood as the use of a medicine outside the terms of its marketing authorisation (MA), i.e., not in accordance with the approved Summary of Product Characteristics (SmPC).
The reference terms for off-label use thus are the terms of marketing authorisation in the country where the product is used.
Examples for off-label use are:
- using a different dosage regimen (a different dosage, frequency, route or method of administration),
- use for an indication (in terms of medical condition) other than that listed in the SmPC,
- use in a group of patients for which it has not been authorised, such as a certain age group like children (paediatric use),
- use despite a contraindication, i.e. a specific situation where the medicine should not be given for safety reasons.
The so-called ‘irrational prescription and use of medicines’ could also to a certain degree be considered off-label use. Examples are:
- the use of too many medicines per patient (polypharmacy), not considering possible interactions between different medicines as per SmPC
- the inappropriate use of antibiotics for non-bacterial infections,
- the failure to prescribe in accordance with the best evidence-based clinical guidelines, and
- inappropriate self-medication
While not optimal, off-label prescribing may remain essential to address unmet medical needs of patients. However, the manner in which countries deal with the off-label use of medicines is not harmonised across the EU as shown in the next section.