A blueprint on good off-label use practice
Frédéric Destrebecq is Executive Director of the European Brain Council (EBC), platform for patients, health professionals, scientists & industry that promotes brain research in Europe with the aim of improved quality of life for patients. As part of that mission, he advocates for the need to implement a uniform approach for off-label prescription at European level. We had the opportunity to ask a few questions.
What is the definition of off-label prescription?
The definition of “off-label use” commonly agreed is the practice of using a medicine outside of its authorized indication. It plays an important part in some medical areas, since it can be of benefit to patients when no other treatment option is available, such as in the case of several brain disorders, such as rare neurological conditions or some psychiatric diseases.
Unlike “off-label medicines”, “on-label” medicines obtain an authorization and a label for their specific indication, before being placed on the market. This process ensures rigorous regulatory standards and procedures to scientifically demonstrate that the medicine is efficacious and of high quality but also reduces as much as possible risks to patient safety.
Patient safety and best possible treatment are the prescribing physicians primary responsibility. In what way would European uniformity regarding off-label prescriptions improve the patient’s situation?
Our campaign to promote good off-label use practices has highlighted that the use of medical products off-label is happening on a large scale across European countries and across medical disciplines. In many of these cases, this is done in light of a specific medical need under close supervision of the prescribing professional, and in the absence of licensed alternatives tolerated by the patient.
Increasingly in certain countries though, medical staff are being pressured in to using certain products off-label for economic reasons. This is a real source of concern since the basis for any medical treatment must remain the patients’ medical need.
What would be your recommendation to Sweden’s health care policy makers on how to handle off-label prescriptions?
Our virtual workshop on 24 November, featuring healthcare stakeholders from both Sweden and Norway, provided a clear sign that this issue is a source of concern for the wider community. The feedback we received during and after the event demonstrated a clear willingness, particularly from patients, to be better informed but also to engage in such debates. We also very clearly heard from doctors and specialists that pharmacovigilance systems in place needs to be strengthened and made more robust.
We trust that this will be considered by regulators and policymakers and that they will implement the necessary measures.
If you would have the mandate to take one decision that would be implemented across Europe – what would it be?
It would certainly involve adopting and implementing common guidelines. Albeit these may not be directly applicable to all Member States, they would at least provide guidance as to how we should address this issue, and ensure a certain level of coherence and curb fragmentation across countries. We believe the Declaration on Good Off-Label Use Practice provides an excellent blueprint that could be broadly adopted.
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