PROMOTING GOOD PRACTICE

 

FOR THE OFF-LABEL

 

USE OF MEDICINES:

A harmonised European approach to prioritise patient safety


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Before being placed on the market, medicines obtain an authorisation and a label for the indication for which they are tested. This testing follows very rigorous regulatory standards and procedures to scientifically demonstrate that the medicine is efficacious and of high quality but also minimises as much as possible risks to patient safety.

Off-label use is the practice of using a medicine outside its authorised 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 it is often the case in rare diseases or in the case of child and adolescent care.



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WHAT IS GOOD PRACTICE?

We believe that off-label use of medicinal products should only occur if the following criteria are met:

  • Presence of a medical therapeutic need based on a current examination of the patient by a suitably qualified health care professional;
  • Absence of authorised treatment and licensed alternatives tolerated by the patient or repeated treatment failure;
  • A documented review and critical appraisal of available scientific evidence favours off-label use to respond to the unmet medical need of the individual patient
  • Patients (or their legal representative) must be given sufficient information about the medicines that are prescribed to allow them to make an informed decision; 
  • Presence of established reporting routes for outcomes and adverse events linked to off-label use.

These criteria, drawn together by an independent expert, stem from decades of research and clinical practice and serve to provide a clear framework on when and how the off-label use of medicinal products could safely take place.


They do not aim to limit off-label use, but seek to promote a harmonised approach for its occurrence in order to maintain the highest levels of patient safety and minimise adverse events.


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    I agree to receive EBC communications on GOLUP and other activities and allow EBC to store and process my data.

    You are entitled to withdraw your consent at any time by contacting EBC at privacy@braincouncil.eu.
    For further information, please read our data privacy policy.

    We thus call on the European Medicines Agency and other national regulatory bodies to adopt strict guidelines to support healthcare practioners to take their decision on the basis of the medical need of their patients and ensure economic benefit does not prevail over public health.

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    The Declaration on Good Off-Label Use Practices is open to any national and European organisation which supports its principles and objectives.

    Download the declaration

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    We are interested in knowing your experience with off-label use. If you are interested in sharing it,




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    WHAT IS GOOD PRACTICE?

    The signatories of this declaration believe that off-label use of medicinal products should only occur if the following criteria are met:

    • Presence of a severe, life-impairing  or life-threatening condition;
    • Absence of authorised treatment  or repeated treatment failure;
    • Absence of alternative treatments authorised for the condition;
    • The off-label use is supported by strong evidence  in scientific literature;
    • The patient has been educated and has given his  or her informed consent;
    • Presence of established reporting routes for  adverse events and linked to off-label use.

    These criteria, independently identified by Professor Marc Dooms, stem from decades of research and clinical practice and serve to provide a clear framework on when and how the off-label use of medicinal products could safely take place.


    They do not purport to limit the off-label use, but intend to provide a harmonised approach for its occurrence in order to maintain the highest levels of patient safety and minimise any adverse events.


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    The Declaration on Good Off-Label Use Practices is open to any national and European organisation which supports its principles and objectives. Current signatories include: 

     

    We thus call on the European Medicines Agency to adopt strict guidelines to support healthcare practioners to take their decision on the basis of the medical need of their patients and ensure economic benefit does not prevail over public health.