Related Experiment Videos
[Administration of MR contrast agents outside of approved indications (off-label use]
M V Knopp1, M Lodemann, U Kage
1Forschungsschwerpunkt Radiologische Diagnostik und Therapie, Deutsches Krebsforschungszentrum (dkfz), Im Neuenheimer Feld 280, 69120 Heidelberg. M.Knopp@dkfz.de
Purpose:
The use of MRI contrast agents outside their labeled indications is routine in radiology. However, physicians feel frequently at unease. It is the aim of this paper to introduce the medical, juridicial and billing relevant issues in order to improve the knowledge on this topic.
Methods:
The basis for off-label use is the physician's prerogative, which finds its basis in the "declaration of Helsinki".
Results:
Off-label use is allowed under special conditions and might be even the medical state of the art.
Conclusion:
The necessity for off-label use will continue to increase for MR-contrast agents, as clinical trials for registration purpose are quite costly and manufactures continuously will concentrate on the essential indications.
Insights
Off-label use of MRI contrast agents is common but raises concerns. This paper clarifies the medical, legal, and billing aspects to enhance physician understanding and confidence in these crucial procedures.
Area of Science:
- Radiology
- Medical Imaging
Context:
- Off-label use of MRI contrast agents is a routine practice in radiology.
- Physicians often experience unease regarding these uses.
Purpose:
- To address the medical, juridicial, and billing issues associated with off-label MRI contrast agent use.
- To improve physician knowledge and reduce apprehension.
Summary:
- Off-label use is permissible under specific conditions and can represent the current medical standard.
- Physician prerogative, rooted in the Declaration of Helsinki, forms the basis for off-label utilization.
Impact:
- The demand for off-label MRI contrast agent applications is expected to grow.
- High costs of clinical trials for registration encourage manufacturers to focus on essential indications.