Dipartimento di Radiologia, Policlinico Universitario, Catanzaro, Italy.
Radiol Med. 2011 Feb;116(1):1-14. doi: 10.1007/s11547-010-0601-5. Epub 2010 Oct 27.
This paper analyses off-label prescribing of the iodinated organic and magnetic resonance (MR) contrast media used in diagnostic imaging and evaluates the liability profiles and medicolegal issues associated with such use. The term off-label generally indicates the use of known drugs for which new scientific evidence suggests use in a manner and in clinical scenarios not explicitly addressed by the drug data sheet and is outside the indications for which the medication was approved. In addition, the term also indicates the use of drugs with a different route of administration and dosage from those indicated in the information leaflet. Intravascular contrast media used in diagnostic imaging are drugs in the complete sense of the term, even though they have unique characteristics which in many ways distinguish them from other pharmacological agents. The off-label use of contrast media in diagnostic imaging is a little-investigated field and most commonly, but not exclusively, applies to gadolinium-based contrast media used in MR angiography as well as cardiac and paediatric applications. In particular, the off-label use of contrast media mostly concerns deviations from the recommended dose. As contrast media are to all effects pharmaceutical agents, their off-label use can be considered admissible within the limitations laid down by the Italian law in force (Article 3 of Law 94/98) and its interpretation, i.e. the following criteria must be present: the lack of a valid diagnostic alternative; written informed consent by the patient; the presence of scientific publications validated at the international level; assumption of responsibility by the radiologist.
The use of contrast media in modern image-guided medicine is essential. In cases in which the information contained in the information leaflet is modified and updated in any way whatsoever (indications, dosage, at others), specifically if restrictions are introduced in accordance with the law in force, the pharmaceutical industry must provide formal and timely notification to radiologists. On their part as prescribers and users of contrast media, radiologists must remain up to date regarding any changes in indications, dosage and route of administration. Lastly, we propose that the radiology report includes not only the type but also the dose of contrast medium used.
本文分析了诊断成像中使用的碘有机和磁共振（MR）造影剂的标签外使用情况，并评估了与这种使用相关的责任状况和医学法律问题。“标签外”一词通常表示使用已知药物，这些药物的新科学证据表明其使用方式和临床情况不在药物数据表中明确解决，并且超出了药物批准的适应症。此外，该术语还表示使用与药物说明书中指示的给药途径和剂量不同的药物。诊断成像中使用的血管内造影剂是完全意义上的药物，尽管它们具有独特的特性，在许多方面将它们与其他药理制剂区分开来。造影剂在诊断成像中的标签外使用是一个研究较少的领域，最常见但不限于磁共振血管造影以及心脏和儿科应用中使用的基于钆的造影剂。特别是，造影剂的标签外使用主要涉及偏离推荐剂量。由于造影剂实际上是药物制剂，因此可以在意大利现行法律（94/98 号法第 3 条及其解释）规定的限制范围内考虑其标签外使用，即必须存在以下标准：缺乏有效的诊断替代方法；患者书面知情同意；具有国际水平验证的科学出版物；放射科医生承担责任。
在现代影像引导医学中，造影剂的使用至关重要。如果信息传单中的信息以任何方式修改和更新（适应症、剂量等），特别是如果根据现行法律引入限制，制药行业必须及时向放射科医生提供正式通知。作为造影剂的开处方者和使用者，放射科医生必须了解适应症、剂量和给药途径的任何变化。最后，我们建议放射科报告不仅包括使用的造影剂类型，还包括剂量。
