National Medical Research Centre for Therapy and Preventive Medicine, Moscow.
Kardiologiia. 2021 May 31;61(5):41-50. doi: 10.18087/cardio.2021.5.n1510.
Aim To evaluate the frequency of off-label prescription of medicines in practice of clinical specialists and the awareness of respondents of the procedure of justified off-label prescription.Material and methods The sample included 542 clinical specialists who worked in definite medical organizations in 26 entities of the Russian Federation. The respondents were proposed to fill in remotely an anonymous questionnaire to evaluate the experience of prescribing medicines off-label to adult patients.Results Prescribing medicines not in consistence with the officially approved instruction for medical use (off-label or "outside instruction") is a relevant issue of global medical care since convincing scientific evidence for safety of such use is scarce. Analysis of information about off-label prescription is one of current tasks of national medical research centers according to the Federal Project "Development of a network of national medical research centers and implementation of innovative medical technologies". According to the responses about the frequency of off-label prescriptions 67.5 % of respondents reported of no experience of off-label prescription, 27.7 % said "rarely" or "sometimes", and 4.8 % said "frequently" and "very frequently". Specialties of physicians who have more often used medicines off-label (50% and more) included obstetrics and gynecology, pediatrics, rheumatology, hematology, and pulmonology. Cardiologists, neurologists and clinical pharmacologists use medicines off-label relatively rarely (19.6%, 28.6 %, and 22.2 %, respectively). 40 % of medicines used off-label were those designed for the treatment of coronavirus infection SARS-CoV-2. The medicines most frequently used off-label included metformin, rituximab, and thioctic acid. 65 % of respondents assessed their knowledge of off-label prescription as insufficient. In addition, 75 % of respondents consider it useful to receive additional information about risks and benefits of off-label prescription in clinical practice.Conclusion The survey revealed the need of physicians for information about risks of the off-label use of medicines in clinical practice.
目的 评估临床专家实践中药品标签外使用的频率以及受访者对合理标签外处方程序的认识。
材料与方法 样本包括来自俄罗斯联邦 26 个实体的 542 名临床专家，他们在特定医疗机构工作。向受访者提出远程填写匿名问卷，评估为成年患者标签外开处方的经验。
结果 不按照药品正式批准的使用说明（标签外或“超说明书”）使用药品是全球医疗保健的一个重要问题，因为此类用途的安全性缺乏令人信服的科学证据。根据《发展国家医学研究中心网络和实施创新医疗技术联邦项目》，分析标签外处方信息是国家医学研究中心的当前任务之一。根据关于标签外处方频率的答复，67.5%的受访者表示没有标签外处方经验，27.7%表示“很少”或“有时”，4.8%表示“经常”和“非常频繁”。更经常标签外使用药品的医生专业包括妇产科、儿科、风湿病学、血液学和肺病学。心脏病学家、神经病学家和临床药理学家相对较少标签外使用药品（分别为 19.6%、28.6%和 22.2%）。40%标签外使用的药品是用于治疗冠状病毒感染 SARS-CoV-2 的药品。最常标签外使用的药品包括二甲双胍、利妥昔单抗和硫辛酸。65%的受访者认为自己对标签外处方的了解不足。此外，75%的受访者认为在临床实践中获得关于标签外处方风险和益处的额外信息是有用的。
结论 调查显示，医生需要了解标签外使用药品在临床实践中的风险信息。
