دورية أكاديمية
Use of unlicensed drugs and off-label drug use: focus on COVID-19
| العنوان: | Use of unlicensed drugs and off-label drug use: focus on COVID-19 |
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| المؤلفون: | S. A. Mishinova, A. A. Zhuravkov, V. K. Zhuravko |
| المصدر: | Качественная клиническая практика, Vol 0, Iss 4S, Pp 120-129 (2020) |
| بيانات النشر: | Izdatelstvo OKI, 2020. |
| سنة النشر: | 2020 |
| المجموعة: | LCC:Medical technology LCC:Pharmacy and materia medica |
| مصطلحات موضوعية: | off-label назначение, covid-19, расширенный доступ, нежелательные лекарственные реакции, клиническая фармакология, жизнеугрожающие заболевания, реальная клиническая практика, Medical technology, R855-855.5, Pharmacy and materia medica, RS1-441 |
| الوصف: | Introduction. In a crisis, like the COVID-19 outbreak, the strategy of experimental drug use in clinical practice increases the availability of potentially effective drugs that have not yet proven the opposite for patients with life-threatening diseases, despite the fact that such use is «off-label» for unregistered indications. The choice of drugs for «off-label» use is most difficult when a large potential benefit justifies higher risks, because the use of drugs for unapproved indications increases the frequency of adverse drug reactions and thereby reduces their clinical value. Goal. Clinical and pharmacological analysis of the «off-label» features of drug use for etiotropic and pathogenetic therapy of COVID-19, description of new opportunities for state registration of medicines in the fight against a new coronavirus infection. Materials and methods. From the Russian temporary guidelines for the treatment of COVID-19 were identified 14 international non-generic names (INN) of drugs. We analyzed the data obtained for the corresponding INN in the State register of medicines of the Ministry of health of the Russian Federation. Results. There is a widespread violation of the requirements of various sections of the current instructions for the medical use of the considered drugs, which requires additional analysis of real-word data. Conclusions. For this purpose, we can use thematic reports, patient registers, and active post-marketing pharmacovigilance. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | Russian |
| تدمد: | 2588-0519 2618-8473 |
| Relation: | https://www.clinvest.ru/jour/article/view/542; https://doaj.org/toc/2588-0519; https://doaj.org/toc/2618-8473 |
| DOI: | 10.37489/2588-0519-2020-S4-120-129 |
| URL الوصول: | https://doaj.org/article/2e28d4f3fcf94b8ebdc51bd2fb4d1ca2 |
| رقم الأكسشن: | edsdoj.2e28d4f3fcf94b8ebdc51bd2fb4d1ca2 |
| قاعدة البيانات: | Directory of Open Access Journals |
| تدمد: | 25880519 26188473 |
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| DOI: | 10.37489/2588-0519-2020-S4-120-129 |