Prescribing Drugs not in Accordance with the Official Instructions for Medical Use (Off-label), Clinical Guidelines, Standards of Medical Care and Legal Regulation in the Russian Federation. Part 2
Prescribing drugs not in accordance with the official instructions for medical use (off-label) has medical and legal aspects. From a medical point of view, such an appointment can be dictated by clinical urgency, when there is no alternative therapy, and on the other hand, doctors often prescribe of...
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| Format: | Article |
| Language: | English |
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Столичная издательская компания
2021-05-01
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| Series: | Рациональная фармакотерапия в кардиологии |
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| Online Access: | https://www.rpcardio.online/jour/article/view/2439 |
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| author | A. R. Navasardyan S. Yu. Martsevich P. G. Gabay |
| author_facet | A. R. Navasardyan S. Yu. Martsevich P. G. Gabay |
| author_sort | A. R. Navasardyan |
| collection | DOAJ |
| description | Prescribing drugs not in accordance with the official instructions for medical use (off-label) has medical and legal aspects. From a medical point of view, such an appointment can be dictated by clinical urgency, when there is no alternative therapy, and on the other hand, doctors often prescribe off-label drugs unknowingly, and also when there is another drug with registered indications. The article analyzes the regulations governing such appointments. The article describes possible inconsistencies between clinical guidelines and standards of medical care in this matter, the role of the medical commission, the impact on the quality and safety of medical care, as well as the types of legal liability of a medical worker that may arise when a drug is prescribed not according to instructions. |
| format | Article |
| id | doaj-art-b2b6fc309cea43c4af19f9cb11fb1b32 |
| institution | Kabale University |
| issn | 1819-6446 2225-3653 |
| language | English |
| publishDate | 2021-05-01 |
| publisher | Столичная издательская компания |
| record_format | Article |
| series | Рациональная фармакотерапия в кардиологии |
| spelling | doaj-art-b2b6fc309cea43c4af19f9cb11fb1b322025-08-23T10:00:33ZengСтоличная издательская компанияРациональная фармакотерапия в кардиологии1819-64462225-36532021-05-0117228629310.20996/1819-6446-2021-04-011878Prescribing Drugs not in Accordance with the Official Instructions for Medical Use (Off-label), Clinical Guidelines, Standards of Medical Care and Legal Regulation in the Russian Federation. Part 2A. R. Navasardyan0S. Yu. Martsevich1P. G. Gabay2Bayer JSCNational Medical Research Center for Therapy and Preventive MedicineFaculty of Medical Law, LLC; Federal Scientific and Clinical Center for Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of RussiaPrescribing drugs not in accordance with the official instructions for medical use (off-label) has medical and legal aspects. From a medical point of view, such an appointment can be dictated by clinical urgency, when there is no alternative therapy, and on the other hand, doctors often prescribe off-label drugs unknowingly, and also when there is another drug with registered indications. The article analyzes the regulations governing such appointments. The article describes possible inconsistencies between clinical guidelines and standards of medical care in this matter, the role of the medical commission, the impact on the quality and safety of medical care, as well as the types of legal liability of a medical worker that may arise when a drug is prescribed not according to instructions.https://www.rpcardio.online/jour/article/view/2439off-label prescription of drugsunregistered druglegal regulationclinical guidelinesquality of medical care |
| spellingShingle | A. R. Navasardyan S. Yu. Martsevich P. G. Gabay Prescribing Drugs not in Accordance with the Official Instructions for Medical Use (Off-label), Clinical Guidelines, Standards of Medical Care and Legal Regulation in the Russian Federation. Part 2 Рациональная фармакотерапия в кардиологии off-label prescription of drugs unregistered drug legal regulation clinical guidelines quality of medical care |
| title | Prescribing Drugs not in Accordance with the Official Instructions for Medical Use (Off-label), Clinical Guidelines, Standards of Medical Care and Legal Regulation in the Russian Federation. Part 2 |
| title_full | Prescribing Drugs not in Accordance with the Official Instructions for Medical Use (Off-label), Clinical Guidelines, Standards of Medical Care and Legal Regulation in the Russian Federation. Part 2 |
| title_fullStr | Prescribing Drugs not in Accordance with the Official Instructions for Medical Use (Off-label), Clinical Guidelines, Standards of Medical Care and Legal Regulation in the Russian Federation. Part 2 |
| title_full_unstemmed | Prescribing Drugs not in Accordance with the Official Instructions for Medical Use (Off-label), Clinical Guidelines, Standards of Medical Care and Legal Regulation in the Russian Federation. Part 2 |
| title_short | Prescribing Drugs not in Accordance with the Official Instructions for Medical Use (Off-label), Clinical Guidelines, Standards of Medical Care and Legal Regulation in the Russian Federation. Part 2 |
| title_sort | prescribing drugs not in accordance with the official instructions for medical use off label clinical guidelines standards of medical care and legal regulation in the russian federation part 2 |
| topic | off-label prescription of drugs unregistered drug legal regulation clinical guidelines quality of medical care |
| url | https://www.rpcardio.online/jour/article/view/2439 |
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