Current issues related to the off-label use of drugs and their potential solutions
Relevance. Off-label use of medications is a common practice in clinical settings. To address the growing interest in this issue, the International Society for Pharmacoepidemiology (ISPE) has developed new general guidelines for off-label prescribing in clinical practice that emphasize the importanc...
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| Format: | Article |
| Language: | Russian |
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Publishing House OKI
2024-04-01
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| Series: | Реальная клиническая практика: данные и доказательства |
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| Online Access: | https://www.myrwd.ru/jour/article/view/62 |
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| _version_ | 1849697473133543424 |
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| author | K. S. Radaeva S. A. Mishinova |
| author_facet | K. S. Radaeva S. A. Mishinova |
| author_sort | K. S. Radaeva |
| collection | DOAJ |
| description | Relevance. Off-label use of medications is a common practice in clinical settings. To address the growing interest in this issue, the International Society for Pharmacoepidemiology (ISPE) has developed new general guidelines for off-label prescribing in clinical practice that emphasize the importance of evidence-based medicine and promote transparent communication between healthcare professionals and patients.Objective. The aim of this work was to analyze and present key trends for optimizing off-label prescribing decisions based on the ISPE recommendations (2023).Results. The report highlights five main recommendations: seeking strong scientific evidence, including the use of real-world data; using expert knowledge to evaluate and summarize evidence; developing recommendations with rigorous consistency; aligning the use of off-label medications with research; and strengthening collaboration among regulators, researchers, clinicians, and the pharmaceutical industry.Conclusions. A comprehensive approach is required to address the problem of off-label use of medicines. Implementation of these initiatives will reduce the risks associated with off-label use, generate sustainable scientific evidence, and improve the quality of patient care. |
| format | Article |
| id | doaj-art-cf08ea81063a42a7b35ce8009962124e |
| institution | DOAJ |
| issn | 2782-3784 |
| language | Russian |
| publishDate | 2024-04-01 |
| publisher | Publishing House OKI |
| record_format | Article |
| series | Реальная клиническая практика: данные и доказательства |
| spelling | doaj-art-cf08ea81063a42a7b35ce8009962124e2025-08-20T03:19:12ZrusPublishing House OKIРеальная клиническая практика: данные и доказательства2782-37842024-04-0141243110.37489/2782-3784-myrwd-4852Current issues related to the off-label use of drugs and their potential solutionsK. S. Radaeva0S. A. Mishinova1First St. Petersburg State Medical University, named after I. P. PavlovFirst St. Petersburg State Medical University, named after I. P. PavlovRelevance. Off-label use of medications is a common practice in clinical settings. To address the growing interest in this issue, the International Society for Pharmacoepidemiology (ISPE) has developed new general guidelines for off-label prescribing in clinical practice that emphasize the importance of evidence-based medicine and promote transparent communication between healthcare professionals and patients.Objective. The aim of this work was to analyze and present key trends for optimizing off-label prescribing decisions based on the ISPE recommendations (2023).Results. The report highlights five main recommendations: seeking strong scientific evidence, including the use of real-world data; using expert knowledge to evaluate and summarize evidence; developing recommendations with rigorous consistency; aligning the use of off-label medications with research; and strengthening collaboration among regulators, researchers, clinicians, and the pharmaceutical industry.Conclusions. A comprehensive approach is required to address the problem of off-label use of medicines. Implementation of these initiatives will reduce the risks associated with off-label use, generate sustainable scientific evidence, and improve the quality of patient care.https://www.myrwd.ru/jour/article/view/62off-label drug usedecision makingrecommendationsreal-world datarwdclinical pharmacologyadverse drug reactions |
| spellingShingle | K. S. Radaeva S. A. Mishinova Current issues related to the off-label use of drugs and their potential solutions Реальная клиническая практика: данные и доказательства off-label drug use decision making recommendations real-world data rwd clinical pharmacology adverse drug reactions |
| title | Current issues related to the off-label use of drugs and their potential solutions |
| title_full | Current issues related to the off-label use of drugs and their potential solutions |
| title_fullStr | Current issues related to the off-label use of drugs and their potential solutions |
| title_full_unstemmed | Current issues related to the off-label use of drugs and their potential solutions |
| title_short | Current issues related to the off-label use of drugs and their potential solutions |
| title_sort | current issues related to the off label use of drugs and their potential solutions |
| topic | off-label drug use decision making recommendations real-world data rwd clinical pharmacology adverse drug reactions |
| url | https://www.myrwd.ru/jour/article/view/62 |
| work_keys_str_mv | AT ksradaeva currentissuesrelatedtotheofflabeluseofdrugsandtheirpotentialsolutions AT samishinova currentissuesrelatedtotheofflabeluseofdrugsandtheirpotentialsolutions |