Current issues related to the off-label use of drugs and their potential solutions
https://doi.org/10.37489/2782-3784-myrwd-48
EDN: APSBCT
Abstract
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.
About the Authors
K. S. Radaeva
First St. Petersburg State Medical University, named after I. P. Pavlov
Russian Federation
Russian Federation
Kseniia S. Radaeva — Resident of the Department of Clinical Pharmacology and Evidence-Based Medicine
St. Petersburg
S. A. Mishinova
First St. Petersburg State Medical University, named after I. P. Pavlov
Russian Federation
Russian Federation
Sofya A. Mishinova — Assistant of the Department of Clinical Pharmacology and Evidence-Based Medicine
St. Petersburg
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For citations:
Radaeva K.S., Mishinova S.A. Current issues related to the off-label use of drugs and their potential solutions. Real-World Data & Evidence. 2024;4(1):24-31. (In Russ.) https://doi.org/10.37489/2782-3784-myrwd-48. EDN: APSBCT
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