Off-Label Prescribing in Paediatric Cardiology: Regulatory Aspects and Safety Assessment by Spontaneous Reporting

• Main Authors: E. O. Kochkina (Author), N. V. Verlan (Author), G. N. Kovalskaya (Author), T. V. Tolstikova (Author)
• Format: Book
• Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2023-03-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

In paediatrics, it is a common practice to use pharmaceuticals outside the approved Summary of Product Characteristics (i.e. off-label). According to the literature, up to 45% of inpatient paediatric prescriptions and 10-20% of outpatient ones are for off-label uses. It is essential to analyse such...