Off-Label Drug Use in Pediatric Practice: Unsolved Problems
The widespread «off-label» drug use and the prescribing of unlicensed medicines in pediatric practice is a major health problem. The authors discuss actual regulatory and legal issues of «off-label» drug use in children in the US, Europe and Russia. The results of different population-based studies...
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| Main Authors: | , , , |
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| Format: | Book |
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Union of pediatricians of Russia,
2015-10-01T00:00:00Z.
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| Online Access: | Connect to this object online. |
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| Summary: | The widespread «off-label» drug use and the prescribing of unlicensed medicines in pediatric practice is a major health problem. The authors discuss actual regulatory and legal issues of «off-label» drug use in children in the US, Europe and Russia. The results of different population-based studies from many countries, showing the structure and frequency of «off-label» drug use in children, are summarized in this article. It is shown that such practice increases the risk of adverse drug reactions. The authors offer practical recommendations for a safer use of drugs in pediatric practice. The priority issue is conducting high quality clinical trials with the participation of children, improving national pharmacovigilance and the monitoring of off-label drug use, developing pediatric formularies, improving doctors' knowledge and awareness of safety and efficacy of medicines in pediatric population. |
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| Item Description: | 1727-5776 2500-3089 10.15690/pf.v12i3.1355 |