Off-label prescribing in pediatrics
Authors:
P. Langerová; K. Urbánek
Authors place of work:
Ústav farmakologie LF UP a FN, Olomouc
přednosta prof. RNDr. P. Anzenbacher, DrSc.
Published in the journal:
Čes-slov Pediat 2011; 66 (6): 380-386.
Category:
Review
Summary
In daily practice it is difficult to find drugs licensed for use in children, therefore many drugs are prescribed in doses or routes of administration and for conditions not approved in the marketing authorization. About 70% of drugs prescribed to the pediatric population are prescribed off-label or unlicensed. It is important to stress the fact that off-label is not synonymous with incorrect. The quality of drug therapy is not necessarily related to drug license status. On the other hand, the risk of adverse drug reactions is 3.6-fold higher in children and adolescents receiving off-label drugs in the hospital setting and 2-fold higher in the outpatient setting. Recent studies also show a relationship between off-label and unlicensed drug prescribing and the age. The younger the child, the more likely he/she is to get an off-label or unlicensed drug prescription. This is typical mainly for the hospital care. In outpatient setting, there is a higher rate of prescription of these drugs in adolescents. There is only a slight difference between countries where studies were done.
The drugs most commonly used off-label or unlicensed are cardiovascular drugs. To avoid exposing children to unnecessary risks and to avoid depriving them of potentially effective pharmacotherapy, an amendment of legislation to facilitate and encourage pediatric clinical trials is needed.
Key words:
off-label, unlicensed, drugs, children, pediatrics, clinical studies, prescriptions, hospitals
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Štítky
Neonatology Paediatrics General practitioner for children and adolescentsČlánok vyšiel v časopise
Czech-Slovak Pediatrics
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