Most Newborns Given Drugs Not Specifically Tested for Pediatric Use, Research Shows
One third of Estonian children are being prescribed medically unindicated drugs, and for newborns the figure reaches 90 percent, according to Jana Lass, a doctoral student at the University of Tartu Institute of Microbiology.
Medical treatment of children is much more complicated than that of adults, and children make up a large proportion of takers of prescription medicines, Lass said at the Kliinik 2011 medical conference in Tartu on February 7.
"Nine to 33 percent of the medications given to children are not medically indicated for use on children. Recent studies have shown that over 50 percent of pharmaceuticals used on children have not been researched on them. The situation is crucial with newborns: 80 to 90 percent of the prescribed drugs have not been tested on the target group and are not medically indicated," Lass said.
Since a large number of pharmaceuticals don't carry information about how they should be used to treat children or babies, pediatrists and general practitioners use different sources at hand to find out what dosage to use, she said.
In case of being unaware of the correct drug dosages for children, physicians often simply use smaller portions of the adult dosage. Due to this uncertainty, the risk of medical errors increases. Also, some additional substances present in medicines may be harmful to children.
"It came as a surprise to us that two pharmaceuticals that have the same active substance, yet are made by different manufacturers, have differing information on how to use the medication in children," Lass said.
Lass' findings were based on 2007 data from the Estonian Health Insurance Fund.
According to Lass, state regulations in this field have appeared only in recent years. At the moment research is being carried out in order see whether the situation has improved in any way.
The European Medicines Agency has compiled a list of pharmaceuticals that desperately need additional clinical testing before being prescribed to children.