When pharmaceuticals are approved by the Food and Drug Administration (FDA) and stocked on pharmacy shelves, they are only approved for certain uses. While medications can be prescribed for off-label uses by physicians, these uses are not explicitly tested for and subsequently approved as safe. This ultimately means that off-label pharmaceuticals are more likely to be the subject of medication errors than when medications are used for explicitly approved purposes.
For better and worse, more than 95 percent of pediatric intensive care patients are prescribed medications for off-label purposes. These off-label treatments may be lifesaving, but because these pharmaceuticals are not tested for safety in the doses, uses and age groups they are prescribed for in these capacities, this trend is both startling and dangerous.
One doctor of pharmacology recently explained that, "It is very difficult when you stand at the bedside and want to treat a sick child with a drug and you don't know if the dose or drug you have chosen or recommended will harm the child or help the child. Everyone does the best they can to find suggested doses and do the right thing, however, it is better medicine to dose or recommend doses based on evidence," according to a recent online article published by Medication Xpress.
Certainly, physicians who are trying valiantly to save a child in critical condition should be given the tools they need to do so. However, when medications have not been approved for use in children with specific conditions, it is critical that more research be done in order to help these physicians make more informed decisions. Without that knowledge, it is more likely that an error will be made and a child will suffer the consequences.
Source: Medication Xpress, "Off-label medications prescribed to nearly all pediatric intensive care patients," Oct. 19, 2012