NCPA - National Center for Policy Analysis

Off-Label Drug Use Common In Europe

January 7, 2000

In the U.S., it is the practice in some medical specialties, such as cancer treatment, for doctors to prescribe drugs for off-label uses. A newly published survey of pediatric wards in five European hospitals found that two-thirds of children admitted there were prescribed drugs that were unlicensed or off label.

Clinical trials of drugs are often not performed in children, which means there are limited data on their safety and many are unlicensed for children.

  • The European Network for Drug Investigation in Children looked at prescribing for 624 children admitted to pediatric units over four weeks in the United Kingdom, Sweden, Germany, Italy, and the Netherlands.
  • They found that 39 percent of the 2,262 drug prescriptions given to children were off label -- with some children, of course, receiving multiple prescriptions.
  • Over two-thirds (67 percent) of the 624 children studied received drugs prescribed in an unlicensed or off label manner.

Licensed drugs are often prescribed outside the terms of the product license (off label) in relation to age, indication, dose frequency, route of administration, or formulation.

Source: Sharon Conroy, et al., "Survey of Unlicensed and Off Label Drug Use in Pediatric Wards in European Countries," British Medical Journal, January 8, 2000.


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