Off-Label Drug Prescriptions
for Children Rampant
Two separate articles from the June 1, 2002 issue of the British Medical
Journal deal with the subject of "Off-Label" drug prescriptions for
children. Off-Label means the usage of a drug for a purpose other than that
which it was approved and licensed for. Off-Labeling also applies when
drugs are used in a population that the drug was never tested on. Such is
the case in many drugs that were never tested on children but are commonly
prescribed for them.
One of the two articles looks at a study in Germany and makes a chilling
opening statement. "Between 35% and 90% of the drugs prescribed to
hospitalized children are either not licensed for children's use or are
prescribed outside the terms of their product license (off label
prescribing). Subsequent adverse reactions are more likely than with
licensed products." Their comments were, "We found that 13.2% of
prescriptions for a representative group of children in primary care in
Germany were off label." The article attributed 75% of the off label usage
to lack of information about the usage of the drugs.
The second article dealt with the same problem in the United States. The
opening statement in that article included a comment about how a new drug
could come to the market in the US. "Until recently, the drug need only to
have been studied in the adult male population. Yet once a drug is approved
it may be prescribed by a physician for any population or disease state
desired." To attempt to change this situation a law was passed, the FDA
Modernization Act of 1997 (FDAMA), which provided that
manufacturers of drugs under patent could seek a six month patent
extension for performing studies leading to labeling in children.
This meant that if the drug companies performed studies on children there
could be six additional months of patent protection worth millions or
billions in revenue.
The moral dilemma of such studies is that children are not of legal age
to volunteer themselves for such drug testing. In the past most studies
were performed on healthy male volunteers. Submitting healthy children by
their parents or guardians carries ethical questions not present in adult
volunteers. Unfortunately, as the article points out that some drug
companies wait until the patent is close to expiration before deciding on
whether or not to initiate studies on children. Often the decision is based
solely on the expected profit potential the drug may carry for the extra six
months of patent protection. This means that these drugs were used on
children for an extended period of time without any studies to justify the
usage.