Healthy Skepticism Library item: 9680

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Choonara I.
Unlicensed and off-label drug use in children: implications for safety.
Expert Opin Drug Saf 2004 Mar; 3:(2):81-3

Abstract:

Throughout the world, many drugs prescribed for children are used in an off-label or unlicensed manner. The incidence of unlicensed and off-label drug prescriptions appears to be greatest in critically ill neonates and children and lowest in the general population. The risk associated with unlicensed and off-label drug use appears to be greater than for prescribing in accordance with the product licence. Health professionals, however, usually have no alternative but to use unlicensed and off-label medicines. More clinical trials for medicines in children are required to provide the evidence base for safe and effective drug prescribing.

Keywords:
Child Drug Approval/legislation & jurisprudence* Drug Labeling*/classification Drug Labeling*/legislation & jurisprudence Drug Therapy/adverse effects* Drug Therapy/utilization Drug Utilization Humans Physician's Practice Patterns*

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909