Off-Label Prescribing of Drugs for Children.
Summary of "Off-Label Prescribing of Drugs for Children."
Under normal circumstances, children are excluded from clinical trials of new drug candidates. Yet, when the drug product is approved for marketing by the authorities, it is only a matter of time before physicians use that drug on pediatric patients. We do know that the practice of prescribing drugs for off-label conditions is found in approximately 50% of all physician prescribing. We should not look at off-label pediatric drug use as always a bad or negative behavior. It may be that a manufacturer has conducted a successful clinical trial for a new pediatric condition and has submitted the documentation to the FDA staff to support that new indication, but the regulatory agency has not completed its review and formally awarded the new indication to the sponsor. Or it might be the case that over a dozen years of clinician experience informs all clinicians that an off-label use of a drug works most effectively and yet the manufacturer is reluctant to spend the money required for a supplemental investigation when it loses patent protection in under a year. As with many other situations where not all of the facts may be known, it seems that the wisest path is to approach the use of drugs for off-label conditions with great caution and with as much knowledge as may be gained before the prescribing decision is arrived at.
Affiliation
Temple University of School of Pharmacy, 3307 North Broad Street, Philadelphia, PA 19140, USA. albertw@erols.com.
Journal Details
This article was published in the following journal.
Name: Current drug safety
ISSN: 1574-8863
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21241243
- DOI: http://dx.doi.org/
Medical and Biotech [MESH] Definitions
Off-label Use
The practice of prescribing or using a drug outside the scope of the drug's official approved label as designated by a regulatory agency concerning the treatment of a particular disease or condition.
Inappropriate Prescribing
The practice of prescribing medications in a manner that poses more risk than benefit, particularly where safer alternatives exist.
Counterfeit Drugs
Drugs manufactured and sold with the intent to misrepresent its origin, authenticity, chemical composition, and or efficacy. Counterfeit drugs may contain inappropriate quantities of ingredients not listed on the label or package. In order to further deceive the consumer, the packaging, container, or labeling, may be inaccurate, incorrect, or fake.
Nelfinavir
A potent HIV protease inhibitor. It is used in combination with other antiviral drugs in the treatment of HIV in both adults and children.
Administration, Rectal
The insertion of drugs into the rectum, usually for confused or incompetent patients, like children, infants, and the very old or comatose.
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