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.
Temple University of School of Pharmacy, 3307 North Broad Street, Philadelphia, PA 19140, USA. firstname.lastname@example.org.
This article was published in the following journal.
Name: Current drug safety
Medical and Biotech [MESH] Definitions
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.
The practice of prescribing medications in a manner that poses more risk than benefit, particularly where safer alternatives exist.
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.
A potent HIV protease inhibitor. It is used in combination with other antiviral drugs in the treatment of HIV in both adults and children.
The insertion of drugs into the rectum, usually for confused or incompetent patients, like children, infants, and the very old or comatose.
Objective To assess current experiences and attitudes of hospital based paediatricians towards off-label medicine prescribing. Setting Paediatric hospital wards and out-patient clinics. Design A prosp...
The use of unlicensed and off-label medicines in children is common because trials in children have not usually been performed during the drug development process. Consequently, the information availa...
BACKGROUND: Off-label use is the practice of prescribing a drug outside the terms of its official labeling. Worldwide, about 20% of the commonly prescribed medications are off-la...
Objective of the study To determine the extent and nature of unlicensed/off-label prescribing patterns in hospitalised children in Palestine. Setting Four paediatric wards in two public health system...
OBJECTIVES: To investigate the knowledge and views of a range of healthcare professionals (consultant paediatricians, general practitioners (GPs), community pharmacists and paediatric nurses) regardin...
Patient safety is at the forefront of critical issues in health care. Medications are the single most frequent cause of adverse events, and in the inpatient setting adverse drug events (AD...
This study investigates the drug utilization pattern of Oral Contraceptives (OC) in Croatia. Gynecologists and Dermatologists were asked to contribute OC prescribing data to this study.
Prevention of Potentially Inappropriate Prescribing in Late Life Using Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) and Screening Tool to Alert Doctors to Right Treatment (START) Criteria
Potentially inappropriate prescribing is common in older patients and encompasses overuse, misuse and underuse of medications. Potentially inappropriate prescribing is associated with nega...
Prescribing decisions by clinicians are often thought to be simple: a patient's clinical problem leads a prescriber to choose the optimal treatment. However, many factors other than the p...
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebilet administered in Korean patients according to the prescr...