PEDIATRICS Vol. 108 No. 5 November 2001, pp. 1089-1093

A Survey of the Use of Off-Label and Unlicensed Drugs in a Dutch Children's Hospital

Received Sep 28, 2000; accepted Jun 13, 2001.

Geert W. 't Jong^*, Arnold G. Vulto^§, Matthijs de Hoog^*, Kirsten J. M. Schimmel^§, Dick Tibboel, and John N. van den Anker^{*, , ¶}

From the Departments of ^* Pediatrics and  Pediatric Surgery, and ^§ Hospital Pharmacy, Sophia Children's Hospital, Erasmus Medical Center Rotterdam (EMCR); Rotterdam, The Netherlands;  Division of Pediatric Clinical Pharmacology and Medical Toxicology, Columbus Children's Hospital, Columbus, Ohio; and ^¶ Department of Pediatrics, Ohio State University, Columbus, Ohio.

Background.  The treatment of pediatric patients with drugs in hospitals is being impeded by a shortage in the availability of licensed drugs in an appropriate formulation. We have studied the extent of use of drugs that are not licensed for use in children (unlicensed) and drugs that are used outside the terms of the product license (off-label). We conducted this study in a Dutch academic children's hospital.

Methods.  In a prospective study of 5 weeks' duration, we reviewed drug prescriptions in a pediatric ward and 3 intensive care units. We classified the prescribed drugs in 3 main categorieslicensed, unlicensed, and off-labeland determined the nature of their unlicensed and off-label use.

Results.  Two thousand one hundred thirty-nine courses of drugs were administered to 237 patients in 442 patient-days. Of 2139 prescriptions, 725 (34%) were licensed, 1024 (48%) were unlicensed, and 390 (18%) were off-label. In 392 (90%) of 435 patient-days, children received 1 or more courses of an unlicensed or off-label drug prescription in hospital.

Conclusion.  With regard to the availability of drugs of proven quality and adequate license for pediatric patients in hospital, dramatic shortcomings exist. As a result, drug legislation originally designed to protect patients and prescribing physicians against unsafe drug use and unjustified claims has turned into an insurmountable threshold to make proper drugs available for a vulnerable minority of patients.  Key words:  children, drug use, labeling, unlicensed, off-label, licensing, drugs.

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