תוצאת חיפוש

Use of Unlicensed and Off-Label Drugs in Hospitalized Children

M. Lifshitz, V. Gavrilov, R. Gorodischer

Toxicology Unit, Pediatrics Dept. A, Soroka Medical Center, and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

Many drugs used in children are based on pharmacological data obtained in adults. Therefore, many drugs are either unlicensed for use in children or are prescribed outside the terms of the product license (off-label). This pilot study assessed use of unlicensed or off-label drugs in hospitalized children.

Drug orders of patients admitted to a general pediatric ward were reviewed retrospectively in a random sample. Assessment was based on the data of the Physicians' Desk Reference and the Israel Drug Compendium. 80 different drugs and 278 drug orders were written for 92 patients (0.5 months - 11 years old, mean 26.9 months) in 97 admissions. Of these 52.9% were either off-label or unlicensed. Patients received 1 or more unlicensed or off-label drugs in 64.9% of admissions. They were more often off-label than unlicensed. The main reasons for use of off-label drugs were unusual doses and inappropriate age. The main reason for unlicensed drugs was modification of a particular formulation of a licensed drug.

This pilot study indicates that use of drugs in an off-label or unlicensed manner in children is probably quite frequent in Israel. Our data emphasize the need for licensing a large number of drugs for use in children, based on the same scientific principles as in adults. Further collaborative studies in different pediatric centers in Israel, involving different types of pediatric settings (ambulatory and in-hospital), is required to evaluate comprehensively the magnitude of this preliminary finding.

Influence of Warning Labels on Medicines and Physicians' Orders on Patient Behavior

Yehuda Limony, Pesah Shwarzman

Child Health Center of Kupat Holim Klalit, Kiryat Gat and Dept. of Family Medicine, Ben-Gurion University of the Negev, Beer Sheba

Compliance of 40 mothers with a warning label, "for external use," on a medicine package was checked in a survey in a primary care clinic for children. We also checked parents' attitudes to giving a medicine to their child when instructions given by the physician or by a friend contradicted the printed warning on the label. All mothers who were told that the medicine was recommended by their physicians accepted the recommendation without hesitation. Another group included 20 mothers who were told that the medicine was recommended by a friend. 9 of 20 mothers in this group refused to use the medicine. Talking with the nurse about the potential risk of medicine in general, some mothers, after second thought, refused to give the medicine to their child. At the end, 65% of recommendations made by a friend were rejected by mothers as compared to only 15% of the physicians' recommendations.

35 of 40 mothers (87%) understood the meaning of the warning label, but only 13 (32%) had noticed it at all. We conclude that patients may accept their physicians' recommendation to use a medicine despite a contradictory warning label much more readily than when it was recommended by a friend. Therefore, any intervention program intended to promote a more cautious use of medicines should include not only the explanations of the various warning labels but should also promote a change in the patient's behavior to a more active search for warning labels.