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.

Leiomyosarcoma of the Stomach

I. Roisman, I. Lifshitz, O. Papo, Z. Kovach, A.Z. Reznick, A.L. Durst

Surgical Dept. A, Rambam Medical Center, Haifa; Depts. of Surgery and Pathology, Hadassah University Hospital, Jerusalem; and Surgical Dept. B, Carmel Medical Center, Haifa

Gastric leiomyosarcoma (GLMS) is a malignant, smooth muscle neoplasm accounting for not more than 0.45%-3.5% of primary gastric malignancies and 17%-20% of all smooth muscle tumors of the stomach. A well-chavariant has been variously referred to as leiomyoblastoma and epithelioid leiomyosarcoma. Because of the rarity of GLMS, few authors have tried to correlate clinical presentation, pathological findings, and treatment. There is no uniform therapeutic approach for leiomyosarcoma of the stomach and reported survival rates vary widely. We present a 56-year-old man whom we treated for this condition.

Penetrating Ocular Injuries: a Retrospective Study

M. Schneck, S. Weitzman, T. Lifshitz, B. Biedner

Dept. of Ophthalmology, and Epidemiology and Health Services Evaluation Unit, Soroka Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

Penetrating injuries of the eye are an important cause of unilateral visual loss. We studied a series of 82 cases of penetrating injuries treated here from 1987 through 1993. The injuries were caused by sharp objects in 66% and blunt trauma in 6%. The prognosis after a penetrating injury is greatly influenced by the nature of the injury and the extent of the initial drainage. Among factors associated with an unfavorable visual outcome were diminished preoperative visual acuity and scleral wounds with dense vitreous hemorrhage.