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.

Impact of Clinical Pharmacist on Drug Therapy in Medical Departments

Ariel Hamerman, Rimona Rotem, Naftali Meidan, Avi Porath

Pharmacy Services, Hospital Management and Medical Dept. F, Soroka University Medical Center, Beer Sheba

Several studies have documented the impact of clinical pharmacy services on patient care and drug costs in hospital wards. However most hospitals in Israel do not provide such services and until recently their benefits in local health care have not been demonstrated. We therefor determined whether the activity of a pharmacist in the medical department of a medical center leads to improved quality of drug utilization and reduced costs.

During the first 3 months of the clinical pharmacist's work all interventions and consultation were documented. The effect of these interventions on drug costs was calculated by the change in drug acquisition costs during the study period compared with those of preceding months, as well as in the other 5 medical departments of the hospital without clinical pharmacy services.

During the study period the pharmacist joined 44 clinical rounds in which he documented 40 consultations in response to physicians' requests for drug information and 42 interventions on his own initiative. The pharmacist's recommendations were accepted in 38 of the 42 cases (90%). In 10 cases the pharmacist's initiative in improving the quality of drug therapy led to an increase in drug acquisition costs. However, the overall drug costs during the study period decreased 12.6%. During the same period drug costs in the other medical departments decreased only 2.2%.

The results of this study conform with those of many other studies that show a beneficial impact of the clinical pharmacist on the quality of drug therapy and on drug costs. They indicate that the clinical pharmacist can play a crucial role in the medical department.