Drug utilization study in pediatric prescriptions of a university hospital in southern Brazil: off-label, unlicensed and high-alert medications

Abstract

Objective: To describe and determine the extent of use of unlicensed, off-label and high-alert drugs in the general pediatric units of a university hospital in southern Brazil.

Methods: A cross-sectional study conducted from November 2007 to January 2008 involving patients up to 14 years of age. Intensive care and pediatric oncology unit patients were excluded. Classification according to the Food and Drug Administration approval criteria was performed using the DrugDex-Micromedex(®) and high-alert medications were classified according to the Institute for Safe Medication Practices.

Results: During the study period, 342 prescriptions were analyzed. Analgesic drugs were the most frequently prescribed therapeutic class of drugs (26.9%) and antispasmodic drugs (31.5%) were the most frequently issued off-label drugs. About 12% of the prescriptions analyzed presented unlicensed drugs and 39% presented at least one off-label drug, especially in relation to its therapeutic indication (38.4%) and age (21.9%). Approximately 6% of the total (2026) were classified as high-alert medications, such as opioid analgesic drugs (35%). No association was observed between off-label use and high-alert drugs.

Conclusion: Frequency of unlicensed and off-label drug prescriptions showed in the study is according to the literature and may be considered high. High-alert drugs, although low in frequency, can present risks due to the harmful effects they can produce in patients. Thus, the highlighted drugs in this study constitute a constant concern in hospitals.