Pediatrics & Therapeutics
Open Access
ISSN: 2161-0665
+44 1478 350008
ISSN: 2161-0665
+44 1478 350008
Lydia Rabbaa Khabbaz
Saint-Joseph University of Beirut, Lebanon
Posters & Accepted Abstracts: Pediat Therapeut
The main objectives of this study were to assess the incidence of off-label (OL) and/or unlicensed (UL) prescriptions in a sample of Lebanese pediatric patients using FDA and ANSM regulations, to analyze the divergences between both regulations and to identify drugs most commonly involved in OL-UL utilization. This study was a retrospective analysis (500 pediatric files) conducted in a Lebanese university hospital in 3 pediatric wards: Chronic diseases, acute diseases, and pediatric intensive care unit. Each medicine was assessed twice, using FDA and ANSM regulations, to determine if it was an OL or UL prescription. The frequency of OL-UL drug was significantly different between pediatric wards (P<0.001) with the highest incidence occurring in the intensive care unit. It was also significantly related to the presenting complaint (P<0.001) with the most frequent OL-UL prescriptions occurring for cancer (oncology) admissions. Age was significantly related to OL-UL frequency (highest incidence in children between 0 and 1 year). The number of drugs prescribed per patient ranged between 1 and 20 (average 4.13�?±2.6). The incidence of OL-UL prescriptions was significantly higher in patients treated with a greater number of medicines (P<0.001). 58.9% of drugs prescriptions were authorized according to ANSM and 50.7% according to FDA regulations; 11.1 % (ANSM) and 15.8% (FDA) were unlicensed; these percentages were 30.2 and 33.5 respectively for OL use (where OL for the indication were the most common). The highest % of OL-UL prescriptions was seen with the following groups: blood and blood forming organs, genitourinary system and sex hormones, and alimentary tract and metabolism. Divergence between FDA and ANSM was mainly observed for OL medicines. UL prescriptions assessed according to both regulations showed similar results. For 40.8% to 41.7% of UL prescriptions, an authorized alternative was available. This study highlights the need for prescribers to continuously examine official regulationsâ�?�? updates in order to avoid using an OL-UL drug whenever it is evitable and calls for a better harmonization between worldwide official guidelines concerning drugs used in children to reduce risk factors for adverse drug reactions.
Email: lydia.khabbaz@usj.edu.lb