OBJECTIVE: The aim of the study was to document off label prescribing in an adult surgical intensive care unit setting and to determine explanatory factors. METHOD: Medical prescriptions of 20 adult patients consecutively admitted in surgical intensive care unit were recorded, from the time of admission to the second day of hospitalisation. Concordance of each prescription to the different sections listed on the approved labeling was checked on the Vidal 1999 dictionary. French guidelines promoted by the two major intensive care societies were looked for to explain the most frequent reason of unapproved use of the 10 main therapeutic classes concerned by off label prescription. RESULTS: In this study, 465 prescriptions were analysed, representing 80 drugs and 35 therapeutic classes. Prescriptions were considered off label in 25.6%. Antibiotics, stress ulcer prophylactic drugs, vitamins, antiepileptic drugs were the main therapeutic classes used off label. The main cause of off label prescription was unapproved indication (66%), dosing schedule (27%) and method of administration (17%). For 5 therapeutic classes, representing 45% of off label prescriptions, a guideline supporting these prescriptions was available or was published in the year following the study. CONCLUSION: Off label prescription is frequent in the setting of adult surgical intensive care unit. Seldom medical situations and the gap between official labeling and medical knowledge are explanatory factors of these off label prescriptions.
OBJECTIVE: The aim of the study was to document off label prescribing in an adult surgical intensive care unit setting and to determine explanatory factors. METHOD: Medical prescriptions of 20 adult patients consecutively admitted in surgical intensive care unit were recorded, from the time of admission to the second day of hospitalisation. Concordance of each prescription to the different sections listed on the approved labeling was checked on the Vidal 1999 dictionary. French guidelines promoted by the two major intensive care societies were looked for to explain the most frequent reason of unapproved use of the 10 main therapeutic classes concerned by off label prescription. RESULTS: In this study, 465 prescriptions were analysed, representing 80 drugs and 35 therapeutic classes. Prescriptions were considered off label in 25.6%. Antibiotics, stress ulcer prophylactic drugs, vitamins, antiepileptic drugs were the main therapeutic classes used off label. The main cause of off label prescription was unapproved indication (66%), dosing schedule (27%) and method of administration (17%). For 5 therapeutic classes, representing 45% of off label prescriptions, a guideline supporting these prescriptions was available or was published in the year following the study. CONCLUSION: Off label prescription is frequent in the setting of adult surgical intensive care unit. Seldom medical situations and the gap between official labeling and medical knowledge are explanatory factors of these off label prescriptions.
Authors: Pamela L Smithburger; Mitchell S Buckley; Mark A Culver; Sarah Sokol; Ishaq Lat; Steven M Handler; Levent Kirisci; Sandra L Kane-Gill Journal: Crit Care Med Date: 2015-08 Impact factor: 7.598