PURPOSE: This study evaluated the use of off-label medications in the intensive care unit (ICU) setting and their varying levels of evidence. MATERIALS AND METHODS: Thirty-seven ICUs from 24 US sites participated in this prospective, multicenter, observational study during a single 24-hour period. All medication orders were evaluated for Food and Drug Administration-labeled indications, strength of evidence, and strength of recommendation. Off-label medication orders were evaluated for indication, dose, route of administration, duration of therapy, and whether they were supported by institutional guidelines. RESULTS: A total of 414 patients were enrolled, yielding 5237 medication orders for analysis. Of these, 1897 orders (36.2%) were off-label. The 3 drug classes that accounted for the most off-label orders were bronchorespiratory, gastrointestinal, and immunology. The majority of off-label medication orders (89.1%) were initiated after patient admission to the ICU. Nine hundred twenty-eight (48.3%) of the off-label medication orders had grade C or no evidence. CONCLUSIONS: The use of off-label medication therapies in the US adult critical care units is common, a majority of which are initiated after admission to the ICU and a significant portion of which are supported with inferior levels of evidence.
PURPOSE: This study evaluated the use of off-label medications in the intensive care unit (ICU) setting and their varying levels of evidence. MATERIALS AND METHODS: Thirty-seven ICUs from 24 US sites participated in this prospective, multicenter, observational study during a single 24-hour period. All medication orders were evaluated for Food and Drug Administration-labeled indications, strength of evidence, and strength of recommendation. Off-label medication orders were evaluated for indication, dose, route of administration, duration of therapy, and whether they were supported by institutional guidelines. RESULTS: A total of 414 patients were enrolled, yielding 5237 medication orders for analysis. Of these, 1897 orders (36.2%) were off-label. The 3 drug classes that accounted for the most off-label orders were bronchorespiratory, gastrointestinal, and immunology. The majority of off-label medication orders (89.1%) were initiated after patient admission to the ICU. Nine hundred twenty-eight (48.3%) of the off-label medication orders had grade C or no evidence. CONCLUSIONS: The use of off-label medication therapies in the US adult critical care units is common, a majority of which are initiated after admission to the ICU and a significant portion of which are supported with inferior levels of evidence.
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
Authors: Melek Simsek; Birgit I Lissenberg-Witte; Milou L M van Riswijk; Sander Verschuren; Frank Hoentjen; Bas Oldenburg; Cyriel Y Ponsioen; C Janneke van der Woude; Andrea E van der Meulen; Marieke Pierik; Gerard Dijkstra; Nanne K H de Boer Journal: Aliment Pharmacol Ther Date: 2019-03-25 Impact factor: 8.171