David McD Taylor1,2, Paul Joffe3, Simone E Taylor4, Alicia Jones5, John A Cheek3,5,6,7, Simon S Craig7, Andis Graudins7,8, Reetika Dhir1,3, David Krieser2,5,9, Franz E Babl2,3,5. 1. Emergency Department, Austin Hospital, Melbourne, Victoria, Australia. 2. Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia. 3. Royal Children's Hospital, Melbourne, Victoria, Australia. 4. Pharmacy Department, Austin Hospital, Melbourne, Victoria, Australia. 5. Murdoch Children's Research Institute, Melbourne, Victoria, Australia. 6. Monash Emergency, Monash Medical Centre, Monash Health, Melbourne, Victoria, Australia. 7. School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia. 8. Monash Emergency, Dandenong Hospital, Melbourne, Victoria, Australia. 9. Emergency Department, Sunshine Hospital, Melbourne, Victoria, Australia.
Abstract
OBJECTIVE: To determine the prevalence and nature of off-label and unlicenced (off-label/unlicenced) medicine administration to paediatric ED patients. METHODS: We undertook a retrospective, observational study in six EDs (July 2011 to June 2012, inclusive). Patients, aged 0-17 years, who were administered a medicine in the ED were included. At each site, 50 eligible patients were randomly selected each month of the study period. An explicit review of each patient's records was undertaken. Medicines were classified as on or off-label/unlicenced according to categories of use approved by the Therapeutic Goods Administration. RESULTS: There were 3343 patients enrolled (56.5% men, mean ± SD age 6.7 ± 5.4 years). Of the 6786 medicine doses administered, 2072 (30.5%, 95% CI 29.4-31.7%) were off-label/unlicenced. The off-label/unlicenced doses were administered to 1213 (36.3%, 95% CI 34.7-37.9%) patients. Patients administered an off-label/unlicenced medicine were younger than those who were not (P < 0.01). Salbutamol, ondansetron, ipratropium, fentanyl and oxycodone were the medicines most commonly administered off-label. In 910 (44.0%) cases, the dose/frequency was not approved; in 592 (28.6%), there was an unapproved indication for treatment; in 158 (7.6%), the medicine was administered via an unapproved route; in 154 (7.4%) the medicine was not approved for the weight or age; and in 74 (3.5%) an unlicenced product was administered. The remaining cases had combinations of reasons. CONCLUSIONS: Off-label/unlicenced medicine administration is common. A registry of commonly used off-label medicines is recommended in which the safety and efficacy of their off-label use have been demonstrated by published evidence.
OBJECTIVE: To determine the prevalence and nature of off-label and unlicenced (off-label/unlicenced) medicine administration to paediatric ED patients. METHODS: We undertook a retrospective, observational study in six EDs (July 2011 to June 2012, inclusive). Patients, aged 0-17 years, who were administered a medicine in the ED were included. At each site, 50 eligible patients were randomly selected each month of the study period. An explicit review of each patient's records was undertaken. Medicines were classified as on or off-label/unlicenced according to categories of use approved by the Therapeutic Goods Administration. RESULTS: There were 3343 patients enrolled (56.5% men, mean ± SD age 6.7 ± 5.4 years). Of the 6786 medicine doses administered, 2072 (30.5%, 95% CI 29.4-31.7%) were off-label/unlicenced. The off-label/unlicenced doses were administered to 1213 (36.3%, 95% CI 34.7-37.9%) patients. Patients administered an off-label/unlicenced medicine were younger than those who were not (P < 0.01). Salbutamol, ondansetron, ipratropium, fentanyl and oxycodone were the medicines most commonly administered off-label. In 910 (44.0%) cases, the dose/frequency was not approved; in 592 (28.6%), there was an unapproved indication for treatment; in 158 (7.6%), the medicine was administered via an unapproved route; in 154 (7.4%) the medicine was not approved for the weight or age; and in 74 (3.5%) an unlicenced product was administered. The remaining cases had combinations of reasons. CONCLUSIONS: Off-label/unlicenced medicine administration is common. A registry of commonly used off-label medicines is recommended in which the safety and efficacy of their off-label use have been demonstrated by published evidence.
Authors: H Christine Allen; M Connor Garbe; Julie Lees; Naila Aziz; Hala Chaaban; Jamie L Miller; Peter Johnson; Stephanie DeLeon Journal: J Okla State Med Assoc Date: 2018-10