title: Off-label use of inhaled tobramycin in Ontario, Canada.
abstract: Inhaled tobramycin solution is indicated for use in the management of Pseudomonas aeruginosa in patients with cystic fibrosis (CF). Concerns have been raised regarding increasing off-label use of inhaled tobramycin, particularly for the management of COPD. We conducted an 8-year repeated cross-sectional study examining the indication for prescription claims for inhaled tobramycin in Ontario paid for by the Public Drug Benefit Program, which covers all Ontario residents with financial needs or aged 65 and older. Inhaled tobramycin prescription claims increased approximately 3 times greater from 86 prescriptions in the second quarter of 2007 to 261 prescriptions in the first quarter of 2015. Approximately half of all prescriptions (range: 46-65%) per quarter were dispensed to patients with CF. A large proportion of prescriptions (range: 31-36%) were dispensed to individuals who did not have a diagnosis of CF but had a diagnosis of COPD. In 2014, there were 324 unique users of inhaled tobramycin solution in the Ontario Public Drug Program (OPDP). Only half of users (54%; n=163) had a diagnosis of CF. Our study found increasing prescriptions of inhaled tobramycin from 2007 to 2015 in the OPDP with approximately half of these claims being for off-label use, mostly among patients with COPD.
authors.affiliation: St. Michael's Hospital, Toronto, Ontario, Canada Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada The Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Mina
authors.identifier: 0000-0003-1911-6129
authors.initials: M
authors.lastname: Tadrous
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
authors.forename: Wayne
authors.initials: W
authors.lastname: Khuu
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada Health Policy, Management, Evaluation, University of Toronto, Toronto, Ontario, Canada Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada Centre for Evaluation of Medicines, St. Joseph's Healthcare, Hamilton, Ontario, Canada.
authors.forename: J Michael
authors.initials: JM
authors.lastname: Paterson
authors.affiliation: St. Michael's Hospital, Toronto, Ontario, Canada Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada The Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada Health Policy, Management, Evaluation, University of Toronto, Toronto, Ontario, Canada Department of Medicine, St. Michael's Hospital, Toronto, Ontario, Canada Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Muhammad M
authors.identifier: 0000-0001-5199-6344
authors.initials: MM
authors.lastname: Mamdani
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada Health Policy, Management, Evaluation, University of Toronto, Toronto, Ontario, Canada Department of Medicine, University of Toronto, Toronto, Ontario, Canada Sunnybrook Research Institute, Toronto, Ontario, Canada Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
authors.forename: David N
authors.initials: DN
authors.lastname: Juurlink
authors.affiliation: St. Michael's Hospital, Toronto, Ontario, Canada Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada The Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Tara
authors.initials: T
authors.lastname: Gomes
mesh_terms: D000280:Administration, Inhalation; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D003550:Cystic Fibrosis / Q000150:complications; D004363:Drug Utilization / Q000639:trends; D006801:Humans; D056687:Off-Label Use / Q000706:statistics & numerical data*; D009864:Ontario; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications; D014031:Tobramycin / Q000008:administration & dosage*
chemical_list: D000900:Anti-Bacterial Agents; D014031:Tobramycin
keywords: Bacterial Infection; COPD epidemiology; Cystic Fibrosis