RT Journal Article
SR Electronic
T1 Off-label use of inhaled bronchodilators in hospitalised patients in Spain: a multicentre observational study
JF European Journal of Hospital Pharmacy
JO Eur J Hosp Pharm
FD British Medical Journal Publishing Group
SP e23
OP e28
DO 10.1136/ejhpharm-2019-002171
VO 28
IS e1
A1 Elena Villamañán
A1 Carmen Sobrino
A1 Cristina Bilbao
A1 Jaime Fernández
A1 Alicia Herrero
A1 Myriam Calle
A1 Dolores Alvaro
A1 Maria Segura
A1 Gracia Picazo
A1 José Miguel Rodríguez
A1 Gema Baldominos
A1 Maria Teresa Ramirez
A1 Yolanda Larrubia
A1 Jesús Llorente
A1 Alicia Martinez
A1 Rodolfo Alvarez-Sala
YR 2021
UL http://ejhp.bmj.com/content/28/e1/e23.abstract
AB Background Off-label prescription of inhaled bronchodilators (IB) is frequent, despite the fact that they can be ineffective and increase avoidable healthcare costs.Objective To analyse the frequency of off-label prescription of IB in hospitalised patients. Indications and level of evidence, involved drugs, medical specialties prescribing off-label IB and patients’ adherence to IBs were also evaluated.Method A descriptive, observational, cross-sectional study was performed in four tertiary hospitals in Spain. The main outcome measure was the number of patients prescribed off-label IBs. Prescriptions were checked against the European Medicines Agency-approved indications. The level of evidence supporting off-label prescription of IBs (according to MICROMEDEX 2.0) was also analysed. Patients were interviewed to test differences (off-label vs on-label) in adherence and knowledge about their inhaled therapy.Results 217 patients were prescribed IBs, 92 of whom were givend off-label IBs (54.7% men, mean age 73.9±12.9 years). The most common off-label prescriptions for IBs were: unspecified dyspnoea (not related to COPD or asthma) (27.2%), respiratory infections (23.9%) and heart failure (22.8%). 76.8% of patients did not have evidence supporting them. Beta2-agonist+corticosteroids and anticholinergics were most commonly prescribed off-label. Internal Medicine was the main medical specialty involved. There were no differences between off-label and on-label users in terms of patients’ knowledge about treatment and adherence.Conclusion Off-label indications for IBs are common in hospitalised patients and are generally indicated without scientific support. Dyspnoea not related to COPD or asthma, respiratory infections and heart failure were the main off-label indications, most frequently treated with anticholinergics and beta2-agonists+corticosteroids, for which their efficacy and safety has not been proved. Our results show that prescribing needs to be improved to follow the evidence that exists. Moreover, further research focused on off-label indications is needed to clarify whether they are effective, safe and cost-effective.Data are available upon reasonable request. Data are abailable upon reasonable request.