Off-label use of inhaled bronchodilators in hospitalised patients in Spain: a multicentre observational study

Villamañán, Elena; Sobrino, C; Bilbao, Cristina; Fernández, J. Zamorano; Herrero, Alicia; Calle, Myriam; Alvaro, Dolores; Segura, María Belén Díaz; Picazo, Gracia; Rodríguez, José Miguel; Baldominos, Gema; Larrubia, Yolanda; Llorente, Jesús; Martínez, Alicia; Álvarez-Sala, R

doi:10.1136/ejhpharm-2019-002171

Cited by 3 publications

(3 citation statements)

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“…In a Spanish study by Villamañán et al . , the off-label prescription of inhaled bronchodilators was common among hospitalised patients, and the most common indications were dyspnoea that was not related to asthma or COPD, respiratory infections, and heart failure [ 12 ]. In Finland, diagnostic assessment of suspected asthma in adults includes a two-week PEF monitoring with twice-daily measurements before and after SABA use [ 6 ].…”

Section: Discussionmentioning

confidence: 99%

“…According to clinical experience, off-label use of R03 medications is quite common. There is little published data on how the use of these drugs is divided between diagnosed and undiagnosed adult patients, and off-label use is often related to the treatment of symptoms associated with airway infections [ 10 – 12 ]. Published data from paediatric populations also suggest that off-label use as short courses for airway infections is remarkable (19.2–38.1%) [ 13 , 14 ].…”

Section: Introductionmentioning

confidence: 99%

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Diagnoses and prescription patterns among users of medications for obstructive airway diseases in Finland

Juntunen,

Salmela,

Pakkasela

et al. 2024

BMC Pulm Med

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Background Asthma and chronic obstructive pulmonary disease (COPD) are common diseases mostly treated in primary care. However, the usage patterns of drugs for obstructive airway diseases (R03 drugs) at the national level are not known. Objective The aims of this study were to describe (1) for which diagnoses each class of R03 drugs were used, (2) the usage pattern of different drug classes for asthma and COPD, and (3) how often these medications were used without a diagnosis of asthma or COPD in Finland. Methods We sent questionnaires that included questions on physician-diagnosed asthma and COPD to a random sample of 2000 Finnish subjects who had been dispensed R03 medications in the previous year. Details of R03 medications dispensed were retrieved from national registries. Results Altogether, 803 subjects (40.6%) responded. Of these, 61.6% had asthma, 5.7% had both asthma and COPD, 5.1% had COPD, and 27.5% had neither asthma nor COPD. Among subjects with asthma or asthma and COPD, inhaled corticosteroids (ICS) were the most frequently dispensed class of drugs (93.7% and 97.8%, respectively). Even among subjects with COPD, ICS were dispensed as frequently (68.3%) as long-acting bronchodilators (70.7%). Antileukotrienes were dispensed mainly to asthmatic individuals only (18.4%) but far less frequently than ICS. The use of theophylline and roflumilast was rare. Conclusions R03 medications are dispensed far more frequently for asthma than for COPD and often also for subjects without asthma or COPD. In line with guidelines, asthma is treated mainly with ICS, but there seems to be overuse of ICS for COPD.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Diagnoses and prescription patterns among users of medications for obstructive airway diseases in Finland

Juntunen,

Salmela,

Pakkasela

et al. 2024

BMC Pulm Med

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“…1 ; 5 ; 6 ; 7 ; 8 ; 9 ; 10 ; 11 ; 12 ; 13 ; 14 ; 15 ; 16 ; 17 ; 18 ; 19 ; 21 ; 22 ; 23 ; 24 ; 25 ; 26 ; 27 .…”

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Inhaled bronchodilators use and clinical course of adult inpatients with Covid-19 pneumonia in Spain: A retrospective cohort study

Villamañán¹,

Sobrino²,

Carpio

et al. 2021

Pulmonary Pharmacology & Therapeutics

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Background In the current coronavirus health crisis, inhaled bronchodilators(IB) have been suggested as a possible treatment for patients hospitalized. Patients with evidence of Covid-19 pneumonia worldwide have been prescribed these medications as part of therapy for the disease, an indication for which this medications could be ineffective taken on account the pathophysiology and mechanisms of disease progression. Objective The main objective was to evaluate whether there is an association between IB use and length of stay. Primary end points were the number of days that a patient stayed in the hospital and death as a final event in a time to event analysis. Pneumonia severity, oxygen requirement, involved drugs, comorbidity, historical or current respiratory diagnoses and other drugs prescribed to treat coronavirus pneumonia were also evaluated. Methods A descriptive, observational, cross-sectional study was performed in this tertiary hospital in Madrid (Spain). Data were obtained regarding patients hospitalized with Covid-19, excluding those who were intubated. The primary and secondary outcomes such as duration of hospitalization and death were compared in patients who received IB with those in patients who did not. Results 327 patients were evaluated, mean age was 64.4±15.8 years. Median length of hospitalization stay was 10 days. Of them 292 (89.3%) overcame the disease, the remaining 35 died. Patients who had received IB did not have less mortality rate (odds ratio 0.839; 95% CI: 0.401 to 1.752) and less hospitalization period when compared with patients who did not received IB (odds ratio 1.280; 95% CI: 0.813 to 2.027). There was no significant association between IB use and recovery or death. Hypertension and diabetes were the most common comorbidities. The prevalence of chronic respiratory disease in our cohort was low (21.1%). Anticholinergics were the IB more frequently prescribed for Covid-19 pneumonia. Better response in patients treated with inhaled corticosteroids was not observed. Conclusion Off-label indication of inhaled-bronchodilators for Covid-19 patients are common in admitted patients. Taken on account our results, the use of IB for coronavirus pneumonia apparently is not associated with a significantly patient´s improvement. Our study confirms the hypothesis that inhaled bronchodilators do not improve clinical outcomes or reduce the risk of Covid-19 mortality. This could be due to the fact that the virus mainly affects the lung parenchyma and the pulmonary vasculature and probably not the airway. More researches are necessary in order to fill the gap in evidence for this new indication.

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“Off-label” drugs: legal problems and socio-economic aspects of application practice

Russkikh

Tarasenko²,

Москвичева

et al. 2023

Farm. farmakol. (Pâtigorsk)

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The aim of the work was to analyze Russian and foreign experience in the regulation and application practice of “off-label” drugs in order to develop recommendations on the optimization of their application in clinical practice.Material and methods. The analysis of scientific articles and legal documents of the Russian Federation and foreign countries published from 2011 to 2022 on the websites Consultant Plus, FDA, EMA, NCBI, e-library, as well as a qualitative sociological study conducted in May-August 2022 ‒ 11 in-depth interviews with experts in the field of the healthcare system of the Russian Federation.Results. The social and economic aspects have been considered and the list of legal problems in the application practice of “off-label” drugs has been disclosed. A state analysis of the regulatory and legal framework on the drugs application practice by healthcare professionals in the absence of registered indications for “off-label” drugs use has been presented. The use of an unregistered medicinal product in the territory of the Russian Federation in everyday medical practice has been considered. The analysis of the Russian and foreign experience in regulating the use of drugs in the absence of their registration in the country, as well as the absence of registration of some indications for their prescription in the instructions for the medical use of such drugs has been also carried out. The authors have formulated the key problems of the use of “off-label” drugs in clinical practice. Based on the results of the in-depth interviews, the recommendations of the expert community on the ways to optimize the use of “off-label” drugs have been identified and concretized.Conclusion. The results of this study made it possible to formulate recommendations for expanding the ability of specialists to prescribe “off-label” drugs treatment while maintaining a proper degree of the state control over this process: a legislative consolidation of the regional health authorities’ obligations and responsibilities on the drug provision; creating an open and transparent system for the “off-label” drugs use by patients and their legal representatives, the mandatory full information of the patient about the fact of using the “off-label” drug, as well as the risk and nature of the development of possible adverse reactions. When prescribing these drugs, the patient safety should be the top priority.

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Off-label use of inhaled bronchodilators in hospitalised patients in Spain: a multicentre observational study

Cited by 3 publications

References 20 publications

Diagnoses and prescription patterns among users of medications for obstructive airway diseases in Finland

Diagnoses and prescription patterns among users of medications for obstructive airway diseases in Finland

Inhaled bronchodilators use and clinical course of adult inpatients with Covid-19 pneumonia in Spain: A retrospective cohort study

“Off-label” drugs: legal problems and socio-economic aspects of application practice

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