Inhalation therapies in COPD — adverse drug reactions impact on emergency department presentations

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Abstract

Purpose

Inhaled drugs have been cornerstones in the treatment of chronic obstructive pulmonary disease (COPD) for decades and show a high prescription volume. Due to the local application, drug safety issues of these therapies are often underestimated by professionals and patients. Data about adverse drug reactions (ADRs) caused by inhaled therapy in patients with COPD and polypharmacy are rare. We aimed to analyze the use and relevance of inhaled therapies in those patients in relation to ADR complaints, which were severe enough to warrant presentation to the emergency department.

Methods

Emergency department cases due to suspected ADRs of the ADRED database ( n = 2939, “Adverse Drug Reactions in Emergency Departments”; DRKS-ID: DRKS00008979, registration date 01/11/2017) were analyzed for inhaled drugs in patients with COPD. ADRs in cases with overdosed inhaled drugs were compared to non-overdosed cases. ADRs, potentially caused by inhaled drugs, were evaluated, clustered into complexes, and assessed for association with inhaled drug classes.

Results

Of the 269 included COPD cases, 67% ( n = 180) received inhaled therapy. In 16% ( n = 28), these therapies were overdosed. Overdosed cases presented the complexes of malaise and local symptoms more frequently. Related to the use of inhaled anticholinergics, local (dysphagia-like) and related to inhaled beta-2 agonists, local (dysphagia-like) and sympathomimetic-like ADRs presented more frequently.

Conclusion

Overdosed inhaled therapies in patients with COPD lead to relevant ADRs and impact on emergency room presentations. These are rarely associated to inhaled therapy by healthcare professionals or patients. Due to the high volume of inhaled drug prescriptions, pharmacovigilance and patient education should be more focused in patients with COPD. German Clinical Trial Register: DRKS‐ID: DRKS00008979

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Most cited references 30

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Polypharmacy in elderly patients.

Emily Hajjar, Angela Cafiero, Joseph Hanlon (2007)

Polypharmacy (ie, the use of multiple medications and/or the administration of more medications than are clinically indicated, representing unnecessary drug use) is common among the elderly. The goal of this research was to provide a description of observational studies examining the epidemiology of polypharmacy and to review randomized controlled studies that have been published in the past 2 decades designed to reduce polypharmacy in older adults. Materials for this review were gathered from a search of the MEDLINE database (1986-June 2007) and International Pharmaceutical Abstracts (1986-June 2007) to identify articles in people aged >65 years. We used a combination of the following search terms: polypharmacy, multiple medications, polymedicine, elderly, geriatric, and aged. A manual search of the reference lists from identified articles and the authors' article files, book chapters, and recent reviews was conducted to identify additional articles. From these, the authors identified those studies that measured polypharmacy. The literature review found that polypharmacy continues to increase and is a known risk factor for important morbidity and mortality. There are few rigorously designed intervention studies that have been shown to reduce unnecessary polypharmacy in older adults. The literature review identified 5 articles, which are included here. All studies showed an improvement in polypharmacy. Many studies have found that various numbers of medications are associated with negative health outcomes, but more research is needed to further delineate the consequences associated with unnecessary drug use in elderly patients. Health care professionals should be aware of the risks and fully evaluate all medications at each patient visit to prevent polypharmacy from occurring.

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Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients.

Munir Pirmohamed, Sally James, Shaun Meakin … (2004)

To ascertain the current burden of adverse drug reactions (ADRs) through a prospective analysis of all admissions to hospital. Prospective observational study. Two large general hospitals in Merseyside, England. 18 820 patients aged > 16 years admitted over six months and assessed for cause of admission. Prevalence of admissions due to an ADR, length of stay, avoidability, and outcome. There were 1225 admissions related to an ADR, giving a prevalence of 6.5%, with the ADR directly leading to the admission in 80% of cases. The median bed stay was eight days, accounting for 4% of the hospital bed capacity. The projected annual cost of such admissions to the NHS is 466m pounds sterling (706m Euros, 847m dollars). The overall fatality was 0.15%. Most reactions were either definitely or possibly avoidable. Drugs most commonly implicated in causing these admissions included low dose aspirin, diuretics, warfarin, and non-steroidal anti-inflammatory drugs other than aspirin, the most common reaction being gastrointestinal bleeding. The burden of ADRs on the NHS is high, accounting for considerable morbidity, mortality, and extra costs. Although many of the implicated drugs have proved benefit, measures need to be put into place to reduce the burden of ADRs and thereby further improve the benefit:harm ratio of the drugs.

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Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.

Peter M.A. Calverley, Julie Anderson, Bartolome R Celli … (2007)

Long-acting beta-agonists and inhaled corticosteroids are used to treat chronic obstructive pulmonary disease (COPD), but their effect on survival is unknown. We conducted a randomized, double-blind trial comparing salmeterol at a dose of 50 microg plus fluticasone propionate at a dose of 500 microg twice daily (combination regimen), administered with a single inhaler, with placebo, salmeterol alone, or fluticasone propionate alone for a period of 3 years. The primary outcome was death from any cause for the comparison between the combination regimen and placebo; the frequency of exacerbations, health status, and spirometric values were also assessed. Of 6112 patients in the efficacy population, 875 died within 3 years after the start of the study treatment. All-cause mortality rates were 12.6% in the combination-therapy group, 15.2% in the placebo group, 13.5% in the salmeterol group, and 16.0% in the fluticasone group. The hazard ratio for death in the combination-therapy group, as compared with the placebo group, was 0.825 (95% confidence interval [CI], 0.681 to 1.002; P=0.052, adjusted for the interim analyses), corresponding to a difference of 2.6 percentage points or a reduction in the risk of death of 17.5%. The mortality rate for salmeterol alone or fluticasone propionate alone did not differ significantly from that for placebo. As compared with placebo, the combination regimen reduced the annual rate of exacerbations from 1.13 to 0.85 and improved health status and spirometric values (P<0.001 for all comparisons with placebo). There was no difference in the incidence of ocular or bone side effects. The probability of having pneumonia reported as an adverse event was higher among patients receiving medications containing fluticasone propionate (19.6% in the combination-therapy group and 18.3% in the fluticasone group) than in the placebo group (12.3%, P<0.001 for comparisons between these treatments and placebo). The reduction in death from all causes among patients with COPD in the combination-therapy group did not reach the predetermined level of statistical significance. There were significant benefits in all other outcomes among these patients. (ClinicalTrials.gov number, NCT00268216 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.

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Author and article information

Contributors

Ingmar Bergs: ibergs@ukaachen.de

Journal

Journal ID (nlm-ta): Eur J Clin Pharmacol

Journal ID (iso-abbrev): Eur J Clin Pharmacol

Title: European Journal of Clinical Pharmacology

Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )

ISSN (Print): 0031-6970

ISSN (Electronic): 1432-1041

Publication date (Electronic): 9 December 2022

Publication date PMC-release: 9 December 2022

Publication date (Print): 2023

Volume: 79

Issue: 2

Pages: 219-227

Affiliations

[1 ]GRID grid.412301.5, ISNI 0000 0000 8653 1507, Department of Pneumology and Intensive Care Medicine, , RWTH Aachen University Hospital, ; Aachen, Germany

[2 ]GRID grid.412301.5, ISNI 0000 0000 8653 1507, Institute for Clinical Pharmacology, , University Hospital RWTH Aachen, ; Aachen, Germany

[3 ]GRID grid.414802.b, ISNI 0000 0000 9599 0422, Research Department, Federal Institute for Drugs and Medical Devices (BfArM), ; Bonn, Germany

Article

Publisher ID: 3433

DOI: 10.1007/s00228-022-03433-9

PMC ID: 9879805

PubMed ID: 36484792

SO-VID: 576c954f-21cb-4e2f-8eaf-528eb512a972

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 11 July 2022

Date accepted : 21 November 2022

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100003107, Bundesministerium für Gesundheit;

Award ID: ZMVI5–2514ATA004

Award Recipient : Catharina Scholl Julia C. Stingl

Funded by: RWTH Aachen University (3131)

Open Access :

Open Access funding enabled and organized by Projekt DEAL.

Custom metadata

ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine

Keywords: adverse drug reaction,inhaled medications,copd,clinical pharmacology,emergency department

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ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine

Keywords: adverse drug reaction, inhaled medications, copd, clinical pharmacology, emergency department

Inhalation therapies in COPD — adverse drug reactions impact on emergency department presentations

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Abstract

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Drug Repurposing Research Collection

Most cited references 30

Polypharmacy in elderly patients.

Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients.

Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.

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