Inhaled drug delivery is the cornerstone treatment for asthma and chronic obstructive pulmonary disease (COPD). However, use of inhaler devices can be challenging, potentially leading to critical errors in handling that can significantly reduce drug delivery to the lungs and effectiveness of treatment. A systematic review was conducted to define ‘critical’ errors and their impact on health outcomes and resource use between 2004 and 2016, using key search terms for inhaler errors in asthma and COPD (Search-1) and associated health-economic and patient burden (Search-2). Search-1 identified 62 manuscripts, 47 abstracts, and 5 conference proceedings (n = 114 total). Search-2 identified 9 studies. We observed 299 descriptions of critical error. Age, education status, previous inhaler instruction, comorbidities and socioeconomic status were associated with worse handling error frequency. A significant association was found between inhaler errors and poor disease outcomes (exacerbations), and greater health-economic burden. We have shown wide variations in how critical errors are defined, and the evidence shows an important association between inhaler errors and worsened health outcomes. Given the negative impact diminished disease outcomes impose on resource use, our findings highlight the importance of achieving optimal inhaler technique, and a need for a consensus on defining critical and non-critical errors.

/pdf/critical-inhaler-errors-in-asthma-and-copd-a-systematic-yeaqkfszd1.pdf

Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes

https://flore.unifi.it/bitstream/2158/1140466/1/JACI%20in%20Practice_March2017_Critikal%20study.pdf

Inhaler Errors in the CRITIKAL Study: Type, Frequency, and Association with Asthma Outcomes

Pulmonary drug delivery is relatively complex because the respiratory tract has evolved defense mechanisms to keep inhaled drug particles out of the lungs and to remove or inactivate them once deposited. In addition to these mechanical, chemical and immunological barriers, pulmonary drug delivery is adversely affected by the behavioral barriers of poor adherence and poor inhaler technique. Strategies to mitigate the effects of these barriers include use of inhaler devices and formulations that deliver drug to the lungs efficiently, appropriate inhaler technique and improved education of patients. Owing to the advantages offered by the pulmonary route, the challenges that the route poses are worth addressing, and if successfully addressed, the pulmonary route offers huge opportunities, often fulfilling unmet clinical needs.

https://www.future-science.com/doi/pdf/10.4155/tde-2017-0037

Drug delivery to the lungs: challenges and opportunities

Background
Chronic obstructive pulmonary disease (COPD) is characterised by airflow obstruction due to an abnormal inflammatory response of the lungs to noxious particles or gases, for example, cigarette smoke. The pattern of care for people with moderate to very severe COPD often involves regular lengthy hospital admissions, which result in high healthcare costs and an undesirable effect on quality of life. Research over the past decade has focused on innovative methods for developing enabling and assistive technologies that facilitate patient self-management.

Objectives
To evaluate the effectiveness of interventions delivered by computer and by mobile technology versus face-to-face or hard copy/digital documentary-delivered interventions, or both, in facilitating, supporting, and sustaining self-management among people with COPD.

Search methods
In November 2016, we searched the Cochrane Airways Group Specialised Register (CAGR), which contains trial reports identified through systematic searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, AMED, and PsycINFO, and we handsearched respiratory journals and meeting abstracts.

Selection criteria
We included randomised controlled trials that measured effects of remote and Web 2.0-based interventions defined as technologies including personal computers (PCs) and applications (apps) for mobile technology, such as iPad, Android tablets, smart phones, and Skype, on behavioural change towards self-management of COPD. Comparator interventions included face-to-face and/or hard copy/digital documentary educational/self-management support.

Data collection and analysis
Two review authors (CMcC and MMcC) independently screened titles, abstracts, and full-text study reports for inclusion. Two review authors (CMcC and AMB) independently assessed study quality and extracted data. We expressed continuous data as mean differences (MDs) and standardised mean differences (SMDs) for studies using different outcome measurement scales.

Main results
We included in our review three studies (Moy 2015; Tabak 2013; Voncken-Brewster 2015) with a total of 1580 randomised participants. From Voncken-Brewster 2015, we included the subgroup of individuals with a diagnosis of COPD (284 participants) and excluded those at risk of COPD who had not received a diagnosis (1023 participants). As a result, the total population available for analysis included 557 participants; 319 received smart technology to support self-management and 238 received face-to-face verbal/written or digital information and education about self-management. The average age of participants was 64 years. We included more men than women because the sample from one of the studies consisted of war veterans, most of whom were men. These studies measured five of our nine defined outcomes. None of these studies included outcomes such as self-efficacy, cost-effectiveness, functional capacity, lung function, or anxiety and depression.

All three studies included our primary outcome - health-related quality of life (HRQoL) as measured by the Clinical COPD Questionnaire (CCQ) or St George's Respiratory Questionnaire (SGRQ). One study reported our other primary outcomes - hospital admissions and acute exacerbations. Two studies included our secondary outcome of physical activity as measured by daily step counts. One study addressed smoking by providing a narrative analysis. Only one study reported adverse events and noted significant differences between groups, with 43 events noted in the intervention group and eight events in the control group (P = 0.001). For studies that measured outcomes at week four, month four, and month six, the effect of smart technology on self-management and subsequent HRQoL in terms of symptoms and health status was significantly better than when participants received face-to-face/digital and/or written support for self-management of COPD (SMD -0.22, 95% confidence interval (CI) -0.40 to -0.03; P = 0.02). The single study that reported HRQoL at 12 months described no significant between-group differences (MD 1.1, 95% CI -2.2 to 4.5; P = 0.50). Also, hospitalisations (logistic regression odds ratio (OR) 1.6, 95% CI 0.8 to 3.2; P = 0.19) and exacerbations (logistic regression OR 1.4, 95% CI 0.7 to 2.8; P = 0.33) did not differ between groups in the single study that reported these outcomes at 12 months. The activity level of people with COPD at week four, month four, and month six was significantly higher when smart technology was used than when face-to-face/digital and/or written support was provided (MD 864.06 daily steps between groups, 95% CI 369.66 to 1358.46; P = 0.0006). The only study that measured activity levels at 12 months reported no significant differences between groups (mean -108, 95% CI -720 to 505; P = 0.73). Participant engagement in this study was not sustained between four and 12 months. The only study that included smoking cessation found no significant treatment effect (OR 1.06, 95%CI 0.43 to 2.66; P = 0.895). Meta-analyses showed no significant heterogeneity between studies (Chi² = 0.39, P = 0.82; I² = 0% and Chi² = 0.01, P = 0.91; I² = 0%, respectively).

Authors' conclusions
Although our review suggests that interventions aimed at facilitating, supporting, and sustaining self-managment in people with COPD and delivered via smart technology significantly improved HRQoL and levels of activity up to six months compared with interventions given through face-to-face/digital and/or written support, no firm conclusions can be drawn. This improvement may not be sustained over a long duration. The only included study that measured outcomes up to 12 months highlighted the need to ensure sustained engagement with the technology over time. Limited evidence suggests that using computer and mobile technology for self-management for people with COPD is not harmful and may be more beneficial for some people than for others, for example, those with an interest in using technology may derive greater benefit.

The evidence, provided by three studies at high risk of bias, is of poor quality and is insufficient for advising healthcare professionals, service providers, and members of the public with COPD about the health benefits of using smart technology as an effective means of supporting, encouraging, and sustaining self-management. Further research that focuses on outcomes relevant to different stages of COPD is needed. Researchers should provide clear information on how self-management is assessed and should include longitudinal measures that allow comment on behavioural change.

Computer and mobile technology interventions for self-management in chronic obstructive pulmonary disease.

Appropriate selection and correct use of inhalation devices is an integral component in the management of asthma and chronic obstructive pulmonary disease (COPD). It is well known that there are many challenges with the use of inhalers, and no one device suits all patients. Challenges can range from difficulties related to lung disease severity and pulmonary function to physical considerations, including manual dexterity and comorbidities such as arthritis. In terms of device selection and adherence, patient engagement and satisfaction are also important factors to consider. Furthermore, problems with inhaler use can be most evident in children and older patients. Here, we discuss aspects for consideration with commonly used devices, including nebulizers, pressurized metered-dose inhalers, dry powder inhalers, and the soft mist inhaler. As each inhaler offers varying technical properties, a tailored and personalized approach to the selection of the most appropriate device for the patient is highly recommended in order to increase the likelihood of achieving improved disease outcomes and enhance persistence with device adherence. Importantly, education and support is crucial, not only to enable patients to recognize the need for optimal disease management, but also to help them develop good inhaler technique. In addition, health care professionals should also aim to increase their knowledge of the devices they prescribe, and develop systems to ensure that they offer comprehensive support to patients in clinical practice. Considering these aspects, this review discusses potential strategies to help address the challenges of inhaler use in asthma and COPD.

/pdf/choosing-the-right-inhaler-for-your-asthma-or-copd-patient-47jgtgo4v1.pdf

Choosing the right inhaler for your asthma or COPD patient.

Asthma and chronic obstructive pulmonary disease (COPD) are common chronic inflammatory respiratory diseases, which impose a substantial burden on healthcare systems and society. Fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA), often administered using dry powder inhalers (DPIs), are frequently prescribed to control persistent asthma and COPD. Use of DPIs has been associated with poor inhalation technique, which can lead to increased healthcare resource use and costs. A model was developed to estimate the healthcare resource use and costs associated with asthma and COPD management in people using commonly prescribed DPIs (budesonide + formoterol Turbuhaler® or fluticasone + salmeterol Accuhaler®) over 1 year in Spain, Sweden and the United Kingdom (UK). The model considered direct costs (inhaler acquisition costs and scheduled and unscheduled healthcare costs), indirect costs (productive days lost), and estimated the contribution of poor inhalation technique to the burden of illness. The direct cost burden of managing asthma and COPD for people using budesonide + formoterol Turbuhaler® or fluticasone + salmeterol Accuhaler® in 2015 was estimated at €813 million, €560 million, and €774 million for Spain, Sweden and the UK, respectively. Poor inhalation technique comprised 2.2–7.7 % of direct costs, totalling €105 million across the three countries. When lost productivity costs were included, total expenditure increased to €1.4 billion, €1.7 billion and €3.3 billion in Spain, Sweden and the UK, respectively, with €782 million attributable to poor inhalation technique across the three countries. Sensitivity analyses showed that the model results were most sensitive to changes in the proportion of patients prescribed ICS and LABA FDCs, and least sensitive to differences in the number of antimicrobials and oral corticosteroids prescribed. The cost of managing asthma and COPD using commonly prescribed DPIs is considerable. A substantial, and avoidable, contributor to this burden is poor inhalation technique. Measures that can improve inhalation technique with current DPIs, such as easier-to-use inhalers or better patient training, could offer benefits to patients and healthcare providers through improving disease outcomes and lowering costs.

/pdf/the-economic-burden-of-asthma-and-chronic-obstructive-4kkwes7q0p.pdf

The economic burden of asthma and chronic obstructive pulmonary disease and the impact of poor inhalation technique with commonly prescribed dry powder inhalers in three European countries

Budesonide + formoterol delivered via Spiromax® for the management of asthma and COPD: The potential impact on unscheduled healthcare costs of improving inhalation technique compared with Turbuhaler®.

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The economic burden of asthma and chronic obstructive pulmonary disease and the impact of poor inhalation technique with commonly prescribed dry powder inhalers in three European countries

Budesonide + formoterol delivered via Spiromax® for the management of asthma and COPD: The potential impact on unscheduled healthcare costs of improving inhalation technique compared with Turbuhaler®.