Does mixing inhaler devices lead to unchecked inhaler technique errors in patients with COPD? Findings from the cross-sectional observational MISMATCH study.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) may be prescribed multiple inhalers that require different techniques for optimal performance. Mixing devices has been associated with poorer COPD outcomes suggesting that it leads to inappropriate inhaler technique. However, empirical evidence is lacking. AIMS: Compare the nature and frequency of dry powder inhaler (DPI) technique errors in patients with COPD using (1) a single DPI or (2) mixed-devices (a DPI and pressurised metered dose inhaler (pMDI)). METHODS: Data from the PIFotal study-a cross-sectional study on Peak Inspiratory Flow in patients with COPD using a DPI as maintenance therapy, capturing data from 1434 patients on demographic characteristics, COPD health status and inhaler technique-were used to select 291 patients using mixed-devices. Frequency matching based on country of residence and DPI device type was used to select 291 patients using a DPI-only for comparison. Predetermined checklists were used for the evaluation of DPI video recordings and complemented with additional errors that were observed in ≥10%. Error proportions were calculated for the (1) individual and total number of errors, (2) number of critical errors and (3) number of pMDI-related errors. RESULTS: The study sample contained 582 patients (mean (SD) age 69.6 (9.4) years, 47.1% female). DPI technique errors were common, but not significantly different between the groups. The majority of patients made at least one critical error (DPI-only: 90.7% vs mixed-devices: 92.8%). Proportions of total, 'pMDI-related' and critical errors did not significantly differ between the groups. CONCLUSION: The nature and frequency of inhaler technique errors did not substantially differ between patients prescribed with a single DPI and mixed-devices. Currently, 'pMDI-related errors' in DPI use are not accounted for in existing checklists. TRIAL REGISTRATION NUMBER: ENCEPP/EUPAS48776.

Sustainability in Inhaled Drug Delivery.

Asthma and chronic obstructive pulmonary disease (COPD) are amongst the most common chronic diseases worldwide, and are largely preventable by improving the quality of the air we breathe. The most commonly deployed treatment, the metered dose inhaler (MDI), uses hydrofluorocarbon propellants, which are powerful greenhouse gases that contribute disproportionately to the climate crisis. Alternative treatment strategies are required if we are to avoid contributing to the worst effects of climate change. These strategies include promoting non-pharmacological therapies like smoking cessation and pulmonary rehabilitation; empowering patients to gain better disease control through written management plans and encouraging preventer, rather than reliever therapies. Pharmacological strategies include: improving inhaler technique and spacer use; minimising propellant release by using smaller volume MDIs and simpler dosing regimes; dose counters to prevent waste; switching to low global warming potential inhalers; and inhaler recycling. There are also opportunities to improve disease control alongside reduced greenhouse gas emissions, including better matching of patients' devices to inhaler technique rather than defaulting to MDIs, stopping unnecessary inhaled steroids in COPD and maintenance and reliever therapy in asthma. New, lower global warming potential propellants are on the horizon, and their introduction could offer a golden opportunity to enhance MDIs usability and sustainability by making them refillable, integrating whistles to optimise inhalation technique, adding integrated caps, optimising materials for recycling and adding dose counters to all MDIs.

Costs of switching to low global warming potential inhalers. An economic and carbon footprint analysis of NHS prescription data in England.

OBJECTIVES: Metered-dose inhalers (MDIs) contain propellants which are potent greenhouse gases. Many agencies propose a switch to alternative, low global warming potential (GWP) inhalers, such as dry powder inhalers (DPIs). We aimed to analyse the impact on greenhouse gas emissions and drug costs of making this switch. SETTING: We studied National Health Service prescription data from England in 2017 and collated carbon footprint data on inhalers commonly used in England. DESIGN: Inhalers were separated into different categories according to their mechanisms of action (eg, short-acting beta-agonist). Within each category we identified low and high GWP inhalers and calculated the cost and carbon impact of changing to low GWP inhalers. We modelled scenarios for swapping proportionally according to the current market share of each equivalent DPI (model 1) and switching to the lowest cost pharmaceutically equivalent DPI (model 2). We also reviewed available data on the carbon footprint of inhalers from scientific publications, independently certified reports and patents to provide more accurate carbon footprint information on different types of inhalers. RESULTS: If MDIs using HFA propellant are replaced with the cheapest equivalent DPI, then for every 10% of MDIs changed to DPIs, drug costs decrease by £8.2M annually. However if the brands of DPIs stay the same as 2017 prescribing patterns, for every 10% of MDIs changed to DPIs, drug costs increase by £12.7M annually. Most potential savings are due to less expensive long-acting beta-agonist (LABA)/inhaled corticosteroids (ICS) inhalers. Some reliever inhalers (eg, Ventolin) have a carbon footprint over 25 kg CO2e per inhaler, while others use far less 1,1,1,2-tetrafluoroethane (HFA134a) (eg, Salamol) with a carbon footprint of <10 kg CO2e per inhaler. 1,1,1,2,3,3,3-Heptafluoropropane (HFA227ea) LABA/ICS inhalers (eg, Flutiform) have a carbon footprint over 36 kg CO2e, compared with an equivalent HFA134a combination inhaler (eg, Fostair) at <20 kg CO2e. For every 10% of MDIs changed to DPIs, 58 kt CO2e could be saved annually in England. CONCLUSIONS: Switching to DPIs would result in large carbon savings and can be achieved alongside reduced drug costs by using less expensive brands. Substantial carbon savings can be made by using small volume HFA134a MDIs, in preference to large volume HFA134a MDIs, or those containing HFA227ea as a propellant.

Bone and ocular safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a 52-week randomized study.

BACKGROUND: Long-term use of inhaled corticosteroids (ICSs) has been associated with increased risk of bone and ocular comorbidities. We evaluated the effects of the triple fixed-dose combination budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI), formulated using co-suspension delivery technology, on bone mineral density (BMD) and ocular safety in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). METHODS: In this extension study, a subset of patients from the 24-week, phase III, randomized, double-blind KRONOS study (NCT02497001) continued treatment (BGF MDI 320/18/9.6 µg, budesonide/formoterol fumarate [BFF] MDI 320/9.6 µg or glycopyrrolate/formoterol fumarate [GFF] MDI 18/9.6 µg, as a non-steroidal comparator) for an additional 28 weeks. Primary endpoints were percentage change from baseline in lumbar spine BMD and change from baseline in lens opacities classification system III posterior subcapsular cataract (P) score, both at Week 52. Adverse events were also assessed. RESULTS: In total, 456 patients were included in the safety population (53.1% male, mean age 62.8 years). Changes from baseline in lumbar spine BMD (least squares mean [LSM] range - 0.12 to 0.38%) and P score (LSM range 0.02-0.15) were small for all treatments. Both BGF MDI and BFF MDI were non-inferior to GFF MDI using margins of -2% (BMD) and 0.5 units (P score). The incidence of treatment-emergent adverse events (TEAEs)  was generally similar among groups. Rates of confirmed pneumonia were low overall (2.4%) and highest in the GFF MDI group (3.4%), followed by BGF MDI (2.1%) and BFF MDI (1.1%). There were no cumulative adverse effects of treatment over time as the incidence and types of TEAEs, were generally similar in the first 24 weeks of the study and after Week 24. CONCLUSIONS: In patients with COPD, both ICS-containing therapies were non-inferior to GFF MDI for the primary BMD and ophthalmological endpoints. Changes from baseline in all three treatment groups over 52 weeks were small and not clinically meaningful. All treatments were well tolerated with no new or unexpected safety findings. TRIAL REGISTRATION: ClinicalTrials.gov NCT02536508. Registered 27 August 2015.

Comparison of adverse events associated with different spacers used with non-extrafine beclometasone dipropionate for asthma.

Co-prescription of Aerochamber® spacer with non-extrafine beclometasone diproprionate (non-EF BDP) is common but unlicensed. We report a comparison of inhaled corticosteroid (ICS)-related adverse events between patients co-prescribed Aerochamber compared to the licensed Volumatic® spacer. We utilised two historical cohorts: questionnaire-based and electronic medical record (EMR)-based, to assess patient-reported and EMR-recorded adverse events in patients with asthma prescribed non-EF BDP. Marginal effect estimate (MEE) was calculated to determine non-inferiority of Aerochamber compared to Volumatic in terms of patient-reported oral thrush and hoarseness with margin of 0.13. Other patient-reported adverse events (sore throat, bruising, weight gain, and coughing), and EMR-recorded adverse events were also assessed. Rate of patient-reported oral adverse events were non-inferior in 385 patients prescribed Aerochamber compared to 155 patients prescribed Volumatic (27.7 vs 29.9%; MEE, -0.043; 95% CI, -0.133 to 0.047). Total patient-reported adverse events did not differ significantly between Aerochamber and Volumatic (53.3 vs 49.7% with ≥1 adverse event). The EMR-based study of 1471 matched pairs of subjects did not show significantly different number of EMR-recorded adverse events between Aerochamber and Volumatic (12.5 vs 12.8% with ≥1 adverse events). Co-prescribing Aerochamber with non-EF BDP does not increase the risk for patient-reported and EMR-recorded ICS-related adverse events compared to co-prescribing Volumatic.

A comparative analysis of errors in inhaler technique among COPD versus asthma patients.

PURPOSE: This study was designed to evaluate errors in inhaler technique in COPD vs asthma patients and to investigate the association of poor inhaler technique with patient demographics and clinical variables. PATIENTS AND METHODS: A total of 509 adult patients with COPD (n=328) or asthma (n=181) who were currently using an inhaler device were included in this study. Data on patient demographics, duration of disease, type and duration of inhaler therapy, and assessment of inhaler technique were recorded. RESULTS: Metered dose inhaler (MDI) was the most common type of inhaler used by a similarly high percentage of patients in both COPD (83.2%) and asthma (77.3%) groups. Failure to exhale before inhaling through device (75.8% and 68.5% for MDIs; 73.2% and 71.8% for Aerolizer®/Handihaler®; 53.1% and 66.7% for Turbuhaler®) was the most common error in inhaler technique, in both COPD and asthma groups. Device-specific errors in inhaler techniques were more common in asthma patients as compared with COPD patients, particularly for MDIs (P-values ranged from 0.046 to 0.0005), as associated with female gender (failure to press the buttons on both sides of Aerolizer®/Handihaler®, P=0.006), shorter duration of disease (failure to hold MDI or head in a vertical position, P<0.001, and to keep Turbuhaler® upright, P=0.005), and shorter duration of inhaler usage (failure to hold head in a vertical position during MDI usage, P=0.006, and to keep Turbuhaler® upright, P=0.012). CONCLUSION: In conclusion, our findings revealed that errors in inhaler technique in terms of inhalation maneuvers and device handling were similarly common in COPD and asthma patients. Errors in certain device handling maneuvers, particularly with MDIs, were more common among asthma patients than among COPD patients and associated with female gender and shorter durations of disease and inhaler therapy.

Vibrating Mesh Nebulizer Compared With Metered-Dose Inhaler in Mechanically Ventilated Subjects.

BACKGROUND: The impact of various aerosol delivery devices on patient outcomes during mechanical ventilation is unknown. If one method of delivery results in a higher ventilator-associated pneumonia (VAP) rate than another, multiple patient outcomes may be affected. This study aimed to determine whether there was a difference in VAP occurrence and patient outcomes (days receiving ventilation and in-hospital mortality) between the vibrating mesh nebulizer (AeroNeb Solo) and the metered-dose inhaler (MDI). METHODS: This retrospective study reviewed medical records for all mechanically ventilated, adult patients with an order for aerosol treatment from August 2011 to August 2013. The hospital converted from MDI to vibrating mesh nebulizers in August 2012, and data were gathered 1 y before/after conversion. Excluded were patients with a tracheostomy, patients who were mechanically ventilated for <24 h, patients who received a combination of nebulizer and MDI treatments, or patients who were re-intubated. RESULTS: Two hundred twenty-eight subjects were included. Forty-eight (21%) received treatment with an MDI, and 180 (79%) were treated with the vibrating mesh nebulizer. Descriptive data did not significantly differ for age or APACHE II (Acute Physiology and Chronic Health Evaluation II) scores between the groups but did for sex (P = .03). Difference in median days receiving ventilation for the MDI (5 d, interquartile range 3.0-8.5 d) and the vibrating mesh nebulizer (6 d, interquartile range 4.0-10.0 d) was not statistically significant. No correlation was found between the use of either device and the primary outcomes of VAP and in-hospital mortality. In multivariable logistic regression analysis, the number of days receiving ventilation increased the odds of VAP (odds ratio [OR] 1.3, 95% CI 1.14-1.49, P < .001) and mortality (OR 1.12, 95% CI 1.04-1.21, P = .002). Higher APACHE II scores increased the odds of mortality (OR 1.05, 95% CI 1.001-1.092, P = .044). CONCLUSION: We found no association between an MDI or vibrating mesh nebulizer and our primary outcomes, days receiving ventilation, in-hospital mortality, or VAP, in mechanically ventilated subjects.

Incidence of oral thrush in patients with COPD prescribed inhaled corticosteroids: Effect of drug, dose, and device.

BACKGROUND AND AIMS: Little information is available on real-life occurrence of oral thrush in COPD patients treated with ICS. We investigated oral thrush incidence in COPD patients prescribed FDC ICS/LABA therapies and assessed whether it is modulated by the ICS type, dose, and delivery device. METHODS: We conducted a historical, observational, matched cohort study (one baseline year before and one outcome year after initiation of therapy) using data from the UK Optimum Patient Care Research Database. We assessed oral thrush incidence in patients initiating long-acting bronchodilators or FDC ICS/LABA therapy. We then compared different combination therapies (budesonide/formoterol fumarate dihydrate [BUD/FOR] and fluticasone propionate/salmeterol xinafoate [FP/SAL]) and devices (DPI and pMDI). RESULTS: Patients prescribed FDC ICS/LABA had significantly greater odds of experiencing oral thrush than those prescribed long-acting bronchodilators alone (adjusted OR 2.18 [95% CI 1.84-2.59]). Significantly fewer patients prescribed BUD/FOR DPI developed oral thrush compared with FP/SAL DPI (OR 0.77 [0.63-0.94]) when allowing for differences in prescribed doses between the drugs. A significantly smaller proportion of patients developed oral thrush in the FP/SAL pMDI arm than in the FP/SAL DPI arm (OR 0.67 [0.55-0.82]). Additionally, in the FP/SAL cohort (both DPI and pMDI), increased risk of oral thrush was significantly associated with high ICS daily dose (OR 1.97 [1.22-3.17] vs low daily dose). CONCLUSIONS: ICS use increases oral thrush incidence in COPD and this effect is dose-dependent for FP/SAL therapies. Of the therapies assessed, FP/SAL pMDI and BUD/FOR DPI may be more protective against oral thrush.

Bronchodilators delivered by nebuliser versus pMDI with spacer or DPI for exacerbations of COPD.

BACKGROUND: Bronchodilators are a central component for treating exacerbations of chronic obstructive pulmonary disease (COPD) all over the world. Clinicians often use nebulisers as a mode of delivery, especially in the acute setting, and many patients seem to benefit from them. However, evidence supporting this choice from systematic analysis is sparse, and available data are frequently biased by the inclusion of asthma patients. Therefore, there is little or no formal guidance regarding the mode of delivery, which has led to a wide variation in practice between and within countries and even among doctors in the same hospital. We assessed the available randomised controlled trials (RCTs) to help guide practice in a more uniform way. OBJECTIVES: To compare the effects of nebulisers versus pressurised metered dose inhalers (pMDI) plus spacer or dry powder inhalers (DPI) in bronchodilator therapy for exacerbations of COPD. SEARCH METHODS: We searched the Cochrane Airways Group Trial Register and reference lists of articles up to 1 July 2016. SELECTION CRITERIA: RCTs of both parallel and cross-over designs. We included RCTs during COPD exacerbations, whether measured during hospitalisation or in an outpatient setting. We excluded RCTs involving mechanically ventilated patients due to the different condition of both patients and airways in this setting. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, extracted data and assessed the risk of bias. We report results with 95% confidence intervals (CIs). MAIN RESULTS: This review includes eight studies with a total of 250 participants comparing nebuliser versus pMDI plus spacer treatment. We identified no studies comparing DPI with nebulisers. We found two studies assessing the primary outcome of 'change in forced expiratory volume in one second (FEV1) one hour after dosing'. We could not pool these studies, but both showed a non-significant difference in favour of the nebuliser group, with similar frequencies of serious adverse events. For the secondary outcome, 'change in FEV1 closest to one hour after dosing': we found a significant difference of 83 ml (95% CI 10 to 156, P = 0.03) in favour of nebuliser treatment. For the secondary outcome of adverse events, we found a non-significant odds ratio of 1.65 (95% CI 0.42 to 6.48) in favour of the pMDI plus spacer group. AUTHORS' CONCLUSIONS: There is a lack of evidence in favour of one mode of delivery over another for bronchodilators during exacerbations of COPD. We found no difference between nebulisers versus pMDI plus spacer regarding the primary outcomes of FEV1 at one hour and safety. For the secondary outcome 'change in FEV1 closest to one hour after dosing' during an exacerbation of COPD, we found a greater improvement in FEV1 when treating with nebulisers than with pMDI plus spacers.A limited amount of data are available (eight studies involving 250 participants). These studies were difficult to pool, of low quality and did not provide enough evidence to favour one mode of delivery over another. No data of sufficient quality have been published comparing nebulisers versus DPIs in this setting. More studies are required to assess the optimal mode of delivery during exacerbations of COPD.

Overuse of short-acting beta-agonist bronchodilators in COPD during periods of clinical stability.

BACKGROUND: Overuse of short-acting beta-agonists (SABA) is described in asthma, but little is known about overuse of SABA in chronic obstructive pulmonary disease (COPD). METHODS: Prospective 3-month cohort study of patients with moderate-to-severe COPD who were provided a portable electronic inhaler sensor to monitor daily SABA use. Subjects wore a pedometer for 3 seven-day periods and were asked to complete a daily diary of symptoms and inhaler use. Overuse was defined as >8 actuations of their SABA per day while clinically stable. RESULTS: Among 32 participants, 15 overused their SABA inhaler at least once (mean 8.6 ± 5.0 puffs/day), and 6 overused their inhaler more than 50% of monitored days. Compared to those with no overuse, overusers had greater dyspnea (modified Medical Research Council Dyspnea Scale: 2.7 vs. 1.9, p = 0.02), were more likely to use home oxygen (67% vs. 29%, p = 0.04), and were more likely to be on maximal inhaled therapy (long-acting beta-agonist, long-acting antimuscarinic agent, and an inhaled steroid: 40% vs. 6%, p = 0.03), and most had completed pulmonary rehabilitation (67% vs. 0%, p < 0.001). However, 27% of overusers of SABA were not on guideline-concordant COPD therapy. CONCLUSIONS: Overuse of SABA was common and associated with increased disease severity and symptoms, even though overusers were on more COPD-related inhalers and more had completed pulmonary rehabilitation. More research is needed to understand factors associated with inhaler overuse and how to improve correct inhaler use.

Use of a Shared Canister Protocol for the Delivery of Metered-Dose Inhalers in Mechanically Ventilated Subjects.

BACKGROUND: Mechanically ventilated patients often need bronchodilators administered via a metered-dose inhaler (MDI). Unfortunately, there are no data examining the impact of shared canister delivery of MDI therapy in mechanically ventilated patients. METHODS: A prospective trial was conducted with subjects assigned to shared canister MDI therapy or single-patient canister MDI therapy. Outcomes assessed were occurrence of ventilator-associated pneumonia (VAP), hospital mortality, length of stay, ventilator-associated events, and MDI costs. RESULTS: Among 486 screened patients, 353 were included for analysis of which 201 (56.9%) received shared canister MDI therapy and 152 (43.1%) received single-patient canister therapy. VAP (7.0% vs 4.6%, P = .35), hospital mortality (21.9% vs 20.4%, P = .73), and ventilator days (median [interquartile range] 3.1 [0.9-7.5] d vs 2.7 [1.2-7.1] d, P = .62) were similar between the shared canister and single-patient canister groups. We did not observe clinically important differences for ventilator-associated events between study groups in our logistic regression analysis (P = .07). There was a savings of $217/subject in the shared canister group due to the use of 299 fewer MDIs. CONCLUSIONS: Our study found that shared canister MDI therapy compared with single-patient MDI use was associated with a significant cost savings and similar rates of VAP, hospital mortality, and length of stay but a greater prevalence of ventilator-associated events. This finding suggests that shared canister delivery of MDIs may be a cost-effective practice in mechanically ventilated patients. Based on our findings, further studies examining the overall safety of shared canister use in mechanically ventilated patients seem warranted before recommending their routine use. (ClinicalTrials.gov registration NCT01935388.).

Assessment of inhaler techniques employed by patients with respiratory diseases in southern Brazil: a population-based study.

OBJECTIVE: To identify incorrect inhaler techniques employed by patients with respiratory diseases in southern Brazil and to profile the individuals who make such errors. METHODS: This was a population-based, cross-sectional study involving subjects ≥ 10 years of age using metered dose inhalers (MDIs) or dry powder inhalers (DPIs) in 1,722 households in the city of Pelotas, Brazil. RESULTS: We included 110 subjects, who collectively used 94 MDIs and 49 DPIs. The most common errors in the use of MDIs and DPIs were not exhaling prior to inhalation (66% and 47%, respectively), not performing a breath-hold after inhalation (29% and 25%), and not shaking the MDI prior to use (21%). Individuals ≥ 60 years of age more often made such errors. Among the demonstrations of the use of MDIs and DPIs, at least one error was made in 72% and 51%, respectively. Overall, there were errors made in all steps in 11% of the demonstrations, whereas there were no errors made in 13%.Among the individuals who made at least one error, the proportion of those with a low level of education was significantly greater than was that of those with a higher level of education, for MDIs (85% vs. 60%; p = 0.018) and for DPIs (81% vs. 35%; p = 0.010). CONCLUSIONS: In this sample, the most common errors in the use of inhalers were not exhaling prior to inhalation, not performing a breath-hold after inhalation, and not shaking the MDI prior to use. Special attention should be given to education regarding inhaler techniques for patients of lower socioeconomic status and with less formal education, as well as for those of advanced age, because those populations are at a greater risk of committing errors in their use of inhalers.

Assessment of inhaler techniques employed by patients with respiratory diseases in southern Brazil: a population-based study / Avaliação da técnica de utilização de dispositivos inalatórios no tratamento de doenças respiratórias no sul do Brasil: estudo de base populacional

OBJECTIVE: To identify incorrect inhaler techniques employed by patients with respiratory diseases in southern Brazil and to profile the individuals who make such errors. METHODS: This was a population-based, cross-sectional study involving subjects ≥ 10 years of age using metered dose inhalers (MDIs) or dry powder inhalers (DPIs) in 1,722 households in the city of Pelotas, Brazil. RESULTS: We included 110 subjects, who collectively used 94 MDIs and 49 DPIs. The most common errors in the use of MDIs and DPIs were not exhaling prior to inhalation (66% and 47%, respectively), not performing a breath-hold after inhalation (29% and 25%), and not shaking the MDI prior to use (21%). Individuals ≥ 60 years of age more often made such errors. Among the demonstrations of the use of MDIs and DPIs, at least one error was made in 72% and 51%, respectively. Overall, there were errors made in all steps in 11% of the demonstrations, whereas there were no errors made in 13%.Among the individuals who made at least one error, the proportion of those with a low level of education was significantly greater than was that of those with a higher level of education, for MDIs (85% vs. 60%; p = 0.018) and for DPIs (81% vs. 35%; p = 0.010). CONCLUSIONS: In this sample, the most common errors in the use of inhalers were not exhaling prior to inhalation, not performing a breath-hold after inhalation, and not shaking the MDI prior to use. Special attention should be given to education regarding inhaler techniques for patients of lower socioeconomic status and with less formal education, as well as for those of advanced age, because those populations are at a greater risk of committing errors in their use of inhalers. .

OBJETIVO: Conhecer os erros na técnica de uso de dispositivos inalatórios empregada por pacientes com doenças respiratórias no sul do Brasil e o perfil daqueles que possuem dificuldades em realizá-la. MÉTODOS: Estudo transversal, de base populacional, com indivíduos com idade ≥ 10 anos e em uso de inaladores pressurizados (IPrs) ou inaladores de pó (IP) em 1.722 domicílios de Pelotas (RS). RESULTADOS: Foram incluídos 110 indivíduos que utilizavam 94 IPrs e 49 IP. Os principais erros no uso dos IPrs e IP foram não expirar antes da inalação (66% e 47%, respectivamente), não fazer uma pausa inspiratória após a inalação (29% e 25%) e não agitar o IPr antes do uso (21%). Os indivíduos com idade ≥ 60 anos mais frequentemente cometeram erros. Das demonstrações de uso do IPr e IP, respectivamente, 72% e 51% apresentaram ao menos um erro, enquanto 13% das demonstrações foram plenamente corretas e 11% apresentaram erros em todas as fases. A proporção de indivíduos com menor nível de escolaridade que cometeram ao menos um erro foi significativamente maior do que a daqueles com maior nível de escolaridade tanto no uso de IPrs (85% vs. 60%; p = 0,018) quanto no de IPs (81% vs. 35%; p = 0,010). CONCLUSÕES: Nesta amostra, os principais erros cometidos no uso dos inaladores foram não realizar a expiração antes da inalação, não fazer a pausa inspiratória após a inalação e não agitar o IPr. Pacientes com menor nível socioeconômico e educacional, assim como aqueles com idade avançada, merecem especial atenção na educação sobre a realização da técnica inalatória, pois apresentam um maior risco de cometer erros durante o uso dos inaladores. .

The use of the faces, legs, activity, cry and consolability scale to assess procedural pain and distress in young children.

INTRODUCTION: Young children frequently undergo diagnostic and therapeutic procedures in the emergency department (ED). Although developed and validated for postoperative pain, Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scores have been recommended and used for the assessment of procedural pain as well. We set out to assess if FLACC scores can differentiate pain and distress and establish a hierarchy of FLACC scores experienced during common ED procedures. METHODS: Prospective observational study at an urban tertiary children's hospital ED. We aimed to recruit 30 children each aged 6 to 42 months undergoing intravenous cannula (IV) insertion, nasogastric tube (NGT) insertion, metered dose inhaler (MDI) use and oxygen saturation (SpO(2)) measurement. Based on videotapes, 2 independent observers assessed pain and distress using FLACC scores during all procedural phases. RESULTS: A total of 125 patients were recruited and filmed for IV (33), NGT (30), MDI (34), and SpO2 (28). Median FLACC scores were as follows: NGT, 10 (interquartile range [IQR] 8.75-10); IV, 6.5 (IQR, 4.5-9.75); MDI, 6.5 (IQR, 0-9); and SpO(2), 0 (IQR, 0-0.5). The FLACC scores increased during each of the 3 phases, before the procedure, during restraint, and during the procedure. Procedural distress decreased with age except for NGT insertions, which remained very high irrespective of age. CONCLUSIONS: FLACC scores can be high during nonpainful procedures and the during restraint phase of painful procedures. This indicates that FLACC measures a composite of pain and distress in young children. This study identified substantial levels of pain and distress in young children by FLACC during commonly performed ED procedures, with nasogastric tube insertion having very high and intravenous cannulation/venepuncture and MDI having high FLACC scores.

Quarterly assessment of short-acting beta(2)-adrenergic agonist use as a predictor of subsequent health care use for asthmatic patients in the United States.

PURPOSE: An annual time frame for risk assessment may not account for the variable course of asthma. The purpose of this study was to determine whether excessive short-acting beta(2)-adrenergic agonist (SABA) dispensed quarterly was associated with asthma exacerbations in the subsequent quarter. PATIENTS AND METHODS: This retrospective cohort analysis included 93,604 health plan members aged 6-56 years with >or=2 years of continuous enrollment (2003-2007), an asthma diagnosis, and asthma prescription claims. The amount of SABA dispensed in claims (metered-dose inhaler and nebulized) was converted to canister equivalents (CEs) in the first observation quarter and categorized as 0, 0.5-3, and >or=3 (excessive SABA use). Asthma exacerbation risk (hospitalization, emergency department [ED] visit, or oral corticosteroid [OCS] claim in the subsequent quarter) was assessed using logistic regression. Covariates used in the regression models were age, sex, geographic region, comorbidities, specialist consultation, asthma controller medication use, and asthma severity. RESULTS: The cohort included 33,951 patients aged 6-17 years (36%) and 59,653 aged 18-56 years (64%); 64% had 0 SABA CE, and 5% had >3 SABA CEs. Compared with 0 CE, excessive SABA use (>3 CEs) was associated with an increased likelihood of hospitalization (adjusted odds ratio [OR]: 3.15, 95% confidence interval [CI]: 1.89-5.27) and an ED/urgent care (UC) visit (adjusted OR: 3.14, 95% CI: 2.32-4.28). CONCLUSION: The risk of an asthma exacerbation was associated with excessive SABA use in the previous quarter. Assessment of excessive SABA dispensed during a calendar quarter can be used to identify patients at increased exacerbation risk in the subsequent quarter.

The functionality of a budesonide/formoterol pressurized metered-dose inhaler with an integrated actuation counter.

Integration of an actuation counter into pressurized metered-dose inhalers (pMDIs) can allow patients to accurately determine the remaining number of medication doses. This study was designed to assess the functionality of budesonide/formoterol (Symbicort; AstraZeneca, Dunkerque, France) pMDI with an integrated actuation counter in a clinical setting. Children aged > or =6 years, adolescents, and adults with inhaled corticosteroid-dependent asthma participated in this 6-week, randomized, open-label, multicenter study (SD-039-0743; D5896C00743). Patients were treated with budesonide/formoterol pMDI with no actuation counter (80/4.5 micrograms x 2 inhalations [160/9 micrograms] twice daily) during a 7- to 10-day run-in period. Qualifying patients were then randomized into one of three groups treated with budesonide/formoterol pMDI with actuation counter (80/4.5 micrograms x 2 inhalations [160/9 micrograms] twice daily): group 1, 96 actuations (24 days); group 2, 120 actuations (30 days); or group 3, 128 actuations (32 days). Actuation count was assessed using position of the counter arrow, patient/caregiver reports (daily log and actuation counter final reading), and device (canister plus actuation counter assembly) weight change. Patients/caregivers rated ease of device use. There was good agreement across treatment groups (n = 254) between patient/caregiver-reported actuation counts and counts determined by the angular position of the arrow. Analysis of device weight change versus other estimates of actuation counts in groups 1 and 2 indicated that the device did not undercount the number of actuations sprayed. Most patients (93%) indicated the device was "extremely easy" or "very easy" to use. Clinical functionality and reliability of the budesonide/formoterol pMDI device with an actuation counter were established.