An in vitro investigation into the release of fugitive medical aerosols into the environment during manual ventilation.

BACKGROUND: During manual resuscitation, nebulizer therapy may be used to deliver therapeutics to patients in respiratory distress. However, the devices used to generate and deliver these medical aerosols have the potential to release these therapeutics into the local environment and expose caregivers to unwanted medical aerosols. AIM: To quantify the levels of fugitive medical aerosol released into the environment during aerosol drug delivery using a manual resuscitation bag with and without filtration. METHODS: Time-varying fugitive aerosol concentrations were measured using an aerodynamic particle sizer placed at a position designed to mimic a caregiver. Two nebulizer types were assessed, a vibrating mesh nebulizer and a jet nebulizer. The aerosol dose delivered to the simulated patient lung was also quantified. FINDINGS: Filtration of the exhalation port of the manual resuscitation bag was seen to reduce fugitive medical aerosols to ambient levels for both nebulizer types. The vibrating mesh nebulizer delivered the greatest quantity of aerosol to the simulated adult patient (18.44 ± 1.03% versus 3.64 ± 0.26% with a jet nebulizer). CONCLUSIONS: The results highlight the potential for exposure to fugitive medical aerosols released during the delivery of aerosol therapy with a manual resuscitation bag and also the potential for significant variation in patient lung dose depending on nebulizer type.

Observational study of newborn infant parasympathetic evaluation as a comfort system in awake patients admitted to a pediatric intensive care unit.

To compare the newborn infant parasympathetic evaluation system (NIPE) scores with a validated clinical scale using two different nebulizers in children with bronchiolitis admitted to a PICU. Comfort was evaluated using the COMFORT-behavior scale (CBS) before (T1), during (T2) and after (T3) each nebulization. In order to compare NIPE and CBS values during the whole T1 to T3 period, the variable Dif-CBS was defined as the difference between maximal and minimal CBS scores, and Dif-NIPE as the difference between 75th and 25th percentile NIPE values. Analyses were carried out, firstly for the total of nebulizations and secondly comparing two different nebulization systems: a jet nebulizer (JN) and a nebulizer integrated in high flow nasal cannulas (NHF). 84 nebulizations were recorded on 14 patients with a median [25th-75th percentile] age of 6 months (3.1-9.5). A Dif-CBS of 4 points (2-7), as well as changes in CBS scores between T1 and T2, defined the nebulization as a discomfort stimulus. The NIPE system, represented as the Dif-NIPE, showed a median variation of 9 points (7-10), and was poorly correlated to Dif-CBS [rs 0.162 (P = 0.142)]. Discomfort during nebulization, assessed by CBS was greater with the JN system compared to NHF: 17 (13-22) vs 13 (9-15) (P = 0.001). NIPE monitoring detected no significant differences between both nebulization systems (P = 0.706). NIPE monitoring showed a variation in comfort during nebulization in the patient with bronchiolitis, though correlation with CBS was poor. Further research is required before NIPE can be suggested as a comfort monitoring system for the awake infant.

The Impact of Adding a Training Device to Familiar Counselling on Inhalation Technique and Pulmonary Function of Asthmatics.

INTRODUCTION: We have investigated the effect of adding a pressurized metered dose inhaler (pMDI) training device to verbal counselling on pulmonary function and inhalation technique. METHODS: A total of 304 adult asthmatic subjects (> 18 years old) were enrolled in a 3-month study of assessment and education. They were divided into an investigation group (Trainhaler plus Flo-Tone and verbal counselling, n = 261, mean age 49.2 years) and a control group (verbal counselling only, n = 43, mean age 48.7 years). Pulmonary function and inhalation technique were evaluated, mistakes noted, and the correct technique advised at three consecutive monthly visits. Visits also included verbal pMDI counselling (both groups) and training device coaching (investigation group). RESULTS: By visit 2, the mean number of technique errors decreased significantly (p < 0.05) in both groups (investigation group p < 0.001). The investigation group demonstrated a marked decrease in the frequency of the critical error of maintaining a slow inhalation rate until the lungs are full-a technique difficult to learn via verbal counselling alone. The improvement in pulmonary function was significant from the second clinic visit in the investigation group (p < 0.05) and from the third visit in both groups (p < 0.001). CONCLUSIONS: Use of a training device combined with verbal counselling improved inhalation technique. An earlier, significant improvement was also noted in pulmonary function.

[The Aut-idem Rule and the Importance of Patient-Individual Selection of Inhalers for the Therapy of Airway Diseases in Practices of Pneumologists and General Practitioners - Assessment and Implementation by Pneumologists and General Practitioners]. / Aut-idem-Regelung und Inhalatorauswahl bei inhalativer Therapie in pneumologischen und hausärztlichen Praxen unter Alltagsbedingungen ­ Einschätzung und Umsetzung durch Pneumologen und Hausärzte.

Drug therapy of obstructive airway diseases mainly relies on inhaled medication. The success of this therapy depends primarily on the selection of the appropriate inhaler considering patient's choice and the correct application. The aut-idem-rule, an active exclusion of the optional substitution by the pharmacist, allows prescribing physicians to ensure the delivery of a particular inhaler, which was selected for that patient, who was trained to use specifically that inhaler. This survey shows that pneumologists and, to a greater extent general practitioners, do not consistently make use of this option, although they unanimously agree on the importance of targeted inhaler selection. As a result, patients may receive different inhalers in the pharmacy, where the inhaler is chosen under consideration of market-driven aspects such as rebate contracts or stock. This causes that patients get confused by the exchange of their inhaler. Thus the exchange of the inhaler by the pharmacist leads to uncertainty and application problems in patients. Hence, the success of the comparatively complex inhaled therapy is endangered. This could be prevented, if prescribing physicians were informed and supported consistently regarding the use of aut-idem exclusion to ensure an optimal therapy for each individual patient.

In Vitro and In Vivo Comparison of Two Nebulizers Used for Inhaled Pentamidine Delivery / Comparación in vitro e in vivo de dos nebulizadores utilizados para administrar pentamidina inhalada

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Uso de inhaladores: detección de errores e intervención por el farmacéutico comunitario / Use of inhalers: Error detection and intervention by the community pharmacist

Introducción: Los inhaladores son medicamentos que requieren un adiestramiento especial para su correcto uso. Conocer a los usuarios de inhaladores y evaluar cuáles son los errores que cometen puede ser el punto de partida para su abordaje y solución. El farmacéutico comunitario es clave para asegurar el uso correcto de inhaladores. Objetivos: Conocer variables sociodemográficas de los usuarios de inhaladores. Analizar los errores que se comenten en el uso de inhaladores e intervenir sobre ellos. Conocer si perciben controlado su problema de salud y evaluar qué opinan sobre la actitud activa del farmacéutico. Material y método: Estudio observacional multicéntrico en seis farmacias de la provincia de Badajoz con hoja de recogida de datos con cuestionario y hojas de evaluación de los sistemas de inhalación. Resultados: Participan 152 pacientes y 26 cuidadores. Se evalúan 202 inhaladores y se detectan e intervienen 876 errores. El error clínicamente significativo más frecuente en la técnica de inhalación es no contener la respiración 10 segundos o lo máximo posible tras la inhalación (57,2% de los casos). En el 60,9% de los casos no conocen correctamente cómo limpiar el inhalador, en el 43,9% no saben cuándo el inhalador está vacío y en el 36,1% no saben que deben enjuagarse la boca tras su uso. El 61,8% de los usuarios cree que el problema de salud para el que usan los inhaladores no está bien controlado y el 99,4% cree que la actitud activa del farmacéutico ayuda a mejorar el uso de los inhaladores (AU)

Introduction: Inhalers are drugs that require special training for proper use. Define users of inhalers and assess what mistakes are made can be the starting point for tackle them and get a solution. The community pharmacist is key to ensuring the correct use of inhalers. Objectives: To find out social and demographic variables of users inhalers. To analyze the mistake made in the use of inhalers and act on them. To find out if users perceive their health problem controlled and to assess what they think about the active role of the pharmacist. Material and methods: Multicenter observational study whose data collection was performed in sixcommunity pharmacies located in the province of Badajoz using a questionnaire and evaluation sheets of the inhalers. Results: Participants included 152 patients and 26 careers. 202 inhalers are evaluated and 876 errors are detected and intervened. The most frequent inhalation technique clinically significant error is not contain the respiration for 10 seconds or as long as possible after inhalation (57.2% of cases). In 60.9% of cases users do not know how to clean the inhaler correctly, in 43.9% users do not know when the inhaler is empty and the 36.1% do not know they should rinse their mouth after use. The 61.8% of users believe that the health problem for using inhalers is not well controlled and 99.4% believe that the active role of the pharmacist helps improve the use of inhalers (AU)

Educación en el niño y adolescente con asma (1.ª parte). Terapia inhalada en el asma: ¿cómo elegir el dispositivo y la técnica de inhalación más adecuados para cada niño? / Education in children and adolescents with asthma (part 1). Inhaled therapy in asthma: how to choose the most appropiate device and inhalation technique for each child?

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A cross-sectional study to assess inhalation device handling and patient satisfaction in COPD.

Delivery of inhaled medications via an inhaler device underpins the effectiveness of treatment for patients with chronic obstructive pulmonary disease (COPD). Correct inhaler technique among patients is also a predictor of achieving treatment compliance and adherence. Reporting of patient satisfaction with inhalers is therefore gaining increasing attention and is now recognized as an important patient-reported outcome in clinical trials involving patients with COPD or asthma. In this cross-sectional study, we use the validated Patient Satisfaction and Preference Questionnaire (PASAPQ) to assess the handling and satisfaction for Respimat(®) Soft Mist™ Inhaler (SMI) compared with the Breezhaler(®) dry powder inhaler (DPI) among patients with COPD in Spain. Patients were already assigned to therapy with either SPIRIVA(®) (tiotropium) Respimat(®) or with Hirobriz(®)/Onbrez(®)/Oslif(®) (indacaterol) Breezhaler(®) for at least 3 but not more than 6 months before completing the PASAPQ at a single visit to the study site. The primary endpoint of the trial was the mean total PASAPQ score. Secondary endpoints were the performance score domain of the PASAPQ, the convenience score domain of the PASAPQ, and the overall satisfaction score of the PASAPQ. For the primary endpoint, the mean PASAPQ total score in the Respimat(®) and Breezhaler(®) groups was 80.7 and 79.9, respectively (difference of 0.8, 95% confidence interval [CI] -2.9 to 4.5; P=0.67). The mean total performance scores were 82.5 and 78.2 (difference of 4.3, 95% CI -0.3 to 8.9; P=0.06), and the mean total convenience scores were 78.6 and 81.9 (difference of -3.3, 95% CI -7.0 to 0.4; P=0.08) for the Respimat(®) and Breezhaler(®) groups, respectively. Patients gave the Respimat(®) SMI and the Breezhaler(®) DPI overall satisfaction PASAPQ scores of 6.0 and 5.9, respectively, which shows that patients were satisfied with these inhalers.

Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Vicks® VapoInhaler®.

This final rule adopts the interim final rule, with a correction to spelling of the manufacturer's name that was published in the Federal Register on October 27, 2015. The Drug Enforcement Administration is amending the table of Excluded Nonnarcotic Products to update the listing for Vicks® VapoInhaler®, containing 50 mg levmetamfetamine in a nasal decongestant inhaler, marketed by The Procter & Gamble Company. This over-the-counter, non-narcotic drug product is excluded from provisions of the Controlled Substances Act.

Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhaler/Vapor Inhaler. Final rule.

This final rule adopts, without change, the interim final rule that was published in the Federal Register on October 27, 2015. The Drug Enforcement Administration is amending the table of Excluded Nonnarcotic Products to update the company name for the drug product Nasal Decongestant Inhaler/Vapor Inhaler (containing 50 milligrams levmetamfetamine) to Aphena Pharma Solutions--New York, LLC. This over-the-counter, nonnarcotic drug product is excluded from the provisions of the Controlled Substances Act.

[Inhaled treatments: Choice of devices, systemic absorption of inhaled drugs and bitter taste receptors in the respiratory tract]. / Traitements inhalés : critères de choix des dispositifs, absorption systémique des médicaments par voie inhalée et récepteurs pulmonaires à l'amertume.

Inhaled drugs are now routinely prescribed in daily medical practice. Recent topics about these treatments have been developed during the fourth annual meeting of the Groupe de travail aérosolthérapie (GAT) of the French-speaking respiratory society (Société de pneumologie de langue française). This article focuses mainly upon the choice of devices, systemic absorption of inhaled drugs and bitter taste receptors in the respiratory tract, a potential new target for drug development.

Antibioterapia inhalada y dispositivos de inhalación en patología infecciosa pulmonar / Inhaled medication and inhalation devices for lung disease

La terapia antibiótica nebulizada es una opción terapéutica muy atractiva en el tratamiento de las infecciones pulmonares dada la alta concentración que se obtiene del antimicrobiano en el sitio de la infección, minimizando efectos adversos y posibles interacciones farmacológicas. Es en la fibrosis quística (FQ) donde se han ensayado mayoritariamente estos medicamentos y dispositivos, aunque existe también experiencia en el área del trasplante pulmonar, bronquiectasias, pacientes críticos ventilados y en inmunocomprometidos principalmente oncohematológicos. La oferta de antimicrobionanos para nebulización es amplia e incluye: betalactámicos, aminoglucósidos, y antifúngicos. Existe muy poca evidencia científica en esta área y prácticamente se basa en ensayos randomizados en la FQ y estudios de cohortes en otras patologías respiratorias. En esta revisión se comentan todos los antibióticos disponibles a fecha de hoy, indicaciones, resultados y dispositivos adecuados para su uso correcto. Varios factores contribuyen a su depósito pulmonar que es altamente variable en función del dispositivo empleado, fármaco, enfermedad pulmonar de base y patrón ventilatorio. Asimismo se resaltan las precauciones que se deberían tener en cuenta cuando se prescribe una terapia antibiótica nebulizada. Por último, a pesar de que muchos médicos han adquirido experiencia positiva con las terapias antibióticas nebulizadas, se necesitan ensayos clínicos fuera del campo de la FQ para responder a preguntas clínicas importantes, como lo es la dosis adecuada de antibiótico, el dispositivo de administración óptimo, así como la farmacocinética precisa del fármaco en aerosol (AU)

Nebulized antibiotic therapy is an attractive therapeutic option given the high concentration obtained from the drug at the site of infection, minimizing the adverse effects and possible drug interactions. Inhalation of drugs as treatment of cystic fibrosis (CF) related lung disease has been proven to be highly effective. Consequently, an increasing number of drugs and devices have been developed for CF lung disease or are currently under development. Other limited areas of experience in this field are lung transplant recipients, immunosuppressed patients, bronchiectasis and ventilated patients. In this review document we analyse the current status of the inhaled medications, their modes of administration and indications and their results as well as side effects. Specifically we address antibiotics, and additionally, we review the current knowledge on devices for inhalation therapy with regard to optimal particle sizes and characteristics of wet nebulisers, dry powder and metered dose inhalers. Several factors contribute to a highly variable pulmonary drug deposition as the devices, the physical properties of the administered antimicrobial agent, the type of respiratory disease and the inhalation technique. Despite many clinicians have obtained a valuable experience from the aerosolized administration of antimicrobials and persuaded of their efficacy and safety. However, RCTs out of CF are needed to answer important clinical questions, such as what is the appropriate dose, the optimal delivery device, the optimal way of drug administration, as well as the exact therapeutic role and pharmacokinetic profile of aerosolized drug (AU)

Comparison of the provocative concentration of methacholine causing a 20% fall in FEV1 between the AeroEclipse II breath-actuated nebulizer and the wright nebulizer in adult subjects with asthma.

RATIONALE: The American Thoracic Society guidelines for methacholine testing for the diagnosis of asthma recommends the 2-minute tidal breathing protocol with the Wright nebulizer, which produces more aerosol than required, generates a small particle size, and requires cleaning between tests. OBJECTIVES: To evaluate methacholine testing using a disposable, breath-actuated AeroEclipse II, which produces aerosol during inspiration and was developed for single-patient use. METHODS: Forty-six adult subjects with asthma (19 men), aged 27.3 (SD, 9.5) years, with FEV1 98.5 (SD, 18.1) % predicted participated in a randomized, crossover, observational study. Subjects were first screened using the Wright nebulizer, then assigned to 2 minutes of tidal breathing from the Wright or 20 seconds of tidal breathing from the AeroEclipse nebulizer on 2 separate days, in random order. Provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) values were calculated by linear interpolation of log dose-versus-response curves, log-transformed, and compared using paired Student t test and Pearson correlation. MEASUREMENTS AND MAIN RESULTS: The 38 subjects demonstrating reproducible PC20 measurements of within 1.5 doubling concentrations were included in the comparison. The geometric mean methacholine PC20 measured with the AeroEclipse nebulizer was approximately 1 doubling concentration lower than the geometric mean methacholine PC20 of the Wright nebulizer (P < 0.05). The Pearson correlation coefficient between the two nebulizers was 0.86 (P < 0.05). CONCLUSIONS: The PC20 measurements using the two nebulizers were highly correlated; however, the PC20 determined with the AeroEclipse nebulizer was significantly lower than those determined using the Wright nebulizer. Clinical trial registered with www.clinicaltrials.gov (NCT 01919424).

Indicators for childhood asthma in Spain, using the Rand method

OBJECTIVE: To develop quality indicators to measure asthma care in primary health care. METHOD: A modified RAND was used, which included the systematic review of the literature in Embase, Cochrane and Pubmed Quality Agencies and Database. The work group identified the indicators, translated them into Spanish and resolved any duplicates. Each indicator is composed of several dimensions (access to care, clinical effectiveness, patient-centred quality and patient safety). A multidisciplinary panel of 98 professionals from all over Spain were invited to score each indicator using a Likert scale. After calculating the average and median of each indicator, this information was sent to those who responded (n = 38) for a second round and further scoring. The agreement percentage for the group was obtained for each indicator. RESULTS: Of the 105 asthma indicators reviewed, we selected 46 that were presented to the panel of experts. In both Delphi phases, 37.1% of the members of the initial panel of experts responded. Of these, 26 were primary care paediatricians, six were pulmonologists, three were nurses, two were pharmacists and one was an allergist. For 32 indicators, agreement exceeded 70% and seven of those scored highest for the various care aspects for asthmatic children. CONCLUSION: Quality indicators are presented for the follow-up of asthma and their implementation in primary care, which have undergone a strict selection and agreement process by a multidisciplinary work group

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[The choice of inhalation device: A medical act]. / Le choix du dispositif d'inhalation (hors nébulisation) : un acte médical.

Inhaled treatments are essential for respiratory diseases management, including COPD and asthma. Optimal control of the disease largely depends on patient's compliance and proper use of these treatments. Different types of ready-to-use inhaler devices are available: metered dose inhaler, dry powder inhaler or soft mist inhaler. Each of these devices presents specific characteristics and constraints that have to be evaluated and taken into account before prescription. In order to optimize adherence and treatment efficacy, the choice of inhaler device should depend on the specific needs, abilities and preferences of each patient and a specific education to treatment should be provided. Inhaled treatments, even containing the same drug, have different technical constraints and are thus not easily interchangeable. Their substitution without prior medical consent and without proper training can lead to errors in taking treatment, treatment failures and increased health care consumption. In France, substitution by the pharmacist is not authorized. While patient education must be carried out in collaboration with all health professionals, it is preferable that the choice of inhaler device remains the responsibility of the physician.

The importance of continuity in inhaler device choice for asthma and chronic obstructive pulmonary disease.

Inhaled therapies are central to the treatment of asthma and chronic obstructive pulmonary disease. Physicians consider many factors when selecting the most appropriate inhaler device, including device efficacy and the cost to the health care system. This review aims to discuss the factors that are important when considering inhaler devices and the importance of continuity in the choice of inhaler device. A large number of factors can contribute to therapeutic outcomes with inhalation devices. The inhalation technique is critical to treatment success and differs substantially between inhaler devices. Misuse of an inhaler is common, and thorough training of patients and physicians is important to ensure correct utilization. Patient satisfaction is an important consideration because it is significantly correlated with compliance and better outcomes. Financial pressures contribute to decision making: although selecting the less expensive inhaler device might reduce direct treatment costs, it can have a large impact on disease control and the patient's well-being. Switching may be associated with a poor inhalation technique, reduced disease control and quality of life, increased use of other treatments and health care resources, and a greater chance of unsuccessful treatment. Nonconsensual switches can result in patient discontent, reduced confidence in the medication, and uncertainty regarding the degree of disease control. It is recommended that patients with stable disease remain on their current device. If a switch is considered, the patient should be consulted and the physician should take into account the patient's preference, their ability to correctly use the device, and the availability of the preferred drug in the preferred device.

A comparative study of two nebulizers in the emergency department: breath-actuated nebulizer and handheld nebulizer.

INTRODUCTION: The breath-actuated nebulizer (BAN) and the handheld nebulizer (HHN) are 2 nebulizers used in the ED of Cooper University Hospital. The purpose of this study was to compare the nebulizers to identify which device resulted in a resolution of symptoms with fewer treatments. The primary hypothesis was that adult ED patients with a chief complaint of wheezing and dyspnea who were given nebulized treatments via the BAN would require less nebulizer treatments than those patients given nebulized treatments via HHN. In addition, the secondary purposes of the study was to determine if the BAN would have significantly higher peak expiratory flow measurements, lower Modified Borg Score, overall decreased respiratory rate, and lower heart rates compared to subjects receiving nebulized treatments via HHN. METHODS: A single-site, prospective, randomized, comparative design study was conducted in the ED between March 2010 and February 2011. Fifty-four subjects presenting with dyspnea and wheezing and an Emergency Severity Index of 3 or 4 were enrolled and randomly assigned to 1 of 2 groups (BAN or HHN). Subjects were administered 1 to 3 nebulizer treatments (#1 ipratropium bromide and albuterol sulfate, #2 ipratropium bromide and albuterol sulfate, #3 albuterol sulfate), which was consistent with the ED Advanced Nursing Guideline for Wheezing. Nebulizer treatments were discontinued if a patient's dyspnea or wheezing resolved. IRB approval was obtained prior to study commencement. RESULTS: There was no significant difference found between the HHN and BAN in respect to number of treatments, respiratory rate, peak flow measurements, and Modified Borg scores in the 54 subjects. There was a difference of 7 points in pulse rate between the pre- and post-second BAN treatment (n = 51, P = 0.01). Subjects in the BAN group who completed all 3 treatments (n = 18) had a total treatment time that was on average of 10 minutes longer than those in the HHN group. CONCLUSIONS: This study demonstrated no clinical difference between the BAN and HHN in terms of respiratory rate, peak flow, perception of dyspnea, and number of treatments. It is possible that the longer treatment times account for the elevated pulse rate. The data suggests that the higher cost and the longer treatment time do not justify the use of the BAN in this setting. We recommend that these devices be tested with a larger sample size to further test the differences between these 2 devices.