Abstract
Inhaler devices play an important role in the management of obstructive lung diseases including asthma, chronic obstructive pulmonary disease (COPD), and asthma–COPD overlap. Some of these patients show suboptimal inhaler techniques; however, time for inhaler instruction by pharmacists is limited in daily clinical practice. Therefore, sufficient education regarding inhaler device handling should be provided within a limited time frame. The current study aimed to investigate the instruction methods provided by community pharmacists and their influence on inhaler device handling techniques in outpatient clinical care settings. We retrospectively collected the data of outpatients with obstructive lung diseases who were referred to our hospital and who underwent inhalation technique assessments conducted by community pharmacists. The prevalence of handling errors, clinical characteristics of patients, and instruction methods were analyzed. In total, 138 patients (170 devices) were included in this study. Approximately 70.0% of patients received verbal explanations combined with leaflets about inhaler instructions. In a device-based analysis, 63 (37.1%) of 170 devices had at least one technical error and 18 (10.6%) of the devices had critical errors. Patients without critical errors received practical demonstration instructions from pharmacists combined with leaflets and verbal explanations more frequently than those with critical errors (22.8 vs. 0%, p < 0.01). This study revealed that patients with obstructive lung diseases commonly present with inhaler device handling errors and critical errors were observed with non-negligible frequency in daily practice in Japan. Combined instruction with leaflet, verbal explanation, and pharmacist demonstration may be effective in improving proper inhaler treatment.
INTRODUCTION
The appropriate use of inhaler devices is essential for the treatment of obstructive lung diseases such as asthma, chronic obstructive pulmonary disease (COPD), and asthma–COPD overlap. However, there are a wide variety of inhaler devices including dry powder inhalers (DPIs), pressurized metered-dose inhalers (pMDIs), and soft mist inhalers (SMIs), and using multiple devices may lead to incorrect inhaler handling.1) Previous reports have shown that approximately 30–70% of patients do not use their inhaler devices properly. Furthermore, a considerable proportion of patients with asthma and COPD had at least one critical error,2) which is defined as errors that are likely to significantly impair the delivery of adequate medication on all occasions.3) Mishandling of inhaler devices is associated with higher use of medical resources and poor disease control.4) The assessment of inhalation technique and patient education are therefore important to achieve treatment goals.
Among healthcare professionals, community pharmacists play a pivotal role in educating patients because they are positioned at the end of the process of delivering medications to patients.5) Indeed, in the previous questionnaire survey, many Japanese patients responded that they could understand the correct use of their medications through the instructions of their regular pharmacists.6) The previous review shows that community pharmacists can have a positive impact on the management of COPD in relation to the inhaler technique.7) A randomized controlled trial also reveals that the provision of face-to-face instructions by pharmacists is a more effective method of reducing inhaler technical errors compared with written materials and web-based videos.8) Repeated, intensive instruction improves the inhaler techniques in hospitalized patients.9) However, the instruction time for device handling in outpatient clinical settings is limited. In fact, many pharmacists agree that they should spend more time evaluating and educating patients about inhaler devices in the previous study.10) It is therefore necessary to investigate what type and combination of instruction methods is the most effective in reducing device mishandling.
Although inhaler device education may be provided in many community pharmacies, few data are available on the relationship between the type of instruction methods provided by pharmacists and the effectiveness of improving inhaler handling techniques in routine outpatient clinical practice in Japan. The present study aimed to evaluate the inhaler instruction methods conducted by community pharmacists and their influence on inhaler device-handling techniques in routine outpatient care settings.
PATIENTS AND METHODS
Patients EnrollmentWith the cooperation of community pharmacies, an instruction program for patients using inhaler devices has been started in January 2019 in our hospital. We evaluated the inhaler handling techniques of the patient under this program. Information about patients’ medical conditions (i.e., main diagnosis, type of device used, comorbidities) and inhalation techniques was shared between community pharmacists and hospital physicians and used to describe the prevalence of poor inhaler handling techniques, and which type of instruction method was associated with a reduced risk of mishandling devices.
This study included outpatients aged ≥18 years old with asthma, COPD, and asthma–COPD overlap who were treated with inhaler medications in the department of respiratory medicine of the University of Tokyo Hospital and who underwent inhalation technique assessment conducted by community pharmacists between January 1, 2019, and March 31, 2022. Both device-naïve patients and those with continuous inhaler treatment were enrolled. However, patients without controller medications (reliever use only) were excluded. Written informed consent was obtained from all patients. Diagnoses were made by respiratory physicians with a clinical experience of 10 years or more and were based on asthma and COPD guidelines.11–13) This study, which used the medical records of patients who were treated at the department of respiratory medicine, was approved by the institutional review board of the University of Tokyo Hospital (Approval No. 2739-[10], April 1998), and was conducted in accordance with the Declaration of Helsinki.
Inhaler Instruction and Data CollectionFigure 1 depicts the study flow diagram. First, attending physicians who prescribed inhaler devices administered instruction evaluation forms to each patient. Information about the diagnoses of patients and prescribed devices was shared among community pharmacists and physicians. Second, patients submitted the evaluation form(s) and received inhaler instructions at the pharmacy. The instruction method provided was based on to discretion of each pharmacist. Third, each patient was evaluated for the comprehension of their disease, prescribed drugs, and inhaler device-handling techniques using an evaluation form. The inhaler devices assessed were DPIs (Turbuhaler, Diskus, Breezhaler, Ellipta, HandiHaler, Twisthaler, Swinghaler, Diskhaler, and Genuair), pMDIs, and SMIs. The form contained the following items, which can be used to evaluate inhaler device-handling techniques: six for DPIs, eight for pMDIs, and seven for SMIs (additional two items for inhaled corticosteroids-containing devices in DPIs and pMDIs) (Table 1). For each step listed in the form for a particular inhaler device, pharmacists were instructed to record if the patient did or did not answer the questions correctly or complete the handling step, and to report the assessment of technical error. Further, they were instructed to report the instruction methods used for each patient using a checklist, which comprises the following categories: provision of leaflet alone, verbal explanation (without leaflet), verbal explanation with leaflet, video, inhalation demonstration by pharmacists using a training kit (pharmacist demonstration), and inhalation demonstration by patients themselves using a training kit (patient demonstration). Finally, the completed evaluation forms were faxed to the attending physicians. Patient information including age, sex, disease diagnosis, comorbidities, and inhaler devices used was collected from the medical records. The relationship between patient characteristics and inhaler device-handling techniques was evaluated.
Table 1. Checklist of Inhalation Instruction
| DPI | pMDI | SMI |
|---|
| Preparation of dose | ✓ | ✓ | ✓ |
| Shaking the device before inhalation | | ✓ | |
| Exhaling before inhalation | ✓ | ✓ | ✓ |
| Synchronization of hand actuation and inhalation | | ✓ | ✓ |
| Inhalation speed (breathe in quickly and deeply) | ✓ | | |
| Inhalation speed (breathe in slowly and deeply) | | ✓ | ✓ |
| Breath holding after inhalation | ✓ | ✓ | ✓ |
| Exhalation after inhalation | ✓ | ✓ | ✓ |
| Gargling (only for ICS including device) | ✓ | ✓ | |
| Mouth rinsing (only for ICS including device) | ✓ | ✓ | |
| Others (additional comments) | ✓ | ✓ | ✓ |
| Total number of checklist items | 6 (8 for ICS including device) | 8 (10 for ICS including device) | 7 |
Abbreviations: DPI, dry powder inhaler; ICS, inhaled corticosteroids; pMDI, pressurized metered-dose inhaler; SMI, soft mist inhaler.
In patients who were prescribed multiple inhaler devices, all devices were included in the error assessment. In terms of technical errors, major errors that are likely to result in the inhalation of significantly reduced, minimal, or no medications were defined as critical errors, according to previous studies with slight modifications2,14,15) (Supplementary Table S1). We focused on the comparison of patients with and without critical error since a previous large clinical trial of patients with COPD revealed that critical device handling error (but not a non-critical error) was associated with severe exacerbation.2) If certain inhaler devices were associated with critical errors, the characteristics of patients who used these devices were also investigated.
Pulmonary Function Test and Symptom AssessmentSpirometry was performed using FUDAC-7 or FUDAC-77 (Fukuda Denshi Co., Ltd., Tokyo, Japan), and all measurements were performed according to the American Thoracic Society/European Respiratory Society guidelines.16,17) The predicted values for each variable were derived using the Japanese criteria.18) The fractional exhaled nitric oxide (FENO) was evaluated using SIEVERS Nitric Oxide Analyzer MODEL-280i NOA (NIPPON MEGACARE Co., Ltd., Tokyo, Japan) until January 7, 2020, and NIOX-VERO after January 29, 2020 (CHEST M.I., Inc., Tokyo, Japan). The severity of comorbidity was assessed using the age-adjusted Charlson comorbidity index.19) The definitions of asthma and COPD exacerbation were based on previous studies.20,21) The results of the pulmonary function test and FENO assessment conducted within a year before obtaining informed consent were included in the analyses.
Statistical AnalysisBetween-group comparisons were performed using the Mann–Whitney U test or one-way ANOVA. The post-hoc test (Dunn’s multiple comparison test) was used for the evaluation of continuous variables, and the Fisher’s exact probability test or the chi-square test for categorical variables. Data were expressed as mean ± standard deviation (S.D.) and percentage (%) as appropriate. Data were analyzed using GraphPad Prism version 5.04 (GraphPad Software, San Diego, CA, U.S.A.). A p-value of < 0.05 was considered statistically significant.
RESULTS
Patient CharacteristicsWritten informed consent was obtained from 155 patients with asthma, COPD, and asthma–COPD overlap who were treated with inhaler devices. Of these, 140 evaluation forms were sent back to the hospital from community pharmacies (response rate: 90.3%). After excluding two evaluation forms with insufficient responses, 138 patients (asthma, n = 65; COPD, n = 62 asthma–COPD overlap, n = 11) were included in the study (total number of instructed inhaler devices: 170) (Table 2). The mean age of the participants was 69.6 ± 13.9 years, and 48.6% were women. The median duration of illness was 5.0 (interquartile range: 1.0–11) years. The mean number of inhaler devices used by one patient was 1.2 ± 0.5. The most frequently used device was DPI (52.5% of the total devices). Approximately 23.2% of patients used multiple devices. The median duration of inhaler device use was 3.0 (interquartile range: 0–30.5) months.
Table 2. Patient Characteristics
| n = 138 |
|---|
| Age (years) | 69.6 (± 13.9) |
| Disease (%) |
| Asthma | 65 (47.1) |
| COPD | 62 (44.9) |
| Asthma–COPD overlap | 11 (8.0) |
| Sex, female (%) | 67 (48.6) |
| Body mass index | 23.8 (± 4.7) |
| Duration of illness (years), median (interquartile range) | 5.0 (1.0–11) |
| Smoking history, former or current (%) | 86 (62.3) |
| Severe exacerbation in the previous year | 0.2 (± 0.5) |
| Total number of comorbidities | 4.1 (± 2.2) |
| Charlson comorbidity index (age-adjusted) | 4.4 (± 2.5) |
| Multiple device use (%) | 32 (23.2) |
| Inhaler device naïve (%) | 68 (49.3) |
| Total number of medications a) | 8.1 (± 4.9) |
| Duration of device use (months), median (interquartile range)b) | 3.0 (0–30.5) |
| Cumulative total number of instructed inhaler devices | 170 |
| Number of inhaler devices used/patient, mean | 1.2 (± 0.5) |
| 1 device | 111 |
| 2 devices | 22 |
| 3 devices | 5 |
| Type of device (%) |
| Dry powder inhaler c) | 91 (53.5) |
| Pressurized metered-dose inhaler | 41 (24.1) |
| Soft mist inhaler | 37 (21.8) |
Abbreviation: COPD, chronic obstructive pulmonary disease. Data are expressed as mean (± standard deviation) unless otherwise specified. a) All medications for asthma, COPD, Asthma–COPD overlap, and comorbidities were included. b) The duration of use was unknown for three devices in patients with asthma, one in a patient with COPD, and two in patients with Asthma–COPD overlap. c) Turbuhaler, n = 21; Diskus, n = 5; Breezhaler, n = 16; Ellipta, n = 49.
In the spirometric analyses, compared with patients with asthma and/or asthma–COPD overlap, those with COPD had a greater decline in pulmonary function, as evidenced by forced expiratory volume in one second (FEV1) (L [± S.D.]: asthma, 1.9 [± 0.7]; COPD, 1.6 [± 0.5]; and asthma–COPD overlap, 2.0 [± 0.6]; p = 0.04) and the percentage of its predicted values (% [± S.D.]: asthma, 86.5 [± 23.6]; COPD, 65.8 [± 15.7]; and asthma–COPD overlap, 85.8 [± 7.6]; p < 0.001), percentage of the predicted vital capacity (% [± S.D.]: asthma, 94.5 [± 17.1]; COPD, 85.4 [± 18.3]; and asthma–COPD overlap, 103.8 [± 15.2]; p < 0.01), and the percentage of the predicted forced vital capacity (% [± S.D.]: asthma, 98.3 [± 18.7]; COPD, 87.2 [± 18.6]; and asthma–COPD overlap, 106.7 [± 14.9]; p < 0.001) (Supplementary Table S2).
Instruction Method and Type of ErrorPharmacists provided inhaler instructions for 170 inhaler devices (Table 3). None of the pharmacists instructed patients with the provision of leaflets alone. Most patients (70.0%) were provided with leaflets combined with verbal explanations. On the contrary, pharmacist or patient demonstration was performed in approximately one-third of patients, and only three patients (1.8%) received video instruction. There was a wide variation in the implementation rate of demonstration instructions among pharmacies, ranging from 0 to 84.6%, however, we could not obtain detailed information on these pharmacies including the number and characteristics of pharmacists employed, the number of daily patients served, and the number of daily prescriptions dispensed.
Table 3. Instruction Method and Type of Error
| n (%) |
|---|
| Total number of instructed devices | 170 (100) |
|---|
| Type of instruction method received (device-based) (%) (multiple choices allowed) |
| Providing leaflet only | 0 |
| Verbal explanation (without leaflet) | 13 (7.6) |
| Verbal explanation with leaflet | 119 (70.0) |
| Video | 3 (1.8) |
| Inhalation demonstration by pharmacist using training kit | 59 (34.7) |
| Inhalation demonstration by patient using training kit | 49 (28.8) |
| Error assessment (patient-based, n = 138) |
| Total number of error (any) | 264 |
| Number of error/patient (mean ± standard deviation) | 1.9 (± 3.0) |
| At least one technical error (non-critical error + critical error) (%) | 57 (41.3) |
| At least one critical error (%) | 16 (11.6) |
| Error assessment (device-based, n = 170) |
| At least one technical error (%) | 63 (37.1) |
| Dose priming before inhalation | 20 (11.8) |
| Exhaling before inhalation | 23 (13.5) |
| Synchronization of hand actuation and inhalation | 26 (15.3) |
| Inhalation speed | 39 (22.9) |
| Breath holding after inhalation | 38 (22.4) |
| Exhalation after inhalation | 20 (11.8) |
| Gargling | 15 (8.8) |
| Mouth rinsing | 14 (8.2) |
| Others a) | 1 (0.6) |
| At least one critical error (%) | 18 (10.6) |
| Dosage and administration | 1 (0.6) |
| Dose priming before inhalation | 8 (4.7) |
| Synchronization of hand actuation and inhalation | 10 (5.9) |
| Inhalation speed | 1 (0.6) |
a) The patient could not recognize the dose counter.
Among 170 instructed devices, 63 (37.1%) inhaler devices had at least one technical error, and the mean number of errors per patient was 1.9. The most common errors were inadequate inhalation speed (22.9%), followed by inadequate breath holding after inhalation (22.4%), and non-synchronization of hand actuation and inhalation (15.3%). Eighteen (10.6%) of the instructed devices had critical errors. Most critical errors were observed during synchronization of hand actuation and inhalation (n = 10; 5.9% of all instructed devices, 55.6% of those with critical errors) and dose priming before inhalation (n = 8; 4.7% of all instructed devices, 44.4% of those with critical errors). As for the relationship between instruction methods and patient characteristics, there were no differences in age, sex, and device type between the patients who received the instruction of only leaflet plus verbal explanation and those who received either demonstration (Supplementary Table S3). We also investigated the relationship between the number of the five instruction resources (leaflet provision, verbal explanation, video, pharmacist demonstration, and patient demonstration) provided and the occurrence of critical errors. Patients who received either four of the instruction resources demonstrated the highest rate of critical errors, although the difference did not reach significance (incidence of critical error; either one of the instruction resources, 0%; either two of the instruction resources, 13.4%; either three of the instruction resources, 7.9%; either four of the instruction resources, 25.9%: p = 0.053, the five-instruction resource group was excluded from the analysis due to a nil sample size).
Error Assessment DetailAlthough the mean age of patients with at least one critical error (74.0 ± 10.4 years) was higher than those without critical error (68.9 ± 14.3 years), the difference was not statistically significant (p = 0.15) (Table 4). Patients with critical errors showed a lower percentage of the predicted FEV1 and used fewer medications than those without critical errors. Most other factors including sex, type of disease, frequency of exacerbation, duration of illness, comorbidities or health impairments, and inhaler device-naïve characteristics did not differ between patients with and without critical errors. Since patients with critical errors were more likely to use SMIs than those without (50.0 vs. 24.0%, p = 0.04), the characteristics of SMI and non-SMI users were also investigated (Table 5). The results showed that compared with non-SMI users, SMI users had a lower pulmonary function, a higher number of inhaler devices used, and a longer duration of device use. Further, they were more likely to be diagnosed with COPD, use multiple devices, and less likely to use DPI concomitantly.
Table 4. Type of Errors and Patient Characteristics
| No critical error (n = 121) | At least one critical error (n = 16) | p-Value |
|---|
| Age (years) | 68.9 (± 14.3) | 74.0 (± 10.4) | 0.15 |
| Sex (%), female | 61 (50.4) | 6 (37.5) | 0.43 |
| Disease (%) | | | 0.36 |
| Asthma | 58 (47.9) | 7 (43.8) |
| COPD | 52 (43.0) | 9 (56.3) |
| Asthma–COPD overlap | 11 (9.1) | 0 |
| Duration of illness (years), median (IQR) | 5.0 (1.0–11.0) | 4.9 (2.6–18.1) | 0.44 |
| Severe exacerbation in the previous year | 0.2 (± 0.5) | 0.3 (± 0.6) | 0.52 |
| FEV1 (L) a) | 1.8 (± 0.6) | 1.5 (± 0.5) | 0.09 |
| FEV1, % predicted a) | 77.6 (± 21.2) | 63.4 (± 20.8) | 0.03 |
| Dementia and other cognitive disorder (%) | 9 (7.4) | 3 (18.8) | 0.15 |
| Hemiplegia or facial nerve paralysis (%) | 2 (1.7) | 1 (6.3) | 0.31 |
| Arthritis or stiffness of hand (%) | 5 (4.1) | 1 (6.3) | 0.53 |
| Neuropathy of hand (%) | 2 (1.7) | 1 (6.3) | 0.31 |
| Visual impairment (%) | 3 (2.5) | 2 (12.5) | 0.1 |
| Number of comorbidities | 4.2 (± 2.1) | 3.7 (± 2.6) | 0.32 |
| Charlson comorbidity index (age-adjusted) | 4.4 (± 2.5) | 4.6 (± 2.3) | 0.66 |
| Total number of medications | 8.3 (± 4.7) | 6.4 (± 5.7) | 0.03 |
| Dry powder inhaler user (%) b) | 84 (69.4) | 7 (43.8) | 0.051 |
| Pressurized metered-dose inhaler user (%) b) | 30 (24.8) | 4 (25.0) | 1 |
| Soft mist inhaler user (%) b) | 29 (24.0) | 8 (50.0) | 0.04 |
| Multiple device user (%) | 27 (22.3) | 5 (31.3) | 0.53 |
| Inhaler device-naïve (%) | 55 (45.5) | 5 (31.3) | 0.42 |
| Duration of device use (months), median (IQR) | 3.0 (0–33.0) | 8.0 (0–20.0) | 0.83 |
Abbreviations: COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in one second; IQR, interquartile range. Data are expressed as mean (± standard deviation) unless otherwise specified. Letters in bold indicate statistical significance. Data on the instruction method in one patient was missing in the evaluation form. a) Spirometry: patients without critical errors, n = 104; patients with critical errors, n = 10. b) The number of devices is shown by the patient-based analysis.
Table 5. Characteristics of Patients with and without the Use of Soft Mist Inhaler
| Non-SMI users (n = 101) | SMI users (n = 37) | p-Value |
|---|
| Age (years) | 69.2 (± 15.1) | 70.7 (± 10.1) | 0.65 |
| Sex (%), female | 54 (53.5) | 13 (35.1) | 0.08 |
| Disease (%) |
| Asthma (n = 65) | 54 (53.5) | 11 (29.7) | 0.04 |
| COPD (n = 62) | 39 (38.6) | 23 (62.2) | |
| Asthma–COPD overlap (n = 11) | 8 (7.9) | 3 (8.1) | |
| Duration of illness (years), median (IQR) | 5.0 (1.2–11.0) | 4.6 (0.5–11.0) | 0.64 |
| FEV1 (L) | 1.8 (± 0.6) | 1.6 (± 0.5) | 0.28 |
| FEV1, % predicted | 79.6 (± 21.1) | 67.2 (± 20.0) | 0.01 |
| Number of comorbidities | 4.1 (± 2.2) | 4.1 (± 2.2) | 0.99 |
| Type of comorbidities (%) |
| Dementia and other mental disorder | 10 (9.9) | 2 (5.4) | 0.51 |
| Hemiplegia or facial nerve paralysis | 3 (3.0) | 0 | 0.56 |
| Arthritis or stiffness of hand | 4 (4.0) | 2 (5.4) | 0.66 |
| Neuropathy of hand | 2 (2.0) | 2 (5.4) | 0.29 |
| Visual impairment | 4 (4.0) | 0 | 0.57 |
| Charlson comorbidity index (age adjusted) | 4.4 (± 2.7) | 4.6 (± 2.0) | 0.45 |
| Total number of medications | 7.6 (± 4.3) | 9.4 (± 5.9) | 0.15 |
| Total number of inhaler devices/patient | 1.1 (± 0.3) | 1.5 (± 0.7) | < 0.01 |
| Duration of device use (months), median (IQR) | 0.9 (0–20.0) | 12.0 (1.0–40.0) | < 0.01 |
| Multiple device user (%) | 17 (16.8) | 15 (40.5) | < 0.01 |
| Concomitant using inhaler (%) |
| DPI (n = 92) | 84 (83.2) | 8 (21.6) | 0.02 |
| pMDI (n = 40) | 30 (29.7) | 10 (27.0) | |
Abbreviations: COPD, chronic obstructive pulmonary disease; DPI, dry powder inhaler; FEV1, forced expiratory volume in one second; IQR, interquartile range; pMDI, pressurized metered-dose inhaler; SMI, soft mist inhaler. Data are expressed as mean (± standard deviation) unless otherwise specified. Letters in bold indicate statistical significance.
There was no statistical difference in the proportion of patients with and without critical error who received the following instruction: leaflet only, verbal explanation with or without leaflet, video, and pharmacist demonstration (Table 6). On the contrary, patients with critical errors were more likely to receive patient demonstration than those without critical errors (52.4 vs. 25.5%, p = 0.02). Among the combination method, the proportion of patients without error who received combined instruction with leaflet, verbal explanation, and pharmacist demonstration was higher than that of patients with at least one critical error (22.8 vs. 0%, p < 0.01).
Table 6. Instruction Methods and Type of Technical Errors (Device-Based)
| No critical error n (%) | At least one critical error n (%) | p-Value |
|---|
| Total number of instructed devices (n = 170) | 149 (100) | 21 (100) | |
|---|
| Instruction method (multiple choices allowed) |
| 1. Providing leaflet only | 0 | 0 | NA |
| 2. Verbal explanation (without providing leaflet) | 13 (8.7) | 0 | 0.37 |
| 3. Verbal explanation with providing leaflet | 105 (70.5) | 16 (76.2) | 0.80 |
| 4. Video | 2 (1.3) | 1 (4.8) | 0.33 |
| 5. Pharmacist demonstration | 51 (34.2) | 7 (33.3) | 1.00 |
| 6. Patient demonstration | 38 (25.5) | 11 (52.4) | 0.02 |
| Combination a) |
| Leaflet + verbal explanation + pharmacist demonstration | 34 (22.8) | 0 | < 0.01 |
| Leaflet + verbal explanation + patient demonstration | 17 (11.4) | 2 (9.5) | 1.00 |
| Leaflet + verbal explanation + pharmacist demonstration + patient demonstration | 14 (9.4) | 5 (23.8) | 0.06 |
Abbreviation: NA, not applicable. Letters in bold indicate statistical significance. Data on the instruction method in one patient and error assessment in one patient were missing in the evaluation form. a) Other combinations and the video instruction item were excluded from this analysis due to the small number of patients.
DISCUSSION
This study revealed the prevalence of inhaler device handling errors in patients with asthma, COPD, and asthma–COPD overlap, and the relationship between these errors and instruction methods in community pharmacy settings in Japan. All kinds of errors and critical errors were detected in 41.3 and 11.6% of patients (37.1 and 10.6% of instructed devices), respectively. Patients with critical errors were more likely to use SMIs than those without critical errors. In the device-based analyses regarding the type of instruction provided, patients without critical errors received more frequently combined instructions via leaflet, verbal explanation, and practical inhalation demonstrated by pharmacists than did those with critical errors.
The incorrect use of inhaler devices was common in outpatients with obstructive lung diseases. The main errors included non-synchronization of hand actuation and inhalation, failure to execute a forceful and deep inhalation, and breath holding after inhalation. These results were in accordance with those of previous studies in other countries.22,23) Although most pharmacists provided instructions using leaflets combined with verbal explanations, only about 30% of patients received practical demonstrations. Meanwhile, a previous questionnaire survey in Japan showed that 80% of pharmacists provided inhalation demonstrations at the first patient visit.24) The discrepancy may be partly attributed to the difference in the patient and pharmacist populations included in the study. The previous survey was only performed when the patients received their first prescription, and it included pharmacists working in hospital pharmacies. By contrast, our study included non-device-naïve patients and focused on community pharmacies. Device-experienced patients might receive fewer intensive instructions than device-naïve patients because the inhaler technique was less commonly checked after the first prescription.25) Moreover, community pharmacies may have limited access to training resources such as inhaler training kits compared with hospital pharmacies.
Patient education with many types of instructions may be time-consuming and impractical in outpatient clinical settings. An effective combination of instruction methods is therefore required. In this study, patients without critical errors were more likely to receive a combination of methods including leaflet provision, verbal explanation, and practical demonstration by pharmacists than those with critical errors. Watching a demonstration or videotape presentation was superior to the information sheet in improving the pMDI handling technique in patients with asthma.26) Further, Bosnic-Anticevich et al. showed that written and verbal instruction plus physical demonstration by pharmacists outperformed the combination of the former two in reducing technical errors associated with pMDIs in a randomized controlled trial.27) A similar result was observed in patients with asthma who were using Turbuhalers.28) Collectively, combined verbal explanation and demonstration by pharmacists may be useful to improve inhaler device handling in time-limited situations such as outpatient clinical settings. To validate this notion, prospective studies with a larger cohort that include all types of inhaler devices should be performed.
On the contrary, patients who performed their own inhalation demonstration had more critical errors than those who did not perform it. Although the cause of this finding must be further investigated, a patient demonstration itself may not have a negative impact on inhaler handling since a previous study showed the efficacy of patients’ practical demonstration for inhaler technique improvement.29) In the present study, the choice of instruction method was based on the discretion of each pharmacist. Thus, patients who were prone to device handling errors, such as elderly individuals and those with impaired cognitive function, might require more intensive instructions including patient demonstrations, leading to a higher number of critical errors in this group.
Patients with critical errors used SMIs more frequently than those without. Patients who used SMIs were more likely than those who did not to present with a decline in pulmonary function as evidenced by a lower percentage of the predicted FEV1, being diagnosed with COPD, using inhaler devices for a longer duration, and using more types of inhalers. An SMI (tiotropium) was approved for COPD earlier than asthma, therefore, it is likely that SMI was used more frequently in patients with COPD than in those with asthma.30) Patients with a decreased pulmonary function might be prescribed multiple bronchodilators, resulting in a larger number of inhaler devices, although a multivariate regression analysis was not performed due to the small sample size in our study. In patients with COPD, SMI was associated with greater critical handling errors than pMDI.31) In a large observational study including 625 SMI users, critical errors were more frequent in those with non-breath-actuated devices such as pMDIs and SMIs compared with DPI, mainly due to poor hand–lung synchronization.2) Based on these findings, with consideration of hand actuation and inhalation coordination, checking inhalation techniques is important when prescribing SMIs, even in patients with a long duration of device use.
Patients with critical errors showed a lower percentage of the predicted FEV1 and used fewer total medications than those without critical errors. The lower percentage of the predicted FEV1 in the critical error group is partly explained by the fact that patients in this group were older than those without, although the difference was not statistically significant. The relationship between the error frequency and the number of inhaler devices used is controversial.32) Furthermore, evidence on the relationship between the number of all medications used and technical errors is scarce. The difference in the total number of medications in our study was due to the difference in the number of medications for comorbidities since the number of medications for obstructive lung diseases was nearly identical in the two groups (1.6 ± 1.2 in the no critical error group vs. 1.6 ± 0.9 in the critical error group). However, Turan et al. showed that the number of medications for comorbidities did not affect inhaler therapy adherence and technique in elderly patients with asthma and COPD.33) The association between the number of total medications and inhaler technique error needs to be examined in a larger number of patients in the future.
The current study has several limitations. First, because of the small number of patients and devices, multivariate analyses about error assessment were not conducted. Therefore, the influence of potential confounding factors such as age and disease type cannot be ruled out. Second, due to the retrospective nature of this study, the causal relationship between error occurrence and provision of inhaler instruction cannot be identified. The instruction time and method were based on the pharmacists’ choice, which could lead to bias regarding the need for more intensive instructions among patients who were prone to handling errors, as described above. Third, education level4,23) and cognitive function33) may be predictors of incorrect inhaler use. However, they were not investigated using appropriate questionnaires in this study. Fourth, this study was conducted in a single institution and included only community pharmacies. The results therefore may not be generalizable to hospital pharmacies and need to be examined in a larger number of facilities and patients. Finally, the inspiratory flow was not evaluated with suitable equipment. Previous studies have shown that a high inhalation flow rate is essential for drug delivery to the lungs via DPI.34,35) The evaluation of inhalation speed in this study was based on the pharmacists’ subjective judgment because inhalation flow meters that fit all devices were not widely used in clinical practice.36) Alternatively, some pharmacists used whistle training tools37,38) to confirm if a patient had a sufficient inhalation speed.
CONCLUSION
In this study, we showed that patients with obstructive lung diseases commonly experienced mishandling of inhaler devices in routine clinical settings in Japan. Critical errors were detected in one-tenth of instructed devices. Written and verbal instructions were provided in most cases; however, practical demonstrations and video instructions were offered to a lesser extent. Combined instruction with leaflet provision, verbal explanation, and practical demonstration by pharmacists may improve inhaler-handling techniques. Pharmacists may play a key role in improving the outcomes of inhalation therapy by demonstrating inhalation techniques. Nevertheless, further studies with a larger cohort should be performed to validate these results.
Acknowledgments
The authors would like to acknowledge the staffs of the Department of Respiratory Medicine and the Department of Pharmacy of the University of Tokyo hospital for their contribution to data collection and analysis.
Conflict of Interest
The authors declare no conflict of interest.
Supplementary Materials
This article contains supplementary materials.
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