Use of inhaler device in patients with Asthma or Chronic obstructive pulmonary disease: Errors and Adherence problems
Shihas Azeez*, Sareena Kalathathoduvil, Shagoofa Basheer, Shafana Parveen Kankadyil,
Dilip Chandrashekar
Department of Pharmacy Practice, Al Shifa College Pharmacy, Perinthalmanna,
Malappuram, Kerala, India – 679321
*Corresponding Author E-mail: shihasshanu@gmail.com, a.sareenasaleem@gmail.com, shagoofab73@gmail.com, shafanaparveenk@gmail.com, dillu7@gmail.com
ABSTRACT:
Background:
Inhaled therapy is a mainstay in the
management of asthma and chronic obstructive pulmonary disease (COPD). Metered
dose inhaler (MDI), dry powder inhaler (DPI) and MDI with spacer are the most
commonly used. Errors in inhaler techniques are very common in asthma and COPD patients.
Poor inhaler technique brings about inadequate drug delivery to respiratory
system leading to poor disease control.
Objectives: The study aims at identifying different types of
inhalers used and to evaluate the errors and non-adherence in their use. Also,
to rectify errors and to improve adherence by education through patient
information leaflet (PIL). Methodology:
The study was conducted in three
phases. Errors were evaluated using self-administered questionnaire and
adherence were evaluated using drug attitude inventory in phase 1. Leaflets
were provided to patients, to minimize errors and educate patients to improve
adherence in phase 2. The entire data were analysed using different statistical
method in phase 3. Results and
Discussion: Out of 100 patients, 58%
of them were asthma patients (n=58) and 42% of them were COPD patients (n=42).
Among 87 patients using MDI and MDI with spacer, 21 patients performed all the
steps correctly. Peak non-adherence was seen in age group >60 years (25%). While
comparing adherence status of various age group the patients >60 years (39%)
shows more adherence. It implies that non adherence and adherence are seen maximum
in the age group of greater than 60 since population density was seen more in
this category. The study was statistically significant (p value of 0.027). Conclusion: The
study emphasises the role of clinical pharmacist in identifying and minimizing errors
through patient information leaflet. The evaluation of adherence was also
carried out and categorized patients into adherent and non-adherent category.
The adherence was increased through patient education.
KEYWORDS: Inhaler; medication error; medication non-adherence; patient education asthma; chronic obstructive pulmonary disease.
INTRODUCTION:
Asthma and chronic obstructive pulmonary disease (COPD) are common conditions among general population. The prevalence of asthma is 1% to 18% whereas COPD affects 6% of adult population[1]. Asthma is characterised by increased responsiveness of tracheobronchial tree to variety of stimuli, which tightens the airway that may be spontaneously relieved by therapy.
Whereas COPD is a condition which results in partial or complete obstruction of airflow and results in functional disability of lungs[2]. Symptoms of asthma include coughing, shortness of breath, chest tightness and episodes of wheezing which occur few times a day or few times per week[3]. The factors which may trigger those conditions include pollutants, humidity and pressure factors[4]. Clinical symptoms of COPD include cough and dyspnoea and high risk among patients with history of smoking[5]. Lack of education is one of the major reason for improper management of COPD and asthma[6]. Inhaled therapy is the cornerstone in the management of asthma and COPD. Many devices have been developed and each have specificities on how to prepare the dose and deliver the drug to the airways although different devices have technological improvement for appropriate drug deliver. The most commonly used devices in respiratory conditions are metered dose inhaler (MDI), dry powder inhaler (DPI) and metered dose inhaler with spacer. As the DPIs are breath activated, the particles that delivers to lungs depends on patient’s inspiratory efforts. The deposition of DPI in target area 5-15% which make it more effective in paediatric population. MDI have advantage of fast deposition which makes Broncho-dilation easier [7]. Decades after the introduction of inhaler devices, their incorrect use remains an obstacle to achieve disease outcomes. The correct use of inhaler devices is one of the most important aspect to be taken into account when evaluating individual with asthma or COPD and guideline emphasize the importance of assessing inhaler technique to improve the efficacy of drug delivery. However, it is recognized that inadequate use of inhaler devise is one of the most common reason for failure to achieve asthma and COPD control. Medication adherence measurement is a keystone to ensure whether therapeutic outcomes are achieved[8]. The benefits of current medical care eroded by lack of knowledge and drug adherence[9]. Adherence could be improved by using simplified treatment regimens, increasing patient knowledge about self-management and enhancing provider skills in patient education, communication, and adherence counselling. The study was conducted to evaluate the errors and adherence problem in asthma and COPD patients on inhaler devices, to identify the different type of inhaler devices used by the asthma and COPD patients, to identify the most frequently used inhalers as well as to provide patient education through patient information leaflet (PIL) which aims at reducing errors in pulmonology department of tertiary care hospital in Perinthalmanna.
MATERIALS AND METHODS:
A Prospective Interventional study was carried out for over a period of 6 months, commencing from September 2018 to march 2019. The study was carried out among the inpatients and outpatients of pulmonology department of a multispecialty tertiary level referral hospital situated in Perinthalmanna.
In-order to satisfy the objective of the study, upon considering inclusion and exclusion criteria we enrolled 100 patients who suffer from asthma and COPD. The study included all male and female with age greater than 10 years with Asthma or COPD, using inhaler devices. Inpatients and outpatients who are willing to participate and newly introduced to inhalation therapy were also included. The study excluded patients in ICU, patients not on inhaler therapy, and all patients with age less than 10 years with asthma and COPD. The inclusion and exclusion criteria as specified in the protocol were submitted and approved by the institutional ethical committee as per the letter no: KAS/EC/2018-42.
Self-administered questionnaire and Drug attitude inventory (DIA) were used to collect data from patients. The questionnaire contains both open and closed ended questions. Errors were evaluated using self-administered questionnaire and adherence were evaluated using DIA. It also contains a series of question which targeted at the adherence of the patient towards the therapy as well as the problems associated with non-adherence by the patient while using the inhaler at home or any place other than the in-patient condition. The data was entered in Microsoft access sheet for easy reference and analysis of the result were carried out later. The entire data was analysed by using different statistical methods.
Patient information leaflet (PIL) were developed and provided after understanding all the aspects of the disease with an aim to help the patients and their care givers to understand something in detail about their medication and the steps involved in the usage of inhaler devices.
RESULTS:
A prospective observational study was carried out in pulmonology department among 100 patients with asthma or COPD in a tertiary care multi-speciality hospital. While considering the total patient population, 62% were found to be outpatients (n=62) whereas 38% were found to be inpatients (n=38). Among the total patient population, 63% were males (n=63) which constitutes the major patient population and 37% were females (n=37). 5 of the 100 patients (5%) were aged between 18-30 years. 10% of the respondents belonged to the age group 31-40 (n=10), followed by age group 41-60 years which constitutes 21% (n=21). Minimum numbers of patients were found in the age group 18-30 years and maximum numbers of patients were found in the age group of greater than 60 years of age. Among the total patient population, 61% patients are high school level graduate (n=61), 15% of patients were undergraduates (n=15), 14% of them with any educational status (n=14) and 10% of them were postgraduates (n=5). On categorising the total patient population based on time of diagnosis, 38% of patients belong to more than 10 years (n=10) of diagnosis category, 27% of patients belong 6-10 years (n=27) of diagnosis category, 25% of patients belong to 1-5 years (n=25) of diagnosis category, 9% of patients belong to 1 month – 1 year (n=9) of diagnosis category and finally 1% of patients belong to less than a month(n=1) of diagnosis category. Among the total patient population 58% were asthma (n=58) patients and 42% were COPD (n=42) patients which include both inpatients and outpatients. While considering the total patient population, 97% of patients undergone for the pulmonary function test (PFT) on the other hand 3% of patients continue the treatment without PFT in both asthma and COPD patients. Among the total patient population, 58% of the patients are under other risk factors (n=58) category which includes conditions such as allergies, hereditary factor and due to some medication, 33% of total patients shows smoking (n=33) as a risk factor whereas 9% of patients show occupation as a risk factor. While considering the total population, most commonly used inhaler device is MDI with spacer (45%) and relatively similar number of MDI users (42%) and only 13% of patients belong the DPI user category (figure 1).
Fig. No. 1: PATIENT DISTRIBUTION BASED ON INHALER TYPE
Based on the patient’s social history, 62% of patients are non-smoker (n=62) and least number of patients are still continuing their smoking habit (13%).and 25% of patients are Ex-smokers (n=25). Among the total patient population, 71% of patients are adherent to the therapy (n=71) whereas 29% of the patients are not adherent to the therapy (n=29) (figure 2).
Among 87 patients using MDI and MDI with spacer, 21 patients performed all the steps correctly. Most common errors made by the MDI users 44% of patients “failed to wash the mouth”, !0% of patients “hold breath for 5 to 10 minutes”,10% of patients failed to “continue slow and deep inhalation”,19% of patients failed to “ seal around mouth piece”, 21% of patients failed to “exhale to residual volume”,12% of patients failed to “hold inhaler upright”,16% of patients failed to “shake the inhaler and remove the mouth cover” and 29 % of the patients “failed to discard the first puff” while considering the whole patient population (figure 3).
Fig. No. 2: PATIENT DISTRIBUTION BASED ON ADHERENCE STATUS
Fig. No.3: Nature of Errors Observed with Metered Dose Inhaler (MDI)
METERED DOSE INHALER WITH SPACER:
Most common errors made by the Dry powder inhaler users are 3% of patients “failed to wash mouth”, 6% of patients “fail to hold breath for 5 seconds”, 6% of patients failed to “inhale forcefully and deeply”, 4 % of patients failed to “keep inhaler horizontally” (4%) and 4% of patients failed to “prepare the inhaler before usage” (4%).While considering the whole patient population (figure 4).
Fig. No. 4: Nature Of Error Observed With Dry Powder Inhaler (DPI)
Marked decline in non-adherence level was seen with decreasing age. Peak non-adherence was seen in age group >60 years (25%). While comparing adherence status of various age group, the patients >60 years (39%) shows more adherence. It implies that non adherence and adherence are seen maximum in the age group of greater than 60, since population density was seen more in this category. The study was statistically significant (p value of 0.027). The adherence level is more in male population (40%) when compared to the female population (31%). The result is statistically significant (p value of 0.031). The chances of non-adherence decrease with increase in education.
Fig. No. 5: Comparison Of Adherence Status With Patient Characteristcs
While considering the non-adherence, 20% of patients belong to category of high school grade or less, 1% of patients belong to undergraduate category and when it comes to post graduate (0%) which shows a gradual decline in the percentage of non-adherence (figure 5).
While considering the total patient population, percentage of adherence in asthma patients (62%) when compared with COPD patients (38%). While considering the total patient population, percentage of adherence among patients using metered dose inhaler users (32%) high when compared to patients using metered dose inhaler with spacer (27%) and dry powder inhaler (12%).
DISCUSSION:
The study suggests that, in asthma and COPD patients the use of MDI and MDI with spacer are frequent, while the use of DPI is infrequent. The percentage of errors among inhaler device users is significantly high. Proper counselling is a necessary factor to minimize the error which in turn helps in the proper delivery of medication in order to produce significant benefit among asthma and COPD patients. The patient’s adherence to inhaler use is adequate and any problems related to non-adherence can be resolved through proper patient counselling. This study evaluates errors and adherence problems in 100 patients with asthma or COPD. The study population was less when compared to similar studies conducted by Krishna B Sriram[10], Mandeep Kaur Sodhi[11] and Wijdan H Ramadan[12]. Out of 100 patients 63 males and 37 females were enrolled in the study which is similar to study conducted by Mandeep Kaur Sodhi[11], in this study asthma patients are more in number while compared to COPD patients which is contrary to the study performed by Mandeep Kaur Sodhi [11]. The majority of patient population belongs to above 60 years of age. The data obtained during the study showed that MDI with spacer (45%) frequently used when compared to MDI (42%) and DPI (13%), which is contradictory to the study conducted Piyush Arora[13] and Mandeep Kaur Sodhi[11]. The education qualification of each individual was considered, 14% belongs to no education, 61% of higher secondary education or less, 15% of undergraduates and 10% of postgraduates. However, before the training, the incorrect use of inhaler device was higher among the patients with no education. Maximum errors observed in those using MDI and MDI with spacer (66%), followed by DPI (99%) while considering the total population of 100 patients which includes all three type of inhaler user. Most common errors made by the MDI users were “fail to wash the mouth” (44%), “hold breath for 5 to 10 minutes” (10%), “continue slow and deep inhalation” (10%), “poor seal around mouth piece” (19%), “exhale to residual volume” (21%), “hold inhaler upright” (12%), “shake the inhaler and remove the mouth cover”(16%), “fail to discard the first puff”(29%). Most common errors made by the DPI users were “fail to wash mouth” (3%), “fail to hold breath for 5 seconds” (6%), “inhale forcefully and deeply” (6%), “keep inhaler horizontal” (4%), “prepare the inhaler before usage” (4%). The study was similar to study conducted by Piyush Arrora[13], which also shows that errors are predominant in metered dose inhaler users. A marked decline in error was observed with the increase in level of education. Most errors were identified in illiterate patients and least were in post graduates and professional qualifiers. Study finding showed that lower socioeconomic status made higher number of mistakes than those living in upper middle class. These findings were similar to study performed by Piyush Arora[13]. The errors in patient population can be minimized by providing instruction about the steps in inhaler using with aid of patient information leaflet (PIL). The adherence status of the patient was measured using Drug attitude inventory (DAI) scale which divides the patient population category in to adherent and non-adherent category. Majority of the candidates in this study were found to be adherent, which is contradictory to the study conducted by Chacko A[14]. Marked decline in non-adherence level was seen with decreasing age. Peak non-adherence was seen in age group >60 years (86.2%). It presently states that adherence to inhaler use are less in geriatrics (>60 years) compared to other age groups. It implies that non adherence and adherence are seen in the age group of greater than 60. This is because the majority patient population belong to this age category. The adherence level is more in male population (40%) when compared to the female population (31%). The non-adherence level decreases with increase in education. The non-adherence level in high school grade or less (69%); undergraduate (3.4%) and post graduate (0%). The adherence level can be increased by proper education through patient counselling.
The limitations of this study are that an error in a critical step might counteract the entire effect and consequently influence the outcome. Since there is no universally accepted GOLD standard for measuring medication adherence, we used the Drug attitude inventory (DAI), which is a self-report questionnaire to measure adherence to medications and hence patient responses may have been subject to reporting bias.
CONCLUSION:
The study evaluated that the most commonly used inhaler devices are metered dose inhaler, metered dose inhaler with spacer and dry powder inhaler. Among the inhaler devices metered dose inhaler is the most frequently used whereas the use of dry powder inhaler is very less. Different types of errors were common among all the type of inhaler device. The most commonly observed errors are” fail to discard the first puff” and” fail to wash the mouth” seen among metered dose inhaler users. The increase in error can result in inadequate delivery of medication and result in poor disease control. Educating the patients regarding the various steps included in using inhaler device with the help of patient information leaflet (PIL) minimises the chance of error and thus provide a better treatment outcome. The study concluded that the percentage of adherence is more among the patient population using inhaler devices. The percentage of adherence was more in asthma patients when compared to COPD patient. The level of non-adherence is more in patients greater than 60 years old and the percentage of non-adherence decrease with decrease in age. While considering the education status, Percentage of non-adherence was found to be more in illiterates when compared to others. On evaluating the inhaler type, metered dose inhaler users were found to be more adherent than other device users. The percentage of adherence can be increased by proper patient education which informs the patients about the proper relevance of adherence and the possible outcome. While considering the total outcome of the study it gives a conclusion that percentage of adherence is more among the patient population on the other side chances of error is also high. Proper patient counselling through appropriate counselling aids will results in better outcome from the treatment which in turn decreases the chances of exacerbation in patients with asthma and COPD.
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Received on 21.11.2019 Modified on 08.01.2020
Accepted on 24.02.2020 © RJPT All right reserved
Research J. Pharm. and Tech 2020; 13(9):4130-4134.
DOI: 10.5958/0974-360X.2020.00729.5