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Inappropriate Use of Inhaled Short Acting Beta-Agonists and Its Association With Patient Health Status

Posted on: Thursday, 9 February 2006, 06:00 CST

By Hong, Song Hee; Sanders, Brittany H; West, Donna

Key words: Asthma inhalers - Medical expenditure panel survey - Medication misuse - Patient reported health status

ABSTRACT

Background: Despite the widespread distribution of guidelines on the proper use of inhaled asthma medication, the overuse of short acting bronchodilators (SABs) persists. This study aims to examine how inhaled asthma medications are used in the US and to examine whether inappropriate use of inhaled SABs is associated with poor patient health.

Research design and methods: The study design was a retrospective analysis of the Medical Expenditure Panel Survey (MEPS) for asthmatic patients 5 years or older who had used SAB medication during the period from 1996 through 2000. Use of SAB medication was defined as inappropriate when a patient inhaled more than 225 defined daily doses (DDDs) of SABs but less than 45.625 DDDs of corticosteroids per year. Health status was evaluated using survey respondents' perceptions on a 5-point Likert scale. Five functional limitations (activities of daily living, instrumental activities of daily living, walking, social function, and cognitive function) were rated on a dichotomous scale.

Results:Atotal of 2386 asthmatic patients were identified as having used a SAB in the period 1996 through 2000. Of these, 272 (11.4%) used excessive doses of SABs, and of this group of excessive users, 151 (55.5%) underused corticosteroids. Compared to appropriate users of SAB medication, inappropriate users had lower perceptions of their overall health (adjusted mean: 3.21 vs. 2.94, p < 0.05) and mental health (adjusted mean: 2.39 vs. 2.13, p < 0.05). They were also at an increased risk of limitations in walking (relative risk [RR]: 1.76,95% confidence interval [CI]:1.15-2.71) and in cognitive function (RR: 2.32,95% Cl: 1.37-3.93).

Conclusion: Despite the national guidelines concerning the proper use of inhaled asthma medication, over-reliance on SAB medication and under-use of corticosteroids persists in the US. Those not using asthma medication according to the guidelines had poor perceptions of their health and were subject to an increased risk of limitations in walking and cognitive function.

Introduction

Asthma is a common disease with a major impact on the health of the population. Currently, about 14 to 15 million persons in the US suffer from asthma, and the rate continues to increase1. Asthma places a burden on society causing more than 130 million days of restricted activity, approximately 500000 hospitalizations and over 5000 deaths each year. The cost of asthma in the United States was 12.7 billion dollars in 1998(2).

Asthma is a chronic condition that requires ongoing long-term control. Recognizing the importance of asthma control, the medical community has issued national guidelines on asthma management3. However, many patients with asthma continue to suffer from mismanagement and experience acute exacerbations that require emergency medical attention4.

In the past decade, effective management of asthma has been a focus of researchers5. Effective management begins with identifying patients who are at increased risk of fatal or near-fatal asthma. Patients who are on inhaled short-acting bronchodilators (SABs) are one of the most vulnerable populations. SAB medications are beneficial when used properly for fast relief of an acute asthma attack. However, a number of clinical studies in the mid-1980s and early 1990s demonstrated that regular use of SABs increases airway hyper-responsiveness and worsens asthma control6,7. Several studies also report increased mortality and morbidity among asthma patients associated with regular use of SABs8-10.

National guidelines now recommend that inhaled SABs are used on an as-needed basis rather than as regular scheduled medication. Furthermore, regular use of inhaled corticosteroids is recommended for the control of severe asthma. Despite the guidelines on the use of asthma inhalers, a Canadian study reports that as many as 24.9% of excessive users of SABs use less than 100 meg of inhaled beclomethasone per day11. The inappropriate use of medication might compromise patient health and increase use of scarce healthcare resources. Many studies have reported that asthma control is associated with health care utilization and patient health12-16. Inappropriate use of SABs would also be associated with health care utilization and patient health; i.e., use of SAB medication is considered as one of the four dimensions of asthma control12. According to Anis and colleagues", inappropriate users made more physician visits and had more hospital admissions and emergency room visits compared to comparative groups. However, little research exists concerning any association between the inappropriate use of SAB medication and health status.

The primary objective of this study was to examine patterns of use of inhaled SABs and corticosteroids among US patients with asthma. This study also examined whether SAB misuse is associated with poor patient health, controlling for patient demographics and comorbidity. Understanding the medication utilization patterns among asthmatic patients would pave the way for more effective asthma medication management.

Patients and methods

Study design, subjects and setting

The design of this study was a retrospective analysis of the Medical Expenditure Panel Survey (MEPS) for asthmatic patients 5 years or older who had used SAB medication during the period from 1996 through 2000. Children less than 5 years of age were excluded because the National Institutes of Health (NIH) guidelines on use of SAB medications differ for these children. Patients who used inhaled SABs for chronic obstructive pulmonary disease (COPD) were excluded as these patients would be expected to use inhaled SABs more frequently than asthmatic patients.

The MEPS is cosponsored by the Agency for Healthcare Research and Quality (AHRQ) and the National Center for Health Statistics (NCHS). The survey collects information on demographic characteristics, health status, healthcare use, and payments for the non- institutionalized US civilian population. It has been administered every year since 1996(17).

The MEPS has four components; household, nursing home, medical provider, and insurance. The household component collects personal and household level data from a subset of households that participated in the prior year's NCHS National Health Interview Survey. The household component forms the basis for all other components. For example, data on the use of prescribed medicine are first collected from household respondents and then ascertained from records obtained from pharmacy providers. Pharmacy records include ate filled, national drug code (NDC), medication name, strength of medicine (amount and unit), quantity (package size/amount dispensed), total charge, and payment source.

Measurements

Asthma patients and inhaled medication

The MEPS has information on health conditions coded by the International Classification of Diseases, Ninth Revision (ICD-9) as well as clinical classification codes (CCCs). The MEPS aggregates ICD-9 codes into mutually exclusive CCCs that are clinically homogenous18. This study identified asthma and COPD patients using the CCCs (128 for asthma and 127 for COPD) in prescribed medicine databases. The Multum drug database was used to generate a list of NDCs for inhaled SABs and corticosteroids19. The list was linked to the NDCs in the MEPS prescribed medicine database to identify inhaled SABs and corticosteroids. When NDCs were missing in the MEPS, they were inferred from drug names, strength, dosage and quantity.

Drug utilization of inhaled medication

Inhaled SAB and corticosteroid medications come in different strengths and package sizes. A canister with 200 actuations of a dose may contain a greater amount of drug than a canister with 400 actuations of another dose, depending on dose strength. To standardize numbers of doses for different drug products, the WHO- defined daily dose (DDD) was assigned to each drug ingredient20. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. The DDD system provides a unit of measurement independent of formulations and package sizes for drug consumption trends and their comparisons between different population groups, although it does not necessarily reflect the recommended or prescribed daily dose. Numbers of defined daily doses (nDDDs) were calculated based on the DDD, strength, and quantity used for each prescription event recorded in the MEPS prescribed medicine database.

Inappropriate use of inhaled SAB medication

This study followed that of Anis et al." in the definition of the inappropriate use of inhaled SAB medication. Use of SAB medication was defined as inappropriate when high doses of short-acting beta- agonists were taken in conjunction with low doses of inhaled corticosteroids. High doses of SAB were defined as nine or more canisters per year, with each canister giving 200 inhalations of albuterol 100meg or equivalent. Low doses of inhaled corticosteroids were defined as less than beclomethasone 100 meg or equivalent per day. In terms of nDDD, a high dose of SAB was defined as equal or more than 225 DDDs per year and a low dose of corticosteroids as less than 45.625 DDDs per year.

Health status

Over\all health status was assessed using the respondent's ratings of his/her perceived health and mental health status. Perceived health was measured based on a 5-point Likert scale of excellent, very good, good, fair, and poor, with one being excellent and five being poor. Perceived mental health status was measured likewise.

Five types of functional limitations were assessed based on patients' self-reports; Instrumental Activities of Daily Living (IADL), Activities of Daily Living (ADL), walking, social functioning, and cognitive function. Individuals were asked to indicate whether they suffered limits in any of these functional areas. IADL consisted of activities such as using the telephone, paying bills, taking medication, preparing light meals, doing laundry, or going shopping. ADL consisted of activities related to dressing, bathing and toileting. Walking represents physical activities such as walking, climbing stairs, lifting or bending. Social functioning represents the ability to work at a job, go to school, or do housework. Cognitive function concerns any confusion or memory loss suffered by the individual.

Comorbidity

The D'Hoore-Charlson Index was used to measure comorbidity. The Charlson Index is constructed from 19 conditions and their weights. D'Hoore et al.21 modified the index so that the Charlson index can be computed from ICD-9 codes and their relevant weights. The D'Hoore- Charlson Index was constructed from ICD-9 codes used in the MEPS condition files.

Statistical analyses

Pearson Chi-square statistics were used to compare the frequency distributions of two health statuses and five functional limitations between inappropriate versus appropriate users of inhaled SAB medication. Analysis of Covariance (ANCOVA) was also used to compare mean levels and 95% confidence intervals of two overall health status measures controlling for patient characteristics. Logistic regression was used to examine relative risks of functional limitations between inappropriate versus appropriate users of inhaled SAB medication, controlling for patient characteristics.

Statistical analysis was performed without using the MEPS sampling weights as the annual MEPS data included only a small number of SAB inappropriate users to produce national estimates. This study combined 5 years of MEPS data to increase the number of study subjects, and treated them as a simple random sample. All hypothesis tests were done at an alpha of 0.05. All analyses were carried out using SAS statistical software22.

Results

A total of 2386 subjects were identified from the MEPS as asthmatic patients aged 5 years or older who had used SAB medication in the period 1996 through 2000 (Table 1). Among the study subjects, 864 (36.2%) were children between 5 and 17 years old and 258 (10.8%) were aged 65 years or older. Females consisted of 58.6% of the study subjects. The majority of the subjects were white (78.0%), followed by black (18.1%). Almost all of the subjects (98.7%) had one or more health conditions other than asthma.

Excessive use of SAB medication indicates poor asthma control. On the other hand, regular use of inhaled corticosteroids helps asthma control and thus reduces the risk of excessive use of SAB medication. There were 272 study subjects (11.4%) who were using excessive doses of SAB medication; i.e., nine or more canisters of SAB medication per year (Table 2). Among them, more than half (151 subjects or 55.5%) were using low doses of corticosteroids; i.e., less than lOOmcg of beclomethasone per day. One hundred and fiftytwo subjects (6.4%) were using inhaled corticosteroids at a level of more than 400mcg equivalents of beclomethasone per day and, of those, 87 (57.2%) were not using excessive doses of SAB medication.

This study classified those who were using excessive doses of SAB medication, without accompanying regular use of corticosteroids, as inappropriate users of SAB medication and then treated the rest of the patients as appropriate users. The percentage who were using SAB medication inappropriately was 6.3% (n = 151). Table 1 compares demographic characteristics and D'Hoore-Charlson comorbidity index between inappropriate and appropriate users. Inappropriate users were more likely to be over 45 years of age than appropriate users (51.0% vs. 31.2%, ρ < 0.01). Inappropriate users also had more severe health conditions than appropriate users; i.e., about 19.2% of the inappropriate users had a D'Hoore-Charlson comorbidity index greater than or equal to 2 compared to 13.4% of the appropriate users (p < 0.01). However, gender and racial distributions were similar between inappropriate and appropriate users.

Figure 1. Overall health status comparing inappropriate and appropriate users of inhaled SAB medication. Note: overall health is patient perception rated on a scale of 1-5 with 1 being excellent

Figure 2. Mental health comparing inappropriate and appropriate users of inhaled SAB medication. Note: mental health is patient perception rated on a scale of 1-5 with 1 being excellent

When asked to rate their overall health and mental health statuses on a 5-point scale of excellent, very good, good, fair, and poor, inappropriate users of SAB medication rated their overall health and mental health more poorly compared to appropriate users (Figures 1 and 2). The percent who rated their overall health 'very good' or 'excellent' was lower among inappropriate users than among appropriate users (25.2% vs. 38.7%, p < 0.01); 18 subjects with missing data were excluded. Mental health was rated a little better for both appropriate and inappropriate users but there was still a difference between the two groups. The percent who rated mental health 'excellent' or Very good' was lower among inappropriate users than for appropriate users (55.0% vs. 64.7%, p < 0.01); 18 subjects with missing data were excluded.

When asked to indicate any functional limitations, inappropriate users of SAB medication were more likely than appropriate users to indicate limitations across all five measures of functional limitations: IADL, ADL, walking, social function, and cognitive function (Figure 3); subjects with missing data on IADL (n = 21), ADL (n = 27), walking (n = 28), social function (n = 24) and cognitive function (n - 946) were excluded from the comparative analysis. The difference was most noticeable in walking (29.8% vs. 15.8%, p < 0.05), followed by cognitive function (18.3% vs. 8.2%, p < 0.05) and social function (15.2% vs. 9.4%, p < 0.05). The differences in IADL (4.9% vs. 8.0%, p = 0.10) and ADL (2.5% vs. 4.6%, p = 0.12) were not statistically significant between the two groups of users.

Table 1. Demographic and comorbidity characteristics of users of inhaled SAB medication

Table 2. Use patterns of inhaled short acting beta-agonists and corticosteroids (n = 2386)*

Figure 3. Percent of patients with functional limitations comparing inappropriate and appropriate users of inhaled SAB medication. *Significant at p < 0.05. IADL = instrumental activities of daily living; ADL = activities of daily living; WLKLIM = limitations with walking; SOCLIM = limitations with social function; COGLIM = limitations with cognitive function

Figure 4. Health status of inappropriate and appropriate users of inhaled SAB medication. Overall health and mental health are patient perceptions rated on a scale of 1-5 with 1 being 'excellent'. Adjusted mean levels of health statuses ( 95% CI) were estimated from ANCOVA, controlling for comorbidity, age, gender and race.

Figure 5. Relative risks of functional limitations for inappropriate versus appropriate users of SAB medication. * Significant at p < 0.05. LADL = instrumental activities of daily living; ADL = activities of daily living; WLKLIM = limitations with walking; SOCLIM = limitations with social function; COGLIM = limitations with cognitive function. Relative risks and their 95% CIs were estimated using logistic regression controlling for comorbidity, age, gender and race

The difference that inappropriate use of SAB medication makes in patient health and functional limitations might have been confounded by covariates such as comorbidity, age, gender, and race. Figure 4 shows the results of analysis of covariance controlling for those covariates. The adjusted mean level of overall health was 3.21 0.19 (95% CI) for inappropriate users and 2.94 0.08 (95% CI) for appropriate users. The adjusted mean level of mental health was 2.39 0.18 (95% CI) for inappropriate users and 2.13 0.08 (95% CI) for appropriate users.

Figure 5 depicts the relative risks of functional limitations between inappropriate and appropriate users of SAB medication controlling for comorbidity, age, gender and race. Compared to appropriate users of SAB medication, inappropriate users were at an increased risk of a limitation in walking (RR: 1.76, 95% CI: 1.15- 2.71) and in cognitive function (RR: 2.32, 95% CI: 1.37-3.93). Inappropriate users were also at increased risk of limitations in all the other measures of functional limitations (i.e., IADL, ADL, social functioning). However, those increased risks were not found to be statistically significant.

Discussion

A total of 2386 asthmatic patients were identified as having used a SAB in the period 1996 through 2000. Of these, 272 (11.4%) filled prescriptions for nine or more canisters of SABs and of this group of excessive users, 151 (55.5%) underused corticosteroids or controllers. Compared to a previous study in Canada11, the rate of excessive use of SABs is similar (11.4% vs. 12.8%). However, the rate of underuse of controllers among the excessive users of SABs is at least twice as high in this study as in the Canadian study (55.5% vs. 24.9%). It appears that asthma medication management in the US is difficult.

Many studies report that asthma medication management practices are not uniform across different countries23-25. For example, the ratio of inhaled c\orticosteroid to quick-relief medication use, frequently used as a performance indicator for asthma medication management, is close to 0.09 in France but up to 0.57 in Sweden for adult patients with severe persistent asthma26. The different performance of asthma medication management between US and Canada can be attributed to various factors such as physician prescribing, patient compliance and different data sources. The Canadian study used a pharmacy claims database while the current study used the MEPS prescribed medicines files constructed by contacting pharmacies reported by household respondents. Typically, a claims database captures prescription drug use history more accurately than self- reports because survey respondents may either incorrectly recall or not reveal what medications they are taking. Data from self-reports inevitably underestimate the rate of inappropriate use compared with claim databases. Therefore, the actual rate of SAB misuse in the US could be worse than estimated here. However, a study has reported that compliance in the use of asthma inhalers is estimated similarly between self-reported and pharmacy claims data27. Furthermore, the MEPS prescribed medicines files are constructed not just from self- reports, but also from pharmacy records obtained by contacting the pharmacies named by household respondents. Moreover, the rate of excessive use of SABs was similar between the two studies, although the rate of SAB misuse among the excessive users was found higher in this study. Poor management of asthma medication therefore appears to be a real problem in the US, possibly due to guideline- discordant prescribing and/or poor patient compliance.

SAB medication was used inappropriately by 6.3% of the total number of asthma patients who had filled at least one prescription in a year. These inappropriate SAB users were found to have poorer perceptions of overall health and mental health compared to the rest of the patients or appropriate users (95% CI: 3.21 0.19 vs. 2.94 0.08) when comorbidity, age, gender and race were controlled for. These poor perceptions about health status may have resulted from increased limitations in walking and cognitive function. Inappropriate users of SAB medication more often reported limitations in walking (RR: 1.76, 95% CI: 1.15-2.21) and in cognitive function (RR: 2.32, 95% CI: 1.37-3.93) than appropriate users (Figure 5). Why do inappropriate users of SAB medication more often report limitations in walking? Inappropriate users of SAB medication suffer from worse asthma control and therefore face frequent asthma attacks. Asthma attacks more often occur outdoors than indoors because allergens such as pollens, molds and pollutants are prevalent outdoors. Thus, the inappropriate users may be cautious of walking outdoors so as to avoid asthma attacks, and thus report limitations in walking. The inappropriate users of SAB medication may also report cognitive limitation because poor asthma control leads to frequent sleep disturbances that may impair cognitive function.

The results show that despite the widespread distribution of evidence-based asthma guidelines that indicate the use of SAB medication only as rescue therapy, and the use of inhaled corticosteroids for all but mild intermittent asthma3, over- reliance on SAB medication and under-use of corticosteroids persists in the US. Those who did not follow the guidelines had poor perceptions of their health and were subject to an increased risk of limitations in walking and cognitive function.

This study calls for effective patient education regarding asthma management to provide asthma patients with the needed dose of inhaled corticosteroids in accordance with current guidelines. It is important that the patient understands that the purpose of inhaled corticosteroids is for long-term prevention and management of asthma and is not intended to give quick relief. Failure to educate patients in this manner often results in TRN' use of inhaled corticosteroids which neither improves asthma control nor gives quick relief28. Furthermore, patients may need more instruction regarding their inhalers, such as directions on use and proper administration technique. Such a patient education program would improve asthma control and thus contribute to better patient health.

This study has limitations in that only prescriptions dispensed were recorded. The design did not allow for the tracking of prescriptions written and not filled, or evaluate adherence to the prescribed regimen. It is possible that more patients received prescriptions for inhaled corticosteroids but chose to fill only the prescription for the SAB due to cost or patient preference. It is not possible to determine from this analysis if the problem lies in lack of physician adherence to guidelines, patient preference for use of only SAB therapy, or improper medication administration technique. Future studies should examine what factors contribute to SAB misuse. Those factors should include physician practice styles, patient education, health literacy, and socio-economic status. Omission of these important variables may bias the result.

Community pharmacists are in the unique position to intervene with regards to asthma medication therapy. A recent study by Barbanel and colleagues demonstrated that an asthma self-management program delivered by community pharmacists was effective in improving asthma control29. When patients visit a pharmacy to have their prescriptions filled, pharmacists have access to the patient's current medication regimen. With this information, pharmacists can determine if a patient is over-utilizing SAB medication in the absence of corticosteroid therapy. If the problem is the lack of a prescription for inhaled corticosteroid therapy, the pharmacist is in the position to speak with the physician regarding the patient's increased use of SAB medication and recommend the addition of corticosteroid therapy. Alternatively, if the patient has a prescription for inhaled corticosteroids but is not using the medication appropriately, based on the refill history, the pharmacist is in a position to counsel the patient regarding the importance of inhaled corticosteroids in the management of asthma.

Conclusion

Despite the widespread distribution of asthma guidelines on the proper use of inhaled asthma medication, overreliance on SAB medication and under-use of corticosteroids persists in the US. Persons not following the guidelines regarding the use of asthma medication had poor perceptions of their health and were subject to increased risks of limitations in walking and cognitive function. Patients should be informed of the importance of inhaled corticosteroids for long-term control and management of asthma.

Acknowledgment

Declaration of interest: The authors thank the UAMS Medical Research Endowment (MRE) Fund for making a research grant available for this project.

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CrossRef links are available in the online published version of this paper: http://www.cmrojournal.com

Paper CMRO-3203_4, Accepted for publication: 17 October 2005

Published Online: 14 November 2005

doi: 10.1185/030079905X74934

Song Hee Hong(a), Brittany H. Sanders(b) and Donna West(a)

a Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences, Little Rock, AR 72223, USA

b College of Pharmacy, University of Arkansas for Medical Sciences, Little Hock, AR 72223, USA

Address for correspondence: Song Hee Hong, PhD, Assistant Professor, Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences, 4301 West Markham St., Slot 522-4, Little Rock, AR 72223, USA. Tel.: +1-501-686-6298; Fax: +1-501-686-5156; email: hongsonghee@uams.edu

Copyright Librapharm Jan 2006

Source: Current Medical Research and Opinion

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