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INTRODUCTION

Asthma is a chronic respiratory disease of the airways characterized by dyspnea, wheezing, and chest tightness with or without cough. It can be associated with airflow limitation that is usually reversible.^1-5 Both symptoms and expiratory airflow limitation vary over time and in intensity and are often triggered by allergen or irritant exposure, exercise, changes in weather, or viral respiratory infections.^1-2,4-5 Symptoms may resolve spontaneously or in response to treatment, and they may be absent for weeks or months at a time.^1-2,4-5 Patients with asthma can experience episodic flare-ups of asthma symptoms that may be life-threatening or interfere with daily activities.^1-2,4-5 These flare-ups, or exacerbations, occur more often in patients with asthma that remains uncontrolled.⁴ Uncontrolled asthma can have a significant negative impact on a patient’s quality of life, healthcare costs, overall treatment satisfaction, and, ultimately, clinical outcomes.

CONSIDERATIONS IN ASTHMA MANAGEMENT

Pathophysiology

The pathophysiology of asthma is complex and involves various components, including bronchial airway hyperresponsiveness (AHR), airway inflammation, and variable airflow obstruction.^1-2,5 AHR is defined as the predisposition of the airways to narrow excessively in response to stimuli that would produce little to no effect in healthy subjects.⁶ Severe AHR is associated with an increased risk in asthma severity as measured by symptoms, an increased risk of asthma exacerbations, and an increased level of treatment required to manage symptoms.⁶

Airway inflammation may be acute or chronic. Cells involved in the inflammation include eosinophils, lymphocytes, mast cells, and neutrophils.^5,7 Inflammation is initiated by mast cell release of histamines and other mediators, such as immunoglobulin E (IgE), leading to infiltration of lymphocytes (specifically, T-helper cells type 2 [T_H2]) and granulocytes into the airway.⁷ T_H2 lymphocytes generate proinflammatory cytokines, such as interleukin (IL)-4, IL-5, and IL-13.⁷ Airway inflammation can occur in response to allergen exposure, but it may also present in response to non-IgE-mediated stimuli, such as exposure to aspirin or other nonsteroidal anti-inflammatory drugs, exercise, cold air, or environmental irritants.^1,2

The presence of AHR and airway inflammation, along with the production of luminal secretions, leads to airflow obstruction, resulting in an increase in airflow resistance and in the work of breathing.^1-2,7 Luminal secretions lead to the formation of a mucus plug, which consists of an exudate of serum proteins and cell debris, that often takes weeks to resolve.⁵ In patients with severe or long-standing disease, airflow obstruction may be fixed or not fully reversible with bronchodilators due to airway remodeling, which involves structural changes that occur due to chronic inflammation.^5,7

Prevalence

Approximately 19.2 million Americans aged 18 years and older and 5.5 million American children have been diagnosed with asthma.³ Asthma affects an estimated 300 million individuals worldwide.⁵ Asthma prevalence is higher in African Americans than in Caucasians, affecting approximately 10.7% of Black Non-Hispanics, compared to 8% of Caucasians; asthma also affects approximately 10.4% of American Indian/Alaskan Natives.³ In children younger than 18 years of age, asthma is more commonly diagnosed in boys (8.3% vs. 6.7% of American girls).³ However, in adulthood, asthma is more prevalent in women than in men, with 9.8% of American women diagnosed with asthma, compared to 5.5% of American men.³

Asthma is common in industrialized nations, with a prevalence of severe asthma ranging from 2% to 10%, suggesting that factors such as urbanization, air pollution, passive smoking, and changes in exposure to environmental allergens contribute to the development of asthma.⁵ In the United States (U.S.), asthma accounts for approximately 10.5 million physician office visits, 1.8 million hospitalizations, and approximately 5000 deaths per year.^3,7 Socioeconomic factors also play a role in asthma, with approximately 10.8% of Americans with a family income below 100% of the poverty threshold having a diagnosis of asthma, compared to 6.5% of Americans with a family income 450% of the poverty threshold or higher.³

The estimated total annual economic cost of asthma in the U.S. from 2008 to 2013 was approximately $81.9 billion, with more than $50 billion attributed to medical costs, approximately $29 billion related to asthma mortality, and another $3 billion due to missed work and school days.⁸ In the 2013 National Health Interview Survey, children with asthma aged 5 to 17 years old reported missing approximately 13.8 million days of school,⁹ and Americans surveyed between 2005 and 2009 reported missing 14.2 million work days due to asthma.¹⁰

Comorbidities and risk factors

Several comorbidities have been identified in patients with asthma; some of the most common include rhinosinusitis, gastroesophageal reflux disease, psychological disturbances, chronic infections, obesity, and obstructive sleep apnea.^11,12 The presence of comorbidities appears to be more prevalent in patients with severe asthma and can affect a patient’s response to current treatments.^11,12 Conditions such as rhinosinusitis and chronic infections have a synergistic effect with other factors that exacerbate asthma, whereas psychological disturbances, such as anxiety, depression, and lack of trust toward healthcare providers, can affect patients’ perceptions of their asthma symptoms and impact medication compliance.^11,12 Identification of comorbidities is key in the management and assessment of asthma control.^1-2,11-12

In addition to these comorbidities, several risk factors have been identified that can complicate clinical outcomes for patients with asthma. Modifiable risk factors increase a patient’s risk of developing exacerbations even in the setting of minimal asthma symptoms and can include suboptimal drug therapy, environmental exposures, impaired lung function, or abnormal biomarkers, such as sputum or blood eosinophils and fractional exhaled nitric oxide (FeNO).^1,13 Examples of suboptimal drug therapy are poor adherence, frequent use of a rescue inhaler, inappropriate drug therapy by way of inadequate inhaled corticosteroid (ICS) dose or an ICS not being prescribed, and incorrect inhaler technique.^1,5 Environmental exposures include air pollution, cigarette smoke, and the presence of allergens (if sensitized).^1,5,13 Patients with impaired lung function, especially those with a forced expiratory volume in 1 second (FEV₁) less than 60% predicted, as well as those who present with elevated biomarkers, are at greater risk for having more frequent asthma exacerbations, despite the use of an ICS.^1,5 Independent risk factors for exacerbations include having ever been intubated or admitted to an intensive care unit for asthma or experiencing one or more severe exacerbations in the previous 12 months.¹ Risk factors that accelerate the decline in a patient’s lung function that is not fully reversible include exposure to cigarette smoke or other environmental irritants, chronic mucus hypersecretion, and exacerbations in patients not using an ICS.^1,13 Patients being treated with higher doses of ICS or more potent formulations are at greater risk for experiencing systemic adverse effects to medications, whereas those patients who demonstrate incorrect inhaler technique are at greater risk for poor control and local side effects.¹ Evaluation of these risk factors, in addition to assessment of a patient’s symptoms, plays a key role in overall asthma management.

Phenotypes

Asthma is a heterogenous disease and patients present with a variety of symptoms and clinical histories; the heterogeneity is also evidenced by the fact that patients do not respond uniformly to asthma medications.^14-18 A number of asthma phenotypes have been proposed that are based on criteria such as age of onset, specific demographic characteristics such as gender and/or weight, severity classification, the presence of atopy, and reactivity to treatment.^14-18 Atopy is the genetic predisposition to develop allergic conditions, such as allergic rhinitis, asthma, and atopic dermatitis and is usually associated with heightened immune responses to common allergens.

To date, no system for defining the various phenotypes has been developed, but recent research has been conducted using cluster analysis to propose classifications of asthma phenotypes. In the United Kingdom, Haldar et al categorized patients with asthma into 5 distinct phenotypes: early-onset atopic asthma, obese non-eosinophilic asthma, benign asthma, early symptom predominant asthma, and inflammation predominant asthma.¹⁴ These classifications group patients according to the presence of eosinophilic inflammation, age of onset, respiratory tract reversibility, and demographic characteristics, such as gender and weight. Similarly, Moore et al conducted a cluster analysis of patients enrolled in the Severe Asthma Research Program (SARP) in the U.S.¹⁵ The SARP research study also identified 5 distinct phenotypes: early-onset atopic asthma with normal lung function, early-onset atopic asthma with preserved lung function and increased medication requirement, late-onset non-atopic asthma, early-onset atopic asthma with severe symptoms, and late-onset atopic asthma with severe symptoms. These phenotypes are also based on characteristics such as the presence of eosinophilic inflammation, age of onset, respiratory tract reversibility, and demographic characteristics, such as gender and weight.¹⁵ Other studies, such as the ongoing World Asthma Phenotypes (WASP) study, have attempted to categorize asthma phenotypes according to the presence of specific biomarkers and clinical information obtained from a risk factor and symptom questionnaire.¹⁸ While more research is necessary to understand the clinical utility of asthma phenotypes, the identification of these phenotypes may help guide decision-making for certain types of therapies, such as the biologic injectable therapies.

TREATMENT PARADIGMS FOR ASTHMA

Two evidence-based guidelines have been published for the treatment and management of asthma: the Global Initiative for Asthma (GINA): Global Strategy for Asthma Management and Prevention 2020 Report (GINA 2020) and the Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR-3). The GINA was established in 1993 after collaboration between the National Heart, Lung, and Blood Institute and the World Health Organization; annual updates of the GINA Report have been published since 2002. EPR-3 was published in 2007 by the National Heart, Lung, and Blood Institute’s National Asthma Education and Prevention Program. At the time of writing this program, a draft of the EPR-4 had been released for comments, but a final version had not yet been published. Once published, EPR-4 will provide updated guidance on the following areas of asthma management: the role of immunotherapy, the role of intermittent ICS and long-acting muscarinic antagonists, the effectiveness of indoor allergen reduction, the effectiveness and safety of bronchial thermoplasty, and the clinical utility of FeNO.^19,20

Both guidelines recommend a stepwise approach to asthma treatment, in which a provider would “step up” therapy intensity if asthma remains uncontrolled after confirming adherence and proper inhaler technique and “step down” to the minimum effective dose once asthma control has been achieved and maintained for at least 3 months. Table 1 depicts the preferred initial pharmacologic options for adults and adolescents with asthma from GINA 2020 and EPR-3.^1,2 Several key differences exist between the guidelines. First, EPR-3 is divided into a 6-step treatment algorithm, and GINA 2020 uses a five-step algorithm. Additionally, GINA 2020 no longer recommends treating asthma in adults and adolescents with a short-acting beta-agonist (SABA) alone.¹ Instead, GINA 2020 recommends all adults and adolescents with asthma receive an ICS-containing controller treatment to reduce the risk of exacerbations and control symptoms.¹ For patients with infrequent asthma symptoms, defined as symptoms less than twice a month, GINA 2020 recommends either as-needed low-dose ICS-formoterol or as-needed ICS taken whenever a SABA is used¹; the EPR-3 recommends the use of an as-needed SABA for intermittent asthma.² Furthermore, GINA 2020 provides phenotypic-guided treatment for patients with severe asthma; EPR-3 recognizes that asthma phenotypes exist and provides recommendations regarding the use of omalizumab in patients with allergies and asthma. It must be noted that at the time of publication of EPR-3, omalizumab was the only biologic treatment approved by the U.S. Food and Drug Administration and commercially available for the treatment of asthma.

Both GINA 2020 and EPR-3 provide recommendations for the long-term management of asthma.^1,2 Table 2 lists the long-term goals of each guideline in more detail. Both GINA 2020 and EPR-3 recognize that optimal symptom control is key in the long-term management of asthma, as is minimizing any future risk of asthma-related mortality.^1,2 Both GINA 2020 and EPR-3 also emphasize the importance of the patient-provider relationship for effective management of patients with asthma. Including the patient in the decision-making process and providing appropriate disease state education leads to an improvement in overall patient outcomes, such as reduction in the number of urgent care visits or hospitalizations and improvements in quality of life and perceived asthma control.^1,2 GINA 2020 and EPR-3 also recommend the development of a written asthma plan for patients to reference at home to manage their asthma symptoms. The written asthma plan should contain therapy recommendations when patients feel that their symptoms are well-controlled, recommendations if asthma symptoms are worsening, and recommendations if symptoms are severe.^1,2

Several factors exist that can lead to an inadequate response to pharmacologic therapies in patients with asthma. These include poor medication adherence, medication adverse effects, persistent exposures, and the presence of biomarkers.^1,2 Factors that contribute to non-adherence include medication burden, such as the use of multiple inhalers or regimens that require multiple doses per day, incorrect inhaler technique, and poor health literacy, which can include unintentionally missing doses or intentionally missing doses due to lack of perceived benefit, adverse effect concerns, or cost.^1,2 Patients who are continually exposed to environmental triggers can also have inadequate responses to therapy. Patients should be counseled on the avoidance of these triggers, when possible, and providers should consider increasing the intensity of therapy only after confirming proper inhaler technique and medication adherence.^1,2

The presence of biomarkers, such as elevated blood or sputum eosinophils or elevated FeNO, is associated with suboptimal response to pharmacologic therapies. In patients with severe asthma who also present with these biomarkers, the addition of biologic therapies is recommended.^1,2 Currently, there are 5 asthma biologics approved in the U.S. and indicated for the add-on treatment of patients with severe asthma. These therapies should be considered in patients with severe asthma whose symptoms remain uncontrolled after confirming adherence and proper inhaler technique. Table 3 summarizes dosing and administration recommendations for these biologic regimens.^21-25

ASTHMA OUTCOMES MEASURES

Disease state management is defined by the Academy of Managed Care Pharmacy as “the concept of reducing health care costs and improving quality of life for individuals with chronic conditions by preventing or minimizing the effects of the disease through integrated care.”²⁶ Disease state management programs positively impact patients with chronic conditions by improving their overall health and reducing avoidable healthcare costs by identifying and treating these chronic conditions more quickly and more effectively.²⁶ A multidisciplinary approach should be taken with disease state management programs and teams may consist of physicians, pharmacists, nurses, dieticians, respiratory therapists, asthma educators, and psychologists.²⁶ From these disease state management programs, targeted interventions can be identified and used in conjunction with adherence monitoring programs to assess clinical and other outcomes in patients with chronic conditions.²⁷

Patient-reported outcomes are one example of the types of outcomes that can be assessed in patients with chronic health conditions.²⁸ Patient-reported outcomes provide a validated instrument to assess health status from the patient’s point of view and can provide evidence on the outcomes of services for the purposes of audit or quality assurance.²⁸ Patient-reported outcomes can also improve the quality of the interactions between healthcare providers and patients.²⁸ The 36-Item Short Form Survey (SF-36) is one of the most widely known validated instruments designed to assess a patient’s perception of health status.²⁸

Asthma is one such chronic condition for which a comprehensive disease state management program can provide significant positive benefits to patients. As previously discussed, asthma is a complex disease that is associated with high morbidity and mortality if not appropriately treated. Uncontrolled asthma can also be quite costly, in the economic sense of missed work or school days, and is also associated with significant medical costs both to the patient and the health plan. Additionally, several pharmacologic options exist for the treatment of asthma that require patient education on proper administration technique, such as inhalers and injectable therapies. These pharmacologic therapies also carry a risk of side effects, which, if not properly managed, can result in nonadherence.

The goals of asthma management can be tied to measurable outcomes, including both clinical and patient-reported outcomes, and the literature supports the assessment of these outcomes, in addition to adherence, in the management of asthma.^27-30 Spirometry is a measurable clinical outcome used to assess a patient’s lung function and is considered an optimal choice because it is reliable, reproducible, and standardized.²⁹ Spirometry results, specifically FEV₁, can be compared at each visit to assess asthma severity and any changes in the degree of airway obstruction.²⁹ However, one disadvantage of spirometry is that it is effort-dependent, requiring a cooperative patient to obtain reliable data.²⁹ Several validated instruments have been published in the literature that evaluate asthma-specific patient-reported outcomes; these instruments assess topics such as symptom control, psychological well-being, impact on activities of daily living, and treatment satisfaction.²⁸ The instruments are administered as questionnaires that may either be self-reported by the patient or administered by a clinician.²⁸ Table 4 summarizes some of the currently available asthma-specific patient-reported outcomes instruments.²⁸

Frequency of asthma symptoms can be assessed with validated instruments such as the Asthma Control Test (ACT) or the Asthma Control Questionnaire (ACQ): both are relatively short surveys, with 5 questions on the ACT and 7 questions on the ACQ, that ask detailed questions related to symptom frequency, the use of rescue therapy, symptoms as they relate to sleep interference, and any limitations in activities.^28,31-32 The ACT also considers a patient’s FEV₁ and analyzes symptom control over the previous 4 weeks. The ACQ assesses symptom control over the past week and does not analyze any physiologic measurements.^28,31-32 

GINA 2020 recommends the use of an asthma symptom control test, specifically the ACT or ACQ, in addition to a risk assessment, to help guide treatment decisions.¹ EPR-3 uses the scores of the ACT or ACQ to guide treatment decisions, and it also advocates the use of the Asthma Therapy Assessment Questionnaire (ATAQ), an assessment that considers use of rescue therapy, asthma-related sleep interferences, activity limitations, and patient self-rating of overall asthma control over the previous 4 weeks.² Quality of life questionnaires are designed to assess a patient’s perception of asthma on overall well-being; examples include the Asthma Quality of Life Questionnaire (AQLQ), the MiniAQLQ, and the Asthma Impact on Quality of Life Scale (A-IQOLS).^33,34 While these tools have been published in the literature, neither GINA 2020 nor EPR-3 make specific recommendations on the use of a quality of life tool in clinical practice to guide treatment decision-making.

Both GINA 2020 and EPR-3 support the concept of involving patients in the development of treatment goals and provision of optimal pharmacotherapy.^1,2 Shared decision-making involves active patient participation by eliciting the patient’s goals for therapy and identifying priorities related to symptom control, convenience of regimen, minimization of adverse effects, and cost.³⁵ Wilson et al assessed the impact of shared decision-making and its impact on adherence and outcomes in patients with poorly controlled asthma.³⁵ In this study, poorly controlled asthma was defined using electronic health records to identify patients who demonstrated an overuse of rescue medications or had a recent asthma-related emergency room visit or hospitalization.³⁵ After identifying a patient’s goals and pharmacotherapy priorities, the patient was shown a list of available treatment options; the patient and the clinician then weighed the pros and cons of the options selected by the patient to arrive at a treatment plan that accommodated both the patient’s and the clinician’s goals.³⁵ The shared decision-making approach was compared against the current standard of clinician decision-making; results indicated that patients who were involved in the decision-making process of their treatment had improved medication adherence and clinical outcomes.³⁵ 

Another method of involving patients in their care is through the use of motivational interviewing. Motivational interviewing is a patient-centric approach designed to enhance motivation to change in patients unwilling to make changes by increasing patients’ intrinsic motivation to accept recommendations related to their health and by resolving patients’ ambivalence about behavior changes, such as adherence.³⁶ Intrinsic motivation can be increased by actively engaging patients in the encounter through the shared decision-making process. Ambivalence is defined as the perception of both the pros and cons between changing and not changing, and studies show that educating and confronting an ambivalent patient can have an effect opposite of what is intended.³⁶ The use of motivational interviewing avoids confronting patients about the need for change and instead utilizes open-ended questions to elicit positive statements about change from patients, and it has been shown to shift attitudes and behaviors toward the new perspective.³⁶

Patient satisfaction is also tied to optimal clinical outcomes in patients with asthma. Price et al surveyed adult asthma patients and physicians in the U.S. to collect data related to symptom and exacerbation history, treatment, comorbidities, type of prescribed inhaler device, treatment adherence, and level of satisfaction with prescribed inhaler device.³⁷ Results demonstrated that higher patient satisfaction with their prescribed inhaler device was associated with positive clinical outcomes, reinforcing the importance that patients should play an active role in asthma therapy selection.³⁷ Patel et al assessed the impact of asthma action plans on patient satisfaction in U.S. adult women.³⁸ Asthma action plans, or written asthma plans, provide details for patients about daily asthma management, as well as for recognition and management of worsening symptoms; these plans may serve as catalysts for dialogue between patients and clinicians.³⁸ Results from this study demonstrated that women without asthma action plans were less likely to initiate discussions with clinicians regarding their asthma, monitor their asthma with the use of a peak flow meter, and use their medications as prescribed; these patients also reported a lower level of satisfaction with their overall asthma care.³⁸

THE ROLE OF THE PHARMACIST IN ASTHMA MANAGEMENT

Pharmacists can play a significant role in the management of asthma: they can provide suggestions regarding the appropriate and effective use of therapies, identify and manage adverse effects, and recognize and address patterns of nonadherence.³⁹ Pharmacists can screen patients for nonadherence by asking open-ended non-judgmental questions or by reviewing refill histories. In addition to nonadherence, patients should also be screened for medication overuse, such as frequent refills of a prescribed SABA, which may indicate uncontrolled disease. Pharmacists also have a unique understanding of medication delivery devices and can provide education regarding proper inhaler or injection use and review patient technique. Pharmacists can aid in the appropriate selection of inhaled devices based on a patient’s clinical picture, such as the recommendation of spacer devices in patients who lack hand-breath coordination. Moreover, pharmacists have the knowledge necessary to perform a comprehensive drug review to identify any serious drug interactions or contraindications to therapy.

Pharmacists can also educate patients on the benefits of therapy, as well as the potential adverse effects of treatment. Adverse effects can include the development of thrush associated with the use of ICS or tachycardia associated with the use of beta-agonists. Patients should be counseled on methods to avoid or minimize adverse effects to therapy, and alternative therapies should be considered in patients who cannot tolerate their current regimen.

Most asthma therapies, including the biologic therapies, can be quite costly, and very few therapies are currently available as generic formulations. Furthermore, many pharmacy benefit managers (PBMs) have established formularies, which detail a list of preferred therapies due to their lower costs and identify therapies that require prior authorization. Pharmacists can collaborate with providers to identify those lower-cost alternatives specified by the PBM or submit requests for prior authorization for non-formulary therapies, if access to the electronic health record exists. Pharmacists can also help ensure patient access to therapy by investigating available financial support, which may include assistance programs administered by the manufacturer or foundational support through nonprofit organizations.

Pharmacists can also evaluate the effectiveness of therapy through the administration of asthma symptom control questionnaires or quality of life surveys. These questionnaires can be incorporated into the refill process or administered at defined intervals. Ideally, assessment of these outcomes measures should occur at therapy initiation, the results of which can be compared to information gathered at follow-up assessments to identify whether positive outcomes occurred in patients with asthma. Pharmacists can also assist in identifying a patient’s treatment goals and assessing progress toward these goals at follow-up encounters. Furthermore, pharmacists are trained in the techniques of motivational interviewing. By employing these techniques, pharmacists can identify what motivates a patient and engage in active listening methods to shift attitudes and behaviors, leading to improved adherence and overall patient outcomes.

CONCLUSION

Asthma is a chronic, complex disease that is associated with significant morbidity and mortality, as well as significant costs, if it remains uncontrolled. In addition to adherence monitoring programs, the current clinical guidelines, GINA 2020 and EPR-3, recommend assessing patient clinical outcomes such as asthma symptom control, quality of life, and overall patient satisfaction. Pharmacists have both the training and medication knowledge to positively impact adherence outcomes and clinical outcomes in asthma patients.

REFERENCES

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