Despite advances in the understanding of asthma and availability of improved medications, the morbidity and mortality of the disease are increasing. In the United States, asthma affects 14 to 15 million persons. From 1982 to 1992, the death rates increased 46%. Each year, about 470,000 people are hospitalized, and close to 5,000 people die of asthma. It is unclear why there is an increase in mortality; however, possible causes include poor assessment of the disease, inappropriate treatment and lack of patient education by healthcare providers. Other possible causes for asthma mortality include patients’ failure to renew their prescriptions, to administer their medications correctly and to seek primary care. Finally, some patients have poor access to healthcare providers and/or are unable to pay for healthcare services.
Questions that Need Answers
|Mrs. Smith, a 27-year-old woman, is visiting her doctor today because she is wheezing and short of breath in the mornings and wakes up in the night approximately once a month because of coughing. Mrs. Smith has been diagnosed with asthma since she was 12 years old and has been hospitalized twice in the last year for acute asthma exacerbations. Her asthma medications include: Ventolin MDI, 2 puffs QID prn; Azmacort MDI, 2 puffs BID; Proventil MDI, 2 puffs prn; and Atrovent MDI, 2 puffs prn.As a pharmacist, can you offer Mrs. Smith and perhaps her physician recommendations regarding her asthma care? How would you assess her asthma symptoms? What other questions might you ask Mrs. Smith about her symptoms and her medications? Any other questions? How would you evaluate her drug therapy?
You may have already formulated a plan of action to further evaluate and address Mrs. Smith’s asthma therapy before you read the second paragraph. As a pharmacist you have the ability to evaluate asthma drug therapy and make positive recommendations, but do you strive to do so in your everyday practice? What if we took Mrs. Smith out of the physician’s office and put her in a community pharmacy? Would your recommendations differ? Are your recommendations valuable to patients? To physicians? To third party payers? What is the monetary worth of the patient care you can provide? Will anyone—patients, physicians, or third party payers—pay you for your services? Why should they? These questions and many more are driving the evolution of the profession of pharmacy. As pharmacists, how far have we come in our quest for recognition as pharmaceutical care providers? To address this last question, this article focuses on the pharmacist’s impact on asthma care. Specifically, it describes the pharmacist’s role in asthma homecare through ambulatory clinics and outlines published literature that describes the pharmacist’s impact on asthma outcomes.
Pharmacists in all practice settings have the opportunity and ability to contribute to the overall management of asthma patients at home. Medication is the principle treatment for asthma. Every year pharmacists fill more than seven million prescriptions for asthma medications. Each prescription offers an opportunity to affect asthma care and to decrease the morbidity and mortality associated with the disease.
Services Pharmacists Can Provide
Non-adherence to drug treatment is a major cause for recurring asthma symptoms. As drug experts, pharmacists can influence adherence to therapy by providing patient education. Involving asthma patients in their own care by explaining their disease and its treatment in simple, understandable terms empowers them to assume responsibility for their health.
In 1987, a major study by Tullio demonstrated the impact of pharmacists’ patient education on compliance with asthma therapy through a controlled patient-blinded study. Nineteen mild to moderate asthmatic patients who were “inhaler-naive” were enrolled. Patients were randomly assigned to a study or control group. Study group patients were orally counseled on inhaler use and its importance in asthma management. In addition, the researchers demonstrated the 11 steps necessary for proper inhaler technique and then observed as the patient repeated the process. Control group patients received instructions about the name of the new inhaler, its purpose and the prescribed dosage. No additional information about the use of the inhaler was given. All patients received a patient package insert (PPI) detailing the method of administration for the inhaler. The authors assessed compliance at the next clinic visit through baseline forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) testing, using a spirometer and by observing patients using their inhalers and counting the number of properly completed steps from the 11-step checklist. Fifteen minutes after inhaler use, a second FEV1 and FVC measurement was taken. An increase of 15% to 25% in FEV1 and FVC was considered an adequate response to bronchodilator therapy.
Of the 19 patients (10 counseled/9 noncounseled) in this study, the authors reported no statistical difference with regard to age, height, number of pulmonary medications, number of other medications, time between visits, pulmonary diagnosis, disease states, baseline FEV1, smoking history and education level (p<0.05). However, patients who were counseled had a higher mean percentage increase in FEV1 than noncounseled patients (18.5±1.5 as compared to 5.2±1.0, respectively). Also, a greater number of counseled patients used their inhalers on a regular daily basis (9 versus 4, respectively, p=0.05). The evaluation of the 11-step inhaler sequence identified three steps that correlated with an adequate pulmonary function test (PFT) response and appeared to contribute to improved bronchodilation. Of the 5 patients who achieved an adequate PFT response, only 4 (all in the counseled group) performed those steps correctly. In addition, the mean number of missed steps was significantly greater for the noncounseled group as compared to the counseled group (2.9±1.8 versus 0.9±1.0, respectively).
Based on the study, the authors concluded that the education and demonstration of inhaler use provided by the clinical pharmacist resulted in better patient understanding, increased correct performance of inhaler use, and improved bronchodilation as measured by PFTs. The study was limited because it only included patients who had not received inhaler therapy in the past and it included patients who had no history of disease reversibility. Therefore, it is unclear whether both groups were equal at study inclusion with regard to their ability to respond to bronchodilator therapy. However, the authors suggested that the PFT results were still valid because the two groups were relatively matched as to age, disease status and baseline FEV1 readings.
As demonstrated by this study, educating patients with respect to the correct use of metered dose inhalers within a clinic setting can improve medication compliance and PFT results. However, patient education should not be limited to describing the correct use of inhalers nor should it be limited to ambulatory care settings. Regardless of the setting, asthma education should include descriptions of asthma pathophysiology, the signs and symptoms of an acute exacerbation and identification and avoidance of asthma triggers. This will enable patients to understand their disease and how it might be triggered, thus removing any mystery and misunderstanding. In addition, asthma education should include an explanation of the role of medication, the differences between maintenance and acute therapy, the benefits and risks of corticosteroid therapy, the risks of nonprescription asthma treatments and instruction in the appropriate use of peak flow meters to monitor airway obstruction. As patients gain a better understanding of asthma, medication compliance improves and exacerbations decrease.
Patient Assessment and Follow-up
Constant monitoring and assessment are essential to successful asthma management. Pharmacists first demonstrated their benefit to the chronic asthma management process through the pharmacokinetic monitoring of theophylline. Today, pharmacists within ambulatory care clinics monitor and assess all asthma medication. Although very few studies describing pharmacist-managed asthma clinics have been published, several abstracts from the 1995 and 1996 ASHP Midyear Clinical Meetings described in limited detail services provided by clinical pharmacists and the impact these services have on asthma patient outcomes, including decreased physician and hospital visits and improved FEV1 and FVC values. In general, patients are enrolled in asthma clinics through either direct physician referral or identification via emergency department records. After enrollment, patients’ compliance with drug treatment is assessed and noncompliance issues are addressed, including correcting poor inhaler technique. Patients are then provided asthma education and are monitored for asthma symptoms.
Pharmacists monitor asthma signs and symptoms and assess asthma treatment through the use of peak flow meters or hand held spirometers, the auscultation of lung sounds and the review of patients’ peak flow and asthma symptom diaries. Changes in peak flow readings of 20%, the appreciation of wheezing in any of the lung fields, and/or increases in asthma symptoms as reported by the patient suggest uncontrolled or worsening asthma. In several states, pharmacists practice under an approved protocol, adjust asthma medication dosages and add additional medical treatment when worsening or uncontrolled asthma is identified.
Pharmacists practicing in the community setting can also provide asthma medication monitoring and assessment. When refilling a patient’s asthma medication, pharmacists can recognize the overuse of beta-agonist inhalers or the underuse of steroid inhalers by observing the patient’s refill history. Usually, when beta-agonist prescriptions are filled more than once a month or steroid inhaler prescriptions are filled less than once a month the patient’s asthma is not well controlled. In addition, community pharmacists can ask patients about their asthma symptoms and their compliance with medication.
Recommendations and/or Plan of Action
Regardless of practice setting, pharmacists can impact asthma treatment. Within the asthma clinic setting, where pharmacists act as an extension of the physician under a practice protocol, pharmacists can directly alter asthma treatment. Within the community setting, pharmacists can alter asthma treatment indirectly through recommendations to physicians and patients.
Can Pharmacists Improve Outcomes?
Positive outcome measures for asthma patients include a decrease in symptoms, improvements in peak flow readings, improvements in spirometry readings, a decrease in emergency department visits, a decrease in asthma-related costs to the patient and/or the healthcare system, and improved patient compliance. Several studies have demonstrated improvements in each of these outcome measures in patients in pharmacist-managed asthma clinics.
In 1992, Hatoum et al. demonstrated through a prospective study of four ambulatory clinics, including an asthma clinic, that 48.8% of the pharmacist’s interventions resulted in a measurable positive patient outcome, 8% resulted in an unchanged patient condition, 0% resulted in a negative patient outcome and 42.2% resulted in unmeasurable outcomes. After subtracting the cost of pharmacist’s time, the net cost avoidance for the study period was set at $30,726.
In 1995, Pauley et al. demonstrated through a six-month controlled study that enrollment in a physician-directed, pharmacist-managed asthma clinic decreased emergency department visits and generated a $30–$60 thousand dollar cost savings. This study included patients who met the National Institutes of Health (NIH) criteria for the diagnosis of asthma. All patients were maintained on metered-dose albuterol and metered-dose triamcinolone acetamide. Other therapy was individualized based on each patient’s clinical status. Over-the-counter medications were discontinued. Allergic rhinitis was treated with intranasal corticosteroids and antihistamines and all patients had access to oral prednisone.
At the beginning of the study, patients were asked to visit the asthma clinic. During this initial visit, a physician investigator reconfirmed the diagnosis of asthma based on the NIH diagnostic criteria (by means of a medical history, physical examination and a review of the patient’s medical record). Also, a treatment plan was developed based on NIH treatment protocols. After the initial visit, patients were scheduled in groups of three for a pharmacist-conducted education session. The education session focused on the definition of asthma, emphasizing the inflammatory process, individualized signs and symptoms of an acute exacerbation, exacerbation triggers, the role of medication (individualized for each patient), plans relating maintenance versus acute therapy, correct use of metered dose inhalers (MDIs) and the benefits and risks associated with corticosteroid therapy. The necessity of follow-up visits was based on the initial severity of the patients’ illness, patients’ status per telephone reports and the patients’ perceived understanding of their illness.
The investigators contacted patients by telephone approximately once a week to reinforce compliance and to identify any breakthrough symptoms requiring an alteration in therapy. In addition, a pharmacist was available by telephone 24 hours each day to instruct patients on how to abort an acute attack. The pharmacist also informed the physician as to the status of the patient after each emergency phone call, and adjusted the patient’s medical regimen to better control the underlying disease.
The authors determined the effectiveness of the program by comparing the number of emergency department (ED) visits that occurred during the six-month study period to the number of such visits that occurred during the six months prior to the study period (control period 2), during the six months after the study period, and during a six-month period of the previous year equal to the study period (control period 1). Patients served as their own historical controls. No objective data concerning symptom control were obtained.
Pauley reported that the number of ED visits per patient was statistically lower during the study period as compared to control periods 1 and 2 (p=0.006 and 0.000, respectively). Also, the authors reported that 47 ED visits occurred in control period 1, 92 ED visits occurred in control period 2, and only six ED visits occurred during the study period. These six ED visits were made by four patients. Two of these patients were encouraged by the pharmacist to go to the emergency department, whereas the other two patients were noncompliant and as a result made four ED visits without contacting the investigators. No patients died or required intubation. One patient required a four-day hospitalization.
To evaluate the cost savings associated with the asthma program, the authors compared the average cost for ED visits to the cost of maintaining the asthma clinic. The average cost of an emergency department visit for an acute exacerbation of asthma was calculated to be $838, which when extrapolated to the 47 ED visits in control period 1 and 92 ED visits in control period 2, equaled $39,386 and $77,096, respectively. In contrast, the authors reported the cost of treating the same patients through the asthma clinic to be $8,283. This figure included the cost of six ED visits and $3,465 for special asthma clinic fees (93 visits x $35 per visit). The special fees included the practitioner’s time allotted for the asthma clinic; the physician and pharmacist were salaried employees. Cost figures did not include medication expenditures since all patients were under Medicaid. Also, the investigators did not account for pharmacists’ telephone time. After comparing costs, the authors reported that the asthma clinic generated a savings of $30,683 for control period 1 and $68,393 for control period 2. They concluded that the asthma clinic improved patient health as well as cost savings. However, the exact features of the program associated with the decline in emergency department visits could not be determined.