B2. PHARMACISTS DIFFICULT TO TREAT ASTHMA/COPD EXACERBATIONS 12:45-1:45PM

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1 B2. PHARMACISTS DIFFICULT TO TREAT ASTHMA/COPD EXACERBATIONS 12:45-1:45PM ACPE UAN: L01-P Activity Type: Application-Based 0.1 CEU/1.0 hr Learning Objectives for Pharmacists: Upon completion of this CPE activity participants should be able to: 1. Distinguish between diffi cult-to-manage asthma and therapy-resistant asthma 2. Identify epidemiological impact of diffi cult-to-manage asthma and therapy-resistant asthma 3. Evaluate factors contributing to diffi cult-to-manage asthma 4. Compose a pharmacotherapy treatment plan for diffi cult-to-manage asthma and exacerbations 5. Compose a pharmacotherapy treatment plan for therapy-resistant asthma and exacerbations Speaker: Dawn Knudsen Gerber, PharmD, CGP, FASCP, received her Doctor of Pharmacy degree from Drake University, Des Moines, Iowa. She completed an ASHP-accredited residency in Pharmacy Practice with an emphasis in Ambulatory Care at the Creighton University Medical Center, Omaha, Nebraska. She completed ASCP s Parkinson s Disease Pharmacotherapy Traineeship at Northwestern University s Parkinson s Disease and Movement Disorders Center, Chicago, Illinois in Fall Dr. Gerber is a Certifi ed Geriatric Pharmacist and recognized as a Fellow of ASCP. Her practice site is Banner Arizona Medical Center, Peoria, AZ. She established and maintains a Medication Therapy Management (MTM) Clinic. Dr. Gerber s areas of interest include geriatric pharmacotherapy, medication therapy management, herbal medicine, and political advocacy. Speaker Disclosure: Dawn Gerber reports no actual or potential confl icts of interest in relation to this CPE activity. Off-label use of medications will not be discussed during this presentation. FEBRUARY 7-9, 2014 THE MEADOWS EVENTS & CONFERENCE CENTER ALTOONA, IOWA

2 Catch your breath: Treating difficult to treat asthma DAWN KNUDSEN GERBER, PHARMD, CGP, FASCP ASSOCIATE PROFESSOR DIRECTOR,PGY2 GERIATRIC RESIDENCY PROGRAM MIDWESTERN UNIVERSITY COLLEGE OF PHARMACY GLENDALE, AZ Faculty Disclosure Dawn Knudsen Gerber reports she does not have actual or potential conflicts of interest associated with this presentation. Dawn Knudsen Gerber has indicated that off-label use of medication will be discussed during this presentation 2 1

3 Learning Objectives Upon completion of this activity, pharmacists (or pharmacy technicians/student pharmacists) should be able to: 1. Distinguish between "difficult-to-manage asthma" and "therapy-resistant asthma" 2. Identify epidemiological impact of "difficult-to-manage asthma" and "therapy-resistant asthma" 3. Evaluate factors contributing to difficult-to-manage asthma 4. Compose a pharmacotherapy treatment plan for difficult-to-manage asthma and exacerbations 5. Compose a pharmacotherapy treatment plan for therapy-resistant asthma and exacerbations 3 4 PRE-ASSESSMENT QUESTIONS 2

4 I like audience participation and so does IPA! 5 Pre-Assessment Questions 6 Difficult to treat asthma and treatment resistance asthma are similar terms for the same type of asthma. A. True B. False 3

5 Pre-Assessment Questions National guidelines include recommendations for difficult to treat or treatment-resistant asthma. A. True B. False 7 Pre-Assessment Questions 8 Difficult to treat or treatmentresistant asthma contribute a high percentage to the overall cost of treating asthma as a disease state nationally. A. True B. False 4

6 Pre-Assessment Questions 9 Pharmacogenomics may play a key role in determining treatment plans for resistant asthma in the future. A.True B.False Pre-Assessment Questions 10 The National Asthma Education and Prevention Program (NAEPP) contains recommendations for management of severe asthma exacerbations. A.True B.False 5

7 11 FIGURE 3-36 Asthma. During a severe asthma attack, hyperinflation, similar to that seen in chronic obstructive pulmonary disease (COPD), can be seen. In this case, hyperinflation is seen, with the superior aspect of the hemidiaphragms located at the level of the posterior eleventh ribs (A); a slight increase in the anteroposterior diameter and some flattening of the hemidiaphragm appear (B). The patient does not have the barrel-shaped chest seen in COPD (see ). Most patients with asthma have normal chest x-rays. Essentials of Radiology. Third Edition. Fred A. Mettler, Jr., MD, MPH The number game 12 Prevalence of difficult asthma is uncertain ~ 5 10% of patients with asthma Allergy Asthma Proc 2012; 33:

8 Definition: Difficult asthma The group of patients who despite being prescribed an appropriate and intensive treatment program for severe asthma continue to have frequent symptoms have exercise limitation due to their asthma have impaired lung function have frequent asthmatic exacerbations 13 Allergy Asthma Proc 2012; 33: /20 rule This small subset of patients with asthma bears a disproportionately large burden of morbidity and risk of mortality 14 poor quality of life due to limitations imposed by illness toxicities caused by treatment require frequent medical visits consequently large costs to the medical system 7

9 15 DISTINGUISHING DIFFICULT- TO-MANAGE ASTHMA FROM TRULY THERAPY- RESISTANT ASTHMA 16 DIFFICULT TO TREAT 8

10 DIFFICULT TO TREAT Non-adherence Adverse environment Comorbidities Incorrect diagnosis Psychosocial problems 17 Non-Adherence 18 Fear of side effects Belief that the medication was not necessary Belief that the illness was not serious Sense of the need for only intermittent use of medication Concern that the medication would lose effectiveness over time Cost of medication Perception: primary reason for noncompliance Survey says: #7 among reasons patients cited for nonadherence. 9

11 Adverse Environment: Medications Beta blockers Aspirin & NSAIDs 19 20% of asthmatic patients experience worsening with exposure BMJ 328:434, 2004 ACE-I Comorbidities Allergic upper airway disease GERD Obesity Obstructive sleep apnea 20 10

12 Differential diagnosis of difficult-to- control asthma COPD Bronchiectasis Vocal cord dysfunction syndrome Tracheobronchomalacia Steroid-withdrawal syndrome Churg-Strauss syndrome Aspirated foreign body Bronchiolitis obliterans Sarcoidosis Disseminated strongylodiasis PE Diastolic dysfunction with CHF (cardiac asthma) 21 Allergy Asthma Proc 2012; 33: DIFFICULT TO TREAT Non-adherence Adverse environment Comorbidities Incorrect diagnosis Psychosocial problems 22 11

13 23 THERAPY-RESISTANT ASTHMA How has our understanding of asthma treatment changed? s 1980s asthma as a disease primarily of bronchoconstriction related to smooth muscle contraction increased understanding of the role of airway inflammation and bronchial hyperreactivity 1990s an additional focus on airway remodeling Current Role of pharmacogenomics? Allergy Asthma Proc 2012; 33:

14 25 WHAT IS DIFFERENT ABOUT ASTHMA IN SOME PATIENTS SUCH THAT IT DOES NOT RESPOND SATISFACTORILY TO CONVENTIONAL THERAPY? 26 It is increasingly recognized that asthma represents a syndrome rather than a single condition and that there is great clinical and pathobiological heterogeneity among the population diagnosed with asthma. This heterogeneity may extend to include genetically programmed differences in the way asthma patients respond to medications. Allergy Asthma Proc 2012; 33:

15 European Task Force Chung KF, Godard P, Adelroth E, et al. Difficult/therapy-resistant asthma: The need for an integrated approach to defineclinical phenotypes, evaluate risk factors, understand patho-physiology and find novel therapies. ERS Task Force on Difficult/Therapy-Resistant Asthma. European Respiratory Society. Eur Respir J 13: , American Thoracic Society released the results of its Asthma Workshop Wenzel SE, Fahy JV, Irvin C, et al. Proceedings of the ATS workshop on refractory asthma: Current understanding, recommendations, and unanswered questions. Am J Respir Crit Care Med 162: , International Workshop assembled in Paris Chanez P, Wenzel SE, Anderson GP, et al. Severe asthma in adults: What are the important questions? J Allergy Clin Immunol 119: , Difficult Treat Options 28 FDA approved for asthma Anti-IgE monoclonal antibody therapy (omalizumab) Lipoxygenase inhibition with zileuton Bronchial thermoplasty Non-FDA approved for asthma Ultrahigh-dose inhaled corticosteroids Long-acting anticholinergic bronchodilators Macrolide antibiotics Vitamin D Allergy Asthma Proc 33: ,

16 Criteria for administration of omalizumab Age > 12 years Positive result on a skin testing or in vivo reactivity to at least one perennial aeroallergen Baseline immunoglobulin E levels of IU/mL Weight kg Calculated dose of omalizumab < 750 mg Severe or inadequately controlled asthma, as defined by frequent exacerbations or the need for daily or frequent oral corticosteroids, despite appropriate environmental control, smoking cessation, patient education and consistent therapy with inhaled corticosteroid at a minimum daily dose of 500 μg of fluticasone or equivalent plus adjunctive therapy 29 Xolair prescribing information. July 2010 Omalizumab (Zileuton) Risks ADE Aseptic meningitis syndrome thromboembolic events renal impairment hemolytic anemia Cost Closely monitor for response 30 Benefits Decreased # of acerbations evaluated at 6 months and therapy discontinued for those who have not benefited 15

17 Difficult Treat Options 31 FDA approved for asthma Anti-IgE monoclonal antibody therapy (omalizumab) Lipoxygenase inhibition with zileuton Bronchial thermoplasty Non-FDA approved for asthma Ultrahigh-dose inhaled corticosteroids Long-acting anticholinergic bronchodilators Macrolide antibiotics Vitamin D Lipoxygenase inhibition with zileuton (Zyflo) Risks Generally well tolerated 2-4% risk of reversible hepatotoxicity Most at risk the first 6 months of therapy 32 Benefits Improved FEV1 Decreased rescue bronchodilator 16

18 Difficult Treat Options 33 FDA approved for asthma Lipoxygenase inhibition with zileuton Anti-IgE monoclonal antibody therapy (omalizumab) Bronchial thermoplasty Non-FDA approved for asthma Ultrahigh-dose inhaled corticosteroids Long-acting anticholinergic bronchodilators Macrolide antibiotics Vitamin D Difficult Treat Options 34 FDA approved for asthma Lipoxygenase inhibition with zileuton Anti-IgE monoclonal antibody therapy (omalizumab) Bronchial thermoplasty Non-FDA approved for asthma Ultrahigh-dose inhaled corticosteroids Long-acting anticholinergic bronchodilators Macrolide antibiotics Vitamin D 17

19 Difficult Treat Options 35 FDA approved for asthma Lipoxygenase inhibition with zileuton Anti-IgE monoclonal antibody therapy (omalizumab) Bronchial thermoplasty Non-FDA approved for asthma Ultrahigh-dose inhaled corticosteroids Long-acting anticholinergic bronchodilators Macrolide antibiotics Vitamin D Difficult Treat Options 36 FDA approved for asthma Lipoxygenase inhibition with zileuton Anti-IgE monoclonal antibody therapy (omalizumab) Bronchial thermoplasty Non-FDA approved for asthma Ultrahigh-dose inhaled corticosteroids Long-acting anticholinergic bronchodilators Macrolide antibiotics Vitamin D 18

20 Difficult Treat Options 37 FDA approved for asthma Lipoxygenase inhibition with zileuton Anti-IgE monoclonal antibody therapy (omalizumab) Bronchial thermoplasty Non-FDA approved for asthma Ultrahigh-dose inhaled corticosteroids Long-acting anticholinergic bronchodilators Macrolide antibiotics Vitamin D Other discussion Methotrexate Tumor necrosis factor inhibition Cyclosporine 38 19

21 Figure 58-1 National Asthma Education and Prevention Program (NAEPP) recommendations for management of asthma exacerbations: emergency department and hospitalbased care. 39 He has multiple exacerbations per year requiring oral steroids Already on LABA and inhaled high dose steroids per treatment guidelines Jack is a 48 yr old male Serum IgE level 430IU/mL He is 165 lbs 40 Does he qualify for Omalizumab therapy? What dose is appropriate for Jack? What benefits could he expect from Omalizumab therapy? When should therapy be discontinued? 20

22 Grace Grace was reading on the internet that Vitamin D might help her asthma. She wants to know if it would help her. 41 Post-Assessment Questions 42 21

23 Post-Assessment Questions 43 Medication cost is a primary factor for non-adherence in difficult to treat asthma. A. True B. False Post-Assessment Questions Medications can contribute to both the improvement and detriment of difficult to treat asthma. A. True B. False 44 22

24 Post-Assessment Questions Omalizumab should be monitored frequently and discontinued if no improvement is seen within: A. 30 days B. 90 days C.6 months D.12 months 45 Post-Assessment Questions Long-acting anticholinergic bronchodilator, tiotropium, has been studied in this condition and has shown consistent benefit. A. True B. False 46 23

25 Post-Assessment Questions 47 National Asthma Education and Prevention Program (NAEPP) recommendations for initial management of severe asthma exacerbations include: A.Systemic corticosteroids B.Inhaled corticosteroids C.Inhaled levoabluterol D.Systemic macrolide 24