Midwinter 2015 Asthma

Transcription

1 National Education and Prevention Program Guidelines National Education and Prevention Program Guidelines Karl D. Fiebelkorn, MBA, RPh, AE-C Clinical Associate Professor Senior Associate Dean UB School of Pharmacy & Pharmaceutical Sciences National Institute of Health National Heart, Lung, Blood, Institute: Guidelines for the Diagnosis and Management of Clinical Guideline for the Diagnosis, Evaluation and Management of Adults and Children with Quick Facts About in NYS Prevalence One in every 12 adults One in every 9 children Morbidity and Mortality For , an average of 258 deaths due to asthma occurred per year in NYS, which is an age adjusted asthma mortality rate of 12.5 per one million residents. NYS children missed more than 1.9 million days of daycare, preschool or school due to asthma each year. Adults with asthma reported approximately 7.6 million days within the past year when they were unable to work or carry out usual activities because of asthma. New York State Department of Health, Office of Public Health Practice and Division of Chronic Disease and Injury Prevention Release Date: 5/12/11 NYS Surveillance Report 2009, Costs $56 Billion Nationally $1.3 Billion NYS (Budget $138) $660 million 2011 hospitalizations 61% increase since % of hospitalizations = Medicaid 35% of cost of hospitalizations = Medicaid - Etiology is primarily a pulmonary disease with many, diffuse triggers. Genetic predisposition appears to play a role. 60%-80% of the susceptibility Important role of atopy The Prevalence and Cost of in NYS Office of Comptroller April 2014 Karl D. Fiebelkorn Page 1

2 Atopy: Greek: Atopos: Out of place The term atopy describes the genetically determined tendency to mount immunoglobulin E (IgE) antibody responses against per se harmless antigens (allergens) Atopy Atopy involves the capacity to produce IgE in response to common environmental proteins such as house dustmite, grass pollen, and food allergens. The genetic tendency to develop the classic allergic diseases -- atopic dermatitis, allergic rhinitis (hay fever), and asthma. Nasal polyps Note Not all asthmatics have atopy Not all individuals with atopy develop asthma. We will cover specific triggers later Disease Manifestation Pathophysiology is a chronic inflammatory disorder of the airways. A key principle of therapy is regulation of chronic airway inflammation. Mucosal edema Basement membrane thickening Broncho-constriction Bronchial Hyperresponsiveness (BHR) Histologic Changes Marked hyperplasia and hypertrophy of airway smooth muscle. Increased airway wall thickness with an exudative inflammatory reaction, epithelial desquamation and edema. Mucus gland hypertrophy and secretion Airway Remodeling Remodeling may lead to irreversible damage to the airways leading to the sequella of COPD Aided by the release of cytokines and growth factors. Epithelial cells Help to clear noxious agents But release other pro-inflammatory chemicals including Nitric Oxide (NO) Activated by IgE dependent mechanisms, viruses, pollutants, histamine Involved in deaths where extensive epithelial cell shedding occurs Karl D. Fiebelkorn Page 2

3 Other cells Eosinophils Lymphocytes Mast Cells Macrophages Release leukotrienes Neutrophils Symptoms Wheezing Breathlessness Chest tightness Coughing Particularly at night/early morning hours Is this reversible? BHR? Pathophysiology Early tic Response (EAR) Late tic Response (LAR) Bronchial Hyperresponsiveness (BHR) Early tic Response Occurs immediately following exposure to a trigger - maximal intensity in minutes. Due to mast cell degranulation and release of mediators of acute inflammation that cause predominantly bronchospasm and increased mucus secretion Lasts 1-2 hours Does not lead to BHR IgE Increase in the number of mast cells lining the airways of the asthmatic Allergen binds to the IgE causing the mast cell to degranulate and release: Histamine Leukotrienes C4, D4 and E4 Prostaglandins Platelet activating factor Causes bronchoconstriction This mechanism is postulated in EIB Allergic asthma = 60% asthmatics (NIH) Late tic Response Delayed with onset about 4 hours after exposure to trigger, maximal intensity at 6-8 hours. Prolonged response - up to 24 hours. May or may not be preceded by an EAR. Leads to BHR and chronic asthma Edema Mucus Inflammatory mediators Karl D. Fiebelkorn Page 3

4 Bronchial Hyperresponsiveness BHR is the hallmark of asthma. It is a hyperreactivity of the airways to physical, chemical and pharmacologic stimuli. May persist for weeks to months after an acute exacerbation. Each successive exacerbation will prolong recovery of the BHR. Classification of Allergic Chronic Acute Severe Exercise-Induced (EIB) Nocturnal Chronic Dyspnea Chest tightness Dry hacking cough Cough variant asthma Atopy Expiratory wheezing upon auscultation Chronic Spirometry demonstrates obstruction ( FEV1/FVC) Bronchodilator improves > 12% Eosinophils IgE FeNO Methacholine challenge Acute (Severe) Dyspnea Chest tightness SOB Patient unable to say few words anxious Unresponsive to SABA Wheezing Dry hacking cough Pale or cyanotic Acute (Severe) Hyperinflated chest Intercostal or supraclavicular retractions Tachypnea Tachycardia FEV1 < 50% SaO2 < 90% (O2 saturation by pulse oximetry) Karl D. Fiebelkorn Page 4

5 Nocturnal Typical fall in pulmonary function at night Possibly due to circulating cortisol and epinephrine. Wakening due to what symptoms? What else can cause this? How do you remedy? What other symptom that could be dangerous? Exercise Induced (EIB) How do you know they have EIB? How do you advise these patients once you know? Onset early in life Symptoms vary day to day Allergy, rhinitis, eczema also present Family history Largely reversible airflow limitation COPD Onset in midlife Symptoms slowly progressive Long smoking history Dyspnea on exertion Largely irreversible airflow limitation COPD Overlap Syndrome >40 years; years Past or current smoker >10 pack-years Atopy present Rhino-sinusitis GERD Exercise very limited Hallmark problem: very frequent exacerbations > COPD alone Management of FOUR Components NAEPP Expert Panel Report #3 Assessing and monitoring asthma severity and asthma control Control of environmental factors and comorbid conditions that affect asthma. Medications and treatment Patient education for partnership in care Spirometry Spirometry is recommended: At initial assessment After treatment has stabilized symptoms At least every 1 to 2 years NHLBI EPR-3 August 2007 Karl D. Fiebelkorn Page 5

6 PEF Peak Expiratory Flow What mimics this? Peak Flow Meters. Talk about later Consider peak flow monitoring for patients who have: A moderate or several persistent asthma a history of severe exacerbations. Poor perception of airflow obstruction and worsening asthma Spirometry Detection of disease and its severity Identification of asthma triggers Progress/natural history monitoring Treatment response assessment Preoperative assessment Fev1 in asthmatics will be High, low, normal Fev1/FVC in asthmatics will be High, low, normal Identify and Assess Next steps Assessment of risk Exacerbations are acute or sub acute worsening of Breath Cough Wheeze Chest tightness 2 or more visits to the ED Psychosocial: Depression Attitudes towards medications accessed Control Questionnaire (ACQ) Validated against the Quality of Life Questionnaire (AQLQ) and Medical Outcomes Survey Short Form- 36 (SF-36).. European Respiratory Journal, 1999: 14: Karl D. Fiebelkorn Page 6

7 Validated against the Quality of Life Questionnaire (AQLQ) and Medical Outcomes Survey Short Form- 36 (SF-36). Validation methods categorized patients into groups known to differ in asthma control derived from 3 criterion measures. Specialist s rating of control FEV1% predicted Whether the specialist changed the patient s therapy as a result of the visit Juniper EF, et al. 1999b. accessed Monitoring Symptoms Symptom history should be based on a short (4 weeks) recall period Symptom history should include: Daytime asthma symptoms Nocturnal wakening as a result of asthma symptoms Exercise-induced symptoms Exacerbations Goals of Therapy Reduce Impairment Maintain (near) normal pulmonary function. Maintain normal activity levels (including exercise and other physical activity and attendance at school or work). Reduce troublesome symptoms Meet patients and families expectations of and satisfaction with asthma care. Karl D. Fiebelkorn Page 7

8 Goals of Therapy Reduce Risk Prevent recurrent exacerbations of asthma and minimize the need for ED visits or hospitalizations. Prevent loss of lung function; for children, prevent reduced lung growth. Provide optimal pharmacotherapy with minimal or no adverse effects of therapy What are the Triggers? Respiratory infections Respiratory syncytial virus (RSV) Rhinovirus Influenza Mycoplasma pneumonia Chlamydia What are the Triggers? Allergens Dust Mites How do you get rid of these guys? Cockroaches Cats/Dogs Skin testing Mold Pollen, grasses, trees Stay inside during peak hours Triggers Exercise (especially in cold climate) Warm up first Use inhaler as in EIB Smoke Primary Secondary Other smokers Fireplaces Triggers Occupations Steel plants Bakeries Work with supervisor: avoidance, ventilation Hairdressing Environment Volatile Organic Compounds (VOC s). Household chemicals Air fresheners Lysol Perfumes Environmental factors: Employment When would symptoms improve? Higher prevalence and morbidity is associated with urban living independent of race. Karl D. Fiebelkorn Page 8

9 Comorbid conditions GERD Avoid heavy meals, fried food, caffeine near bedtime H2 s Tilt head of the bed 6-8 inches Emotions Depression, stress, laughter Obesity Weight loss programs Comorbid conditions Obstructive Sleep Apnea Other Psychological Factors Rhinitis/Sinusitis Premenstrual 30-40% worsening of asthma 2 days before 4 days after What are the Triggers? Foods Dairy Peanuts Shell fish Preservatives, benzalkonium chloride Nebulizer solutions Vitamin D insufficiency Vitamin D helps regulate T cells and improves the secretion of anti-inflammatory cytokines in response to corticosteroids. Wine All wines have sulfites Medication Sensitivities Beta-Blockers Non-selective Sulfite Sensitivities Some medications Eye drops Processed potatoes Shrimp dried fruit beer Aged alcohol Salad bars NHLBI EPR-3 August 2007 Aspirin Sensitive tics Arachidonic Acid Some asthmatics are intolerant to aspirin Related to: Rhinitis Nasal polyps May also be allergic to NSAIDS, severity of which depends on the potency to act as a COX-inhibitor LTB4 LT A 4 Not Anti-inflammatory (Neutral) LTC4 LTD4 LTE4 PGD2 PGF2α PGG2 Pro -inflammatory Mucous Bronchoconstriction Edema, eosinophilia PGH2 PGG2 Anti-inflammatory NHLBI EPR-3 August 2007 Karl D. Fiebelkorn Page 9

10 Aspirin Sensitivity (Triad) Adult patients who have severe persistent asthma, nasal polyps, or a history of sensitivity to aspirin or nonsteroidal antiinflammatory drugs (NSAIDs) should be counseled regarding the risk of severe and even fatal exacerbations from using these drugs Alternatives to aspirin that usually do not cause acute bronchocontriction in aspirinsensitive patients include acetaminophen Aspirin desensitization NHLBI EPR-3 August 2007 All tics Should receive an annual seasonal influenza shot and H1N1 vaccine FluMist should not be administered to persons with asthma. NHLBI EPR-3 August Persons aged 19 through 64 years who have asthma should receive a single dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23). CDC Advisory Committee for Immunization Practices (ACIP) Provisional Recommendations Oct NHLBI EPR-3 August 2007 Indicators or Poor Control Always check adherence first Inhaler techniques Environmental changes Remove allergens and triggers Change of job or school or home Comorbid conditions? Medications? New ones Lack of understanding current ones Side effects of current or additional medications? Lack of understanding disease state Severity Proper use of an MDI 4 methods in all! Remove the cap and shake inhaler. Breathe out slowly away from inhaler Position Inhaler in one of the following ways: Actuate inhaler as you begin to inhale Inhale slowly over 3 to 5 seconds, through your mouth. Hold your breath for 10 seconds Wait between puffs, if multiple puffs. Proper Use of a DPI Move/open indicator or puncture dose Exhale away from device Place device to mouth Inhale swiftly and deeply through the device Hold breathe for 10 seconds Exhale slowly May repeat but do not re-actuate DPI Pharmacotherapy Quick Relief Rescue Long-Term Control Controllers Karl D. Fiebelkorn Page 10

11 Overview of Medications As-needed: Quick Relief Short-acting beta 2 -agonists (SABA) Anticholinergics Systemic corticosteroids Quick Relief: Albuterol Pregnancy Category: C 1-2 p q4h prn Sympathomimetic Increase HR CV Hypokalemia Paradoxical bronchospasm Quick Relief: Albuterol Proventil Shake well: yes Prime/re-prime Manufacturer s expiration date on package Dose counter: no ProAir Shake well: yes Prime/re-prime Manufacturer s expiration date on package Dose counter: yes Quick Relief: Albuterol Ventolin Shake well: yes Prime/Re-prime Dose counter: yes 12 months from removal from foil pouch What is the goal of Albuterol use? Pharmacists Letter Feb 2014 Pharmacists Letter Feb 2014 Quick Relief: Levalbuterol Albuterol Nebulizer Solutions Xopenex Shake well: yes Prime/ re-prime Clean at least weekly Warm water Dosing counter: no Manufacturer s Expiration Date Levalbuterol nebulizer solution Karl D. Fiebelkorn Page 11

12 Quick Relief Note: ipratropium has an off-label use for asthma Acetylcholine Activates GMP Constricts smooth muscle Ipratropium blocks the acetylcholine Parasympathetic innervation is responsible for maintaining normal bronchial tone. Anticholinergics broncho-dilate and decrease mucus production Atrovent ATROVENT HFA Shake well: No Prime/re-primed should be "primed" 2 times before you use the first dose of a new ATROVENT HFA inhaler or when the inhaler has not been used for more than 3 days Dose indicator: yes 2p qid Wash with warm water Manufacturer s expiration date Pharmacists Letter Feb 2014 Combivent Respimat Ipratropium HFA / Albuterol Shake well: no Manufacturer Expiration: 3 months after assembly Prime/re-prime complicated Dosing counter: inexact Clean: wipe Pregnancy: C Quick Relief Oral corticosteroids Methylprednisolone Prednisolone Prednisone Adults: Short burst 40-60mg as single or BID doses for 3-10 days. ADR: Hypothalamus/Pituitary/Adrenal Injection Methylprednisolone 240mg IM once Long Term Control Inhaled Corticosteroids (ICS) Cromolyn/Nedocromil Long-Acting Beta2-agonists Methylxanthines (Theophylline) Leukotriene modifiers DPI s Advantages and Disadvantages What populations of patient would your recommend a DPI? Should patients rinse their mouths after use? Do these require the patients to shake them? Karl D. Fiebelkorn Page 12

13 Long-Term Control Inhaled corticosteroids Long term use for prevention Rinse mouth after use Dysphonia Thrush How would you incorporate this into someone s daily habits? Another way to prevent the above ADR? Overview of Medications Inhaled Corticosteroids (ICS) MDI s and DPI s Use lowest dose possible Use in combination with long-acting beta 2 -agonists Monitor growth in children No problem with low-medium doses High doses are a concern Low-Dose ICS and the Prevention of Death from Discontinuance of the ICS can be detrimental Regular use of low-dose inhaled corticosteroids is associated with a decreased risk of death from asthma Suissa, et al. N Engl J Med. 2000;343: Overview of Medications Inhaled Corticosteroids (ICS) Fewer severe exacerbations Reduced use of quick-relief medicine Improved lung function Reduced airway inflammation Small risk for adverse events at recommended dosage Suissa, et al. N Engl J Med. 2000;343: Long-Term Control Inhaled corticosteroids Beclomethasone R HFA (QVAR) MDI Shake well? no BID dosing Dose counter: no Dipropionate prodrug Monopropionate (active) Pregnancy: C Long-Term Control Inhaled corticosteroids Budesonide (Pulmicort Flexhaler R ) DPI Shake well: No Prime before first use: twist to set BID Dose counter: yes Manufacturer s expiration date Respules: Jet Nebulizers only, not ultrasonic Pregnancy: B Pharmacists Letter Feb 2014 Pharmacists Letter Feb 2014 Karl D. Fiebelkorn Page 13

14 Long-Term Control Inhaled corticosteroids Ciclesonide (Alvesco R ) MDI Shake well: No Dose counter: yes Manufacturers expiration date Prodrug descicloesonide (active) Pregnancy: C Long-Term Control Inhaled corticosteroids Flunisolide (Aerospan R ) MDI Shake well: yes Prime/Re-prime Dose counter: No Manufacturer expiration date Built-in Spacer No cleaning is required Pregnancy: C Pharmacists Letter Feb 2014 Pharmacists Letter Feb 2014 Long-Term Control Inhaled corticosteroids Fluticasone propionate (Flovent R HFA) MDI Shake well: yes Prime / Re-prime BID Dose counter: yes Manufacturer s expiration date Pregnancy: C Long-Term Control Inhaled corticosteroids Fluticasone propionate (Flovent R ) DPI: Diskus Shake well: no Priming: no Dose counter: yes BID No cleaning 6 Weeks after removal from foil pouch 50mcq 2 months after removal from foil pouch 100mcq and 250mcq Pregnancy: C Pharmacists Letter Feb 2014 Long-Term Control Inhaled corticosteroids Mometasone (Asmanex Twisthaler R ) DPI Shake well: no No priming Dose counter: yes QD in the evening 45 days after removal from foil pouch Pregnancy: C Side note: Long Acting Beta Agonists Increased risk of severe exacerbation, hospitalizations and death 12 years of age Should never be used alone without a corticosteroid Contraindicated Should not be used in patients whose asthma is adequately controlled on low/medium dose ICS Used only as additional therapy in patients not adequately controlled on a long term asthma control medication, e.g., ICS Pharmacists Letter Feb yinformationforpatientsandproviders/ucm htm: accessed Karl D. Fiebelkorn Page 14

15 FDA Drug Safety Communication LABA s for June 2010 To ensure the safe use of these products: The use of LABAs is contraindicated without the use of an asthma controller medication such as an inhaled corticosteroid. Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone. LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications. Combinations Advair Fluticasone propionate/salmeterol MDI Shake well: yes Prime / Re-prime Dose counter: yes BID Manufacturer s expiration date Pregnancy: C Combinations Advair Diskus Fluticasone propionate/salmeterol DPI Shake well: no BID Dose counter: yes No cleaning required 1 month after removal from foil pouch. Pregnancy: C Combinations Dulera Mometasone furoate /Formoterol MDI Shake well: yes Prime/Re-prime Dose counter: yes Manufacturer s expiration date Pregnancy: C Combinations Symbicort Budesonide/Formoterol MDI Bid Shake well: yes Dose counter: yes 3 months after removal from foil pouch Pregnancy: C Overview of Medications Leukotriene Modifiers Mild persistent asthma Onset of effect is immediate compared to slower onset with inhaled steroids Advantage taken orally Some benefit with allergic rhinitis Overall, less effective than low dose inhaled steroids. Possibly a role in aspirin induced asthma. Karl D. Fiebelkorn Page 15

16 Overview of Medications Leukotriene Modifiers Leukotriene D 4 Receptor Antagonists Montelukast (Singulair) 10mg hs Reduced dose in kids down to 6 mos Pregnancy: B Zafirlukast (Accolate) 20mg bid Reduced dose in kids down to 5 yo Pregnancy: B Overview of Medications Leukotriene Modifiers 5-Lipoxygenase Inhibitor Zyflo CR 600mg tabs Two 600-mg extended release tablets two times a day within one hour after the morning and evening meals for a total daily dose of 2400 mg. Tablets should not be chewed, cut or crushed Pregnancy: C. Leukotriene Modifiers Adverse Effects Zileuton: (Zyflo) Hepatotoxicity (frequent monitoring of LFTs) Drug interactions - inhibits CYP3A4 (warfarin, theophylline, etc) Zafirlukast: (Accolate) Hepatotoxicity LFTs Drug Interaction with warfarin Montelukast: (Singulair) Instruct patients to be alert for neuropsychiatric events accessed Component #4 Education for a Partnership in Care Written Action Plans Develop active partnership with patient and family Treatment goals Patient s education level and cultural beliefs Short and long term goals Write it down! Give resources where they can find more information Peak Flow Meters Karl D. Fiebelkorn Page 16

17 Peak Flow Monitoring Patients with moderate to severe persistent asthma should: Have a peak flow meter and learn to monitor their peak flows Do daily long-term monitoring or shortterm (2-3 weeks) monitoring Use peak flow monitoring during exacerbations Peak Flow Monitoring How should they use these? How do you know what the measurement means? When is the best time to use these during the day? How do you start someone on a peak flow meter? Peak Flow Monitoring Mary Medicaid Peak Flow Diary Patients should always use the same peak flow meter Many types out there Measure peak flow on waking before taking a bronchodilator Use his/her personal best reading 100 Mary Medicaid Peak Flow Monitoring Having the patient jot down their symptoms and medication usage is very helpful But some patients may see this as a burden. Karl D. Fiebelkorn Page 17

18 Action Plans Written Action Plan htm The plan should include: Signs, symptoms, and peak flow levels that indicate deteriorating asthma How to adjust medications in response to deteriorating asthma When to seek medical help Emergency phone numbers 104 Mucus Clearance Postural Drainage Breathing Exercises Physical Exercise Increase rate and depth of breathing Devices for Mucus Clearance Cause Positive Expiratory Pressure Acapella Mechanical Vibration High frequency chest wall oscillations VEST Acoustic Impedance Devices Lung Flute Acoustic wave technology Reed Resources American Academy of Allergy, and Immunology American College of Allergy, and Immunology American Lung Association Resources American Association of Educators Centers for Disease Control and Prevention National Heart, Lung and Blood Institute Karl D. Fiebelkorn Page 18