Chronic Obstructive Pulmonary Disease Guidelines and updates

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Chronic Obstructive Pulmonary Disease Guidelines and updates October 20, 2018 Saratoga Springs, NY COPD (Chronic obstructive pulmonary disease) is a major cause of mortality and morbidity in the United States. Alarmingly, COPD recently became the third leading cause of death behind heart disease and cancer. Current estimates suggest that COPD costs the nation almost $50 billion annually in both direct and indirect health expenditures. While there are an increasing number of treatment options for managing patients with COPD; determining which treatments are appropriate for patients has become more complex. Recent evidence-based guidelines, from both the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the COPD Foundation, have been developed to assist clinicians in their diagnosis of COPD and treatment decision making. Although these two guidelines provide broadly similar criteria for COPD diagnosis, their approaches to disease characterization differ, which ultimately may affect treatment strategies. With the right tools and critical decision making we can manage clinical risks and improve patient outcomes. Kayur V. Patel, MD, MRO, FACP, FACPE, FACHE, FACEP Chief Medical Officer Access2MD

..... Hospital Course Decompensated over next 2 hours Intubated Codes.

09/15/2018 California Society of Health Systems Pharmacists

A 55-year old man whom you have been following for the last 5 years comes to the emergency room because he has increasing difficulty breathing. He has a history of smoking related COPD. The patient has no fever, chills, chest pain or sweats. The mild productive cough he has been having during the last year has not increased. When the patient is supine, his dyspnea is worse. His previous ABGs are ph 7.36, pco 2 : 60, po 2 : 70. His normal peak expiratory flow is 275 cc. You initiate therapy with Ipratropium and Albuterol inhalers, but the patient does not improve with continued inhaler use. On examination, respiratory rate 22, Pulse 125, Temp 99.2, BP 120/80, decreased breath sounds in both lungs with dry inspiratory rales at the bases. Heart: no murmur. Lab: Hgb 12/dL, Hct 53%, WBC 8000/mm 3, Peak expiratory flow is 280 cc, ABGs: ph 7.50, pco 2 40, po 2 50. Chest x-ray reveals no changes, EKG shows sinus tachycardia and normal rhythm. Patient was started on oxygen therapy as necessary with a venturi mask with 60% oxygen in order to reach a 90% oxygen saturation. What is the next step in the patient s management?

A 55-year old man whom you have been following for the last 5 years comes to the emergency room because he has increasing difficulty breathing. He has a history of smoking related COPD. The patient has no fever, chills, chest pain or sweats. The mild productive cough he has been having during the last year has not increased. When the patient is supine, his dyspnea is worse. His previous ABGs are ph 7.36, pco 2 : 60, po 2 : 70. His normal peak expiratory flow is 275 cc. You initiate therapy with Ipratropium and Albuterol inhalers, but the patient does not improve with continued inhaler use. On examination, respiratory rate 22, Pulse 125, Temp 99.2, BP 120/80, decreased breath sounds in both lungs with dry inspiratory rales at the bases. Heart: no murmur. Lab: Hgb 12/dL, Hct 53%, WBC 8000/mm 3, Peak expiratory flow is 280 cc, ABGs: ph 7.50, pco 2 40, po 2 50. Chest x-ray reveals no changes, EKG shows sinus tachycardia and normal rhythm. Patient was started on oxygen therapy as necessary with a venturi mask with 60% oxygen in order to reach a 90% oxygen saturation. What is the next step in the patient s management?

Risk Management Are we assigning a pretest probability? Did we think about the Pre PERC Does PERC rule apply? Documentation of Wells criteria? Did we order a D-dimer? Did we think of immaging?

Most common diagnosis for a missed PE? COPD flair is the most common diagnosis for a missed PE 12% of proven PE have no risk factors 25% of DVT will recur even if treated 5-15% of obese patient on a 8 hour flight will have DVT 50% of iliofemoral DVT embolize 20% of calf DVT propagates and embolizes 50% sensitivity for clinical exam 30% of PE will have negative ultrasound exam of LE 80% of fatal PE have DVTs in LE.

Common 3 rd leading cause of death in US 2 nd leading cause of disability 50 billion dollar Preventable.

Who Has COPD? 1 in 5 Americans has COPD 16 million people are diagnosed, but millions more may have it and not know it

COPD: Challenges Public Health Burden is Large 3 rd leading cause of death in the U.S. Causes serious, long-term disability. Kills >135,000 Americans each year. Available Treatments are Inadequate Self-Management Education and Smoking Cessation Bronchodilators Inhaled Corticosteroids Pulmonary Rehabilitation Oxygen Surgery

COPD Foundation Definition Serious lung disease that over time makes it hard to breathe Emphysema Chronic Bronchitis Refractory Asthma and Some forms of bronchiectasis Blocked (obstructed) airways make it hard to get air in and out

ATS / ERS Definition Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease state characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.

NHLBI Definition Serious lung disease that over time makes it hard to breathe Emphysema Chronic Bronchitis Blocked (obstructed) airways make it hard to get air in and out

GOLD COPD, a common preventable and treatable disease, is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients.

Our Definition in 2017 Chronic bronchitis Emphysema 1. Preventable and treatable 2. Airflow not fully reversible 3. Progressive disease 4. Abnormal inflammatory response 5. Subsets of patients. COPD Asthma Box = FEV1/FVC < 70% Spirometry is REQUIRED for diagnosis

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A. Obstruction B. Decrease surface area 09/15/2018

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Our Definition in 2017 Chronic bronchitis Emphysema 1. Preventable and treatable 2. Airflow not fully reversible 3. Progressive disease 4. Abnormal inflammatory response 5. Subsets of patients. COPD Asthma Box = FEV1/FVC < 70% Spirometry is REQUIRED for diagnosis

Impact of Smoking

Risk Factors Genes Infections Socio-economic status Aging Populations 09/15/2018

Irritants Inflammation Increase in elastoses Breakdown of elastin fibers

Our Definition in 2017 Chronic bronchitis Emphysema 1. Preventable and treatable 2. Airflow not fully reversible 3. Progressive disease 4. Abnormal inflammatory response 5. Subsets of patients. COPD Asthma Box = FEV1/FVC < 70% Spirometry is REQUIRED for diagnosis

Normal

Velocity FEV1 FEV1/FVC FVC < 70%

What is COPD? Chronic obstructive pulmonary disease (COPD) is a progressive lung disease that over time makes it hard to breathe. Less air flows in and out of the airways because of one or more of the following: Left untreated, people with COPD gradually lose their stamina and ability to perform daily activities.

Diagnostic Criteria Should be considered in any patient who has dyspnea, chronic cough or sputum production, and a history of tobacco smoking. Airflow limitation that is not fully reversible and is usually progressive. Requires demonstration by spirometry of airflow limitation that is not fully reversible, in addition to symptoms of dyspnea and cough and exposure to risk factors for the disease such as smoking.

Global Strategy Assessing, Diagnosis, Management and Prevention Symptoms severity Comorbidity Degree of airflow limitation (FEV1) Exacerbation/hospitalizations

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 (C) (D) > 2 3 2 (A) (B) 1 1 0 mmrc 0-1 CAT < 10 Symptoms (mmrc or CAT score)) mmrc > 2 CAT > 10

PLEASE TICK IN THE BOX THAT APPLIES TO YOU (ONE BOX ONLY) mmrc Grade 0. I only get breathless with strenuous exercise. mmrc Grade 1. I get short of breath when hurrying on the level or walking up a slight hill. mmrc Grade 2. I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level. mmrc Grade 3. I stop for breath after walking about 100 meters or after a few minutes on the level. mmrc Grade 4. I am too breathless to leave the house or I am breathless when dressing or undressing. mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

COPD Assessment Test (CAT) Measures health status Based on 8 questions Score from 0 to 5 High scores = symptoms May predict exacerbation May reveal improvement after attending Rehab http://www.catestonline.org/english/index.htm

Modified British Medical Research Breathlessness Measurement Questionnaire Relates well to other measures of health status and predicts future mortality risk

PLEASE TICK IN THE BOX THAT APPLIES TO YOU (ONE BOX ONLY) mmrc Grade 0. I only get breathless with strenuous exercise. mmrc Grade 1. I get short of breath when hurrying on the level or walking up a slight hill. mmrc Grade 2. I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level. mmrc Grade 3. I stop for breath after walking about 100 meters or after a few minutes on the level. mmrc Grade 4. I am too breathless to leave the house or I am breathless when dressing or undressing.

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 (C) (D) > 2 3 2 (A) (B) 1 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 (C) (D) > 2 3 2 (A) (B) 1 1 0 mmrc 0-1 CAT < 10 Symptoms (mmrc or CAT score)) mmrc > 2 CAT > 10

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 (C) (D) > 2 3 2 1 Global initiative for Chronic Obstructive Lung (A) (B) Disease 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

Stage I: Mild FEV 1 /FVC < 0.70 FEV1 80% predicted GOLD Guidelines 2016 Stage II: Moderate FEV 1 /FVC < 0.70 50% FEV 1 < 80% predicted Stage III: Severe FEV 1 /FVC < 0.70 30% FEV 1 < 50% predicted Stage IV: Very Severe FEV 1 /FVC < 0.70 FEV 1 < 30% predicted Active reduction of risk factor(s); smoking cessation, Elimination of Occupational Exposure, Benefit from Physical Activity Add long-acting bronchodilator (as needed) Add regular treatment with long-acting bronchodilators; Begin Pulmonary Rehabilitation Add inhaled glucocorticosteroids if repeated acute exacerbations Add LTOT for chronic hypoxemia. Consider surgical options

Risk (GOLD Classification of Airflow Limitation) My Approach FEV 1 /FVC < 0.70 GOLD Guidelines 2017 IV: Very Severe I: Mild FEV1 100-80% predicted II: Moderate FEV1 50-79% predicted III: Severe FEV1 30-49% predicted FEV 1 0-29% predicted Active reduction of risk factor(s); smoking cessation, Elimination of Occupational Exposure, Benefit from Physical Activity Add long-acting bronchodilator (as needed) Add regular treatment with long-acting bronchodilators Begin Pulmonary Rehabilitation Add inhaled glucocorticosteroids if repeated acute exacerbations Add LTOT for chronic hypoxemia. Consider surgical options

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 (C) (D) > 2 3 2 (A) (B) 1 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 (C) (D) > 2 3 2 (A) (B) 1 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment To assess risk of exacerbations use history of exacerbations and spirometry 4 (C) (D) Two or more exacerbations within the last year or an FEV 1 < 50 % of predicted value are indicators of high 3 risk > 2 Tease out all exacerbations Increase in symptoms 2 that requires change in tx Hospitalizations (A) ER / Urgent Care visits PCP / Pulmonologist 1 visit Ask about infection or use of antibiotics (B) 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 3 (C) Less symptoms with high risk (D) More symptoms with high risk > 2 2 1 (A) Less symptoms with low risk (B) More symptoms with low risk 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 (C) (D) > 2 3 2 (A) (B) 1 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

Management

One treatment modality that improves survival?

Muscaranic Antagonist Iprtorpium Tiotropium Acldinium Inhaled Steroids Fluticasone Butersoidme Beta Agonist Albuterol Salmetrol Fomotenal PDE4 Inhibitor Roflumilast Oxygen

Muscaranic Antagonist Iprtorpium Tiotropium Acldinium Inhaled Steroids Fluticasone Butersoidme Beta Agonist Albuterol Salmetrol Fomotenal PDE4 Inhibitors Roflumilast

Muscaranic Antagonist Iprtorpium Tiotropium Acldinium Inhaled Steroids Fluticasone Butersoidme Beta Agonist Albuterol Salmetrol Fomotenal PDE4 Inhibitor Roflumilast Oxygen

62 year old lady is admitted for the 3 rd time this year with acute exacerbation of her COPD. FEV1 was 35% predicted. She quite smoking 5 years ago. 1. Long acting B2 agonists 2. Inhaled steroid 3. Long acting anti-muscarinic 4. Theophylline 5. Oral steroid (6 x this year)

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 (C) (D) > 2 3 2 (A) (B) 1 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

Risk (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Combined Assessment 4 (C) (D) > 2 3 2 (A) (B) 1 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score))

My Approach FEV 1 /FVC < 0.70 GOLD Guidelines 2017 IV: Very Severe I: Mild FEV1 100-80% predicted II: Moderate FEV1 50-79% predicted III: Severe FEV1 30-49% predicted FEV 1 0-29% predicted Active reduction of risk factor(s); smoking cessation, Elimination of Occupational Exposure, Benefit from Physical Activity Add long-acting bronchodilator (as needed) Add regular treatment with long-acting bronchodilators Begin Pulmonary Rehabilitation Add inhaled glucocorticosteroids if repeated acute exacerbations Add LTOT for chronic hypoxemia. Consider surgical options

1. GOLD Stage III 2. Stopped smoking (decrease symptoms, decrease infection rate) 3. Smoke free environment? 4. Annual influenza vaccine 5. PDE4 inhibitor

Almost Always Preventable. Almost Always Treatable. Someday Curable.

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The single most valuable currency for you and I is information

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Acknowledgements TEAMHealth Institute James Davidson, JD Stephen W. Elliott, JD Howell & Fisher, PLLC Julie Vanoven, RN Nancy Walley, RN Gar LaSalle, MD Luis Quintero, MD If You Want To Get To The Top, Prepare To Kiss A Lot Of The Bottom.

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KayurPatel@Access2.MD

09/15/2018 California Society of Health Systems Pharmacists