Inhaler Use in Older COPD Patients. Disclosures. Objectives 6/4/2014

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Inhaler Use in Older COPD Patients Amber M. Hutchison, PharmD, BCPS Assistant Clinical Professor Auburn University Harrison School of Pharmacy Disclosures Neither I, nor my spouse, have relationships with pharmaceutical companies, biomedical device manufacturers, or other commercial companies whose products or services are related to the subject matter of this presentation. Objectives Discuss guideline recommendations for treatment of chronic obstructive pulmonary disease (COPD) Demonstrate the burden of COPD management in elderly patients Define age-related physical changes associated with long-term COPD in relationship to medication management Recommend appropriate medication therapy adjustments as needed for longterm COPD management to accommodate age-related physical changes 1

COPD Definition Chronic obstructive pulmonary disease (COPD) Preventable and treatable Characterized by ypersistent airflow limitation that is usually progressive Associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases COPD Prevalence The direct costs of COPD for the US has been estimated at $29.5 billion Worldwide COPD is estimated to become the third leading cause of death in 2020 and fourth leading cause of death in 2030 In the United States: In 2011, 6.5% of the US population had COPD In 2010, there were 133,575 deaths caused by COPD Overall, death rates for COPD have not declined Ford ES. CHEST. 2013;144(1):284 305. COPD Prevalence Age Adjusted Prevalence of COPD in adults >25 years of age in 2011 Ford ES. CHEST. 2013;144(1):284 305. 2

COPD Prevalence Age Adjusted Death-rates (per 100,000) of COPD in adults >25 years of age between 1999-2000 Ford ES. CHEST. 2013;144(1):284 305. COPD Prevalence Age Adjusted Death-rates (per 100,000) of COPD in adults >25 years of age between 2009-2010 Ford ES. CHEST. 2013;144(1):284 305. COPD in Older Adults The number of people >60 years of age is expected to rise from 810 million in 2012 to 2 billion in 2050 People >80 years of age is expected to increase 4-fold COPD is one of the most common chronic diseases affecting older adults The United Nations. http://www.un.org/esa/population/publications/2012popageingdev_chart/ 2012PopAgeingandDev_WallChart.pdf Valente S. Respiration 2010;80:357-368. 3

Risk Factors for COPD Development & Progression Cigarette smoking Genetic factors Alpha-1 antitripsyn deficiency Age Lung growth and development Exposure to particles Socioeconomic status questionable Asthma/bronchial hyperreactivity Chronic bronchitis Infections COPD Symptoms and Diagnosis Symptoms Dyspnea Cough Sputum production Wheezing and chest tightness Diagnosis Spirometry demonstrating postbronchodilator FEV 1 /FVC <0.70 COPD Assessment 4

COPD Assessment Goals of assessment Determine severity of the disease Impact on health status Determine risk of future events Used to guide therapy Disease characteristics considered Spirometry Patient symptoms Exacerbation risk Comorbidities Normal Spirometry Volum me (liters) 5 4 3 2 1 FEV 1 = 4L FVC = 5L FEV 1 /FVC= 0.8 1 2 3 4 5 6 Time (seconds) Spirometry in Obstructive Disease 5 Volum me (liters) 4 3 2 FVC = 2.9L 1 FEV 1 = 1.5L FEV 1 /FVC= 0.57 1 2 3 4 5 6 Time (seconds) 5

COPD Assessment Spirometry Based on post-bronchodilator FEV 1 GOLD Classification Severity FEV 1 GOLD 1 Mild FEV 1 >80% predicted GOLD 2 Moderate 50% < FEV 1 <80% predicted GOLD 3 Severe 30% < FEV 1 <50% predicted GOLD 4 Very severe FEV 1 < 30% predicted COPD Assessment Patient symptoms COPD Assessment Test (CAT) 8 items Score ranges 0-40 <10 means less symptoms, >10 means more symptoms COPD Control Questionnaire (CCQ) 10 items self administered <1 more symptoms, >1 less symptoms Modified British Medical Research Council Questionnaire (mmrc) 5 grades score of 0-4 <2 less symptoms, >2 more symptoms COPD Assessment Exacerbation risk assessment Exacerbation Acute event Characterized by worsening of patient s respiratory symptoms Leads to change in medications Frequent exacerbations are more than 2 per year 6

COPD Assessment Exacerbation risk assessment High risk: >2 exacerbations per year >1 exacerbation leading to hospital admission Lower risk: 1 exacerbation per year (not leading to hospital admission) COPD Assessment Comorbidities All comorbidities should be evaluated at each visit and treated according to guidelines GOLD Spirometry COPD Assessment Combined Exacerbation History 3-4 C D >2/year OR >1 leading to admit 1-2 A B 0-1 exacerbation /year CAT < 10 CAT > 10 Symptoms mmrc <2 mmrc > 2 Breathlessness 7

Method of Assessment 1. Assess symptoms with CAT or mmrc 2. Assess risk of exacerbations A. Evaluate spirometry B. Assess number of exacerbations within the previous 12 months C. Assess if patient has been hospitalized for exacerbation Patient Case MS is a 67 year old female who has had COPD for 9 years. During an MTM visit, you ask several questions to assess her COPD. Her CAT score is 16. FEV 1 at last measurement was 35%. She had one COPD exacerbation 8 months ago and was admitted to the local hospital for 5 days. Patient Case What group would you place MS into? A B B C D 8

Patient Case SN is a 72 year old male with COPD. As a part of his outpatient visit, you need to assess his COPD. His mmrc score is 2. He had one COPD exacerbation 3 months ago which was treated outpatient. His FEV 1 at last measurement was 52%. Patient Case What group would you place SN into? A B C D COPD Assessment Combined Pt Category A B C D Character Spriometry Exacer/ year Low risk, Less symptoms Low risk, More symptoms High risk, Less symptoms High risk, More symptoms CAT FEV 1 >50% <1 <10 <2 FEV 1 >50% <1 >10 >2 FEV 1 <50% >2 <10 <2 FEV 1 <50% >2 >10 >2 mmrc 9

Pharmacologic treatment No agent has been shown to decrease mortality for COPD patients Reduces COPD symptoms, frequency of exacerbations, and improve health status Smoking cessation Slows disease progression Oxygen therapy Increases survival in patients with severe resting hypoxemia Common Agents Inhalers Beta agonists Short vs. long acting Anticholinergics Short vs. long acting Corticosteroids Combination inhalers Oral agents Methylxanthines Theophylline Aminophylline Phosphodiesterate-4 inhibitor (PDE4 inhibitor) Roflumilast (Daliresp ) 10

Inhalers Beta 2 -agonists SABA: Short-acting beta agonists Albuterol, levalbuterol LABA: Long-acting beta agonists Formoterol, aformoterol, indacaterol, salmterol Anticholinergics (muscarinic agents) SAAC: Short-acting anticholingerics Ipratropium LAAC: Long-acting anticholinergics Aclidinium, tiotropium Corticosteroids ICS inhaled corticosteroid Inhalers Combination SABA + SAAC Albuterol + ipratropium LABA + LAAC Vilanterol + umeclidinium (Anoro Ellipta ) LABA + ICS Formoterol + budesonide (Symbicort ) Formoterol + mometasone (Dulera ) Salmeterol + fluticasone (Advair ) Vilanterol + fluticasone (Breo Ellipta ) Methods of inhalation administration Metered dose inhalers Dry powder inhalers Dry powder inhalers Nebulizer solutions 11

Metered dose inhaler Medication is administered as aerosol with propellant Actuation and inhalation require coordination Can use with spacer to help with coordination Patient should inhale slowly Priming is required Shake before use Dry powder inhaler Multiple forms on the market Need to understand mechanics of each Medication is in powder form No propellant Patient inhalation triggers actuation Coordination is not necessary Spacer cannot be used Patient should inhale quickly Nebulizers Medication is in liquid form Device uses compressed air to aerosolize medication Nebulization device is bulky and requires electricity Administration time is prolonged compared to other devices No coordination required 12

Self-Check Which method of inhalation requires the least hand-breath coordination? Metered dose inhaler Dry powder inhaler Nebulizer Selection Bronchodilator medications are central to symptom management Inhaled therapy is preferred Choice of therapy is dependent on availability and patient response Long-acting inhaled bronchodilators are convenient and more effective for maintained symptom relief Combination products may improve efficacy and decrease risk of side effects Selection Long acting beta2-agonists and anticholinegrics are preferred over short term Long-term use of ICS alone is not recommended Less effective than the combination of ICS + LABA Long-term monotherapy of oral corticosteroids is not recommended 13

Selection Group First Line Alternative Other A SABA or SAAC LAAC or LABA or SABA+SAAC Theophylline B C D LAAC or LABA ICS+LABA or LAAC ICS+LABA and/or LAAC LABA+LAAC SABA and/or SAAC or Theophylline LABA+LAAC or SABA and/or LAAC+PDE4 inhibitor SAAC or LABA+PDE4 inhibitor Theophylline ICS+LABA+LAAC Carbocysteine or ICS+LABA+PDE4 SABA and/or SAAC inhibitor Or Theophylline LAAC+LABA Or LAAC+PDE4 inhibitor Patient Case Earlier, we decided MS s group was. MS is currently on scheduled formoterol and PRN albuterol. She is experiencing symptoms which are limiting her quality of life. What is your recommendation? Change formoterol to nebulized albuterol Change formoterol to mometasone Change formoterol to formoterol plus budesonide Change formoterol to formoterol plus budesonide and tiotropium Patient Case Earlier, we decided SN s group was. SN is currently on albuterol as needed. As you have discovered, he is having increased dyspnea. What is your recommendation? Discontinue albuterol and start tiotropium Continue albuterol and start tiotropium Discontinue albuterol and start fluticasone Continue albuterol and start mometasone and formoterol 14

Application to Older Adults Treatment of COPD in Older Adult Considerations for pharmacists Age-related changes Peak inspiratory flow Patient education Smoking cessation Immunizations Age Related Changes Physical changes Manual dexterity Visual changes Age is inversely related to extremity muscle strength, respiratory muscle strength, and pulmonary function Cognitive changes Patients with a Mini Mental Status Exam score of less than 23 out of 30 are unlikely to learn and retain correct MDI technique Vincken W. Prim Care Resp J. 2010;19(1):10 20. Valente S. Respiration. 2010;80:357 368. 15

Peak Inspiratory Flow Inhalers require a minimum peak inspiratory flow Optimal peak inspiratory flows MDI minimum 25 L/min DPI Turbuhaler minimum 60 L/min HandiHaler minimum 20 L/min Diskus minimum 30 L/min Nebulizer no peak inspiratory flow needed Patient Education Progression of disease Not curable and progressive Medical therapy will not be stepped down Medication counseling Role of medications Rescue medication vs maintenance medication Inhaler devices Ensure correct use at each visit Demonstrate technique for patient Use teach-back approach Smoking Cessation Has the greatest impact on the progression of COPD In 2011, 39% of the 15 million adults with COPD continued to smoke Recommended for all GOLD categories Most trials have been done in middle-aged populations Ford ES. CHEST. 2013;144(1):284 305. 16

Smoking Cessation Lung function FEV V1 (% of value at age 25) Age Lung function vs. age and the relationship between smoking and lung function decline Parkes G. BMJ. 2008;336(7644):598 600 ronchodilator FEV1 (Liters) Average post-br Smoking Cessation Time (years) Loss of lung function over 11 years based on smoking status Tashkin DP. Resp Med. 2009;103:963 974. Anthonisen NR. Am J Respir Crit Care Med. 2002;166(5):675 679. Smoking Cessation Counseling delivered by healthcare professionals increases quit rates Brief strategies to help the patient willing to quit (the 5 A s): Ask identify all tobacco users Advise strongly urge all tobacco users to quit Assess determine willingness to make a quit attempt Assist aid the patient in quitting Arrange schedule follow-up contact JAMA. 2000;283(24):3244 3254. 17

Smoking Cessation Products available for smoking cessation OTC Nicotine replacement in the form of patches, gum, or lozenges Prescription only Nicotine replacement in the form of inhaler or nasal spray Varenicline (Chantix ) Buproprion (Zyban ) JAMA. 2000;283(24):3244 3254. Nicotine. In: Lexi Comp Online [AUHSOP Intranet]. Self-Check Which of the following is FALSE regarding smoking cessation? It is recommended for all stages of COPD Counseling by healthcare professionals increases likelihood of quitting Smoking cessation stops the progression of COPD Immunizations Review the immunization history for all patients Can be done in community setting, clinic setting, or hospital setting Follow guidelines from the Centers for Disease Control Advisory Committee on Immunization Practices (CDC ACIP) Guidelines are released yearly Available from: http://www.cdc.gov/vaccines/schedul es/hcp/adult.html 18

Immunizations Influenza vaccination Inactivated influenza vaccine (IIV) recommended yearly 18-64 years of age may receive intradermal or intramuscular IIV >65 years of age may receive the standard IIV or the high-dose IIV Benefits Reduces exacerbations Reduces influenza infections Decreases risk of death CDC ACIP 2014 Adult Immunization schedule. http://www.cdc.gov/vaccines/schedules/downloads/adult/adult combinedschedule.pdf Immunizations Pneumococcal vaccination All patients >65 should receive one dose of the pneumococcal polysaccharide vaccine (PPSV23) COPD patients 19-64 years of age should receive PPSV23 Patients should be revaccinated after age 65 if 5 years has passed since last vaccination Benefits Reduces community acquired pneumonia caused by pneumococcus Reduces pneumonia caused by both pneumococcus and unknown etiology for COPD patient <65 years of age and FEV 1 <40% predicted CDC ACIP 2014 Adult Immunization schedule. http://www.cdc.gov/vaccines/schedules/downloads/adult/adult combined schedule.pdf Sehatzadeh S. Ont Health Technol Assess Ser [Internet]. Available from: www.hqontario.ca/en/mas/tech/pdfs/2012/rev_copd_vaccinations_march.pdf Patient Case WE is a 74 year old female patient with COPD. Upon reviewing her charts, you find out she received her influenza vaccine October of last year and a pneumococcal vaccine when she was 67. What are your recommendations for vaccination? 19

Patient Case AP is a 68 year old male patient with COPD. Upon reviewing his charts, you find out he received her influenza vaccine December of last year. He received a pneumococcal vaccine when he was 64. What are your recommendations for vaccination? Potential Solutions for Older Patients Problem Requires hand-breath coordination Lacking hand strength or dexterity Difficulty generating adequate peak inspiratory flow Possible cognitive impairment Patient on multiple inhalers Solution Use a spacer or nebulizer Use a spacer or nebulizer Change DPI to MDI Consider nebulizer Have patient demonstrate proper technique at each visit Change inhalers to same administration type (for example, all DPI) Combine active ingredients if possible into single inhalers Ensure proper use at each visit Assessment Questions Which method of inhalation requires the most hand-breath coordination? Metered dose inhaler Dry powder inhaler Nebulizer 20

Assessment Questions Which therapy has been shown to increase survival in COPD patients with persistent hypoxemia? LABA + LAAC LABA + ICS Smoking cessation Oxygen therapy Assessment Questions TRUE or FALSE: Smoking cessation is recommended only for COPD groups C and D. 21