Transcript (PowerPoint)

Disclosures
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Off-label Discussion Disclosure
This educational activity may contain discussion of published and/or
investigational uses of agents that are not indicated by the Food and
Drug Administration. PCME does not recommend the use of any agent
outside of the labeled indications. Please refer to the official
prescribing information for each product for discussion of approved
indications, contraindications and warnings. The opinions expressed
are those of the presenters and are not to be construed as those of the
publisher or grantors.
Learning Objectives
• Identify lapses in COPD care that led to the Centers for
Medicare and Medicaid Services (CMS) quality measures,
and identify opportunities to improve the quality of that care
across the healthcare continuum
• Apply current clinical evidence and guidelines to develop a
comprehensive care plan that addresses common reasons
for repeat exacerbations and hospital readmissions
• Apply quality-of-care models and develop programs to
foster effective transitions of care and ongoing
maintenance treatments for patients with COPD
Polling Question
Pre-activity Survey
What percentage of your COPD patients who present for
management of exacerbations do you refer for pulmonary
rehabilitation?
A. All of my COPD patients
B. 51%-75% of my COPD patients
C. 25%-50% of my COPD patients
D. <25% of my COPD patients
Polling Question
Pre-activity Survey
In what percentage of your patients presenting for
management of COPD exacerbations do you evaluate and
manage comorbidities?
A. All of my COPD patients
B. 51%-75% of my COPD patients
C. 25%-50% of my COPD patients
D. <25% of my COPD patients
Polling Question
Pre-activity Survey
Please rate your level of familiarity with the CMS Core
Measures for COPD:
1
Not at all familiar
2
3
4
5
Expert
Polling Question
Pre-activity Survey
Please rate your level of confidence in your ability to
implement strategies to ensure continuity of care for COPD
patients based on the CMS Core Measures for COPD:
1
Not at all confident
2
3
4
5
Expert
Polling Question
Pre-activity Survey
What is the most common cause of mortality in COPD
patients?
A. COPD
B. Depression
C. Cardiovascular disease
D. Diabetes
Polling Question
Pre-activity Survey
A 72-year-old woman is released after management of COPD
exacerbation. She has type 2 diabetes, hypertension, hypothyroidism,
and rheumatoid arthritis. She is not at the goal for hemoglobin A1C nor
blood pressure. She also has mild depression, for which she is
successfully managed with trazodone. What is her greatest risk for
frequent exacerbations going forward?
A. Her age
B. Age at onset of COPD
C. Her uncontrolled diabetes
D. Her history of exacerbations
Polling Question
Pre-activity Survey
Based on the GOLD 2014 recommendations, which of the
following criteria should be present before hospital discharge
following COPD exacerbation?
A. Patient has been clinically stable for 12-24 hours
B. Patient is able to walk around the block (if previously
ambulatory)
C. Patient requires inhaled short-acting beta2-agonist
therapy every 2-4 hours
D. Patient had stable arterial blood gases for 24-48 hours
Polling Question
Pre-activity Survey
Which of the following non-pharmacologic interventions has
been shown to decrease readmissions for COPD
exacerbation?
A. Vitamin D supplementation
B. Decreased physical activity
C. Yearly influenza vaccination
D. None of the above
Polling Question
Pre-activity Survey
So far, the only therapy documented to reduce COPD
disease progression is:
A. Physical activity
B. Influenza vaccination
C. Smoking cessation
D. Good nutrition
Polling Question
Pre-activity Survey
Which of the following outcomes may be seen when
enrolling patients in an integrated disease management plan
for COPD?
A. Decreased frequency of viral infection
B. Weight gain
C. Decreased readmissions and lengths of stay
D. Significantly increased health care costs
Polling Question
Pre-activity Survey
When selecting a medication delivery system for your COPD
patient, which is your most important criteria?
A. Amount of medication deposited in the lungs
B. Cost
C. Disease severity
D. Hand-breath coordination
E. Presence of support system to help administer the
medication
Opportunities to Improve
COPD Care
Focus on the CMS Quality Measures
The Impact of COPD
• ~15 million people diagnosed (additional 12M are undiagnosed)
– 2nd leading leading cause of disability
– 3rd leading cause of 30-day readmissions
– 3rd leading cause of death (2nd to CV disease and cancer)
• Mortality rate predicted to increase by 30% over the next decade
• Exacerbations
– ~800,000 hospitalizations (+ 3.5 million COPD 2nd dx)
– 1.5 million ER visits/year
• Costs for COPD in the United States, 2010 = $50 billion and rising
CDC. http://www.cdc.gov/copd/. Accessed Dec. 2, 2014. The COPD Foundation. www.copd.org. Accessed Nov. 10, 2014.
National Heart, Lung and Blood Institute (NHLBI). COPD – Learn More, Breath Better.
https://www.nhlbi.nih.gov/health/educational/copd/index.htm. Accessed Nov. 10, 2014.
Guarascio AJ et al. Clinicoecon Outcomes Res. 2013;5:235-245.
Most COPD Costs are Hospital-related
New Clinic Visit
(1%)
Emergency
(7%)
Exacerbation
(70%)
Hospitalization
(92%)
30-day readmission rates for COPD are ~25%
Miravitlles M et al. Chest. 2002;121:1449-1455.
Jencks SF et al. N Engl J Med. 2009; 360:1418-1428.
COPD Readmissions are Common and Costly
Condition
Types of
Hospital
Admission
# of Admits
with
Readmission*
Readmission
Rate
Avg. Medicare
Payment for
Readmission
Total Spending
on
Readmissions
Heart Failure
Medical
90,273
12.5%
$6,531
$590,000,000
COPD
Medical
52,327
10.7%
$6,587
$345,000,000
Pneumonia
Medical
74,419
9.5%
$7,165
$533,000,000
Acute MI
Surgical
20,866
13.4%
$6,535
$136,000,000
CABG
Surgical
18,554
13.5%
$8,136
$151,000,000
PTCA
Surgical
44,293
10.0%
$8,109
$359,000,000
Other
Vascular
Surgical
18,029
11.7%
$10,091
$182,000,000
Total for 7
Conditions
318,760
$2,296,000,000
Total DRGs
(% of Total)
1,134,483
(28.1%)
$7,980,000,000
(28.8%)
CABG = coronary artery bypass graft; MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty
*Readmissions within 15 days of discharge of the initial inpatient stay
MedPAC (Medicare Payment Advisory Commission), Report to Congress. 2007.
Hospital Readmissions and the Affordable
Care Act (ACA): CMS Performance Report
• Hospital readmissions have been singled out for improvement by CMS
National Strategy for Quality Improvement in Health Care
• The goal of the CMS strategy is a 20% reduction in hospital readmission
rates, potentially preventing 1.6 million hospitalizations and saving an
estimated $15 billion
• CMS will publicly report COPD measures on Hospital Compare beginning in
2014 as part of the Hospital Inpatient Quality Reporting (IQR) program
• Data reported in the 2013 Chartbook (1/2009 – 12/2011) summarize “dry
run” results shared with hospitals
• COPD readmission measure will be included in the Fiscal Year 2015
Hospital Readmissions Reduction Program (HRRP)
Centers for Medicaid and Medicare Services. Medicare Hospital Quality Chartbook. Performance Report on Outcome Measures
(September 2014). Available at:http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/
HospitalQualityInits/Downloads/Medicare-Hospital-Quality-Chartbook-2014.pdf. Accessed Nov. 14, 2014.
Benefits of Guideline-based Treatment
• Improved lung function1,2
• Improved symptoms1,2
• Delayed time to first
exacerbation1,2
• Improved exercise
tolerance1,2
• Fewer exacerbations1,2
• Improved QoL1,2
• Cost savings3
• Fewer hospitalizations1,2
• Prolonged life and better
QoL with smoking
cessation1,2
1. Restrepo RD et al. Int J COPD. 2008;3:371-384.
2. Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. www.goldcopd.org. Accessed 3/10/14.
3. Asche CV et al. Int J Chron Obstruct Pulmon Dis. 2012;7:201-209.
Management of Acute
Exacerbations
Patient Case Study (1 of 4)
• JS is a 58-year-old white male who presents to
his primary care physician with painful right
inguinal hernia
• Past medical history
– Lack of routine health care x 20 years
– Considers himself to be active, works outside as a
construction supervisor and teaches horseback-riding lessons
– Denies other significant medical conditions other than punctured lung in
his early 30s due to a horseback-riding accident
– Smokes 1½ to 2 PPD x 39 years
• Successfully underwent 2 open hernia repairs 3 months apart
– Never screened for COPD on pre-operative evaluation and no chest
x-ray performed
Patient Case Study (2 of 4)
• JS underwent his 2nd open hernia repair
• Post-operative course after 2nd surgery was
complicated by episode of bronchitis for which
he presented to his PCP and was treated with
azithromycin x 5 days
• PCP also prescribed:
–
–
–
–
–
–
Albuterol nebulizer solution
Ipratropium nebulizer solution
Advair inhaler BID
Albuterol inhaler prn
Prednisone 5 mg po q day
Roflumilast 500 mcg po q day
• No follow-up appointment or referral to pulmonologist
Impact of Exacerbations in COPD
Patients With Frequent Exacerbations
Faster Decline
in Lung Function
Poorer Quality
of Life
COPD Foundation.
Greater Airway
Inflammation
Higher Mortality
Patient Case Study (3 of 4)
• JS had 2 episodes of bronchitis over the next
3 months characterized by shortness of breath
limiting activity and copious sputum production
• The first episode he received a breathing treatment
in the office, chronic medications were continued
and he was given levofloxacin x 10 days
• The 2nd episode he self-treated with levaquin leftover from his previous
episode and refill of prednisone
• 3 months later JS presents to the emergency department with acute
bronchitis, shortness of breath, copious sputum production
– Treated with IV corticosteroids, nebulizers, supplemental oxygen,
cefuroxime IV
– Spirometry performed on hospital day 3 confirmed a diagnosis of
COPD , FEV1 65% predicted
Management of Severe (Not Life-Threatening)
Exacerbations Requiring Hospitalization
• Assess severity of symptoms, blood gases, chest radiograph
• Supplemental oxygen therapy
• Bronchodilators:
– Increase doses and/or frequency of short-acting bronchodilators
– Combine short-acting beta2-agonists and anticholinergics
– Use spacers or air-driven nebulizers
• Add oral or intravenous corticosteroids
• Consider antibiotics (oral or intravenous) when signs of bacterial infection
• Consider noninvasive mechanical ventilation
• Monitor fluid balance and nutrition
• Consider subcutaneous heparin or low molecular weight heparin
• Identify and treat associated conditions (e.g. heart failure, arrhythmias)
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. www.goldcopd.org. Accessed 11/10/14.
Indications for ICU Admission
• Severe dyspnea that responds inadequately to initial emergency
therapy
• Changes in mental status (confusion, lethargy, coma)
• Persistent or worsening hypoxemia (PaO2 <5.3 kPa, 40 mmHg)
and/or
• Severe/worsening respiratory acidosis (pH <7.25) despite
supplemental
• Oxygen and noninvasive ventilation
• Need for invasive mechanical ventilation
• Hemodynamic instability – need for vasopressors
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. www.goldcopd.org. Accessed 11/10/14.
Stage 1: Initial Management Pathway for
Hospitalized Patients
Slide provided by Thomashow B. NewYork-Presbyterian Hospital Clinical Pathway.
A 5-day Course of Oral CS May Be
Appropriate after COPD Exacerbations
Re-exacerbations in the REDUCE Trial
Proportion of patients without re-exacerbation
ITT analysis
HR, 0.95 (90% CI, 0.70-1.29)
P for noninferiority = 0.006
Proportion of patients without re-exacerbation
Per-protocol analysis
HR, 0.93 (90% CI, 0.68-1.26)
P for noninferiority = 0.005
ITT = intention to treat; REDUCE = Reduction in the Use of Corticosteroids in Exacerbated COPD
Lueppi JD et al. JAMA. 2013;309:2223-2231.
Stage 2: Management Pathway
Slide provided by Thomashow B. NewYork-Presbyterian Hospital Clinical Pathway.
Strategies for Improving
COPD Across the Continuum
High Index of Suspicion for COPD Screening
and Diagnosis
Consider COPD in patients with any symptoms and history
of exposure to risk factors
SYMPTOMS
RISK FACTORS
SYMPTOMS
RISK FACTORS
Persistent shortness of breath
Chronic cough
Chronic sputum production
Wheezing
Tobacco smoke
Indoor/outdoor air pollution
Occupational pollutants
Family history
Age >40 years
Spirometry is required to make diagnosis
Post-bronchodilator FEV1/FVC <0.70 confirms presence of
persistent airflow limitation*
*Post-bronchodilator FEV1/FVC measured 10-15 min after 2-4 puffs of a short-acting bronchodilator
FEV1, forced expired volume in 1 second; FVC, forced vital capacity
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. www.goldcopd.org. Accessed 11/10/14.
Facilitate Discharge Transitions of Care
Patient can be discharged when he/she:
 Is able to use long-acting bronchodilators, either beta2-agonists
and/ or anticholinergics with or without inhaled corticosteroids
 Does not require inhaled short-acting beta2-agonist therapy
more frequently than every 4 hours
 Is able to walk across room, if previously ambulatory
 Is able to eat and sleep without frequent awakening by dyspnea
 Has been clinically stable for 12-24 hours
 Has stable arterial blood gases for 12-24 hours
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. www.goldcopd.org. Accessed 11/10/14.
Stage 3: Discharge Planning
Slide provided by Thomashow B. NewYork-Presbyterian Hospital Clinical Pathway.
COPD Exacerbations
Preventative Measures
• Spirometry to confirm diagnosis and determine severity of
COPD
• Improve guideline-based non-pharmacologic treatment
• Improve guideline-based pharmacologic treatment
• Manage comorbidities
• Identify and address social issues
• Engage in continuous care
Prevention: The Ultimate Way to Prevent
Readmissions for COPD
• Smoking cessation
– Like home oxygen therapy, smoking cessation is the only
intervention that has been shown to decrease mortality at all
levels of COPD
– Effective at primary, secondary, and tertiary levels of care
• Pulmonary rehabilitation
• Physical activity
• Good nutrition
• Immunizations (influenza vaccine)
Smoking Cessation is The Most Important
Thing to Slow Progression of COPD
• Quitting is challenging but achievable
• Many options are available to help patients quit smoking
– Gums
– Patches
– Prescription medicine
• More information at: www.smokefree.gov
COPD Foundation. Quitting Smoking. Available at: http://www.copdfoundation.org/What-is-COPD/Living-withCOPD/Quitting-Smoking.aspx. Accessed Nov. 10, 2014.
Pulmonary Rehabilitation Decreases
Readmissions
• Physiology of acute COPD
exacerbations1
– Decline in quadriceps muscle strength
of 5% between day 3 and 8 of hospital
admission
– Quadriceps force continues to decline
for up to 3 months after hospital
discharge
– Hospitalized patients spend
<10 minutes per day walking and
remain inactive for up to 1 month after
discharge vs those with stable COPD
and similar disease severity
NNT = number needed to treat
• High re-exacerbation and
readmission risk in early recovery
phase
• Cochrane Review of 9 in 432
patients
• Pulmonary rehabilitation significantly
reduced
─
Hospital admissions (pooled OR 0.22,
95% CI 0.08 to 0.58), NNT = 4 (95%
CI 3 to 8) over 25 weeks
─
Mortality (OR 0.28; 95% CI 0.10 to
0.84), NNT = 6 (95% CI 5 to 30) over
107 weeks
1. Suh ES et al. BMC Medicine. 2013;11:247.
2. Puhan MA et al. Cochrane Database Syst Rev. 2011:5;CD005305. doi: 10.1002/14651858.CD005305.pub3.
Advances in Pulmonary Rehabilitation
• Exercise training includes: endurance training, strength training, upper-limb
training, and transcutaneous neuromuscular electrical stimulation
• Can be home-based
• Exercise training reduces anxiety and depression
• Exercise rehab started during acute or critical illness reduces the
extent of functional decline and speeds recovery
• Pulmonary rehab started after a hospitalization for COPD
exacerbation is effective, safe, and leads to a reduction in subsequent
hospital admissions
• Symptomatic patients with lesser degrees of airflow limitation derive similar
benefits as those with severe disease
Spruit MA et al. Am J Respir Crit Care Med. 2013;188:e13–e64.
Increased Physical Activity Prevents
Readmissions for COPD
Mean Minutes Per Day of Higher Level Physical Activity
Without 30-day
Readmission
Mean
n
With 30-day
Readmission
Mean
n
P Value
Week 1
114 ± 19
26
42 ± 14
12
0.02
Week 2
126 ± 20
25
46 ± 13
10
0.02
Week 3
139 ± 25
23
35 ± 09
9
0.20
Week 4+
131 ± 27
17
1312 ± 10
2
0.16
Those with lower physical activity (<60 mins/day) over week 1 after discharge were more likely
to have 30-day all-cause readmissions than those with higher activity: odds ratio = 6.7; P=0.02.
Chawla H et al. Ann Am Thorac Soc. 2014;11:1203-1209.
Oral Nutritional Supplements Reduce
Readmissions
• Malnutrition is common among patients with COPD.
• A well balanced diet is beneficial to all COPD patients for
pulmonary benefits and benefits in metabolic and
cardiovascular risk.1
• ONS usage improves the quality of life of COPD patients.2
• ONS significantly reduces hospital readmissions in patient
groups with disease-related malnutrition.3
1. Schols AM et al. Eur Respir J. 2014; in press | DOI: 10.1183/09031936.00070914.
2. Planas M et al. Clin Nutr. 2005; 24:433-441.
3. Stratton RJ et al. Ageing Res Rev. 2013;12:884-897.
Recommended Vaccines for Patients with
COPD
• 2014 GOLD Guidelines recommend:1
– Pneumococcal vaccine
•
May reduce mortality2-4
•
Newer conjugated vaccines may have greater
efficacy
– Influenza vaccine2,5-8
•
May decrease risk for acute COPD exacerbations
1. Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. www.goldcopd.org. Accessed 11/10/14.
2. Osthoff M et al. Swiss Med Weekly. 2013;143:213777. 3. Schembri S et al. Thorax. 2009;64:567-572.
4. Pitsiur GG et al. Respir Med. 2011;105:1776-1783.
5. Poole PJ et al. Cochrane Database Syst Rev. 2006;(1):CD002733.
6. Michiels B et al. Vaccine. 2011;29:9159-9170.
7. Walters JA et al. Cochrane Database Syst Rev. 2010;(11):CD001390.
8. Vila-Corcoles A et al. Expert Rev Vaccines. 2012;11:221-236.
Outcomes of Noninvasive Ventilation (NIPPV)
for Acute Exacerbations of COPD in US
1998-2008
• >4-fold increase in NIPPV use
• 5% NIV required invasive mechanical support (IMV)
• Those transitioning from NIPPV to IMV had a 61% greater chance of
death (30% in-hospital mortality) compared to those only treated
with IMV alone (more than 20% mortality)
• Clearly defines need for
– Close observation and potentially earlier intubation in some
– Alternative to IMV
Chandra D et al. Am J Respir Crit Care Med. 2012;185;2;152-159.
Long-term NPPV Targeted to Reduce
Hypercapnea Improves Survival in Stable COPD
• Randomized to NPPV (n=102)
or control (n=93)
– Stable GOLD stage IV COPD
– Partial PaCO2 of ≥7 kPa (51.9
mm Hg) or pH >7.35
• NPPV to  baseline PaCO2 by
≥20% or PaCO2 <6.5 kPa (48.1
mm Hg)
• Only ADE: rash in 14% change type of mask
1-year mortality
12% NPPV vs 33% control
HR 0.24 (95% CI 0.11-0.49; P=0.0004)
HR = hazard ratio; NPPV = non-invasive positive pressure ventilation; PaCO2 = carbon dioxide pressure
Köhnlein T et al. Lancet Respir Med. 2014;2:698-705.
COPD Exacerbations
Preventative Measures: Non-pharmacologic
• Spirometry to confirm diagnosis and determine severity of
COPD
• Improve guideline-based non-pharmacologic treatment
• Improve guideline-based pharmacologic treatment
• Manage comorbidities
• Identify and address social issues
• Engage in continuous care
GOLD 2014 Categories of COPD Severity
and Suggested Therapies
LABA + LAMA
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. www.goldcopd.org. Accessed 11/10/14.
COPD Foundation Guidelines
Spirometry Grades
• SG 0
– Normal spirometry does not rule out emphysema, chronic bronchitis,
asthma, or risk of developing either exacerbations or COPD
• SG 1 (Mild)
– FEV1/FVC ratio <0.7, FEV1 >60% predicted
• SG 2 (Moderate)
– FEV1/FVC ratio <0.7, 30%-60% predicted
• SG 3 (Severe)
– FEV1/FVC ratio <0.7, FEV1 <30% predicted
• SG U (Undefined)
– FEV1/FVC ratio >0.7, FEV1 <80% predicted
– Consistent with restriction, muscle weakness, and other pathologies
COPD Foundation. COPD Treatment. www.copdfoundation.org/Learn-More/For-Medical-Professionals/Treatment.aspx. Accessed 11/8/14.
COPD Foundation Guide for COPD Treatment
*Indicated if chronic bronchitis, high exacerbation risk, and spirometry grades 2/3 all present
**Suggest regular exercise program for all with COPD; those with SG2/3 should be considered for pulmonary rehab
+Recommended in select cases with upper lobe predominant emphysema
++Off label, consider potential cardiac risks and resistance concerns
COPD Foundation. COPD Treatment. www.copdfoundation.org/Learn-More/For-Medical-Professionals/Treatment.aspx. Accessed 2/8/14.
Consider Switching from
LABA/ICS TO LABA Only if Low Risk
• Moderate COPD and no exacerbations in previous year
• 26-week, randomized double-blind, double-dummy, parallel-group study
– 581 patients with moderate COPD who were receiving salmeterol/fluticasone
(SFC) for ≥ months
– Randomized to indacaterol 150 μg once daily or SFC 50/500 μg twice daily
• Non-inferiority achieved based on trough FEV1 after 12 weeks
• No significant differences for
– Breathlessness (transition dyspnea index)
– Health status (Saint George's Respiratory Questionnaire)
– Rescue medication use or COPD exacerbation rates over 26 weeks
ICS = inhaled corticosteroids; LABA = long-acting beta2 agonist
Rossi A et al. Eur Respir J. 2014. pii: erj01268-2014. [Epub ahead of print].
COPD* Exacerbations and Lung Function after
Withdrawal of ICS on 2 Long-acting Bronchodilators**
*Patients with severe COPD; ** tiotropium + salmeterol; ICS, inhaled corticosteroids
Magnussen H et al; WISDOM Investigators. N Engl J Med. 2014;371:1285-1294.
There are Many Inhaler Devices Available
in the United States – Choice is Important
Neohaler™
Respimat®
Soft Mist™
Aerolizer™ Twisthaler®
Breo Ellipta®
Neohaler™
Pressair®
MDI
Handihaler®
Diskus®
Flexhaler®
SMI
Strategies for Individualizing Inhaler Choice
• Good hand-breath coordination is required for meter-dose
inhalers (MDIs)
– May not be suitable for elderly, confused, or those with hand
conditions (e.g. arthritis)
• Dry-powder inhalers (DPIs) do not require coordination of
actuation and inhalation and are easier to use than MDIs
– Breath actuation may be difficult in patients with poor inspiratory
effort
• Avoid changing inhaler types for individual patients
Vincken W et al. Prim Care Respir J. 2010;19:10-20.
De Coster DA et al. Cur Respir Care Rep. 2014;;3:121-132.
Nebulizers May be Beneficial for Some
Patients with COPD
Small-Volume
Nebulizers
• Effective drug delivery requires less intensive patient
training vs pMDIs and DPIs1
• Newer portable and efficient models available1
• Efficacy of long-term nebulizer therapy is similar or
superior to pMDI/DPIs in moderate-to-severe COPD,
including during exacerbations1
• Consider maintenance nebulizers in1
– Elderly patients
– Severe COPD
– Frequent exacerbations
– Physical and/or cognitive limitations
• Patient/caregiver satisfaction is high2
1. Dhand R et al. COPD. 2012;9:58-72.
2. Sharafkhaneh A et al. COPD. 2013;10:482-492.
Medications Available via Nebulizer
Medication (Class)1
Notes
Albuterol (SABA)
Formoterol (LABA)
Significantly improved FEV(1) and dyspnea, decreased rescue medication
use, and a lower incidence of AEs and COPD exacerbations when added to
maintenance tiotropium in patients with moderate to severe COPD2
Arformoterol (LABA)
∼40% lower risk of respiratory death or COPD exacerbation-related
hospitalization over 1 year versus placebo in patients with COPD and FEV1
≤ 65% predicted3
Ipratropium bromide
(Short-acting
anticholinergic)
Beclomethasone
dipropionate, flunisolide,
fluticasone propionate,
budesonide
Valid alternative to inhalers in acute exacerbations of COPD with similar
efficacy as oral or ICS and good tolerability4
ICS = inhaled corticosteroid; SABA = short-acting beta2 agonist; LABA = long-acting beta2 agonist
1. Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. www.goldcopd.org. Accessed 3/10/14.
2. Tashkin DP et al. Adv Ther. 2009; 26:1024-1034. 3. Donohue JF et al. Chest. 2014. doi:10.1378/chest.14-0117.
4. Melani AS. Respiratory Care. 2012;57:1161-1174.
Identify and Address Poor Adherence
Barriers to adherence
Red Flags for non-adherence
 Inadequate education about
COPD and therapy1
 Perceived burden of
medication regimen1,2
 Device is difficult to use3
 Depressed
mood3
• Failure to refill prescriptions
• Excessive use of rescue
medication
 Medication-related cost3
• Frequent exacerbations
 Adverse effects3
• Rapid decline in FEV1
1. LaForest L et al. Prim Care Resp J. 2010;19:148-154.
2. George J et al. Chest. 2005;128:3198-3204.
3. Restrepo RD et al. Int J COPD. 2008;3:371-384.
Predictors of Exacerbations and Readmissions
Opportunities for Improvement in the Inpatient Setting
• Spirometry to confirm diagnosis and determine severity of
COPD
• Improve guideline-based pharmacologic treatment
• Improve guideline-based non-pharmacologic treatment
• Manage comorbidities
• Identify and address social issues
• Engage in continuous care
Interplay of Comorbidities in COPD
Barnes PJ et al. Eur Respir J. 2009;33:1165-852.
Barnes PJ. PLoS Med 2010;7:e1000220.
Comorbidities Increase the Risk of
Readmission
Only 30% of readmission
secondary to index cause
First-choice Treatments for
Comorbidities in COPD
Comorbidity
1st Choice Treatment
Issues
Hypertension
ACEI or ARB
Avoid beta blockers if hypertension the only comorbidity
Heart failure
Cardioselective beta1-blocker in addition to
ACEI or ARB
Diuretics (loop preferred)
If asthmatic component avoid beta blocker
Oral corticosteroids may worsen HF – use ICS
Ischemic heart
disease
Cardioselective beta1-blocker in addition to
ACEI (regardless of BP or LV function)
ICS may have protective effect for CV events
Avoid high dose beta 2 agonists in USA
Atrial fibrillation
Non-dihydropyridine CCB (verapamil or
diltiazem) or a cardioselective beta-blocker
(i.e. bisoprolol)
Avoid beta 2 agonist, nonselective beta blockers, theophylline, oral
corticosteroids
Diabetes
Metformin at a low dose and gradual titration
Consider contraindications: (diarrhea/abdominal cramp- ing/ lactic
acidosis risk/ vitamin B12
deficiency/acidosis/hypoxia/dehydration/unstable heart failure)
Metabolic syndrome
Metformin
Statins
ACE or ARB
Consider drug interactions and contraindications for statins, niacin
Osteoporosis
Vitamin D 800 IU/day and calcium 1 gr/day
Bisphosphonates if osteoporosis
Oral bisphosphonates cause significant gastrointestinal effects and
dosing requirements
Depression and
anxiety
Psychological therapy, benzodiazepines and
SSRIs
Choice of antidepressant should be made with consideration of
risks, age, previous treatment, interactions, preferences and costs
Tsiligianni IG et al. Curr Drug Targets. 2013;14:158-176.
Considerations for Specific Medications
for Comorbidities in COPD
Medication
Considerations
Cardioselective
beta blockers
• Reduce the risk of exacerbations and improve survival in patients with COPD in long term
treatment
• Associated with reduced mortality in acute COPD exacerbation and in COPD with
atherosclerosis
• No significantly change in FEV1 or respiratory symptoms, no affect on the FEV1 treatment
response to beta2-agonists
• Conflicted results in FEV1 improvement in long term treatment studies [146, 147].
Suggestions:
•
•
•
•
Angiotensin
converting
enzyme inhibitors
or Angiotensin
receptor blockers
Despite benefits they are still underused in COPD
Not a first choice for hypertension
An individualized approach starting at low doses and gradually titrating up is recommended
Caution with cardioselective agents as cardioselectivity decreases with increased doses
• Chronic lowering of ACE improves pulmonary inflammation, respiratory muscle function,
peripheral use of oxygen for long term treatment in COPD
• Reduce hospitalization and mortality in patients with COPD
Suggestions:
• May be used in hypertension, CVD, metabolic syndrome with hypertension component
Tsiligianni IG et al. Curr Drug Targets. 2013;14:158-176.
Considerations for Specific Medications
for Comorbidities in COPD (cont’d)
Medication
Considerations
Statins
• Recent prospective, randomized, double-blind, placebo-controlled trial in moderate to severe COPD
showed no difference in exacerbation rate or mortality
• Have anti-inflammatory and anti-oxidant properties in the lungs
• Increase exercise time and decrease the levels of high-sensitivity C-reactive protein
• Reduce the decline in lung function
• Provide protection against the development of lung cancer
• Reduce requirement for intubation in exacerbations
Suggestions:
• May be useful in metabolic syndrome, dyslipidemias, cardiovascular disease
Beta 2 agonists
• Beta-blockers may neutralize the b2-agonists’ efficacy and COPD patients may have high tolerance for
beta-blockers
• Survival benefit for beta-blockers was not found among patients concurrently using beta-agonists or
with severe COPD or asthma after myocardial infarction
Suggestions:
• Best to avoid if possible in CVD and concomitant cardioselective beta-blocker use in COPD.
Anticholinergic
agents
• Reduction in cardiac adverse events was associated with tiotropium in the UPLIFT study
Suggestions:
• Start treatment with a long-acting antimuscarinic agent rather than LABA when patients have COPD
with heart failure or when they have other CVD requiring use beta-blockers
1. Tsiligianni IG et al. Curr Drug Targets. 2013;14:158-176.
2. Criner GJ et al; COPD Clinical Research Network; Canadian Institutes of Health Research. N Engl J Med. 2014;370:2201-2210.
Effect of Simvastatin on Time to First Acute
Exacerbation of COPD
Criner GJ et al. N Engl J Med. 2014;370:2201-2221.
Considerations for Specific Medications for
Comorbidities in COPD (cont’d)
Medication
Considerations
Inhaled
Corticosteroids
• Possible protective effect against ischemic cardiac events and acute myocardial
infarction
Suggestions:
• In cases of COPD and DM glucose monitoring and titration of antidiabetic treatment is
required.
• Evaluate for increased risk of fractures and loss of bone mineral density
• In patients receiving high dose of ICS or low to medium dose ICS with frequent use of
oral CS screening for osteopenia or osteoporosis should be performed
Systemic
Corticosteroids
• Meta-analysis that included 24 studies suggested high dose oral CS have potentially
harmful adverse effects (e.g. diabetes, hypertension, osteoporosis)
• In the case of AECOPD if systemic glucocorticoid steroids used close monitoring of
serum glucose is recommended
Suggestions:
• If used in COPD close monitoring for diabetes and osteoporosis is recommended.
Specific recommendations for osteoporosis management should be followed if patients
take GC>3 months
• GOLD guidelines suggest limited dosage (7-10 days) and avoidance of recurrent
courses of systemic CS for COPD exacerbations
Tsiligianni IG et al. Curr Drug Targets. 2013;14:158-176.
The Frequent Exacerbator Phenotype:
Identify and Target (Non-pharmacologic and Pharmacologic)
THE FREQUENT EXACERBATOR PHENOTYPE
Higher exacerbation susceptibility
Exacerbation
triggers
-Bacteria
-Viruses
-Irritants
•
•
•
•
•
•
•
•
Greater inflammation
Increases susceptibility to viral infection
Greater bacterial colonization
Faster FEV1 and functional decline
Worse health status
More severe depression
Worsened comorbidity
Increase hospitalization and mortality
INCREASED EXACERBATION
SUSCEPTIBILITY
EXACERBATION
Anti-inflammatory agents can modify the frequent exacerbator phenotype
so that patients become infrequent exacerbators
Wedzicha JA et al. BMC Med. 2013;11:181.
Persistent inflammation/slower recovery
Stable state
COPD Exacerbations
Preventative Measures
• Spirometry to confirm diagnosis and determine severity
of COPD
• Improve guideline-based non-pharmacologic treatment
• Improve guideline-based pharmacologic treatment
• Manage comorbidities
• Identify and address social issues
• Engage in continuous care
Impact of Social Issues
• Among the countries in the Organization for Economic
Development, the United States ranks first in health care
spending, but 25th in spending on social services
• Studies have shown the powerful effects that “social
determinants” like safe housing, healthful foods, and
opportunities for education and employment have on
health
• Experts estimate that medical care accounts for only 10%
of overall health, with social, environmental, and behavioral
factors accounting for the rest
Bradley EH et al. BMJ Qual Saf. 2011;20:826-831.
Social Issues Have a Significant Impact on
Readmissions
The “Post-Hospital Syndrome”
• Sleep deprivation
• Nutritional issues
• Aspiration risks
• Deconditioning
• Inadequately addressed pain or discomfort
• Cognitive issues – sleep/stress/medications
• “Marginal clothing”
Krumholz HM. N Engl J Med. 2013;368:100-102.
COPD Exacerbations
Preventative Measures
• Spirometry to confirm diagnosis and determine severity of
COPD
• Improve guideline-based non-pharmacologic treatment
• Improve guideline-based pharmacologic treatment
• Manage comorbidities
• Identify and address social issues
• Engage in continuous care
Care Transition and
Coordination
Models of Care and Strategies for
Implementation
Provide a Spectrum of Support for
Patients With COPD
Spruit MA et al. Am J Respir Crit Care Med. 2013;188:e13–e64.
30-day Readmission
Patients 40-64 Years of Age Admitted for COPD
50%
Sharif R et al. Ann Am Thorac Soc. 2014;11:685-694.
Transitional Care Management (TCM)
 CMS 2013 – 2 new payment codes (99495/99456) to incentivize
ambulatory care providers to participate in TCM
 CMS will pay provider submitting the claim during 30-day post
discharge window
 To bill, must provide 3 key services:
 Must contact patient within 2 days of discharge
 Have face-to-face visit within 7-14 days of discharge
 Provide indicated care-coordinated services during 30 days post
discharge, including review of discharge info, review of pending
tests and treatments, education, and arrange referrals and
needed community resources
Kangovi S, Grande D. Chest. 2014;145:149-155.
Patient Case Study (4 of 4)
• JS is discharged on hospital day 3 following
admission for COPD exacerbation
• He returns for follow-up visit, pulmonary
rehabilitation and patient education
1 week later
• He successfully stops smoking after realizing the seriousness
of his condition
• He noted: “Nothing has slowed me down like this before…
I did not know I had a lung condition, I just thought it was part
of getting older and smoking for so long. I know now that it is
serious and I have to deal with it.”
Integrated Disease Management (IDM)
Programs Work
• Aim of IDM: To establish a program of different components of care
(i.e. self-management, exercise, nutrition) in which several health care
providers collaborate to provide efficient and good quality of care
• Cochrane review of 26 RCTs
– 2997 patients with COPD (mean age 68 years)
– Mean FEV1 44% predicted
• Patients in IDM vs controls
– Significantly improved quality of life scores
– Clinically relevant improvement of 44 m on 6-min walking distance
– Fewer patients with ≥1 respiratory related hospital admission (decreased
from 27 to 20 per 100 patients)
– Significantly decreased duration of hospitalization (by nearly 4 days)
Kuis AL et al. Thorax. 2014. doi: 10.1136/thoraxjnl-2013-204974. [Epub ahead of print].
A Multicomponent Disease Management
Program Can Be Cost Effective
• Intervention
– Single 1.5-h group education session conducted by case manager
– Individualized written action plan that included: (1) a description of the signs and symptoms
of an exacerbation that should prompt initiation of self-treatment, (2) refillable prescriptions
for prednisone and an oral antibiotic, (3) contact information for a case manager, and (4) the
telephone number of the 24-hour VA nursing helpline
– Began action-plan medications for symptoms that were substantially worse than usual
– Case manager made monthly phone calls to each patient
– Patients encouraged to call the case manager during regular working hours if they took
action-plan medications or if they had questions relating to their medical care
– No regularly scheduled clinic visits for the remainder of the 1-year follow-up period
• Intervention cost: $241,620 or $650 per patient
• The total mean±SD per patient in the DM group was $4491±4678 compared to
$5084±5060 representing a $593 per patient cost savings
Dewan NA et al. COPD. 2011;8:153-159.
Patient and Caregiver Engagement is
Important
• Educate, engage patient and family
• Develop individualized self-treatment plan for
exacerbations
• Follow-up call monthly by a case manager
– Lower hospitalization rate and ED visits
Rice KL et al. Am J Respir Crit Care Med. 2010;182:890-896.
Key Points
• No simple answer to reducing hospital readmissions:
– Move away from “disease-centered” to “patient-centered”
care
– Optimize medical therapy and address comorbidities
– Prevent “post-hospital syndrome”
– Address social issues
– Coordinate follow-up care (in-hospital care and with PCP) –
communicate with treating physicians
– Engage patient (education, phone call reminders, etc.)