S

COPD in Transitions of Care

– an opportunity for

Pharmacists

Chad Worz, Pharm.D.

President, Medication Managers, LLC

Adjunct Professor, University of Cincinnati, College of Pharmacy

Objectives and Agenda

S Recognize the burden of disease in older adults

S Acknowledge Burden on our Health Care System

S Describe the pharmacology of treatments and their

impact on the disease process

S Demonstrate the varied administration methods for

treatments and the importance in post acute care

S Recognize the new Treatment Guidelines for COPD

S Define the role of the pharmacist

COPD Defined.

S Chronic Obstructive Pulmonary Disease

(COPD) is a common, preventable and

treatable disease that is characterized by

persistent respiratory symptoms and airflow

limitation that is due to airway and/or alveolar

abnormalities usually caused by significant

exposure to noxious particles or gases.

COPD Defined.

S The most common respiratory symptoms include

dyspnea, cough and/or sputum production. These

symptoms may be under-reported by patients.

S The main risk factor for COPD is tobacco smoking

but other environmental exposures such as biomass

fuel exposure and air pollution may contribute.

Besides exposures, host factors predispose

individuals to develop COPD. These include genetic

abnormalities, abnormal lung development and

accelerated aging.

COPD Has Been Shown to Be a

Common and Costly Condition

COPD is the 3rd leading cause of death in the United

States1,2

COPD is the 2nd leading cause of disability3

By 2010, there were 14.8 million diagnosed COPD

patients in the US4

COPD accounts for an estimated $29.5 billion in

direct healthcare expenses5

5

1. Kochanek KD, et al. Deaths: Preliminary data for 2009. National vital statistics reports. 2011;59:1-51. 2. Miniño AM, et al. Deaths: Preliminary data for 2008.

National vital statistics reports. 2010;59:1-52. 3. Wise RA. Chronic Obstructive Pulmonary Disease (COPD): Merck Manual Home Edition. 2007. 4. National

Heart, Lung, and Blood Institute. Unpublished Tabulations of the National Health Interview Survey, 2010.

http://www.cdc.gov/nchs/nhis/nhis_2010_data_release.html. Accessed June 2014. 5. American Lung Association. Chronic obstructive pulmonary disease (COPD)

fact sheet. http://www.lung.org/lung-disease/copd/resources/facts-figures/COPD-Fact-Sheet.html. Accessed May 23, 2014.

COPD in Long Term Care

One of every six admissions to nursing homes was for patients with a history of emphysema or COPD1

In the last 12 months of COPD patients’ lives, one recent study reported there was a 40% likelihood of being admitted to a LTC facility2

Approximately 22% of the respiratory-related healthcare costs are nursing home costs; a greater amount was spent on hospitalizations (approximately 50%)

7

1. Kochanek KD, Xu J, Murphy SL, Miniño AM, Kung HC. Deaths: preliminary data for 2009. National vital statistics

reports. 2011;59:1-51.

2. Miniño AM, Xu J, Kochanek, KD. Deaths: preliminary data for 2008. National vital statistics reports. 2010;59:1-52.

COPD in Long Term Care

The majority of persons with COPD have cardiovascular

disease including coronary artery disease, heart failure, and

hypertension.

Stroke occurs in a significant portion of persons with COPD.

About 25% of persons with COPD have concurrent asthma.

Age-related and steroid-induced osteoporosis occur frequently

in persons with the disease, and COPD is a risk factor for

nursing home–associated pneumonia.

A significant number of persons with COPD have obstructive

sleep apnea.

8

National Heart, Lung, and Blood Institute. Unpublished Tabulations of the National Health Interview

Survey, 2010. http://www.cdc.gov/nchs/nhis/nhis_2010_data_release.htm. Accessed June 2014.

COPD in Long Term Care

Depression and anxiety are also common in COPD; one study found that 40% of persons with COPD have depressive symptoms.

Diabetes mellitus occurs in about 25% of persons with COPD.

Malnutrition is a significant issue in some individuals with COPD.

Substantial chronic airway obstruction leads to greater energy requirements due to the increased work of breathing, as well as inactivity from deconditioning

9

Wise RM. Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease (COPD):

Merck Manual Home Edition. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of

Merck & Co., Inc., 2007.

1. American Lung Association. COPD Fact Sheet. http://www.lungusa.org/diseases/copd_factsheet.html. 2. Grasso ME et al. Am J

Respir Crit Care Med. 1998;158:133-138. 3. Fishman P et al. Health Aff. 1997;16:239-247.

Economic Burden of COPD

S Annual cost in the US: $30.4 billion1

S Direct cost: $14.7 billion

S Indirect cost: $15.7 billion

S Emergency services, hospitalization

S Per capita Medicare expenditure nearly 2.5 times higher with a

COPD diagnosis than without2

S $8,482 vs. $3,511 without COPD

S Diagnosis of chronic respiratory disease is associated with a 172%

increase in mean health care costs3

Correlation Between Disease Severity

and Total Treatment Cost1

S Retrospective pharmacoeconomic analysis S 413 patients, 5 years

S Stage 1 (Mild) COPD: $ 1,681/patient/year

S Stage 2 (Moderate) COPD: $ 5,037/patient/year

S Stage 3 (Severe) COPD: $10,812/patient/year

1. Hilleman DE et al. Chest. 2000;118:1278-1285.

Stepwise Approach to Treament

Early and accurate diagnosis

Prevention of disease progression

(deterioration of pulmonary function)

Relief of symptoms

Improvement in exercise tolerance and health

status

12

Wise RM. Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease

(COPD): Merck Manual Home Edition. Whitehouse Station, NJ: Merck Sharp & Dohme

Corp., a subsidiary of Merck & Co., Inc., 2007.

Stepwise Approach to Treament

Prevention and treatment of exacerbations and

complications

Improvement in quality of life

Reduction in mortality

Includes drug therapy, smoking cessation, oxygen,

pulmonary rehabilitation, and nutritional intervention.

13

Wise RM. Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease

(COPD): Merck Manual Home Edition. Whitehouse Station, NJ: Merck Sharp & Dohme

Corp., a subsidiary of Merck & Co., Inc., 2007.

GOLD GUIDELINES

14

From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic

Obstructive Lung Disease (GOLD) 2017. Available from: http://goldcopd.org.

Maintenance Therapy for Long-term

COPD Care–Considerations

Focus of COPD care is shifting from acute treatment to long-term

maintenance1-3

Many patients did not receive any maintenance COPD therapy4

GOLD can be used to inform the prescribing of maintenance therapy3,5

When selecting an inhaled COPD therapy, drug delivery and training

should be considered5

15

1. Centers for Medicare & Medicaid Services. Accountable Care Organization 2012 program analysis. Quality performance standards narrative measure

specifications. Final report. http://www.cms.gov/medicare/medicare-fee-for-service-payment/sharedsavingsprogram/downloads/aco_qualitymeasures.pdf.

Accessed May 23, 2014. 2. National Committee for Quality Assurance. Insights for quality improvement: advancing COPD care through quality improvement.

2009. Available at http://www.ncqa.org/portals/0/publications/NCQA_Insights_improvement_FINAL.pdf. Accessed May 23, 2014. 3. Fromer L. Int J Chron

Obstruct Pulmon Dis. 2011;6:605-614. 4. Make B, et al. Int J Chron Obstruct Pulmon Dis. 2010;5:341-349 5. Global Initiative for Chronic Obstructive Lung

Disease (GOLD). http://www.goldcopd.org. Accessed May 14, 2014.

Maintenance Therapy for Long-term

COPD Care–Considerations

In the hospital prior to discharge, patients should start long-acting

bronchodilators, either beta2-agonists and/or anticholinergics with or

without inhaled corticosteroids5

Add 1 or more classes of long-acting bronchodilators when needed5

16

1. Centers for Medicare & Medicaid Services. Accountable Care Organization 2012 program analysis. Quality performance standards narrative measure

specifications. Final report. http://www.cms.gov/medicare/medicare-fee-for-service-payment/sharedsavingsprogram/downloads/aco_qualitymeasures.pdf.

Accessed May 23, 2014. 2. National Committee for Quality Assurance. Insights for quality improvement: advancing COPD care through quality improvement.

2009. Available at http://www.ncqa.org/portals/0/publications/NCQA_Insights_improvement_FINAL.pdf. Accessed May 23, 2014. 3. Fromer L. Int J Chron

Obstruct Pulmon Dis. 2011;6:605-614. 4. Make B, et al. Int J Chron Obstruct Pulmon Dis. 2010;5:341-349 5. Global Initiative for Chronic Obstructive Lung

Disease (GOLD). http://www.goldcopd.org. Accessed May 14, 2014.

Risk Factors for COPD

S Smoking is the predominant risk factor1,2 S Implicated in >90% of US patients with COPD

S Others include1: S Air pollution S Poor nutrition S Childhood respiratory infections S Preexisting bronchial hyperreactivity S 1-Antitrypsin deficiency (genetic, rare) S Occupational and environmental exposure (eg, coal dust,

silica)

1. NCAP. J Respir Dis. 2000;21(Suppl):S5-S21. 2. Buist AS, Vollmer WM. In: Textbook of Respiratory Medicine. 1994:1259-1287.

Risk Factors for COPD

1. NCAP. J Respir Dis. 2000;21(Suppl):S5-S21. 2. Buist AS, Vollmer WM. In: Textbook of Respiratory Medicine. 1994:1259-1287.

Age-Related Decline in FEV1 Is

Accelerated in Smokers

Adapted with permission from Fletcher C, Peto R. BMJ. 1977;1:1645-1648.

Never smoked or not susceptible to smoke

Stopped at 45 y

Stopped at 65 y

0

25

50

75

100

FE

V1 (

% o

f valu

e a

t ag

e 2

5 y

)

25 50 75

Age (y)

Disability

Death

Age-Related Decline in FEV1 Is

Accelerated in Smokers

Mechanisms of Airflow

Limitation in COPD

Pharmacological Reviews December 2004, 56 (4) 515-548; DOI:

https://doi.org/10.1124/pr.56.4.2

Pharmacotherapy:

Anticholinergic Agents

S Block bronchoconstriction S Increase FEV1

S Have been shown to reduce exacerbation rate S May be associated with lower treatment costs1,2

S Anti-cholinergics are considered first line3-5 S Minimal side effects S Do not cross blood-brain barrier S Minimal gastrointestinal absorption

S Extended therapy associated with improved baseline pulmonary function6

1. NCAP. J Respir Dis. 2000;21(suppl):S5-S21. 2. Friedman et al. Chest. 1999;115:635-641. 3. NLHEP. 1998:113(suppl):123S-163S.

4. PDR.net. Atrovent Inhalation Aerosol. 5. ATS Am J Respir Crit Care Med. 1995;152:S77-S121. 6. Rennard SI et al. Chest.

1996;110:62-70.

Cholinergic Tone

Barnes PJ: β2-agonists, anticholinergics, and other nonsteroid drugs. In Albert RK, editor:

Clinical respiratory medicine, ed 3, Philadelphia, Mosby, 2008

Long-Acting 2-Adrenergic

Agonists1

S Effective in improving FEV1 and FVC, and may reduce COPD exacerbations

S May provide relief from nocturnal symptoms

S Can be used with ipratropium if short-acting 2-agonist used frequently for rescue

S Unlike short-acting 2-agonists, NOT for rescue

1. NCAP. J Respir Dis. 2000;21(suppl):S5-S21.

Inhaled Corticosteroids

S If response to anticholinergic and other bronchodilator therapy is suboptimal, inhaled corticosteroid therapy may provide benefit in some patients1

S Indicated only in patients

S who are already receiving chronic low-dose corticosteroid therapy, or

S who have a documented objective response to corticosteroid therapy

1. NCAP. J Respir Dis. 2000;21(suppl):S5-S21. 2. Vestbo J et al. Lancet. 1999;353:1819-1823. 3. Pauwels RA et al.

N Engl J Med. 1999;340:1948-1953. 4. The Lung Health Study Research Group. N Engl J Med. 2000;343:1902-1909.

5. Burge PS et al. BMJ. 2000;320:1297-1303.

S 4 major studies have been conducted2–5

S No effect on mortality, rate of decline of FEV1

S No significant increase in FEV1 short term

1. NCAP. J Respir Dis. 2000;21(suppl):S5-S21. 2. Vestbo J et al. Lancet. 1999;353:1819-1823. 3. Pauwels RA et al.

N Engl J Med. 1999;340:1948-1953. 4. The Lung Health Study Research Group. N Engl J Med. 2000;343:1902-1909.

5. Burge PS et al. BMJ. 2000;320:1297-1303.

Inhaled Corticosteroids

1. Combivent Inhalation Aerosol Study Group. Chest. 1994;105:1411-1419. 2. NCAP. J Respir Dis. 2000;21(suppl):S5-S21. 3. Campbell

S. Arch Intern Med. 1999;159:156-160. 4. Friedman M et al. Chest. 1999;115:635-641.

Short-Acting 2-Adrenergic Agonists

S If response to initial anticholinergic therapy suboptimal, add 2-adrenergic agonist1,2

S Combination MDI (ipratropium and albuterol)1,3,4: S Greater efficacy, equivalent safety

S Lower rate of exacerbations

S Lower total treatment costs

S Improved cost-effectiveness

MDI, metered-dose inhaler

PDE4 Inhibitors

S Roflumilast therapy has a limited role in patients with severe COPD, and no role in patients with mild to moderate COPD.

S It will not decrease the number of hospitalizations.

S It will slightly lower the number of exacerbations requiring oral corticosteroid treatment, but only in select patients (i.e., those with a combination of severe COPD, current bronchitic symptoms, and a previous exacerbation).

Am Fam Physician. 2014 Feb 15;89(4):300-301

Theophylline1

S If response to initial anticholinergic/2-agonist therapy suboptimal, consider adding theophylline

S Long-acting formulations generally preferred

S Modest bronchodilation, mild anti-inflammatory effects

S Useful for noncompliant patients and those who have trouble with inhalation aerosols and those preferring oral drugs

S Titrate dose to serum level up to a maximum of 12 g/mL

S Some patients experience side effects at lower serum levels

1. NCAP. J Respir Dis. 2000;21(suppl):S5-S21.

Anti-Inflammatory Agents

S If bronchodilator response is suboptimal, consider adding an anti-inflammatory drug1 S Corticosteroids (oral/inhaled)

S Useful in few patients1 S Consider 2-week trial of oral corticosteroid (40 mg prednisone QD)

S Discontinue if no response

S If patient responds, taper to minimal effective dose level and switch to inhaled corticosteroid

1. NCAP. J Respir Dis. 2000;21(suppl):S5-S21. 2. Callahan CM et al. Ann Intern Med. 1991;114:216-223. 3. Chanez P et al. Am J Respir

Crit Care Med. 1997:155:1529-1534. 4. Pizzichini E et al. Am J Respir Crit Care Med. 1998;158(5 pt 1):1511-1517.

Anti-Inflammatory Agents

S Limited role in chronic COPD

S 10% improve FEV1 20%2

S May actually detect “hidden” asthma3,4

S Cromolyn, nedocromil, and leukotriene modifiers have not been proven effective in COPD1

1. NCAP. J Respir Dis. 2000;21(suppl):S5-S21. 2. Callahan CM et al. Ann Intern Med. 1991;114:216-223. 3. Chanez P et al. Am J Respir

Crit Care Med. 1997:155:1529-1534. 4. Pizzichini E et al. Am J Respir Crit Care Med. 1998;158(5 pt 1):1511-1517.

Long-Term Oxygen Therapy

S Indicated for PaO2 <55 mm Hg or SaO2 <88%1

S Improves1-4: S Survival in hypoxemic patients

S Cognitive function, affect

S Exercise performance

S Sleep quality

S Activities of daily living

1. NCAP. J Respir Dis. 2000;21(suppl):S5-S21. 2. Report of the Medical Research Council Working Party. Lancet. 1981;681-686.

3. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980;93:391-398. 4. Bye et al. Am Rev Respir Dis. 1985;132:236-240.

Administration

S MDI (Metered Dose Inhaler) vs. HHN (Hand Held Nebulizer) S A HHN is not superior to an MDI S The problem is technique (consider a spacer)

S With optimal technique a MDI delivers close to 12% of the drug to the lung.

S In general, the HHN dose needs to be 6 to 10 times higher than the MDI to deliver the same degree of bronchodilation.

S Consider nursing administration time

S Consider the patient

Device

Post Acute and Long Term Care

S What does all of this mean to us?

S A New Focus on management and an effort to reduce hospitalizations

S Impact to SNF

S Impact on therapeutic decisions

S Assessing devices and matching them to patients

S COST EFFECTIVENESS

Post Acute and Long Term Care

S Formulary development

S Assessment surveys or work ups

S Cost management

S Working with industry

S Education

S Discounts to Nursing Homes?

S Product placement

Post Acute and Long Term Care

S Today:

S Hospitals work to discharge

S May or may not reconcile the medication list when sent to the

nursing home

S Goal is to maximize pulse ox and limit resources

S (related to payment mechanisms)

S Not effective at medication counseling

S LTC – day 1 – clean up the profile on admission, limit cost

Post Acute and Long Term Care

S Tomorrow:

S Hospitals work to discharge

S Better data and reconciliation

S Recognition of penalties for re-hospitalizations

S May add resources for medication counseling

S LTC :

S Day 1 – clean up the profile on admission

S Plan of Care for discharge

S Reconciliation and Counseling critical

S On the hook for re-hospitalizations

Questions