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3/11/2013 1 Waiting to Exhale: Optimizing Patient Outcomes in the Management of COPD Kyle Copeland, PharmD Clinical Pharmacist Specialist Parkwest Medical Center Knoxville, Tennessee Presenter: Kyle Copeland, PharmD Clinical Pharmacist Specialist Parkwest Medical Center Knoxville, Tennessee Moderator: Elena Beyzarov, PharmD Director of Scientific Affairs Pharmacy Times Office of Continuing Professional Education Plainsboro, New Jersey This activity is supported by an educational grant from Boehringer Ingelheim Pharmaceuticals, Inc. and Sunovion Pharmaceuticals, Inc. Faculty Information

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3/11/2013

1

Waiting to Exhale:

Optimizing Patient

Outcomes

in the Management of COPD

Kyle Copeland, PharmD

Clinical Pharmacist Specialist

Parkwest Medical Center

Knoxville, Tennessee

Presenter:

Kyle Copeland, PharmD Clinical Pharmacist Specialist Parkwest Medical Center Knoxville, Tennessee Moderator:

Elena Beyzarov, PharmD Director of Scientific Affairs Pharmacy Times Office of Continuing Professional Education Plainsboro, New Jersey

This activity is supported by an educational grant from

Boehringer Ingelheim Pharmaceuticals, Inc. and Sunovion

Pharmaceuticals, Inc.

Faculty Information

3/11/2013

2

Disclosures Kyle Copeland, PharmD, has no financial relationships with commercial interests to disclose

Pharmacy Times Office of Continuing Professional Education

Planning Staff—Judy V. Lum, MPA, Elena Beyzarov, PharmD, and Donna W. Fausak—have no financial relationships with commercial interests to disclose.

The contents of this webinar may include information regarding the use of products that may be inconsistent with or outside the approved labeling for these products in the United States. Pharmacists should note that the use of these products outside current approved labeling is considered experimental and are advised to consult prescribing information for these products.

Explore current prevalence, diagnosis, and treatment of COPD

Evaluate the GOLD recommendations on COPD management and apply current guideline recommendations to improve standards of care and patient outcomes

Examine proper selection and use of currently available medication devices for COPD

Discuss the pharmacist’s role in optimizing management of COPD

Objectives

3/11/2013

3

Pharmacy Times Office of Continuing

Professional Education is accredited by

the Accreditation Council for Pharmacy

Education (ACPE) as a provider of

continuing pharmacy education. This

activity is approved for 1.0 contact hours

(0.10 CEUs) under the ACPE universal

activity number 0290-0000-13-113-L01-P.

The activity is available for CE credit

through February 28, 2013.

Type of Activity: Knowledge

Pharmacy Accreditation

Waiting to Exhale:

Optimizing Patient Outcomes

in the Management of COPD

Kyle Copeland, PharmD

Clinical Pharmacist Specialist

Parkwest Medical Center

Knoxville, Tennessee

3/11/2013

4

Prevalence and Diagnosis

GOLD Guideline, 2013 www.goldcopd.org

J Am Pharm Assoc. 2011;51:203-211.

N Engl J Med. 2004;350:2689-2697.

4th leading cause of death in the U.S.

Expected to become 3rd leading cause of

death very soon

Accounts for 10% of hospital occupancy

More than 24 million Americans

estimated to have COPD

Prevalence

3/11/2013

5

Common preventable and treatable

disease, characterized by persistent

airflow limitation that is usually

progressive and associated with

enhanced chronic inflammatory

response in the airways and the lung to

noxious particles or gases.

GOLD Guideline, 2013 www.goldcopd.org

COPD: Definition

Burden

GOLD Guideline, 2013 www.goldcopd.org

Economic Burden (U.S.)

Direct costs: $29.5 billion

Indirect costs: $20.4 billion

Economic Burden (Europe)

€38.6 billion euros

3.3% of total health care budget in

European Union

3/11/2013

6

GOLD Guideline, 2013 www.goldcopd.org

Key indicators for considering COPD

Dyspnea

Chronic cough

Chronic sputum production

Exposure to risk factors

Family history of COPD

Additional risk factors

Pattern of symptom development

History of previous hospitalizations

Diagnosis

GOLD Guideline, 2013 www.goldcopd.org

Diagnosis

Spirometry

Required to make diagnosis clinically

post-bronchodilator fixed ratio of

FEV1/FVC of <0.7 confirms COPD

Degree of reversibility of airflow limitation

(FEV1 before and after bronchodilators) no

longer recommended

3/11/2013

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Assessment

of Disease

GOLD Guideline, 2013 www.goldcopd.org

Symptoms

Modified British Medical Council (mMRC)

Grade 0 (breathless with exercise) to

Grade 4 (breathless at rest)

Predicts future mortality risk

COPD Assessment Test (CAT)

8 item, uni-dimensional measure of

impairment of health status in COPD

Score ranges from 0 (lowest) to 40 (highest)

3/11/2013

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Clinical COPD Questionnaire (CCQ)

-- NEW --

Self-administered questionnaire developed

specifically to measure clinical control

Data supports validity, reliability, &

responsiveness

Short and easy to administer

GOLD Guideline, 2013 www.goldcopd.org

Symptoms

GOLD Guideline, 2013 www.goldcopd.org

Airflow Limitation

Spirometric Assessment

Based on % FEV1 compared with predicted

Performed post-bronchodilator

GOLD Level

1. Mild: FEV1 > 80% predicted

2. Moderate: 50% < FEV1 < 80%

3. Severe: 30% < FEV1 < 50%

4. Very Severe: FEV1 < 30%

3/11/2013

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Exacerbation Risk

2 or more exacerbations in 12 months

Increased risk of hospitalization and

worsening airflow limitation

Less than 2 exacerbations in 12 months

Lower risk of hospitalization

Reprinted with permission from Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary

Disease. Global Initiative for Chronic Obstructive Lung Disease. www.goldcopd.org, Feb 2013.

Overall Assessment

3/11/2013

10

GOLD Guideline, 2013 www.goldcopd.org

Imaging

Lung Volumes & Diffusing Capacity

Oximetry & ABG Measurements

Alpha-1 Antitrypsin Deficiency Screening

Exercise Testing

Additional

Treatment of

COPD

3/11/2013

11

GOLD Guideline, 2013 www.goldcopd.org

Therapeutic Goals

Reduce Symptoms

Relieve immediate symptoms

Improve exercise tolerance

Improve health status

Reduce Risk of Exacerbations

Prevent disease progression

Prevent & treat exacerbations

Reduce mortality

GOLD Guideline, 2013 www.goldcopd.org

Non-Pharmacologic

Smoking Cessation

Rehabilitation

Oxygen Supplementation

Pharmacologic

Bronchodilators

Corticosteroids

Other Options

Therapeutic Options

3/11/2013

12

GOLD Guideline, 2013 www.goldcopd.org

Smoking Cessation

The intervention with the greatest

capacity to influence the natural history

of COPD

Nicotine Replacement (vs) Medications

The 5 “A’s”

Ask, Advise, Assess, Assist, & Arrange

GOLD Guideline, 2013 www.goldcopd.org

Non-Pharmacologic

Rehabilitation

Exercise

Education

Assessment and Follow-up

Nutrition Counseling

Oxygen Therapy

Improves survival in patients with chronic

respiratory failure & severe resting hypoxia

3/11/2013

13

GOLD Guideline, 2013 www.goldcopd.org

Pharmacologic

Bronchodilators

Beta2-agonists

Anticholinergics

Theophylline

Corticosteroids

Inhaled

Systemic

Other Therapies

Phosphodiesterase-4

Inhibitors

Alpha-1 Antitrypsin

Therapy

Increase FEV1 or change other

spirometric variables, usually by altering

airway smooth muscle tone

Inhaled therapy is preferred

Dose-response relationships

Outcomes in acute episodes

Toxicity

As needed (vs.) regular basis

GOLD Guideline, 2013 www.goldcopd.org

Bronchodilators

3/11/2013

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GOLD Guideline, 2013 www.goldcopd.org

Beta2-Agonists

Short-Acting

Regular and “as needed” use improve FEV1 and symptoms

Usually wear off in 4-6 hours

Long-Acting

Significantly improve FEV1, lung volumes, dyspnea, quality of life, exacerbation rates

Adverse Effects

Sinus tachycardia, cardiac arrhythmias

Beta2-Agonists

Short-Acting

Albuterol

Levalbuterol

Terbutaline

Long-Acting

Formoterol

Arformoterol

Salmeterol

GOLD Guideline, 2013 www.goldcopd.org

3/11/2013

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GOLD Guideline, 2013 www.goldcopd.org

Anticholinergics

Short-Acting

Longer duration than short-acting beta2-agonists

Long-Acting

Reduce exacerbations & related hospitalizations, improve symptoms & health status

Adverse Effects

Dryness of mouth, bitter taste

GOLD Guideline, 2013 www.goldcopd.org

Anticholinergics

Short-Acting

Ipratropium

Long-Acting

Tiotropium

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GOLD Guideline, 2013 www.goldcopd.org

Methylxanthines

Theophylline

Less effective and less tolerated than

long-acting bronchodilators

Not recommended if other options available

and affordable

Problems include: atrial & ventricular

arrhythmias, grand mal convulsions

Significant drug-drug interactions

GOLD Guideline, 2013 www.goldcopd.org

Corticosteroids

Inhaled vs. Systemic

Inhaled always chosen for regular therapy

Systemic reserved only for short courses in treatment of exacerbations

Regular Treatment

Improves symptoms, lung function, quality of life,

Reduces frequency of exacerbations in patients with FEV1 <60% predicted

3/11/2013

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GOLD Guideline, 2013 www.goldcopd.org

Corticosteroids

Adverse Effects

Oral candidiasis, hoarse voice, skin bruising

Combination with Bronchodilators

Inhaled corticosteroid combined with a

long-acting beta2-agonist more effective

than the individual components in patients

with moderate to severe COPD

Corticosteroids

GOLD Guideline, 2013 www.goldcopd.org

Inhaled

Beclomethasone

Budesonide

Fluticasone

Systemic

Prednisone

Methylprednisone

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GOLD Guideline, 2013 www.goldcopd.org

PDE4 Inhibitors

Single Agent Roflumilast

No direct bronchodilator activity

Improves FEV1 in patients treated with

salmeterol or tiotropium

Adverse Effects

More common than inhaled medications

Nausea, abdominal pain, diarrhea,

sleep disturbances, headache

Other Therapies

Vaccines

Alpha-1 Antitrypsin Therapy

Antibiotics

Mucolytics

Antitussives

GOLD Guideline, 2013 www.goldcopd.org

3/11/2013

19

Patient Specific Regimens

and Management of

Exacerbations

Reprinted with permission from Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive

Pulmonary Disease. Global Initiative for Chronic Obstructive Lung Disease. www.goldcopd.org, Feb 2013.

Patient Specific Regimens

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20

“A” – Few Symptoms, Low Risk

Recommended First Choices:

• Short-acting anticholinergic “prn”

• Short-acting beta2-agonist “prn”

Alternates:

• Short-acting anticholinergic PLUS

Short-acting beta2-agnoist

• Long-acting anticholinergic

• Long-acting beta2-agonist

GOLD Guideline, 2013 www.goldcopd.org

Patient Specific Regimens

“B” – More Symptoms, Low Risk

Recommended First Choices:

• Long-acting anticholinergic

• Long-acting beta2-agonist

Alternate:

• Long-acting anticholinergic PLUS

Long-acting beta2-agonist

GOLD Guideline, 2013 www.goldcopd.org

Patient Specific Regimens

3/11/2013

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“C” – Few Symptoms, High Risk

Recommended First Choices:

• Inhaled Corticosteroid PLUS Long-acting beta2-agonist

• Long-acting anticholinergic

Alternates:

• Long-acting anticholinergic PLUS Long-acting beta2-agonist

• Long-acting anticholinergic (or) beta2-agonist PLUS Phosphodiesterase-4 Inhibitor

GOLD Guideline, 2013 www.goldcopd.org

Patient Specific Regimens

“D” – Many Symptoms, High Risk

Recommended First Choices:

• Inhaled Corticosteroid PLUS Long-acting beta2-agonist (and/or)

• Long-acting anticholinergic

Alternates:

• Inhaled Corticosteroid PLUS Long-acting anticholinergic PLUS Long-acting beta2-agonist

• Long-acting anticholinergic (or) beta2-agonist PLUS Phosphodiesterase-4 Inhibitor

GOLD Guideline, 2013 www.goldcopd.org

Patient Specific Regimens

3/11/2013

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Short-Acting Bronchodilators

Increased doses and/or frequency

Corticosteroids, Systemic

Short duration

Shortens recovery, reduce early relapse risk

Antibiotics

Recommended duration 5-10 days

Oxygen & ventilator support as needed

GOLD Guideline, 2013 www.goldcopd.org

Exacerbations

Heart Failure

Osteoporosis

Lung Cancer

Difficult to Treat

3/11/2013

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Proper Device Selection and

Utilization

Delivery Systems

Nebulized Solutions (Nebs)

Metered Dose Inhalers (MDI’s)

Dry-Power Inhalers (DPI’s)

Breath-Actuated MDI’s (BA-MDI’s)

Soft-Mist Inhalers (SMI’s)

J Am Acad Nurs Pract. 2012;24:113-20

www.nationalasthma.org.au, 2008

Selection & Utilization

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Selection & Utilization

Considerations

Medication availability / Insurance coverage

Previous / current inhaler types

Cognitive function

Lung function

Strength & Dexterity

Patient specific issues

Selection & Utilization

Virchow et al.

1. Determine devices in which the medication is available

2. Determine inspiratory effort

a. If sufficient inspiratory flow or effective vital capacity, DPI is preferred

b. Second choice is MDI w/ spacer

3. Use same device type, if possible, for continuity when multiple inhalers are used

a. DPI preferred when multiple inhalers used

Respir Med. 2008;102:10-19

3/11/2013

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Nebulized Meds

Oldest form of inhaled medication

delivery

Requires “nebulizer”

machine

Uses oxygen, compressed air, or

ultrasonic power to aerosolize the

medication

Delivered to using mouthpiece or mask

Limited to hospital and home use

One of the most common delivery

systems

Medication delivered as a mist

Slowly inhaled into lungs and

held for a few seconds before

being exhaled

Higher degree of coordination / strength

Spacer or no spacer?

Metered Dose Inhalers

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Developed as alternative to MDI’s

Multiple delivery systems

Proprietary Systems

Capsule-Based Delivery

Minimum inspiratory requirements

Minimum coordination / strength needed

Wide number of medications available

Dry Powder Inhalers

Breath-Actuated MDI’s

Derivative of traditional MDI’s

Incorporates flow trigger

Removes coordination requirement

Highly preferred among patients who

have tried it

Limited by minimal number of available

meds utilizing it

3/11/2013

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Soft-Mist Inhalers

Approved in July 2012

Currently only one (combination) product is approved

Propellant-free device

Generates very fine, slow moving mist

Very specific priming steps

Extra education required

The Pharmacist’s

Role

3/11/2013

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Counseling

Patients up to 68% unable to use inhaler

devices properly

Healthcare up to the same percent

cannot demonstrate proper use

Must be routine part of care from

prescribing to dispensing

Every time a prescription is filled,

new (or) refill… check technique GOLD Guideline, 2013 www.goldcopd.org

Jour Asthma. 2007;44:593-598

Respir Care. 2005;50:1360-1374

Pharmacist’s Role

Pharmacist’s Role

Am J Health-Syst Pharm. 2011;68:1221-32

Proper Device Selection

What is available?

What are they using now?

Can they demonstrate proper use?

What do they prefer?

All Things Equal…

First Choice: Dry Powder Inhaler

Second Choice: MDI (with spacer)

3/11/2013

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Get Proactive!

COPD will soon be the number 3 cause

of death in the U.S.

Chronic airway disease management is

“10% medication & 90% education”

COPD is “preventable” with irreversible

airway progression

Educate & reinforce at every opportunity

GOLD Guideline, 2013 www.goldcopd.org

Jour Asthma. 2007;44:593-598

Pharmacist’s Role

Questions

3/11/2013

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Disclaimer The information provided in this CPE activity is for continuing

medical and pharmacy education purposes only and does not

constitute any form of professional advice or referral. Discussions

concerning drugs, dosages, and procedures may reflect the clinical

experience of the faculty or they may be derived from the

professional literature or other sources and may suggest uses that

are investigational in nature and not based on approved labeling or

indications. Participants are encouraged to refer to primary

references or full prescribing information resources for all products

discussed.

The opinions expressed in the content and provided verbally by

faculty in this Webinar are solely those of the individual faculty

members and do not reflect those of Pharmacy Times Office of

Continuing Professional Education or the company providing

commercial support for this CPE activity.

Thank You!