copd guidelines update: opportunities for growth and

10/22/2019

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COPD Guidelines Update:Opportunities for Growth and

Transitions of CareRobert J. Kuhn, PharmD - UK

Lauren Kormelink, PharmD - UK

Rachael Hiday, PharmD - IU Health

Sarah Vickery, PharmD - Ephraim McDowell Danville

Agenda

• Introduction and Development Plan - BK

• New COPD Guidelines - Dr. Lauren Kormelink

• Transitions in Care- Selection of Programs

• Ambulatory Care COPD Clinic, Indianapolis Indiana Dr. Rachael Hiday

• EMMC- Transition clinic and follow up - Dr. Sarah Vickey

• Special Thanks to :

• Dr. Emily Henderson, PharmD

• KSHP

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2019 Guideline Update: Chronic Obstructive Pulmonary Disease (COPD)Lauren Kormelink, PharmD, BCACP

Clinical Pharmacy Specialist – Adult Pulmonology

UK HealthCare

Faculty Disclosure

I have no conflicts of interest to disclose regarding this presentation.

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Educational Need/Practice Gap

COPD is very prevalent in the state of Kentucky.

The GOLD workgroup released updated treatment guidelines for COPD in the spring of 2019.

In order to provide Kentuckians with optimal COPD treatment outcomes, practitioners across the state should be able to implement the most updated evidence based treatment approaches.

Objectives

Upon completion of this educational activity, you will be able to: Review risk factors and pathophysiology of COPD

Recommend initial pharmacologic and non-pharmacologic interventions for a patient with newly diagnosed COPD

Assess appropriateness of a patient’s current COPD treatment and determine when changes are warranted

Evaluate need for COPD exacerbation treatment

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Expected Outcome

The goal of this presentation is for attendees to be able to implement 2019 guidelines into clinical practice to provide patients with the most updated evidence based treatment and monitoring strategies.

Secondarily, attendees can work to make other practitioners aware of the new guidelines and how to implement them into practice.

Definition

Small Airway Disease(Chronic Bronchitis)

Airway InflammationAirway Fibrosis, Luminal PlugsIncreased Airway Resistance

Parenchymal Destruction(Emphysema)

Loss of Alveolar AttachmentsDecrease of Elastic Recoil

AIRFLOW LIMITATION

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Risk Factors

Tobacco smoke

Tobacco smoke

Air pollution (indoor/outdoor) & occupational

exposure

Air pollution (indoor/outdoor) & occupational

exposure

Genetics (alpha-1 antitrypsin)

Genetics (alpha-1 antitrypsin)

Age & female sex

Age & female sex

Lung development

Lung development

Socioeconomic status

Socioeconomic status

AsthmaAsthma Chronic bronchitisChronic

bronchitis

Severe respiratory

infections as child

Severe respiratory

infections as child

Classifying Disease Severity

Assess Risk of ExacerbationAssess Risk of Exacerbation

Assess SymptomsAssess Symptoms

Assess Degree of Airflow LimitationAssess Degree of Airflow Limitation

DiagnoseDiagnose

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COPD Diagnosis

COPD Diagnosis

Symptoms

Risk Factors

and Personal History

SpirometricTesting

Dyspnea: Progressive over timeWorsens with exercise

Persistent

Chronic CoughMay be intermittent

May be productive or non-productive

Presence of wheeze

Sputum ProductionChronic or intermittent but

recurrent

Risk Factors (current or past)-especially tobacco smoke or environmental/occupational

exposures

Family History of COPD

Recurrent Lower Respiratory Tract Infections

Grading Airflow Limitation

Grading Airflow Limitation

Grade Severity FEV1 Percent Predicted

GOLD 1 Mild ≥ 80

GOLD 2 Moderate 50-79

GOLD 3 Severe 30 to 49

GOLD 4 Very Severe < 30

Determined by spirometry (FEV1/FVC <0.7)

Must be post-bronchodilator FEV1

Predicted FEV1 is calculated based on population norms accounting for body habitus, age, gender, etc.

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Assess Symptoms

Symptom Rating Scales

Modified Medical Research Council (mMRC) Assess breathlessness

COPD Assessment Test (CAT) Comprehensive assessment of symptoms

Dyspnea

Sputum Production

Cough

“Less symptomatic”

• mMRC 0 – 1• CAT < 10

“More symptomatic”

• mMRC ≥ 2• CAT ≥ 10

Exacerbation Risk

High Risk

≥ 2 exacerbations within the last

year

≥1 hospitalization

for COPD exacerbation

History repeats itself! Exacerbation risk is determined by exacerbation

history in the past year

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ABCD Assessment Tool

Exacerbation History

2 or moreOR

1 or more requiring

hospitalization

0 or 1 not requiring

hospitalization

mMRC 0-1CAT <10

mMRC ≥ 2CAT ≥ 10

Symptoms

GOLD GROUP

Group C

In Summary:

Spirometry:

Confirmation of diagnosis

Grading: Assessment of airflow limitation

Grouping:

Assessment of symptoms/risk of exacerbation

Post-bronchodilator

FEV1/FVC < 0.7

GRADE FEV1

GOLD 1 ≥ 80%GOLD 2 50-79%GOLD 3 30-49%GOLD 4 < 30%

GROUP

C D

A B

Ex: JZ is a 48 yo male with GOLD Grade 3 Group D COPD

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The Case of MK

MK is a 68 yo female with no significant PMH and newly diagnosed COPD presenting to the pharmacist led COPD management clinic

2 year history of chronic, dry cough and dyspnea on exertion with 1 self limiting lower respiratory infection in the past year Retired, operated her own hair salon x 30 years

Lives at home with husband

Smokes ½ PPD (recent decrease from 1-1.5)

FEV/FVC= 0.67, ppFEV1=55%, MMRC=2

MK continued…

How would you classify MK’s COPD?

A. GOLD Grade 1 Group A

B. GOLD Grade 2 Group A

C. GOLD Grade 1 Group B

D. GOLD Grade 2 Group B

E. MK does not meet diagnostic criteria for COPD

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MK continued…

Which of the following are risk factors for MK’s COPD?

A. Occupational exposure

B. Tobacco smoke exposure

C. Gender

D. A and B

E. A, B, and C

COPD Management

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Treatment Goals

Reduce Symptoms

Relieve Symptoms

Improve Exercise Tolerance

Improve Health Status

Reduce Risk

Prevent Disease

Progression

Prevent and Treat

Exacerbations

Reduce Mortality

Non-Pharmacologic Treatment

Risk factor reduction Smoking cessation!!!!

Assess at every visit

Vaccinations Influenza, pneumonia per CDC recommendations

Pulmonary rehabilitation Group B, C, and D

Supplemental oxygen To help maintain O2 saturations >88-90%

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Maintenance Therapies

Maintenance Pharmacologic Therapy

Bronchodilator

Beta-2 Agonists

SABA/LABA

Muscarinic Antagonists

SAMA/LAMA

Methylxanthine

Anti-inflammatory

ICS (LOW DOSE ONLY)

PDE-4 Inhibitor

Oral Corticosteroids

Macrolide Antibiotics

Other

SABA: Short acting beta agonistLAMA: Long acting beta agonistSAMA: Short acting muscarinic antagonistLAMA: Long acting muscarinic antagonistICS: Inhaled corticosteroidPDE-4: Phosphodiesterase type 4

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Types of Inhaled Medications

Metered Dose Inhaler (MDI) i.e. “HFA®,” “Aerosphere®”

Soft Mist Inhaler (SMI) Type of MDI

i.e. “Respimat®”

Dry Powder Inhaler (DPI) i.e. “Ellipta®,” “RespiClick®,” “Diskus®,”

“Neohaler®,” “Redihaler®,” “Flexhaler®,” “Twisthaler®,” or “Handihaler®”

Solutions for nebulization Standard nebulizer machine vs. vibrating mesh

Agent Selection

Patient history

Insurance formulary

Drug delivery

Ease of device use for patient

Patient preference

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Inhaler Assessment and Education

Continuous counseling Importance of adherence

Appropriate inhaler technique

Controller vs. rescue inhaler

Continuous assessment Demonstration of inhaler technique

Teach back method

Check refill history when possible

Barriers to treatment

Initial Treatment

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Initial Treatment

Based on ABCD Assessment tool

** Disclaimer from the guidelines: “There is a lack of high-quality evidence supporting initial pharmacologic treatment strategies in newly diagnosed COPD patients”

Blood Eosinophils

Type of WBC often indicative of inflammatory or allergic response by the immune system

Some trials have demonstrated better performance of ICS therapy in patients with eosinophilia Mostly subgroup analyses

Some trials failed to exclude patients with asthma

New guidelines have expert opinion-based cutoffs This is likely an area of future research

Still must weigh risk/benefits of ICS

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Group A

Treat with any bronchodilator Could be short or long acting

Short acting can be PRN or scheduled

Can be beta agonist or muscarinic antagonist

Combination SABA/SAMA > monotherapy Better improvement in FEV1 and symptoms

Group B

LABA or LAMA is acceptable No evidence to support one over the other

Long-acting bronchodilators Formulated once or twice daily

Increased compliance vs QID regimens

Severe breathlessness (mMRC 4) LABA + LAMA as initial therapy

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Group C

LAMA superior to LABA in prevention of exacerbations Supported by two head to head trials Tiotropium vs. Salmeterol

Vogelmeier C, et al. N Engl J Med 2011; 364 (12): 1093-1103.

Tiotropium vs. Indacaterol Decramer ML, et al. Lancet Respir Med 2013; 1(7):524-

533.

Group D

Individual patient

LAMA•Most patients

LABA/LAMA• CAT≥20

• Exercise limitation• Dyspnea

ICS/LABA• Eosinophils ≥300 cells/μL

• H/O asthma

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MK continued…

Which non-pharmacologic treatments are appropriate for MK?

A. Tobacco cessation/assessment of readiness to quit

B. PPSV 23 and Influenza Vaccine today

C. PCV 13 and Influenza Vaccine today

D. A and B

E. A and C

MK continued…

In addition to PRN albuterol, which option would be appropriate initial treatment for MK’s group B COPD?

A. Salmeterol 50 mcg – 1 puff PO BID

B. Tiotropium 2.5 mcg – 2 puffs PO daily

C. Fluticasone/Salmeterol 100/50 mcg – 1 puff PO BID

D. A or B

E. A, B, or C

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Therapy adjustment after initial treatment

Follow up Pharmacologic Treatment

Management Cycle

Well-managed disease Every 3-6 months

After therapy change with no exacerbation 6-12 weeks

After acute exacerbation Within 4 weeks

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Monitoring Tests

Spirometry At least annually

ABCD Grouping At every visit to assess disease progression/severity

Imaging In some cases

Eosinophils counts Initial visit or if you are considering starting ICS therapy

Targeted Adjustments

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Dyspnea:

LAMA or LABA monotherapy Try LAMA/LABA

LABA/ICS Try LAMA/LABA

Try LABA/LAMA/ICS

If at any point, ICS is ineffective or causes ADRs, take it off

Patient reports persistent breathlessness or exercise limitations

Exacerbations:

If on monotherapy: try LAMA+LABA

ICS/LABA (if appropriate)

If on LAMA/LABA: try LAMA/LABA/ICS

Azithromycin

Roflumilast

If on LABA/ICS: try LAMA/LAMA

LAMA/LABA/ICS

Patient presents with persistent exacerbations +/- dyspnea

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Roflumilast

Phosphodiesterase-4 inhibitor

Reduce inflammation by decreasing the breakdown of cAMP

DOES NOT REDUCE SYMPTOMS

FDA Approved to reduce moderate to severe exacerbations in patients with

Chronic bronchitis

Severe or very severe COPD Grade 3-4

i.e. FEV1<50%

History of exacerbations requiring hospitalization or steroid/antibiotic courses

Roflumilast

Precautions and Side Effects: Neuropsychiatric effects Increased anxiety, depression, sleep disturbances

Avoid in depression with suicidality

Weight Loss 20% of patients lost 5-10% of body weight

7% of patients lost >10% of body weight

Avoid in underweight, frail population

Diarrhea 9.5%

Severe weight

loss 7.5%

Nausea 4.7%

Headache 4.4%

Back pain 3.2%

Insomnia 2.4%

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Macrolide Antibiotics

Chronic use = anti-inflammatory effect NOT antimicrobial

May reduce rate of exacerbations, NOT symptoms

Little to no benefit in current smokers

Dosing Azithromycin 250 mg/day or 500 mg MWF

Erythromycin 500 mg BID

Studies lack data for use > 1 year

Concern for antimicrobial resistance, QTcprolongation, and impaired hearing test with chronic use

Other Treatments

Studied, but no/little evidence in support Mucolytics N-acetylcysteine

Carbosysteine

Leukotriene modifiers

Simvastatin

Vitamin D supplementation

Chronic Systemic Steroids Risk>Benefit in most cases

Methylxanthines Risk>Benefit in most cases

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MK continued…

MK returns to clinic 6 mo later She quit smoking using NRT (3 mo tobacco free)

Reports continued dyspnea, even at rest

mMRC = 3, no exacerbation in past 6 mo

Current medications: Albuterol HFA 1-2 puffs PO Q4-6Hr PRN

Tiotropium 2.5 mcg – 2 puffs PO daily

Demonstrated good technique of each inhaler device and states she misses 1-2 doses per month of maintenance inhaler

MK continued…

Which of the following is the best intervention for MK?

A. Stop tiotropium, start umeclidinium/vilanterol

B. Continue tiotropium, add salmeterol

C. Continue tiotropium, add fluticasone

D. Stop tiotropium, start salmeterol

E. Stop tiotropium, start fluticasone/salmeterol

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Acute worsening of respiratory symptoms that results in the need for additional therapy Increased dyspnea, coughing, changes in

sputum amount and/or color

Often triggered by respiratory viral infections

Treating Exacerbations

Consequences of Exacerbations

Exacerbations

Negative Impact on Quality of

Life

Impact on Symptoms and Lung Function

Increased Economic

Costs

Increased Mortality

Accelerated Lung

Function Decline

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Management: Exacerbations

Oxygen Bronchodilators

Systemic Corticosteroids Antibiotics

Location of treatment

80% of exacerbations are treated in the outpatient setting

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Bronchodilators

Increase use of SABA

No difference between nebulization vs. MDI Sicker patients may do better with nebulized SABA if unable to take

deep breath without coughing

MDI: Use 1 puff PO every hour for 2-3 doses, then every 2-4 hours based on response

Educate patients about COPD action plan

Systemic Corticosteroids

Role in therapy: Shorten recovery time

Improves lung function

Reduces risk of early relapse

Reduces length of hospital stay

Prednisone 40 mg daily for 5 days Trials have shown:

5 days course is non-inferior to 14 day course

PO steroids non-inferior to IV steroids

For patients with contraindications to systemic steroids, can consider budesonide 2 mg nebulization Q6Hr for 5-7 days

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Antibiotics

Antibiotic therapy is warranted when:Patient exhibits 3 cardinal symptoms Increased dyspnea

Increased sputum volume

Increased sputum purulence

OR increased sputum purulence + Increased dyspnea or sputum volume

Patient requiring mechanical ventilation

Treatment duration: 5-7 days

Antibiotic Selection

Most common pathogens are S. pneumoniae, H. influenza, M. catarrhalis, and atypical organisms

Macrolide• Azithromycin 500mg PO on day once, then 250 mg PO daily on days 2-5

Tetracycline• Doxycycline 100mg PO BID x 5-7 days

Beta-lactams• Aminopenicillin + β-lactamase inhibitor

• Amoxicillin/clavulanic acid 875 mg PO BID x 7 days• Ampicillin/sulbactam 3G IV Q6H x 7 days

• 2nd or 3rd generation cephalosporin

Respiratory fluoroquinolone• ONLY if severe exacerbation + β-lactam allergy (or failure)

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Key points

All patients should increase SABA use Continue maintenance therapy

For moderate or severe, use glucocorticoids Prednisone 40 mg PO daily x 5 days

No additional benefit of longer duration or IV therapy

If evidence of bacterial infection Antibiotics targeting common pathogens x 5-7

days

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Post Exacerbation Transition

Education Inhaler technique, Maintenance vs. Rescue

COPD Action Plan

Medication Access Prior Authorizations, financial assistance, network

pharmacies

Appropriate Follow up With outpatient team within 4 weeks

MK continued…

MK returns to clinic 3 months after her last visit

increased dyspnea, frequent coughing, increased use of albuterol inhaler x 48 hours

O2 sat 99% on room air, no signs of acute respiratory failure

Current medications: Umeclidinium/Vilanterol

Albuterol 1-2 puffs PO Q4-6Hr PRN

Adherent to her medications, but feels like the powder inhaler is getting stuck in her throat

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MK continued…

Which of the following is appropriate treatment for MK’s current COPD exacerbation in addition to increased albuterol use?

A. Prednisone 40 mg PO daily x 5 days

B. Doxycycline 100 mg PO BID x 5 days

C. Oxygen

D. A and B

E. A, B, and C

MK continued…

Which counseling point is pertinent to ensure MK is using her dry powder inhaler correctly?

A. Always use a spacer with the DPI inhaler

B. Inhale a deep, steady breath

C. Hold inhaler upright (perpendicular to floor)

D. Clean inhaler with soap and water after each use

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Chronic Obstructive Pulmonary Disease

Based on GLOBAL STRATEGY FOR THE DIAGNOSIS, MANAGEMENT AND PREVENTION OF COPD, GLOBAL INITIATIVE FOR CHRONIC OBSTRUCTIVE LUNG DISEASE (GOLD) 2019. AVAILABLE FROM:

HTTP://WWW.GOLDCOPD.ORG/.

[email protected]

Appendix Slides

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mMRC Dyspnea Scale

CAT Assessment

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Short-Acting Beta 2-Agonists (SABA)

Medication Formulation Strength Daily Dose Max Dose/Day

Albuterol*generic only*

Nebulization solution

0.63 mg/3 mL1.25 mg/3 mL2.5 mg/3 mL

5 mg/mL

1.25-5 mg Q4-8H prn30 mg/day

Albuterol(Proventil®

HFA, ProAir® HFA,

Ventolin® HFA)

MDI

90 mcg 1-2 puff Q4-6H prn 1,080 mcg/day

Albuterol(ProAir®

RespiClick)DPI

Levalbuterol(Xopenex®)

Nebulizationsuspension

0.31 mg/3 mL0.63 mg/3 mL1.25 mg/3 mL

1.25 mg/0.5 mL

0.63-1.25 mg Q6-8H 3.75 mg/day

Levalbuterol(Xopenex®

HFA)MDI 45 mcg 1-2 puff Q4-6H prn 540 mcg/day

Short-Acting Muscarinic Antagonists (SAMA)

Medication Formulation Strength Daily Dose Max Dose/Day

Ipratropium bromide

(Atrovent® HFA)

MDI 17 mcg 2 puffs QID 204 mcg/day

Ipratropium bromide

*generic only*


500 mcg/2.5 mL

1 vial Q6-8H 2000 mcg/day

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Long-Acting Beta2-Agonists (LABA)

Medication Formulation Strength Daily Dose Max Dose/DayArformoterol(Brovana®)

Nebulization suspension

15 mcg/2mL 1 vial nebulized BID 30 mcg/day

Formoterol(Perforomist®)


20 mcg/2mL 1 vial nebulized BID 40 mcg/day

Indacaterol(Arcapta®

Neohaler®)DPI 75 mcg 1-4 puffs QD 300 mcg/day

Olodaterol(Striverdi® Respimat®)

SMI 2.5 mcg 2 puffs QD 5 mcg/day

Salmeterol(Serevent®

Diskus)DPI 50 mcg 1 puff BID 100 mcg/day

Long-Acting Muscarinic Antagonists (LAMA)

Medication Formulation Strength Dosing Max Dose/Day

Aclidinium bromide(Tudorza® Pressair) MDI 400 mcg 1 puff BID 800 mcg/day

Glycopyrrolate bromide

(Seebri® Neohaler®)DPI 15.6 mcg 1 puff BID 31.2 mcg/day

Glycopyrrolate bromide

(Lonhala® Magnair™)Nebulization

solution25 mcg 1 vial BID 50 mcg/day

Tiotropium bromide(Spiriva® Handihaler) DPI 18 mcg 1 puff QD 18 mcg/day

Tiotropium bromide(Spiriva® Respimat®) SMI

1.25 mcg2.5 mcg

2 puffs QD 2.5 mcg/day

Umeclidinium(Incruse® Ellipta) DPI 62.5 mcg 1 puff QD 62.5 mcg/day

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ICS/LABAMedication Formulation Strength Daily Dose Max Dose/Day

Budesonide/ formoterol

(Symbicort® HFA)MDI

80/4.5 mcg160/4.5 mcg

2 puffs BID 320/9 mcg/day

Fluticasone/ salmeterol

(Advair® Diskus)DPI

100/50 mcg250/50 mcg500/50 mcg

1 puff BID 1000/100 mcg/day

Fluticasone/ salmeterol

(Advair® HFA)MDI

45/21 mcg115/21 mcg230/21 mcg


Mometasone/ formoterol

(Dulera® HFA)MDI

100/5 mcg200/5 mcg


Fluticasone/vilanterol

(Breo® Ellipta®)**According to the TRINITY study, only LOW DOSE ICS should be used for COPD due

to lower risk of side effects and complications and similar efficacy

Other Combination ProductsSABA/SAMA

Medication Formulation Strength Dosing Max Dose/Day

Albuterol/ipratropium(Combivent®Respimat®)

MDI 100 mcg 1 puff QID 600 mcg/day

Albuterol/ipratropium *generic only*


0.5 mg/2.5 mg 1 vial Q6H6 vials/day

(18 mL/day)LABA/LAMA

Formoterol/glycopyrrolate(Bevespi®

Aerosphere®)MDI

4.8 mcg/9 mcg

2 puffs BID 19.2/36 mcg/day

Indacaterol/glycopyrrolate

(Utibron™Neohaler®)DPI

27.5mcg/15.6 mcg

1 puff BID 55/31.2 mcg/day

Olodaterol/tiotropium(Stiolto® Respimat®)

MDI2.5 mcg/2.5

mcg2 puff QD 5/5 mcg/day

ICS/LAMA/LABAFluticasone/

Umeclidinium/Vilanterol

(Trelegy® Ellipta)

DPI100 mcg/62.5 mcg/25 mcg

1 puff QD100 mcg/62.5 mcg/25 mcg

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Inhaled Corticosteroids (ICS)Medication Formulation Strength Low Daily Dose Medium Daily Dose High Daily Dose

Beclomethasonedipropionate

(QVAR® RediHaler™)MDI

40 mcg80 mcg

80-240 mcg/day 240-480 mcg/day> 480 mcg/day

Budesonide(Pulmicort® Flexhaler™)

DPI90 mcg180 mcg

180-600 mcg/day 600-1,200 mcg/day > 1,200 mcg/day

Budesonide(Pulmicort Respules®)


0.25 mg/2 mL0.5 mg/2 mL1 mg/2 mL

0.5 mg/day 1 mg/day 2 mg/day

Ciclesonide(Alvesco®)

MDI80 mcg160 mcg

80-160 mcg/day160-320 mcg/day > 320 mcg/day

Fluticasone furoate(Arnuity® Ellipta®)

DPI100 mcg200 mcg

ICS-naïve: 100 mcg/day

prior ICS: 200 mcg/day

Fluticasone propionate(Flovent® Diskus®)

DPI50 mcg100 mcg250 mcg

100-300 mcg/day > 300-500 mcg/day> 500 mcg mcg/day

Fluticasone propionate(Flovent® HFA)

MDI44 mcg110 mcg220 mcg

88-264 mcg/day > 264-440 mcg/day >440 mcg mcg/day

Mometasone(Asmanex® Twisthaler®)

DPI110 mcg220 mcg

220 mcg/day 440 mcg/day > 440 mcg/day

**According to the TRINITY study, only LOW DOSE ICS should be used for COPD due to lower risk of side effects and complications and similar efficacy

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