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Respiratory Update: Guidelines, Novel Inhalers and More
Dennis Williams, PharmD, BCPS, FAPhA
University of North Carolina Eshelman School of Pharmacy
Chapel Hill, North Carolina
Michael J. Cawley, PharmD., RRT, CPFT, FCCM
Philadelphia College of Pharmacy / University of the Sciences
Philadelphia, PA
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Supporter
• Supported by an independent educational grant from AstraZeneca LP.
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Disclosures
• Dennis Williams reports that his spouse is an employee of GlaxoSmithKline and also holds stock in the company
• Michael J. Cawley: “declare(s) no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.”
The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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• Target Audience: Pharmacists
• ACPE#: 0202-0000-16-050-L01-P
• Activity Type: Application-based
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Learning Objectives• Classify symptom severity, assess control, and select and
monitor appropriate therapy for patients with asthma or COPD
• Given representative patient cases, develop care plans for patients with asthma or COPD based on current guidelines for assessing and treating patients
• Discuss current and emerging therapeutic options for the management of asthma and COPD
• Discuss patient related factors to consider when selecting among available inhaler devices
• Demonstrate how to use devices for the management of asthma and COPD and educate patients on proper use
• Robin is an 11 year old Caucasian male who is brought to the clinic by his parents after a visit to the emergency department last evening because of an acute asthma episode
• He was treated with albuterol and oxygen and discharged on an albuterol MDI and prednisone for 5 days, and advised to come to the clinic today
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Robin
• According to his parents, the patient developed a head cold about 3 days prior which moved into his chest
• Yesterday, he began coughing and complaining of chest tightness and shortness of breath
• His parents could hear wheezing in his chest and took him to the emergency department
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Robin
• His PMH is relatively unremarkable. He has had nasal allergies since age 7 for which he uses loratadine as needed. His mom feels that his allergies are more of a problem in the spring when the pollens are present.
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Robin
• He is a moderately obese male, 50 kg and 56 inches tall who appears healthy and in NAD
• Vitals are WNL and he is afebrile
• Scattered and diffuse wheezes are present on auscultation
• Peak flow is measured at 235 (predicted is 300). Spirometry is not performed
Adapted from EPR-3, Oct 2007. NIH Pub # 08-5846 http://www.nhlbi.nih.gov/files/docs/guidelines/asthsumm.pdf 26
Components of Asthma Management
• Assessment and monitoring
• Patient education
• Control of environmental factors and comorbid conditions
• Pharmacotherapy
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Asthma: Assessment and Monitoring Check Points
• Adherence with therapy
• Optimal inhalation technique
• Avoidance of triggers and aggravating conditions
• Vaccines up to date
• Provision of asthma action plan
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EPR-3, Oct 2007. NIH Pub # 08-5846 http://www.nhlbi.nih.gov/files/docs/guidelines/asthsumm.pdf
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Bob• Bob Davis is a 34 year old male with mild persistent
asthma treated with budesonide 180 mcg twice daily and PRN albuterol. He indicates that he has had mild asthma his entire life and that the only thing that makes it worse is cigarette smoke. Sometimes he gets symptoms with exercise which he doesn’t do very often.
• He feels that his asthma was well controlled in the past and estimates that he uses his albuterol 3 or 4 times a month.
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More about Bob
• Recently, he has noticed that his symptoms are occurring more frequently, requiring him to use albuterol almost daily. The increased symptoms are limiting his ability to exercise and play tennis.
• Last evening, his symptoms acutely worsened and he went to an urgent care center where he received nebulized albuterol and a 5 day course of prednisone 40 mg.
“Chronic Obstructive Pulmonary Disease (COPD), a common preventable and treatable disease, is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients.”
2013 GOLD Guidelines. www.goldcopd.org38
Inflammation in COPD
GeneratesBurning
Hydrocarbons Respiratory Tract Macrophages
Activates
Neutrophils
Release
Release
Proteases
Airway and ParenchymalDamage
Resulting in
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Ray—The Case Study
• Ray is a 63 year-old male known to have COPD who visits his clinician because he feels that his albuterol/ipratropium inhaler is not working well
• The patient was diagnosed with COPD five years ago attributed to a 48 pack year smoking history (Continues to smoke about ¾ PPD)
• Patient is s/p MI three years ago and treated with metoprolol, lisinopril, and furosemide
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Ray—The Case Study• Over the past few months, Ray has noticed decreased exercise
tolerance
• He gets SOB easily and feels that his albuterol/ipratropium is not working as well as it has in the past. He uses it PRN and has often required it three or four times daily
• He has not been hospitalized or in the ED because of his COPD
• His physical exam is relatively unremarkable and his chest x-ray shows some scarring consistent with his tobacco history
• Pulse oximetry is 91% and spirometry reveals:
– FEV1 is 2.4 L (72% predicted); FVC is 3.49 L (85% predicted) with a ratio of 69%
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Global Initiative for Chronic Obstructive Pulmonary Disease
• Available at www.goldcopd.com
• First version published in 2001
• Most recent update: 2015
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Combined Assessment of COPD
• Three components determine severity – Spirometry to assess degree of airflow limitation
Spirometry is essential for diagnosis of COPD and monitoring progression
I: Mild II: Moderate III: Severe IV: Very Severe
FEV1/FVC < 0.70
50% ≤ FEV1 < 80% predicted
FEV1/FVC < 0.70
30% ≤ FEV1 < 50% predicted
Post-bronchodilator FEV1 is recommended for the assessment of COPD severity
American Thoracic Society, European Respiratory Society. Standards for the diagnosis and Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of COPD. Updated 2015 44
Global Strategy for Diagnosis, Management and Prevention of COPD
None 0 Only breathlessness with strenuous exercise
Mild 1 Short of breath hurrying or walking up a slight hill
Moderate 2 Walks slower than age group or has to stop for breath when walking on the level at own pace
Severe 3 Stops for breath after walking 100 meters or a few minutes on the level
Very Severe 4 Breathless when dressing/undressing or too breathless to leave the house
MMRC patient questionnaire available at http://copd.about.com
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COPD Assessment Test™ (CAT)*• Eight questions; 5-point scale • (0 = least severe; 5 = most severe)
– Cough– Phlegm (mucus)– Chest tightness– Breathless walking up a hill or one flight of stairs– Activity limitations– Confident to leave home– Sleep– Energy
• Assessment– Minimum score: 0– Maximum score: 40
* This assessment tool is a trademark of the GlaxoSmithKline group of companies.
– Failure to coordinate pMDI depression (actuation) on inhalation
• pMDI with spacer
– Delay between actuation and inhalation
• Dry-powder inhalers
– Failure to pierce or open drug package
– Exhaling through the mouthpiece
– Not inhaling forcefully enoughAmerican Association for Respiratory Care Guide to Aerosol Delivery Devices. https://c.aarc.org/resources/aerosol_nonrts.pdf. Accessed Nov 2015 62
Criteria for Selecting an Aerosol Delivery Device
• Patient related factors
– Age, physical and cognitive abilities
• Drug related factors
– Availability of drug
– Combination of aerosol treatments
• Device related factors
– Convenience, durability, cost and reimbursement of aerosol generator
• Environmental and clinical factors
– When and where aerosol therapy is required
American Association for Respiratory Care Guide to Aerosol Delivery Devices. https://c.aarc.org/resources/aerosol_nonrts.pdf. Accessed Nov 2015
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Respiratory Delivery Devices
ProAir RespiClick (albuterol sulfate)
RxList: The internet drug indexhttp://www.rxlist.com/proair-respiclick-drug/medication-guide.htm 64
Food and Drug Administration. Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/ drugsatfda/index.cfm. http://experts.respimat.com/functions_and_use/components_of_Respimat.html
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Respiratory Delivery Device
Tudorza Pressair (aclidinium bromide)
Dose button
Dose indicator
Colored dose window
Mouthpiece
Protective Cap
Personal Photograph: August 201570
Clinical Case – Back to Richard
Richard has improved with the addition of fluticasone/vilanterol inhaler, however is still needing to use his albuterol 3x daily.
The pharmacist recommends adding a long‐acting anticholinergic to his present regimen
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Which of the following long‐acting anticholinergics would be the most optimum selection(s) for Richard at this time?
A. Tiotropium (Handihaler) or umeclindinium
B. Tiotropium (Respimat) or umeclindinium
C. C. Aclidinium or umeclindinium
D. D. All of the above
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Question – Follow‐up
A B
CD
Richard has a broken right arm. Inserting medication capsule in device A or twisting device B would be difficult.
Pushing the button of device C or opening cover of device D would be most optimum.