complex case: pulmonary “i think i have another chest cold.”

16
Complex Case: Pulmonary “I think I have another chest cold.” Seena Haines, Pharm.D., FASHP, FAPhA, BCACP, BC-ADM, CDE Professor and Department Chair for Pharmacy Practice University of Mississippi, School of Pharmacy Jackson, Mississippi and Jenny A. Van Amburgh, Pharm.D., FAPhA, BCACP, CDE Clinical Professor and Assistant Dean for Academic Affairs Northeastern University – School of Pharmacy Learning Objectives: At the conclusion of this session, given a patient case, the participant should be able to Correctly answer case-based questions about appropriate ambulatory treatment of a complex patient with multiple conditions and needs, including chronic obstructive pulmonary disease (COPD), upper respiratory tract infection (URI), benign prostatic hyperplasia (BPH), anemia, and gastroesophageal reflux disease (GERD). Given a medication profile, recognize medications classified by ISMP as leading to potential misuse or patient harm. Evaluate the patient’s administration technique for medications that are not administered orally (for example nasal inhalers, oral inhalers). Format: Today’s session will use a series of audience response questions to engage the audience and to prepare participants to answer similar questions on a board certification examination. The facilitators will discuss practical management strategies and the scientific rationale that supports these strategies. Premise: You are a pharmacist who works in a community health center (CHC) that is a patient-centered medical home. You work in collaboration with a group of providers (physicians, nurse practitioners, and nurses). You have access to patient’s electronic and paper medical records – the CHC is in the process of converting from paper to electronic medical records (EMRs). You are responsible for providing comprehensive patient management and education and evaluating and monitoring the patient’s therapy. 1 ©2016 American Society of Health System Pharmacists and the American Pharmacists Association. All rights reserved. 1

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Page 1: Complex Case: Pulmonary “I think I have another chest cold.”

Complex Case: Pulmonary “I think I have another chest cold.”

Seena Haines, Pharm.D., FASHP, FAPhA, BCACP, BC-ADM, CDE Professor and Department Chair for Pharmacy Practice

University of Mississippi, School of Pharmacy Jackson, Mississippi

and Jenny A. Van Amburgh, Pharm.D., FAPhA, BCACP, CDE Clinical Professor and Assistant Dean for Academic Affairs

Northeastern University – School of Pharmacy

Learning Objectives:

At the conclusion of this session, given a patient case, the participant should be able to • Correctly answer case-based questions about appropriate ambulatory treatment of a complex patient with multiple

conditions and needs, including chronic obstructive pulmonary disease (COPD), upper respiratory tract infection(URI), benign prostatic hyperplasia (BPH), anemia, and gastroesophageal reflux disease (GERD).

• Given a medication profile, recognize medications classified by ISMP as leading to potential misuse or patientharm.

• Evaluate the patient’s administration technique for medications that are not administered orally (for example nasalinhalers, oral inhalers).

Format: Today’s session will use a series of audience response questions to engage the audience and to prepare participants to answer similar questions on a board certification examination. The facilitators will discuss practical management strategies and the scientific rationale that supports these strategies.

Premise: You are a pharmacist who works in a community health center (CHC) that is a patient-centered medical home. You work in collaboration with a group of providers (physicians, nurse practitioners, and nurses). You have access to patient’s electronic and paper medical records – the CHC is in the process of converting from paper to electronic medical records (EMRs). You are responsible for providing comprehensive patient management and education and evaluating and monitoring the patient’s therapy.

1 ©2016 American Society of Health System Pharmacists and the American Pharmacists Association.All rights reserved. 1

Page 2: Complex Case: Pulmonary “I think I have another chest cold.”

PATIENT CASE Date: Today Initials OG

DOB/Age 64 y.o.

Sex M

Race/Ethnicity Greek

Source Paper & electronic medical records

CC/HPI (including symptom analysis for CC): “I think I have another chest cold” OG returns to clinic today complaining of shortness of breath, a fever, and coughing up more ‘yellowish junk’ than normal. He reminds you that he doesn’t want to go back to the hospital (discharged ~1 month ago for acute exacerbation of COPD and URI and 4 months ago for COPD exacerbation). He has a long-standing history of COPD secondary to chronic tobacco use. He stopped smoking 2 years ago but expresses frustration about the reason for doing so because his breathing was better before he stopped smoking than it is now. Additionally, he complains about how ‘blah and tired’ he has been feeling and how his energy level isn’t the same as in the past – do you have the results of the bloodwork done a few weeks ago? OG also informs you that he has been experiencing a burning substernal chest pain and burning in his throat most noticeably around dinnertime but he is having trouble recalling how frequently these symptoms occur. He has no pain on swallowing, but does find it harder to eat now. He denies emesis or unexpected weight loss but does mention frequent urination at night with incomplete voiding. Past Medical History From Medical Record COPD x 7 years BPH x 1 years HTN x 4 years Current Prescription/OTC Medications Start Date Drug Name/Strength/Regimen Indication 09/2011 Atenolol 100 mg orally daily HTN 11/2013 Docusate 100 mg orally daily PRN Constipation 01/2014 Albuterol 90 mcg – 2 inhalations q 4-6 hr PRN Shortness of breath 01/2014 MVI daily Vitamin supplementation 10/2015 Tiotropium 18 mcg – 1 capsule by inhalation BID COPD 10/2015 Calcium carbonate (500 mg PO QID) OTC Heartburn 12/2015 Amlodipine 10 mg orally daily HTN 05/2016 Doxycycline 100 mg orally BID x7 days COPD – bronchitis Vaccinations: Influenza, Pneumococcal and Tdap – Current Pharmacy Used: Community Health Pharmacy RX Payment: Private Insurance Meds Admin by: Self Drug Allergies/Adverse Effects: PCN allergy (rash); erythromycin (nausea) Family Medical History: Father type 2 DM, HTN died at age 59 yr; Mother hypertension, died at age 64 yr natural causes; no siblings Social History Residence: lives at home alone Occupation: owns a Greek diner that his son manages; OG occasionally

works on weekends Smoking: Smoked 2 ppd x 35 years (70 pack-years); quit (2013)

EtOH: Occasional alcohol use (2-4 beers twice per week)

Illicit Drugs: Never Typical Diet: Likes an egg sandwich most days of the week for breakfast; sandwich and chips with condiment use for lunch; snacks on fruits several days a week; rice, pasta or potatoes with meat for dinner. Occasional ice cream some nights or weekends.

Education: finished 12th grade Family/Social Environment: Lives alone; wife passed away 2011 Review of Systems: [Obtained from EMR] Respiratory: (+) cough, wheezing, sputum (clear); recurrent URI

2 ©2016 American Society of Health System Pharmacists and the American Pharmacists Association.

All rights reserved.

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Page 3: Complex Case: Pulmonary “I think I have another chest cold.”

Genitourinary: (+) decreased stream and urine output; (+) frequent urination & nocturia All other findings negative Objective Data (observations) General: pleasant male in no apparent distress; discomfort when coughing BP: 142/84 mm Hg HR: 72 bpm RR: 18/min Pulse Ox: 96% PFTs (spirometry 2006): FEV1 75%; FEV1/FVC(2.57/4.25) 60% Labs: (from ~3 weeks ago)

Normal Normal RBC (cells/L) 4.44 4.4 - 6 Serum iron (mcg/dL) 65 50-160 Hgb (g/dL) 11.9 14-17.4 TIBC (mcg/dL) 398 250-400 Hct (%) 34.2 36-45 RDW (%) 13.3 11-16 MCV (fl/cell) 89 80-100 Ferritin (ng/dL) 24 15-200 MCHC (%) 30 31-37 Folate (ng/mL) 5 6.5-20 MCH (pg/cell) 33.5 26-34 Vit B12 (pg/mL) 256 100-900

140 103 22 [N:134-145] [N:97-110] [N:8-25] Ca 10.2 [N: 8.6-10.3] ALT 18 [N:7-53] AST 20 [N:11-47] 98 5.1 23 1.2 [N:65-109] PSA 2.8 [N: 0-4] FOBT: Negative [N:3.3-4.9] [N:22-26] [N:0.7-1.3]

3 ©2016 American Society of Health System Pharmacists and the American Pharmacists Association.

All rights reserved.

3

Page 4: Complex Case: Pulmonary “I think I have another chest cold.”

Presentation Questions COPD 1. Based on the 2014 update of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, OG’s forced

expiratory volume in 1 second (FEV1) of 55% and an FEV1/forced vital capacity (FVC) of 0.68 would categorize him in which of the following severity levels? A. GOLD 1/ Category A/ Mild B. GOLD 2/ Category B/ Moderate C. GOLD 3/ Category C/ Severe D. GOLD 4/ Category D/ Very Severe

Domain: 1 Task: 3 Knowledge: 2

2. OG recently experienced an exacerbation that required a subsequent hospitalization. He scored 10 on the COPD Assessment Test (CAT) and 2 on the modified Medical Research Council dyspnea scale (mMRC). Which of the following best characterizes this patient according to the combined risk assessment in the 2014 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines? A. Patient group B and recommended treatment is ICS + LABA and/or LAMA B. Patient group D and recommended treatment is ICS + LABA and/or LAMA C. Patient group B and recommended treatment is ICS + LABA and PDE-4 inhibitor D. Patient group D and recommended treatment is LAMA and LABA + SAMA

ICS = Inhaled corticosteroid; LABA= long-acting beta agonist; LAMA = long-acting muscarinic antagonist; PDE = Phosphodiesterase 4 Inhibitor; SAMA = Short-acting muscarinic antagonist

Domain: 1 Task: 6 Knowledge: 1 Domain: 1 Task: 7 Knowledge: 2

3. Based on the 2014 GOLD guidelines, OG’s recent COPD exacerbation should have been treated for how long with 40 mg/day of oral prednisone? A. 5 days B. 10 days C. 14 days D. 28 days

Domain: 1 Task: 6 Knowledge: 1 Domain: 1 Task: 7 Knowledge: 2

URI / Pneumonia 4. Based on OG’s presenting symptoms, a chest x-ray is ordered by the PCP and shows hyperinflation and right lower lobe

pneumonia. Which of the following assessments and treatment recommendations are most appropriate for OG? A. CURB-65 score 0: azithromycin plus supportive care B. CURB-65 score 0: doxycycline plus supportive care C. CURB-65 score 1: amoxicillin/clavulanic acid plus azithromycin D. CURB-65 score 1: levofloxacin plus supportive care

Domain: 1 Task: 2 Knowledge: 1 Domain: 1 Task: 3 Knowledge: 2 Domain: 1 Task: 6 Knowledge: 1

GERD 5. In probing OG further about his heartburn symptoms, which of the following would make him a candidate for a 14-day course of

therapy with an OTC proton pump inhibitor? A. Heartburn once daily B. Discomfort in the upper abdomen and upper abdominal bloating approximately 3 days per week C. Heartburn approximately 3 days per week D. Heartburn and regurgitation once daily

Domain: 1 Task: 3 Knowledge: 6 Domain: 1 Task: 6 Knowledge: 3

4 ©2016 American Society of Health System Pharmacists and the American Pharmacists Association.

All rights reserved.

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Page 5: Complex Case: Pulmonary “I think I have another chest cold.”

BPH 6. When would you recommend treating OG for Benign Prostatic Hypertrophy (BPH)/lower urinary tract symptoms (LUTS)?

A. AUA/IPSS score >7, mild symptoms that are not bothersome with an enlarged prostate on DRE B. AUA/IPSS score >8, bothersome symptoms with a normal prostate on DRE C. AUA/IPSS score >8, moderate symptoms that are bothersome with a normal prostate on DRE D. AUA/IPSS score >9, mild symptoms that are not bothersome with a normal prostate on DRE

Domain: 1 Task: 6 Knowledge: 1

7. Which of the following actions do you recommend for OG at this time? A. Give alpha-blocker monotherapy for 4 weeks, then switch to 5 alpha reductase inhibitor monotherapy B. Give alpha-blocker monotherapy for 4 weeks, then consider adding a 5 alpha reductase inhibitor C. Give alpha-blocker monotherapy for 4 months, then add a 5 alpha reductase inhibitor D. Refer patient to a urologist for surgical intervention

Domain: 1 Task: 6 Knowledge: 1 Domain: 1 Task: 7 Knowledge: 2

Anemia 8. Prior to OG’s visit, his PCP contacted you to discuss OG’s most recent lab test results. Which of the following is most

appropriate based on OG’s CBC and iron studies? A. Ferric citrate TID and cyanocobalamin daily B. Ferrous fumarate BID and cyanocobalamin daily C. Ferrous gluconate BID and folic acid daily D. Ferrous sulfate TID and folic acid daily

Domain: 1 Task: 2 Knowledge: 2 Domain: 1 Task: 3 Knowledge: 2 Domain: 1 Task: 6 Knowledge: 3

5 ©2016 American Society of Health System Pharmacists and the American Pharmacists Association.

All rights reserved.

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Page 6: Complex Case: Pulmonary “I think I have another chest cold.”

Treatment Algorithm - GERD

Both images “Used with permission from Tytat GN et al. Reflux treatment guidelines for prescription medications. Alimentary Pharmacology & Therapeutics, Wiley. [2003; 18:291-301.]”

Anemia Etiology, Differential Diagnosis, and Treatment

6 ©2016 American Society of Health System Pharmacists and the American Pharmacists Association.

All rights reserved.

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Page 7: Complex Case: Pulmonary “I think I have another chest cold.”

MCV Other markers Treatment options Iron deficiency anemia ‘microcytic’

Low - Low serum ferritin and iron - High TIBC - Later stages: low Hgb & Hct

- 200 mg elemental iron orally daily (2-3 divided doses)

- Taken 1 hr before food - Treatment for 3-6 months after anemia

has resolved - If iron malabsorption or intolerance to

oral tx, parenteral iron may be warranted

Anemia of chronic diseases ‘microcytic’

Normal - Normal or high serum ferritin - Low serum iron

- Treat the underlying disorder and correct reversible causes of anemia

- Iron therapy is only effective if iron deficiency is present

- Erythropoietic agents (EPO) Vitamin B12 deficiency anemia ‘macrocytic’

High - Elevated methylmalonic acid (MMA)

- Low levels of vit B12 (cyanocobalamin)

- Oral vitamin B12 – 1 mg daily (as effective as IM)

- Cyanocobalamin 1000 mcg IM daily x 1 wk, weekly x 1 month, then monthly

- Vitamin B12 intranasally (weekly) Folic acid deficiency anemia ‘macrocytic’

High - Must rule out vit B12 deficiency when suspected

- MMA levels NOT elevated - Low levels of folate (normal vit B12

levels)

- Folic acid 1 mg orally daily (may need up to 5 mg daily)

- Therapy should be considered for 4 months

MCV = mean corpuscular volume

7 ©2016 American Society of Health System Pharmacists and the American Pharmacists Association.

All rights reserved.

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Page 8: Complex Case: Pulmonary “I think I have another chest cold.”

References (Selected Review Articles and Resources): • Anemia

o Short MW, Domagalski JE. Iron deficiency anemia: evaluation and management. Am Fam Physician. 2013; 87(2):98-104. Available at: http://www.aafp.org/afp/2013/0115/p98.html (accessed 2014 Oct 16)

o Goddard AF, James MW, McIntyre AS et al. Guidelines for the management of iron deficiency anaemia. Gut. 2011;60:1309-16. Available at: http://www.bsg.org.uk/images/stories/docs/clinical/guidelines/sbn/bsg_ida_2011.pdf. (accessed 2014 Oct 16)

• BPH o Silva J, Cruz F. Current Medical Treatment of Lower Urinary Tract Symptoms/BPH: Do We Have a Standard? Current

Opinion. 2014; 24:21-8. o BPH treatment algorithm http://www.auanet.org/common/pdf/education/clinical-guidance/Benign-Prostatic-Hyperplasia.pdf

GlaxoSmithKline. Practical considerations for implementing the NICE guideline for lower urinary tract symptoms (LUTS). March 2011. Available at: http://hcp.gsk.co.uk/content/dam/Health/en_GB/HCP_Home/content/therapy_areas/urology/22882/practical_considerations_for_implementing_the_nice_guideline_for_lower_urinary_tract_symptoms_2010.pdf (accessed 2014 Oct 20)

o McVary KT, Roehrborn CG, Avins AL et al. American Urological Association guideline: management of benign prostatic hyperplasia. Revised 2010. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm?sub=bph (accessed 2014 Oct 20).

o Nickel JC, Mendez-Probst CE, Whelan TF et al. 2010 update: guidelines for the management of benign prostatic hyperplasia. Can Urol Assoc J. 2010; 4(5):310-6. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2950766/. (accessed 2014 Oct 20)

o American Urological Association. AUA symptom score form. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines/main-reports/bph-management/chapt_1_appendix.pdf (accessed 2014 Oct 20)

• COPD o Qaseem A, Wilt TJ, Weinberger SE et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a

clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011; 155:179-91. Available at: http://annals.org/article.aspx?articleid=479627 (accessed 2014 Oct 20)

o Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (revised 2014). http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html (accessed 2014 Oct 20).

• GERD o Tytat GN, Heading RC, Müller-Lissner S et al. Reflux treatment guidelines for prescription medications. Alimentary

Pharmacology & Therapeutics. 2003; 18:291-301. o Tytat GN, Mccoll K, Tack J et al. New Algorithm for the treatment of gastro-esophageal reflux disease. Alimentary

Pharmacology & Therapeutics. 2007; 27:249-56. o American College of Gastroenterology. GERD guidelines update. Available at: http://gi.org/guideline/diagnosis-and-

managemen-of-gastroesophageal-reflux-disease/ (accessed on 2014 Oct 20). o DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J

Gastroenterol. 2005; 100:190-200. o Pharmacist’s Letter. Proton pump inhibitors: appropriate use and safety concerns. July 2010;26:#260705. Available at

www.pharmacistsletter.com • Upper respiratory infection

o Watkins RR, Lemonovich TL. Diagnosis and management of community-acquired pneumonia in adults. Am Fam Physician. 2011; 83(11):1299-306. Available at: http://www.aafp.org/afp/2011/0601/p1299.pdf. (accessed 2014 Oct 16).

o Waterer GW, Rello J, Wunderink RG. Management of community-acquired pneumonia in adults. Am J Respir Crit Care Med. 2011; 183:157-64. Available at: http://www.atsjournals.org/doi/pdf/10.1164/rccm.201002-0272CI. (accessed 2014 Oct 16).

8 ©2016 American Society of Health System Pharmacists and the American Pharmacists Association.

All rights reserved.

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Page 9: Complex Case: Pulmonary “I think I have another chest cold.”

Seena Haines, Pharm.D., FAPhA, FASHP,  BCACP, BC‐ADM, CDE Professor and Department Chair for Pharmacy PracticeUniversity of Mississippi ‐ School of Pharmacy 

Jenny A. Van Amburgh, Pharm.D., FAPhA, BCACP, CDEClinical Professor and Assistant Dean for Academic AffairsNortheastern University – School of Pharmacy

Complex Case: Pulmonary“I think I have another 

chest cold”

Disclosures

• Faculty and planners have nothing to disclose related to the content of this presentation.

Learning Objectives

• Correctly answer case‐based questions about appropriate ambulatory treatment of a complex patient with multiple conditions and needs, including chronic obstructive pulmonary disease (COPD), upper respiratory tract infection (URI), benign prostatic hyperplasia (BPH), anemia, and gastroesophageal reflux disease (GERD).

• Given a medication profile, recognize medications classified by ISMP as leading to potential misuse or patient harm. 

• Evaluate the patient’s administration technique for medications that are not administered orally (for example nasal inhalers, oral inhalers). 

SettingYou are a pharmacist who works in a community health center (CHC) that is a patient‐centered medical home.  You work in collaboration with a group of providers (physicians, nurse practitioners, and nurses).  You have access to patient’s electronic and paper medical records – the CHC is in the process of converting from paper to electronic medical records (EMRs).  You are responsible for providing comprehensive patient management and education and evaluating and monitoring the patient’s therapy.

You have 5 minutes to review the case in the materials provided.

OG 64 year‐old Greek Male

“ I feel sicker now than when I was smoking!”

“Am I getting another chest cold?”

Question 1:Based on the 2014 update of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, OG’s forced expiratory volume in 1 second (FEV1) of 55% and an FEV1/forced vital capacity (FVC) of 0.68 would categorize him in which of the following severity levels

A. GOLD 1/ Category A/ Mild

B. GOLD 2/ Category B/ Moderate

C. GOLD 3/ Category C/ Severe

D. GOLD 4/ Category D/ Very Severe

A. B. C. D.

0% 0%0%0%

©2016 American Society of Health System Pharmacists and the American Pharmacists Association. All rights reserved.

9

Page 10: Complex Case: Pulmonary “I think I have another chest cold.”

Question 2:OG recently experienced an exacerbation that required a subsequent hospitalization. He scored a 10 on the COPD Assessment Test (CAT) and a 2 on the modified Medical Research Council dyspnea scale (mMRC). Which of the following best characterizes this patient according to the combined risk assessment in the most recent 2014 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines?

A. Patient group B and recommended treatment is ICS + LABA and/or LAMA

B. Patient group D and recommended treatment is ICS + LABA and/or LAMA

C. Patient group B and recommended treatment is ICS + LABA and PDE‐4 inhibitor

D. Patient group D and recommended treatment is LAMA and LABA + SAMA

A. B. C. D.

0% 0%0%0%

Question 3:Based on the 2014 GOLD guidelines OG’s recent  COPD exacerbation should have been treated for how long with 40mg/day of oral prednisone?

A. 5 days

B. 10 days

C. 14 days

D. 28 days

A. B. C. D.

0% 0%0%0%

COPD Debrief

Clinical diagnosis of COPD is based on symptoms and/or history of exposure to high risk factors for the disease

• Diagnosis should be confirmed by spirometry– Presence of airflow limitation is defined by post‐bronchodilator  FEV1/FVC 

<0.70

– Evidence does not support use of spirometry after initiation of therapy

• Assessments of symptoms for staging – Modified British Medical Research Council (mMRC)

— Measure of breathlessness

– COPD Assessment Test (CAT)— Comprehensive symptom assessment

– COPD Control Questionnaire (CCQ)— Comprehensive symptom assessment

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronicobstructive pulmonary disease (revised 2014). URL in handout.

C‐Confirm Diagnosis, O‐ Optimize FunctionP‐ Prevent Deterioration D‐Develop support & 

self management 

Classification of COPD (2014)

C D

A B

Symptoms / Breathlessness

1

0

>2

HighmMRC >2/CAT >10

LowmMRC<2/CAT <10

2

3

4

1

Exacerbatio

n Histo

ry per ye

ar

GOLD

 Classificatio

n

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronicobstructive pulmonary disease (revised 2014). URL in handout.

Classification of Disease 2014Patient Category

Characteristics SpirometricClassification

Exacerbations (per year)

mMRC CAT

A LOW risk, LESS symptoms

Gold 1‐2Airflow Limitation (mild to moderate: 

FEV1 ≥ 80%)

<1 0‐1 <10

B LOW risk, MORE symptoms

Gold 1‐2Airflow Limitation (mild to moderate: 

FEV1 50‐80%)

<1 >2 >10

C HIGH risk, LESS symptoms

Gold 3‐4Airflow Limitation (mild to moderate: 

FEV1 30‐50%)

>2 0‐1 <10

D HIGH risk, MOREsymptoms

Gold 3‐4Airflow Limitation (mild to moderate: 

FEV1 <30%)

>2 >2 >10

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (revised 2014). URL in handout.

Classification of COPD (2014)

C D

A B

Symptoms / Breathlessness

1

0

>2

HighLow

2

3

4

1

Exacerbatio

n Histo

ry per ye

ar

GOLD

 Classificatio

n

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (revised 2014). URL in handout.

Inhaled corticosteroid + Long‐acting beta‐ 2 agonist 

ORLong acting anticholinergic (LAMA) 

Inhaled corticosteroid + Long‐acting beta‐ 2 agonist 

And/ORLong acting anticholinergic (LAMA) 

Short‐acting beta‐ 2 agonist OR

Short‐acting anticholinergic (SAMA) 

Long‐acting beta‐ 2 agonist OR

Long‐acting anticholinergic (LAMA) 

Also Influenza/ Pneumococcal &Pertussis Vaccines A‐D

©2016 American Society of Health System Pharmacists and the American Pharmacists Association. All rights reserved.

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Page 11: Complex Case: Pulmonary “I think I have another chest cold.”

Pharmacologic Therapy (GOLD 2014)

Patient Group

First Choice Second Choice Alternate

A SA anticholinergic 

SABA prn 

LA anticholinergic

LABA 

SABA + SA anticholinergic

Theophylline

B LA anticholinergic

LABA

LA anticholinergic + LABA SABA +/‐SA anticholinergic

Theophylline

C ICS + LABA

LA anticholinergic (LAMA)

LA anticholinergic + LABA

LA anticholinergic + PDE‐4 inhibitor

LABA + PDE‐4 inhibitor

SABA +/‐SA anticholinergic

Theophylline

D ICS + LABA +/‐

LA anticholinergic(LAMA)

ICS + LA anticholinergic + LABA

ICS + LABA + PDE‐4 Inhibitor 

LA anticholinergic + LABA 

LA anticholinergic + PDE‐4 Inhibitor

Carbocysteine

SABA +/‐SA anticholinergic

Theophylline

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (revised 2014). URL in handout.  SA= short acting, LA= long acting, SABA=short acting beta agonist, LABA= long acting beta agonist 

See table 5 in guidelines 

COPD Acute Exacerbations

• Oral agents

– Antibiotics (azithromycin, moxifloxacin), PDE 4 inhibitor (Cat C)

• Pulmonary Rehabilitation 

– Improve exercise capacity, education, and quality of life 

• Oxygen for more than 15 hours/day

– For hypoxemia PaO2 of 55mmHg or less/ resting O2 sat <88%

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronicobstructive pulmonary disease (revised 2014). URL in handout.

COPD Patient Considerations

• Disease Severity– Level of obstruction, functional disability (mMRC), comorbidities

• Patient Profile– Safety concerns, age, cognition, dexterity for device use

• Therapy– Safety and efficacy, bioavailability & drug interactions, time of day 

drug given

• Device– Availability, inspiratory flow rate of device, convenience, cost, and 

patient preference 

Pulmonary Function  COPD Symptoms  Exacerbation History 

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronicobstructive pulmonary disease (revised 2014). URL in handout.

Available and Emerging Bronchodilators

• LABA (twice daily)– Formoterol, salmeterol

• LAMA (twice daily)– Aclidinium

• LABA (once daily)– Indacaterol, olodaterol, 

vilanterol

• LAMA (once daily)– Glycopyrronium, 

tiotropium, umeclidinium 

LABA/LAMA Combinations

• Once Daily 

– Indacaterol/glycopyrronium 

– Vilanterol / umeclidinium

– Olodaterol / tiotropium 

• Twice Daily

– Formoterol / aclidinium

– Formoterol / glycopyrrolate

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronicobstructive pulmonary disease (revised 2014). URL in handout.

Question 4:Based on OG’s presenting symptoms, a chest x‐ray is ordered by the PCP and shows hyperinflation and right lower lobe pneumonia.  Which of the following assessments and treatment recommendations are most appropriate for OG?

A. CURB‐65 score is 0: azithromycin plus supportive care

B. CURB‐65 score is 0: doxycycline plus supportive care

C. CURB‐65 score is 1: amoxicillin/clavulanic acid plus azithromycin

D. CURB‐65 score is 1: levofloxacin plus supportive care

A. B. C. D.

0% 0%0%0%

Community Acquired Pneumonia (CAP) 

Watkins RR. Am Fam Physician. 2011 ;83:1299‐306.

• The most common symptom is cough, with or without fever, and possibly sputum production. 

• Common pathogens to consider:

– Streptococcus pneumoniae

– Mycoplasma pneumoniae

– Haemophilus influenzae

– Moraxella catarrhalis 

• Sputum production:

– May be clear, purulent, or occasionally bloody

– Characteristics do not correspond with a particular etiology (i.e., viral vs. bacterial) 

©2016 American Society of Health System Pharmacists and the American Pharmacists Association. All rights reserved.

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CAP – Mortality Prediction Tool

C Confusion

U Blood urea nitrogen > 20mg/dl

R Respiratory rate ≥ 30 bpm

B Blood pressure (SBP <90mmHg or DBP ≤60mmHg)

65 Years of age or greater

0 – 1 pointOutpatient

2 pointsInpatient

≥ 3 points ICU

Watkins RR. Am Fam Physician. 2011 ;83:1299‐306.

CAP – Empiric Therapy

Previously healthy; no antibiotic use in the past 3 months

Macrolide (azithromycin; clarithromycin) ORDoxycycline

Presences of comorbidities* Respiratory fluoroquinolone(levofloxacin, gemifloxacin, moxifloxacin) ORBeta‐lactam (high‐dose amoxicillin, amoxicillin / clavulanic 

acid, or cefpodoxime) PLUS a macrolide 

Medical Respiratory fluoroquinolone  OR Beta‐lactam PLUS a macrolide 

ICU Beta‐lactam (ceftriaxone, cefotaxime, ampicillin/sulbactam) PLUS azithromycin OR respiratory fluoroquinolone

Am Fam Physician. 2011; 83:1299‐306.

Mandel LA et al. Clinical Infectious Diseases. 2007; 44:S27‐72.

*Chronic heart, lung, liver or renal disease; diabetes mellitus; alcoholism; malignancies; asplenia; immunosuppressing conditions or use of immunosuppressingdrugs; use of antimicrobials within the previous 3 months (alternate from a different class) 

Question 5:In probing OG further about his heartburn symptoms, which of the following would make him a candidate for a 14‐day course of therapy with an OTC proton pump inhibitor? 

A. Heartburn once dailyB. Discomfort in the upper 

abdomen and upper abdominal bloating approximately 3 days per week 

C. Heartburn approximately 3 days per week

D. Heartburn and regurgitation once daily

A. B. C. D.

0% 0%0%0%

Copyright 2003 Wiley. Used with permission from Tytgat GN et al. Reflux treatment guidelines for prescription medications. Alimentary Pharmacology & Therapeutics, Wiley. [2003; 18:291-301.]

Handout p. 6

Copyright 2007 Wiley. Used with permission from Tytgat GN et al. New Algorithm for the treatment of gastro-esophageal reflux disease. Alimentary Pharmacology & Therapeutics, Wiley. [2007; 27:249-56.]

Handout p. 6

OTC GERD Treatment Exclusion Criteria

• Consumers <18 years of age (unless advised by a physician)

• Those with atypical and/or nonspecific symptoms– Predominant epigastric pain

– Belching

– Hoarseness

– Sore throat

– Cough

DeVault KR, Castell DO. Am J Gastroenterol. 2005; 100:190‐200.

©2016 American Society of Health System Pharmacists and the American Pharmacists Association. All rights reserved.

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OTC GERD Treatment Exclusion Criteria

• Those with significant comorbidities, including any requiring multiple other therapies that can interact with PPIs, such as:– Medications that require a low gastric pH for absorption: 

prescription antifungal or anti‐ yeast medicines (e.g., ketoconazole), digoxin, tacrolimus, and atazanavir

– CYP450 interaction: clopidogrel, warfarin, and theophylline

• Chronic NSAID takers• Those with heartburn lasting >3 months• Consumers needing >1 course of treatment every 4 months• Those with a family history of gastric and/or esophageal 

cancer

DeVault KR, Castell DO. Am J Gastroenterol. 2005; 100:190‐200.

GERD Treatment Data

DeVault KR, Castell DO. Am J Gastroenterol. 2005; 100:190‐200.

Uncomplicated Heartburn Empiric trial with PPI 

Healing Esophagitis and Heartburn PPI > H2RA > PlaceboEffect of doubling PPI dose is modest 6‐12 mos data demonstrate benefit for maintaining symptom relief and preventing recurrenceLimited data to support doses higher than standard  

Nocturnal H2RA dosing No evidence of improved long‐termefficacy by adding to BID PPI

Role of Metoclopramide Lack of high quality data for monotherapywith metoclopramide or adjunctive in esophageal or suspected extraesophageal GERD 

Extraesophageal PPI dosing Weak association for treatment 

GERD Debrief• Antacids

– First line for mild GERD (<2x/week) or breakthrough with H2RA and PPIs (most effective when heartburn is present)

– Usually taken 3‐4x day

– ADRs (diarrhea with Mg) (constipation with Al)

– Accumulation with renal dysfunction (Mg/Al)

• H2RAs– For mild troublesome GERD

– Prolonged use leads to reduced efficacy and tolerance

– Drugs with pH‐dependent absorption may be altered [ketoconazole, protease inhibitor]

– Reduce dosing in renal dysfunction

.DeVault KR, Castell DO. Am J Gastroenterol. 2005; 100:190‐200.

GERD Treatment Pearls• PPIs

– Moderate to severe GERD 

– Daily to twice daily dosing before first meal

– Watch for vitamin B12 deficiency 

– May lead to decreased Ca absorption‐ fracture risk (hip, wrist, and spine) 

– Drugs with pH‐dependent absorption may be altered (ketoconazole, protease inhibitor)

– Possible interaction with clopidogrel due to CYP2C19 inhibition and genetic polymorphism (clinically significant?) (separate times for administration proposed) 

.DeVault KR, Castell DO. Am J Gastroenterol. 2005; 100:190‐200.

GERD Treatment Selection• Atypical vs. typical symptoms (mild‐moderate‐severe)

• Counseling pearls (lifestyle modification)

• Timing of antacid vs. H2RA vs. PPI* (*30‐60 minutes before breakfast and dinner if BID dosing) 

• Screen elderly patients for osteoporosis and vitamin B12 deficiency (PPI)

• Parameters for maintenance therapy or managing patients with inadequate symptom relief with once daily PPI 

– 80% symptom relief is adequate

– Consider desired onset of effect and side effects

.

DeVault KR, Castell DO. Am J Gastroenterol. 2005; 100:190‐200.

http://gi.org/guideline/diagnosis‐and‐managemen‐of‐gastroesophageal‐reflux‐disease/ 

Question 6:When would you recommend treating OG for benign prostatic hypertrophy (BPH)/lower urinary tract symptoms (LUTS)?  

A. AUA/IPSS score >7, mild symptoms that are not bothersome with an enlarged prostate on DRE

B. AUA/IPSS score >8, bothersome symptoms with a normal  prostate on DRE

C. AUA/IPSS score >8, moderate symptoms that are bothersome with normal prostate on DRE

D. AUA/IPSS score > 9, mild symptoms that are not bothersome with normal prostate on DRE 

A. B. C. D.

0% 0%0%0%

LUTS – Lower Urinary Tract Symptoms IPSS= International Prostate Symptom score DRE – digital rectal exam  AUA= American Urology Association 

©2016 American Society of Health System Pharmacists and the American Pharmacists Association. All rights reserved.

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Question 7:Which of the following actions do you recommend for OG at this time?

A. Give alpha‐blocker monotherapy for 4 weeks, then switch to 5 alpha reductase inhibitor monotherapy

B. Give alpha‐blocker monotherapy for 4 weeks, then consider adding a 5 alpha reductase inhibitor

C. Give alpha‐blocker monotherapy for 4 months, then add a 5 alpha reductase inhibitor

D. Refer patient to a urologist for surgical intervention

A. B. C. D.

0% 0%0%0%

BPH Debrief• Obstructive vs. irritative symptoms

• Checking PSA: for patients with lower urinary tract symptoms (LUTS) and a life expectancy of >10 yr in whom the diagnosis of prostate cancer would change the treatment plan

• Physical exam (DRE) – helps determine presence of prostate cancer and size of prostate gland

• Urinalysis can rule out UTI

PSA ‐ prostate specific antigen; DRE – digital rectal exam

.McVary KT et al. American Urological Association guideline on the management of benign prostatic hyperplasia.

Revised 2010. URL in handout. Nickel JC et al. Can Urol Assoc J. 2010; 4(5):310-6.

BPH Treatment • Nonpharmacological

– Restrict fluid intake at bedtime

– Avoid caffeine and alcohol

– Schedule voiding

• Screen profile for medications that can exacerbate symptoms– Testosterone replacement

– α‐adrenergic agonists (decongestants)

– Anticholinergics

– Diuretics

.

McVary KT et al. American Urological Association guideline on the management of benign prostatic hyperplasia. Revised 2010. URL in handout. Nickel JC et al. Can Urol Assoc J. 2010; 4(5):310-6.

BPH Urinary Tract Symptoms

• Filling or Irritative

– Frequency

– Urgency*

– Nocturia*

– Dysuria

– Odynuria

* Common symptoms

McVary KT et al. American Urological Association guideline on the management of benign prostatic hyperplasia. Revised 2010. URL in handout. Nickel JC et al. Can Urol Assoc J. 2010; 4(5):310-6.

• Voiding or Obstructive

– Poor stream*

– Hesitancy*

– Terminal dribbling*

– Incomplete voiding*

– Overflow incontinence(w/ chronic retention)

BPH Questionnaires

.

McVary KT et al. American Urological Association guideline on the management of benign prostatic hyperplasia. Revised 2010. URL in handout. Nickel JC et al. Can Urol Assoc J. 2010; 4(5):310-6. Silva J, Cruz F. Current Medical Treatment of

Lower Urinary Tract Symptoms/BPH: Do We Have a Standard? Current Opinion. 2014;24:21-8.

• Symptom score indexes: – International Prostate Symptom Score (IPSS)

– American Urological Association Symptom Score (AUA)

• AUA BPH Symptom Score Index to evaluate enlarged prostate symptoms (0‐35 points)– Mild (0 to 7) 

– Moderate (8 to 19)

– Severe (20 to 35)

BPH Treatment Selection

.

McVary KT et al. American Urological Association guideline on the management of benign prostatic hyperplasia. Revised 2010. URL in handout.

Nickel JC et al. Can Urol Assoc J. 2010; 4(5):310-6.

When to use a 5‐α reductase inhibitor (5‐ARI) vs. α1‐adrenergic receptor blocker

• α1‐adrenergic receptor blockers– First line for mild, moderate, or severe without complications

– Extensively metabolized by CYP 3A4 enzymes

– Choose uroselective agents

– Monitor for orthostatic hypotension 

• 5‐ARIs– First line for moderate to severe symptoms, but most effective with 

enlarged prostate >40 mL or PSA >1.4‐1.6ng/mL

– Onset of action not for 3‐6 months

Combination of α1‐adrenergic receptor blockers &5‐ARIs may be needed for enlarged prostate 

and moderate to severe symptoms

©2016 American Society of Health System Pharmacists and the American Pharmacists Association. All rights reserved.

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Alpha‐1 Adrenergic Blockers &            5 Alpha Reductase Inhibitors 

.

McVary KT et al. American Urological Association guideline on the management of benign prostatic hyperplasia. Revised 2010. URL in handout. Nickel JC et al. Can Urol Assoc J. 2010; 4(5):310-6. Silva J, Cruz F. Current Medical Treatment of Lower Urinary

Tract Symptoms/BPH: Do We Have a Standard? Current Opinion. 2014; 24:21-8.

• Antagonize α1 (2nd generation‐selective)

– Prazosin

– Doxazosin

– Terazosin

– Alfuzosin

They improve urinary voiding symptoms but cause 

less tachycardia and cardiac arrhythmias than first‐generation 

agents.

• Antagonize α1(3rd generation) 

– Tamsulosin

– Silodosin

Uroselective in that they are competitive antagonistsfor prostatic α1A‐receptors

5‐ARI’s (reserve for prostate >40g)‐ Finasteride‐ Dutasteride‐ Dutasteride w/ tamsulosin

PosturalHypotension 

Risk

.

McVary KT et al. American Urological Association guideline on the management of benign prostatic hyperplasia. Revised 2010. URL in handout. Nickel JC et al. Can Urol Assoc J. 2010; 4(5):310-6. Silva J, Cruz F. Current Medical Treatment of Lower Urinary

Tract Symptoms/BPH: Do We Have a Standard? Current Opinion. 2014; 24:21-8.

Product Finasteride Terazosin/Doxazosin Tamsulosin HCL/ Silodosin 

Class 5 alpha reductaseinhibitor

Alpha antagonistSelective alpha 

blocker

Alpha 1A antagonist

subtype selective alpha blocker

Dosing Frequency Once daily Once daily Once daily

Time to Onset 3‐6 months 2‐4 weeks 1 week

Mechanism Reduction of prostatic volume

Relaxation of prostatic smooth 

muscle

Relaxation of prostatic smooth 

muscle

Side effects Sexual dysfunction Postural hypotensionDizzinessHeadacheAsthenia

RhinitisDizzinessAbnormalejaculation

Alpha‐1 Adrenergic Blockers & 5 Alpha Reductase Inhibitors 

BPH Treatment Selection

.

McVary KT et al. American Urological Association guideline on the management of benign prostatic hyperplasia. Revised 2010.Nickel JC et al. Can Urol Assoc J. 2010; 4(5):310-6. Silva J, Cruz F. Current Medical Treatment of Lower Urinary Tract

Symptoms/BPH: Do We Have a Standard? Current Opinion. 2014; 24:21-8.

• Antimuscarinics and 5‐phosphodiesterase (5‐PDE) inhibitors 

– Used in treatment of BPH/LUTS when storage symptoms are persistent or predominant

– 5‐PDE inhibitors have been studied alone and in combination with alpha blockers (clinical trial 12 weeks)

– Antimuscarinics (tolterodine) precipitating of acute urinary retention no longer a concern (clinical trial 12 weeks)

— Can be used as add on after treatment failure with alpha blockers and fixed combinations with alpha blockers or 5 alpha reductase inhibitors

Question 8:Prior to OG’s visit, his PCP contacted you to discuss OG’s most recent labs.  Based on OG’s CBC and iron studies, the PCP would like the most appropriate treatment recommendation for OG?

A. Ferric citrate TID and cyanocobalamin daily

B. Ferrous fumarate BID and cyanocobalamin daily

C. Ferrous gluconate BID and folic acid daily

D. Ferrous sulfate TID and folic acid daily

A. B. C. D.

0% 0%0%0%

MCV Other markers Treatment optionsIron deficiency anemia‘microcytic’

Low - Low serum ferritin and iron

- High TIBC- Later stages: low Hgb & Hct

- 200mg elemental iron daily(2‐3 divided doses)

- Taken 1 hr before food

- Treatment for 3‐6 months after anemia has resolved

- If iron malabsorption or intolerance to oral tx –parenteral iron may be warranted

Anemia of chronic diseases‘microcytic’

Normal - Normal or high serum ferritin

- Low serum iron

- Treat the underlying disorder & correct reversible causes of anemia

- Iron therapy is only effective if iron deficiency is present

- Erythropoietic agents (EPO)

AnemiasMCV Other markers Treatment options

Vitamin B12 deficiency anemia‘macrocytic’

High - Elevated methylmalonic acid (MMA)

- Low levels of Vit B12 (cyanocobalamin)

- Oral vitamin B12 – 1mg daily (as effective as IM)

- Cyanocobalamin 1000mcg IM daily x1wk, weekly x1 month then monthly

- Vitamin B12 intranasally (weekly)

Folic acid deficiency anemia ‘macrocytic’

High - Must rule‐out vit B12 deficiency when suspected

- MMA levels NOT elevated

- Low levels of folate (normal Vit B12 levels)

- Folic acid 1mg daily (may need up to 5mg daily)

- Therapy should be considered for 4 months

Anemias

©2016 American Society of Health System Pharmacists and the American Pharmacists Association. All rights reserved.

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• Discuss iron formulations and differences in the % elemental iron (12‐100%) available in each formulation

• Educate the patient about common side effects with iron supplementation and identify strategies to minimize them (e.g., stool softener for constipation)

Formulation % Elemental Iron 

Ferric citrate 18

Ferrous fumarate 33

Ferrous gluconate 12

Ferrous sulfate 20‐30

Polysaccharide‐iron complex 46

Anemias

Inhibit iron absorption Facilitate iron absorption

Coffee, tea, milk, cereals, dietary fiber, phosphate‐containing carbonated beverages

Vitamin C

Multivitamin or dietary supplements containing calcium, zinc, manganese or copper

Acidic foods (e.g., tomato sauce)

Antacids, H2 blockers and proton pump inhibitors.

Non‐enteric coated iron tablets

Quinolones and tetracycline antibiotics

Taking iron supplements on an empty stomach

Foods / Medications that Affect Iron Absorption:

Summary of Topics

.

• COPD 

• URI / Community Acquired Pneumonia

• GERD

• BPH

• Anemia

©2016 American Society of Health System Pharmacists and the American Pharmacists Association. All rights reserved.

16