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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
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.
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2
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.
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3
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.
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4
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.
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5
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.
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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
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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.
8
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
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
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10
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.
11
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.
12
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.
13
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.
14
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
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