aNew Therapies in Domain I (Clinical Content) Content

By A. Author, Pharm.D., BCACP; and C. Coauthor, Pharm.D., BCACPReviewed by A. Reviewer, Pharm.D., FCCP, BCACP; and B. Reviewer, Pharm.D., BCACP

Chapter Outline (A)

I. IntroductionA. HistoryB. EpidemiologyC. Nomenclature

II. PathophysiologyA. Type 2 diabetesB. Type 1 diabetesC. Other types of diabetes

1. Gestational2. Maturity-onset diabetes of the young3. Latent autoimmune diabetes of the adult4. Drug-induced hyperglycemia

III. Screening and PreventionA. Screening

1. Paper (“bloodless”) screening2. High-risk population identification and management

B. Prevention of diabetes: recent evidence1. Lifestyle modification2. Evidence for prevention with drug therapy

IV. Diagnosis and PrognosisA. Recent American Diabetes Association recommendations for diagnosis

1. Fasting plasma glucose2. Casual plasma glucose3. Oral glucose tolerance test

B. Other recommendations by organizations: American Association of Clinical Endocrinologists

C. New classification of prediabetes1. Impaired fasting glucose2. Impaired glucose tolerance

D. Issues with hemoglobin A1C used for diagnosisV. Treatment Goals

A. Control blood glucose to prevent long-term micro- and macrovascular complicationsB. Prevent acute hyperglycemic complicationsC. Minimize hypoglycemia risk and other adverse effects of therapyD. Restore health to allow normal activities and personal and work needsE. Maintain and update patients’ education and self-care of their diabetes

VI. Quality Patient CareA. Lifestyle management

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1. Diet management: evidence-based approach2. Exercise and activity3. Stress and depression management

B. Recent outcomes evidence1. Implications of the Steno-2 trial2. United Kingdom Prospective Diabetes Study update

C. Pharmacotherapy1. Nonsulfonylurea secretagogues: new products

a. Nateglinide2. Insulin sensitizers: recent findings

a. Rosiglitazoneb. Pioglitazone

3. New analogue insulinsa. Aspartb. Glarginec. Detemird. Glulisine

4. Emerging therapiesa. Inhaled insulinb. Glucagon-like peptide 1 agonistsc. Dipeptidyl peptidase intravenous inhibitorsd. Pramlintide

D. Monitoring1. Home blood glucose monitoring

a. Traditional capillary metersb. Non-invasive technologyc. Future technology

VII. Patient EducationA. Effect of illiteracyB. Self-management effectiveness

VIII. Quality ImprovementA. Healthy People 2010 reportB. Quality-of-life indicators useful in practice and research

IX. Conclusion

Learning Objectives (A)

1. Demonstrate an understanding of the epidemiology of burns in children including the risk factors and predictors of morbidity and mortality.2. Distinguish the depth and severity of a burn based on physical characteristics and history.3. Assess the increased risk of morbidity and mortality associated with concomitant inhalation injury in a child with burn injury. 4. Design a treatment plan for appropriate volume resuscitation in a child with burns.5. Apply knowledge of the hypermetabolic response in acute stress to the overall treatment plan for a child with burns.

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6. Develop a pharmacotherapy plan for a child with burns, including pharmacokinetic and pharmacodynamic considerations, appropriate immunizations, stress ulcer prophylaxis, pain and anxiety management, and antimicrobial agents.7. Write a nutrition care plan for a child with burns which includes the need for additional nutritional supplements.

Abbreviations in This Chapter (A)AUASI American Urological Association Symptom IndexBPH Benign prostatic hyperplasiaCombAT Combination of Avodart and TamsulosinCP/CPPS Chronic prostatitis/chronic pelvic pain syndromeDRE Digital rectal examinationED Erectile dysfunctionLUTS Lower urinary tract symptomsMTOPS Medical Therapy of Prostatic Symptoms (trial)NIH-CPSI National Institutes of Health Chronic Prostatitis Symptoms IndexPCPT Prostate Cancer Prevention TrialPDE-5 Phosphodiesterase type-5REDUCE Reduction by Dutasteride of Prostate Cancer Events (trial)

Baseline Knowledge Statements (A)Readers of this chapter are presumed to be familiar with the following: Criteria for NYHA functional classification in patients with heart failure. Pharmacologic management of patients with systolic heart failure and diabetes mellitus, as

recommended by the Heart Failure Society of America

Additional Readings (A)The following free resources are available for readers wishing additional background information on this topic. American College of Chest Physicians/American Heart Association. 2011 Expert Consensus

Document on Hypertension in the Elderly [homepage on the Internet]. Available at http://circ.ahajournals.org/content/123/21/2434.full.pdf. Accessed January 17, 2012.

National Kidney Foundation. GFR calculator [homepage on the Internet]. Available at www.kidney.org/professionals/tools/. Accessed January 17, 2012.

Introduction (A)

Stroke is classified into two major categories based on etiology and presentation:

ischemic stroke and hemorrhagic stroke. Ischemic stroke accounts for more than 80% of cases

whereas hemorrhagic stroke, including primary intracerebral hemorrhage (ICH) and

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subarachnoid hemorrhage, makes up the remaining 15% to 20%. This chapter focuses on

ischemic stroke, which has well-established guidelines for prevention and treatment.

Although advances in the understanding and treatment of stroke have been made since

the Hippocratic era, stroke remains the third leading cause of death behind heart disease and all

cancer, and is a principal cause of long-term disability in the United States. A meta-analysis

showed that strokes result in 162,672 deaths and $56.8 billion in health care expenditures

annually, which makes stroke a major economic burden on society (Woodcock 2009). Prevention

is still the most effective strategy in reducing the health and economic burden of stroke. Research

is needed to gain further understanding of the pathophysiology of stroke to develop therapeutic

strategies that may ultimately improve quality of life.

Epidemiology (A)

Incidence and Economic Impact (B)

Ischemic stroke results from reduced blood flow to a focal region of the brain due to a

cerebral artery occlusion. Ischemia ultimately leads to irreversible brain injury because of

inadequate blood flow. On average, a stroke occurs every 45 seconds and a death every 3

minutes in the United States. Environmental factors, age, and genetics have all been suggested to

influence the incidence of stroke. Seasonal and temporal variations have also been reported to

affect the incidence of stroke. A longitudinal report from the Framingham Study showed that

cardioembolic stroke occurred most commonly during August and January (Tinker 2010). On

any given day, the peak occurrence of stroke appeared to be in the late morning between 8 AM

and noon.

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Over the past 3 decades, stroke mortality has decreased nationwide. As stroke mortality

has decreased, there has been a corresponding increase in patients who need rehabilitation due to

cognitive and functional disability. The results of lost productivity and an increased need for

rehabilitation have been an increase in the average lifetime cost of ischemic stroke per patient

from $91,000 in 1990 to $140,048 in 1999. This cost is expected to increase as the population

ages.

Pharmacotherapy (A)

Acute Management (B)

An overview of the early management of AIS is outlined in Figure 1. As recommended

by American Heart Association (AHA) and American Stroke Association (ASA) guidelines, a

dedicated stroke unit with an integrated team, including a neurologist and neurosurgeon,

experienced nurse, pharmacist, respiratory therapist, and other personnel with training in

rehabilitation, is important in improving patient care and outcomes. The guidelines addressed the

diagnosis and evaluation of AIS and acute management of stroke, including criteria for

thrombolytic therapy. In addition, supportive care for prevention and treatment of medical

complications are also important steps for AIS management, which include the management of

fever, hyperglycemia, correction of underlying cardiac arrhythmias, thromboprophylaxis, prompt

treatment of infection when suspected, and early initiation of nutritional support and

rehabilitation.

Reperfusion Therapy (C)

Rationale for Use (D)

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Whereas the ischemic core consists of necrotic tissues and is beyond repair, the penumbra

region is most likely to benefit from reperfusion therapy. Intravenous rtpa is the only therapy that

has shown to improve clinical outcomes when administered within 3 hours of symptom onset.

The Merci Clot Retriever, an endovascular device, is a nonpharmacologic alternative for patients

who are not eligible for rtpa and recently received labeling approval for use from the Food and

Drug Administration (FDA) for removing clots from the brain within 8 hours symptom onset of

AIS. This is the first mechanical reperfusion device approved for AIS treatment; however, its

efficacy and safety have been debated. In fact, there appeared to be more harm in patients who

did not achieve recanalization using the Merci Clot Retriever than in patients who did not receive

the treatment at all.

Efficacy and Therapeutic Role (D)

Intravenous Thrombolysis (E)

Intravenous rtpa was approved by the FDA in 1996 for the treatment of AIS because of

the National Institute of Neurological Disorders and Stroke rtpa Stroke Study (NINDS). Patients

who received rtpa were more likely to have minimal or no deficits as assessed by four outcome

measures (Barthel index, modified Rankin scale, NIHSS, and Glasgow outcome scale) at 3

months (odds ratio in favor of rtpa was 1.7) (Saver 2012). However, two other large-scaled

clinical trials, the European Cooperative Acute Stroke Study (ECASS) and the Alteplase

ThromboLysis for Acute Non-intervention Therapy in Ischemic Stroke (ATLANTIS), failed to

report the similar positive results (Bluhmki 2010a; Bluhmki 2010b). This was mainly attributed

to a higher dose used (1.1 mg/kg rtpa in ECASS trial) and the extended treatment window (6

hours instead of 3 hours). Although there is some evidence as suggested by a pooled analysis that

6

patients treated within 4.5 hours of onset may benefit from thrombolysis, this finding has not

been validated in clinical trials. Initiating the therapy within 3 hours of stroke onset is important

to ensure positive outcomes and safety (see section on complications and cost-effectiveness).

References (A)

Bluhmki E (a), von Kummer R, Brott TG, et al. Time to treatment with intravenous alteplase and

outcome in stroke: an updated pooled analysis. Lancet 2010;375:1695-703.

Bluhmki E (b), von Kummer R, Brott TG, et al. Stroke treatment with alteplase given 3.0-4.5 h

after onset of acute ischaemic stroke (ECASS III): additional outcomes and subgroup analysis of

a randomised controlled trial. Lancet Neurol 2010;8:1095-102.

Demling RH. The burn edema process: current concepts. J Burn Care Rehabil

2012;26:207-27.

Mold JW, Peterson KA. Primary care practice-based research networks: working at the interface

between research and quality improvement. Ann Fam Med 2005;3(suppl 1):S12-S20.

Saver JL, Warach S, Janis S, et al. Standardizing the structure of stroke clinical and

epidemiologic research data: The National Institute of Neurological Disorders and Stroke

(NINDS) Stroke Common Data Element (CDE) Project. Stroke 2012, Feb 2. [Epub ahead of

print]

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Tinker J, Evers T, Johnson B, et al. Seasonal and temporal variations in stroke. N Engl J Med

2010;33:450-1.

Westfall JM, Mold J, Fagnan L. Practice-based research—“Blue Highways” on the NIH

roadmap. JAMA 2007;297:403-6.

Woodcock NP, Zeigler D, Palmer D, et al. The hidden costs of stroke in the United States.

MMWR 2009;17:1-12.

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Box 1. Patient Requirements for OPATWilling to administer antimicrobials reliably in the home or alternative care settingWilling to adhere to follow-up measures such as central line care and laboratory monitoringMedical needs can be met in the home or alternative care settingHome or alternative setting is safe and supportiveShows a clear understanding of the need to contact on-call personnel for questions or

concerns at any time during therapyWilling to follow up with the medical team at the end of therapyOPAT = outpatient parenteral antimicrobial therapy.

9

Table 2. Characteristics of Selected Drugs for Treating Atypical Mycobacterial InfectionsDrug First-line Therapy Alternative

TherapyDosage Regimena Toxicities

Isoniazid Mycobacterium kansasii

MAC 5 mg/kg/day up to 300 mg/day

Hepatotoxicity

M. scrofulaceum M. malmoense Peripheral neuritis

Rifampin M. kansasiiM. haemophilumM. lepraeM. malmoenseM. marinumM. scrofulaceumM. ulceransM. xenopi

MAC 10 mg/kg/day up to 600 mg/day

Fluid discoloration

 (red-orange)RashHepatic

cholestasis

Ethambutol MACM. genavenseM. kansasiiM. malmoenseM. marinumM. ulceransM. xenopi

15–25 mg/kg/day Optic neuritisHyperuricemia

Rifabutin MAC M. genavenseM.

haemophilumM. kansasii

300 mg/day UveitisFluid

discoloration  (red-orange)Rash

Tobramycin

M. chelonae 3–5 IV mg/kg/day NephrotoxicityOtotoxicity

aDoses listed are adult dosages based on normal kidney function and oral administration unless otherwise noted.IV = intravenously; MAC = Mycobacterium avium complex.Information from Fraimow HS. Systemic antimicrobial therapy in osteomyelitis. Semin Plast Surg 2009;23:90-9.

10

11

Diagnosis of PD

Nonpharmacologic: education, exercise/physical therapy, nutrition,

Pharmacotherapy for motor symptoms

Management of nonmotor symptomsa

Minimal functional impairment: consider rasagiline

Consideranticholinergic

If there is a need for more symptomatic control of motor complications (despite optimized pharmacotherapy), consider surgery

< 65 yearsb > 65 yearsb

Bradykinesia, rigidity, tremor

Add amantadine, carbidopa/levodopa, dopamine agonist or rasagilinec

Need for additional symptomatic control

Tremor-predominant

Management of motor fluctuations: Increase dosing frequency of levodopa Add MAO-B inhibitor or COMT inhibitor Add a dopamine agonist

Management of peak-dose dyskinesia:: Reduce dopaminergic drug dose Add amantadine

Figure 3. General approach to the management of early to advanced PD.aNonmotor symptoms include anxiety, cognitive impairment, constipation, depression, dysphagia, orthostatic hypotension, sialorrhea, sleep disorders, speech impairment, and urinary incontinence.bAge is not the sole determinant for drug choice. Other factors such as cognitive function and overall safety and tolerability of drug (especially, in the elderly) should be considered.cIf not yet on rasagiline.COMT = catechol-O-methyltransferase; MAO = monoamine oxidase; PD = Parkinson disease.Adapted from Boucher BA, Neurotrauma. In Pharmacotherapy Self-Assessment Program, 2nd ed. Module 2: Critical Care, Kansas City, MO: American College of Clinical Pharmacy, 1995;220.

Pivotal Study that May Change Practice

12

Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007;356:1503-16.

Setting: Despite treatment guidelines recommending aggressive interventions after optimal medical therapy, PCI is commonly used as an initial management strategy in CSA. Previous underpowered comparisons of aggressive and intensive medical strategies have shown that PCI reduces only the frequency of angina and short-term exercise performance, with no difference in mortality, MI, or hospitalization observed. The COURAGE trial was conducted to compare the effect of PCI plus optimal medical therapy with optimal medical therapy alone on death and MI in patients with CSA. Design: A total of 2287 patients were randomized to PCI plus optimal medical therapy (n=1149) or optimal medical therapy alone (n=1138). Optimal medical therapy included antiplatelet therapy (aspirin plus clopidogrel), anti-ischemic therapy (nitrate, β-blocker, or calcium channel blocker), and lipid-lowering therapy (low-density lipoprotein cholesterol goal, 60–85 mg/dL). A PCI included target lesion revascularization in the culprit vessel, resulting in less than 50% stenosis after balloon angioplasty or less than 20% after stent implantation. Outcomes: After a median follow-up of 4.6 years, no difference in the primary outcome was observed in the PCI plus optimal medical therapy (19.0%) compared with optimal medical therapy alone (18.5%) (hazard ratio [HR] for the PCI group, 1.05; 95% confidence interval [CI], 0.87-1.27; p=0.62). Furthermore, no difference was observed in death (HR, 0.87; 95% CI, 0.65-1.16); p=0.38), MI (HR, 1.13; 95% CI, 0.89 to 1.43; p=0.33), or hospitalization for an acute coronary syndrome (HR, 1.07; 95% CI, 0.84-1.37; p=0.56). Only the number of subsequent revascularization procedures was different (228 in PCI plus optimal medical therapy vs. 348 in optimal medical therapy alone; HR, 0.60; 95% CI, 0.51-0.71; p<0.001).

IMPACT: These findings underscore the importance of intensive optimal medical therapy as a first-line strategy in patients with CSA. This trial also reinforces the need for aggressive risk factor modification and the use of PCI as a second-line therapy as suggested in the ACC/AHA stable angina guidelines.

Patient Case Scenario

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Four days ago, a 29-year-old non-Hispanic white man underwent aortic valve replacement surgery with a St. Jude mechanical heart valve. He has been receiving warfarin and an intravenous heparin infusion for 3 days, and his target INR is 2.5. Data on his INRs and warfarin doses in the past 3 days are as follows:

Day 1 2 3 4

INR (measured in the morning) 1.4 1.5 1.6 1.6

Warfarin Dose (given at night) 5 4 4

His warfarin pharmacogenetic test results, received today, are CYP2C9*1/*3 and VKORC1 -1639AG. A publicly available warfarin pharmacogenetic dosing algorithm that can adjust warfarin doses estimates 2.4 mg for today’s dose. His clinician must decide on the most appropriate dose to give this patient today.

AnswerAlthough a warfarin pharmacogenetic algorithm that adjusts warfarin doses on

the basis of the previous warfarin doses and the resultant INR responses recommends 2.4 mg/day, the patient’s INR was changed only by 0.2 unit for the past 3 days while he received 5 mg, 4 mg, and 4 mg of warfarin. The warfarin pharmacogenetic dosing table on the warfarin label estimates 3–4 mg/day of warfarin for the CYP2C9*1/*3 and VKORC1 1639A/G genotype combination. In addition, patients carrying two variants in CYP2C9, VKORC1, or both genes required 3–4 mg/day in a study. Thus, administering 2.5 mg as recommended by the dosing algorithm is likely to further delay reaching a therapeutic INR. In addition, it is unlikely that the anticoagulation effect of the previous warfarin doses has completely been reflected in the INR. Therefore, continuing 4 mg is the best option today. This case illustrates the importance of clinical judgment, even if a warfarin pharmacogenetic algorithm is used.1. Barnes-Jewish Hospital at Washington University Medical Center. Warfarin Dosing. Available at www.warfarindosing.org. Accessed April 21, 2011.2. Bristol-Myers Squibb Company. Coumadin package insert. Revised 2010.3. Anderson JL, Horne BD, Stevens SM, et al. Randomized trial of genotype-guided versus standard warfarin dosing in patients initiating oral anticoagulation. Circulation 2009;116:2563-70.

Developing a New Asthma or /COPD/Smoking Cessation Clinic or Service A business/practice plan should include the following: Other health professionals on the team (e.g., physician, registered nurse,

counselor for smoking cessation, respiratory therapist, someone to perform spirometry)

Resources that would be needed (e.g., spirometry, carbon monoxide monitor, placebo inhaler, holding chambers)

Criteria to evaluate the success of a service/clinic (quality measures, below) Need for certification (e.g., Certified Asthma Educator [AE-C])

Quality Measures Specific to PharmacyAsthma Quality Measuresa

Documentation of asthma severity classificationUse of inhaled corticosteroids for persistent asthmaProvision of asthma action plansPatients have been educated on managing their asthma and avoiding

triggersInfluenza vaccines givenSmoking cessation counseling completedDaily symptom burden: Frequency of symptoms and β2-agonist use (per week) Number of days of (or free from) asthma symptoms in past month Days with nocturnal symptoms in past month Number of school/workdays missed in past month Frequency of urgent care or acute office visits Frequency of ED visits or hospitalizationNumber of full β2-agonist canisters used in past 3 monthsNumber (or %) of patients who have been taught

COPD Quality Measuresb

Pneumococcal vaccinationInfluenza vaccinationNumber (or %) of patients who received smoking cessation counselingNumber (or %) of patients prescribed long-acting bronchodilators for

stage II (moderate) COPDNumber (or %) of patients prescribed inhaled corticosteroids for stage III

(severe) COPD with frequent exacerbationsaFrom the Agency for Healthcare Research and Quality. Available at www.ahrq.gov/qual/asthmacare/asthmod4.htm. Accessed September 22, 2010.bHeffner JE, Mularski RA, Calverley PM. COPD performance measures: missing opportunities for improving care. Chest 2010;137:1181-9.COPD = chronic obstructive pulmonary disease; DPI = dry power inhaler; ED = emergency department; MDI = metered dose inhaler.

Practice Management

14

You are developing a cultural competence initiative for your outpatient pharmacy clinic. An organizational self-assessment is performed and shows that the department functions as if culture plays no role in health care. You don’t know which cultures and ethnic groups most often visit the pharmacy, and therefore are unsure of the cultural needs regarding health care. You consider each of the following in deciding the best first step toward cultural competence for the pharmacy: Collect data on the race and ethnicity of patients using

pharmacy services. This will provide good information, but it is not enough to understand the needs of the community

Host cultural competence training sessions for the pharmacy staff. This is an integral part of cultural competence development, and it could help understand the needs of the staff; however, it would not help understand the needs of the community

Attend community meetings to determine broad concerns facing the community. Although a good way to gather information about the community concerns, this would not necessarily provide specific information related to health issues, unless the community meeting is focused on health issues

Create a geographical map of the community that includes data related to health, ethnicity, and social services. This would help the pharmacist gather cultural knowledge about the patient population that uses the pharmacy. Knowing this information can then help the pharmacy create services tailored to the needs of the community.

1. O’Connell M, Rickles N, Sias J, et al. Cultural competency in health care and its implications for pharmacy. Part 2: Emphasis on pharmacy systems and practice. Pharmacotherapy 2009;29:14e-34e. Available at http://pharmacotherapyjournal.org/doi/pdf/10.1592/phco.29.3.362. Accessed December 21, 2011.

2. Campinha-Bacote J. The process of cultural competence in the delivery of healthcare services: a

Decision Scenario

15

In determining the optimal treatment for a patient with type 2 DM, the clinician has several considerations to piece together: Lifestyle modifications should be

recommended to all patients with diabetes. In the absence of contraindications,

metformin therapy is the initial pharmacologic therapy of choice.

Further steps are often more difficult. The algorithms from AACE/ACE and ADA/EASD do not define treatment but provide recommendations based primarily on a patient’s risk of hypoglycemia and the cost-effectiveness of various treatments.

Warnings about pancreatitis, fractures, and cardiovascular adverse events limit the utility of some of the newer medications.

Safety and drug interaction concerns must be kept in mind for the newest medications.

Practice Points

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Self-Assessment Questions (A)

Questions 1 and 2 pertain to the following case.

R.F., a 54-year-old African American man with systolic dysfunction, presents with a 2-week

history of increased lower extremity edema and shortness of breath that limits his normal daily

activities. His weight has increased by 4.5 kg during the past 3 days. His physical examination is

notable for blood pressure 148/72 mm Hg, heart rate 88 beats/minute, respiratory rate 24

breaths/minute, rales, and 3+ lower extremity edema. His laboratory values include sodium 138

mEq/L, potassium 5.4 mEq/L, blood urea nitrogen 35 mg/dL, serum creatinine 0.9 mg/dL, and

digoxin 2.1 ng/mL. His medical history is significant for HTN, gout, and chronic obstructive

pulmonary disease (COPD). His current drugs include lisinopril 20 mg/day, diltiazem extended

release 120 mg two times/day, digoxin 0.25 mg/day, allopurinol 100 mg/day, colchicine 0.6 mg

two times/day, and salmeterol/fluticasone 250/50 two puffs two times/day. R.F. began taking

naproxen 220 mg three times/day about 7 days ago for pain associated with gout.

1. Which one of the following drugs pairs is most likely to have contributed to R.F.’s fluid

overload? (Learning Objectives 1,4; Domain 1, Task 2)

A.Diltiazem and naproxen.

B.Lisinopril and digoxin.

C.Salmeterol/fluticasone.

D.Allopurinol and colchicine.

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2. R.F. is counseled on salt and fluid restriction. Which of the following pharmacologic options

would be best to add to manage R.F.’s fluid overload? (Learning Objective 3; Domain 1, Task 3)

A.Hydrochlorothiazide 50 mg orally daily.

B.Furosemide 40 mg orally two times/day.

C.Metolazone 2.5 mg orally daily.

D.Spironolactone 25 mg orally daily.

3. A man who recently received a diagnosis of COPD has been referred to a pharmacist for

monitoring and education. The pharmacist has a collaborative practice agreement for asthma and

COPD with the patient’s physician. The pharmacist meets with the patient, discusses treatment

goals and his newly prescribed drugs for COPD therapy, and schedules a follow-up appointment

at the pharmacy in 1 month. Which one of the following is the best classification for the

pharmacist’s intervention? (Learning Objective 5, 6; Domain 1, Task 1)

A. Medication therapy management (MTM).

B. Medication therapy review (MTR).

C. Medication-related action plan (MAP).

D. Disease state management.

a Revised March 27, 2012.

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Answers to Self-Assessment Questions (A)

1. Answer: A

Diltiazem has negative inotropic properties, and nonsteroidal anti-inflammatory agents such as

naproxen can result in fluid retention. Therefore, these agents should be avoided in patients with

heart failure (HF) (Answer A is correct). Lisinopril and digoxin are both valuable therapies for

managing this patient’s HF (Answer B is incorrect). Salmeterol/fluticasone is appropriate for

asthma management (Answer C is incorrect); however, frequent use of short-acting β-agonists

should be minimized. Allopurinol and colchicine are not known to result in fluid retention

(Answer D is incorrect).

1. Heart Failure Society of America; Lindenfeld J, Albert NM, Boehmer JP, et al. HFSA 2010

Comprehensive Heart Failure Practice Guideline. J Card Fail 2010;16:e1-194.

2. Parker RB, Rodgers JE, Cavallari LH. Heart failure. In: DiPiro JT, Talbert RL, Yee G, et al,

eds. Pharmacotherapy: A Pathophysiologic Approach, 8th ed. New York: McGraw-Hill,

2011:173–216.

2. Answer: B

Loop diuretics such as furosemide are the treatment of choice for managing volume overload

in patients with HF (Answer B is correct). Thiazide diuretics such as hydrochlorothiazide and

metolazone are not effective options for monotherapy (Answer A and Answer C are incorrect);

however, these therapies may be added if the patient is not responding adequately to loop

diuretic dose escalation. In refractory fluid overload, the combined use of a loop and thiazide

diuretic works synergistically through complementary mechanisms of action. Answer D is

incorrect; spironolactone is effective in reducing mortality when added to standard HF therapy

19

for patients with moderately severe to severe (NYHA class III–IV) symptoms. The low doses

(e.g., 12.5–25 mg/day) used to manage HF typically do not result in clinically significant

diuresis.

1. Brater DC. Diuretic therapy in congestive heart failure. Congest Heart Fail 2000;6:197-201.

2. Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortality in

patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl

J Med 1999;341:709-17.

3. Answer: D

Focusing on his COPD only is an example of disease state management (Answer D is correct).

The pharmacists did not provide a MAP in this scenario (Answer C is incorrect). Medication

therapy management and an MTR would both include a complete review of the patient’s drug

profile, not just the drugs prescribed for his COPD (Answer A and Answer B are incorrect).

1. Doucette WR, McDonough RP, Klepser D, et al. Comprehensive medication therapy

management: identifying and resolving drug-related issues in a community pharmacy. Clin Ther

2005;27:1104-11.

2. McGivney MS, Meyer SM, Duncan-Hewitt W, et al. Medication therapy management: its

relationship to patient counseling, disease management, and pharmaceutical care. J Am Pharm

Assoc 2007;47:620-8.

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