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32

MTM can be the vehicle to allow pharmacists to serve an integral role in applying

pharmacogenomics into clinical practice to improve the quality and safety of health

care. Incorporating pharmacogenomics into MTMS allows pharmacists to lend their

expertise to the treatment planning process to optimize treatment outcomes.

Pharmacists, working collaboratively with prescribers and laboratory facilities,

could review medications prescribed for a patient as well as the patient’s genomic

data to then offer an assessment on whether a prospective drug would provide the

best fit for the condition and patient. Through MTMS and pharmacogenomics,

pharmacists can optimize drug choice and maximize therapy outcomes (see Chapter

4, Pharmacogenomics and Personalized Medicine).

In order to successfully integrate a pharmacogenomic component within the

clinical decision making process, key pharmacogenomic data must be identified. The

challenge is complex, and research has begun to bring the application of

pharmacogenomics to patients as part of the health care delivery system. The

pharmacy profession must define a process for the application of pharmacogenomic

data into pharmacy clinical practice that is aligned with MTMS delivery. A viable

business model should be developed for these practices that encourages and

promotes the use of the clinical expertise of pharmacists working in collaboration

with other health care providers and laboratories. The development of technology

solutions that support the pharmacist’s role in this emerging field should also be

encouraged and directed.

32

CONCLUSION

MTMS are intended to be applicable to patients in all care settings where the

patients or their caregivers can be actively involved with managing their medication

therapy. The goals of all pharmacists providing MTMS are to confirm that the

patient’s medication therapy is ideal and that the best possible outcomes from

treatment are achieved. The MTM process needs to be properly documented and

accurately shared with all providers that are part of the patient’s health care team. As

drug therapy and technology options continue to evolve, pharmacists are encouraged

to provide and optimize MTMS to improve patient outcomes and medication use.

ACKNOWLEDGMENT

The authors acknowledge Mary Anne Koda-Kimble, Wayne Kradjan, Robin Corelli,

Lloyd Young, B. Joseph Guglielmo, Brian Alldredge, Marilyn Stebbins, Timothy

Cutler, and Patricia Parker for their contributions to the version of this chapter found

in previous editions.

KEY REFERENCES AND WEBSITES

A full list of references for this chapter can be found at

http://thepoint.lww.com/AT11e. Below are the key references and websites for this

chapter, with the corresponding reference number in this chapter found in parentheses

after the reference.

Key References

American Pharmacists Association; National Association of Chain Drug Stores Foundation. Medication therapy

management in pharmacy practice: core elements of an MTM service model (version 2.0). J Am Pharm Assoc

(2003). 2008;48(3):341. (23)

Bluml BM. Definition of medication therapy management: development of professionwide consensus. J Am Pharm

Assoc (2003). 2005;45(5):566. (1)

Cipolle RJ et al., eds. Pharmaceutical Care Practice: The Clinician’s Guide. 2nd ed. New York, NY: McGraw-Hill;

2004. (14)

Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria

for Electronic Health Record Technology. Fed Regist. 2010;75(144):44589. (15)

Health Care and Education Reconciliation Act of 2010. Pub L No. 111-152, 124 Stat 1029. (6)

Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm.

1990;47(3):533. (3)

Patient Protection and Affordable Care Act (PPACA). Pub L No. 111-148, 124 Stat 119. (5)

Rovers JP, Currie JD, eds. A Practical Guide to Pharmaceutical Care: A Clinical Skills Primer . 3rd ed.

Washington, DC: American Pharmacists Association; 2007. (3)

Key Websites

National Patient Safety Goals. Joint Commission on Accreditation of Healthcare Organizations.

http://www.jointcommission.org/standards_information/npsgs.aspx. Accessed June 17, 2015. (11)

COMPLETE REFERENCES CHAPTER 1 MEDICATION

THERAPY MANAGEMENT AND ASSESSMENT OF

THERAPY

Bluml BM. Definition of medication therapy management: development of professionwide consensus. J Am Pharm

Assoc (2003). 2005;45(5):566–572.

Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm.

1990;47(3):533.

Rovers JP, Currie JD, eds. A Practical Guide to Pharmaceutical Care: A Clinical Skills Primer . 3rd ed.

Washington, DC: American Pharmacists Association; 2007.

Isetts BJ, Buffington DE; Pharmacist Services Technical Advisory Coalition. CPT code-change proposal: national

data on pharmacists’ medication therapy management services. J Am Pharm Assoc (2003). 2007;47(4):491.

Patient Protection and Affordable Care Act (PPACA). Pub L No. 111-148, 124 Stat 119, to be codified as

amended at scattered sections of 42 USC. Enacted March 23, 2010.

Health Care and Education Reconciliation Act of 2010. Pub L No. 111-152, 124 Stat 1029. Enacted March 30,

2010.

Wu SY, Green A. Projection of Chronic Illness Prevalence and Cost Inflation. Santa Monica, CA: RAND; 2000.

Gerteis J et al. Multiple Chronic Conditions Chartbook. AHRQ Publications No, Q14-0038. Rockville, MD: Agency

for Healthcare Research and Quality; 2014. Accessed June 17, 2015.

ASHP-APhA Medication Reconciliation Initiative Workgroup Meeting, February 12, 2007.

https://www.ashp.org/-/media/assets/pharmacy-practice/pharmacy-topics/quality-improvement/carecoordination-medication-reconciliation-initiative-workgroup-meeting.ashx?la=en. Accessed July 4,

2017.

National Patient Safety Goals. Joint Commission on Accreditation of Healthcare Organizations.

https://www.jointcommission.org/standards_information/npsgs.aspx. Accessed July 4, 2017. Accessed

June 1, 2008.

National Patient Safety Goals. Joint Commission on Accreditation of Healthcare Organizations.

http://www.jointcommission.org/standards_information/npsgs.aspx. Accessed June 17, 2015.

National Community Pharmacist Association, NCPA Summary of CMS 2013 Final Call Letter.

http://www.ncpanet.org/pdf/NCPA-Summary-of-CMS-2013-Final-Call-Letter.pdf. Accessed June 17,

2015.

Perlroth D et al. Medication Therapy Management in Chronically Ill Populations: Final Report. Baltimore, MD;

2013.

Cipolle RJ et al., eds. Pharmaceutical Care Practice: The Clinician’s Guide. 2nd ed. New York, NY: McGrawHill; 2004.

Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria

for Electronic Health Record Technology. Fed Regist. 2010;75(144):44589.

Miller WR, Rollnick S. Motivational interviewing: Preparing people to change addictive behavior. New York, NY:

Guilford Press; 1991. Pp. xvii + 348.

Center for Substance Abuse Treatment. Enhancing Motivation for Change in Substance Abuse Treatment.

Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 1999. (Treatment

Improvement Protocol (TIP) Series, No. 35.) Chapter 3—Motivational Interviewing as a Counseling Style.

Available from: http://www.ncbi.nlm.nih.gov/books/NBK64964/.

Nester TM, Hale LS. Effectiveness of a pharmacist-acquired medication history in promoting patient safety. Am

J Health Syst Pharm. 2002;59(22):2221.

Varkey P et al. Multidisciplinary approach to inpatient medication reconciliation in an academic setting. Am J

Health Syst Pharm. 2007;64(8):850.

Forster AJ et al. The incidence and severity of adverse events affecting patients after discharge from the

hospital. Ann Intern Med. 2003;138(3):161.

Unroe KT et al. Inpatient medication reconciliation at admission and discharge: a retrospective cohort study of

age and other risk factors for medication discrepancies. Am J Geriatr Pharamcother. 2010;8(2):115–126.

Bourgeois FT et al. Adverse drug events in the outpatient setting: an 11-year national analysis.

Pharmacoepidemiol Drug Saf. 2010;19(9):901.

American Pharmacists Association; NationalAssociation of Chain Drug Stores Foundation. Medication therapy

management in pharmacy practice: core elements of an MTM service model (version 2.0). J Am Pharm Assoc

(2003). 2008;48(3):341.

Centers for Medicare & Medicaid Services, HHS. HIPAA administrative simplification:standard unique identifier

for health care providers; final rule. Fed Regist. 2004;69(15):3433.

Cranor CW et al. The Asheville Project: long-term clinical and economic outcomes of community pharmacy

diabetes care program. J Am Pharm Assoc (Wash). 2003;43(2):173.

Chrischilles EA et al. Evaluation of the Iowa Medicaid pharmaceutical case management program. J Am Pharm

Assoc (2003). 2004;44(3):337.

Bodenheimer T et al. Confronting the growing burden of chronic disease: can the U.S. health care workforce do

the job? Health Aff (Millwood). 2009;28(1):64.

Smith M et al. Why pharmacists belong in the medical home. Health Aff (Millwood). 2010;29(5):906.

Stone NJ et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic

cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task

Force on Practice Guidelines. J Am Coll Cardiol. 2014;63 (25, pt B):2889–2934.

Fick DM et al. Updating the Beers criteria for potentially inappropriate medication use in older adults. Arch Intern

Med. 2003;163(22):2716.

American Geriatrics Society. Pharmacological management of persistent pain in older persons. J Am Geriatr Soc.

2009;57(8):1331.

American Pharmacists Association. Integrating pharmacogenomics into pharmacy practice via medication

therapy management. J Am Pharm Assoc. 2011;51:e64–e74.

p. 14

Laboratory findings should be used to complement other subjective and

objective findings and must not be evaluated in isolation. The values

must be assessed in context of the clinicalsituation and incorporate

understanding of human physiology.

Case 2-3 (Question 1),

Case 2-4 (Question 1), Table

2-2

Case 2-5 (Questions 1, 2),

Table 2-3,

Case 2-6 (Questions 1, 2)

Lack of availability, expense, or inconvenience may limit the usefulness

of some clinical laboratory tests. Estimations by means of equations or

nomograms may be used in clinical practice to overcome these barriers.

Case 2-1 (Question 1), Table

2-2

Test reliability is impacted by various factors including statistical and

preanalytical variations, accuracy, and precision.

Case 2-1 (Question 1),

Case 2-2 (Question 1),

Case 2-4 (Question 1), Table

2-1, Table 2-2

Laboratory findings can be helpful in assessing clinical disorders,

establishing a diagnosis, assessing drug therapy, or evaluating disease

progression.

Case 2-1 (Question 1), Table

2-2

Case 2-2 (Question 1), Table

2-3

Case 2-3 (Question 1),

Case 2-4 (Question 1),

Case 2-5 (Questions 1, 2),

Case 2-6 (Questions 1, 2)

This chapter provides the reader with an overview of laboratory tests commonly

used in clinical practice. Specialized laboratory tests, which are used to monitor

specific disease states or specific drug therapies, are integrated into the case

histories, questions, and answers in the disease-specific chapters of this textbook.

Over-the-counter or patient-directed laboratory tests are briefly discussed at the end

of this chapter because of their increased availability and use. All stated laboratory

ranges were obtained from the key references listed at the end of this chapter.

1–3

GENERAL PRINCIPLES

Generally, laboratory tests should be ordered only if the results of the test will guide

decisions about the care of the patient. Serum, urine, and other bodily fluids can be

analyzed routinely; however, the economic cost and impact on the quality of life

related to obtaining these data must always be balanced by benefit to patient-specific

outcomes.

Reference Ranges

The term reference range is typically preferred in clinical practice rather than normal

range because there are several factors that contribute to the “normal” value for each

individual. Laboratory findings, within and outside the reference range, can be

helpful in assessing clinical disorders, establishing a diagnosis, assessing drug

therapy, or evaluating disease progression. In addition, baseline laboratory tests are

often necessary to evaluate disease progression and response to therapy or to monitor

the development of toxicities associated with therapy.

When assessing laboratory findings, it is important to be mindful that values

outside the reference range may not require clinical intervention. Values must be

assessed in context of the clinical situation and incorporate understanding of human

physiology. Likewise, values that fall within the reference range may need further

assessment secondary to limitations of the test or impact of biologic or physiologic

considerations. Laboratory findings should also be used to complement other

subjective and objective findings and must not be evaluated in isolation.

p. 15

p. 16

Laboratory test results are specific to the clinical laboratory conducting the test

and can vary based on the type of equipment and testing methods used. Consequently,

clinicians should rely on reference ranges listed by their own clinical laboratory

when assessing laboratory tests.

Evaluating Laboratory Results

The reference ranges provided in this chapter are for general illustrative purposes.

When applying this information to the clinical setting, appropriate clinical

assessment and judgment should be applied. Patient-specific attributes such as the

individual’s age, sex, race, clinical presentation, and lifestyle are factors that may

influence reported laboratory results and, therefore, must be taken into consideration.

Statistical and preanalytical variations are common and must also be evaluated in

context of the result obtained. Refer to Table 2-1 for examples of common

preanalytical variables.

Test Reliability

As a result of probability, if the same test is completed multiple times on the same

sample, typically 1 of 20 results or 5% will be reported outside of the provided

reference range. Indicators of test reliability include accuracy, precision, sensitivity,

and specificity. Precision refers to the repeatability of a laboratory test (i.e., test

results fall within a similar value when repeated), whereas accuracy is the ability of

a test to provide a result that is reflective of the “true” value (i.e., the test result

matches the actual real value). Quality control and assurance practices at each

laboratory are monitored regularly to ensure reliability of results. Typically, if a

result is obtained that is significantly outside the reference range, the laboratory will

repeat the test to confirm or refute the finding.

Table 2-1

Preanalytical Variation: Factors Affecting the Test Result from the Time the

Test Is Ordered Until It Arrives at the Laboratory

Variable Example(s)

Incorrect test ordered Albumin ordered to assess impact of recent dietary change

(prealbumin better marker for acute changes)

Sample incorrectly labeled Sample obtained from one patient and labeled with another name

Improper preparation for test Fasting indicated but not followed: fasting glucose, complete lipid

panel

Pretest medications not administered in the appropriate manner

Pretest diet restrictions not met: rare meat ingested before guaiac

test

Medication Medication interfered with testing procedure or by pharmacologic

effect: β-agonist can reduce serum potassium concentrations,

thiazides can increase serum uric acid levels

Improper timing of test Vancomycin trough taken after first dose (rather than before the

fourth dose)

aPTT measured 2 hours after initial dose (rather than 6 hours after

start)

Fasting glucose test completed shortly after a meal, TSH

measured 2 weeks after dose change (rather than 4–6 weeks after

change)

Collection incomplete or improper Abnormal 24-hour urine collection secondary to patient forgetting

to void in provided container, blood specimen obtained from

extremity with IV infusion site resulting in dilutional effect of

glucose, BUN, and electrolytes, specimen collected in incorrect

container

Improper handling or storage Hyperkalemia because of hydrolysis of blood specimen

Poor accuracy or precision Faulty or outdated laboratory reagents in use

Technical Result incorrectly read, computer keying error

Sex Many laboratory findings are sex dependent

Age Neonatal, pediatric, adult, and geriatric populations have unique

reference ranges for numerous laboratory tests

Pregnancy Gestationalstatus impacts numerous laboratory findings: alkaline

phosphatase, cholesterol, iron, etc.

Posture Being in upright position during laboratory sampling can increase

albumin, calcium, iron, etc.

Exercise Strenuous exercise before testing can impact lactate, creatine

kinase, ALT, AST, uric acid, etc.

Normal physiologic fluctuations Circadian rhythm can impact cortisol, serum iron, serum creatinine,

WBC count, etc.

Medical procedures Blood transfusion with red blood cells before hemoglobin A1c

measured results in normal A1c

for poorly controlled individual

with diabetes, creatine kinase elevated secondary to recent

cardioversion

A1c

, hemoglobin A1c

(also glycosylated hemoglobin); ALT, alanine aminotransferase; aPTT, activated partial

thromboplastin time; AST, aspartate aminotransferase; BUN, blood urea nitrogen; IV, intravenous; TSH, thyroidstimulating hormone; WBC, white blood cell.

p. 16

p. 17

Research studies generally establish the sensitivity and specificity of laboratory

tests. Clinically, these are essential to distinguish the presence or absence of a

disease or condition. Sensitivity is the ability of the test to correctly identify the

disease or condition. If a test is 95% sensitive, then 95% of the individuals will be

correctly identified as having the disease or condition, but 5% will have a negative

test result even though they have the disease or condition (false negative). Specificity

is the ability of the test to rule out individuals who do not have the disease or

condition. If a test is 95% specific, then 95% of the individuals without disease will

have a correct negative result, but 5% will be identified as having the disease or

condition even though they are negative (false positive).

Units of Measure

The International System of Units (SI) reports clinical laboratory values using the

metric system. The basic unit of mass for the SI system is the mole, which is not

influenced by the added weight of salt or ester formulations. Therefore, the mole is

technically and pharmacologically more meaningful than the gram because each

physiologic reaction occurs on a molecular level. Efforts to implement the SI system

internationally for laboratory test reports have been resisted in the United States.

Despite adopting SI transition policies in the late 1980s, major American medical

journals have since reverted back to the traditional units for laboratory test

reporting.

4,5

In this chapter, reference ranges for common laboratory tests are

presented in both conventional and SI units, along with “conversion factors” to

interchange traditional and SI units (Tables 2-2 and 2-3).

p. 17

p. 18

Table 2-2

Blood Chemistry Reference Values

Laboratory

Test

Normal Reference Values

Conversion

Factor Comments

Conventional

Units SI Units

Electrolytes

Sodium 135–147 mEq/L or

mmol/L

135–147

mmol/L

1 Low sodium is usually caused by excess

water (e.g., ↑ serum antidiuretic hormone)

and is treated with water restriction. ↑ in

severe dehydration, diabetes insipidus,

significant renal and GI losses

Potassium 3.5–5 mEq/L 3.5–5 mmol/L 1 ↑ with renal dysfunction, acidosis, Ksparing diuretics, hemolysis, burns, crush

injuries. ↓ by diuretics, alkalosis, severe

vomiting and diarrhea, heavy NG

suctioning

CO2

content 21–32 mEq/L 21–32 mmol/L 1 Sum of HCO3− and dissolved CO2

.

Reflects acid–base balance and

compensatory pulmonary (CO2

) and renal

(HCO3−) mechanisms. Primarily reflects

HCO3−

Chloride 95–110 mEq/L 95–110

mmol/L

1 Important for acid–base balance. ↓ by GI

loss of chloride-rich fluid (vomiting,

diarrhea, GI suction, intestinal fistulas,

overdiuresis)

BUN 8–20 mg/dL 2.8–7.1

mmol/L

0.357 End product of protein metabolism,

produced by liver, transported in blood,

excreted renally. ↑ in renal dysfunction,

high protein intake, upper GI bleeding,

volume contraction

Creatinine ≤1.5 mg/dL ≤133 μmol/L 88.4 Major constituent of muscle; rate of

formation constant; affected by muscle

mass (lower with aging and gender);

excreted renally. ↑ in renal dysfunction.

Used as a primary marker for renal

function (GFR)

CrCl 90–130 mL/minute 1.5–2.16 mL/s 0.01667 Reflects GFR; ↓ in renal dysfunction.

Used to adjust dosage of renally

eliminated drugs

Estimated

GFR

90–120

mL/minute/1.73 m

2

n/a n/a Possibly a more accurate reflection of

renal function than CrCl. Still influenced

by muscle mass

Cystatin C <1.0 mg/dL <0.749 μmol/L 0.749 Indicator of renal function—not influenced

by patient muscle mass, age, or sex. May

also help predict patients at risk for

cardiovascular disease

Glucose

(fasting)

65–115 mg/dL 3.6–6.3

mmol/L

0.05551 ↑ in diabetes or by adrenal corticosteroids

Glycosylated

hemoglobin

3.8%–6.4% 3.8%–6.4% 1 Used to assess average blood glucose over

1–3 months. Used to diagnose diabetes,

monitor disease progression, and/or assess

the efficacy of drug therapy

Calcium—total 8.6–10.3 mg/dL 2.2–2.74

mmol/L

0.250 Regulated by body skeleton redistribution,

parathyroid hormone, vitamin D, calcitonin.

Affected by changes in albumin

concentration. Total calcium ↓ when

albumin ↓ (the serum total calcium

concentration falls by 0.8 mg/dL for every

1-g/dL fall in serum albumin concentration).

↓ by hypothyroidism, loop diuretics, vitamin

D deficiency; ↑ in malignancy and

hyperthyroidism

Calcium—

unbound

(ionized)

4.4–5.1 mg/dL 1–1.3 mmol/L 0.250 Physiologically active form. Unbound

“free” calcium remains unchanged as

albumin fluctuates

Magnesium 1.3–2.2 mEq/L 0.65–1.1

mmol/L

0.51 ↓ in malabsorption, severe diarrhea,

alcoholism, pancreatitis, diuretics,

hyperaldosteronism (symptoms of

weakness, depression, agitation, seizures,

hypokalemia, arrhythmias). ↑ in renal

failure, hypothyroidism, magnesiumcontaining antacids

Phosphate

(inorganic

phosphorus)

2.5–5 mg/dL 0.8–1.6

mmol/L

0.323 ↑ with renal dysfunction, hypervitaminosis

D, hypocalcemia, hypoparathyroidism. ↓

with excess aluminum antacids,

malabsorption, renal losses, hypercalcemia,

refeeding syndrome

Uric acid 3–8 mg/dL <0.42 mmol/L 0.06 ↑ in gout, neoplastic, or myeloproliferative

disorders, and drugs (diuretics, niacin, lowdose salicylate, cyclosporine)

Proteins

Prealbumin 19.5–35.8 mg/dL 195–358 mg/L 10 Indicates acute changes in nutritionalstatus,

useful for monitoring TPN

Albumin 3.6–5 g/dL 36–50 g/L 10 Produced in liver; important for

intravascular osmotic pressure. ↓ in liver

disease, malnutrition, ascites, hemorrhage,

protein-wasting nephropathy. May influence

highly protein-bound drugs

Globulin 2.3–3.5 g/dL 23–35 g/L 10 Active role in immunologic mechanisms.

Immunoglobulins ↑ in chronic infection,

rheumatoid arthritis, multiple myeloma

CK Female: 20–170

IU/L

Male: 30–220 IU/L

Female: 0.33–

2.83 μkat/L

Male: 0.5–3.67

μkat/L

0.01667 In tissues that use high energy (skeletal

muscle, myocardium, brain). ↑ by IM

injections, MI, acute psychotic episodes.

Isoenzyme CK-MM in skeletal muscle;

CK-MB in myocardium; CK-BB in brain.

MB fraction >5%–6% suggests acute MI

CK-MB <6% <6% 0.01667

cTnI 0–0.04 ng/mL 0–0.04 mcg/L 1 More specific than CK-MB for myocardial

necrosis; cTnI >0.04 suggests acute

myocardial necrosis

p. 18

p. 19

Myoglobin Female: 12–76

mcg/L

Male: 19–92 mcg/L

Female: 12–76

mcg/L

Male: 19–92

mcg/L