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administration to serum sample acquisition. When serum drug levels
are obtained, they must be reviewed for validity before alterations in
medication regimens are made. If a serum drug concentration seems
unusually high or low, the clinician must consider all of the various
factors that might influence the serum concentration of the drug in
that particular patient. When the reason for an unexpected abnormal
serum drug concentration is not apparent, the test should be
repeated before considering a dose change that may cause
supratherapeutic or subtherapeutic concentrations resulting from
erroneous data (see Chapter 2, Interpretation of Clinical Laboratory
Tests).
When M.C. was seen in the community pharmacy, the pharmacist
assessed her chronic conditions, her cost issues, and her drug
therapy. Monitoring in the community pharmacy–based MTM
program occurs at regular time intervals and is less sensitive to the
day-to-day changes of the patient. However, in the inpatient setting,
M.C. has acute conditions (renal failure and urosepsis) in addition to
her chronic conditions. Monitoring of medication therapy will occur
frequently, resulting in a dynamic treatment plan for her acute and
chronic conditions.
Although the inpatient setting is relatively data rich, the information
gathered and the assessment and plan formulated in the facility must
be communicated to other providers once the patient is discharged.
At discharge, it is critical to ensure that the patient has follow-up with
their primary care physician or coordinated care team in a timely
manner. At this point, it is again critical for the pharmacist to perform
medication reconciliation to determine exactly what did happen once
the patient returned home. This closes the loop at a critical time
when the patient is prone to medication errors and readmission.
MEDICATION THERAPY MANAGEMENT AND
PHARMACOGENOMICS
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The use of genetic information to predict an individual’s response to
a drug, known as pharmacogenomics, is currently factoring into drug
design and development. Using genetic information to tailor drug
therapy for an individual will reduce the risk of adverse events,
potentially improve patient outcomes, and create a more efficient
drug development process. By transforming drug therapy into a
patient-specific approach, the health care community is one step
closer to achieving the new medical paradigm of personalized health
care.
33
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
and 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).
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 that encourages and promotes the use of the
clinical expertise of pharmacists working in collaboration with other
health care providers and laboratories should be developed for these
practices. The development of technology solutions that support the
pharmacist’s role in this emerging field should also be encouraged
and directed.
33
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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 who 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.
ACKNOWLEDGMENTS
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/AT12e. Given here 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
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1.
2.
3.
elements of an MTM service model (version 2.0). J Am Pharm Assoc (2003).
2008;48(3):341–353. (24)
Bluml BM. Definition of medication therapy management: development of
professionwide consensus. J Am Pharm Assoc (2003). 2005;45(5):566–572.
(1)
Cipolle RJ, Strand L, Morley P, Cipolle R, eds. Pharmaceutical Care Practice: The
Clinician’s Guide. 2nd ed. McGraw-Hill; 2004. (15)
Health Care and Education Reconciliation Act of 2010. Pub L No. 111–152, 124
Stat 1029. (7)
Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care.
Am J Hosp Pharm. 1990;47(3):533–543. (3)
Office of the National Coordinator for Health Information Technology (ONC),
Department of Health and Human Services. Health information technology:
initial set of standards, implementation specifications, and certification criteria
for electronic health record technology. Fed Regist. 2010;75(144):44589–
44654. (16)
Patient Protection and Affordable Care Act (PPACA). Pub L No. 111–148, 124 Stat
119. (6)
Rovers JP, Currie JD, eds. A Practical Guide to Pharmaceutical Care: A Clinical
Skills Primer. 3rd ed. American Pharmacists Association; 2007. (4)
Key Website
Ambulatory Health Care: 2022 National Patient Safety Goals. Joint Commission on
Accreditation of Healthcare Organizations.
https://www.jointcommission.org/standards/national-patient-safetygoals/ambulatory-health-care-national-patient-safety-goals/
COMPLETE REFERENCES CHAPTER 1
MEDICATION THERAPY MANAGEMENT AND
ASSESSMENT OF THERAPY
Bluml BM. Definition of medication therapy management: development of
profession wide consensus. J Am Pharm Assoc (2003). 2005;45(5):566–572.
Wolters Kluwer. A decade of Medicare Part D: driving MTM services.
Accessed November 6, 2020. https://www.wolterskluwer.com/en/expertinsights/a-decade-of-medicare-part-d-driving-mtm-services
Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical
care. Am J Hosp Pharm. 1990;47(3):533–543.
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4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Rovers JP, Currie JD, eds. A Practical Guide to Pharmaceutical Care: A
Clinical Skills Primer. 3rd ed. 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–
495.
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.
Raghupathi W. An empirical study of chronic diseases in the United States: a
visual analytics approach to public health. Int J Environ Res Public Health.
2018;15(3):431. doi:10.3390/ijerph15030431
Tinker A. How to improve patient outcomes for chronic diseases and
comorbidities. Accessed December 30, 2020.
http://www.healthcatalyst.com/wp-content/uploads/2014/04/How-to-ImprovePatient-Outcomes.pdf
ASHP-APhA Medication Reconciliation Initiative Workgroup Meeting,
February 12, 2007. Accessed July 4, 2017.
https://www.ashp.org/-/media/assets/pharmacy-practice/resourcecenters/quality-improvement/care-coordination-medication-reconciliationinitiative-workgroup-meeting.pdf
National Patient Safety Goals. Joint Commission on Accreditation of
Healthcare Organizations. Accessed July 4, 2017.
https://www.jointcommission.org/standards/national-patient-safety-goals/
National Patient Safety Goals. Joint Commission on Accreditation of
Healthcare Organizations. Accessed June 17, 2015.
http://www.jointcommission.org/standards_information/npsgs.aspx
2020 National Patient Safety Goals. Joint Commission on Accreditation of
Healthcare Organizations. Accessed December 1, 2020.
https://www.jointcommission.org/-/media/tjc/documents/standards/nationalpatient-safety-goals/2020/simplified_2020-ome-npsgs-eff-july-final.pdf
Centers for Medicare and Medicaid Services. 2017 Start Ratings. Accessed
December 1, 2020. https://www.cms.gov/newsroom/fact-sheets/2017-starratings
Cipolle RJ, Strand L, Morley P, Cipolle R, eds. Pharmaceutical Care Practice:
The Clinician’s Guide. 2nd ed. McGraw-Hill; 2004.
Office of the National Coordinator for Health Information Technology (ONC),
Department of Health and Human Services. Health information technology:
initial set of standards, implementation specifications, and certification criteria
for electronic health record technology. Fed Regist. 2010;75(144):44589–
44654.
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17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
Miller WR, Rollnick S. Motivational Interviewing: Preparing People to Change
Addictive Behavior. Guilford Press; 1991.
Center for Substance Abuse Treatment. Motivational interviewing as a
counseling style. In: Enhancing Motivation for Change in Substance Abuse
Treatment. Substance Abuse and Mental Health Services Administration
(US); 1999:chap 3. Treatment Improvement Protocol (TIP) Series, No. 35.
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):2221–2225.
Varkey P, Cunningham J, O’Meara J, Bonacci R, Desai N, Sheeler R.
Multidisciplinary approach to inpatient medication reconciliation in an
academic setting. Am J Health Syst Pharm. 2007;64(8):850–854.
Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and
severity of adverse events affecting patients after discharge from the
hospital. Ann Intern Med. 2003;138(3):161–167.
Unroe KT, Pfeiffenberger T, Riegelhaupt S, Jastrzembski J, Lokhnygina Y,
Colón-Emeric C. 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, Shannon MW, Valim C, Mandl KD. Adverse drug events in the
outpatient setting: an 11-year national analysis. Pharmacoepidemiol Drug
Saf. 2010;19(9):901–910.
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):341–353.
Gray C, Cooke CE, Brandt N. Evolution of the Medicare Part D Medication
Therapy Management Program from inception in 2006 to the present. Am
Health Drug Benefits. 2019;12(5):243–251.
Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term
clinical and economic outcomes of community pharmacy diabetes care
program. J Am Pharm Assoc (Wash). 2003;43(2):173–184.
Chrischilles EA, Carter BL, Lund BC, et al. Evaluation of the Iowa Medicaid
pharmaceutical case management program. J Am Pharm Assoc (2003).
2004;44(3):337–349.
Bodenheimer T, Chen E, Bennett HD. Confronting the growing burden of
chronic disease: can the U.S. health care workforce do the job? Health Aff
(Millwood). 2009;28(1):64–74.
Smith M, Bates DW, Bodenheimer T, Cleary PD. Why pharmacists belong in
the medical home. Health Aff (Millwood). 2010;29(5):906–913.
Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the
primary prevention of cardiovascular disease: a report of the American
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College of Cardiology/American Heart Association Task Force on Clinical
Practice Guidelines. Circulation. 2019;140(11):e596–e646.
https://doi.org/10.1161/CIR.0000000000000678
Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH.
Updating the Beers criteria for potentially inappropriate medication use in
older adults. Arch Intern Med. 2003;163(22):2716–2724.
American Geriatrics Society. Pharmacological management of persistent
pain in older persons. J Am Geriatr Soc. 2009;57(8):1331–1346.
Reiss SM; American Pharmacists Association. Integrating
pharmacogenomics into pharmacy practice via medication therapy
management. J Am Pharm Assoc. 2011;51:e64–e74.
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1
2
3
2
Interpretation of Clinical
Laboratory Tests
Erika Felix-Getzik, Yulia A. Murray, and Stefanie C. Nigro
CORE PRINCIPLES
CHAPTER CASES
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 clinical
situation 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
Case 2-1 (Question 1)
Case 2-2 (Question 1)
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4
factors including statistical and
preanalytical variations, accuracy, and
precision.
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)
INTRODUCTION
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-thecounter 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
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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.
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,
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