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Applied Therapeutics: The Clinical Use of Drugs

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This widely used text uses a case-based approach to help students master the fundamentals of drug therapeutics. Students will learn the basics of common diseases and disorders and develop practical problem-solving skills for devising and implementing successful drug treatment regimens. Case studies integrated into each chapter illustrate key concepts and principles of therapeutics and give students practice in developing their own evidence-based therapeutic plans. This completely updated Ninth Edition incorporates the latest drug treatments and therapeutic practices and guidelines. New chapters cover pharmacogenomics and osteoporosis. Transplantation is now broken into two chapters to ensure adequate coverage. Culturally competent care issues are now incorporated into many chapters. Over 850 tables provide quick access to comparative drug information, pharmacokinetic properties, treatment options, dosing guidelines, risk factors, and disease and diagnosis information. A companion Website offers the fully searchable text, animations of pathophysiologic concepts, and additional case studies.
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Editors: Koda-Kimble,
Mary Anne; Young, Lloyd Yee; Alldredge, Brian K.; Corelli, Robin L.;
Guglielmo, B. Joseph; Kradjan, Wayne A.; Williams, Bradley R.

Title: Applied Therapeutics: The Clinical Use Of Drugs, 9th Edition

Copyright ©2009 Lippincott Williams & Wilkins

 > Table of Contents > Section
One - General Principles > Chapter 1 - Assessment of Therapy and
Medication Therapy Management

Chapter 1

Assessment of Therapy and Medication Therapy Management

Marilyn R. Stebbins

Timothy W. Cutler

Patricia L. Parker

This chapter presents several approaches to assessing
drug therapy and provides the framework for medication therapy
management services (MTMS) across the continuum of care. The
illustrations in this chapter primarily focus on the pharmacist;
however, the principles used to assess patient response to drug therapy
are of value to all health care providers.

MTMS was first described in the Medicare Modernization
Act of 2003 (MMA 2003), which also established the first outpatient
prescription drug benefit (also known as Part D) for those eligible for
Medicare.1 MTMS was defined in MMA 2003 as a
program of drug therapy management that may be furnished by a
pharmacist and that is designed to assure, with respect to targeted
beneficiaries described in clause (ii), that covered Part D drugs under
the prescription drug plan are appropriately used to optimize
therapeutic outcomes through improved medication use, and to reduce the
risk of adverse events, including adverse drug interactions. Such a
program may distinguish between services in ambulatory and
institutional settings.

According to MMA 2003, individuals can qualify to receive MTMS if they meet the following three criteria:

		Take multiple Medicare Part D–covered drugs

		Have multiple chronic diseases

		Are likely to incur annual costs of at least $4,000 for all covered Part D drugs

Although MTMS is the term used in MMA 2003 to describe
medication management for those eligible under the Medicare Part;  D
benefit, the same approach may be used for any patient. To respond to
the need for further clarification of the term MTMS, 11 professional
pharmacy associations more formally defined MTMS in a consensus
document published in 2004.2
According to this definition, MTMS could be applied to any patient in a
variety of settings. Furthermore, this definition clarifies the type of
activities involved in a medication therapy management (MTM) program.

MTMS has a direct relationship to pharmaceutical care. Pharmaceutical care has been described as the responsible provision of drug therapy to achieve definite outcomes that are intended to improve a patient's quality of life.3,4 In fact, MTMS has been described as a service provided in the practice of pharmaceutical care.5 However, unlike pharmaceutical
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care, MTMS is recognized by payers, has current procedural technology
(CPT) codes specifically for pharmacists, and has several clearly
defined interventions. Therefore, MTMS will be the term used to
describe the activity of MTM in various patient populations.

Both patient self-care and medication reconciliation are
critical aspects of any MTMS encounter regardless of the setting (i.e.,
inpatient, community, ambulatory, or institutional). Patient self-care
is defined by the World Health Organization as those activities
[that] individuals, families, and communities undertake with the
intention of enhancing health, preventing disease, limiting illness,
and restoring health. These activities are derived from knowledge and
skills from the pool of both professional and lay experience. They are
undertaken by lay people on their own behalf, either separately or in
participative collaboration with professionals.6
Patient self-care requires the patient to take responsibility for the
illness; however, the help of a professional to structure healthy
self-care is important. For example, patients with diabetes who monitor
their blood glucose levels regularly and adjust their diet according to
the guidelines published from the American Diabetes Association (ADA)
would be practicing self-care. Self-care is often the work that the
patient performs between visits with the provider. The patient should
be involved in his own care to ensure the best outcomes.

Medication reconciliation is the process by which
medication prescribing accuracy is ensured from one care setting to
another or from one practitioner to another. Although not a new concept
to the profession of pharmacy, there has been heightened awareness and
intensified effort in this area of practice as a result of the Joint
Commission. The Joint Commission is the national accrediting body for
hospitals and other health care delivery organizations that has
committed to improving patient care through an inspection and
evaluation process. Through this process, the Joint Commission holds
institutions to national consensus-based standards. In 2005, the Joint
Commission announced its National Patient Safety Goal (NPS goal 8A and
8B) to accurately and completely reconcile medications across the continuum of care.
This NPS goal required institutions to develop and test processes for
medication reconciliation and to implement them by January 2006.7

The general approach to an MTMS patient encounter in various clinical settings will be discussed in the next sections. Figure 1-1
provides an overview of a patient encounter that includes patient
information gathering from various data sources; interviewing the
patient while utilizing effective communication skills; assessing the
medical illness(es); developing a plan to manage the illness(es);
documenting the service (including billing); and monitoring, follow-up,
or referral for any additional issues that cannot be resolved during
the encounter.

Sources of Patient Information

Successful patient assessment and monitoring requires the gathering and organization of all relevant information.4,8
The patient (or family member or other representative) is always the
primary source of information. The provider asks the patient a series
of questions to obtain subjective information that is helpful in making
a diagnosis or evaluating ongoing therapy. Likewise, pharmacists, home
care nurses, and other providers without direct access to patient data
also must obtain subjective data or measure objective physical data to
guide recommendations for therapy and to monitor previously prescribed

Data-Rich Environment

In a “data-rich environment,” such as a hospital,
long-term care facility, or outpatient medical clinic, a wealth of
information is available to practitioners from the medical record,
pharmacy profile, and nursing medication administration record (MAR).
In these settings, physicians, nurses, and patients are readily
available. This facilitates timely, effective communication among those
involved in the drug therapy decision-making process. Objective data
(e.g., diagnosis, physical examination, laboratory and other test
results, vital signs, weight, medications, medication allergies,
intravenous flow rates, and fluid balance) are readily available.
Likewise, the cases presented throughout this text usually provide
considerable data on which to make more thorough assessments and
therapeutic decisions. The patient record provides readily available
information that is needed to identify and assess medical problems. It
is necessary in order to design patient specific care plans and
document MTMS. In some settings, patient insurance information is
important to help understand the formulary choices and coverage of
medications. When billing for MTMS, this insurance information is very
important and would be available in a data-rich environment.

Paper Charts

A paper chart may be a source of valuable patient
information. Paper charts may exist in a variety of settings, including
the hospital, outpatient clinic, or institutional setting. This source
of information is considered data rich but does have limitations. Paper
charts are organized differently by site and by setting. The
information contained in a hospital chart will be different from that
contained in an outpatient clinic. Furthermore, it may be difficult to
obtain a paper chart, or access may be delayed if another professional
is using the chart. Significant data delays may occur in paper charts,
as information such as laboratory results, test results, and chart
notes may not be placed in the chart for several days after the test or
documentation is complete. As a result, it is important to realize the
limitations of this data-rich environment and that the information
obtained during the patient interview is still extremely important.

Electronic Medical Record

An electronic medical record (EMR) is an electronic
version of the paper chart. Once again, these records are available in
hospitals, clinics, and institutional settings, but the type of EMR and
the organization of information will vary among the different settings
and software applications. The EMR provides a wealth of information and
is one of the most complete sources of reliable information. Unlike a
paper chart, the EMR may be interfaced with the laboratory, pharmacy,
and radiology systems so that data is available real time with minimal
delays. Unfortunately, clinicians may rely on the EMR too much for the
patient information, which could lead to assumptions. For example, a
patient who has metformin 500 mg twice daily listed in the EMR may
actually be taking the medication once daily. Therefore, the data in
the EMR is extremely useful, but it is still important to obtain
information directly from the patient.

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		[image: ]

		Figure 1-1 General approach to a patient encounter.

Data-Poor Environment

In reality, clinicians are often required to make
assessments with limited information. Even in a relatively data-poor
environment, such as a community pharmacy, valuable sources of
information are still available, including (a) the medication profile,
(b) patient data, and (c) the patient's insurance coverage information.
In addition, it is often possible to consult with the prescriber (or
the prescriber's office staff); however, contact may be delayed, and
requests for information may be met with resistance due to time
constraints or other factors. As illustrated later in this chapter, the
successful practitioner can make assessments and intervene on the
patient's behalf even in the absence of all the available information.

Pharmacy Information Systems

Pharmacy information systems (PIS) are generally
considered data poor. When discussing PIS, it is important to look at
both inpatient and outpatient PIS. Pharmacy billing and inventory
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were the motivation behind the establishment of the early PIS. These
initial systems provided fill lists, generated patient profiles, and
produced medication labels, which were valuable to institutional
pharmacies as the profession moved toward a unit dose medication
distribution system. More modern functionalities allow for some limited
documentation of clinical pharmacy activities, but still, this system
is data poor. Current work flow for institutions functioning off of PIS
consists of medication processing via a physician-generated hard copy
medication order, which is provided to the pharmacy via delivery,
facsimile, or scanner. After pharmacist review of the medication order
for clinical appropriateness, the nurse is provided access to the
medication either by direct pharmacy delivery or by means of an
automated dispensing system. The nurse ensures that the patient
receives the medication at the appropriate time and documents the
administration on the medication administration record (MAR). Increased
emphasis on patient safety has highlighted the importance of
integrating PIS with other computerized systems utilized throughout the
inpatient setting. This involves a transition from PIS to a data-rich
clinical information system (CIS), which includes direct computerized
physician order entry, clinical decision support, EMR, an electronic
medication administration record (eMAR), and integration of various
ancillary information systems such as pharmacy and laboratory services.
Additional functionality incorporates the use of bar code technology,
which allows the ability to track and promote quality assurance during
the medication administration process. Information generated by the CIS
is electronically transmitted to the pharmacy in real time, eliminating
lost, illegible, or incomplete medication orders. Improved
communication between various health care providers, decreased
medication turnaround time, enhanced compliance with medication use
policies and formularies, and reductions in medication errors may be
benefits seen from this system. Although increasing numbers of
institutions are incorporating this technology into their practice
settings, implementation of CIS in hospitals has not occurred for
numerous reasons, including expense and system complexity.

A variety of outpatient PIS exist. Some of these systems
contain only basic data such as the medication profile, refill history,
allergies, and insurance information. Other PIS allow the pharmacist to
enter information such as progress notes, vital signs (blood pressure
[BP], pulse, respirations), and lab results (blood glucose, cholesterol
levels), but these systems are rarely linked to an EMR. Therefore, the
information contained in the outpatient PIS is dependent on the ability
of the pharmacist to obtain the information. As pharmacists perform
more advanced services in the community pharmacy (such as
immunizations, tobacco cessation, MTMS, etc.) that require
documentation of services, the PIS will need to become a more robust
source of data.

Especially in a data-poor environment, it is important
that the clinician be a proactive interviewer where the interviewer
often becomes an investigator. The investigative approach is direct and
requires strong problem-solving abilities as well as requires the
interviewer to actively listen to the patient. Questions should be
formulated to obtain information such as the medication history, actual
medication use, patient perception of care, use of over-the-counter
(OTC) and natural or herbal products, and health beliefs (cultural or
otherwise). This approach with the patient can help to verify and
ensure the accuracy of other data sources. Not all patients are
reliable historians, and some are poor sources of information. Even
when the patient is a poor historian, the interview is a critical
source of information that cannot be obtained from other data sources.
Patient interview techniques will be discussed in the next section.

Effective Communication and the patient Interview

The ability to use effective communication principles and history-taking skills is crucial to a successful patient interaction.4,8
The importance of interviewing the patient, how to set the stage for
the interview, general interview rules, and the essential information
to be obtained from the interview are outlined in Table 1-1.

Ideally, the initial patient interaction should occur by
appointment in a private, professional, and unhurried environment;
however, the ideal often is not an option. The setting
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be the pharmacy, a clinic, or the bedside. Regardless of the setting,
the process may be expedited by asking or helping the patient to
complete a written self-assessment history form (current medical
conditions and medications, height, weight, allergies, adverse drug
reactions, immunizations, tobacco and alcohol use, pregnancy status,
etc.) before obtaining a verbal history. Figure 1-2 presents a sample form.4

		Table 1-1 Interviewing the Patient

						Importance of Interviewing the Patient

Establishes professional relationship with the patient to:		Obtain subjective data on medical problems

		Obtain patient-specific information on drug efficacy and toxicity

		Assess the patient's knowledge about, attitudes toward, and pattern of medication use

		Formulate a problem list

		Formulate plans for medication teaching and pharmaceutical care

		How to Set the Stage for the Interview

		Have the patient complete a written health and medication questionnaire, if available

		Introduce yourself

		Make the setting as private as possible

		Do not allow friends or relatives without permission of the patient

		Do not appear rushed

		Be polite

		Be attentive

		Maintain eye contact

		Listen more than you talk

		Be nonjudgmental

		Encourage the patient to be descriptive

		Clarify by restatement or patient demonstration (e.g., of a technique)

		General Interview Rules

		Read the chart or patient profile first

		Ask for the patient's permission to conduct an interview or make an appointment to do so.

		Begin with open-ended questions

		Move to close-ended questions

		Document interaction

		Information to Be Obtained

		History of allergies

		History of adverse drug reactions

		Weight and height

		Drugs: dose, route, frequency, and reason for use

		Perceived efficacy of each drug

		Perceived side effects

		Adherence to prescribed drug regimen

		Nonprescription medication use (including complementary and alternative medications)

		Possibility of pregnancy in women of childbearing age

		Family or other support systems

		Adapted from work by Teresa O'Sullivan, PharmD, University of Washington.


Once the self-assessment form is completed and reviewed,
the pharmacist can focus on the patient interview. Setting the stage
for the interview and getting off to a good start can be accomplished
by greeting the patient with a smile, providing formal introductions,
and explaining the purpose of the encounter. Asking the patient what
expectations she may have will help to ensure that concerns are
addressed. At this point, several other key issues may surface. During
the interview, language barriers or cultural issues may be identified
that need to be addressed. This will also provide an opportunity to
look for clues that can help to determine the patient's level of health
literacy. These concepts will be discussed later in this section.
Specific communication skills that can be used to guide the
practitioner through a productive patient interview include the

		Effective questioning by using open-ended questions

		Active listening

		Reflective responding

		Careful attention to body language

		Identifying cultural differences and disparities

		Understanding the patient's level of health literacy

Effective questioning techniques include both open- and
closed-ended questions. To the extent possible, the practitioner should
ask open-ended questions so that the patient is encouraged to explain
and elaborate. Skilled use of these questions puts the practitioner in
the role of observer, listener, recorder, and prompter and the patient
in the role of storyteller. This technique also allows the practitioner
to assess quickly the patient's depth of knowledge and understanding of
his medications and health situation. For example, at the beginning of
the interview, the practitioner may ask, “If there is one thing I can
accomplish for you today, what would that be?” Or, perhaps during the
interview when discussing adherence to a specific medication, the
practitioner may ask, “How many times a day do you take this
medication?” or “What time of day do you take this medication?” To
conclude the interview, the practitioner may choose to ask, “Just to be
sure we haven't missed anything important, what other medication issues
have you had since your last visit?” Open-ended questions are asked one
at a time with a pause in between each to allow the patient to answer.
Closed-ended questions (e.g., those that can be simply answered “yes”
or “no”) can be used to prompt patients who know little about their
health situation and to systematically minimize inadvertent omissions.
If closed-ended questioning is used, all “yes or no” responses should
be followed with additional questions such as, “Please explain what you

The patient should be encouraged to do most of the
talking, while the practitioner utilizes active listening techniques.
In order to be an effective active listener, distractions should be
minimized. This may be difficult in certain settings, but finding a
private area for the interview, ensuring that mobile phones and pagers
are off (or at a minimum set to the silent or vibrate mode), and not
allowing interruption from the staff during the visit can all lead to
enhanced communication. The active listening technique requires the
interviewer to focus on what the patient is saying without
interrupting. Providing verbal and nonverbal cues such as “Yes, please
go on” or nodding affirmatively lets the patient know that the
practitioner is listening.

Reflective responding allows the practitioner to
periodically check in with the patient to ensure understanding of what
the patient is communicating. This technique demonstrates caring and
helps to build a rapport with the patient. An example of reflective
responding may be, “From what you have told me, I understand that you
are not taking your medications because they are too expensive” or “It
seems like you are not having any difficulty taking your new
cholesterol medication.” By periodically summarizing the information
obtained from the patient, the practitioner can clarify and bring
closure to one segment of the interview before progressing further.

As the practitioner gains experience and becomes more
sophisticated in interviewing patients, subtle clues (e.g., unusual
information, observation, and body language) can be used to pursue a
line of questioning that could explain an unexpected problem or clarify
an existing problem. For example, a patient may become very nervous and
fidget when asked to play back what was explained to her, or she may
state, “I understood everything you said, and I don't need to waste
your time repeating it.” This may be a sign that the patient is hearing
impaired or has cognitive difficulties that need to be addressed.

Cultural differences and health disparities must also be
recognized and addressed for practitioners to achieve successful health
outcomes. By definition, cultural competence is a set of congruent
behaviors, attitudes, and policies that come together among a group of
people, a system, or an agency that enables them to work effectively in
cross-cultural situations.9 There are several core elements to cultural competence:

		Awareness and acceptance of difference

		Awareness of one's cultural values

		Development of knowledge of different cultures

		Understanding the dynamics of difference

		Ability to adapt skills to fit the cultural context of others

Health disparities refer to gaps in the quality of health and health care across racial, ethnic, and socioeconomic groups.10
These gaps result in worse clinical outcomes, and these differences
persist after adjustment for known factors including, but not limited
to, social determinants and access to health care. It is generally
accepted that disparities can result from three main areas:11,12

		From the personal, socioeconomic, and environmental characteristics of different ethnic and racial groups

		From the barriers encountered by certain racial and ethnic groups when trying to enter into the health care delivery system

		From the quality of health care that different ethnic and racial groups receive

In order to provide culturally competent care,
practitioners must tailor care to meet the patient's linguistic,
cultural, and social needs, recognizing that communication is directly
linked to health outcomes. Linguistically, the patient and provider's
spoken language, dialects, accents, and speed of the spoken language
are important factors that will influence communication.
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a personal or impersonal approach to the encounter is culturally
acceptable will be important to know. Also, the degree of formality
expected, appropriate subjects for conversation, directness, touch, and
loudness of conversation may play a role in the success of the
encounter. Often overlooked but critically important are health and
healing beliefs that the patient and her family or community may have.
It is only after these factors are recognized and acknowledged that a
practitioner can make recommendations and negotiate a plan with the
patient or her caregiver. From a communication standpoint, the
practitioner must determine, at a minimum, the preferred mode of
communication, the level of literacy, the preferred language, and
whether an interpreter or a cultural broker (an individual who shares
the cultural identity with the client/patient and can effectively
mediate when cross-cultural communication is necessary) is needed.

		[image: ]

		Figure 1-2 Patient history form. Reprinted with permission from Rovers JP, Currie JD. A Practical Guide to Pharmaceutical Care: A Clinical Skills Primer, Washington, DC: American Pharmacists Association; 2007, p. 61–62.

		Table 1-2 Behaviors Suggestive of Inadequate Health Literacy

						Asking for help

		Bringing someone along who can read

		Inability to keep appointments

		Making excuses like “I forgot to bring my glasses”

		Nonadherence with medications

		Poor adherence to recommended medical interventions

		Postponing making decisions

		Watching others and mimicking behaviors

Health literacy is a component of cultural competence. It was defined in the Institute of Medicine Report in 2004 as the degree
to which individuals have the capacity to obtain, process, and
understand basic health information and services needed to make
appropriate health decisions.13
There are several behaviors or cues that may be suggestive of
inadequate health literacy skills that a provider can look for when
interacting with patients. These behavioral cues can be found in Table 1-2.
There are several communication techniques that may be helpful in
determining the level of health literacy and may aid the provider in
addressing a patient with inadequate health literacy. These
communication techniques are presented in Table 1-3.

In all interactions, the health care provider must treat
the patient with respect as well as make every effort to ask questions
and receive information in a nonjudgmental way (e.g., “Please tell me
how you take your medications” as opposed to “Do you take your
medications exactly as prescribed?”). Practitioners who provide MTMS
must keep in mind that patients hold them in trust and often share
intimate details of their medical and social histories. Thus,
practitioners must maintain the confidentiality of that information and
share it only with those providers who need this information to provide
patient care. Additionally, clinicians must adhere to the regulations
set forth by the Health Insurance Portability and Accountability Act
(HIPAA) of 1996, which provides standards to protect the security and
confidentiality of individually identifiable protected health
information (PHI). PHI includes information created during the
provision of patient care that can be linked with a specific patient.
Examples of PHI include the patient's name, home address, date of
birth, medical record number, medical diagnoses, treatment records,
prescriptions, and laboratory and test results. Further discussion of
the HIPAA regulations is beyond the scope of this chapter; consult the
U.S. Department of Health and Human Services website for additional

		Table 1-3 Communication Tips for Identifying and Addressing Inadequate Health Literacy

						Assess patient's baseline understanding before providing extensive information

		Speak slowly

		Use lay language instead of medical terminology

		Emphasize only 1 to 3 points in any one encounter

		Encourage questions by using the open-ended question approach

		Show or draw pictures to enhance understanding and subsequent recall, if appropriate

		Use the teach-back or show-me method

		Write down important instructions

		Provide useful educational materials

		Be respectful, caring, and sensitive

Obtaining A patient History

Those who provide MTMS should develop standardized forms
to record patient information obtained from the patient interview.
Standardization facilitates quick retrieval of information, minimizes
the inadvertent omission of data, and enhances the ability of other
practitioners to use shared records.4,8

For convenience, the patient interview and record can be
divided into sections with subjective and objective data as well as an
assessment and plan (including expected outcomes). Components of
subjective and objective data are the medical history, drug history,
and social history. In some situations, these histories can be
supplemented by the generation of flowchart diagrams to monitor changes
in specific parameters (e.g., blood glucose concentration, BP, weight)
over time. These charts and documentation systems may be incorporated
into the EMR, PIS, or a similar electronic platform.

Medical History

The medical history is essential to the provision of
MTMS. It can be as extensive as the medical records that are maintained
in an institution or physician's office, or it can be a simple patient
profile that is maintained in a community pharmacy. The purpose of the
medical history is to identify significant past medical conditions or
procedures; identify, characterize, and assess current acute and
chronic medical conditions and symptoms; and gather all relevant health
information that could influence drug selection or dosing (e.g.,
function of major organs such as the gastrointestinal tract, liver, and
kidney, which are involved in the absorption and elimination of drugs;
height and weight, including recent changes in either; age and gender;
pregnancy and lactation status; and special nutritional needs). Not all
interviews require the interviewer to ask for this much general
information; however, in a data poor environment, more information is
required directly from the patient. A more focused interview may be
appropriate in settings where the information required is available
electronically or is specific to a single disease state. For example,
in an anticoagulation clinic, the information that is elicited from the
patient is often specific to the patient's anticoagulation therapy
(e.g., bleeding incidents,
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newly started medications, dietary changes, missed warfarin doses, etc.).

P.J., a 45-year-old woman of normal height and weight, states that she
has diabetes. What questions might the practitioner ask of P.J. to
determine whether type 1 or type 2 disease should be documented in her
medical history?

Patients usually can enumerate their medical problems in
a general way, but the practitioner often will have to probe more
specifically to refine the diagnosis and assess the severity of the
condition. Diabetes mellitus is used to illustrate the types of
questions that can be used to gather important health information and
assess drug therapy. The following questions should generate
information that will help to determine whether P.J. has type 1 or type
2 diabetes mellitus.

		How old were you when you were told you had diabetes?

		Do any of your relatives have diabetes mellitus? What do you know of their diabetes?

		Do you remember your symptoms? Please describe them to me.

		What medications have you used to treat your diabetes?

When questions such as these are combined with knowledge
of the pathophysiology of diabetes, appreciation of the typical
presenting signs and symptoms of the disease, and understanding of the
drugs generally used to treat both forms of diabetes, meaningful MTM
can be provided. Even simple assessments such as the observation of a
patient's body size can provide information useful for therapeutic
interventions. For example, a person with type 2 diabetes is more
likely to be an overweight adult (see Chapter 50).

Medication History

In the community pharmacy setting, patients generally
present themselves in one of four ways: (a) with a self-diagnosed
condition for which nonprescription drug therapy is sought; (b) with a
newly diagnosed condition for which a drug has been prescribed; (c)
with a chronic condition that requires refill of a previously
prescribed drug or the initiation of a new drug; or (d) on referral
from their health plan, provider or self-referral for focused
medication therapy review (MTR). In the first and second situations,
the practitioner must confirm the diagnosis by using disease-specific
questions as illustrated in Question 1. In the
third situation, the practitioner uses the same type of questioning as
in the first two situations; however, this time the practitioner needs
to evaluate whether the desired therapeutic outcomes have been
achieved. The practitioner must evaluate the information gleaned during
follow-up visits in the context of the history and incorporate it into
his or her assessment and medication action plan (MAP). The fourth
situation, in which patients require a focused MTR, the medication and
medical history information are equally important. Without the medical
history, it is not possible to evaluate whether the drug therapy is
appropriate, and without an accurate medication history, it is not
possible to determine if the patient has reached the desired goals of
therapy for her condition. The goal of the medication history is to
obtain and assess the following information: the specific prescription
and nonprescription drugs that the patient is taking (the latter
includes OTC medications, botanicals, dietary supplements, recreational
drugs, alcohol, tobacco, and home remedies); the intended purpose or
indications for each of these medications; how taken (e.g., route,
ingestion in relation to meals), how much, and how often these
medications are used; how long these agents have been taken or used
(start and stop dates); whether the patient believes that any of these
agents are providing therapeutic benefit; whether the patient is
experiencing or has experienced any adverse effects that could be
caused by each of these agents (idiosyncratic reactions, toxic effects,
adverse effects); whether the patient has stopped taking any of the
medications for any reason; and allergic reactions and any history of
hypersensitivity or other severe reactions to drugs. This information
should be as specific as possible, including a description of the
reaction, the treatment, and the date of its occurrence.

The approach and process by which the medication history
is obtained does not necessarily change based on the setting of the
encounter. However, one primary difference in the inpatient setting is
the Joint Commission requirement for medication reconciliation. A
successful medication reconciliation process consists of a standardized
systematic approach, with the initial step in this process involving
the collection of the best medication history possible from every
patient that enters any point in the health care system. The
appropriate health care professional to obtain this information varies
widely from one institution to the next, involving an array of
individuals. Although pharmacists are uniquely qualified and have
demonstrated increased accuracy in acquiring the medication history14,
ultimately, medication reconciliation requires a multidisciplinary
effort in which all available resources are integrated into each step
of the process where appropriate.15
Shared accountability by utilizing key members of the health care team
such as direct-care nurses, pharmacy technicians, pharmacists, and the
prescriber is essential in this process. Once an accurate medication
history is obtained, the information is used to ensure that any
deviation from prescribing as the patient moves through the health care
system is deliberate and based on acute changes in the patient's
condition. If a discrepancy is an intended therapeutic decision by the
prescribing clinician, appropriate documentation with either the reason
for or intention to change, hold, or discontinue the medication should
be completed in a manner that is clear to all members of the health
care team. Unintentional variances in the lists should be considered as
potential medication errors pending clarification from the prescribing

Since medication errors are most commonly seen at
interfaces of care, the essential times to conduct medication
reconciliation are when a patient is admitted to, transferred within
(setting, service, practitioner, or level of care change), or
discharged from a health care facility.16,17
A crucial final step in the reconciliation process and a vital piece of
MTMS occurs at discharge to avoid therapeutic duplication, drug
interactions, and omissions of medications that may have been
discontinued or placed on hold during hospitalization. On departure
from the health care facility, a complete list of the patient's
medications must be communicated to the patient and the next provider
of service regardless of whether it is within or outside the
organization. It is important to realize that efforts to implement a
medication reconciliation process should not focus simply on fulfilling
a Joint Commission standard but that this process allows for informed
prescribing decisions and creates
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a safer environment for patients by improving the accuracy of medication administration throughout the continuum of care.

Perhaps the most important aspect of the medication
history is to ensure that no assumptions related to medication use go
unverified with the patient. The provider should ask questions related
to how the current medication therapy is actually taken by the patient.
The interviewer should then compare the use of medications as defined
by the patient to the prescription information on the bottle or in the
PIS/EMR. This information may identify discrepancies or
misunderstandings between the prescriber and patient. As discussed
previously, the patient may not have adequate health literacy, and the
interpretation of the medication instructions printed on the bottle or
described by a health professional may not be understandable to a
patient. The review of the medication history is an opportune time to
identify and clarify such misunderstandings.

2. P.J. has indicated that she is
injecting insulin to treat her diabetes. What questions might be asked
to evaluate P.J.'s use of and response to insulin?

The following types of questions, when asked of P.J.,
should provide the practitioner with information on P.J.'s
understanding about the use of and response to insulin.

Drug Identification and Use

		What type of insulin do you use?

		How many units of insulin do you use?

		When do you inject your insulin in relationship to meals?

		Where do you inject your insulin? (Rather than the more judgmental question, “Do you rotate your injection sites?”)

		Please show me how
you usually prepare your insulin for injection. (This request of the
patient requires the patient to demonstrate a skill.)

		What, if anything, keeps you from taking your insulin as prescribed?

Assessment of Therapeutic Response

		How do you know if your insulin is working?

		What blood glucose levels are you aiming for?

		How often and when during the day do you test your blood glucose concentration?

		Do you have any blood glucose records that you could share with me?

		Would you show me how you test your blood glucose concentration?

		What is your understanding of the hemoglobin A1c blood test?

		When was the last time you had this test done?

		What were the results of the last hemoglobin A1c test?

Assessment of Adverse Effects

		Do you ever experience reactions from low blood glucose?

		What symptoms warn you of such a reaction?

		When do these typically occur during the day?

		How often do they occur?

		What circumstances seem to make them occur more frequently?

		What do you do when you have a low blood glucose?

The patient's responses to these questions on drug use,
therapeutic response, and adverse effects will allow a quick assessment
of the patient's knowledge of insulin and whether she is using it in a
way that is likely to result in blood glucose concentrations that are
neither too high nor too low. The responses to these questions also
should provide the practitioner with insight about the extent to which
the patient has been involved in establishing and monitoring
therapeutic outcomes. Based on this information, the practitioner can
begin to formulate the patient's therapeutic plan.

Social History

The social history is used to determine the patient's
occupation and lifestyle; important family relationships or other
support systems; any particular circumstances (e.g., a disability) or
stresses in her life that could influence the MAP; and attitudes,
values, and feelings about health, illness, and treatments.

3. A patient's occupation,
lifestyle, insurance status, ability to pay, and attitudes often can
determine the success or failure of drug therapy. Therefore, P.J.'s
prescription drug coverage, nutritional history, her level of activity
or exercise in a typical day or week, the family dynamics, and any
particular stresses that may affect glucose control need to be
documented and assessed. What questions might be asked of P.J. to gain
this information?


		Describe a typical work day and a typical weekend day.


		What type of
prescription drug coverage do you have? What are the copays for your
insulin and diabetic supplies? How often do you go without your insulin
or supplies due to cost?


		Describe your
exercise habits. How often, how long, and when during the day do you
exercise? Describe how you change your meals or insulin when you


		How many times per day do you usually eat? Describe your usual meal times.

		What do you usually eat for each of your main meals and snacks?

		Are you able to eat at the same time each day?

		What do you do if a meal is delayed or missed?

		Who cooks the meals at home? Does this person understand your dietary needs?

		How often do you eat meals in a restaurant?

		How do you order meals in a restaurant to maintain a proper diet for your diabetes? (Note: This is asked of patients who frequently dine in restaurants.)

Support Systems

		Who else lives with
you? What do they know about diabetes? How do they respond to the fact
that you have diabetes? How do they help you with your diabetes
management? Does it ever strain your relationship? What are the issues
that seem to be most troublesome? (Note:
These questions apply equally to the workplace or school setting.
Often, the biggest barrier to multiple daily injections is refusal of
the patient to inject insulin while at work or school.)

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		Table 1-4 Elements of the Problem Oriented Medical Recorda

				Problem name: Each
“problem” is listed separately and given an identifying number.
Problems may be a patient complaint (e.g., headache), a laboratory
abnormality (e.g., hypokalemia), or a specific disease name if prior
diagnosis is known. When monitoring previously described drug therapy,
more than one drug-related problem may be considered (e.g.,
nonadherence, a suspected adverse drug reaction or drug interaction, or
an inappropriate dose). Under each problem name, the following
information is identified:

		Subjective		Information that explains or
delineates the reason for the encounter. Information that the patient
reports concerning symptoms, previous treatments, medications used, and
adverse effects encountered. These are considered nonreproducible data
because the information is based on the patient's interpretation and
recall of past events.

		Objective		Information from physical
examination, laboratory results, diagnostic tests, pill counts, and
pharmacy patient profile information. Objective data are measurable and

		Assessment		A brief but complete
description of the problem, including a conclusion or diagnosis that is
supported logically by the above subjective and objective data. The
assessment should not include a problem/diagnosis that is not defined

		Plan		A detailed description of
recommended or intended further workup (laboratory radiology,
consultation), treatment (e.g., continued observation: physiotherapy,
diet, medications, surgery), patient education (self-care, goals of
therapy, medication use and monitoring), monitoring, and follow-up
relative to the above assessment.

		aSometimes referred to as the SOAP (subjective; objective, assessment, plan) note.


		How do you feel about having diabetes?

		What worries or bothers you most about having diabetes? (Note:
Participate in the patient's care. This approach is likely to enhance
the patient–provider relationship, which should translate into improved

Approach to and Assessment of Patient Therapy

The provider–patient encounter will vary based on the
location and type of services provided and access to necessary
information. However, the general approach to the patient encounter
should follow the problem-oriented medical record (POMR). Organizing
information according to medical problems (e.g., diseases) helps to
break down a complex situation (e.g., a patient with multiple medical
problems requiring multiple drugs) into its individual parts.3,4 The medical community has long used a POMR or SOAP note to record information in the medical record or chart by using a standardized format (Table 1-4). Each medical problem is identified, listed sequentially, and assigned a number. Subjective data and objective data in support of each problem are delineated, an assessment is made, and a plan
of action identified. The first letter of the four key words
(subjective, objective, assessment, and plan) serve as the basis for
the SOAP acronym.

The POMR is a general approach and helps to focus the
encounter, which provides a structure for the documentation of the
services provided. The following section will describe the POMR and
SOAP note in more detail.

Problem List

Problems are listed in order of importance and are
supported by the subjective and objective evidence gathered during the
patient encounter. Each problem in the list can then be given an
identifying number. All subsequent references to a specific problem can
be identified or referenced by that number (e.g., “problem 1” or simply
“1”). These generally are thought of in terms of a diagnosed disease,
but they also may be a symptom complex that is being evaluated, a
preventive measure (e.g., immunization, contraception), or a cognitive
problem (e.g., nonadherence). Problems should be identified based on
the practitioner's level of understanding. For example, the symptoms of
“difficulty breathing at night” or “two-pillow orthopnea” are
consistent with the symptom complex of heart failure (HF); however,
these symptoms could be assessed as individual problems if the student
or practitioner is unaware of the association of these symptoms with
HF. Any condition that requires a unique management plan should be
identified as a problem to serve as a reminder to the practitioner that
treatment is needed for that problem. Different settings and activities
or clinical services will determine the priority of the problems

Medical problems can be drug related,
including prescribing errors, dosing errors, adverse drug effects,
adherence issues, and the need for medication counseling. Drug-related
problems may be definite (i.e., there is no question that the problem
exists) or possible (i.e., further investigation is required to
establish whether the problem really exists). The most commonly
encountered types of drug-related problems are listed in Table 1-5.4,8

The distinction between medical problems and
drug-related problems sometimes is unclear, and considerable overlap
exists. For example, a medical problem (i.e., a disease, syndrome,
symptom, or health condition) can be prevented, cured, alleviated, or
exacerbated by medications. When assessing drug therapy, several
situations could exist: treatment is appropriate and therapeutic
outcomes have been achieved; drugs that have been selected are
ineffective or therapeutic outcomes are partially achieved; dosages are
subtherapeutic or medication is taken improperly; an inappropriate drug
for the medical condition being treated has been prescribed or is being
used; or the condition is not being treated.

Likewise, a drug-related problem can cause or aggravate
a medical problem. Such drug-related problems could include
hypersensitivity reactions; idiosyncratic reactions; toxic reactions
secondary to excessive doses; adverse reactions (e.g., insulin-induced
hypoglycemia or weight gain); drug-drug, drug-disease, drug-laboratory
test, and drug-lifestyle interactions; or polypharmacy (using multiple
medications), which may increase the risk of adverse drug events.18

Subjective and Objective Data

Subjective and objective data in support of a problem
are important because assessment of patients and therapies requires the
gathering of specific information to verify that a
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continues to exist or that therapeutic objectives are being achieved.
Subjective data refer to information provided by the patient or another
person that cannot be confirmed independently. This is the data most
commonly obtained during a patient interview. Objective data refer to
information observed or measured by the practitioner (e.g., laboratory
tests, BP measurements). The objective data is most commonly obtained
from the EMR or paper chart (data-rich-environment). However, some
objective data can be obtained in data-poor-environments. In the
absence of a medical record, weight, height, pulse, BP, blood glucose
readings, and other objective information can be gathered during the
provider–patient encounter.

		Table 1-5 Drug-Related Problems

						Drug Needed (also referred to as no drug)

		Drug indicated but not prescribed; a medical problem has been
diagnosed, but there is no indication that treatment has been initiated
(maybe it is not needed)

		Correct drug prescribed but not taken (nonadherence)

		Wrong/Inappropriate Drug

		No apparent medical problem justifying the use of the drug

		Drug not indicated for the medical problem for which it has been prescribed

		Medical problem no longer exists

		Duplication of other therapy

		Less expensive alternative available

		Drug not covered by formulary

		Failure to account for pregnancy status, age of patient, or other contraindications

		Incorrect nonprescription medication self-prescribed by the patient

		Recreational drug use

		Wrong Dose

		Prescribed dose too high (includes adjustments for renal and hepatic function, age, body size)

		Correct prescribed dose but overuse by patient (overadherence)

		Prescribed dose too low (includes adjustments for age, body size)

		Correct prescribed dose but underuse by patient (underadherence)

		Incorrect, inconvenient, or less-than-optimal dosing interval (consider use of sustained-release dosage forms)

		Adverse Drug Reaction

		Hypersensitivity reaction

		Idiosyncratic reaction

		Drug-induced dis ease

		Drug-induced laboratory change

		Drug Interaction

		Drug-drug interaction

		Drug-food interaction

		Drug-laboratory test interaction

		Drug-disease interaction

4. P.N., a 28-year-old man, has a
BP of 140/100 mmHg. What is the primary problem? What subjective and
objective data support the problem, and what additional subjective and
objective data are not provided but usually are needed to define this
particular problem?

The primary problem is hypertension. No subjective data
are given. The objective data are the patient's age, gender, and BP of
140/100 mmHg. Each of these is important in designing a
patient-specific therapy plan. Because hypertension often is an
asymptomatic disease (see Chapter 13),
subjective complaints such as headache, tiredness or anxiety, shortness
of breath (SOB), chest pain, and visual changes usually are absent. If
long-term complications such as rupturing of blood vessels in the eye,
glomerular damage, or encephalopathy were present, subjective
complaints might be blurring or loss of vision, fatigue, or confusion.
Objective data would include a report by the physician on the findings
of the chest examination (abnormal heart or lung sounds if secondary HF
has developed), an ocular examination (e.g., presence of retinal
hemorrhages), and laboratory data on renal function (blood urea
nitrogen, creatinine, or creatinine clearance). To place these
complications in better perspective, the rate of change should be
stated. For example, the serum creatinine has increased from a level of
1 mg/dL 6 months ago to a value of 3 mg/dL today. Vague descriptions
such as “eye changes” or “kidney damage” are of little value, because
progressive damage to these end organs results from uncontrolled high
BP, and disease progression needs to be monitored more precisely.

5. D.L., a 36-year-old construction
worker, tripped on a board at the construction site 2 days ago,
sustaining an abrasion of his left shin. He presents to the emergency
department with pain, redness, and swelling in the area of the injury.
He is diagnosed as having cellulitis. What is the primary problem? What
subjective and objective data support the problem? What additional
subjective and objective data are not provided but usually are needed
to define this particular problem?

The primary problem is cellulitis of the left leg.
Useful pieces of subjective information are D.L.'s description of how
he injured his shin at a construction site and his current complaints
of pain, redness, and swelling. The fact that he was at a construction
site is indirect evidence of a possible dirty wound. Further
information must be obtained about how he cleaned the wound after the
injury and whether he has received a booster dose of tetanus toxoid
within the past 10 years. Objectively, the wound is on the left shin.
No other objective data are given. Additional data to obtain would be
to document the intensity of the redness on a one-to-four-plus scale,
the size of the inflamed area as described by an area of demarcation,
the circumference of his left shin compared with his right shin, the
presence or absence of pus and any lymphatic involvement, his
temperature, and a white blood cell count with differential.

6. C.S., a 58-year-old woman, has
had complaints of fatigue, ankle swelling, and SOB, especially when
lying down, for the past week. Physical examination shows distended
neck veins, bilateral rales, an S3 gallop rhythm, and lower
extremity edema. A chest radiograph shows an enlarged heart. She is
diagnosed as having HF and is being treated with furosemide and
digoxin. What is/are the primary problem(s)? What subjective and
objective data support the problem(s)? What additional subjective and
objective data are not provided but usually are needed to define this
(these) particular problem(s)?

The primary problem is systolic HF. Subjectively, C.S.
claims to be experiencing fatigue, ankle swelling, and SOB, especially
when lying down. She claims to have been taking furosemide and digoxin.
An expanded description of these symptoms and her medication use would
be helpful. The findings on physical examination and the enlarged heart
on chest
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are objective data in support of the primary problem of HF. In
addition, other objective findings that would help in her assessment
would be the pulse rate, BP, serum creatinine, serum potassium
concentration, and digoxin blood level and a more thorough description
of the rales on lung examination, extent of neck vein distension, and
degree of leg edema. Pharmacy records could be screened to determine
current dosages and refill patterns of the medications.

In this case, a second primary problem may be present.
Current recommendations for the management of HF include use of an
angiotensin-converting enzyme (ACE) inhibitor before or concurrent with
digoxin therapy. Thus, a possible drug-related problem is the
inappropriate choice of drug therapy (“wrong drug”). The patient and/or
prescriber should be consulted to ascertain whether an ACE inhibitor
has been used previously, if any contraindications exist, or if
possible adverse effects were encountered.


After the subjective and objective data have been
gathered in support of specific listed problems, the practitioner
should assess the acuity, severity, and importance of these problems.
She should then identify all factors that could be causing or
contributing to the problem. The assessment of the severity and acuity
is important because the patient expects relief from the symptoms that
are of particular concern at this time. During the initial encounter
with a patient, it might be discovered that the medical problem is only
a symptom complex and that a diagnosis is needed to more accurately
identify the problem and further define its severity.

The assessment is usually performed during or
immediately following the data gathering while the provider keeps in
mind evidence-based practices. For example, if diabetes is assessed and
pertinent subjective data (medication history, social history, diet and
exercise, etc.) and objective data exist (labs like glycosylated
hemoglobin [A1c], low-density lipoprotein cholesterol
[LDL-C], BP, etc.), then the assessment of diabetes may be to determine
if the patient is meeting the goals for the disease as defined by the
ADA. If the patient is not at goal, then the explanation of the reasons
why would be described in the assessment, and the plan would then be
centered on helping that patient get to goal. Sometimes, the
distinction between subjective information provided by the patient and
assessments made by the practitioner are confused in the POMR. What the
patient reveals belongs in the subjective data, and how the provider
interprets it belongs in the assessment. For example, a patient stating
that she is having difficulty affording her medications belongs in the
subjective information. However, a patient appearing to have difficulty
affording her medications belongs in the assessment, as it is the
provider's interpretation of what the patient has stated.

Drug Therapy Assessment

A responsibility of the practitioner is to monitor the
response of patients to prescribed therapeutic regimens. The purpose of
drug therapy monitoring is to identify and solve drug-related problems
and to ensure that all therapeutic objectives are being achieved.
Unless proven otherwise, the medical diagnosis should be assumed to be
correct. On occasion, the diagnosis may not be readily apparent, or a
drug-induced problem may have been diagnosed incorrectly as being a
disease entity.

Nurses, pharmacists, physicians, physician assistants,
and other health care practitioners share the responsibility to assess
and monitor patient drug therapy. For the pharmacist, the drug therapy
assessment may occur in many practice settings, including the community
pharmacy while dispensing or refilling prescriptions or counseling
patients, during MTMS encounters, assessing therapy for the
hospitalized patient, through medication reconciliation, or as part of
routine monthly evaluations of patients residing in long-term care
facilities. Many states have enacted legislation allowing pharmacists
to develop collaborative drug therapy agreements with physicians for
disease state management of common disorders such as asthma, diabetes,
dyslipidemia, and hypertension. Additional services commonly provided
by pharmacists through collaborative drug therapy agreements include
anticoagulation monitoring, emergency contraception, and immunizations.5
These services often involve more detailed drug therapy assessment and
may occur within or outside the traditional pharmacy setting.
Regardless, the patient's need (this should be the primary
consideration), time constraints, working environment (a determinant of
the amount of patient information that is available), and
practitioner's skill level governs the extent of monitoring. Similarly,
the exact steps used to monitor therapy and the order in which they are
executed need to be adapted to a practitioner's personal style. Thus,
the examples given in this chapter should be used by the reader as a
guide rather than as a recipe in a cookbook.


After the problem list is generated, subjective and
objective data are reviewed, and the severity and acuity of the
problems are assessed and prioritized, the next step in the
problem-oriented (i.e., SOAP) approach is to create a plan, which at
the minimum should consist of a diagnostic plan and a MAP that includes
patient education. The plan is the action that was justified in the
assessment. The plan is clear and direct and does not require
explanation (this should be explained in the assessment). For example,
if a patient is experiencing constipation while taking an opioid pain
reliever, the plan would be to recommend a stool softener and stimulant
laxative such as docusate sodium and bisacodyl. The plan should also
include any follow-up that would be necessary related to the action

Patient Education

Educating patients to better understand their medical
problem(s) and treatment is an implied goal of all treatment plans.
This process is categorized as the development of a patient education
plan. The level of teaching has to be tailored to the patient's needs,
health literacy, willingness to learn, and general state of health and
mind. The patient should be taught the knowledge and skills needed to
achieve and evaluate his therapeutic outcome. An important component of
the patient education plan emphasizes the need for patients to follow
prescribed treatment regimens.

The POMR will allow the provider to focus the interview
and encounter independent of the site or service offered. The POMR
facilitates documentation of the provision of MTMS across multiple
sites and services (across the continuum of care).

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The next few sections will discuss how to approach MTMS in various clinical settings.

Medication therapy management services in the Community Pharmacy/Ambulatory Setting

The core elements of MTMS have been described by the
American Pharmacists Association (APhA) and the National Association of
Chain Drug Stores.19 According to these organizations, the core elements of MTMS should include the following components:

		Medication Therapy Review (MTR)

		Personal Medication Record (PMR)

		Medication Action Plan (MAP)

		Intervention and referral

		Documentation of services/Billing for services

Medication Therapy Review (MTR)

The MTR may be a comprehensive review in which the
provider reviews all of the medications the patient is currently
taking, or it may be a focused review of one medication-related issue
such as an adverse event. Examples of services provided during the MTR
are described in Table 1-6. MTR is dependent
on the information that is available from the patient or other data
sources. Community pharmacies may be a data-poor environment, and
access to necessary information may be limited. In some ambulatory
clinics, the provider may have access to the EMR (data-rich
environment). Regardless of the setting, a necessary tool to help with
the gathering of the medication information is the PMR. This medication
record should be updated after any change in medication therapy and
should be shared with other health care providers. The patient is
responsible for the upkeep of the PMR, but the PMR requires periodic
review by the pharmacist or other provider. The goal of this record is
to promote self-care and ownership of the medication regimen.19
The PMR should be used at all levels of care, thereby facilitating the
medication reconciliation process required across the continuum of
care. An example of a PMR is shown in Figure 1-3.

		[image: ]

		Figure 1-3 Example of a Personal Medication Record (PMR).

		Table 1-6 Examples of Services Provided During a Medication Therapy Review

						Assess the patient's health status

		Assess cultural issues, health literacy, language barriers,
financial status, and insurance coverage or other patient
characteristics that may affect the patient's ability to take
medications appropriately

		Interview the patient or caregiver to assess, identify, and resolve
actual or potential adverse medication events, therapeutic
duplications, untreated conditions or diseases, medication adherence
issues, and medication cost considerations

		Monitor medication therapy, including response to therapy, safety, and effectiveness

		Monitor, interpret, and assess patient laboratory values, especially as they relate to medication use/misuse

		Provide education and training on the appropriate use of medications

		Communicate appropriate information to other health professionals, including the use and selection of medication therapy

		Adapted from reference 19.

Once the patient interview has occurred and the PMR has
been updated, the provider may still require information to make an
assessment. In such cases, the provider must do his best with the
available information, or may obtain missing information such as the
medical history or objective data from other providers. Lack of
objective information is common in the community pharmacy setting, and
the ability to address all problems effectively may be limited in this
data-poor environment. In some encounters, obtaining the necessary
information may take the entire visit, necessitating a follow-up

Medication Action Plan (MAP)

If adequate information is available to assess the
current problem, a MAP should be developed. Because the MAP is patient
centered and is prioritized based on the urgency of need, the provider
and the patient should develop it together. An example of a MAP can be
seen in Figure 1-4.

The MAP often describes the intervention performed in an MTM encounter and may serve as documentation that can be
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shared with the patient and other health care providers (like the PMR).
The primary purpose of the MAP is to make the action plan patient
centered and to provide the patient with documentation of what they
need to do next in the action plan. It also provides space for the
patient to document what they did related to this action and when they
did it. In some instances, the MAP may involve referral to another
provider (a physician or pharmacist with additional qualifications) if
the issue is beyond the scope of the intervening pharmacist. Some
reasons for referral may include diabetes education by a certified
diabetes educator, diagnosis of a new or suspected medical condition,
or laboratory testing that may be beyond the scope of the pharmacist.

		[image: ]

		Figure 1-4 Example of a Medication Action Plan (MAP).

Coordination of care is a key element of MTMS and MTR.2
This may include improving the communication between the patient and
other health care providers, enhancing the patient's understanding of
his health issues or concerns, maximizing health insurance coverage,
advocating on behalf of the patient to get needed medications utilizing
available resources and programs, and various other functions that will
improve the patient's understanding of their health care environment
and promote self-care. Coordination of care may be the primary action
taken on behalf of the patient and may be included in the MAP.

Documentation of Services

The development of a documentation process is a necessary component of MTMS.19
Documentation should be standardized and based on the POMR format. All
appropriate records, including the PMR and MAP, should be shared with
other providers to promote communication and continuity of care. If the
encounter requires follow-up, the documentation should reflect the
timing of the follow-up care, and any expectations of the patient and
providers should be included. Thorough documentation of the encounter
allows all providers to quickly assess the progress of the patient and
determine that the desired outcome has been achieved.

Billing for Medication Therapy Management Services

Although billing for MTMS is not universally accepted by all payers, the introduction of the national provider identifier (NPI)
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and pharmacist-specific current procedural terminology (CPT) codes may soon make this a reality.5,20
The implementation of Medicare Part D in 2006 allowed pharmacists in
pharmacies contracted with prescription drug plans to provide MTMS to
plan-identified Medicare recipients. Pharmacists bill these plans
through the contracted pharmacy by using their individual NPI and one
of three CPT codes. The NPI number designates the provider to be paid,
and the CPT determines the amount of payment based on the services
rendered. The CPT codes specific to pharmacists providing MTMS include
the following:

		CPT 99605: Initial face-to-face assessment or intervention by a pharmacist with the patient for 1 to 15 minutes

		CPT 99606: Subsequent face-to-face assessment or intervention by a pharmacist with the patient for 1 to 15 minutes

		CPT 99607: Each additional 15 minutes spent face-to-face by a pharmacist with the patient; used in addition to 99605 or 99606

Although the NPI number and CPT codes allow pharmacists
to bill for MTMS, the reimbursement varies by plan and negotiated
contract and is beyond the scope of this text. Pharmacists have also
developed patient self-pay reimbursement strategies as well as
contracts with self-insured employers and state-run Medicaid programs
to provide services.21,22

M.C. is a 76-year-old female who comes to an appointment at the
community pharmacy with her daughter for a focused MTR. She has a
Medicare Part D prescription drug plan and is asking for help with her
medication costs. She indicates that she has type 2 diabetes,
hypertension, back pain, and hyperlipidemia. Her medications include
lisinopril 40 mg once daily, metoprolol 50 mg twice daily, glipizide 5
mg once daily, propoxyphene/acetaminophen 100 mg/650 mg one tablet
every 6 hours as needed for pain, and rosuvastatin 40 mg once daily.
M.C. tells you that she has trouble paying for her rosuvastatin (tier
3, $60 copayment) and would rather have something generic that costs
less (tier 1, $5 copayment). Further, she complains of muscle soreness
and weakness over the last 3 weeks. What objective information can be
obtained in a community pharmacy setting? What is the primary problem?
What additional information is necessary to determine the cause of her
problem? How would a clinician assess and document her problem(s) in a
SOAP format?

Although generally not considered a data-rich
environment, increasing amounts of objective information can be
gathered during the patient encounter at a community pharmacy.
Specifically, information such as weight, BP, temperature, and
finger-stick glucose and cholesterol levels can be measured if
indicated for this patient. This information may be useful to the
community pharmacist when performing the MTR in order to determine if
the medications are achieving the desired therapeutic outcomes.
Although the patient presented for MTR, the primary complaint is the
patient's self-reported muscle weakness and soreness over the last 3
weeks. It is impossible to determine if this problem is a
medication-related adverse event, because she did not provide a
medication history or PMR. Assuming that M.C. is a patient of this
pharmacy, the practitioner could gather the necessary medication
history from the PIS. Because the patient is present, this is a good
opportunity to develop a PMR with M.C. While developing the PMR with
the patient, the practitioner should gather additional information from
M.C. about her medication use. For example, the name of one of M.C.'s
medicines could be read with the practitioner continuing to ask
open-ended questions such as, “How do you take this medication?” “What
is your routine for taking your medication?” and “What types of
problems, if any, have you had while using this medication?” This
process will help to quickly identify any medication discrepancies
between the pharmacy computer system and the patient's understanding of
medication administration. If discrepancies are noted, the practitioner
can clarify them with M.C. right away as part of the intervention. The
PMR should also include a section to list medication allergies. The
type of reaction should also be included on the PMR so that other
providers will know the severity of the medication allergy (i.e.,
intolerance vs. anaphylactic reaction).

Based on data gathered from the pharmacy computer and M.C., a PMR (depicted in Fig. 1-3)
could be developed. Once the PMR has been developed, the provider will
have more information to determine if the current problem is medication
related. Unfortunately, reviewing the medications alone often does not
provide enough information to determine if M.C. is experiencing a
medication-related event. Further questioning may be necessary. M.C.
should be asked questions such as “How often do you experience muscle
weakness and soreness?” “Which muscles are hurting?” “Show me where the
problem is,” “What do you think is causing the problem?” or “Describe
the problem you are experiencing in more detail.” Asking questions
related to the onset of her symptoms of muscle soreness and weakness
will help to determine whether this is a medication-related problem.

Based on this questioning and the PMR, the practitioner
can develop an assessment of the current problem that she is
experiencing. As indicated on the PMR, M.C. started rosuvastatin most
recently. The initiation of this medication corresponds to the onset of
her recent soreness and weakness. HMG-coA reductase inhibitors like
rosuvastatin are known to cause myositis, or muscle breakdown, which
may lead to weakness and muscle soreness. Furthermore, the prescribed
dose is high for a female of M.C.'s age. Based on this information, an
assessment of the problem can be pursued. If rosuvastatin is the
suspected agent, the plan would include actions necessary to solve the
problem or to determine if rosuvastatin is the cause of her muscle
soreness and weakness. Unfortunately, all of the necessary information
is not available (e.g., her baseline cholesterol, serum creatinine,
liver function tests, or creatine kinase levels) to develop a formal
plan of action to resolve the adverse medication event. However, part
of the plan may be to obtain the labs necessary to identify or act on
the adverse medication event. An example of the documentation of the
SOAP note follows.

Primary Problem:

Muscle soreness and weakness (possible adverse medication event)


M.C. reports weakness and soreness, predominantly in her
legs over the past 3 weeks. She has difficulty rising from her chair
after sitting for long periods and describes the
[bookmark: PG1p17] P.1p17

pain as aching. The patient reports taking her medications as prescribed and rarely misses a dose.


Total Cholesterol: 137 mg/dL; LDL-C: 56 mg/dL; HDL: 54 mg/dL; Triglycerides: 136 mg/dL

Temperature: 98.5°F


M.C. has muscle weakness and soreness in her large
muscle groups. She is currently at the recommended LDL-C goal level for
a person with diabetes and hypertension per NCEP ATP III guidelines
(very-high-risk LDL-C goal is <70 mg/dL).23
Her current lipid therapy is rosuvastatin 40 mg once daily, which was
started by her cardiologist 4 weeks ago. The initiation of rosuvastatin
40 mg correlates to the timing of her muscle soreness and weakness.
HMG-coA reductase inhibitors (i.e., rosuvastatin) are known to cause
myositis/myalgias, and this patient is at particular risk given her
age, gender, and starting dose. It is possible that the rosuvastatin
could be causing her muscle soreness and weakness. Other lipid-lowering
agents could be tried or the dose of rosuvastatin could be reduced,
which might eliminate or reduce this adverse event. A creatine kinase
level should be obtained to determine the severity of the myositis. A
serum creatinine should also be measured, as myositis can lead to renal
damage and rhabdomyolisis in severe cases; however, this is usually
accompanied by fever and other symptoms that the patient is not
currently experiencing.


		Discussed the possibility of an adverse medication event, which included the signs and symptoms of myalgias and myositis.

		Contacted Dr. Hart (M.C.'s cardiologist) to discuss the current problem with rosuvastatin.

		Per discussion with Dr. Hart, will obtain a creatine kinase level and serum creatinine.

		Discontinue rosuvastatin per the
pharmacist recommendation. Dr. Hart agreed that M.C. should temporarily
stop her rosuvastatin until her laboratory values are reviewed.

		Alternative dosing of rosuvastatin 5 mg
or another equivalent agent (atorvastatin 10 mg or simvastatin 20 mg)
was discussed with Dr. Hart.

		M.C. is to see Dr. Hart in the cardiology clinic in 2 days to discuss the laboratory values and alternative therapies.

		Discussed the entire plan with M.C., and
she verbalized understanding of steps that she is to take with respect
to her current medication-induced problem.

8. Based on M.C.'s medication
profile, what other problems can be identified with her medication
therapy? What can be done to address these issues?

There are three remaining issues that may need to be
addressed. The first issue relates to the pain medicine
(propoxyphene/acetaminophen) that M.C. is taking. It is well documented
that propoxyphene is not an effective opioid pain reliever, and it may
lead to increased adverse events in the elderly.24
Other prescription medications such as hydrocodone/acetaminophen or
nonprescription medication such as acetaminophen alone or nonsteroidal
anti-inflammatory drugs could be used to help treat M.C.'s pain (see Chapters 8 and 99).
Second, it is not clear from the current information if the various
providers are communicating. It is the responsibility of the pharmacist
to help coordinate care between multiple prescribers as described by
the APhA MTMS consensus document.2
Therefore, it is important to be sure that both providers (Drs. Smith
and Hart) receive a copy of the documentation of the issues addressed
during the visit (SOAP note).

		Table 1-7 Cost Containment Strategies

						Patient with Prescription Drug Coverage

		Maximize generic drugs

		Maximize formulary coverage		Switch to agents covered on the least expensive formulary tier

		If patient has Medicare Part D, determine eligibility for low-income subsidy through the Social Security Administration

		Consider mail-order prescription programs

		Uninsured Patient

		Use low-cost generic programs (e.g., Rx Outreach, Wal-Mart, Target generic programs)

		Switch to therapeutically equivalent lower-cost brand name drugs when generics are unavailable

		Consider tablet splitting, if appropriate

		Consider pharmaceutical industry–sponsored patient assistance programs

		Determine if the patient is eligible for Medicaid, Medicare, Medicare Part D, or other assistance programs

Finally, M.C. came into the pharmacy asking for help
with her medication costs. In order to assess this problem, it is
important to ask if there are specific cost issues with a particular
drug or if it is her overall medication regimen that causes her
concern. Another important question to ask is if she has stopped taking
any medications or changed the way that she takes her medications due
to cost. Many patients will discuss cost and adherence issues with
their pharmacist, because the point of sale for medications occurs at
the pharmacy. However, they may not discuss this problem with the
prescriber. Cost and nonadherence due to cost may be medication-related
problems that the pharmacist must communicate to the prescriber on
behalf of the patient. In assessing drug cost, there are several steps
that can be taken. First, determine the patient's ability to pay for
medications; implement low-cost, medically appropriate interventions
targeted to patient needs; facilitate enrollment into relevant benefit
programs; and confirm medication changes with the patient and
prescribers (Table 1-7).

For M.C., the rosuvastatin is her biggest concern, as it
costs $60 per month and her Medicare Part D plan lists it as a
nonpreferred (tier 3) agent on the formulary. With the possible
discontinuation of her rosuvastatin, it is important for the pharmacist
to anticipate her need for an alternative lipid-lowering agent and to
determine if there are cost-effective formulary alternatives that may
be appropriate. This information can then be relayed to the prescriber.
Furthermore, the alternative lipid-lowering formulary choice can be
integrated into the plan developed for the primary issue of muscle
soreness and weakness (see Question 7 above). The integration of multiple problems is a complicated but important aspect of the MAP.

9. What additional information can be provided to M.C. at this time?

[bookmark: PG1p18] P.1p18

As discussed previously, an important part of MTMS
involves the MAP. The MAP is a document that may empower the patient
and promote self-care. The information on the MAP is important for both
the patient and provider and facilitates communication among multiple
providers. When a patient presents the PMR and MAP to all providers,
complex medication information can be shared across the continuum of
care. An example of M.C.'s MAP is included in Figure 1-4.

Because extensive information was communicated to the
patient and other providers, follow-up (phone or face-to-face) would be
appropriate and necessary to determine the resolution to the
medication-related issues identified. Follow-up should occur in a
timely manner, likely after M.C. has obtained the necessary labs and
has been evaluated by her cardiologist as outlined in the plan. The
follow-up should include questions related to the changes that were (or
were not) made based on the practitioner recommendations and any new
issues that have surfaced. Follow-up should be considered after any
encounter in which an action plan is developed in order to determine if
the medication-related problem has been resolved. Additionally,
problems may be identified and prioritized during the initial visit
but, due to time constraints, may not be addressed. A follow-up visit
allows for assessment of these problems.

10. Assuming that the pharmacy
provider had an NPI number and a contract with M.C.'s Medicare Part D
prescription drug plan, how could the 30 minutes spent with M.C. be
billed to her insurance?

Provided that M.C. was identified by her Medicare
prescription drug plan as eligible for MTMS, the practitioner could
bill for the 30-minute encounter. Using the practitioner's NPI number
and the appropriate CPT codes, the practitioner could bill for one CPT
99605 (for the first 15 minutes of initial face-to-face MTM encounter)
and one CPT 99607 (for an additional 15 minutes spent with the patient
in a face-to-face MTM encounter). M.C.'s Medicare Part D plan may
require the practitioner to bill the prescription drug plan initially,
and then the plan would pay the community pharmacy directly instead of
reimbursing the individual pharmacist. Documentation of the visit would
need to be stored at the site of the encounter in case any information
was requested from M.C.'s prescription drug plan.

Medication Therapy Management in the Acute Care Setting

11. M.C. has just been hospitalized
in a large medical center for renal failure and urosepsis. The
pharmacist has access to the medical chart, nursing record, MAR, and a
computer that directly links to the clinical laboratory. The
pharmacists at this facility assess the patient's drug therapy and
routinely provide clinical pharmacokinetic monitoring. How would the
pharmacist approach M.C. differently in this inpatient setting compared
with the pharmacist in Question 7 who worked in a community pharmacy?

Similar to the outpatient setting, the SOAP format is
often used when documenting the encounter of the hospitalized patient;
however, obtaining the information needed poses unique challenges. In
this setting, subjective information may be more difficult to obtain at
the time of assessment in those patients presenting with cognitive
impairment resulting from their acute condition, such as the seriously
ill or injured. Objective data, on the other hand, is more readily
available and retrievable with access to pharmacy, laboratory, and
other medical record information. On admission to the health care
facility, the medication reconciliation process should be initiated to
identify any variances in the admission orders when compared with the
patient's home medication list. With acute medical problems
superimposed on chronic conditions, it is not unusual to have new
medications added and home medications held, changed, or discontinued.

Assessing the appropriateness of drug therapy requires a
basic understanding of both pharmacokinetic (e.g., absorption,
distribution, metabolism, and elimination of the drug) and
pharmacodynamic (e.g., the relief of pain with an analgesic or
reduction of BP with an antihypertensive agent) principles. This
detailed assessment and monitoring is dependent on the availability of
robust patient and laboratory data. The inpatient setting is a
relatively data-rich environment where access to needed information is
generally readily available. Knowledge of the patient's height, body
weight, and hepatic and renal functions are essential for proper dosage
considerations. The type of hospitalized patient will vary from the
short-stay, otherwise healthy elective surgery patient to the
critically ill, hemodynamically compromised patient. The pharmacist
must be intimately aware of how pharmacokinetics and pharmacodynamics
can be markedly altered throughout the hospitalization or disease-state
process in each patient evaluated. This heightened awareness will allow
for timely interventions and minimize medication errors resulting from
improper or delayed dosage adjustments as the clinical status of the
patient changes. Drug level monitoring may be suitable for certain
medications and are of great clinical value; nevertheless, it is
important to take into consideration clinical response to drug therapy
along with the assessment of a specific laboratory value. Accurate
interpretation of any drug level requires review of the nursing MAR (or
eMAR), evaluating time of drug administration to that of 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 supra- or subtherapeutic concentrations resulting from erroneous

When M.C. was seen in the community pharmacy, the
pharmacist assessed her chronic conditions (diabetes, hypertension, and
hyperlipidemia and her cost issues), and her drug therapy. Monitoring
in the community pharmacy–based MTM program will occur 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) superimposed on 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
[bookmark: PG1p19] P.1p19

the facility must be communicated to other providers once the patient
is discharged. At a minimum, communication of the patient's new
medication therapy regimen (or PMR) should be communicated to the
patient's primary care physician and pharmacist. This step in the
process (medication reconciliation) is important to ensure appropriate
medication use across the continuum of care.


Interventions in any setting require interdisciplinary
communication, assessment of patient-specific needs, and documentation
of the visit. The health care system is complicated, and it is often
difficult for the patient to effectively navigate. Consistency and
follow through are important to both patients and other providers
regardless of MTMS setting. As illustrated in Figure 1-1,
communication to the patient, documentation by using the SOAP note and
the MAP, and follow-up are all closely correlated. To develop a
successful action plan, information must be gathered in an organized
and concise fashion. This information, if properly documented and
shared with other providers, will help in the provision of care to the
patients served within the health care system.


The authors acknowledge Mary Anne Koda-Kimble, Wayne
Kradjan, Robin Corelli, Lloyd Young, B. Joseph Guglielmo. and Brian
Alldredge for their contributions to previous editions of this chapter.


1. Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
Cost and Utilization Management; Quality Assurance; Medication Therapy
Management Program. Public Law 108–173. Section 101, Subpart 2, Sec.
1860-D49(c). Enacted December 8, 2003.

2. Bluml BM. Definition of medication therapy management: development of profession wide consensus. J Am Pharm Assoc 2005;45:566.

3. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm 1990;47:533.

4. Rovers JP, Currie JD eds. A Practical Guide to Pharmaceutical Care: A Clinical Skills Primer, Washington, DC: American Pharmacists Association; 2007.

5. Isetts BJ, Buffington DE. CPT code-change proposal: national data on pharmacists medication therapy management services. J Am Pharm Assoc 2007;47:491.

6. World Health Organization. Health Education in Self-care: Possibilities and Limitations. Geneva, Switzerland; 1983.

7. Hospitals National Patient Safety Goals. Joint Commission on Accreditation of Healthcare Organizations. Available at: Accessed June 1, 2008.

8. Cipolle RJ et al., eds. Pharmaceutical Care Practice: The Clinician's Guide. New York: McGraw-Hill; 2004.

9. U.S.
Department of Health and Human Services (HHS), Office of Minority
Health. National Standards for Culturally and Linguistically
Appropriate Services in Health Care. Final Report. Washington, DC;
March 2001. Available at: Accessed June 1, 2008.

10. U.S. Department of Health and Human Services (HHS), Healthy People 2010. National Health Promotion and Disease Prevention Objectives. Conference Ed. in Two Vols. Washington, DC; January 2000.

11. Henry
J. Kaiser Family Foundation (KFF). A synthesis of the literature:
racial and ethnic differences in access to medical care; October 1999.

12. Goldberg J et al. Understanding Health Disparities. Health Policy Institute of Ohio; November 2004:6.

13. Nielson-Bohlman L, Panzer A, Kindig DA, eds, Health Literacy: A Prescription to End Confusion. Washington, DC: National Academy Press; 2004.

14. Nester TM, Hale LS. Effectiveness of a pharmacist-acquired medication history in promoting patient safety. Am J Health Syst Pharm 2002;59:2221.

15. Varkey P et al. Multidisciplinary approach to inpatient medication reconciliation in an academic setting. Am J Health Syst Pharm 2007;64:850.

16. Forster AJ et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 2003;138:1617.

17. Beers MH et al. The accuracy of medication histories in the hospital medical records of elderly persons. J Am Geriatr Soc 1990;38:1183.

18. Hanlon JT et al. Adverse drug events in high risk older outpatients. J Am Geriatr Soc 1997;45:945.

19. American
Pharmacists Association and 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 2008;48:341.

Administrative Simplification: Standard Unique Identifier for Health
Care Providers; Final Rule. Federal Register. Department of Health and
Human Services. 45 CFR Part 162; July 23, 2004.

21. Cranor CW et al. The Asheville Project: long-term clinical and economic outcomes of community pharmacy diabetes care program. J Am Pharm Assoc 2003;43:173.

22. Chrischilles EA et al. Evaluation of the Iowa Medicaid pharmaceutical case management program. J Am Pharm Assoc 2004;44:337.

23. Grundy
SM et al. Implications of recent trials for the National Cholesterol
Education Program Adult Treatment Panel III guidelines. Circulation 2004;110:227.

24. Fick DM et al. Updating the Beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716.

Editors: Koda-Kimble,
Mary Anne; Young, Lloyd Yee; Alldredge, Brian K.; Corelli, Robin L.;
Guglielmo, B. Joseph; Kradjan, Wayne A.; Williams, Bradley R.

Title: Applied Therapeutics: The Clinical Use Of Drugs, 9th Edition

Copyright ©2009 Lippincott Williams & Wilkins

 > Table of Contents > Section One - General Principles > Chapter 2 - Interpretation of Clinical Laboratory Tests

Chapter 2

Interpretation of Clinical Laboratory Tests

Catrina R. Schwartz

Mark W. Garrison

This chapter provides the reader with an overview of
laboratory tests commonly used in clinical medicine. 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 book.
Over-the-counter, or patient-directed laboratory tests, are briefly
presented at the end of this chapter because these are being used to a
greater extent. The most recent edition of a comprehensive laboratory
textbook should be reviewed when comprehensive understanding of
clinical laboratory tests is required.1

General Principles

Generally, laboratory tests should be ordered only if
the results of the test will affect decisions about the care of the
patient. The serum, urine, and other bodily fluids can be analyzed
routinely; however, the economic cost of obtaining these data must
always be balanced by benefits to patient outcomes.

Normal Values

Clinical laboratory test results that appear within a
predetermined range of values are referred to as “normal,” and those
outside this range are typically referred to as “abnormal.” Laboratory
findings, both normal and abnormal, 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

Clinical laboratories can analyze sample specimens by
different laboratory methods; therefore, each laboratory has its own
set of normal values. Consequently, clinicians should rely
[bookmark: PG2p2] P.2p2

on normal values listed by their own clinical laboratory facility when interpreting laboratory tests.

Laboratory Error

A variety of factors can interfere with the accuracy of
laboratory tests. Patient-related factors (e.g., age, gender, weight,
height, time since last meal) can affect the range of normal values for
a given test. Laboratory-based issues can also influence the accuracy
of laboratory values. For example, a specimen can be spoiled because of
improper handling or processing (e.g., hyperkalemia due to hydrolysis
of a blood specimen); because it was taken at a wrong time (e.g.,
fasting blood glucose level taken shortly after a meal); because
collection was incomplete (e.g., 24-hour urine collection that does not
span a full 24-hour period); Errors also can arise due to faulty or
poor quality reagents (e.g., improperly prepared, outdated); due to
technical errors (e.g., human error in reading result, computer-keying
error); due to interference from medical procedures (e.g.,
cardioconversion increases creatine kinase [CK] serum concentrations);
due to dietary effects (e.g., rare meat ingestion can cause a
false-positive guaiac test); and because medications can interfere
either with the testing procedure or by their pharmacologic effects
(e.g., thiazides can increase the serum uric acid concentration,
β-agonists can reduce serum potassium concentrations). Clinicians might
not be aware of when laboratory-related issues arise. As a result,
laboratory findings must always be interpreted carefully, and the
validity of a test result questioned when it does not seem to correlate
with a patient's clinical status.

Units of Measure

The International System of Units (SI) reports clinical
laboratory values using the metric system. For example, the basic unit
of mass for the SI system, the mole is not
influenced by the added weight of salt or ester formulations. The mole,
therefore, is technically and pharmacologically more meaningful than
the gram because each physiological reaction occurs on a molecular
level. Nevertheless, 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,2,3
major American medical journals have since reverted back to the
traditional units for laboratory test reporting. The “normal” values
for common blood chemistry tests are presented in both conventional
units and SI units, along with “conversion factors” to interchange
traditional and SI units in Tables 2-1 (blood
chemistry reference values) and 2-2 (hematologic laboratory tests).
Formulas for converting conventional units to SI units are also
available in the primary literature.4,5

Electrolytes and Blood Chemistries


Normal: 135–145 mEq/L or mmol/L

Sodium is the predominant cation of extracellular fluid
(ECF). Only a small amount of sodium (~5 mEq/L) is in intracellular
fluid (ICF). Along with chloride, potassium, and water, sodium is
important in establishing serum osmolarity and osmotic pressure
relationships between ICF and ECF. Dietary intake of sodium is balanced
by renal excretion of sodium, which is regulated by aldosterone
(enhances sodium reabsorption), natriuretic hormone (increases
excretion of sodium), and antidiuretic hormone (enhances reabsorption
of free water). An increase in the serum sodium concentration could
suggest either impaired sodium excretion or volume contraction.
Conversely, a decrease in the serum sodium concentration to
less-than-normal values could reflect hypervolemia, abnormal sodium
losses, or sodium starvation. Although healthy individuals are able to
maintain sodium homeostasis without difficulty, patients with kidney
failure, heart failure, or pulmonary disease often encounter sodium and
water imbalance. In adults, changes in serum sodium concentrations most
often represent water imbalances rather than sodium imbalances. Hence,
serum sodium concentrations are more reflective of a patient's fluid
status rather than sodium balance.


Hyponatremia can result from dilution of the sodium
concentration in serum or from a total body depletion of sodium. The
finding of hyponatremia implies that sodium has been diluted throughout
all body fluids because water moves freely across cell membranes in
response to oncotic pressures. Dilutional hyponatremia occurs when the
ECF compartment expands without an equivalent increase in sodium. Some
clinical conditions (e.g., cirrhosis, congestive heart failure, renal
impairment), as well as the administration of osmotically active
solutes (e.g., albumin, mannitol), are commonly associated with
dilutional hyponatremia. Hyponatremia that results from sodium
depletion presents as a low serum sodium concentration in the absence
of edema. Sodium-depletion hyponatremia can be caused by
mineralocorticoid deficiencies, sodium-wasting renal disease, or
replacement of sodium-containing fluid losses with nonsaline solutions.


Hypernatremia represents a state of relative water
deficiency and, therefore, excessive concentrations of sodium in all
body fluids (hypertonicity). Hypernatremia can be caused by the loss of
free water, loss of hypotonic fluid, or excessive sodium intake. Free
water loss is uncommon, except in the presence of diabetes insipidus.
Gastroenteritis is the most common cause of hypotonic fluid loss in
infants and the elderly. Increased retention of sodium in patients with
hyperaldosteronism can also increase serum sodium concentrations.
Excessive salt intoxication is usually accidental or iatrogenic and
most commonly results from inappropriate intravenous administration of
hypertonic salt solutions. Some β-lactam antibiotics (e.g.,
ticarcillin) contain a modest sodium load and can cause fluid overload
when high dosages are administered.

The primary defense against hypertonicity is thirst and
subsequent fluid intake. Hypernatremic syndromes, therefore, usually
occur in patients who are unable to drink sufficient fluids. For
example, infants who cannot de