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Although the application of a consistent process of care serves as a foundational principle for most
health care professions, this is not true for the discipline of clinical pharmacy. Without an explicit,
reproducible process of care, it is not possible to demonstrate to patients, caregivers, or health profes-
sionals the ways in which the clinical pharmacist can reliably contribute to improved medication-
related outcomes. A consistent patient care process should describe the key steps that all clinical
pharmacists will follow when they encounter a patient, regardless of the type of practice, the clinical
setting, or the medical conditions or medications involved. Four essential elements serve as the corner-
stones of the clinical pharmacist’s patient care process: assess the patient and his or her medication
therapy, develop a plan of care, implement the plan, and evaluate the outcomes of the plan. Despite the
fact that several processes of care have been advocated for clinical pharmacists, none has been adopted
by the clinical pharmacy discipline. In addition, numerous publications evaluate outcomes related to
clinical pharmacy services, but it is difficult to determine what process of patient care was used in
most of these studies. In our view, a consistent process of direct patient care that includes the four
essential elements should be adopted by the clinical pharmacy discipline. This process should be clear,
straightforward and intuitive, readily documentable, and applicable to all practice settings. Once
adopted, the process should be implemented across practice settings, taught in professional degree pro-
grams, integrated into students’ clinical rotations, refined during residency training, and used as a
foundation for future large-scale studies to rigorously study the effects of the clinical pharmacist on
patients’ medication-related outcomes.
KEY WORDS clinical pharmacy, clinical pharmacist, direct patient care, process of care.
(Pharmacotherapy 2014;34(8):e133–e148) doi: 10.1002/phar.1459
Clinical pharmacists focus on identifying, can vary greatly. Even within similar practice
resolving, and preventing medication-related environments, the process of direct patient care
problems (MRPs); improving medication use; and used by clinical pharmacists is often not uniform
optimizing patients’ pharmacotherapeutic out- or consistent. As the U.S. health care system
comes. However, their approach to patient care increases emphasis on providing high-quality
This document was prepared by the 2011–2012 ACCP Professional and Public Relations Committee: Ila M. Harris,
Pharm.D., FCCP, BCPS (Chair); Beth Phillips, Pharm.D., FCCP, BCPS (Vice Chair); Eric Boyce, Pharm.D.; Sara Griesbach,
Pharm.D., BCPS; Charlene Hope, Pharm.D., BCPS; Cynthia Sanoski, Pharm.D., FCCP, BCPS; Denise Sokos, Pharm.D., BCPS;
and Kurt Wargo, Pharm.D., BCPS. Approved by the American College of Clinical Pharmacy Board of Regents on October, 13,
2013.
*Address for correspondence: Ila M. Harris, American College of Clinical Pharmacy, 13000 W. 87th Street Parkway, Suite
100, Lenexa, KS 66215; e-mail: accp@accp.com.
Ó 2014 Pharmacotherapy Publications, Inc.
e134 PHARMACOTHERAPY Volume 34, Number 8, 2014
patient-centered and team-based care, defining sional autonomy.4 Nurse practitioners use a sys-
how and what the clinical pharmacist contributes tematic approach to patient care similar to that
to that care is of paramount importance. How- used in the nursing process, but their standards
ever, without an explicit, reproducible process of of practice include some additional dimensions.5
care, it is not possible to demonstrate to patients, The American Physical Therapy Association pro-
caregivers, or health professionals the ways in vides standards of practice for physical therapy.
which the clinical pharmacist can reliably con- These standards address patient care management
tribute to improved medication-related outcomes. criteria including patient/client collaboration; ini-
Therefore, it is imperative that a well-defined tial examination, evaluation, diagnosis, and prog-
process of direct patient care be adopted by the nosis; plan of care; intervention; reexamination;
clinical pharmacy discipline and that this process discontinuation of intervention; and communica-
be used consistently in patient-centered, team- tion/coordination/documentation.6
based care environments. Although a discipline may define its own stan-
In a 2008 paper, the American College of dards of practice, all patient care practices have
Clinical Pharmacy (ACCP) defines clinical phar- three common components: a philosophy of
macy as “that area of pharmacy concerned with practice, a process for patient care, and a system
the science and practice of rational medication to manage the practice.7 This white paper
use.”1 In that paper, ACCP notes that “clinical focuses on the second component, the process
pharmacists are involved in direct interaction for direct patient care used by clinical pharma-
with, and observation of, the patient.” It is this cists. The process of care may be applied differ-
“direct patient care” approach that forms the ently by each health care discipline and in
foundation of the practice of clinical pharmacy. varied practice settings, but it should always
However, using a consistent process to render involve key components focused on assessment,
direct patient care is essential. In a recent com- planning, and follow-up.7
mentary, the ACCP Board of Regents emphasizes A seminal examination of quality in health care
this point, stating, “This consistent process, as and medical outcomes research in 1966 noted
applied by clinical pharmacists when collaborat- three aspects of caregiving that could be evalu-
ing with the patient’s other health professionals, ated: structure, process, and outcomes.8 Applying
is the critical factor in ‘operationalizing’ direct these aspects to the subject of this white paper, it
patient care.”2 can be stated that one potential strength of clini-
cal pharmacy as a discipline lies in its fundamen-
Patient Care Processes in Other Health Care tal “structure”—the education, training, and
clinical experience of the clinical pharmacists
Professions
who provide direct patient care in team-based
The application of a consistent process of care settings.1 However, the lack of a well-defined
serves as a foundational principle for most direct patient care process has made the study of
health care professions. For example, when a the clinical pharmacist’s impact on patient out-
patient interacts with a physician, nurse, physi- comes difficult. Although studies assessing the
cal therapist, or dentist, the patient knows the effects of clinical pharmacists on health care out-
approach to care that will be used. comes have shown positive results in varied prac-
The nursing profession has used a systematic tice settings, these studies used different or
approach to the care of patients (“the nursing unspecified processes of care.9–11 Thus, as one
process”) for more than 25 years.3 Although this might expect, applications of these research
process is dynamic and its steps are continually results can be highly variable, and their impact
reevaluated, the basic approach to the patient on patient outcomes may not be reproducible.
remains the same. The American Nurses Associa- Therefore, establishing a well-defined, consis-
tion describes the following five steps in its pro- tently delivered process of care is needed to fully
cess of care: assessment, nursing diagnosis, evaluate the impact and transferability of the clin-
outcomes/planning, implementation, and evalua- ical pharmacist’s direct patient care activities.1
tion. This process, used by nurses in all practice
settings, ensures consistency in nursing care. The The Rationale for Adopting a Consistent
approach also provides quality control in the pro-
Process of Care
vision of individualized nursing care, promotes
professional growth, establishes a foundation for The clinical pharmacy discipline should adopt
nursing’s scope of practice, and reinforces profes- a single, consistent direct patient care process
ADOPTING A CONSISTENT PROCESS OF DIRECT PATIENT CARE Harris et al e135
for several reasons including the wide variation matters further, definitions of current terminol-
in patient care processes used across different ogy such as “practice,” “patient care process,”
practice settings or even within similar practice “clinical service,” and “practice model” are often
settings, the use of terminology by pharmacists interchanged loosely or inappropriately. This
that differs from what is used outside the profes- imprecise use of terms is confusing and adds to
sion, the use of inconsistent terminology within the profession’s concern that a single patient
the profession, and the uncertainty that other care process used in different clinical settings
health professionals, patients, and caregivers may not be possible. Establishing consistent ter-
may have regarding the patient care services minology within the clinical pharmacy discipline
that can be consistently expected from clinical can help establish specific quality measures by
pharmacists. linking the clinical pharmacist’s patient care pro-
In addressing the four reasons just listed, the cess to outcomes, fostering the use of these mea-
variability in the patient care process both sures in conducting more rigorous and
within and across practice settings is reflected reproducible research, and stimulating the use of
by the differing priorities given to various clini- appropriate third-party billing codes for the pay-
cal pharmacist activities. Some inpatient clinical ment of services.
pharmacists are responsible for performing med- Given the inconsistent terminology and the
ication histories on all new patients, when ill-defined process of care described earlier, it is
appropriate (i.e., if the patient/caregiver is able not surprising that a general lack of understand-
to provide a history), whereas other clinical ing exists among other health care professionals
pharmacists are not involved in this activity con- and patients regarding what a clinical pharma-
sistently or at all. Some outpatient clinical phar- cist does. Other health professionals often may
macists are engaged in assessing all of the not know how to determine when a clinical
patient’s medication-related needs, whereas pharmacist is needed, frequently may not under-
others may address only a specific pharmaco- stand what to expect from him or her, and
therapeutic issue (e.g., antithrombotic or lipid- invariably are not certain what to ask for from
lowering therapy). Moreover, outpatient and the clinical pharmacist. In addition, employers
inpatient clinical pharmacists differ in the degree and health care payers are not likely to know
to which they directly interact with both how to compensate a clinical pharmacist if they
patients and other health professionals, even do not understand the clinical pharmacist’s
when opportunities for such direct interactions actual practice process and, consequently, can-
are readily available. not readily determine how he or she contributes
In addition, the terminology used by clinical to improved patient outcomes as a member of
pharmacists is not always consistent with that the health care team.
used outside the profession. For example, many However, with the adoption of the Patient
pharmacists use the term counseling to define Protection and Affordable Care Act (ACA) in
the provision of education to patients regarding 2010,12 opportunities finally exist for clinical
their medications. To clinical psychologists and pharmacists to positively affect patients’ medica-
most other health care professionals, counseling tion-related outcomes within ACA-driven initia-
involves active listening and feedback when tives including the patient-centered medical
needed, with or without behavioral intervention. home (PCMH) and the Independence at Home
Moreover, the terminology used within the program. To establish clinical pharmacists as
profession of pharmacy is sometimes inconsis- integral members of the health care team central
tent. For example, many clinical pharmacists to the success of these recently introduced pro-
use the term medication therapy management or grams, the clinical pharmacy discipline must
medication management to define their practice, communicate the unique set of knowledge, clini-
even if the process is completely different from cal skills, and experience that qualified clinical
the pharmacy profession’s consensus medica- pharmacists bring to the health care team, and
tion therapy management (MTM) process as the consistent process of direct patient care that
described in the literature. The term medication- clinical pharmacists use to help improve patient
related problem (MRP) is used interchangeably outcomes. Specifically, it is essential that well-
with the terms drug therapy problem and drug- trained, experienced clinical pharmacists lever-
related problem, depending on the process being age a predictable and reproducible care process
described. For consistency, we use the term that can be counted on to optimize patients’
MRP throughout this paper. However, to confuse medication-related outcomes.
e136 PHARMACOTHERAPY Volume 34, Number 8, 2014
(continued)
e137
e138
Table 2 (continued)
(continued)
Table 2 (continued)
interface with all other and decision making in drug and when goals are achieved
records (EMR, pharmacy therapy; and providing patients
records, laboratory records) with medication information that
is individualized and that complements
the therapeutic care plan
(continued)
e139
e140
Table 2 (continued)
Pharmacists
a
of Australia; SOAP = subjective, objective, assessment, and plan in the problem-oriented medical record.
However, a letter to a physician with recommendations does not mean the plan was implemented! Implementation is only partly addressed.
ADOPTING A CONSISTENT PROCESS OF DIRECT PATIENT CARE Harris et al e141
and identifying MRPs.7 Medication-related prob- to be synonyms for MMP. The MMP focuses on
lems can be classified as one of seven types, and overall patient outcomes and the many clinical
they fall into one of four categories: indication, activities to be carried out by the clinical phar-
effectiveness, safety, or adherence. macist in implementing the plan. Patient assess-
ment is a key component within the SHPA
practice standards and includes identifying, pri-
Comprehensive Medication Management
oritizing, and managing actual and potential
The PCPCC’s resource guide for CMM draws “medicines-related problems.” Seven categories
directly from and mirrors much of the pharma- of problems are provided that are similar to
ceutical care process. It includes assessment as those used in other processes, in addition to a
an essential element, together with the key steps category designated “nonclassifiable.” Although
that fall under assessment. Assessment also the terminology used by SHPA is slightly differ-
includes identifying and categorizing all of the ent, we refer to “medicines-related problems” as
patient’s MRPs for appropriateness, effectiveness, MRP in this paper. The SHPA standards provide
safety, and adherence for each medical condition explicit procedures for carrying out each activ-
or preventive therapy. Within these four catego- ity. Although the MMP does not use the term
ries, there are seven specific types of MRPs.14 medication experience, it describes a process that
generally encompasses the many elements of
assessing the patient’s medication experience.
Medication Therapy Management
The MTM process of care includes assessment
Essential Element II: Develop a Plan of Care
as a key element primarily through the medica-
tion therapy review (MTR).15 In the MTM pro-
Pharmaceutical Care
cess are four major categories (and seven
specific types) of MRPs (indication, effective- Medication management under pharmaceuti-
ness, safety, and compliance), which is similar cal care includes the essential element of devel-
to the taxonomy used in the pharmaceutical care oping a plan of care as well as the key steps of
process of care. MTM does not explicitly use the establishing goals of therapy, developing a plan
term medication experience, but the components to resolve MRPs, and developing a follow-up
included are similar to those used in the phar- plan.7 Nine types of interventions or resolutions
maceutical care process. can occur through these steps.
tioner’s plan occurs as part of the MTR. In con- a key element, and the key steps of communica-
trast, the MAP, which is intended for patient use, tion and documentation are within this ele-
contains an individualized list of actions for self- ment.7 Plan implementation can be carried out
management that have been agreed on by the directly by the pharmacist or with involvement
patient’s physician. Because the MAP is different of the prescriber (with or without a collaborative
from the therapeutic plan developed as part of practice agreement). Depending on the setting,
the MTR, it should be written in language the the pharmacist may or may not have face-to-face
patient can understand and should contain action contact with the patient’s physician, and the
steps to be completed by the patient. The MAP physician may be difficult to reach by telephone
should also contain space for the patient to during every encounter. Nevertheless, this ele-
include his or her accomplishments and the time- ment includes a description of the pharmacist’s
frame in which each action was completed. Infor- documentation and communication, both to the
mation regarding the patient’s next follow-up patient and to the physician. Moreover, this ele-
appointment with the pharmacist can also be ment contains detailed recommendations on the
included as part of the MAP. type of documentation system necessary in the
medication management process.
Individualized Medication Assessment and
Planning Comprehensive Medication Management
One step (step 4) in the iMAP process per- Plan implementation is incorporated into the
tains to the essential element of developing a CMM model by addressing and acting on spe-
plan (“formulate assessment/propose plan to cific items in the collaborative care plan.14 Medi-
optimize medication use”).16, 17 When develop- cation management cannot be done effectively
ing the plan for implementation or discussion unless all the patient’s providers are informed
with the provider, the drug therapy recommen- and care is coordinated with the team. Specific
dations to resolve the MRPs may be classified guidelines outline the essential components of
into 20 different categories. The categories documentation that support the process of CMM
appropriately classify most of the recommenda- in the PCMH.
tions clinical pharmacists provide or implement,
whereas other processes do not have as many Medication Therapy Management
category choices. The last category is essentially
a miscellaneous category for recommendations The MTM process addresses the essential ele-
not otherwise classified. Establishing goals of ment of plan implementation including commu-
therapy and developing a follow-up plan are not nication and documentation in the MAP,
explicitly mentioned in the iMAP process. development of a personal medication record
(PMR), pharmacist intervention and/or referral,
SHPA Standards of Practice for Clinical and follow-up.15 The patient implements the
plan detailed in the MAP, as it is his or her per-
Pharmacy Services
sonal document. However, the provision of evi-
The SHPA standards include the essential ele- dence by the pharmacist for implementation of
ment of developing a plan and include the key the plan is a key step that is missing. To be
steps of establishing goals and developing a compensated for MTM services, pharmacists
plan.18 Although developing a follow-up plan is must submit documentation to payers. Several
not explicitly stated, it is included in the clinical different pharmacist-specific electronic systems
review step of evaluating response to therapy. are available to facilitate the documentation pro-
Four categories of pharmacist resolution of cess, especially with payers.
MRPs are provided, as well as a category of “no
recommendation necessary.” Individualized Medication Assessment and
Planning
Essential Element III: Implement the Plan
Steps 5, 6, 7, and 8 of the iMAP process
address plan implementation. These steps delin-
Pharmaceutical Care
eate the basic processes for implementing a drug
Medication management within the practice of therapy plan that include communicating the plan
pharmaceutical care involves implementation as to the primary care provider, reaching consensus
ADOPTING A CONSISTENT PROCESS OF DIRECT PATIENT CARE Harris et al e143
with the provider, and implementing the plan. Comprehensive Medication Management
Alternatively, some steps may be modified if the
Comprehensive medication management relies
pharmacist is working under a collaborative drug
on follow-up evaluations to determine actual
therapy management agreement or other scope of
patient outcomes. The patient is evaluated on an
practice privileging arrangement. Under these cir-
ongoing basis to determine whether appropriate
cumstances, the plan may be communicated to
outcomes are being achieved and/or maintained.14
the provider through the medical record includ-
Care is coordinated with the team, which is par-
ing notification of any medication changes that
ticularly important during care transitions (e.g.,
were made. Educating the patient and document-
during hospital admission and discharge).
ing the plan (both to the patient and in the medi-
cal record) are included.16, 17
Medication Therapy Management
The MTM process addresses plan evaluation,
SHPA Standards of Practice for Clinical monitoring, and follow-up during the MTR and
Pharmacy Services documentation/follow-up steps.15 A follow-up
The SHPA standards include the element of MTM visit is recommended depending on a
implementing the plan and the key steps of patient’s medication-related needs and when the
communicating and documenting the plan.18 patient undergoes a transition of care. In the lat-
Pharmacists should participate in interdisciplin- ter scenario, the pharmacist responsible for con-
ary care planning and collaborate with the pre- ducting the initial MTM visit with the patient
scriber to resolve medication issues (i.e., may need to work with another pharmacist who
implement the plan). The pharmacist communi- is located in the patient’s current care setting to
cates recommendations to the prescriber through ensure the continuity of MTM services.
this collaboration. However, communicating rec-
ommendations do not ensure that those recom- Individualized Medication Assessment and Planning
mendations will be implemented. The SHPA
standards also include detailed requirements for The final two steps in the iMAP model focus
documenting patient-specific clinical pharmacist on plan evaluation and include monitoring and
activities including medication reconciliation, follow-up.16, 17 These steps involve the monitor-
plan for management of clinical problems and ing of laboratory results or other objective data
attainment of therapeutic goals, actual or poten- as well as the provision of a direct follow-up
tial MRPs, and recommendations for manage- with the patient. Together with the subjective
ment of MRPs. In addition, documentation of information provided by the patient, the phar-
pharmacist interventions is also recommended macist determines what, if any, adjustments
including MRPs identified, level of risk, recom- need to be made to the plan.
mendations to resolve problems, and the cate-
gory of action taken. There are five categories of SHPA Standards of Practice for Clinical
possible actions and one category of “unknown Pharmacy Services
at the time.”
The SHPA standards include plan evaluation
as a part of the MMP step that involves monitor-
Essential Element IV: Evaluate the Outcomes of ing patient outcomes to determine if goals are
the Plan achieved.18 In addition, there is a step included
to modify goals when outcomes are not
Pharmaceutical Care achieved, but other follow-up steps are not
explicitly stated. Nevertheless, monitoring is
Pharmaceutical care includes the essential ele- intended to be patient focused and related to the
ment of evaluating plan outcomes including the clinical problems identified. As articulated by
critical key steps of monitoring and follow-up.7 the standards, the medication use process/plan is
Evaluation is achieved by subjective and objec- ongoing; thus care is intended to be continuous.
tive monitoring, by asking the patient and/or
reviewing/checking laboratory results and other
Summary of Published Patient Care Processes
data. During follow-up evaluations, each health
condition is classified into one of eight outcome After reviewing the published clinical phar-
categories. macy patient care processes, it is evident that
e144 PHARMACOTHERAPY Volume 34, Number 8, 2014
most of them contain most, if not all, of the pro- common in collaborative practices with physi-
posed essential elements: assess the patient and cians and other health professionals.
his or her medication therapy, develop a plan of
care, implement the plan, and evaluate the out-
Comprehensive Medication Management
comes of the plan. Three of the four processes
do not use the term medication experience The CMM process can also be applied to vari-
(MTM, iMAP, SHPA), but they do describe a ous practice settings. However, it was designed
similar consideration within their respective for use in the PCMH and other collaborative
steps of care. Implementing the plan a critical outpatient primary care settings.14 The process
element of the care process is not explicitly can be implemented outside the office or clinic
described as a component of MTM when physi- setting, such as in a community pharmacy,
cian involvement is necessary. Although the pro- within a health plan, or in the institutional envi-
cess includes sending a formal communication ronment. In addition, because face-to-face con-
to the provider, this step does not ensure the tact is not required in this model, telephonic or
plan is implemented. Yet without this implemen- “virtual” interactions with patients and health
tation step, the outcome of any care process is care professionals are acceptable. This flexibility
uncertain. regarding how communication can take place
allows the involvement of clinical pharmacists
Applicability of Current Processes Across who may be at distant locations and obviates the
need to place a clinical pharmacist physically
Clinical Practice Settings
within every practice locale.
Ideally, clinical pharmacists should be able to When a prescriber identifies a patient in need
use a single comprehensive process of patient of CMM, a referral is made to the qualified med-
care that includes the four essential elements ication management practitioner. In many prac-
and is flexible enough to be applied in any clini- tices, the CMM practitioner is engaged by the
cal practice setting or type of practice. Toward PCMH as either a full-time or a part-time
that end, we review the potential application of employee. Other medication management prac-
published patient care processes across different tices may be established outside the PCMH
clinical practice settings. (associated with a community pharmacy, health
plan, or health system), where the referral is
made to a non-PCMH employee practitioner.
Pharmaceutical Care
The patient is followed by the CMM practitioner
The concept of pharmaceutical care was until medication therapy goals are met or until
introduced more than 20 years ago and is the physician determines CMM is no longer nec-
widely recognized within the pharmacy profes- essary. Comprehensive medication management
sion. The medication management described as frequently involves the use of collaborative prac-
part of the pharmaceutical care process is com- tice agreements between the physician and the
prehensive and systematic. It includes the nec- practitioner providing medication management.
essary key elements, and the pharmacist takes In the inpatient or specialty setting, CMM may
responsibility for the outcomes pertaining to a be more difficult to implement in its entirety
patient’s medication-related needs. Detailed because of its comprehensive nature. Nonethe-
descriptions of the process and its outcomes are less, it can be modified as needed yet still retain
available in textbooks,7 but they have not been the four essential elements.
published in the biomedical literature. There-
fore, the specifics of the pharmaceutical care
Medication Therapy Management
process are not readily accessible to all practi-
tioners and providers. The MTM process was developed for applica-
Pharmaceutical care practice is usually used tion in any health care setting where patients or
in primary care practices, although it is pro- their caregivers can be actively involved in
posed to be applicable to all patient care settings managing individual medication therapies. Medi-
including hospitals and long-term care facilities. cation therapy management services can be pro-
It is described as a generalist practice but can be vided in the community pharmacy, in a primary
applied in specialist practice as well. As cur- care clinic, within a long-term care facility, or
rently used, this process of care is most often in the institutional setting during admission or
observed in independent practice and is less discharge. Technically, the provision of MTM
ADOPTING A CONSISTENT PROCESS OF DIRECT PATIENT CARE Harris et al e145
services does not depend on the care setting. macy practice is closely aligned with ACCP’s
However, it does require that an opportunity be definition. However, the standards may not be
provided for the pharmacist to conduct a medi- widely recognized by health care professionals
cation evaluation with the patient. or payers in the United States.
Although it is preferable for MTM to occur
during face-to-face encounters, this service is
Evidence Supporting Processes of Care
also frequently provided by telephone. Although
the MTM process was developed for use in any Although many publications evaluate outcomes
clinical setting, two of its core elements, the related to clinical pharmacy services, it is diffi-
PMR and the MAP, may have to be omitted in cult to determine what process of patient care
acute care settings when patients are unable to was used in most of these studies. Inconsistent
actively participate in their care (e.g., while hos- terminology and definitions of “medication ther-
pitalized with a very acute or critical illness). In apy management,” “pharmaceutical care,” “com-
addition, the MTM process does not address the prehensive medication management,” and
pharmacist’s role in providing MTM services “clinical pharmacy practice” are used. Many
when the patient cannot actively participate in studies state that an MTM service was evaluated.
his or her own care. Therefore, the MTM pro- However, a close review of the study reveals that
cess tends to be implemented more often in the some other process of care or clinical service was
community pharmacy or primary care settings. evaluated or that the precise care process was
not adequately described. Older studies usually
Individualized Medication Assessment and call the process of care “pharmaceutical care,”
Planning whereas newer studies often label the process
“medication therapy management,” reflecting the
To date, iMAP has only been studied in a terms in vogue when the research was con-
geriatric ambulatory patient population.17 How- ducted. However, although the actual processes
ever, the components of iMAP involve the basic studied involved components of clinical phar-
processes a clinical pharmacist can use when macy practice, they frequently did not fully meet
providing patient care to any patient population. the criteria for any defined process of care. Fur-
Moreover, this patient care process can be thermore, no clinical studies exist that compare
implemented in all types of clinical practice different processes of care. Therefore, it cannot
including primary care and acute care settings. be determined whether a particular process is
The only step that might require modification in responsible for improved patient outcomes, nor
an acute care setting involves situations in which can it be determined whether one process is
a discussion with the patient might not be possi- associated with better outcomes than another.
ble. In these cases, retrieving data solely from
other sources such as the medical record, pre-
scription refill history, and/or caregivers or fam- Pharmaceutical Care
ily members would be appropriate. One report described the outcomes of an
“MTM” service.19 However, the service provided
SHPA Standards of Practice for Clinical in this study was actually a pharmaceutical care
practice because all providers first received
Pharmacy Services
training in pharmaceutical care, and the practice
This process and set of practice standards is was described as the collaborative practice of
straightforward, flexible, and systematic. The pharmaceutical care. Although the background
SHPA standards state that the clinical pharmacy of the study described what a patient care pro-
activities described can be delivered in many set- cess should include (assess the patient, identify
tings and are not restricted to hospital practice MRPs, develop a care plan, and perform a fol-
alone; however, the designation of a clinical low-up evaluation), the study did not describe
pharmacy service usually relates to a hospital the specific process of care the pharmacists
practice.18 The standards provide more details followed, other than “MTM.” Nonetheless, phar-
on institutional practice but are definitely appli- macists in the study did identify, categorize,
cable to other practice settings. The components and resolve MRPs, identify goals of therapy,
of the MMP and the clinical activities associated determine whether goals were being met, and
with it are familiar to clinical pharmacists. In document the information. Moreover, the study
addition, the SHPA definition of clinical phar- compared preintervention data with those
e146 PHARMACOTHERAPY Volume 34, Number 8, 2014
obtained postintervention. At study conclusion, plan development, plan implementation, and fol-
637 MRPs in 285 patients had been resolved low-up evaluation) were included in the care
(2.2 per patient). In addition, this study showed process. Comprehensive medication management
that the percentage of patients meeting their in this team-based care environment helped
goals of therapy increased from 76% preinter- achieve quality performance and control spend-
vention to 90% postintervention; moreover, the ing growth.
Healthcare Effectiveness Data and Information
Set (HEDIS) measures improved for hyperten-
Medication Therapy Management
sion (71% vs 59%; p=0.03) and hypercholester-
olemia (52% vs 30%; p=0.001). Furthermore, Although numerous published studies have
the total expenditure per person significantly evaluated the outcomes associated with the pro-
decreased by 31.5% postintervention compared vision of MTM services, the investigators’ meth-
with preintervention, and after factoring in the ods must be closely analyzed to determine
estimated cost of providing these services, the whether the MTM process was the process of
reduction in total yearly health expenditures still patient care actually studied. Indeed, in many of
exceeded this cost by a factor of 12 to 1. the studies, the term medication therapy manage-
In another study, the researchers summarized ment is often used interchangeably with other
data from 2985 adult patients who received patient care processes including pharmaceutical
pharmaceutical care.20 They reported the num- care and disease state management. After care-
ber of MRPs identified and resolved as well as fully analyzing the interventions used, we found
the estimated improvement in status by virtue of only a few studies that evaluated the outcomes
the practitioner’s interventions, with 83% of associated with the MTM process using the pre-
patients reaching a stable or improved status. viously defined core elements.15 In one study,
The estimated health care savings was which had enrolled employees who were taking
$1,124,162, which represented a benefit-cost at least seven prescription medications, the out-
ratio of 2:1. However, this article was descrip- comes of an employer-based MTM program were
tive, provided limited specific data, and did not evaluated.23 Individuals enrolled in the study
use a comparative group. were randomized to either the MTM group or
Another study described the outcomes from a the control group (i.e., patients for whom no
“pharmaceutical care–based MTM practice” in a MTM services were provided). Participants ran-
population of 9068 adults.21 The patient care domized to the MTM group received two face-
process used in this study included assessment to-face meetings with a clinical pharmacist.
of the patient; performance of a comprehensive Pharmacist recommendations were either imple-
medication review; identification, resolution, and mented by the patient or communicated to the
prevention of MRPs; formulation of a medication patient’s prescriber through the university’s elec-
treatment plan; provision of follow-up assess- tronic medical record. All employees received a
ment (including monitoring and evaluating written copy of the MAP. A total of 128 employ-
patient’s response to therapy); and documenta- ees completed both of the designated MTM visits
tion of the care delivered. Implementation in this and were compared with a similar number of
study was described as collaborating with all participants in the control group. Overall, phar-
members of a patient’s care team and communi- macists identified 385 MRPs, which translated
cating with the patient and prescriber. Over into about 3.3 problems per patient. The major-
10 years, 38,631 MRPs were identified and ity of these MRPs (55%) were classified in the
addressed. In patients who were not at goal at safety category. Most of the recommendations
baseline, clinical status was improved in 55%, (80%) made to resolve the MRPs suggested a
was unchanged in 23%, and had worsened in change in medication therapy. During this
22%.21 1-year study, out-of-pocket costs for patients in
the MTM group were significantly reduced com-
pared with baseline. No significant difference in
Comprehensive Medication Management
these costs occurred in the control group.
We identified one study addressing the impact In another study, the clinical and economic
of team-based care and incorporation of CMM outcomes associated with a pharmacist-delivered
on per capita expenditures, quality performance comprehensive MTM model were evaluated in
measures, and resolution of MRPs in the PCMH 13 community pharmacies in rural Mississippi.24
setting.22 The essential elements (assessment, In this study, the services provided, which were
ADOPTING A CONSISTENT PROCESS OF DIRECT PATIENT CARE Harris et al e147
based on the MTM process of care, were either be implemented across practice settings, taught
specialized (focusing on asthma and/or diabetes; in professional degree programs, integrated into
delivered by school of pharmacy faculty, com- students’ clinical rotations, and refined during
munity pharmacy residents, or student pharma- residency training. In addition, we believe that
cists) or general in scope (any patient with at embracing a consistent, reproducible, and trans-
least two chronic medical conditions; delivered ferrable process of care is needed to establish a
by community pharmacists).15 For the 468 foundation for future large-scale studies that rig-
patients enrolled, 1471 MRPs were identified. orously study the effects of the clinical pharma-
Most of the MRPs (48–55%) in both the special- cist on patients’ medication-related outcomes.
ized and the generalized MTM cohorts were These data will be critical to validating the need
related to indication (needing additional ther- for clinical pharmacists as members of health
apy). After a 2-year period, the patients’ thera- care teams in the future.
peutic goals for diabetes (hemoglobin A1C),
hypertension (systolic and diastolic blood pres-
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