ACCP WHITE PAPER

Developing a Business-Practice Model for

Pharmacy Services in Ambulatory Settings
American College of Clinical Pharmacy
Ila M. Harris, Pharm.D., FCCP, Ed Baker, Pharm.D., Tricia M. Berry, Pharm.D.,
Mary Ann Halloran, Pharm.D., Kathleen Lindauer, Pharm.D., Kelly R. Ragucci Pharm.D., FCCP,
Melissa Somma McGivney, Pharm.D., A. Thomas Taylor, Pharm.D., and Stuart T. Haines, Pharm.D., FCCP
A business-practice model is a guide, or toolkit, to assist managers and
clinical pharmacy practitioners in the exploration, proposal, development and
implementation of new clinical pharmacy services and/or the enhancement of
existing services. This document was developed by the American College of
Clinical Pharmacy Task Force on Ambulatory Practice to assist clinical
pharmacy practitioners and administrators in the development of business-
practice models for new and existing clinical pharmacy services in ambulatory
settings. This document provides detailed instructions, examples, and
resources on conducting a market assessment and a needs assessment, types
of clinical services, operations, legal and regulatory issues, marketing and
promotion, service development and exit plan, evaluation of service
outcomes, and financial considerations in the development of a clinical
pharmacy service in the ambulatory environment. Available literature is
summarized, and an appendix provides valuable citations and resources. As
ambulatory care practices continue to evolve, there will be increased
knowledge of how to initiate and expand the services. This document is
intended to serve as an essential resource to assist in the growth and
development of clinical pharmacy services in the ambulatory environment.
Key Words: pharmacy practice, business-practice model, ambulatory care,
primary care.
(Pharmacotherapy 2008;28(2):7e–34e)

Section 1: Introduction pharmacy practitioners and administrators to

develop business-practice models for new and
This document was developed by the American
existing clinical pharmacy services in the
College of Clinical Pharmacy (ACCP) Task Force
outpatient and ambulatory setting. Translating
on Ambulatory Practice to assist clinical
the evidence supporting clinical pharmacy
This document was written by the 2005 ACCP Task Force services into practice in the ambulatory setting
on Ambulatory Practice: Ila M. Harris, Pharm.D., FCCP, has been hampered by the lack of a clear
BCPS, Chair; Ed Baker, Pharm.D.; Tricia M. Berry, business-practice model. A business-practice
Pharm.D., BCPS; Mary Ann Halloran, Pharm.D., BCPS;
Kathleen Lindauer, Pharm.D.; Kelly R. Ragucci, Pharm.D.,
model is a guide, or toolkit, to assist managers
FCCP, BCPS; Melissa A. Somma, Pharm.D.; A. Thomas and clinical pharmacy practitioners in the
Taylor, Pharm.D.; Stuart T. Haines, Pharm.D., FCCP, BCPS. exploration, proposal, development, and
Approved by the ACCP Board of Regents on October 24, implementation of new clinical pharmacy
2006; final revisions received on February 27, 2007. services and the enhancement of existing
Address reprint requests to the American College of
Clinical Pharmacy, 13000 W. 87th Street Parkway, Lenexa,
services. The goal of this publication is to
KS 66215-4530; e-mail: [email protected]; or download from provide pharmacists with a framework to build a
http://www.accp.com. clinical practice in an ambulatory setting within
8e PHARMACOTHERAPY Volume 28, Number 2, 2008
the premise of a business model. Section 2: Market Assessment
The key to building a successful ambulatory
Definition of Ambulatory Practice pharmacy practice is matching personal interest,
Clinical pharmacy has been defined by the professional knowledge, and the specific needs of
ACCP as “that area of pharmacy concerned with potential customers. A market assessment allows
the science and practice of rational medication the pharmacist to determine the customers’ needs
use.” 1 Clinical pharmacy services in the in the context of the business environment. Such
ambulatory environment can be broadly defined an evaluation is the foundation on which the
as pharmaceutical care services for patients who business will be built. Everything from starting
walk in to seek care.2 Ambulatory environments the business to future growth is based on an
may include, but are not limited to, pharmacists accurate market assessment.4 Many resources are
practicing in physician’s offices, physician available to help conduct a market assessment.
residency programs, community pharmacies, and Helpful literature and web sites for starting a new
institutional ambulatory environments. business and identifying customers are included
Institutional ambulatory environments can in Appendix 1, and a list of all pharmacy
include clinics in hospitals, specialty clinics (e.g., organizations, with a description of the
transplant, cardiology), emergency departments, association and its Web site address, is provided
urgent care centers, outpatient treatment centers in Appendix 2.
(e.g., cancer chemotherapy, dialysis), correctional
institutions, managed care clinics, and Steps to Successful Market Assessment
government programs (e.g., Indian Health
The first step in a successful market assessment
Services, federally qualified health centers,
is to look at the industry and assess trends. The
Veterans Affairs hospitals). 2, 3 In addition,
following three questions should be answered:
pharmacists may have independent practices
What is the current state of the proposed service?
providing medication therapy management.
What is the current standard of care? What
The scope of this business-practice model is for
current and future developments may affect the
pharmacists practicing in ambulatory care
service?
environments providing clinical services.
Clinical services include those where a What is the Current State of the Proposed Service?
pharmacist works directly with individual
patients to evaluate their drug regimen and to Is the provided service new and growing, or is
identify, prevent, and resolve drug-related it on the downswing? Is it affected by managed
problems. In a community pharmacy setting, care? Is there proposed legislation pending?
these services may be an adjunct to dispensing or Will it be affected by government regulation?
consultative services, but are provided as a Pharmacy associations that may specialize in the
distinct service. Services such as immunization specific area of pharmacy practice can help in
and screening programs are generally not answering these questions. Attendance at
considered to be comprehensive clinical services. national pharmacy meetings and networking
Clinical services may include disease-oriented with other pharmacists who may be involved in
services or phone-based services (e.g., similar clinical services are also helpful. The
anticoagulation services) only when individual medical and pharmacy literature is another
patient evaluations are performed.2 excellent source to determine the current state of
In most ambulatory practices, the pharmacist a specific practice.5
works collaboratively with other health care
providers. This may occur within the same What Is the Current Standard of Care?
physical location, as with an institutional There should be a standard of care at which a
ambulatory clinic or physician’s office practice, or practitioner is expected to provide a certain level
at a distance, as with community pharmacy of quality to a patient. It has also been defined as
practice. Distant collaboration is often “the set of behaviors of a practitioner that is
accomplished through collaborative practice subject to evaluation by peers, regulators, and the
agreements. Pharmacists in ambulatory clinical public.”6 The first definition focuses on actual
practice can be independent providers or work as patient care whereas the second leans toward
part of an interprofessional team.2 legal liability. Legal requirements for the
business need to be determined. Legal
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 9e
requirements for equipment, Clinical Laboratory practitioners, will there be enough pharmacists to
Improvement Amendments requirements for provide such service? Other factors that need to
blood monitoring, and professional licenses, if be considered are the value and quality of the
any, will need to be obtained. service, and the convenience of referral.
The price of the service is important and may
What Current and Future Developments May Affect be the determining factor for some customers.8
the Service? The pharmacist’s wage, benefits, and overhead
costs must all be factored in the cost
The answer to this query is very important to
considerations. Only after the cost of the service
the longevity of the business. In order for the
has been determined can the price to the
business to grow and prosper, it must provide
customer be derived. The customer’s previous
drug therapy management for years to come.
experience with similar services should also be
Consideration may also be given to drugs that are
considered.
in the pipeline. A state law requiring a
pharmacist to have a certain credential for the Customer Needs to Be Addressed
service would create an instant demand for
pharmacists with that credential. Customer needs must be addressed when
The location of the new service should be beginning the service. Customers will often look
convenient and accessible to most patients. outside of their own organization for solutions to
Consideration should be given to patients who their problems. Contracting the service to a
do not have their own transportation and who pharmacist may be less costly than initiating
may rely on public transportation. The parking their own services internally.
lot should be big enough to accommodate Improving quality of care and clinical
increased patient load for the new service. outcomes are two customer needs that the service
Patients may appreciate the quality of service will address. Pharmacists should be prepared to
provided but if they cannot get in and out of the show customers that the service will help
building or parking lot, the quality of service may increase quality of care and improve clinical
be overshadowed by problems with accessibility.7 outcomes. Financial outcomes will also be of
It should also be determined whether the importance, and the effect may be more on cost
service will be local or regional. This will savings. Examples can be obtained from the
provide an estimate of the total number of people literature (Appendix 1).
within the target market area. Once all this
information has been collected, the pharmacist Timing of the Service
will be able to better estimate the number of Is the timing right for beginning a new
customers and growth potential for the business. business offering clinical pharmacy services?
Any current changes taking place in the proposed
Factors to Be Considered business area should be evaluated, including new
Before implementing the service, several things laws or regulations; shortage of pharmacists and
must be considered: factors in customer other health care providers; and patient safety
decision-making, customer needs to be initiatives. A need for an outside service can be
addressed, and the timing of the service. brought about by a change in a regulation or by
legislative action. Pharmacists that have kept
Identify Factors in Customer Decision-Making abreast of new laws and regulations will be
poised to take advantage of changing situations
To survive, the service must meet the needs of and fill the void created by regulations.
the customers. Table 1 provides examples of
customers to target in planning for a new service. Operational Advantages Over Competitors
Understanding the audience that will approve the
business plan will help the pharmacist make a As an ambulatory care clinical pharmacy
stronger case regarding the need and financial service is planned, pharmacists should project
viability of the proposed service(s). The the advantages and distinctive attributes of their
customers will base their decision to use the service over the services currently provided by
service on their perception of the quality, value, other practitioners. It will also be necessary to
and convenience of the service.4 In a time when identify what clinical pharmacy services are
there is a shortage of qualified clinical pharmacy already being provided in close proximity. The
10e PHARMACOTHERAPY Volume 28, Number 2, 2008
Table 1. Targeted Customers and Interest Areas
Practice Environment Customer Key Areas of Interest and Driving Forces
Physician or provider, Physician or provider Improved patient care outcomes, consultation on complicated
office-based practice staff drug-related problems, assistance with financially viable options
to obtain drugs, direct patient care for drug-related needs.
Administrators Financial impact of improved patient care outcomes, improved
formulary adherence, reduction in hospitalizations and
emergency room visits, increased physician or provider
productivity, and potential new revenue stream.
Managed care Physician or provider Improved patient care outcomes, consultation on complicated
staff drug-related problems, assistance with financially viable options
to obtain drugs, direct patient care for drug-related needs.
Administrators Financial impact of improved patient care outcomes, improved
formulary adherence, reduction in hospitalizations and
emergency room visits, and cost-benefit of a pharmacist
providing the care versus another health care provider.
Physician residency Physician educators and Enhanced education of physician residents leading to improved
program program director patient outcomes, consultation on complicated drug-related
problems, assistance with financially viable options to obtain drugs.
Administrators Financial impact of improved patient care outcomes, improved
formulary adherence, reduction in hospitalizations and
emergency room visits, increased physician or provider
productivity, and potential new revenue stream.
Institutional ambulatory Physician or provider Improved patient care outcomes, consultation on complicated
clinic staff drug-related problems, assistance with financially viable options
to obtain drugs, direct patient care for drug-related needs.
Administrators Financial impact of improved patient care outcomes, improved
formulary adherence, reduction in hospitalizations and
emergency room visits, increased physician or provider
productivity, and potential new revenue stream.
Community pharmacy Pharmacy staff Improved job satisfaction, increased career opportunities, and
impact on current services provided.
Pharmacy administrators Potential new revenue stream, increased prescription, over-the-
counter, and store sales, improved employee satisfaction and
retention, enhanced public perception of pharmacy and company.
Community physicians Improved patient care outcomes, consultation on complicated.
drug-related problems, assistance with financially viable options
to obtain drugs, direct patient care for drug-related needs.
Community organizations Access to reliable health information, enhancement of services
provided to the community.
Health plans and insurer Financial impact of improved patient care outcomes, improved
groups formulary adherence, reduction in hospitalizations and
emergency room visits, and cost-benefit of a pharmacist
providing the care versus another health care provider.
Employers Financial impact of improved patient care outcomes, improved
formulary adherence, reduction in hospitalizations and
emergency room visits, cost-benefit of a pharmacist providing
the care versus another health care provider, a decrease in
lost days from work, and improved employee satisfaction
with their health care and employer.
Patients Improved patient care, comprehensive educational services,
drug therapy management.
Academia College of pharmacy High-quality advanced practice experiences.
experiential director

advantages and strengths of the proposed new Specifically, pharmacists should consider the
services should be determined.5 drug-related services already offered by other
departments, particularly those of physicians,
Within the Organization physician assistants, and nurse practitioners.
Pharmacists should evaluate the services of Whenever possible, pharmacists should develop
other practitioners within the organization. services that draw on their distinctive
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 11e
qualifications and are complementary rather than benefits of including a pharmacist both in the
duplicative. Practitioners from other disciplines clinical decision-making process and in
will often embrace the clinical activities of providing care directly to patients. The concept
pharmacists when they are viewed as of pharmaceutical care has been explored for
contributing to the overall care of patients. more than two decades, but there are still few
Perhaps one of the best ways to achieve published examples of financially sustainable
acceptance from other disciplines is for ambulatory clinical pharmacy practices in
pharmacists to focus on drugs and drug-related existence.9
issues, particularly in areas in which pharmacists The “business” behind the practice being
have specialized education, training, and developed should begin when the service is
experience. In the event that a pharmacist would planned. The goal of caring for unmet needs of
like to offer a service similar to one already patients should be combined with the goal of
offered by another practitioner, the pharmacist being a financially viable service. Understanding
should carefully coordinate his/her mission, the financial drivers within the organizational
objectives, and specific activities with those of structure of the pharmacist practice will allow
the established practitioner in order to identify the provision of care to a wider patient base and
the unique attributes of the new service. To the will help sustain the service over time. The long-
extent that complementary roles can be term and short-term goals for proposed clinical
identified, the pharmacist may have more or less services should be described.
success with offering a new service. However, if The type of patient care service a pharmacist
the new service is viewed by patients and/or designs is based on two primary factors: the
practitioners as duplicative, the new service may practice environment and the needs of the
fail, often simply because of the allegiance to the patient population to be served. Table 2
established service. In this situation, the describes several practice environments and the
pharmacist should identify other potentially business models that exist. Understanding the
successful roles and move toward establishing a business model will assist in proposing a
service that will be more favorably received. In particular type of practice. For example, if the
some circumstances, the pharmacist may practice will be in a physician’s office where the
collaborate with other health care providers. physicians are provided incentives for “best
practices,” and they are not meeting the goals of
Outside the Organization their patients with diabetes, a proposal might be
Pharmacists should also evaluate the services written to begin a service directed toward the
provided by pharmacy, medical, or other groups patient population with diabetes. Understanding
outside the organization in planning their new the business model where the clinical service will
service. As above, practitioners may easily accept be established aids in directing the proposed plan
new services that are not currently available to to the appropriate audience, including those who
patients, even outside the organization by have the authority to approve the plan.
referral. In such situations, pharmacists may Collaboration with other health care providers
choose to associate with an outside group rather should be described, and the overall goals should
than independently develop a new service. be clarified.
Pharmacists should plan services with the The mission for all ambulatory clinical
expectation of having as few disadvantages as pharmacy services is to improve patient care.
possible. These disadvantages should be Numerous studies clearly demonstrate that many
identified and minimized early in the planning patients are not achieving optimal results from
process. their drugs. In 2003, only 56% of patients in the
United States with chronic medical illnesses
received the recommended treatment. 10
Section 3: Needs Assessment
Furthermore, patients continue to experience
Establishing an ambulatory clinical pharmacy drug-related adverse effects at increasing rates.
practice begins first with an understanding of the In the ambulatory environment, the most
needs of the patients that will be served by the common problems in the drug use process that
practice and the potential revenue streams that result in preventable adverse effects occur during
can financially support the service. The medical the prescribing and monitoring stages. 11 Drug
literature describes numerous examples regarding safety is highlighted in many recent studies in
the drug-related needs of patients and the community-dwelling populations 12–15 and in
12e PHARMACOTHERAPY Volume 28, Number 2, 2008
Table 2. Existing Business Models in Ambulatory Clinical Pharmacy Practice Environments
Practice Environment Business Model Pharmacy Business Opportunities
Physician or provider, Fee-for-service Direct billing for services under physician with a level 1
office-based practice (99211) office code; direct billing using medication therapy
management Current Procedural Terminology reimbursement
codes, when available.
Per-member-per-month Risk-sharing model where a physician or provider agrees to
(health maintenance pay the pharmacist a certain amount per-member-per-month
organization) to avoid unnecessary emergency room or hospital utilization;
anticoagulation services is a common example.
Incentives for “best practices,” Similar to above, physicians or providers agree to pay a certain
meeting predetermined amount to have pharmacist assist practice to achieve best
treatment goals practices; physicians or providers choosing this method are
likely to have incentives from insurance carriers to achieve
disease-state goals; this savings may be passed on to the
pharmacist.
Managed care Office-based practice See options 2 and 3 in office-based practice examples above.
Physician residency Education and training model Unique to this practice, funding may be available directly for
program (Federal funding for training) residency training of physicians; in this role, pharmacists may
consider seeing patients collaboratively with physicians to
provide education and training in advanced patient care.
Office-based practice See all three office-based practice examples.
Institutional ambulatory Clinic code When an ambulatory clinic is a part of a health care system, a
clinic basic “facility fee” may be charged per patient visit with the
pharmacist.
Office-based practice See all three office-based practice examples.
Community pharmacy Prescription and over-the- More prescription and over-the-counter product sales can
counter product sales serve to pay for clinical services; amount of services provided
limited by product sales.
Partnership with office-based Can participate in per-member-per-month or incentives for best
practices practice (options 2 and 3 in office-based practice examples).
Partnership with self-insured Self-insured employers often seek means to decrease drug costs,
employer group improve patient quality of life, and increase healthy days
working. Since the Asheville Project, self-employers are
more willing to establish paid partnerships with pharmacists
to improve employee health; payment methods may be
modeled after any of the office-based practice examples.
Consulting services As an adjunct to the business model, pharmacists are often paid
for speaking engagements, community events, screenings, and
consultation to nursing homes and physician practices; these
funds can support clinical services including expansion and
serve as a mechanism to advertise pharmacist services.
Fee-for-service A pharmacist in a community pharmacy may provide a service
for a fee to patients; the patient may be directly billed.
Academia Practice in a college Clinics may be set up within a college of pharmacy; often this
of pharmacy is done as a fee-for-service, or as a free service due to the
educational nature of the clinic for students.
All practice Medication therapy With the initiation of Medicare Part D in January 2006, many
environments management services health plans are developing payment mechanisms for
(per pharmacy benefit pharmacists to provide advanced care to patients; this care can
manager) be provided in all areas of ambulatory practice listed above;
some states may have payment for medication therapy
management for Medicaid patients.

home health care patients.16 Adverse drug events the health care system to reduce medication
often can result in hospital and emergency room errors.20
visits.17–19 The Institute of Medicine report in the Because there is a clear societal need to
Quality Chasm series, titled “Preventing improve the drug use process, it is important to
Medication Errors” outlines changes needed in demonstrate how pharmacists can meet this
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 13e
need. Numerous studies demonstrate how a detecting nonadherence or a drug-related
pharmacist can positively affect a patient’s care. problem that could not be easily addressed at the
The American Pharmacists Association21 provides time of dispensing. Alternatively, a patient or
an extensive overview of studies demonstrating a caregiver may self-refer after learning of the
pharmacist’s impact on patient care, including pharmacist’s service. If the pharmacist is a part
patient safety, asthma, diabetes, drug therapy of an interprofessional practice, the service or
compliance, dyslipidemia, immunization, pain referral may be an integrated component of the
management, and vaccinations. Furthermore, patient care process. In some cases, a referral
studies demonstrating the economic benefit of may not be necessary. In an interprofessional
clinical pharmacy services have been practice, it may be a standing policy that any
summarized.9 In addition, the Lewin Report is a patient taking more than a certain number of
useful resource.22 The reference list included in drugs or with certain conditions sees the
this paper provides studies in practice pharmacist before seeing other practitioners.
environments specific to community practice, Once a referral to the pharmacist is made, an
institutional ambulatory care, managed care, and individual appointment or consultation with the
family medicine (Appendix 1). patient should be set up.
The pharmacist must also recognize the
financial driving forces in a particular practice The Patient Encounter
environment. A practice can be financially viable Patient encounters ideally should occur in a
through a number of mechanisms such as cost private area where the pharmacist, patient and/or
avoidance (e.g., reduction in hospitalizations) caregiver can comfortably discuss the patient’s
and direct payment of services. drug-related needs. The encounter should begin
with a simple introduction of the pharmacist to
Section 4: Description of Services the type of service and follow-up the patient can
Essential Components of a Service expect. The second step is gathering from the
patient the reason for the visit and drug
In the medical model, the patient care process experience.6 The medical record or other patient
is the same whether the physician is a generalist documentation, if available, can provide
or specialist. The same is true for other health important details of the patient’s medical history
care providers.6 The identical concept needs to and laboratory and test results, and may aid in
be applied to ambulatory clinical pharmacy further identifying the patient’s needs. In most
services. The work of the American Pharmacists cases, the pharmacist would also complete a
Association and National Association of Chain thorough medication therapy review. 23 The
Drug Stores Foundation points to a clear components of this review are described in Table 3.
framework of the design of a pharmacist
medication therapy management (MTM) service Documentation
in the community pharmacy setting,23 which can
serve as a model for all areas of pharmacy Documentation of the patient encounter is
practice. One model of ambulatory clinical absolutely necessary not only to record the
pharmacy practice is important to set the nature of the encounter, the patient problems
standard for patients and health care providers to identified, and the follow-up plans, but also to
understand the value they will receive when a serve as evidence of the service(s) provided. The
pharmacist meets with a patient. format of the documentation can take different
forms depending on the practice environment
Patient Enrollment or Referral and the resources available. Patient records can
be stored in either paper or electronic medium.
There are multiple sources for patient Documentation should minimally include patient
enrollment or referrals to a clinical pharmacy demographics, reason for visit, subjective and
service. A physician or other health care objective information obtained, the pharmacist’s
professional may refer the patient for MTM, assessment and plan, any interventions or
disease state management, monitoring or recommendations made, and planned follow-up.
adjustment (e.g., anticoagulation service), and/or National organizations offer standards for
education (e.g., diabetes or asthma). A community practice23 and for documentation in
pharmacist at the point of dispensing in a medical records. 24, 25 Standardization of the
community pharmacy may enroll a patient after pharmacist’s documentation for each patient
14e PHARMACOTHERAPY Volume 28, Number 2, 2008
Table 3. Components of a Medication Therapy Review6, 23
Component Description
Perform medication regimen Inquiry and comprehensive review of all prescription and nonprescription medications
review the patient is taking as well as any herbal or vitamin products
Gather patient’s medical history Medication-related medical history, including physical examination findings, history
of diagnoses, hospitalizations, and surgeries
Gather social history, cultural, and Relevant social history; cultural and patient preferences toward drug therapy as it may
lifestyle preferences relate to adherence and drug choice; lifestyle management
Review laboratory and physical Review of laboratory data and test results, and the performance of any physical
examination data (as available) examination or laboratory procedures as appropriate based on the patient’s
medication therapy needs and as allowable by state law
Assess overall medication therapy Review of the patient’s medication regimen for appropriate indication, efficacy, and
and identify medication therapy safety for the individual patient, as well as the patient’s adherence patterns; evaluate
needs and problems; evaluate the patient’s response to medication therapy, and identify potential adverse events
and monitor response to and drug-drug interactions; financial and cultural considerations must be considered
medication therapy in addition to appropriate monitoring suggestions and dosage regimens
Create a medication therapy plan A plan to address and resolve medication therapy problems identified during the visit;
the plan should be developed collaboratively with the patient and other health care
providers as appropriate; the plan may include a lifestyle change by the patient, a call
or collaboration with the physician or other health care provider, or the pharmacist
resolving a financial or therapy concern
Provide education, patient At the conclusion of the visit, patients should be given appropriate medication- and
recommendations, and follow-up disease-related education as well as therapy and lifestyle recommendations as
considered appropriate with their other health care providers; patients should be
provided with a personal medication record (comprehensive medication list) and a
medication action plan detailing how they should take their drugs as well as lifestyle
recommendations
Communicate results to other Results of the visit and medication therapy recommendations should always be
health care providers documented and provided to the patient’s other health care provider(s) if necessary;
in an interdisciplinary setting, documenting in the medical record in written, verbal,
or combination form is usually sufficient; in addition, patients should be referred to
other health care providers as needed to support their medication therapy regimen
(e.g., dietician referral)

encounter is essential. Within existing medical on the practice environment and may include
records, pharmacists may elect to use a standard physicians and physician assistants; nurses and
“SOAP” note (i.e., subjective data, objective data, nurse practitioners; dieticians; other pharmacists;
assessment, and plan) to be consistent with other pharmacy technicians; and other support
providers or may use a separate pharmacy note personnel. Communication with the patient’s
using a standardized documentation template. If health care provider(s) is essential to ensure
the pharmacist practices independently, the optimal use of drugs. The type of
documentation (written or electronic) should be communication is determined by the urgency of
stored in an easily retrievable location. A the patient’s need. An acute need should be
consultation letter should be sent to the patient’s communicated verbally followed by written
health care provider(s), and a copy should be communication. A chronic care need should
maintained in the medical record. The always be communicated in written format. In
consultation letter may be sent to the prescriber addition, patient-focused communication with
by standard mail, fax, or secured electronic other health care providers helps to build
method. working relationships and encourage continued
referrals from providers for future consultations
Communication with the Patient’s Other Health regarding patient drug therapy needs.26 In order
Care Providers to document the pharmacist’s findings and
recommendations in the patient’s medical
Collaborating with a number of individuals
records, some institutions require pharmacists to
within the health care team is essential to build
obtain privileges and provider numbers.27
and sustain a patient care practice. The
collaborations, both formal and informal, depend
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 15e
Table 4. Operational Processes and Facility and Equipment Needs for a New Clinical Service28, 30
Requirements Recommendations
Operational processes
Information services Adequate information systems are required and should be online and computerized,
if possible; examples include Micromedex, Lexi-Comp, DynaMed, Up To Date,
and Cochrane Library; access to MEDLINE is required; when possible, PDAs should
be available for access to drug information; access to full-text pharmacy and medical
journals is desirable
Record systems Should be user friendly and designed with pharmacist’s input to allow full pharmacist
documentation; electronic medical record (EMR) should integrate with pharmacy
systems, if possible; if EMR is available, pharmacist should seek full access; if no
medical record (e.g., at a community pharmacy), patient care notes should interface
with available record keeping methods, and a method of providing documentation to
other health care providers should be determined; also, if no medical record, patients
can sign release statements so that records from physicians’ offices can be obtained
Materials and supplies Patient education materials, personal drug records, preprinted materials often available
from government organizations, drug manufacturers and national associations
(e.g., American Diabetes Assocation, National Kidney Foundation); demonstration
devices and kits for product and device education (e.g., placebo inhalers, insulin pens,
topical patches); general office and computer supplies
Data analysis and reporting Director or coordinator is responsible for compilation, analysis, and reporting of all
pertinent data (general or specific); data may be collected in an ongoing fashion or
retrospectively; data that should be collected include patient demographics, medical
conditions, drug therapy, drug-related problems, action taken during visit, and
quality indicators and goals achieved
Facility and Equipment
Space for clinical services At least one examination or consultation room, fully equipped with necessary items
(e.g., blood pressure cuff, examination table or chair, work area for basic laboratory
supplies, scales, sharps container)
Space for pharmacists Office space or work area; office furniture, file cabinet, computer, printer, photocopy-fax
machine, bookshelves
Computer services Types and level of service may vary; ideally located in both examination room and office
area, especially for EMR
Special equipment May become apparent as services are developed; depends on type of service
(e.g., glucometer, point-of-care testing)

Section 5: Operations department of pharmacy, the coordinator of these

services should report directly to the director of
Organization pharmacy to ensure a commitment to these
An organizational structure that represents the services equal to that acknowledged for other key
array of ambulatory care services provided by services of the department. In the case of
pharmacists is extremely important. Job titles freestanding ambulatory clinics or community
and descriptions for pharmacists and pharmacy pharmacies, pharmacists should either provide
technicians providing ambulatory care pharmacy direct leadership for ambulatory services or
services should be positioned within the report to an appropriate administrator.
organizational structure in a manner denoting a Additional reporting lines to physicians and
high level of commitment. All services must be other health care providers may be appropriate,
included in the overall mission statement as well based on day-to-day clinical activities.28
as in the goals and objectives of the organization
and must be represented accordingly in the Operational Processes and Facility and
structure of the pharmacy department and the Equipment Needs
institution or the overall organization. Anything
less than full representation at these levels may In starting a new clinical pharmacy practice in
result in a diminished outcome. an ambulatory setting, several operational
processes, and facility and equipment needs, are
necessary. These are discussed in detail in Table
Reporting Structure
4.28–30
In a hospital setting in which the ambulatory
care pharmacy services are provided through a
16e PHARMACOTHERAPY Volume 28, Number 2, 2008
Personnel Requirements included in their total time. As a general rule,
the length of time allotted for a patient visit may
Adequate attention for determining the overall
be as much as 1 hour for an initial session and
personnel requirements for each ambulatory care
may range from 10–30 minutes in the case of an
pharmacy service is critical. There should be an
established patient session or encounter,
adequate mix and number of personnel to
depending on the required levels of assessment
provide appropriate backup and coverage.
and intervention. When needed, administrators
Failure to provide adequate personnel for each
should seek new positions for the department so
service will lead to frustration of physicians and
that the service can be successful.
others who refer patients, of patients themselves,
as well as of the pharmacy personnel involved in Qualifications of Pharmacists Participating in the
providing the specific service.28
Service
Areas of Practice Each pharmacist who participates in the
Determining the specific areas of practice for service must be appropriately educated and
ambulatory care pharmacy services will depend trained. Strong consideration should be given to
on a number of factors, including availability of require residency training and board certification
pharmacists and support personnel to provide (e.g., Board Certified Pharmacotherapy
each specific service as well as the time, space, Specialist). If appropriately trained and
equipment, and funding available to devote to experienced pharmacists are not available to
each service. Each of these variables should be provide a new service at the time it is desired, the
considered in advance of actually beginning a director or coordinator should seek training
service, allowing more opportunity for success programs or other methods to assist the
and continuation. The service may be general pharmacist(s) to acquire the necessary skills and
MTM or specific disease-state management. experience. Continuing education and
Factors outside the control of the pharmacy certification programs are often available to assist
department or the pharmacist that may affect any pharmacists in developing new skills and practice
pharmacy service may include the participation expertise while remaining in their positions.
of physicians and other health care practitioners Pharmacy residents and fellows may be involved
who also have an interest in such services. in provision of services when appropriate, but
Physicians may be involved in determining the never in the absence of qualified personnel to
overall direction and success of clinical services, supervise their activities. A resident or fellow
particularly if their referral of patients is critical should not be the sole provider of the service,
for receiving patients. unless he/she has already demonstrated expertise
in this service through previous training or
Number of Full-Time Equivalents Needed experience.

The number of full-time pharmacists and Areas of Support

pharmacy technicians needed for any specific
service will vary depending on the number of Pharmacy technicians and clerical and
patients to be served and the depth and breadth financial personnel can play important roles in
of the service. The director or coordinator for establishing and maintaining ambulatory care
the service should cautiously predict the need for pharmacy services. Pharmacy technicians can
personnel, employing additional personnel for assist in the preparation of drugs, record-keeping
anticipated growth and unexpected details. activities, and supervised patient interactions.
Administrators should attempt to calculate the Clerical personnel can place phone calls and send
maximum number of patients who can e-mail or letters to patients regarding
appropriately receive the service in a given day appointment scheduling and follow-up
based on review of medical records for the information. Financial personnel may be
occurrence of specific diseases or medical responsible for billing and keeping ledgers
problems; pharmacy profiles for the occurrence necessary to track the flow of money through the
of specific drugs or drug categories; discussions system.
with physicians who may be associated with the
Desired Areas of Expansion
service, and any other means of understanding
the demand for each service. In addition, Desired areas of expansion may become
administrative time for pharmacists must be apparent after a service has been offered for a
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 17e
period of time based on requests from patients, projected to have the greatest positive impact,
physicians, administrators, or others. These while not duplicating the services of other
expansion areas should be considered carefully practitioners. Pharmacists should identify areas
using all the variables used initially to determine of practice in which their education, training,
need and capability. Qualifications for personnel and experience will allow their optimal level of
needed for expansion of services may be different practice, and they should evaluate their practices
from those initially in developing the service. as often as possible to determine their impact on
Specifically, pharmacists with more specialized overall patient care.
training may be required as the depth and
breadth of the overall services become more Within the Department Organization
defined and detailed. For example, an The primary impact of ambulatory care
ambulatory care pharmacy service may begin pharmacy services within the department or
with activities for general medicine patients and organization may be on personnel and staffing.
develop over time to include more complex Administrators should make every effort to
patients who may need specific services in ensure that changes in professional rank or
cardiology, pulmonology, infectious disease, appointment levels, staffing patterns, salaries,
nephrology, and/or other specialties in a similar professional advancement, and other important
manner to the services offered by physicians. As personnel issues are understood by all personnel.
more specialized services are desired, the demand Any new arrangements brought about by the
for specialized practitioners will follow. implementation of a new service or the hiring of
new personnel should not negatively affect the
Subcontracting and Outsourcing
overall department. The primary clinical impact
Subcontracting and outsourcing for specific of ambulatory services may be most realized
services associated with an ambulatory care within the department or organization by the
pharmacy service may be desirable when the benefits observed from patient care, such as
needed personnel or services are not available on improved surrogate markers, actual outcomes, or
site, particularly in the early stages of a new positive financial impact.
program when full-time staff or services cannot
be financially justified. However, a commitment Other Departments and Practitioners
of full-time personnel to each area will provide When pharmacists initiate clinical services,
the continuity of care that is often needed. there may be either a positive or a negative
Examples where this may be helpful are in the impact on other departments or practitioners.
areas of information technology and dispensing. Depending on the methods in which patients are
identified for ambulatory care clinical pharmacy
Evaluating the Need for Training
services and the outcomes associated with the
The director or coordinator should assess the service, the impact on other departments and
need for additional training when new personnel practitioners, particularly physicians and nurses,
are recruited or new programs are established. In may vary. However, the impact of each
each case, training should be based on the need ambulatory care pharmacy service should be
to provide updated policies and methods anticipated before initiation of the service. By
required for excellence in specific clinical anticipating such impact, other practitioners and
practice areas. The director or coordinator administrators can be consulted in the early
should provide adequate material and time to planning stages so that the primary impact will
become established in the performance of be positive and the service will be viewed for its
expected activities before these personnel take strengths rather than as a source of competition.
full responsibility for the service.
Section 6: Legal and Regulatory Issues
Operational Impact of Services
Compliance with Practice Standards
The impact of ambulatory care pharmacy
services should be anticipated prior to initiating Several factors must be evaluated and
the service. Pharmacists should identify gaps in considered when implementing ambulatory
the types and levels of service already being pharmacy services, including organizational
provided in an area and begin services that are structure, opportunities for collaboration, access
to patients and patient information, employment
18e PHARMACOTHERAPY Volume 28, Number 2, 2008
requirements, affiliation needs and agreements, for their members. Because the legislation does
and policies and procedures for the service.2, 31 not stipulate details related to these plans, there
When establishing a collaborative practice is significant variability in the design of MTM
agreement, the following steps should be services. The Lewin Group was enlisted to create
considered and outlined during the planning and a resource to assist with designing and
early implementation process: define scope of implementing MTM services.22 To specifically
practice, apply for privileges at the practice site, assist the community pharmacist, the American
identify evidence-based practice standards, Pharmacists Association and National
establish policies and procedures, determine Association of Chain Drug Stores jointly
qualifications for participants, create a identified the core elements and a framework to
continuous quality improvement process, deliver MTM services within this setting.23 Some
measure outcomes (economic, clinical and states are now reimbursing pharmacists for
humanistic), document activities, and investigate providing MTM to Medicaid patients.38, 39
compensation processes.31
Health Insurance Portability and Accountability Act
Collaborative Drug Therapy Management Compliance
Pharmacy and medical organizations have All health care practitioners and medical
published position statements supporting the practices must understand and comply with the
pharmacists’ role in collaborative drug therapy Health Insurance Portability and Accountability
management (CDTM). 31, 32 As of November Act (HIPAA). Compliance with the HIPAA
2005, 43 states have enacted legislation that legislation requires careful evaluation of policies
grants pharmacists the authority to engage in and procedures related to patient information
some form of CDTM.33 Several resources provide and implementation of measures to ensure the
an overview of CDTM and summarize state- privacy and security of patient information. At
specific regulations. 31, 34, 35 A survey of the first office visit, patients should receive a
ambulatory care pharmacy practices identified Notice of Privacy Practices, and a written
collaborative practice agreements as a significant acknowledgement of receipt must be obtained.
enabling factor for the integration of pharmacists Although patient authorization is not required
in the ambulatory care setting.36 To facilitate for routine disclosures related to treatment,
further expansion of the pharmacist’s role in the payment, or health care operations, it is required
ambulatory setting, states should review and when protected health information is disclosed to
make necessary changes in the pharmacy practice a third party; for marketing of products or
laws and regulations to allow pharmacists to services (except if marketed in a face-to-face
participate in CDTM. Examples and descriptions encounter); for raising of funds for other
of collaborative practice agreements may be organizations; and for conducting research,
found in the literature (Appendix 1). unless a waiver was approved by the institutional
review board.40 To facilitate the implementation
Medication Therapy Management Services of HIPAA policies and procedures, adequate
The Medicare Prescription Drug, Improvement training of all staff should be conducted and
and Modernization Act of 2003 was intended to documented. Appendix 1 includes resources for
increase access to prescription drugs by HIPAA compliance.
providing drug coverage for beneficiaries. 37
Furthermore, specified patients enrolled in the Miscellaneous Regulations
prescription drug benefit are entitled to receive The Occupational Safety and Health
MTM services. Although pharmacists were not Administration (OSHA) has established
granted “provider status” and are ineligible to standards that apply to all employees who may be
receive compensation for services under exposed to blood or other potentially infectious
Medicare Part B, the legislation requires materials. 41 These regulations describe
prescription drug plans to pay for MTM services requirements that employers must fulfill to
as a Part D benefit. Other providers are not protect individuals who have a risk of
excluded from providing MTM services; occupational exposure. Pharmacists in
pharmacists are the only health care practitioners ambulatory care settings, including community
specified in the regulation. The prescription pharmacies, who perform point-of-care testing
drug plans create and implement MTM programs may be exposed to bloodborne pathogens and
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 19e
other potentially infectious materials. These sites Pharmacists are pursuing postgraduate
would need to comply with OSHA standards training, becoming more specialized, and
(Appendix 1). attaining certification in a specific domain of
The Clinical Laboratory Improvement practice (e.g., certification through the Board of
Amendments were initially passed in 1988. The Pharmaceutical Specialties, Commission on
Centers for Disease Control and Prevention and Certification in Geriatric Pharmacy), specific
the Centers for Medicare and Medicaid Services disease states (e.g., certified diabetes educator,
published final regulations that have been certified asthma educator), or specific therapy
effective since 2003. 42 The purpose of the (e.g., certified anticoagulation care provider).
laboratory amendments is to create standards Other than the requirements for pharmacy
that will ensure quality laboratory testing and licensure, no credential is required by law to
procedures. A laboratory is defined as any provide specific clinical pharmacy services in an
facility that performs laboratory testing, ambulatory care setting. However, each
including ambulatory and community institution, health care system, or organization
pharmacies performing point-of-care testing. can establish its own criteria for pharmacist
Many resources summarize the procedures and practice descriptions and credentialing and/or
regulations associated with laboratory testing. privileging processes. 27 The Lewin Group
Appendix 1 includes a list of Web-based concluded that MTM services can be provided at
resources. multiple levels of complexity, with licensed
pharmacists providing first-line drug
Certification and Credentialing management and more highly trained or
Credentialing and privileging for pharmacists credentialed pharmacists delivering more
are important and complex issues intended to complex services.22 Appendix 1 includes a list of
protect patients from incompetent providers, to resources on this topic.
safeguard organizations from malpractice
Liability Insurance
allegations, and to meet regulatory agency and
third-party payer requirements. When Professional liability insurance is needed and
establishing ambulatory care services, developing should provide coverage for any activity that
CDTM protocols or providing MTM services, the pharmacists can do legally in the state in which
public and other members of the health care they practice, including CDTM if permissible by
team need to have an agreement on and common state law.44 Generally, the institution is liable for
understanding of the education and training of an employee’s acts of professional negligence that
pharmacists and their contribution to patient occur within the practitioner’s typical scope of
care. Thirteen national pharmacy organizations practice. Therefore, most employers and
founded the Council on Credentialing in institutions carry a professional liability policy on
Pharmacy to provide leadership, standards, their employees. An employed pharmacist who
information, and coordination for professional is covered by his/her employer’s policy may
credentialing programs in pharmacy. Pharmacist obtain an additional, secondary policy. Although
credentials may be divided into three not required, an individual pharmacist may
fundamental categories: college or university choose to obtain additional coverage for several
degree; licensure; and certificates, awards or reasons. An employer may disclaim its
postgraduate work.43 Privileging is the process responsibility if the situation is proven to be
used by a health care organization, after outside the scope of normal practice or
evaluating a practitioner’s credentials and protocol.45 In some cases, the claim may exceed
performance, to grant an individual permission the employer’s policy and the individual’s
to provide certain patient care services. 43 A personal, secondary policy would apply. Finally,
pharmacist may be recognized by the an employer’s policy covers the pharmacist’s
organization to be credentialed and obtain a activity occurring at work whereas an individual
provider number. 27 Some states, such as policy would include coverage for work and non-
Minnesota, may require the pharmacist to be work related advice and activities. Primary
credentialed through the state government, liability policies are also available for
especially if providing services for Medicaid.38 independent contractors and consultants.
Credentialing may also be necessary for billing
purposes. Risk Management
20e PHARMACOTHERAPY Volume 28, Number 2, 2008
Site-specific policies and procedures, clinic services currently available. It is important that
protocols, and collaborative practice agreements the definition of the service includes how the
based on evidence-based medicine principles service will be different from any other service
should be established to optimize patient available in the community and why the patient,
outcomes and minimize risks. An attorney health care provider, or third party payer should
should write or review any agreement or contract select the new service. The service has to meet
for services before securing signatures. The basic the expectations of the customer to be a success.7,
50
elements to be addressed in a contract have been
described.46 Although the exposure for liability
increases as pharmacists’ practice activities and Physicians and Other Health Care Providers
responsibilities expand, many techniques can be Once the benefits of the service have been
employed to minimize that risk. The key steps to defined, the marketing design needs to be
managing risk include identifying, assessing, molded around the groups to be marketed. To
eliminating, minimizing, and transferring risk.47, 48 evaluate the opinions of health care
A proactive approach should emphasize measures professionals, insurers, and patients regarding the
to eliminate, minimize, and transfer risk, which perceived need for and anticipated use of the
can be accomplished in a variety of ways. proposed service, a simple questionnaire can be
Examples include ensuring adequate distributed to assess the best way to market the
credentialing, hiring qualified personnel, service. Gathering these opinions before
improving procedures and protocols, maintaining investing in a new service can be helpful and
good patient and staff relations, and cost-effective. The questionnaire can also
communicating and documenting activities ascertain whether a similar service existed in the
well. 47, 48 Reasonable extrapolations to past and how successful it was.51 If the primary
ambulatory care pharmacy practice would person making referrals to the service will be a
include obtaining the medical staff’s endorsement physician, it should be determined which
of pharmacist involvement and clinical pharmacy physicians should be targeted for marketing by
protocols, clearly documenting all pharmacist specialty or subspecialty and special interests.
interventions and communication in the patient’s Talking to other health care professionals may
medical record, maintaining professional provide insight as to the demand for the service.
competence and achieving appropriate For example, endocrinologists, internal medicine
credentials, and evaluating pharmacist physicians, and primary care physicians would be
intervention and patient outcomes as part of the the groups one would market to for a diabetes
comprehensive quality improvement efforts. A education service, as they are the ones who will
worksheet to assist with identifying, evaluating, refer potential patients.
and addressing various liability risks is Physicians will be evaluating the service on a
available.46 The evolution of risk management more professional level. They may inquire about
and quality improvement processes in recent the educational background and specialty
years has led to a logical interface between the training of the pharmacist(s) providing the
two concepts. Integrating risk management and particular service, the disease-state management
quality improvement is sensible and can enhance plans, and the outcomes that are expected.49
the effectiveness of both.47, 48 Establishing a relationship with other health
care providers is essential in establishing or
Section 7: Marketing and Promotion expanding any service. Providing physicians and
Marketing includes researching customer other practitioners with additional services may
needs and wants, developing strategies, enable them to better meet the needs of their
maintaining customer records, delivering patients. The ability of pharmacists to identify
products and services, financing, promotion, potential problems, such as drug adherence, can
pricing, and monitoring customer satisfaction.49 result in appropriate and timely interventions
and build confidence with the health care
Preparing to Advertise provider, leading to requests for further
pharmacist consultations.52
Being able to define the service in a way that is
appealing to all customer groups is key to the Patients
marketing process. Therefore, services should be
evaluated to identify the health needs and Research has demonstrated that patients are
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 21e
often unaware of the services pharmacists are It may also help with identifying legal
able to provide and are unlikely to appreciate the restrictions, which may limit the scope of the
roles and responsibilities of pharmacists. 53 service or the ability to provide the proposed
Therefore, the marketing plan for patients will service.
need to be different from the marketing plan for
health care providers or payers. Patients will be Public Advertising
evaluating the service for value, convenience, and
quality of care. Patients will want a guarantee Products can be marketed or promoted in
that the service for which they are paying will several ways, including internal and external
meet their needs and expectations as well as marketing.
being price competitive; therefore, extensive,
Internal Marketing
straightforward education about a new service
needs to be provided.54 Internal marketing is dependent on the staff.
The staff needs to be knowledgeable about the
Payers and Stakeholders new service so that when there are questions
When promoting the service to payers, it is regarding pharmacy services, they are able to
necessary to clearly describe how the new service answer the questions and promote the benefits of
will improve both outcomes and cost-effective the specialized service. It is also prudent for
care. It will be necessary to document decreased patients to see promotional items around the
emergency department, hospital, or office visits; waiting areas. Another option is mailing out
improved patient care or satisfaction; and/or program information to current patients either
reduced overall drug costs. Some managed care with a particular disease state or to all patients to
organizations contract health care services if the reach family members who may have the specific
proposed service meets the payer’s goals. The disease being targeted.7, 50
potential is there to have a steady flow of patients
External Marketing
through their health care plan.
Knowledge of the key stakeholders is critical. Because the intangible nature of pharmacy
These individuals have a vested interest in the services makes it difficult for consumers to grasp
success or failure of the proposed service and what pharmacists do, patients who have used the
represent the real customers in the process. It is service will be instrumental in promotion outside
critical to know how success is defined for them office walls.49 They will be describing the service
with regard to both financial and nontangible to their family, neighbors, and friends, which will
benefits. From a financial perspective, certainly increase knowledge of the new service
understanding how they value cost-savings, within the community. Other methods of
enhanced revenues, and risk reduction is vital in promoting a service include broadcast (radio or
planning the approach. In assessing nontangible television spots), print (newspaper
benefits, consideration should be given to advertisements, yellow pages, leaflets, posters,
growth, new opportunities that may evolve from newsletter), Web page information, and
the service, and strategic positioning within the volunteer screening for support groups (heart
health care sector in which they operate. failure, diabetes) to help monitor disease states
Soliciting input from these key individuals is a and educational programs for professional and
critical step in the planning process. A new consumer groups.55, 56
service should seek to solve a previously
identified problem or improve an existing Evaluation of Advertising
process, which can often be identified by
conducting a needs assessment. This assessment To justify the cost of a marketing campaign, it
can often identify areas of strength relative to will be necessary to evaluate the effect the
areas of concern and can provide useful insight campaign has on the customers. Piloting an
into what the customers perceive as “valuable” advertising campaign using a sample of the
versus the proposed needs of various parties who targeted population (health care providers and
will interact with the service. It can also assist patients) can provide positive or negative
with identification of how the current needs of a feedback regarding the current plan.
particular sector are addressed and how the new Adjustments may need to be made to the original
service can address those needs in a better way. design to accommodate for focus areas that were
inadvertently missed or not fully explained.57
22e PHARMACOTHERAPY Volume 28, Number 2, 2008
Once the campaign is under way and the new Planning for service development involves
service is operating, it is important to consider knowledge of the many factors that influence the
how to maintain the customer base (professionals patient outcomes. At the center of all of these
and patients) that currently uses the service and factors lies an understanding of the process by
how to expand to other potential customers. As which individuals 60 and systems 61 implement
part of a quality assurance follow-up, the number change. Change, whether viewed in a positive or
of visits and what profit was gained should be negative light, is one of the most difficult aspects
evaluated. It would be valuable to determine for many people to accept and work with
what parts of the service customers like best and initially.62 A strong sense of consensus among
build on those focus points. 50, 56 This can be contributing parties can be valuable in reducing
done through questionnaires or surveys. From some of the stresses associated with
the responses, it can be determined what needs implementing change in the workplace,
to be done to retain current customers and particularly with service development.
hopefully obtain ideas on how to reach other During the planning stages of service
potential customers. Some ideas may include development, efforts to conduct background
sending out newsletters regarding a new drug on research can be a productive use of time and
the market (drug information) or making phone effort. The collective development of the
calls to follow-up on a patient visit in which business plan proposal is often the most
changes were made to therapy. Anything that can productive means of initial planning and ensures
personalize the service will separate it from other that the interests of those likely to be affected by
community programs.57 the plan are identified and addressed. Collective
input should also serve as the foundation for
Section 8: Service Development and Exit Plan acceptance and ensures that inordinate amounts
of time are not spent on small details at the
Milestones for Service Development expense of momentum.
A well-constructed strategic plan is the Group effort requires the selection of a
cornerstone of success in the business qualified leader63 who understands the business
environment. The strategic plan describes the environment and who has sufficient background
projected direction of the patient care pharmacy and experience in establishing and conducting
service within the scope of the overall the day-to-day activities of the proposed service.
organization and the best approach for achieving The leader should be able to establish clear goals
defined goals.58 It is the essential starting point and appropriate timelines, assign responsibilities,
for determining whether or not there is a need to coordinate efforts of the group, and select group
establish a new service. members who understand the goal to be achieved
Although marked in a variety of ways, with the initiative. The leader should have well-
milestones are broadly defined as indicators or defined strategies for implementation and be able
events placed at key points in the life of a project to delegate when appropriate. The leader should
or service, intended to measure achievement in be credible among administrators in the
the ongoing project or service.59 The indicators organization and should represent the interests of
must be measurable, realistic, and consistent major stakeholders who stand to benefit or lose
with the strategic plan to ensure progress. from the success or failure of a program or
Milestones are measured at interim stages rather project. Finally, a good leader should be able to
than at completion of the project, and they are accept responsibility for successes and failures of
absolutely essential in the process of service the project at all points in development.
development. Milestones developed in advance
of the start of the service serve as points for Planning Phases
reflection and evaluation while allowing for The planning process involves multiple stages.
redirection and modification of the service if A planning guide was recently published for the
necessary. The milestones also serve as interim establishment of palliative care programs. 64
markers of progress to help ensure the success of Although specific for palliative care, many of the
the service both in the development process and core elements of the program development are
as continuing measures of quality once the applicable to other clinical services.
service is established. Assessment of the factors affecting project or
service development status should include those
Planning for Service Development
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 23e
internal and external to the service. Internal interaction of the service to existing clinical
factors would include core strengths, as well as programs. In addition, lines of responsibility
deficiencies, as these drive priorities and within the larger system should also be clearly
processes for development. External factors are defined to ensure integration and completion of
more difficult to control but should be included the interrelated aspects of the service within the
in the planning process. These factors include institution.
MTM services, 22 legal issues (which vary by Finally, criteria defining the success of the
locale), payers (whose benefit coverage varies service should be established to systematically
substantially from one another), and similar monitor progress. Key customers and decision-
services within the institution or organization makers should be present to assure that all
that are in direct competition with the proposed concerns regarding the proposed service are
service and from whom the service must be adequately addressed through an objective
distinguished. process.

Service Development Launching a Service

Service development requires a keen Once approval of the proposed plan and
understanding of the business culture into which financial arrangements has been secured, the
the clinical service is being introduced, the major service can be launched. Personnel to assist with
competitors in the marketplace, and the potential the implementation process should now be
impact of the service in that system. Implicit in identified and a training plan should be
this process is the knowledge of the key decision- developed to ensure a smooth transition and
makers. These individuals can assist or impede continuity of patient care. A new patient care
the development of the service and its service will have numerous new record-keeping
implementation. These decision-makers should processes and operating procedures. Strong
have a clear understanding of how the proposed administrative and clinical support will be
new service will benefit the organization and how essential in these early days as the risk for errors,
it will fit into the overall strategic plan. omissions, and harm to a patient will likely be
For ambulatory clinical pharmacy practice, higher than usual due to the unfamiliarity of
market analysis should be done to evaluate personnel with new processes.
model practices and implement ideas to assist in Operation of the new service will need to be
creating an excellent clinical practice. Other coordinated with other services in the health care
clinical pharmacy practitioners are often willing organization that are involved with or affected by
to help share their materials. Resources are the service, such as laboratory or pharmacy
available to assist pharmacists in setting up their dispensing services, and equipment needed to
own ambulatory clinical practices, including run the service, such as computer systems and
protocols and collaborative practice agreements communications networks. Integration of these
from other clinics and institutions.65 systems will ensure a smooth transition period
The financial implications of the proposed and reduce the likelihood of compromising care
service should be explored with the business unit because of inefficient or ineffective system
of the institution where the service will operate. processes.
A proposed business plan should be developed to
compare current and future costs because these Providing the Service
can be used to determine the financial feasibility Policies and procedures approved by the
of the project and how the new service affects the director or coordinator of the service and
organization financially. A well-constructed descriptions of how the service will operate
business plan can also increase the credibility of should be in place from the start. These help
the project with regard to the proposed financial ensure that guidance exists for consistent
benefit. The business plan should identify not operation across most aspects of the service and
only current and future sources of funding, but should reflect the current business environment.
also contingency plans for covering unexpected Key information should be provided in sufficient
operating expenses. detail to give an outside observer a relatively
Lines of authority within the system should be clear understanding of the structure, function,
well established. The scope and impact of the and basic operation of the service.
proposed clinical service are vital to relating the
24e PHARMACOTHERAPY Volume 28, Number 2, 2008
Assessing the Impact on Existing Services keep the project moving forward.
Reasonable expectations should also be
During the early stages of operation, periodic
established to ensure that the success of the new
monitoring of the new service’s impact on
service is not undermined by too aggressive an
existing services should be performed. At
approach. They should take into account both
predefined intervals, careful evaluation of
internal and external factors, which will
whether the service is performing at the
markedly influence progress and direction of the
projected levels should be considered.
new service. Periodic assessment should be
Unplanned events and other influences that
performed to evaluate progress in meeting
have an impact on the success of the program
established objectives.
should be reviewed, and modifications should be
made as necessary. The evaluation should
consider system and process changes that have Expansion of Services
occurred as a result of the service as well as Clinical services that are well established and
changes in predefined outcomes as quantifiable successfully managed should continue to grow
measures of success. Continuous quality over time. At some time in the process,
improvement activities are often used to consideration may be given to expansion of
complete the evaluative process and should be services, whether to cover additional therapeutic
conducted by individuals without a substantial areas, or to meet the needs of a larger number of
stake in the service to improve objectivity. patients and customers within the same
therapeutic area. Ideally, the need for expanded
Establishing a Timeline for Implementation services should be quantified and documented
because the simple desire to expand services may
Timelines include dates by which particular
be insufficient for expansion. The expanded
milestones or objectives are expected to be
service must also be consistent with the strategic
accomplished. Timelines are often established
plan for the health care system.
concurrently with the milestones to provide
consistency in expectations and improve
accountability for the various elements being Plans for Modification of the Business-Practice
managed by different individuals. The timeline Model
should establish a priority ranking for aspects of The initial model developed for the service
the project that require completion of specific should include a fair degree of flexibility to
tasks that are required for project or service address change, whether anticipated or
development. unexpected. Change can appear in a variety of
Many successful implementation plans use ways, including, but not limited to, customer
Gantt charts to structure a timeline for complex needs, the regulatory environment, budgetary
projects. A Gantt chart, developed in the 1910s issues, administrative changes, and leadership
by Henry Gantt, is a diagram that shows tasks changes. To address the potential impact of any
and deadlines necessary for completing a project, of these changes, outcome assessments should be
and graphically represents how long a project used to measure the relative success of the
should take, identifies necessary resources, and service and to guide modifications. The
assists with planning for elements that must be possibility of redirection of the service should
completed in sequence to be positioned among always remain an option if undesired outcomes
those which can be completed at any time in the or previously unanticipated outcomes occur. The
process.66 Although proprietary programs such service should solicit input from customers with
as Microsoft Project (Microsoft Corp., Redmond, a vested interest in the service. Efforts should be
WA) make the development of Gantt charts directed to determining whether or not they are
relatively easy, several free software computer satisfied with the outcomes.
programs are also available for download
(Appendix 1). Exit Plan
The timeline may be modified as necessary
after an interim analysis of progress to date and The successful business model for a new
as unexpected obstacles are encountered in the patient care service must always consider the
process. The findings of the analysis may possibility of the need to cease provision of the
necessitate minor changes in focus or major service at some point in time. This decision may
redirection of the project to address issues and come in the middle of glowing success, overt
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 25e
failure of the service, or a change in the overall evaluate clinical outcomes, humanistic outcomes,
direction of the organization where the service is and economic outcomes in an appropriate and
being provided. The need to exit can be driven organized manner. The timeline for outcomes
by a variety of factors, which are quite similar to assessment will depend on the service provided
those that drive modification of the service. and the disease or problem addressed.
Before an exit strategy is seriously considered,
care must be taken to ensure that all initial Clinical Outcomes
processes related to the identified need for exit
have been adequately tested. Exit strategies A number of clinical outcomes can be
should be considered when recommended measured and assessed using generic and disease-
modifications do not address problems or specific tools. Examples of such outcomes might
deficiencies that have been identified or because include monitoring specific laboratory
of the potential effect of impending parameters related to disease or problem (e.g.,
administrative changes. Although these glycosylated hemoglobin level reduction in
problems may serve as initial indicators that the patients with diabetes mellitus or low-density
service may need to be discontinued, a separate lipoprotein cholesterol level reduction in patients
set of clearly defined criteria must be developed with dyslipidemia) or physical assessment
as part of the self-assessment process to guide in parameters (e.g., blood pressure in patients with
the decision toward modification of the service or hypertension). These measures may be
implementation of an exit strategy. Although it is compared to baseline, a group not exposed to the
difficult to entirely separate the financial aspects service, internal standards (specific health care
of the service from the personal investment of system standards), and/or external standards
time and energy, financial viability is probably (guidelines or benchmarking data). Ideally, data
one of the most critical features of the evaluative should be compared at specified time points
process. (quality improvement) as well as to both internal
The professional staff of the service must also and external standards.
realize that the exit does not equate with failure In addition, the Institute for Clinical Systems
of the service itself. Facility needs and priorities Improvement has developed and validated 51
may simply change over time. In addition, outcome instruments that can be used to evaluate
administrative changes can alter priorities despite patient outcomes after interventions by health
the apparent success of the service. care providers, including pharmacists. 67
Communication is a key component of the exit Examples of these patient outcome
strategy. Data justifying the proposed need to measurements have been published previously.2
discontinue the service should be presented to Other clinical performance measures for
the key administrative figures, key stakeholders, ambulatory care services are available from the
and all others with an implied or direct influence AQA Alliance (formerly called the ambulatory
on the service. In addition, the exit plan must care alliance). 68 The AQA Alliance is a joint
include a strategy for caring for the patients who effort between the American Academy of Family
receive their care through the service if the exit Physicians, the American College of Physicians,
strategy ultimately becomes necessary. This America’s Health Insurance Plans, and the
strategy may include training for the providers Agency for Healthcare Research and Quality. The
within the facility who will assume the care of mission of the AQA Alliance is to “improve
these displaced patients, as well as other health care quality and patient safety through a
resources made necessary by the shift in the collaborative process in which key stakeholders
delivery of patient care. agree on a strategy for measuring performance at
the physician or group level...” Outcome
measurements are valuable in assessing an
Section 9: Evaluation of Service Outcomes
ambulatory care clinical pharmacy service and
The evaluation of service outcomes is an include disease-related outcomes, as well as
integral part of the overall business plan for many drug-specific outcomes, such as the
clinical pharmacy services in the ambulatory care percentage of patients with persistent asthma
setting. In the current health care environment, who are prescribed inhaled corticosteroids and
clinical pharmacists need to continue to the percentage of patients with coronary artery
demonstrate the value of their services to ensure disease who are prescribed a lipid-lowering
continued growth. In general, it is important to agent. The AQA Alliance also provides
26e PHARMACOTHERAPY Volume 28, Number 2, 2008
information on how to develop additional States Department of Health and Human
outcome measures. These outcome measures Services, is a database and Web site for
may be used to assess a population with a information on specific evidence-based health
specific disease or as a research method to care quality measures and measure sets.71 The
examine how process changes affect outcomes.69 mission of NQMC is to provide practitioners,
For example, in the case of the patient with health care providers, health plans, integrated
diabetes, an external standard would be the delivery systems, purchasers, and others an
American Diabetes Association (ADA) standards accessible mechanism for obtaining detailed
of care and the ADA–National Committee for information on quality measures and to further
Quality Assurance benchmarking data. It is their dissemination, implementation, and use in
imperative that clinical pharmacists have a order to inform health care decision makers.
working knowledge of the health-related quality Measures are submitted to the NQMC by a
of life instruments that are relevant to their variety of national, state and local organizations,
services and are able to determine the including health care systems, accreditation
appropriate methods to assess their organizations, professional associations, research
interventions. institutions and licensing boards.
The Pharmacy Quality Alliance, a new Humanistic outcomes are as important as
collaborative initiative, has also been clinical outcomes and can add additional
established. 70 It recently endorsed pharmacy information to the decision process. It is helpful
quality measures, which can be used in a clinical to determine whether patients are satisfied with
pharmacy practice. Its mission is as follows: their care and/or feel as though their quality of
To improve health care quality and patient safety life has improved as a result of the service
through a collaborative process in which key provided. Patient surveys and questionnaires,
stakeholders agree on a strategy for measuring involving Likert scales and open-ended
performance at the pharmacy and pharmacist- questions, can provide this information to the
levels; collecting data in the least burdensome way; clinical pharmacist and may include both
and reporting meaningful information to consumers, functioning and well-being surveys and
pharmacists, employers, health insurance plans, satisfaction surveys. Satisfaction surveys, which
and other healthcare decision-makers to help make tend to employ both ratings and objective
informed choices, improve outcomes and stimulate information, are used primarily to inform or
the development of new payment models.70 guide administrative decisions. Functioning and
well-being surveys are more likely to be used at
Additional methods to determine effectiveness an individual patient level. More detailed
of clinical pharmacy interventions include information on measuring patient satisfaction
examining whether a particular service resulted and designing surveys can be found in the
in a reduction of clinic visits, emergency literature.72
department visits, or overall hospitalizations. Patient surveys are often institution and/or
These patient-oriented outcomes would be situation specific but may include statements
preferable to disease-oriented outcomes such as such as “The pharmacist increased my
blood pressure reduction in a patient with knowledge of my problem/disease state”; “I am
hypertension or peak flow meter readings in a satisfied with the care I received from my
patient with asthma. Although these outcomes pharmacist.” Patients are then asked to rate
are important, they can be time intensive and these statements (5 [strongly agree] to 1
costly to measure in the most objective manner. [strongly disagree]). To evaluate more
thoroughly, it may be helpful to add open-ended
Humanistic Outcomes questions to the survey as well, such as “What
Perhaps the best method of assessing the are you most happy/frustrated with?”; “What
impact of a service on a specific disease state or changes would you like to see?” It is important
problem is health-related quality of life outcome to note that pharmacists should test any newly
measures,2 which actually measure the impact of created questionnaires before use to determine
therapy on the disease process. Payers are now flaws and make necessary adjustments. These
using these data in reimbursement policies. The pilot instruments can be completed internally
National Quality Measures Clearinghouse and/or externally in order to validate them.
(NQMC), sponsored by the Agency for Development and validation of an instrument to
Healthcare Research and Quality and the United measure patient satisfaction with pharmacy
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 27e
services has been described in the literature.73, 74 information already documented in the literature
Clinical pharmacists involved in the Asheville (e.g., a 1% reduction in glycosylated hemoglobin
Project used these surveys in their own level results in significant cost avoidance of
humanistic assessments.75 $685–950/year of mean total health care costs for
Primary care providers and other health care patients with diabetes).79 Alternatively, this may
professionals can also be surveyed after be achieved through use of software available
implementation of the service. It can be useful through a particular health care system.
for the clinical pharmacist to be aware of Rxpertise (www.rxpertise.com), Assurance
individual provider satisfaction with a particular (www.medsmanagement.com), and Outcomes
service, including ease of referral. As a result, (www.getoutcomes.com) are examples of systems
clinical pharmacists can better prioritize their that attempt to assign cost savings for each
involvement and make necessary adjustments to individual intervention and that are used by
current services. various institutions around the country. Other
documentation systems are available for
Economic Outcomes community pharmacy, which may have some
components of outcome documentation.80
It has become increasingly necessary to
demonstrate economic benefit to the institution Section 10: Financial Considerations for
or overall health care system. Essentially, there
Business-Practice Model Development
are four types of economic evaluations: cost
effectiveness, cost benefit, cost minimization, and A hallmark step in business model
cost utility. A detailed review of each of these development involves the definition of what
evaluations is beyond the scope of this paper and precisely constitutes a “service.” Possibilities
has already been described in the literature.76, 77 include a patient encounter, a consultation
There have been reviews in the pharmacy (written or otherwise), or perhaps even the
literature of the economic benefit of clinical dispensing of a prescription. 81 This service
pharmacy services in the ambulatory care should be discrete, measurable, and
setting. 9, 78 In general, clinical pharmacists “deliverable,” so as to ensure that it can be billed
should be able to demonstrate that the overall or at least counted in some fashion.
cost savings to the health care system is greater Essentially two cost estimates are to be
than the initial and continued cost of the service. considered: direct and indirect costs. An
Examples of initial costs may include personnel, explanation of these costs is summarized in Table 5.
space, paperwork, laboratory costs, and devices
purchased. These costs will obviously vary Revenue Generation
depending on the setting and individual situation
and must be carefully evaluated before Generation of revenue is a cornerstone of any
implementation. With regard to determining viable service and the establishment of a revenue
cost savings, it is necessary to look at both direct estimate is critical to business model
and indirect costs. Although emphasis is often development. 9, 82 Several factors should be
placed on direct drug costs (e.g., switching from evaluated continually to ensure a revenue stream
a more expensive to a less expensive drug; that allows the business to remain fiscally sound
discontinuing unnecessary therapies), indirect and solvent. The payer mix should be known in
costs may have long-term impact. For example, order to analyze the source of the revenue.
recommending a drug to prevent a future illness Different reimbursement structures include fee-
or health consequence may increase drug costs for-service billing to private insurance, incident-
but may improve overall health outcomes to-billing under Medicare, payment for MTM
(decreased clinic visits, emergency room visits, services under Medicare part D, and (in some
hospitalizations) and/or decrease adverse events, states) payment from state Medicaid programs.38, 39
which will have economic benefits to the patient Other potential reimbursement may come directly
and health care system. from employers or self-paying patients. In some
Documentation of clinical pharmacy instances, the clinical pharmacist’s salary may
interventions and of the economic value of these come from the managed care organization or
services is absolutely vital. Assignment of a health care system where the primary financial
specific dollar value to interventions is often incentive is to increase cost-effective prescribing
difficult but may be achieved by using and improve health outcomes, rather than
generate revenue. Revenue is sometimes also
28e PHARMACOTHERAPY Volume 28, Number 2, 2008
Table 5. Direct and Indirect Costs to Be Considered service delivered, and an estimate of total
Costs Examples revenue.83
Direct costs The computation of net revenue is also
Labor Salary, fringe benefits, training, important. Net revenue is calculated by
annual fees, certification fees, subtracting the total cost of the operation (direct
consultants (potential)
and indirect) from total revenue. When
Minor equipment Telephones, pagers
considering net revenue, it should be pointed out
Capital equipment Office equipment (copiers, that both fixed costs (e.g., personnel salary,
chairs, desks, storage space),
remodeling of existing space, utilities) and variable costs (e.g., professional
fax machines, computers, service fees, certain utilities) have a significant
software and online resources, impact on net revenue. Fixed costs cannot be
laboratory equipment controlled per se, but financial restraint and
(e.g., point-of-care testing discount purchasing can minimize variable costs.
equipment)
Administrative Relocation expenses of
employees, recruitment, Pro Forma Evaluation
contract negotiations, Another significant measure in maintaining the
marketing, compliance
(e.g., licenses), malpractice viability of a service includes a pro forma
insurance, billing, collections, evaluation.84, 85 This evaluation should include a
office manager and staff timetable for analysis and how far into the future
Miscellaneous Travel for employees, continuing the service will be considered. Evaluative criteria
education reimbursement, should include return on investment, the “break-
interpreters, supplies and even point,” and the time to “break even.” In
operational expenses (record
keeping, photocopying,
other words, it should be determined whether
printing, postage, laboratory, the service is generating revenue or losing money,
telecommunications) and how long it would take to not lose money.
Indirect costs Some other considerations include the
Overhead potential for volume changes (increases and
Physical space Rent or lease decreases) and their impact on costs. Fixed
expenses should not change with small-to-
moderate increases in volume. Variable
generated from honoraria payments from a expenses, however, will potentially change as
college of pharmacy for precepting students volume changes. Certain expenses, termed
during advanced practice experiences. It is “hybrid expenses,” may change in the event of a
important to keep track of payments received for sudden or dramatic change in volume (e.g., need
services because billed charges may be to hire additional personnel).
substantially more than the amount paid. Salary, fringe benefits, technology charges, and
One specific situation for special consideration legal charges are other specific costs of concern.9
is the case where a pharmacist in an ambulatory Employees will expect periodic increases in
clinical practice is funded by a college of wages, usually annually. Fringe benefits may be
pharmacy. If the clinic or organization is not offered depending on the success of the services.
contributing to the pharmacist’s salary, revenue For example, if net revenue exceeds expectations,
generated may be routed back to the college of all employees could be paid a “dividend” to boost
pharmacy, after administrative fees have been morale and provide incentive for increased
removed. If the college of pharmacy contributes productivity. Technology, such as wireless
half of the pharmacist’s salary, a portion may still Internet, may increase or decrease costs
be sent back to the college of pharmacy. What depending on its impact on productivity.
happens to this money will be up to the
discretion of the college of pharmacy and the Cost Avoidance
clinical faculty member. It is important that a Cost avoidance is an alternate financial model.
detailed practice plan be written that outlines the This is especially true for a clinical pharmacist
procedure. employed by a managed care organization or
Some other considerations include the health care system. For example, it may be
prediction of patient volume or service volume to difficult to determine who financially benefits
be delivered, establishment of a price per unit of from decreasing unnecessary drug use as
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 29e
pharmacy benefits are not always managed by starting your business, making money, and achieving your
goals! Palo Alto, CA: The Planning Shop, 2004.
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51. Dedrick SC. Marketing outpatient pharmacy services. Top 78. Schumock GT, Meek PD, Ploetz PA, Vermeulen LC. Economic
Hosp Pharm Manage 1985;5(1):73–7. evaluations of clinical pharmacy services—1988–1995.
52. Smith JE, Sheaffer SL. Marketing clinical pharmacy services. Publications committee of he American College of Clinical
Top Hosp Pharm Manage 1985;5(1):53–62. Pharmacy. Pharmacotherapy 1996;16:1188–208.
53. Chewning B, Schommer JC. Increasing clients’ knowledge of 79. Wagner E, Sandhu N, Newton K, et al. Effect of improved
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54. Bernard M. Overview of marketing for the pharmacist. Top 2001;285:182–9.
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55. Levine N. Physician marketing: a word of caution [editorial]. systems. Available from http://www.aphanet.org. Accessed July
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24, 2007. 84. Kuo GM, Buckley TE, Fitzsimmons DS, Steinbauer JR.
81. Dix A. Clincal management: change the script. Health Serv Collaborative drug therapy management services and
2005;115:26–8. reimbursement in a family medicine clinic. Am J Health Syst
82. Snella KA, Sachdev GP. A primer for developing pharmacist- Pharm 2004;61:343–54.
managed clinics in the outpatient setting. Pharmacotherapy 85. Jameson J, VanNoord G, Vanderwoud K. The impact of a
2003;23:1153–66. pharmacotherapy consultation on the cost and outcome of
83. Schlosberg C. The medicare prescription drug, improvement medical therapy. J Fam Pract 1995;41:469–72.
and modernization act and the impact on care of people with 86. Strandberg LR. Pharmacy benefits management and
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Manag J 2004;5:113–21. 1996;15:19–26.

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Ambulatory care clinics and institutional ambulatory care
ACCP Task Force on Ambulatory Care Clinical Pharmacy Practice. ACCP white paper: establishing and evaluating clinical
pharmacy service in primary care. Pharmacotherapy 1994;14(6):743–58.
Blair MM, Blake EW, Harris IM, et al, eds. Ambulatory care new practitioner survival guide. Kansas City, MO: American
College of Clinical Pharmacy, 2004.
ASHP guideline: minimum standards for pharmaceutical services in ambulatory care. Am J Health Syst Pharm
1999;56:1744–53.
Ables AZ, Baughman OL. The clinical pharmacist as a preceptor in a family practice residency training program. Fam Med
2002;34:658–62.
Barner JC, Brown CM, Shepherd M, Chou J, Yang M. Provision of pharmacy services in community health centers and
migrant health centers. J Am Pharm Assoc 2002;42:713–22.
Bazaldua O, Ables AZ, Dickerson L, et al. Suggested guidelines for pharmacotherapy curricula in family medicine residency
training: recommendations from the Society of Teachers of Family Medicine Group on Pharmacotherapy. Fam Med
2005;37(2):99–104.
Borgsdorf LR, Miano JS, Knapp KK. Pharmacist-managed medication review in a managed care system. Am J Hosp Pharm
1994;51:772–7.
Britton ML, Lurvey PL. Impact of medication profile review on prescribing in a general medicine clinic. Am J Hosp Pharm
1991;48:265–70.
Carmichael JM, Alvarez A, Chaput R, DiMaggio J, Magallon H, Mambourg S. Establishment and outcomes of a model
primary care pharmacy service system. Am J Health-Syst Pharm 2004;61:472–82.
Chen J, Britten N. “Strong Medicine”: An analysis of pharmacist consultations in primary care. Fam Pract 2000;17:480–3.
Dickerson LM, Denham AM, Lynch T. The state of clinical pharmacy practice in family practice residency programs.
Fam Med 2002;34:653–7.
Knapp KK, Okamoto MP, Black BL. ASHP survey of ambulatory care pharmacy practice in health systems—2004.
Am J Health Syst Pharm 2005;62:274–84.
Kuo GM, Buckley TE, Fitzsimmons DS, et al. Collaborative drug therapy management services and reimbursement in a
family medicine clinic. Am J Health-Syst Pharm 2004;61:343–54.
Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure,
and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA 2006;296:2563–71.
Taylor CT, Byrd DC, Krueger K. Improving primary care in rural Alabama with a pharmacy initiative. Am J Health-Syst
Pharm 2003;60:1123–9.
Yanchick JK. Implementation of a drug therapy monitoring clinic in a primary-care setting. Am J Health Syst Pharm
2000;57(suppl 4):S30–7.
Community practice
Bernsten C, Bjorkman I, Caramona M, et al. Improving the well-being of elderly patients via community pharmacy-based
provision of pharmaceutical care: a multicentre study in seven European countries. Drugs Aging 2001;18:63–77.
Carter BL, Chrischilles EA, Scholz, D, Hayase N, Bell N. Extent of services provided by pharmacists in the Iowa Medicaid
pharmaceutical case management program. J Am Pharm Assoc 2003;43:24–33.
Chrischilles EA, Carter BL, Lund BC, et al. Evaluation of the Iowa Medicaid pharmaceutical care management program. J Am
Pharm Assoc 2004;44:337–49.
Cranor CW, Christensen DB. The Asheville project: factors associated with outcomes of a community pharmacy diabetes care
program. J Am Pharm Assoc 2003;43:160–72.
Grainger-Rousseau TJ, Miralles MA, Hepler CD, Segal R, Doty RE, Ben-Joseph R. Therapeutic outcomes monitoring:
application of pharmaceutical care to community pharmacy. J Am Pharm Assoc 1997;NS37:647–61.
Harris WE, Rivers PH, Goldstein R. The potential role of community pharmacists in care management. Health Soc Care
Community 1998;6:196–203.
Linville C. Wyoming’s PharmAssist program is helping residents improve their health and cut medication costs. America’s
Pharmacist 2004;126:26–9.
Miller LG, Scott DM. Documenting indicators of pharmaceutical care in rural community pharmacies. J Managed Care
Pharm 1996;2:659–66.
Rupp MT, DeYoung M, Schondelmeyer SW. Prescribing problems and pharmacist interventions in community practice.
Med Care 1992;30:926–40.
Sturgess IK, McElnay JC, Hughes CM, Crealey G. Community pharmacy based provision of pharmaceutical care to older
patients. Pharm World Sci 2003;25(5):218–26.
32e PHARMACOTHERAPY Volume 28, Number 2, 2008
Appendix 1. Resources for Development of a Business-Practice Model (continued)
Description and development of services
American Pharmacists Association and National Association of Chain Drug Stores Foundation. Medication therapy
management in community pharmacy practice: core elements of an MTM service (version 1.0). J Am Pharm Assoc
2005;45:573–9.
ASHP guidelines for obtaining authorization for documenting pharmaceutical care in patient medical records. Am J Hosp
Pharm 1989;46:338–9.
ASHP guidelines on documenting pharmaceutical care in patient medical records. Am J Health Syst Pharm 2003;60:705–7.
Brock KA, Doucette WR. Collaborative working relationships between pharmacists and physicians: an exploratory study.
J Am Pharm Assoc 2004;44:358–65.
Ferro LA, Marcrom RE, Garrelts L, et al. Collaborative practice agreements between pharmacists and physicians. J Am Pharm
Assoc 1998;38:655–66.
Hammond RW, Schwartz AH, Campbell MJ, et al, for the American College of Clinical Pharmacy. Collaborative drug therapy
management by pharmacists—2003. Pharmacotherapy 2003;23(9):1210–25.
Heitz RM, Van Dinter M. Developing collaborative practice agreements. J Pediatr Health Care 2000;14:200–3.
Pharmacy Access Partnership. Collaborative practice agreements. Available from www.go2ec.org/CollabPracticeAgreements.
htm. Accessed July 24, 2007.
Zillich AJ, McDonough RP, Carter BL, Doucette WR. Influential characteristics of physician/pharmacist collaborative
relationships. Ann Pharmacother 2004;38:764–70.
Financial impact
Benrimoj SI, Langford JH, Berry G, et al. Economic impact of increased clinical intervention rates in community pharmacy: a
randomized trial of the effect of education and a professional allowance. Pharmacoeconomics 2000;18(5):459–68.
Cranor CW, Bunting BA, Christensen DB. The Asheville project: long-term clinical and economic outcomes of a community
pharmacy diabetes care program. J Am Pharm Assoc 2003;43:173–84.
Dobie RL, Rascati KL. Documenting the value of pharmacist interventions. Am Pharm 1994;NS34(5):50–4.
Ellis SL, Carter BL, Malone DC, et al. Clinical and economic impact of ambulatory care clinical pharmacists in management
of dyslipidemia in older adults: the IMPROVE study. Pharmacotherapy 2000;20(12):1508–16.
Farris KB, Kumbera P, Halterman T, Fang G. Outcomes-based pharmacist reimbursement: reimbursing pharmacists for
cognitive services, part 1. J Manag Care Pharm 2002;8(5):383–93.
Galt KA. Cost avoidance, acceptance, and outcomes associated with a pharmacotherapy consult clinic in a Veterans Affairs
medical center. Pharmacotherapy 1998;18(5):1103–11.
Hatoum HT, Witte KW, Hutchinson RA. Patient care contributions of clinical pharmacists in four ambulatory care clinics.
Hosp Pharm 1992;27:203–6,208–9.
Jameson J, VanNoord G, Vanderwoud K. The impact of a pharmacotherapy consultation on the cost and outcome of medical
therapy. J Fam Pract 1995;41:469–72.
Knapp KK, Katzman H, Hambright JS, Albrant DH. Community pharmacist interventions in a captivated pharmacy benefit
contract. Am J Health Syst Pharm 1998;55:1141–5.
The Lewin Group. Medication therapy management services: a critical review. J Am Pharm Assoc 2005;45:580–7.
McMullin ST, Hennenfent JA, Ritchie DJ, et al. A prospective, randomized trial to assess cost impact of pharmacist-initiated
interventions. Arch Intern Med 1999;159:2306–9.
Smith DH, Fassett WA, Christensen DB. Washington State CARE project: downstream cost changes associated with the
provision of cognitive services by pharmacists. J Am Pharm Assoc 1999;39:650–7.
Snella KA, Trewyn RR, Hansen LB, Bradberry JC. Pharmacist compensation for cognitive services: focus on the physician
office and community pharmacy. Pharmacotherapy 2004;24:372–88.
Helpful business-oriented Web sites for starting a new business and identifying customers
www.USChamber.com: Resources from both the national and local chambers for business development
www.TSNN.com: Searchable database of trade shows worldwide
www.SBA.gov/sbdc: Small business development centers offer low-cost help
http://adage/americandemographics: American Demographics is a fee-for-service monthly magazine that offers information on
consumer trends and analysis
www.hoovers.com: Offers fee-for-service business and industry data, sales, marketing business development, and other
information on public and private companies
www.Entrepreneur.com/FormNet: Offers forms to analyze a business
www.fedstats.gov: Main portal for government statistics
www.census.gov: Free demographic information and access to all U.S. census data
http://quickfacts.census.gov/qfd/: Information on the state or county level census
www.census.gov/econ/census02: Economic census, compiled every 5 years; gathers business activity information by industry
and subsectors of industry compiled down to a ZIP code
Medicare resources
CMS: www.cms.hhs.gov/
ACCP: www.accp.com/position.php#commentaries
APhA: www.aphanet.org/AM/Template.cfm?Section=APhA_Resources_Medicare
ASHP: www.ashp.org/
 AMBULATORY CARE BUSINESS-PRACTICE MODEL ACCP 33e
Appendix 1. Resources for Development of a Business-Practice Model (continued)
Clinical Laboratories Improvement Act resources
CDC: http://www.cdc.gov/clia/regs/toc.aspx
CMS: www.cms.hhs.gov/clia/default.asp
FDA: www.fda.gov/cdrh/CLIA/index.html
Occupational Safety and Health Administration resources
OSHA Bloodborne Pathogens Facts Nos. 1–6: www.osha.gov/OshDoc/data_BloodborneFacts/Health Insurance Portabilty and
Accountability Act resources
Department of Health and Human Services: www.hhs.gov/ocr/hipaa
American Academy of Family Physicians: www.aafp.org/hipaa
Sample Forms: www.aafp.org/fpm/20030200/29theh.html
Manual: www.aafp.org/x20716.xml
American Medical Association: www.ama-assn.org/ama/pub/category/4234.html
U.S. Department of Health and Human Services, National Institutes of Health, Privacy Rule:
http://privacyruleandresearch.nih.gov/
Bush J. The HIPAA privacy rule: three key forms. Fam Pract Manag 2003;10(2):29–33.
Kibbe DC. 10 steps to HIPAA security compliance. Fam Pract Manag 2005;12(4):43–9.
Credentialing and privileging for pharmacists resources
Council on Credentialing in Pharmacy: www.pharmacycredentialing.org
Board of Pharmaceutical Specialties: www.bpsweb.org
Commission on Certification in Geriatric Pharmacy: www.ccgp.org
Gantt charts for service implementation timelines: programs available for download
http://associate.com/gantt
http://www.mindtools.com/pages/article/newPPM_03.htm

Appendix 2. Professional Pharmacy Organizations

Organization Web Site Purpose and Goals
AACP (American Association www.aacp.org Represents pharmaceutical education
of Colleges of Pharmacy)
AAPT (American Association www.pharmacytechnician.com Provides continuing education and services to pharmacy
of Pharmacy Technicians) technicians, represents members’ interests to the public
and other health care organizations
ACA (American College www.acainfo.org Research and education resource center that provides
of Apothecaries) pharmacists with information regarding issues affecting
the pharmacy profession; ACA also provides a support
line, specialty practice education program, and
pharmacy-related publications
ACCP (American College www.accp.com Supports and promotes clinical pharmacy practice,
of Clinical Pharmacy) research, and education
AFPE (American Foundation www.afpenet.org Supports pharmacists to further their studies in advanced
for Pharmaceutical Education) pharmacy, in industry, association work, academia,
and other areas of professional practice
AMCP (Academy of www.amcp.org Professional society, dedicated to promoting the
Managed Care Pharmacy) development and application of pharmaceutical care
and to ensure appropriate health care outcomes for
all patient care
APhA (American Pharmacists www.aphanet.org Provides professional information and education for
Association) pharmacists and advocates improvement of health care
through the provision of comprehensive pharmaceutical
care
ASAP (American Society www.asapnet.org Aids members in applying computer technology into
for Automation in Pharmacy) pharmacies; ASAP includes independent pharmacies,
hospital pharmacies, colleges of pharmacy, state and
national associations, and government agencies
ASCP (American Society www.ascp.com Pharmacy association for consultant pharmacists
of Consultant Pharmacists) specializing in long-term care; the association provides
members with leadership, education and resources for
the practice of pharmacy in senior care
ASHP (American Society www.ashp.org Represents pharmacists who practice in health
of Health-System Pharmacists) maintenance organizations, long-term care facilities,
home care, and other community care systems
34e PHARMACOTHERAPY Volume 28, Number 2, 2008
Appendix 2. Professional Pharmacy Organizations (continued)
Organization Web Site Purpose and Goals
ASPEN (American Society for www.nutritioncare.org Involved in the provision of nutritional therapies;
Parenteral and Enteral prepares standard guidelines for the use of
Nutrition) nutrition support and professional practice
ASPL (American Society for www.aspl.org Furthers the legal knowledge of pharmacists, students of
Pharmacy Law) law, attorneys, government, and other professions
interested in issues affecting pharmacy and drugs
BPS (Board of Pharmaceutical www.bpsweb.org Trains and certifies pharmacists in a specialized field
Specialties)
CCGP (Commission for www.ccgp.org National certification program for pharmacists who want
Certification in Geriatric to specialize in geriatric pharmacy practice
Pharmacy)
CCP (Council of Credentialing www.tcpf.org Provides leadership, standards, and public information
in Pharmacy) as well as coordinating the profession’s voluntary
credentialing programs
CPF (Community Pharmacy www.tcpf.org Assists community pharmacists in achieving targeted
Foundation) therapeutic goals and fostering improvements in
patient care
ICPT (Institute for the www.advancepharmacy.org Supports educational initiatives, research projects, and
Advancement of Community programs to advance community pharmacy practice
Pharmacy) in the United States
NCPA (National Community www.ncpanet.org Represents pharmacy owners, managers, and employees
Pharmacists Association) of independent community pharmacies across the
United States
NCPDP (National Council for www.ncpdp.org Creates and promotes data interchange standards in
Prescription Drug Programs) industry, provides information and resources to
education industry, and support its members
NIPCO (National Institute for www.nipco.org National accrediting organization for pharmacist care
Pharmacist Care Outcomes) education and training, leading to the pharmacist care
diplomate credentialNPhA (National
www.npha.net Represents the interests and needs of minorities in all
Pharmaceutical Association) practice settings
NPTA (National Pharmacy www.pharmacytechnician.org An organization for pharmacy technicians
Technician Association)