I RESEARCH

l
l Therapeutic Outcomes Monitoring:
Application of Pharmaceutical Care
Guidelines to Community Pharmacy
Timothy-John Grainger-Rousseau, Maria A. Miralles, Charles D. Hepler,
Richard Segal, Randell E. Doty, and Rami Ben-Joseph

Objective: To design a pharmaceutical care model, and develop and field test a set of community pharmacy guidelines and practice
support materials-Therapeutic Outcomes Monitoring (TOM) modules. Design: Concept interviews with pharmacists, physicians, and
patients; development and field testing of practice guidelines. Setting: Community pharmacies. Participants: Five independent, five
chain, and two clinic site pharmacies. Interventions: A prototype TOM module for asthma was developed through a seven-step pro-
cess. Concept interviews were held with pharmacists, physicians, and patients to determine the desirability and feasibility of the TOM
concept, prototype, and materials. Two field tests were completed and modifications made. Results were gathered through further
concept interviews at the completion of the second field tests. Main Outcome Measures: Participants' opinions and experiences.
Results: Pharmacists, physicians, and patients expressed favorable attitudes about community pharmacists' participation in this phar-
maceutical care model. Of the 12 participating pharmacists, 7 successfully implemented TOM in their practice sites and participated in
the project throughout the testing; 49 patients were recruited into the study; and 22 patients remained in the program at the end of the
second field test. In providing TOM services to these patients, the two most problematic areas for the pharmacists were in document-
ing care and reporting to physicians. A final phase of the TOM project has not been conducted in the United States because of insuffi-
cient numbers of patients for evaluating patient outcomes. Conclusion: The TOM project was successful from a technical but not a
marketing perspective. Useful practice guidelines can be written and taught to pharmacists. Enrollment of patients was difficult, and
the concept is not likely to spread spontaneously within the existing market for pharmaceutical services.
JAm Pharm Assoc. 1997;NS37:647-61.

Drug therapy is essential for managing many patients. For in community pharmacy practice. Reports of treatment failures
example, up to 60% of non-federal physician office visits involve and adverse effects from medication use have been appearing in
one or more prescriptions. 1,2 However, it is often difficult to the literature for years. Formerly, "adverse drug reactions" were
accomplish safely and effectively within the usual arrangements considered unavoidable "diseases of medical progress"3 or "the
price we have to pay"4 for drug therapy. Researchers often over-
looked treatment failure, perhaps because of the "adverse event"
Received March 27, 1996, and in revised form May 30, 1997. Accepted
orientation of the research method.
for publication June 26, 1997. In the 1970s Melmon recognized that many adverse drug
Timothy-John Grainger-Rousseau, PhD, is assistant professor, Faculty events could be prevented. 5 Since then, reports have documented
of Pharmaceutical Sciences, University of British Columbia. Maria A. avoidable injury and death following drug therapy. The literature
Miralles, PhD, is training and operations research coordinator, Drug describes two types of drug-related morbidity (DRM):
Management Program, Management Sciences for Health, Inc., Arling-
ton, Va. Charles D. Hepler, PhD, is professor, pharmacy health care
• Adverse events (AEs}-Appearance of a new medical problem
administration, and director, DuBow Family Center for Research in in a patient (e.g., adverse drug reaction, side effect, toxicity).
Pharmaceutical Care, College of Pharmacy, University of Florida, • Treatment failure (TF}-Failure to resolve an existing medi-
Gainesville. Richard Segal, PhD, is professor and chair, pharmacy cal problem because drug therapy was not provided or was
health care administration, College of Pharmacy, University of Florida,
Gainesville. Randell E. Doty, PharmD, is clinical associate professor of ineffectual.
pharmacy practice, and director of experiential programs, College of Both types of DRM have been associated with additional use
Pharmacy, University of Florida, Gainesville. Rami Ben-Joseph, PhD, is of outpatient services, more hospital admi ssions, increased
manager, outcomes research, Merck & Co., Inc., New York, N.Y.
lengths of stay, and even death. 6-26 A recent economic analysis
Correspondence: Charles D. Hepler, PhD, Box 100496, College of
estimated the health care costs of DRM in the United States to be
Pharmacy, University of Florida, Gainesville, FL 32610-0496.
Fax (352)392-7782; E-mail : Hepler@cop.health.ufl.edu $76.6 billion in the ambulatory population.27

Vol. NS37, No.6 NovemberlDecember 1997 Joumal of the American Phannaceutical Association 647
 RESEARCH Therapeutic Outcomes Monitoring

Interpretation of the DRM literature suggests five areas from model. This practice model, Therapeutic Outcomes Monitoring
which DRM can arise: (TOM), was intended to demonstrate the concept of pharmaceuti-
• Unintended and idiosyncratic effects of drug products. cal care in the ambulatory setting, especially in community
• Decisions of whether to treat, and choice of regimen (includ- practice.
ing deci sio ns about nonpre scription and prescription The objective of the TOM project was to develop and field test
medicines). the TOM modules, a set of guidelines for community pharmacy
• Drug dispensing, administration, and advising. practice and practice support materials. The modules were intend-
• Patient behavior (e.g., nonadherence to prescribed regimens). ed to support the systematic monitoring of the clinical and psy-
• Medication-use "system" design or performance (interactions chosocial effects of drug therapy in patients.
of one or more factors), in particular, recognizing and respond- The TOM project entails four phases. This paper describes
ing to clinical signs and symptoms. phases 1-3:
Interpretation of the literature on DRM suggests that "systems" • Theoretical analysis of medication use.
performance may be the most important factor. 28 In fact, the root • Product development.
cause of preventable DRM may be the unsystematic nature of • Product evaluation and modification.
medication use in community and institutional practice. The sim- The fourth phase, which involves studies of clinical, psychoso-
ple fact that avoidable DRM occurs when highly trained profes- cial, and economic outcomes of TOM, is underway at the Univer-
sionals prescribe and dispense medications sanctioned by govern- sity of Florida and elsewhere.
ments as safe and efficacious implies that the manner of use is a
major problem. The weaknesses of the drug-use process are tacit-
ly acknowledged; the Food and Drug Administration (FDA) was Phase 1: Theoretical Analysis
reluctant to approve clozapine, a medication of proven efficacy, of Medication Use
because its use requires simple safety precautions such as weekly
white blood cell counts. 29 Critique of Conventional Programs
In response to evidence that the drug-use process is flawed, Each patient visit, even each cbnical event, is the consequence
pharmaceutical practitioners, educators, and professional organiza- of a variety of biological, socioeconomic, and psychological fac-
tions, including the American Pharmaceutical Association, the torS.33 -35 Many efforts to improve drug-use outcomes deny the
American Society of Health-System Pharmacists, and the Ameri- complexity of clinical practice. Health care professionals and
can Association of Colleges of Pharmacy, have supported the con- managers devote substantial time and money to single compo-
cept of pharmaceutical care. The purpose of pharmaceutical care is nents of this process (such as prescribing pattems or patient com-
" ... to provide drug therapy intended to achieve definite outcomes pliance) but ignore or depreciate monitoring-actively seeking
that will improve a patient's qUality of life. These outcomes are evidence in the form of drug-related problems that may warn of
cure of a disease, elimination or reduction of a patient' s symptoms, impending DRM. In the systems (biopsychosocial) view, all nec-
arresting or slowing of a disease process, or preventing a disease essary components must be effectively present and coordinated to
or symptoms.,,30 improve therapeutic outcomes. 33
The concept of pharmaceutical care has attracted interest On the basis of the DRM literature and our own professional
among pharmacists and other health care providers, but further observations, we identified three important weaknesses in the way
theoretical exploration and practical development are required that people use medications:
before it is likely to be adopted widely in the United States. Relat- • Inadequate communication of clinical information among
ed ideas are comprehensive drug therapy managemenPl and dis- physician, pharmacist, and patient.
ease management. Disease management has been described as a • Missing or vague therapeutic objectives or end points.
comprehensive, integrated approach to care and reimbursement • Irregular (or infrequent) attention to early results of therapy
based on the natural course of a disease, with treatment designed (drug-related problems or progres s toward therapeutic
to address an illness with maximum effectiveness and efficien- objectives).
cy.32 While having some goals in common with pharmaceutical A recent systems analysis of adverse drug events corroborates
care, it differs sharply by emphasizing the disease instead of the our findings. Seven factors associated with information systems
patient. accounted for 78% of the errors resulting in these adverse drug
events. 36 Although this study was conducted in a hospital setting,
analogous problems likely exist in ambulatory care settings.
Objectives

In this context, a group of researchers at the University of Ideal Pharmaceutical Care System
Florida College of Pharmacy, in cooperation with practicing phar- After identifying the problems inherent in the typical drug ther-
macists, began in 1991 to design a pharmaceutical care practice apy process, we sought to identify what elements are theoretically

648 Journal of the American Phannaceutical Association NovemberlDecember 1997 Vol. NS37, No. 6
 Therapeutic Outcomes Monitoring RESEARCH

necessary and sufficient to ensure safe, effective, and humane

Table 1. Eight Essential Elements of Safe,
drug therapy in community practice. The drug therapy system Effective, and Humane Drug Therapy
should focus on patients' quality of life. Table 1 lists eight neces-
sary elements of such a pharmaceutical care system. 28 1. Timely recognition of drug indications and other signs and
symptoms relevant to drug use with accurate identification of
The DRM literature suggests that improved monitoring of the underlying causes
results of therapy typically would provide the greatest improve-
2 . Safe, effective, and accessible products (Le ., products that are
ment in outcomes for the greatest number of patients. Monitoring affordable and can be used correctly)
would not only uncover drug-related problems before the patient 3. Prescribing as part of a therapeutic plan directed at clear,
was harmed, but it might also influence other system elements. measurable, and communicable objectives

For example, monitoring implies at least passive participation by 4. Drug product distribution, dispensing, and administration with
patient advice appropriate for item 5
patients and caregivers, since the patient is the primary source of
5 . Active patient or caregiver participation in care (intelligent
information about his or her own quality of life. In ambulatory adherence)
care, the patient is also the primary source of monitoring informa-
6 . Professional monitoring (systematic detection and resolution
tion. Monitoring is often difficult or impossible without a defmite of drug therapy problems)
therapeutic objective for each medication; therefore, its inclusion a. Determining what information to collect to evaluate the
in a medication-use process might encourage physicians to clarify progress of therapy

the purpose of each prescription. Monitoring requires cooperation b. Evaluating progress toward therapeutic objectives
among physicians, nurses, pharmacists, patients, and caregivers, c. Responding to evaluations, including revising therapeutic
objectives or regimen based on evaluation of monitoring
making communication and documentation essential. Finally, a
evidence
method for managing product and system performance would be
7 . Documentation and communication of information and
necessary for the success of the system over time. decisions
8 . Product and system performance evaluation and improvement

Guiding Principles and Assumptions

The Working Group developed a set of practice guidelines and
supporting materials that would encourage the development of macist in at least two ways: the pharmacist can offer his services
pharmaceutical care systems with the elements outlined in Table l. directly or the patient's physician may refer the patient to the phar-
Throughout the project, the Working Group was guided by the macist. Even in the first instance, TOM requires active cooperation
seven principles and assumptions shown in Table 2. among physicians, patients, and pharmacists. Accordingly,
marketing-advocacy information-is an essential component of
the TOM program. The TOM project framework could be adapt-
Phase 2: Product Development ed to many disease states by including the appropriate disease-
specific material. Marketing, promotional, and reimbursement
The Working Group developed a product description for the materials include the following:
TOM program. The final specification is shown in Table 3. • Presentation graphics (in an oversized free-standing notebook)
for use in face-to-face presentations (e.g., to physicians).
• Brochure describing the TOM program from physician's
TOM Patient-Care Model viewpoint.
The patient-care model is the nexus of the program, the com- • Brochure describing the TOM program from patient's
mon basis and linkage among disease-specific modules and mod- viewpoint.
ule components. The patient-care model describes the core tasks • Sample offer and service agreement between physician and
of the TOM process as a series of six steps, irrespective of dis- patient.
ease or other specific details of care. The sequence shown in Fig- • Combination patient referral form and statement of medical
ure 1 and described in Table 4 is appropriate for prescription necessity.
medications, but with minor modification would apply to phar- • "How to" information on fee-for-service reimbursement using
macist-recommended nonprescription medications, as well. The standardized codes and forms.
model is actually cyclic, and fits into medical practice as shown
in Figure 1 (page 652).
Continuous Improvement
The Working Group developed a system for evaluating, assess-
Marketing and Reimbursement ing, and continually improving the performance of the TOM pro-
In developing marketing materials for TOM, we recognized gram during the field testing of the asthma prototype. Pharmacy
that a patient can enter into a therapeutic relationship with a phar- managers often have less experience in managing patient care than

Vol. NS37, No.6 NovemberlDecember 1997 Journal of the American Pharmaceutical Association 649
 RESEARCH Therapeutic Outcomes Monitoring

Table 2_ Guiding Principles and AssulTlptions Based on the management philosophy of continuous quality
for TOM Product DeveloplTlent improvement (CQI), the PBES consists of three interrelated com-
ponents: performance guidelines and standards, performance indi-
1. Cooperation among physicians, pharmacists, and patients in cators, and a performance database. 44 Indicators developed for the
managing drug therapy requires an explicit (communicable)
structure of functions, relationships, and responsibilities. TOM project, which are still in testing, were:
Pharmacist "membership" on a primary care team requires: • Completeness of documentation.
a. Performing a set of core tasks • Accuracy of documentation.
b. Shared authority and responsibility • Mis-timed refills (early and late).
c. Access to information
2. Monitoring and managing drug therapy should be the
pharmacist's principal function on the team. The pharmacist is Product Development Procedure
qualified because:
We developed the TOM asthma prototype through a seven-
a. Pharmacists are educated in the sciences of
biopharmaceutics, pharmacokinetics, and
step process as described below. The clinical aspects of module
pharmacotherapy. development required the collaboration of experts in the man-
b. Pharmacists can integrate monitoring with drug agement of each disease state. Marketing and reimbursement
dispensing, so that drug products and advice about their materials required the participation of professional consultants.
use are well coordinated.
Our approach was to design materials that could easily be adapt-
c . Pharmacists have been shown to provide cost savings
while improving medication use. 37 · 42
ed to almost any disease state that might later serve as a TOM
d . Pharmacists are accessible and trusted health
module.
professionals. Identify stakeholders and their needs. To develop a functional
3. Therapeutic outcomes monitoring is practical for all competent product based on the conceptual model, we sought comment and
pharmacists. Pharmacists can improve drug use in many needs assessment from all parties who would influence the
patients through simple interviews and examinations.
Examples of observable indicators of therapeutic problems are
product or be influenced by it: pharmacists, physicians, patients,
beta 2 -agonist inhaler refill rates, use patterns, and third party payers, pharmaceutical manufacturers, and clinical
administration technique; pulse in patients taking theophylline
laboratories.
or digoxin; dizziness or sedation in elderly patients taking
antihypertensives or longer-acting benzodiazepines; bruises or Create an advisory panel. We recruited an external advisory
discolored fingernails in patients taking anticoagulants; occult panel to communicate stakeholders' interests; it included three
blood in stools; delay in the resolution of symptoms in patients
with infections.
pharmacists, one physician, one patient ombudsman, two repre-
4. Changes in the organization and relationships of pharmacy
sentatives of third party payers, and one representative of a
practice may be more important initially than extensive pharmaceutical manufacturer. Throughout the project we con-
reeducation in pharmacotherapy. More pharmacists may need sulted panel members as sources of ideas and modifications to
additional training in communications and problem-solving
skills than need reeducation in therapeutics. the product.
5. A disease-oriented implementation strategy may allow
Focus the TOM prototype. We chose to use a disease-specific
pharmacists to target high-risk patients in their practices, modular approach to help pharmacists learn the process of phar-
simplify training, and allow phased implementation of the new maceutical care without their becoming overwhelmed by content
practice.
details and to teach new skills in a way that built realistic self-
6. Managing patients holistically, so that each patient's quality of
life is improved, requires management of all aspects of confidence.
therapy, not merely therapy for specific diseases. A disease- Potential disease states were evaluated for inclusion according
oriented implementation strategy must not default to a drug-
to four criteria: (l) frequency of DRMs in the treatment of the dis-
or disease-management approach to patient care.
ease, and disease prevalence; (2) severity of DRMs; (3) probable
7. Systematic performance evaluations are required to maintain
initial improvements. These evaluations should address many amenability of therapeutic management problems to increased
levels ofthe system (e.g., patient, practice, and program) and pharmacist participation (i.e., to what degree pharmacists could
be based on the philosophy of continuous improvement.
improve the situation); and (4) feasibility and practicality of phar-
TOM = Therapeutic Outcomes Monitoring . macists marketing TOM services for the disease (i.e., convincing
other stakeholders that pharmacists could improve therapy for the
disease).
The five highest-ranked disease states, according to the four
do those primarily responsible for distributive activities. The perfor- criteria, were asthma, diabetes mellitus , seizure disorders
mance-based evaluation system (PBES) gives pharmacy managers (emphasis on phenytoin therapy), coagulation disorders, and
a formal tool for assessing performance, identifying opportunities hypertension. Asthma was chosen as the disease focus for the
for improvement, and tracking the consequences of improvement TOM prototype module because it ranked highest based on the
actions. In doing so, PBES satisfies "report card" requirements of above criteria.
many third party payers and accrediting organizations. Develop the prototype. The prototype was designed with "open

650 Journal of the American Phannaceutical Association NovemberlDecember 1997 Vol. NS37, No.6
 Therapeutic Outcomes Monitoring RESEARCH

I architecture" so that it could be easily generalized to the next Table 3_ Final Product Description of TOM Program
, product (i.e., disease state). The TOM modules were designed to
provide a "product line" of clearly defined therapeutic monitoring Patient care model-Specific pharmacy practice guidelines based
services that pharmacists could offer to physicians, patients, and on and supportive of medical consensus guidelines whenever
possible
, payers. The prototype TOM module was prepared to incorporate
Monitoring aids-Information about technical aspects of
product specifications shown in Figure 2. monitoring (e.g., peak flow meters, blood glucose measurement)
Present the concept and prototype to major stakeholders Clinical record system-For patient referral, care documentation,
through concept interviews. Methods and results of field testing and reporting
with pharmacists, physicians, and patients are described below. Marketing and reimbursement materials- Program descriptions
Evaluate the prototype module with pharmacists through field for potential patients and physicians; referral and report forms;
billing materials; standard forms and codes
testing. The prototype module was field tested in two separate
Simulation-based training and evaluation-Emphasizing the
phases, alpha-l and alpha-2. The nomenclature "beta testing" was patient care model, monitoring aids, drug therapy, problem
reserved for later field testing involving outcomes assessment. detection and resolution , communication, and documentation
The objective of the alpha-l test was to decide whether the TOM Performance-based evaluation system- Indicators and data
prototype was therapeutically correct and functional, as deter- collection to support management and to verify contract
fulfillment
mined by pharmacists who are experienced in caring for asthma
Self-study materials-Covering pathogenesis, and phYSiologic
outpatients. The objective of the alpha-2 test was to decide and pharmacologic bases of drug therapy management in specific
whether community pharmacists could use the system without disease
extensive prior experience in asthma management and to evaluate Patient education materials-From the public domain when
possible
the technical acceptability of the system.
Modify the module. Based on advisory committee assessment, TOM = Therapeutic Outcomes Monitoring .
in-depth interviews, and field testing, we resolved deficiencies in
content, organization, presentation, and training programs for the
prototype module.
We used assigned readings and a structured program to train
interviewers. After a practice interview, interviewers were evalu-
Phase 3A: Evaluation Methods ated during their first exchange with a pharmacist, physician, or
patient. The interviews, which were structured according to a
Concept Interviews: Methods questionnaire with open-ended questions, lasted about one hour
In-depth interviews were used to obtain opinions from pharma- on average, and were taped and transcribed.
cists, physicians, and patients about the desirability (acceptability) All subjects were asked about their overall reaction to the idea
and feasibility of the TOM concept, prototype, and materials. of pharmacist participation in the management of drug therapy for
Subjects were chosen who could provide useful information in asthma through TOM. The interviewers probed each subject's
each domain of interest and who would be potential users of the understanding of the concept and asked about potential benefits,
TOM program, as follows: concerns, problems to be overcome, willingness to cooperate, and
I Pharmacists-Community, chain, and managed care practi- the anticipated reactions of others.
tioners, reflecting a range of practice-related attitudes, received Pharmacists were asked, in addition, about the TOM prototype:
a narrated demonstration of the TOM program on videotape, a suggestions for improving the prototype and organizing the
brief written description, and a module mock-up. module, whether they could provide TOM services, and potential
I Physicians-Interviews were divided equally by category of pricing of the service.
experience (i.e., less than 5 years in practice, 5-10 years in Physician questions included, in addition, the number of
practice, and greater than 10 years) to reflect a range of atti- patients in their practices with uncontrolled asthma, possible rea-
tudes toward change. Physicians received brief written and oral sons for lack of control, and whether their willingness to cooper-
descriptions of the TOM program and a sample referral form. ate depended on the identity of the pharmacist. They were asked
I Patients-Patients with both controlled and uncontrolled asth- to comment on the patient referral form.
ma were represented. To capture variations in responsiveness Interviewers asked patients or parents of patients additional
secondary to age, all interviews were divided equally among questions about how asthma affected their (or other children's)
adult patients and parents of children with asthma. Uncon- lives, how well informed they felt they were about the disease and
trolled patients were identified from two sources: behavioral its management, whether their willingness to participate would
data from pharmacy records suggesting overuse of asthma depend on which pharmacist provided the care, willingness to pay
medications and referrals from physicians of difficult-to-man- for the service, perceived convenience of the service, and key fac-
age patients. Patients received brief written and oral descrip- tors in personal interest. They were asked to comment on the
tions of the TOM program. patient diary.

Vol. NS37, No.6 NovemberlDecember 1997 Journal of the American Pharmaceutica1 Association 651
 RESEARCH Therapeutic Outcomes Monitoring

Figure 1. Therapeutic Outcomes Monitoring Integrated into Drug Therapy --

Patient Recognize Assess Therapeutic
entering or patient patient plan,
~ ~
continuing problem problem prescription
care liS", 110" IIAII lip"
(subjective, objective)

6. Implement 6a. Evaluate 6b.Respond

monitoring patient to problems
plan progress (if any)
1. Record and
interpret
patient
information

5. Dispense 2. Document
product(s); desired
advise patient therapeutic
objectives

3. Evaluate
therapeutic
objectives and
plan
4. Design
monitoring
plan

Field Testing: Methods bility of the TOM program. We sought to learn whether
community pharmacists could provide patient care with the
Alpha-1 Test TOM program (with the necessary physician and patient
Three pharmacists who had extensive experience in asthma cooperation) and to assess the technical performance (i.e.,
management and whose practices could support TOM participat- acceptability) of the program. A total of 12 alpha- 2 test
ed in the alpha-1 test. Information was gathered through struc- pharmacists received TOM materials that had been revised
tured interviews, either in person or by telephone, regarding the according to the results of the alpha-1 test. They also partici-
content of the protocol and documentation system. Results of the pated in three half-day training programs that focu sed pri-
alpha-1 test were used to identify and assess (1) editorial presen- marily on the skills necessary to use the system. (We later
tation of the protocol; (2) accuracy of the therapeutic content of refined the training program so that it could be completed in
the protocol; (3) usefulness and convenience of the protocol and two and one-half days or less. We have trained approximate-
documentation; (4) patient responses to the services (e.g., accep- ly 60 pharmacists using this compressed schedule. The
tance, cooperation); and (5) physician acceptance (e.g., of phar- development of the TOM training program will be reported
macists' requests for cooperation and offers of information). separately.)
All three pharmacists met with the module designers in a final During the alpha-2 test period, the following support activities
group interview to discuss improvements to the prototype. were initiated:
• Conference calls among alpha-2 pharmacists, a Working
Alpha-2 Test Group member, and an alpha-1 pharmacist to discuss progress
The objective of the alpha-2 test was to evaluate the feasi- and problems.

652 Journal of the American Phannaceutical Association NovemberlDecember 1997 Vol. NS37, No.6
 Therapeutic Outcomes Monitoring RESEARCH

I ..
I Table 4. Explanation of Steps in the Patient-Care Model (see Figure 1)

r I. Record and interpret patient information. ("What do we need to know about this patient?")
2. Document desired therapeutic objectives for the patient and document the therapeutic plan. ("What do we intend to achieve with
this therapy in this patient?,,)
/
The pharmacist considers two basic types of therapeutic objectives: clinical objectives (from a professional viewpoint) and quality-of-
life objectives (from the patient's viewpoint). If possible, the pharmacist learns the patient's objective from the patient or caregiver
and clinical objectives/therapeutic plan from the physician or other health care providers.
Evaluate the therapeutic objectives and the therapeutic plan . ("Are these appropriate therapeutic objectives, and is this an acceptable
plan for achieving those objectives for this patient?,,)
The pharmacist evaluates potential drug-related problems (any obstacle to achieving therapeutic objectives).43 Keeping in mind the
patient' s medical problems, lifestyle, and preferences, the pharmacist:
• Decides whether the patient has or is likely to develop problems with therapy
• Decides whether modifying the regimen is necessary, and if so, consults the prescriber
• Documents the evaluation, potential prob l ems, and any prescriber consultation
4. Design a monitoring plan. ("What should we look for to assess therapeutic success or failure?")
On the basis of potential problems identified in Step 3, the pharmacist:
• Devises a procedure to obtain the data needed to monitor the patient's progress toward therapeutic objectives
• Establishes when and how the monitoring data will be collected and documents the plan in the patient record (a daily calendar
diary or other reminder log may be necessary)
5. Dispense drug products, advise patient. ("Can the patient now optimally use this medicine?")
The pharmacist includes specific information about how the patient or caregiver can monitor the progress of therapy, how to detect
pharmacotherapeutic problems, and what actions to take if a possible problem is detected. The pharmacist provides supplementary
written material as appropriate. Before the interview ends, the pharmacist decides whether the patient (caregiver) understands the
therapeutic objective and what to do to reach it.
6. Implement the monitoring plan (collect monitoring data) .
The pharmacist carries out the monitoring plan as decided in Step 4. (This step will usually occur some days or weeks after Step 5,
and may require an appointment for a visit or a telephone calL)
a. Evaluate patient progress and identify pharmacotherapeutic problems. ("Is this patient progressing toward therapeutic
objectives?")
On the basis of monitoring data, therapeutic objectices, and patient data, the pharmacist systematically evaluates the patient's
progress. He or she evaluates and documents the following :
• Availability. Is there evidence that the patient is receiving the therapy as intended?
• Effectiveness. Is there evidence that the patient is obtaining the intended benefit from therapy?
• Adverse effects. Does the patient show any signs or symptoms consistent with a new medical problem that could result from
an adverse drug event, toxicity, or side effect?
b. Respond to problems. ("What action should I take now?")
The pharmacist considers pharmacotherapeutic problems and follows through. He or she exercises judgment in the patient's
interest. Most responses take one of two courses:
• Resolution: Resolving the problem entails five steps: defining the problem , identifying the cause (review information from
Step 3 for possible causes), choosing alternative solutions, selecting the best alternative, and implementing the solution.
Then, monitoring resumes.
• Referral: The pharmacist refers to others (e .g., physicians) problems that he or she cannot resolve alone.
c. Review the record (documentation of earlier steps) and complete documentation of the episode, problems noted, and actions taken .

d. Report to the physician periodically as necessary.

e. Revise or update the monitoring plan as necessary.

I Direct support of alpha-2 pharmacists (on request) from alpha-l visits, and training programs. The prototype and the educational
pharmacists and Working Group liaison. program were modified during field testing based on information
I Formation of a "TOM User Group" to encourage pharmacists obtained in the periodic pharmacist interviews. After the comple-
to support one another. tion of the test phase, a follow-up summative evaluation was
I Site visits to pharmacists requesting assistance. conducted using a combination of questionnaire and structured
I Establishment of PBES Working Group. interview. The questionnaires, mailed in May 1995, comprised
Information from the 12 alpha-2 test pharmacists was collect- six sections, as summarized in Table 5. The information from
ed through loosely structured biweekly telephone interviews, site interviews was evaluated to assess four factors: (I) patient issues

Yol. NS37, No.6 November/December 1997

Journal of the American Pharmaceutical Association 653
 RESEARCH Therapeutic Outcomes Monitoring

Figure 2. Therapeutic Outcomes Monitoring Module -

Treatment and Marketing and
Management Protocol reimbursement
(TOM Protocol) materials

Clinical Record
System- Performance-
• Data, assessment, based
plan evaluation
• Patient referral and system
report forms

TOM Module

Patient/parenti
Self-study materials:
caregiver
Pathophysiology
educational
and therapeutics
materials

(acceptance of and cooperation with care), (2) practicelbusiness The panel strongly accepted the professional team approach to
issues, (3) personal/profes sional issues, and (4) TOM patient care. Their comments indicated a belief that the concept
module/protocol. clearly delineated a legitimate role for pharmacists in cooperation
with physicians. They said that TOM services by pharmacists
would complement physician care, and that physicians would
Phase 38: Evaluation Results benefit because their patients would be less likely to become ill
and physicians' workload would therefore be reduced.
Concept Interviews: Results Reaction to TOM asthma prototype. Most of the panel pharo
Interviews were conducted with a panel of 12 pharmacists, rep- macists believed that they and their colleagues could successfully
resenting different practice settings (5 independent, 5 chain, and 2 implement the TOM program if pharmacy management were
clinic pharmacies); 9 primary care physicians who reported see- committed to the goal. Of the 12 pharmacists, 10 wanted to start
ing many patients with asthma in their practices (i.e., 10% or the TOM program when it became available.
more of all patients); and 9 patients diagnosed with asthma or The most frequently mentioned potential barriers to provision
their parents. of TOM services were the following:
• Reorganizing pharmacists' work to free up the time necessary
Pharmacists to perform TOM.
General concept of monitoring drug therapy outcomes. All • Finding space in the pharmacy.
pharmacists interviewed responded positively to the idea of sys- • Obtaining reimbursement.
tematically monitoring the outcomes of drug therapy. All agreed • Marketing the new services to physicians and patients.
that the basic concept was consistent with their view of profes- • Facing physician resistance ("turf' problems).
sional pharmacy practice. Reflecting a frustration with their cur- • Winning commitment from management.
rent practice, all pharmacists favored loosening their identifica- About one-half of the pharmacists considered compensation
tion with drug products and drug distribution activities and for TOM essential. Two of the pharmacists were specifically
moving toward the provision of patient-focused services. Com- interested in the profit-making potential of TOM, especially with
ments included: "It's long overdue," and "It's what we were patients who may be frustrated with their physicians and therefore
trained to do a long time ago." willing to pay for this type of care. Most of the pharmacists

654 Journal of the American Phannaceutical Association NovemberlDecember 1997 Vol. NS37, No.6
 Therapeutic Outcomes Monitoring RESEARCH

I believed that a capitated fee program was possible, although they Table 5. Outline of Follovv-Up Questionnaire
favored a fee-for-service arrangement. Most pharmacists agreed
II that a monthly fee of $20 per patient was a reasonable level of 1. Background information (practice type, pharmacy degree,
I reimbursement. However, 4 of the 12 pharmacists believed that years of pharmacy practice)

I patients would use the program only if their third party insurance 2. Patient and physiCian recruitment (number of patients enrolled,
number of physicians contacted)
carrier paid for it. Several pharmacists noted that patients with
3. Initial patient encounters
limited means would be reluctant to pay for this service.
4 . Follow-up patient encounters (number, time, activities
Five of the 12 pharmacists were concerned with the receptive- performed, activities documented)
ness of physicians to the TOM program. To address this concern 5. Difficulties using TOM
the pharmacists recommended the following marketing strategies:
For the most important problems:
I "Need documentation that supports the value of the program to
a. Difficulty of solution (rating from 0 = easy, to 10 = very
patients." difficult or impossible)
I 'Target the program to physicians who are more likely to be b. Actions by pharmacist necessary to overcome problem
receptive, such as younger physicians and physicians with c. Actions by project necessary to overcome problem
whom the pharmacist is already on good terms." 6. Overall impressions of TOM (desire to continue using TOM;
I "Show the physician the protocol you will be using and dis- TOM impact on patient outcomes; importance of physician
cuss ways in which it might be modified." contact; patient acceptance of TOM services; pharmacist's
interest in further modules; general comments)
I "Use advertising to market the program to physicians, such as
advertising in physician journals, news releases to physicians." TOM = The rapeutic Outcomes Monitoring.
Reaction to TOM materials. The majority of pharmacists
found the TOM module overall to be accurate, complete, and
readable. Four pharmacists raised the concern that the module's ease and drug therapy. All of the physicians stated that, if patients
level of detail was overwhelming, although they preferred too knew more about their medications and used them appropriately,
much detail to too little. The sections of the module that were less use of physicians' services should decrease. Advertising and mar-
satisfactory to them were billing, marketing, and setup of the keting materials could promote this advantage to patients, physi-
TOM program. Two pharmacists suggested that the indexing sys- cians, and third party payers.
tem be improved. TOM asthma program. Physicians were guarded about the
Opinions were mixed about the need for a training program TOM program logistics. In contrast to pharmacists' responses,
beyond what was available in the introductory video and module. physicians indicated TOM might increase their workload. They
Suggestions included a one- or two-day seminar, a hotline to worried that the TOM program would mean: " ... more meet-
answer questions about difficult-to-manage patients, and a ings ... more time out of [their] schedule," " ... tie up telephone
newsletter to keep pharmacists up-to-date regarding changes in lines," "taking a lot of time to fill out paperwork or meeting with
the protocol or the availability of special monitoring devices. pharmacists." Despite their agreement that pharmacists should be
compensated for TOM services, physicians were unwilling to bill
Physicians insurance companies on behalf of the pharmacists. They also
General concept of monitoring drug therapy outcomes. The thought that it would be difficult to convince third party payers
nine physicians supported the concept of pharmacists monitoring and patients of the need for TOM services for asymptomatic
drug therapy for essentially the same reasons mentioned by the patients with asthma.
pharmacists. They viewed monitoring as a professional activity of TOM materials. Physicians were asked only to examine the
pharmacists that could complement their own primary role in diag- referral forms for enrolling patients into the TOM program. No
nosis, potentially improving medication use and patient well- suggestions for improvement were offered.
being. Although they were comfortable with pharmacists perform-
ing "drug" monitoring activities (e.g., looking for interactions, Patients
compliance problems), the physicians had reservations about phar- General concept of monitoring outcomes of drug therapy.
macists, in general, monitoring patient outcomes. For example, the All of the patients responded positively to TOM services. Most
physicians expressed skepticism about the credibility of pharma- patients expressed general appreciation of a trusted, caring profes-
cists as information resources, advisors, and even as colleagues. sional who would take the extra time to explain their condition, its
Nonetheless, each physician was able to identify at least one phar- treatment, and preventive measures in a manner they could under-
macist whom he believed could competently monitor patient out- stand. The following statement is illustrative: "I like the idea of
comes. Several physicians stated that a "PharmD-trained" pharma- getting more information from someone who knows more than I
cist would be more capable of monitoring patient outcomes. do. I mean, presumably it would be a pharmacist who is familiar
Like the pharmacists, the physicians perceived a need for pro- with many people and their conditions."
grams that would improve patients' knowledge about their dis- The patients also responded favorably to the idea of a pharma-

Vol. NS37, No.6 NovemberlDecember 1997 Journal of the American Phannaceutical Association 655
 RESEARCH Therapeutic Outcomes Monitoring

cist in a cooperative relationship with a physician. However, improve page format, alter placement of forms in the patient
patients had reservations about the feasibility of chart, or provide a more comfortable and logical flow of the
pharmacist-physician cooperation. In the words of one patient: "I TOM protocol.
wonder if a physician would take seriously the pharmacist's con- • Overall, most of the patients responded well to the TOM pro-
sultation? Knowing how physicians think-they are the experts gram: (1) initial intake interviews typically lasted from 30
and everybody else is obviously not as competent as they are. Yet minutes to 1 hour, (2) patients kept more than 75 % of appoint-
the physician may have all this knowledge, but he doesn't have ments, and (3) patients perceived value in TOM services.
time to convey it to you." • Most of the physicians accepted the pharmacists' interven-
Patients said they would be more comfortable enrolling in such tions. Since the pharmacists included in the alpha-l testing
a program if their physicians supported their involvement in the already had a working relationship with physicians, this result
program, and many stated that they would use the service only indicated that the TOM program did not interfere with existing
upon physician referral. relationships.
TOM asthma program. Patients expressed doubts about the Several important structural and functional changes were made
possibility of finding a pharmacist willing and able to spend time to the TOM prototype based on the interviews, especially the final
providing TOM services. Some were unable to envision a new group interview with the alpha-l test pharmacists. Most signifi-
type of pharmacist-patient relationship. Some patients noted cant was the recommendation that the process of documentation
potential problems with scheduling appointments, and others should lead the user through the protocol (previously, documenta-
were concerned about being "locked into" a program that tion had not been as closely integrated with the action steps in the
required a set number of appointments. Like some physicians, protocol). Each patient folder became an encapsulation of the
some patients believed that TOM might be most attractive to the TOM guidelines. This concept directed the further design of the
symptomatic patient or to those recently diagnosed. prototype and the present version of the TOM system.
Patients generally agreed that a monthly fee of $20 (paid out of
pocket) was reasonable: "You would expect that it would cost Alpha-2 Test
something .... I don ' t think it should cost as much as a physician's This test was planned for approximately eight months (March
visit." to November 1993), but continued until September 1994 because
''I' d pay in a second assuming-if and only if-I got help from participants continued to provide useful suggestions for improve-
it. I guess I would only do it on a trial basis." ment. A total of 12 pharmacists, including the 3 alpha-l test
TOM materials. Patients' reactions to the educational materi- pharmacists, started the alpha-2 test. Seven pharmacists complet-
als were mostly positive; many patients said that they could never ed the follow-up questionnaire (one still-active participant and
have enough information about asthma. However, reactions to the one inactive participant did not return the questionnaire), one had
patient diary were mixed or negative: "It's too detailed, and for changed practice site, one had stopped practicing because of ill-
my kids, they had the same numbers almost always all the way ness, and one inactive participant had moved away. Characteris-
across ... basically pretty boring ... a nuisance." tics of the seven who responded to the questionnaire are shown
"This is a personal thing. I like to function when I don't dwell in Table 6.
on my illness, and this feels like I am dwelling on it. That's prob- A total of 57 patients had been enrolled in the TOM project by
ably a negative attitude for a prevention program." March 1994, with about half of the pharmacists accounting for
Clearly, the amount of time and detailed information asked of approximately 75 % of the caseload. At the time of the follow-up
the patients were perceived as a burden--and some patients felt interviews, 6 of the 7 responding pharmacists enrolled 49 of the
the effort outweighed potential benefits. 57 patients. The 49 enrolled patients ranged in age from younger
than 10 to older than 60 years. Children under 10 years old were
most difficult to maintain in the study. A total of 11 were
Field Testing: Results enrolled, with only 2 remaining in the program as of June 1995,
whereas 13 of the 27 adult patients (19-60 years) enrolled by
Alpha-1 Test study pharmacists were still enrolled as of June 1995.
The alpha-l test phase lasted approximately four months The questionnaire (see Table 5) asked for the four most impor-
(November 1992 to February 1993). The major findings of this tant difficulties involved in the pharmacists' efforts to implement
test were as follows: the TOM program. A total of 25 issues were listed. These were
• No therapeutic errors were noted in the protocol. Recommen- categorized into the four themes discussed below. Quotation
dations included additional reference material (e.g., oral corti- marks indicate a quotation from one of the respondents, and diffi-
costeroid dosing guidelines, a guideline for adjusting theo- culty was scored as shown in Table 5, item 5a.
phylline dosages, a metered-dose inhaler technique scoring Patient issues. Notably, lack of patient demand or interest was
method, a peak flow rate reference chart). not mentioned as a problem. The difference between patients cur-
• Changes to structure and function were recommended: rently enrolled in TOM and the total patients enrolled reflects

656 Journal of the American Phannaceutical Association NovemberlDecember 1997 Vol. NS37, No. 6
 Therapeutic Outcomes Monitoring RESEARCH

..
Table 6_ Alpha-2 Test Pharmacist Characteristics

Years in Total no. No. Patients

Pharmacist Practice Type Degree Practice Patients by March 1994
Cha i n BS 27 5 2
Chain BS 17 2 0
Independent BS 16 10 2
Chain PharmD 7 0 0
Chain BS 19 8 3
Ambulatory clinic BS 33 15 6
7* Chain BS 30 9 9
Total 49 22

• Pharma c ist 7 w as trained w ith the asthma m o dul e. Howeve r, s he p refe rre d to limit her p ractice to diabeti c patie nts, and m ost of her
experience ref ers t o the diabetes TOM m odule. (All others f o r asthma TOM modul e .)

TOM ; Th era pe uti c Outcomes M o nito ring.

patient attrition in follow-up . For example: "Patients lost to fol- • "Time-my site during those months typically dispensed 400+
low-up as finances change and eligibility changes" (difficulty = prescriptions per day."
10); "Patients find difficulty coming in for prescriptions them- • "I am not the only pharmacist in the setting, but I am the only
selves" (difficulty = 1); "Getting patients back for follow-up" TOM pharmacist."
(difficulty not reported). • "Time to allow for thorough evaluation and follow-up. "
Pharmacists saw the problem of scheduling follow-up visits as • " [Time to make] physician appointments."
fairly easy to overcome. One pharmacist used telephone follow- Comments concerning practice issues included the following:
up as needed, and another scheduled visits during slow times. • "Changing my practice to accommodate a new modality" (dif-
However, both pharmacists noted that these are not ideal solu- ficulty = 8).
tions. Another suggestion was to develop computerized software • "Privacy. Missing an area [for] confidentiality" (difficulty = 10).
for TOM to assist in tracking patients for follow-up. • "Identifying patients to enroll" (difficulty = 3).
Practice and business issues. Seven pharmacists (including Two comments concerned financial difficulties, primarily
six of those responding to the follow-up questionnaire) imple- reimbursement for TOM services. Both were rated as 10 ("impos-
mented the TOM program in their practices. Respondents fre- sible" to overcome) (none of the pharmacists obtained additional
quently mentioned the time required for patient assessment and payment for TOM services):
follow-up monitoring. For the six questionnaire respondents, the • "Lack of remuneration for time spent."
average time for an initial patient encounter was 26 minutes • "Apathy with [sic] insurance carriers."
(range 15-45 minutes) and for a follow-up encounter was 11 min- The high difficulty ratings given to most of these factors sug-
utes (range 5-20 minutes). One pharmacist did not follow up with gest that providing TOM services involves factors that are
any patients. beyond the direct control of an employed pharmacist or
Responding pharmacists reported difficulties related to the owner/manager. If TOM is perceived as an additional service to
demands of their existing practices. Pharmacists often had diffi- be fitted in, rather than a new practice modality, these difficulties
CUlty reaching patients at home and/or scheduling follow-up visits are not likely to be overcome. Respondents recommended that
to the pharmacy. Difficulties were most evident when the TOM others (e.g ., managers , insurance companies, academicians)
program was used as an "add-on service to the existing practice should resolve these problems. Our findings suggest that provid-
model of dispensing with minimal patient counseling." Com- ing a patient-focused service such as TOM would require major
ments in this theme were grouped into three specific subthemes: changes in the workflow of most current community pharmacy
time, practice, and finance. practices.
Seven comments concerned time issues. These problems tend- Personal and professional issues. Five comments concerned
ed to be assessed as impossible to overcome, with 4 ratings of 10. personal or professional issues. These tended to be assessed as
Time issues were based on difficulties with workflow and person- very difficult to overcome. The median difficulty rating was 9 (of
nel. Comments related to workflow included the following, all of a possible 10) points. Difficulties in this category included the fol-
which had difficulty ratings of 10: lowing:
• "Time! Patients are waiting for prescriptions while I'm busy • "Getting the confidence to do the first patient and each
with a TOM patient." patient" (difficulty =7).

Vol. NS37, No.6 NovemberlDecember 1997

Joumal of the American Pharmaceutical Association 657
 RESEARCH Therapeutic Outcomes Monitoring

Table 7. Adher.e nce to TOM Protocol -

Activity Initial Encounter Follow-Up Encounter
No. Pharmacists (n = 7) No. Patients (n = 49) No. Pharmacists (n = 5)
Performed Documented Performed Documented Performed Documented
n(%) n(%) n(%) n(%) n(%) n(%)
Review PMHQ 6 (100) 3 (50) 31 (63) 9 (23) 0 4(80)
Use PMR 5 (83) N/A 30 (61) N/A 3 (60) N/A
Assess knowledge 6 (100) 3 (50) 32 (65) 16 (33) 2 (40) 1 (20)
Discuss monitoring 5 (83) 4 (67) 31 (63) 17 (35) N/A N/A
Use DTG 5 (83) 3 (50) 23 (47) 16 (33) 1 (20) 1 (20)
Evaluate all DRPs 6 (100) 3 (50) 32 (65) 15 (31) 3 ·(60) 0
Send MD report 1 (17) N/A 3 (6) N/A 0 N/A
Use encounter form N/A N/A N/A N/A 1 (20) N/A

PMHQ = patient medical history questionnaire; PMR = patient monitoring record; DTG = drug therapy guidelines; DRP = drug-related problems;
MD = physician; N/A = not app licabl e; TOM = Therapeutic Outcomes Monitoring. Six of the seven questionnaire respondents used the TO M
program with patients .

• "Getting over my own paradigms [sic] about how I practice" included support group and other activities to foster peer pressure
(difficulty =4). and special training in making change. Some suggested that TOM
• "My lack of follow-through after the initial visit" (difficulty =9). project management should provide such training and moral sup-
• "Physicians do not follow current treatment guidelines" port. These feelings of inadequacy and fear may have affected
(difficulty =9). other aspects of implementation of the TOM program.
Even though pharmacists had been encouraged to visit a small TOM module and protocol. Table 7 summarizes data on
number of key physicians who were caring for asthma patients, compliance with key processes in the TOM protocol in both ini-
many were wary about doing so. Five pharmacists contacted a total tial and follow-up patient encounters. For example, the first activ-
of 16 physicians about the TOM program in general; 8 of those ity in the protocol is to administer and review the Patient Medical
were contacted about specific patients whom the pharmacists had History Questionnaire (PMHQ). All respondent pharmacists
emolled in the program. Seven of the physicians-five in general (100%) reviewed this on the initial encounter, but only half of
practice and two specialists-referred patients to two pharmacists. them reported documenting the review or information from the
While pharmacists saw value in describing the TOM program PMHQ at the initial encounter. Overall, the PMHQ was reviewed
to physicians before enrolling the first patient in the program, for 63% of the patients in the alpha test, and 23% of these had
some described their fear of rejection by physicians, for example, documented PMHQ information at the initial encounter. None of
"I was pretty sure that, when I walked up, the receptionist would the five pharmacists who had follow-up encounters reviewed the
say, 'I'm sorry but the doctor is too busy to see you today.'" PMHQ on follow-up, but four of them had documented changes
Pharmacists chose to enroll patients directly. They said that to PMHQ information.
patients who benefited from the service would inform their physi- Overall, most problems with adherence to the TOM program
cians about the TOM program and that physicians would cooper- involved documentation, especially written communication with
ate based on patients' wishes. Clearly, these concerns about physicians. Only one pharmacist sent the report to physicians for
physician rejection stemmed from lack of confidence by the phar- initial encounters. None were sent for follow-up encounters.
macists in their own clinical skills. This fear of rejection contin- Three comments addressed module and protocol issues. Each
ued to be a problem for many of the pharmacists even after they received a difficulty rating of 5: "paperwork"; "TOM notebook
all had demonstrated use of the TOM module and reported confi- somewhat complex but usable"; "patient encounter form some-
dence in their abilities to deliver care. In the follow-up question- what complex."
naire, four pharmacists who made physician visits reported that The respondents recommended that the TOM Working Group
these visits were "very important," while the fifth respondent said design a computer program to simplify data entry, reduce the
they were "somewhat important." One pharmacist had made no amount of information in the TOM notebook, and shorten the
physician visits, believing that such visits were not needed. length of the patient-encounter form. One pharmacist commented
The pharmacists recommended several solutions to these per- that the physician information brochures were a good idea bul
sonal and professional difficulties. One pharmacist noted that that he had never used them.
identifying and overcoming these difficulties would involve per- All seven respondents reported that they would like to continue
sonal responsibility and commitment to change. Solutions offered using the TOM program in their practices. All reported that TOM

658 JournaJ of the American Phannaceutical Association NovemberlDecember 1997 Vol. NS37, No.6
 Therapeutic Outcomes Monitoring RESEARCH

had a positive impact on patient outcomes. Five pharmacists low the TOM process. Some pharmacists who demonstrated
reported that TOM had been well received by patients, while two acceptable knowledge and skill in the intermediate evaluations
were uncertain about patient response. Respondents also reported (e.g., interviewing patients) performed unacceptably in the overall
that TOM had a positive effect on their own self-confidence and evaluation because they did not follow the protocol through each
knowledge, even if they did not enroll patients: "TOM was con- practice component. When they adhered to the protocol, they per-
crete proof that I cared about patients' well-being and gave formed acceptably. Similarly, some pharmacists who did not
patients the incentive to take better care of themselves. Even begin enrolling and monitoring patients promptly after training
without enrolling patients [in the TOM program] the education seemed to lose the necessary familiarity with the system, and this
and insights I obtained on asthma helped me guide patients in eventually becarne an obstacle to their enrolling patients.
controlling their drug therapy." Pharmacists successfully implemented TOM in their practices,
Negative comments reflected the theme that TOM was a good overcoming many obstacles to do so. Successful pharmacists
idea, but not ready for "real world" practice conditions. For exam- tended not to see insurmountable barriers to implementation, but
ple, although the protocol (including documentation and reim- rather viewed these as problems to solve. 45 When they tried to
bursement) was seen as important, pharmacists perceived it as solve these problems, despite fears or negative assumptions,
cumbersome and time-intensive to maintain without the benefit of many overcame "barriers" that appeared real or insurmountable to
acomputerized system. others, including patient and physician acceptance of the new
services.
Finding sufficient time was a major issue. However, most phar-
Discussion macists found ways to increase efficiency and fit TOM services
into their busy practice, albeit for a minimum number of patients.
The objective of the TOM project was to develop practice Times required for patient intake and follow-up tended to fall
guidelines and supporting materials for pharmaceutical care in sharply after the first one or two patients. The opportunity cost of
ambulatory practice and to study their use in community phar- providing TOM (lost opportunities to do other revenue-generating
macy practice. tasks) was linked by many pharmacists to reimbursement and
Pharmacists, physicians, and patients expressed favorable atti- other business issues, discussed further below.
tudes about community pharmacists' participation in pharmaceu- Adherence to TOM protocol in pharmacists' daily practices
tical care. Many subjects in each group qualified their approval, ranged from nil to 65% (Table 7). Adherence was highest for
but most of these qualifications could be satisfied, except for direct patient-care activities. The two most problematic areas
pharmacists' resource needs. were documenting care and reporting to physicians. Pharma-
The results demonstrate that useful practice guidelines for com- cists reported on follow-up that they documented about half of
munity pharmacist participation in pharmaceutical care can be the direct patient-care activities (e.g., assessing patient knowl-
written and taught to pharmacists. Asthma is an effective model edge). This is a serious problem; if care is not documented, the
for teaching the process of pharmaceutical care. The results of pharmacist may inadvertently omit an important step or datum
written tests, formal observations of performance in simulated in providing care. The time required to document care (or the
patient care, and examination of practice records show that com- amount of documentation recommended) was mentioned as
munity pharmacists with various backgrounds can learn to pro- one reason for not documenting patient encounters. However,
vide TOM services for asthma in both simulations and actual time pressure does not explain why pharmacists chose to
practice. Two days of guided experience (simulations) was suffi- neglect this activity instead of others. Incomplete documenta-
cient for almost all of the pharmacists trained. tion is a common problem for many health care professionals,
The experience of training and field testing has confirmed the and many pharmacists are accustomed to only minimal docu-
importance of pharmaceutical care as a process. While some dis- mentation. Also, direct patient care is valued by, and visible to,
eases and drug therapies surely would differ from our experience the patient, while documentation may be invisible. Documenta-
with asthma, we believe that this experience can be repeated for tion may be an activity that highlights the difference between
patients with many other diseases. The working group has now pharmaceutical care as a practice and pharmaceutical care as an
developed modules for managing drug therapy in cardiovascular "add-on" service in a dispensing practice. Documentation via
diseases. Perhaps training for additional diseases would require computer, as many pharmacists recommended, might be more
even less time than the initial training since basic principles of convenient and efficient, but this begs the question of pharma-
patient management would not need to be repeated. cists' acceptance of their duty to document the care they pro-
No relationship was evident between educational level and suc- vide. Such acceptance may depend ultimately on requirements
cess in adopting the model. In particular, theoretical and technical of reimbursement programs or practice standards.
knowledge of subjects such as pharmacotherapy was seldom the Low compliance in reporting to physicians is theoretically a
limiting factor in development of competence among pharma- serious problem for two reasons: the pharmacist may possess
cists. Often, the limiting factor was a pharmacist's ability to fol- essential information about the patient that the physician does

Vol. NS37, No.6 Novembermecember 1997 Journal of the American Pharmaceutical Association 659
RESEARCH Therapeutic Outcomes Monitoring

not, and feedback is important in building collegial have so far not been met in the United States.' The TOM project
relationships.46 Reluctance to report should perhaps be interpret- generated significant interest but did not become self-sustaining.
ed in the context of some pharmacists' similar reluctance to con- It does not appear that use of the model will spontaneously
tact physicians to describe the program, or even to send spread in the presently constituted market for pharmaceutical
brochures that the program provided (and that pharmacists services.
agreed were acceptable). Perhaps some pharmacists were appre-
hensive about developing collegial relationships with physi-
cians-or about making claims of value in their drug therapy Recommendations
management. Future pharmaceutical care projects should attempt
to understand the causes of this reluctance and should include The TOM Working Group began with a " minimalist"
methods to overcome it. approach. That is, we added components to the TOM program as
Many pharmacists were enthusiastic about learning to provide we recognized a need for them. For example, we formalized our
TOM services. Once involved in the project, they typically report- simulation-based training program after results of simpler and less
ed that pharmaceutical care would be a desirable practice, one formal training approaches proved unsatisfactory. Therefore, we
that may be necessary for their future professional survival. All believe that the present content of the program is essential. Fur-
seven respondents to the follow-up questionnaire reported that ther improvements may involve streamlining of certain elements
TOM had a positive effect on patient outcomes and that they (e.g., computerized documentation system) or addition of new
would like to continue to provide TOM services. elements as suggested below.
One possible explanation for the difficulties in enrolling large num-
bers of pharmacies and patients would be that the TOM program, as
Conclusion field tested, is too cumbersome for use. However, careful examination
of the evidence does not support this explanation. Our field test results,
The TOM project was successful from a technical viewpoint, formal and informal interviews with test pharmacists and others
but not from a marketing viewpoint. We demonstrated, in a limit- trained for phase 4, and the success of similar projects conducted else-
ed number of pharmacies, one technically feasible approach to where show that TOM represents an effective means for implement-
establishing pharmaceutical care practice in community phar- ing pharmaceutical care in many community pharmacies.
macy. Other approaches-<mes that may have different strengths We believe that the following changes in the TOM program
and weaknesses-are being tested. 47 would improve it and increase the possibility of success:
The major points demonstrated by this project are as follows: • Practice reorganization. A systematic means for pharmacy
• The modules provided most of the necessary support for pro- managers to reorganize their prescription-oriented practices
viding the major elements of pharmaceutical care for patients into patient-oriented practices. This includes workplace layout,
with asthma in community settings. job definition, work organization, and performance evaluation.
• In about one weekend of training, most pharmacists learned to • Practice management training. Supplementation of written
use the modules correctly and to incorporate them into their management material with exercises (e.g., simulations) in
practices, at least for a limited number of patients initially. practice reorganization, practice management (as above), mar-
• In interviews, physicians and patients expressed acceptance of keting to patients and physicians, and billing.
the program . Anecdotally, the physicians and patients • Computerization of the protocols, documentation system, and
approached by study pharmacists accepted the pharmacists' background information.
new service and cooperated appropriately.
• TOM protocols and documentation provided an acceptable means Acknowledgments: This work was funded in part by a grant
for third party payers to verify that services were provided. from Sandoz Corporation. The TOM modules were developed at
• Most pharmacists who participated in the TOM project wished the University of Florida College of Pharmacy by the TOM
to continue this level of practice in their community pharmacies. Working Group: Angaran DM, Ben-Joseph R, Berardo DH, Doty
Nonetheless, enrollment of patients in these phases of the RE, Grainger-Rousseau T-J, Hepler CD, Lipowski EE, Marshall
study was difficult, and total enrollments were much less than M, Miralles MA, Nau DP, Ried LD, Segal R. Content experts on
expected. The sample size requirements for phase 4 of the therapeutic guideline development for asthma and diabetes were
study-evaluation of patient outcomes associated with TOM- Hendeles L, White Jr. JR, Campbell RK. The TOM Working
Group received guidance from the TOM Advisory Committee:
Browning G, Burns WR, Camp R, Cirillo F, Dewar M, Highness
* An outcomes study has been completed in Denmark and D, Presnell R, Wilson R. Modules were field tested by alpha test
manuscripts are under review and preparation (Herborg H, et al. Quality pharmacists: Accardi R, Accardi V, Camp R, Fucarino D, Klo-
improvement of drug therapy for asthma patients--evaluation of a co-
operative Danish programme). Outcomes studies are underway in British man A, Krzanowski P, Martin D, Ostrowsky N, Owen P, Piau a
Columbia (Canada), The Netherlands, and Spain. E, Regan T, Switzler T.

660 Joumal of the American Phannaceutical Association NovemberlDecember 1997 Vol. NS37, No.6
 Therapeutic Outcomes Monitoring RESEARCH

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Vol. NS37, No.6 November/December 1997 Journal of the American Phannaceutical Association 661