Measuring the impact of patient counseling in the outpatient pharmacy setting: the research design...

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CLINICAL THERAPEUTICSVVOL. 17, NO. 5, 1995 Measuring the Impact of Patient Counseling in the Outpatient Pharmacy Setting: Development and Implementation of the Counseling Models for the Kaiser PermanenteAJSC Patient Consultation Study Kathleen A. Johnson, PharmD, PhD,’ Matt Nye, PharmD,2 Kathleen Hill-Besinque, PhurmD, MS Eg’ and Marisue Cody, PhD, RN1 ‘University of Southern California, School of Pharmucy, Los Angeles, and 2Kaiser Pemzanente Medical Care Program, Pharmucy Operations, Downey, California ABSTRACT The Southern California region Kaiser Per- manente Medical Care Program, which serves 2.2 million patients, and the Uni- versity of Southern California School of Pharmacy have designed and implemented a patient consultation study to determine the cost-effectiveness of three different ap- proaches to providing pharmacist consul- tation to outpatients. This paper describes the development and implementation of these three models. A total of 107 pharma- cies (approximately 600 pharmacists) par- ticipated in the study and were assigned to provide one of the models of patient con- sultation, designated the Kaiser Perma- nente (KP) model, the state model, and the control model. The KP model (20 pharma- cies) provided targeted pharmaceutical care services to high-risk patients based on drug use. The state model (67 pharmacies) pro- vided California-mandated patient consul- tation to patients with new or changed pre- scriptions, instructions for use, relevant warnings and precautions, storage require- ments, and the importance of compliance. The control model (20 pharmacies) pro- vided consultation when deemed necessary by the pharmacist and provided care simi- lar to that provided before mandatory con- sultation in California. The KP and state models used the same pharrnacist/techni- cian/clerk resources, but the control phar- macies limited personnel resources to those existing before the mandatory consultation law was passed in California. The paper describes the KP model in detail and pro- vides a literature-based rationale for tar- geting particular high-risk patients for ex- panded services. The paper also describes the training process, gives an example of a high-risk patient intervention, provides in- formation on documenting pharmacist in- 988 0149-2918/95/$3.50

Transcript of Measuring the impact of patient counseling in the outpatient pharmacy setting: the research design...

CLINICAL THERAPEUTICSVVOL. 17, NO. 5, 1995

Measuring the Impact of Patient Counseling in the Outpatient Pharmacy Setting: Development and Implementation of the Counseling Models for the Kaiser PermanenteAJSC Patient Consultation Study

Kathleen A. Johnson, PharmD, PhD,’ Matt Nye, PharmD,2 Kathleen Hill-Besinque, PhurmD, MS Eg’ and Marisue Cody, PhD, RN1 ‘University of Southern California, School of Pharmucy, Los Angeles, and 2Kaiser Pemzanente Medical Care Program, Pharmucy Operations, Downey, California

ABSTRACT

The Southern California region Kaiser Per-

manente Medical Care Program, which serves 2.2 million patients, and the Uni- versity of Southern California School of Pharmacy have designed and implemented a patient consultation study to determine the cost-effectiveness of three different ap- proaches to providing pharmacist consul- tation to outpatients. This paper describes the development and implementation of

these three models. A total of 107 pharma- cies (approximately 600 pharmacists) par- ticipated in the study and were assigned to provide one of the models of patient con- sultation, designated the Kaiser Perma- nente (KP) model, the state model, and the control model. The KP model (20 pharma- cies) provided targeted pharmaceutical care services to high-risk patients based on drug use. The state model (67 pharmacies) pro-

vided California-mandated patient consul- tation to patients with new or changed pre- scriptions, instructions for use, relevant

warnings and precautions, storage require- ments, and the importance of compliance. The control model (20 pharmacies) pro- vided consultation when deemed necessary by the pharmacist and provided care simi- lar to that provided before mandatory con- sultation in California. The KP and state models used the same pharrnacist/techni- cian/clerk resources, but the control phar- macies limited personnel resources to those existing before the mandatory consultation law was passed in California. The paper describes the KP model in detail and pro- vides a literature-based rationale for tar- geting particular high-risk patients for ex- panded services. The paper also describes the training process, gives an example of a high-risk patient intervention, provides in- formation on documenting pharmacist in-

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terventions in all models, and explains the

method used for monitoring implementa-

tion of the models.

INTRODUCTION

The Southern California region Kaiser Permanente Medical Care Program (KPMCP), Downey, California, and the University of Southern California (USC) School of Pharmacy, Los Angeles, Cali-

fornia, have designed and implemented a patient consultation study to determine the cost-effectiveness of three different meth- ods of providing pharmacist consultation

to outpatients. This paper describes the de- velopment and implementation of these three models of patient consultation. These models are designated the Kaiser Perma- nente (KP) model, the state model, and the control model. For each of the three mod-

els, the rationale for development, phar- macist training, implementation strategy, documentation requirements, and compli- ance audits are described.

BACKGROUND

The Omnibus Reconciliation Act of 1990 legislation requires pharmacist consulta- tion for Medicaid patients.’ In addition, several states, including California, have

implemented mandatory patient counsel- ing laws.2 However, limited data exist to show the value this pharmacist consulta-

tion has in terms of the impact on patient or drug therapy outcomes. Rupp3 has shown that pharmacists can identify po- tential medication problems, and Carter and Helling4 have discussed the impact of clinical pharmacy services in ambulatory care settings. Kimberlin et al5 found that pharmacists who were given an extensive training program engaged in more exten-

sive and consistent assessment/education activities with elderly patients. However,

a literature review on the value and ac-

ceptance of ambulatory care provided by pharmacists6 concluded that more focused

research on pharmaceutical services in the community that link patient outcomes and pharmaceutical services is needed. Also needed is research on the barriers to phar- macist provision of patient counseling and other clinical services.

Hepler and Strand’ define pharmaceu- tical care as the “ . ..responsible provision of drug therapy for the purpose of achiev-

ing definite outcomes that improve a pa- tient’s quality of life.” While mandatory patient consultation, as implemented in California, does not necessarily imply “pharmaceutical care” as defined by Hep- ler and Strand, it is assumed that manda-

tory patient consultation has the potential to improve patients’ outcomes to drug

therapy. However, mandatory consulta- tion for every new or changed prescrip- tion is costly and the direct influence on patient outcomes remains unknown.

This paper describes an alternative ap- proach to pharmaceutical care that is be- ing tested in a large group model health

maintenance organization (HMO) serving more than 2.2 million patients in the Southern California region and filling more than 12 million prescriptions per

year. This alternative pharmaceutical care approach uses the same resources (phar-

macists/clerks/technicians) as those re- quired for mandatory consultation. The demonstration project compares the out- comes achieved in the targeted pharma- ceutical care model (KP model) with outcomes achieved via mandated consul- tation (state model) and consultation based on pharmacists’ discretion (no man- dated consultation-control model).

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PATIENT CONSULTATION MODELS

State Model

In this study, 63% (67 pharmacies) of the pharmacies are assigned to provide the state model of patient consultation, The state of California implemented

mandatory patient consultation on No- vember 1, 1992. This law requires that pharmacists counsel all patients receiving new or changed prescriptions on the di- rections for use, storage requirements, rel- evant warnings and precautions, and im-

portance of compliance. The development of new practice regulations created an op- portunity to compare mandatory consulta-

tion with alternative models of patient consultation. The state model conforms to the requirements mandated by the patient consultation law.

Control Model

Nineteen percent (20 pharmacies) of the pharmacies in the Southern California re- gion of KPMCP are assigned to provide

the control model of pharmacy services. This model preserves the traditional way of providing pharmacy services, where the pharmacist provides patient consultation as deemed necessary in his or her profes- sional judgment or upon request of the pa-

tient. The pharmacies in this model were not provided any additional resources and thus could not implement counseling be- yond those traditionally provided. Al- though KPMCP was not particularly inter- ested in continuing this model once mandatory consultation laws were insti- tuted, for research purposes the mainte- nance of a control pharmacy model pro- vided the baseline for comparison of the

patient outcomes gained under mandatory consultation (state model) and the targeted approach (KP model). The California State Board of Pharmacy provided a waiver of the mandatory counseling requirement for the purposes of the research project to the control and KP model pharmacies.

The Kaiser Permanente Model

The KP model targets pharmacists’ in- terventions toward high-risk patients. Nineteen percent (20 pharmacies) of the pharmacies in the Southern California re- gion of KPMCP are assigned to deliver the KP model. The rationale for the KP

model, development of the patient-care interventions, identification of high-risk patients, the pharmacist training program,

and implementation of the KP model are discussed in more detail below.

Kaiser Permanente Model Rationale The KF’ model is an alternative model

to mandatory consultation based on two provisions. The first is that pharmacists’ cognitive services should be directed to- ward patients at high risk for a drug-

related problem. The second provision is that pharmacists in organized health care settings have access to the patient’s physi- cian and relevant clinical information that facilitate broader cognitive services than patient consultation.

There is considerable precedent in cur- rent medical practice for focusing health care resources on specific problematic ar- eas (ie, high risk and problem prone). The Joint Commission on Accreditation of Healthcare Organizations requires institu- tions to perform drug usage evaluations on drugs that will result in the most ben- efit for the effort performed.* Drugs are selected by the institution based on their

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practice patterns and patient demograph- ics. The Minnesota Medicaid program uses a similar approach by targeting se- lected high-risk drugs and patient groups in their Drug Utilization Review Pro- gram.9 In a report describing a pharma- cist-monitoring service for ambulatory patients, the pharmacists identified screening criteria, termed “prognostic in- dicators,” which would identify patients who would most likely benefit from phar- macist monitoring.10

There are also examples of focused ef- forts in the ambulatory patient consultation arena. A large institution in Ohio selected seven drug classes for which consultation would be mandatory. l1 The drug classes in this study were chosen because of their po- tential for drug-drug and drug-food inter- actions, adverse drug reactions (ADRs), and impact if the patient is noncompliant. Because of the high prescription volume in the outpatient pharmacy, the Ohio program chose to focus on medications that carry the greatest risk of adverse effects and that may carry the worst consequences if not taken as directed.

Pharmacists in organized health care settings have access to the patient’s physi- cian and relevant clinical information that facilitate broader cognitive services than patient consultation. Comprehensive clin- ical pharmacy services have been shown to improve drug therapy outcomes through the detection and prevention of drug-related problems. A study t* measur- ing the effect of pharmacist-monitoring and educational services provided to hy- pertensive patients found that both com- pliance and blood pressure control were significantly better in the experimental group. A cost-benefit analysis of integra- tion of drug therapy monitoring and physi- cian consultation in a family practice set-

ting found that the service decreased physician time and number of referrals.13 Further, the pharmacists’ recommenda- tions were implemented 75% of the time.14 Comprehensive education by a pharmacist may improve patient under- standing of their medication regimen and, in some cases, improve compliance.12*15 Unfortunately, none of these studies con- sidered the impact of these interventions on total health care costs or the patients’ quality of life.

Development of the Kaiser Permanente Model

The Kp model consists of two key com- ponents based on the premises described above. The first component is that the pharmacist intervention is directed toward patients who meet one of three high-risk screening criteria. The second component is that the pharmacist intervention will consist of more than point-of-service con- sultation. The pharmacist intervention will consist of drug regimen review, drug mon- itoring, physician consultation (when nec- essary), patient education, and follow-up.

Screening Criteria for the Kaiser Permanente Model

A team of KP pharmacists and USC fac- ulty researchers representing hospital, am- bulatory care, and outpatient pharmacy practice developed the screening criteria for determining high-risk patients and the list of target drugs (Table I). The team re- viewed the literature and internal KPMCP data concerning drug-related problems as- sociated with a high likelihood of hospital admission. From this information, three screening criteria were developed that were used in selecting the target drugs.

1. Drugs with a narrow therapeutic in- dex lo,16

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Table I. Target drugs identified for patient consultation study.

Phenytoin

Carbamazepine Theophylline Metered-dose inhalers Digoxin Quinidine Procainamide Antidiabetic agents (sulfonylureas and insulin) Nonsteroidal anti-inflammatory drugs Benzodiazepines

Beta-blockers Warfarin Calcium channel blockers 5 or more concurrent medications

These drugs are commonly used for po- tentially life-threatening conditions, which

could be exacerbated if the patient under- uses the medication. Also, toxicity from

these drugs is likely if the patient overuses the medication. Many drugs in this cate- gory have significant drug interactions. Drugs in this category include carba-

mazepine, digoxin, phenobarbital, pheny- toin, procainamide, quinidine, theophyl- line, and warfarin.

2. Drugs with a signijcant incidence of

ADRs that have been shown to signif-

cantly contribute to hospitalization.‘C20

The literature is replete with reports of drugs commonly implicated in hospital admissions. Many of the drugs with a nar- row therapeutic index are also included in this category. A variety of drugs have been implicated in the medical literature in- cluding antidiabetic agents, benzodi- azepines, beta-blockers, calcium channel blockers, digoxin, and sympathomimetic metered-dose inhalers.

3. Patients concurrently taking jive or

more chronic prescription medications.1o

The elderly are the patients most likely to be taking multiple medications. Although age itself has not been correlated with the

incidence of ADRs, the presence of mul- tiple disease states or multiple medica- tions does correlate with the incidence of ADRs.t7 The number of medications taken is also correlated with the number of potential drug interactions21 and drug problems5 in the elderly. Pharmacists can easily identify patients taking multiple medications and provide intervention as

appropriate.

Pharmacist Interventions for the Kaiser

Permanente Model The interventions developed were de-

signed to (1) be suitable for the outpatient HMO pharmacy practice setting; (2) use the same personnel resources required to implement patient consultation laws man- dated by the state of California (state

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model); (3) target high-risk patients; and

(4) target problems for which pharmacists

can make a difference in the outpatient

setting. The pharmacist in the KF’ model iden-

tifies and remedies patient medication problems prospectively and takes a proac- tive role. A general template (Figure 1)

describes the components of the pharma- ceutical care intervention services to be provided by the pharmacist, which include an assessment of the patient and drug ther- apy, monitoring of drug and disease, eval- uation of potential problems, intervention

with problems, and patient education and feedback/follow-up. A “mode of opera- tion” (Table II), suggesting steps in the intervention process, assists the pharma- cists in providing appropriate patient ser- vices. A specific “grid” for each of the

targeted drugs or drug class designated as high risk assists the pharmacists in pro- viding appropriate interventions. An ex- ample of an intervention grid for non- steroidal anti-inflammatory drugs (NSAlDs) that illustrates the KP model is shown in

Figure 2. For each patient presenting with a pre-

scription for any of the target drugs, or five or more concurrent medications, the pharmacist conducts the intervention. Be-

cause it was unclear at the beginning of the project how much time would be re- quired to provide the interventions, or how many patients would tit the high-risk cri- teria in any one pharmacy, services were to be provided to patients with new pre- scriptions and at first refill if possible. At prescription refill, compliance and ADRs were monitored, and patient questions were answered. As time permitted and pharmacist comfort and efficiency with the model developed, all target drug re- fills were included.

A Kaiser Permanente Model Example: NSAIDs

In the case of a patient presenting a new prescription for an NSAID, the KP protocol directs the pharmacist to review the patient profile for patient history and to obtain additional history from the pa- tient as necessary, including over-the-

counter drug use. The pharmacist as- sesses the profile in the computer for interacting medications, duplicate thera- pies, disease-state contraindications, age

(265 years), and past NSAID use. The pharmacist also assesses drug, dosage, and directions for optimal therapy. If there are potential problems, the phar-

macist contacts the patient or prescriber for further information to intervene with

appropriate recommendations. Some po- tential problems are resolved by talking to the patient and providing counseling. If it is determined that the prescription should be dispensed, the patient is ver-

bally counseled about the appropriate use of the drug, potential interactions, duplicate therapies, signs and symptoms of potential problems, how to avoid

problems, and the importance of com- pliance. A patient information leaflet is also provided.

If a major potential or real problem ex-

ists, the patient may be managed by the pharmacist or referred to the physician or

to a pharmacist-managed clinic (eg, asthma clinic or anticoagulation clinic) for fur- ther action. In any of these cases, the pre- scription may not be dispensed or may be

changed and then dispensed. On refill, the pharmacist assesses compliance, the pres- ence of ADRs, any new information or changes in patient disease status, and dis- ease control; he or she also answers pa- tient questions.

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Patientpresentsanew orchangedRxorr&ll 1

Figure 1

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Template for pharmaceutical care intervention services provided by the Kaiser Permanente model in a patient consultation study. Rx = prescription; PIMS = pharmacy information management system; pt = patient; MD = physician.

K.A. JOHNSON ET AL.

Table II. Steps in the intervention process for the Kaiser Permanente model of a patient

consultation study.

For a new prescription: 1. 2. 3.

4. 5. 6.

7.

8.

Target drug or XI concurrent medications identified on new prescription. Review patient profile; obtain drug history if necessary. Assess drug (dosage, directions), drug interactions, drug-disease interactions, over-the-counter

use, duplication, new therapy, appropriateness of therapy, polypharmacy. Identify potential problems. Clarify/solve potential problems by provider or patient contact. Dispense prescription or changed prescription or do not dispense. Provide written patient

information leaflet if appropriate. Provide patient education (counseling on drug, disease, compliance); answer patient questions,

warn of potential problems. Refer to physician, member health education, or pharmacist-managed specialty clinic if necessary.

For a refill prescription: 1. Assess compliance, monitor therapeutic end points and adverse drug reactions; reinforce

instructions and compliance, answer questions (all the above as appropriate).

Differences Between the Kaiser Permanente Model and State Model

There are three primary differences be-

tween the KP and state models. First, the KP model provides comprehensive clini- cal pharmacy services rather than just point-of-service consultation. Second, the

KP model targets only high-risk patients, as opposed to the state model, which cov-

ers all patients. Three, the KP model grids outline the common problems for each high-risk drug so the pharmacist has a guideline for intervention with high-risk patients. The state model has no drug- specific guidelines for the pharmacist con- sultations or intervention, only topics that should be covered during the consultation.

Because the staffing resources provided to the KP and state model pharmacies are the same, KP model pharmacies focus their additional resources on providing drug- and patient-specific interventions to

high-risk patients. State model pharma- cists use their additional resources to pro- vide point-of-service consultation to all patients with a new or changed refill pre- scription. Therefore, the level of intensity

of the KP model intervention is greater than that in the state model. The state

model, however, provides many more consultations than the KP model.

DOCUMENTATION

Pharmacists in all models are asked to document a potential problem that re- quires action be taken, the action taken to resolve the problem, and prescription dis- position after resolution of the problem. This information is documented on an en- counter form (Figure 3), developed using materials adapted from Rupp et alz2 Also recorded on the encounter form are the prescription number, date, time required for the intervention, and pharmacist ini-

CLINICAL THERAPEUTICS’

Figure 2. An example of a target drug grid (for nonsteroidal anti-inflammatory drugs). These grids were not meant to serve as complete documentation of clinical ser- vices to be provided to patients using these medications and were derived from many reference sources. The purpose of the grids were to: (1) guide pharma- cists providing services to the Kaiser Permanente (KP) model patient on target drugs; (2) improve KP pharmacist efficiency in providing the KP model; (3) provide pharmacist triggers for potential further action; and (4) assist in KP model pharmacist training.

tials. Although pharmacists intervene (provide patient-care services) with all target drugs in the KP model, the en- counter form is completed only when a problem or potential problem that requires action (provider contact, patient contact, or referral to resolve the problem) is iden- tified. Similarly, pharmacists in the con-

trol and state models are asked to com- plete an encounter form when a problem requiring action is identified.

TRAINING

Given the major change in pharmacy prac- tice required by the mandatory consulta-

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B, tdonttfler (Complete EACH time form is used)

Fbc N&r: Da% PharmacyLO&bllNo._

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4ppmprllmrr~Thurw Plwldorconmu P-Mlpowon 0~ndfoauon 0 MD accept& recommendation a Fbcdfspensadaswftttsn 0 Dosags/mgimenMrength 0 MD mjeoted mcommendetIon 0 Rxohangedanddkpensscl QDosageformIroute 0 MD modRed recommendation 0 Rx not dispensed (enter QQuantHykMatfon 0 MD Communicatbn Form sent Panenrs Med Record n):

Monltoling 0 MDolariflcation PFI 0 Side Effeots~Toxkity PawlIt coma (Rogaldlng Pmblem) 0 Dupricata Them 0 Counseled regardng problem 0 Non-complianca 0 lnfonnaUon fmm patient

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0 Allergy/!3enslWity Cl ToMHE IntefwntionTime: mhutes

Figure 3. Example of an encounter form used by the study models in the patient consul-

tation study.

tion law in California, as well as the KP model during the demonstration project, a considerable amount of training was pro- vided to all 600 KPMCP outpatient phar-

macists, including those working in con- trol pharmacies. In preparation for the

mandatory patient-consultation require- ments, all pharmacists working in the out- patient setting were given instruction in general counseling skills in a 2-day course

(16 hours) provided by the KPMCP The 2&y program consisted of the following topics: Verbal communication (communi- cation model, face-to-face communication tips, and active listening skills), nonverbal communication, model consultation script, role clarification for pharmacists as con- sultants, handling unusual circumstances, and consultation reference books.

All pharmacists (KP, state, and control models) were provided reference materi- als to appropriately counsel patients, and

United States Pharmacopeia Drug Infor- mation patient information leaflets were available for use in all pharmacies. Phar- macists in all models were provided train- ing on how to complete the encounter form to document activities (problem

identified, action taken, prescription dis- position). Although pharmacists in the control pharmacies were not provided re- sources to implement consultation, it is possible that the consultation training pro- gram increased consultation activities in control pharmacies. Audits and other meth- ods will be used to determine whether this occurred and the magnitude of the effect.

Training for the Kaiser Permanente Model

The training for the KP model was more extensive to prepare the pharmacists to provide the appropriate services required

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of the model. This additional training con- sisted of 12 hours of home study and 12 hours of a live continuing education pro- gram specific to the target drugs.

The home study component of the KP model training used portions of the Com- munity and Nursing Home Practice Drug Therapy OBRA Monitoring and Patient

Education Guidelines-1993.23 The home study material contained background in- formation on the management and treat- ment of major disorders in which target, high-risk drugs are used. These included congestive heart failure and digoxin, an- tiarrhythmics, anticoagulants, antidiabet- its, pulmonary drugs, analgesics and anti-inflammatory drugs; stroke and anticonvulsants; and anxiolytics. A self- assessment examination was submitted af- ter completion of each of the home study modules and graded by a USC faculty pharmacist/researcher, The pharmacists were required to score 70% on the mate- rial to successfully complete the program and receive 12 hours of pay.

The 1Zhour continuing education pro- gram for KP model pharmacists consisted of six 2-hour lectures given by USC fac- ulty and KP pharmacists in the areas of asthma, diabetes, cardiovascular disease, seizure disorders, management of patients using multiple drugs, benzodiazepines, NSAIDs, and patient assessment and in- terview techniques. An introduction to the research project and training on how to complete the encounter form were also included. Continuing education credit was given after completion of all 12 hours of lectures. The program focused on infor- mation exchange oriented toward prob- lem solving, use of case studies, and prac- tical information that could be applied in the outpatient setting. These training ses- sions were videotaped to be used later in

training new pharmacists who joined KP model pharmacies during the demonstra- tion project.

Additional information resources were provided to the pharmacists in the KP model, including a list of ambulatory-care pharmacist specialists who were available to answer patient-specific questions. Phar- macists in the KP model were trained to use the Micromedex@, Denver, Colorado, drug information system, which had re- cently been installed on the mainframe computer at KPMCP. This system allowed the pharmacists to acquire more in-depth drug information via computer.

IMPLEMENTATION

In preparation for mandatory patient con- sultation in the state model and targeted services for high-risk patients in the KP model, the Southern California region of the KPMCP employed additional pharma- cists and technicians. State and KP model pharmacy managers met (separately) to discuss implementation of mandatory con- sultation and the KP model, respectively. Mandatory consultation and KP model ser- vices were implemented in the respective pharmacies over a 4-month period after the training programs were completed. Control pharmacies, maintaining the tradi- tional pharmacy model, did not receive additional personnel resources and did not participate in implementation meetings.

Implementation of the Kaiser Permanente Model

To ensure that the KP model was im- plemented as planned, KP model meet- ings included discussions about the re-

K.A. JOHNSON ET AL.

search project in general, use of techni- cians, expectations for KP model pharma- cists, plans for the project, case studies for completing the encounter forms, and potential challenges and possible solu- tions to problems.

Liaison pharmacists from each KP model pharmacy were identified, and separate meetings were held with these individuals to discuss data collection, problem identification/resolution, and fu- ture plans. Much like the managers’ meetings, liaison pharmacists were in- volved in discussions about the research project, technician use, expectations of KP model pharmacists, encounter forms, case studies, and challenges/solutions. The pharmacist researchers led the first few meetings; KP management then com- pleted the implementation of the project at the pharmacies and held subsequent meetings.

At these implementation meetings with managers and pharmacy liaisons, several issues emerged. To facilitate implementa- tion and operation of the models, several pharmacies suggested innovative ideas and various problems were discussed with solutions provided. For example, during one of the KP model meetings, it was sug- gested that the information provided by the computer during a prescription refill be expanded to facilitate identification of potential compliance problems. A com- puter consultant was able to implement this suggestion by providing the data of the last refill on the label printout along with remaining refills. In another exam- ple, problems with the ease of use of the encounter form were discussed, which re- sulted in changes to the form. These ses- sions provided real-world solutions and innovations in practice, as well as oppor- tunities to improve the research process.

IMPLEMENTATION OF MONITORING

The process of evaluating the implemen- tation of all the pharmacy models (state, control, and KP) was ongoing during the study. The State Board of Pharmacy con- ducted a number of routine inspections to assure that the state and KP models were implemented with consultation as set forth in state law or the research proj- ect protocol as appropriate. Faculty re- searchers made unannounced, anony- mous visits to pharmacies, allowing each of the three models to be observed in op- eration. Because the control model phar- macists were not provided additional re- sources to implement consultation, it is unlikely that consultation occurred be- yond what was provided before the im- plementation of the patient consultation law. Lack of consultation was docu- mented during audits, although it is pos- sible that some pharmacists provided ad- ditional services as they always have. The State Board of Pharmacy primarily audited the state model pharmacies. Au- dits of the KP model by researchers demonstrated general overall compliance with the model. KP pharmacies imple- mented the model in a variety of ways. The most compliant-appearing pharma- cies identified a “KP consulting” phar- macist who was in charge of the provi- sion of the model during the operating hours of the pharmacy.

We also surveyed patients to identify how often they were consulted by phar- macists in each of the models. We will use the patient survey, pharmacist survey (discussed below), and audit information to generate an overall impression of phar- macist participation and implementation of each of the models.

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At the end of the study, a survey was given to all outpatient pharmacists in the Southern California region of KPMCP. This survey captures information on pharmacist self-reported implementation of the model, an evaluation of colleagues’ performance during the study, perceived management support, job satisfaction, and pharmacist’s intervention activities, as well as demographic and professional characteristics and perceptions during the course of the study. This information will then be used to help identify how well each pharmacy model was implemented and the pharmacist factors which corre- lated to model implementation.

SUMMARY

This paper describes an alternative ap- proach to the provision of pharmaceutical care in the outpatient pharmacy, which uti- lizes the same resources required by mandatory consultation to focus pharma- ceutical care on high-risk patients in a large HMO. In this paper, we reported our ap- proach concerning the design and imple- mentation of outpatient pharmaceutical care services. We will learn a number of things from the project, including new ways of organizing services using techni- cians and computers, the personnel and clinical resources required to provide ser- vices to high-risk patients, educational needs for pharmacists to implement phar- maceutical services in current practice, the clinical resources needed and available that are specifically designed for use in the out- patient setting, pharmacist characteristics that contribute to innovations in practice, and improved mechanisms to document problems identified and pharmacist inter- ventions provided. In times of limited re- sources, we must identify the most effec-

tive ways to utilize outpatient pharmacists to maximize patient outcomes.

The impact of the three consultation models on patient outcomes will be eval- uated several ways. First, health care use and costs (hospitalizations, physician vis- its, drug use) will be compared among the three models using KPMCP data. Patients were surveyed to obtain information on: (1) patient quality of life using the short- form 36 (SF-36)24; (2) global assessment of health-related quality of life using a vi- sual analog scaleZ; (3) patient self-reported compliance26; and (4) patient satisfaction with pharmacy and physician services. Patient compliance is also evaluated from pharmacy records of refills. Pharmacy records will be used to determine number of drugs used and duplicate therapies. The encounter form completed by the phar- macist when an intervention occurred cap- tures information on the nature of prob- lems encountered, pharmacist action taken to resolve the problem, and prescription disposition result.

An article in a future issue of Clinical Therapeutics@ will discuss the research de- sign of the study, the baseline population data, analysis plan, and study limitations.

ACKNOWLEDGMENTS

The authors acknowledge the leadership of Albert L. Carver, RPh, Director of Phar- macy Operations, KPMCP Southern Cal- ifornia, for proposing the demonstration project and the KPMCP for funding the project. Furthermore, we would like to acknowledge the leadership of Dr. Kim Seketura in the preparation of the drug grids and to all the pharmacists and man- agers at Kaiser Permanente for their input into this project and into the design of the intervention.

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K.A. JOHNSON ET AL.

Address correspondence to: Kathleen A.

Johnson, PharmD, PhD, University of Southern California, School of Pharmacy, 1985 Zonal Avenue, Los Angeles, CA

90033.

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