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Canadian Pharmacists Journal / Revue des Pharmaciens du Canada http://cph.sagepub.com/

Bringing the Benefits of Anticoagulation Management Services to the Community: Alberta Program May Serve as a Model of Care Tammy J. Bungard, Stephen L. Archer, Peter Hamilton, Bruce Ritchie, Wayne Tymchak and Ross T. Tsuyuki Canadian Pharmacists Journal / Revue des Pharmaciens du Canada 2006 139: 58 DOI: 10.1177/171516350613900207 The online version of this article can be found at: http://cph.sagepub.com/content/139/2/58

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CLINICAL REVIEW PEER-REVIEWED

T. Bungard

This initiative was created through the combination of my direct experiences of pharmacy practice in the United States, my realization that anticoagulant therapy could most optimally be performed by pharmacists and serve as a template to cross other disease states, and the visionary mentorship provided by Drs. Tsuyuki and Archer. La mise en œuvre de ce programme résulte à la fois de mon expérience directe de la pratique pharmaceutique aux États-Unis, d’une prise de conscience m’ayant révélé que les anticoagulants produiraient des effets optimaux, s’ils étaient administrés par les pharmaciens, et qu’ils serviraient de modèles comme traitement d’autres états pathologiques, ainsi que du mentorat visionnaire des docteurs Tsuyuki et Archer.

Bringing the benefits of anticoagulation management services to the community Alberta program may serve as a model of care Tammy J. Bungard, BSP, PharmD; Stephen L. Archer, MD, FRCP(C); Peter Hamilton, MBBCh, FRCP(C); Bruce Ritchie MD, FRCP(C); Wayne Tymchak, MD, FRCP(C); Ross T. Tsuyuki, BSc(Pharm), PharmD, MSc, FCSHP

Abstract Background: While warfarin is efficacious for the prevention of thromboembolic disorders, many patients are undertreated. To optimize therapy, anticoagulation management services (AMSs) deliver a coordinated, focused approach to this care; however, AMSs are limited in their ability to impact patients outside of tertiary care settings. Objective: To describe the methods used to develop community-based AMSs across Alberta. Methods: Through a three-staged approach, this project created community-based, pharmacistmanaged AMSs for patients requiring warfarin therapy. Stage I was the initiation of a central or “core” AMS, located at a quaternary referral centre. Starting with the core enabled us to develop and test the program and create an environment to serve as a training and support centre for future aspects of the program. Next, an

nticoagulant therapy with warfarin is important in the treatment and prevention of thromboembolic disorders.1 The degree of anticoagulation with warfarin must be maintained within

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educational program was developed and implemented (Stage II) for a diverse group of pharmacists to establish and manage a communitybased or “satellite” AMS (Stage III) at their practice site. All three stages are undergoing detailed evaluation, capturing project-specific (patient outcome) data as well as system-level (integration within the health care infrastructure) data. Conclusion: By offering a focused, coordinated, and consistent approach to warfarin management, with ongoing collaboration with other providers, the ultimate goal of this program is to optimize patient outcomes. Utilizing pharmacists as central players within a collaborative setting will enhance the use of our current infrastructure. This program may serve as a model for other health regions and other chronic diseases.

a very narrow therapeutic range.2-5 Failure to adequately anticoagulate patients consistently predicts thromboembolic events (stroke or pulmonary embolism), while excessive anticoagulation places

C P J / R P C • M A RC H / A P R I L 2 0 0 6 • VO L 1 3 9 , N O 2

patients at risk of bleeding. Warfarin management is complicated by numerous factors, including drug interactions, acute and chronic diseases, diet, and interindividual variability in responding to warfarin. As such, the prescription of warfarin initiates a time-intensive relationship with the patient that requires longitudinal follow-up and laboratory testing. Despite the publication of numerous robust randomized clinical trials, practice guidelines, and consensus statements,2,6-10 the use of warfarin for the prevention of thromboembolic disease remains suboptimal. Internationally, only 15% to 44% of patients with atrial fibrillation (AF) without contraindications to warfarin are prescribed it.11 Similarly, in Canada, a review of 3575 patients managed at 12 hospitals and admitted for AF revealed that only 24% of eligible patients received warfarin during their hospital stay or upon discharge.12 An analysis comparing the temporal trends (from 1993/94 to 1995/96) at the University of Alberta Hospital (UAH) showed little improvement in warfarin utilization.13 Further, as recently as 1998/99, a study of 1240 consecutive patients admitted to the same quaternary care centre found that only 32% of eligible AF patients were receiving warfarin prior to admission.14 Of those prescribed warfarin, only one-third were within their desired therapeutic range. In a recently published retrospective medical record review, warfarin use was significantly greater among a group of AF patients having access to an anticoagulation management service (AMS).15 This highlights the need for alternate strategies to improve the use and management of anticoagulant therapy. Specialized AMSs have been successful in optimizing anticoagulation therapy by systematically evaluating and monitoring patients, providing ongoing patient education, and serving as a resource for patients and physicians.16-37 Through the implementation of this focused, coordinated, and consistent approach, pharmacist-managed AMSs in the United States (US) have consistently demonstrated superior control of warfarin therapy, which has translated into superior patient outcomes and cost savings to health care systems.16-37 The majority of AMS evaluations have been retrospective and have shown that therapeutic anticoagulation is achieved 60% to 90% of the time.23,25,27,34,35 Only two randomized controlled trials of anticoagulant management have been published. Wilson et al.38 showed that AMSs achieve superior anticoagulation compared with usual care, while Matchar and colleagues39 found control was similar to that achieved by usual care. The latter trial demon-

strated disappointing anticoagulation adequacy, with patients in the AMS group being within the therapeutic • While warfarin therapy has been shown range only 52% of the time. to prevent thromboembolic disorders, This may, in part, be due to many patients remain undertreated. the design of the study • The paper describes methods used in (cohort) and the training an anticoagulation service in Alberta, offered to those operating the Canada. AMS — they received only a • The project’s goal is to implement “three-day intense course” in community-based, pharmacist-run anticoagulation management. anticoagulation services that are widely While AMSs are very accessible and integrated into an existing common in the US (with well infrastructure. over 1000 currently in existence), many are limited in scope by either offering the service to only a few referring physicians or to a limited spectrum of patients. Moreover, these services are usually only offered through tertiary care medical facilities — their impact at a community level is unknown. Given the many potential benefits of AMS care, we sought to improve its effectiveness through the development of community-based AMSs. In this paper we describe the methods used to develop community-based anticoagulation management services in Alberta, Canada.

Key points

Methods The goal of our AMS program is to implement a network of AMSs across the province of Alberta, with the aim of optimizing anticoagulation management while efficiently using health care resources. It was our intent to use a multidisciplinary team, led by a doctoral-trained pharmacist (PharmD), to manage anticoagulation therapy in accordance with the general policies and procedures adopted by the Division of Cardiology at the UAH and accepted by local medical experts. With funding from Alberta Health and Wellness through the Health Innovation Fund, we designed a unique three-staged program to bring the benefits of AMSs to the community. Applicable ethics approval was obtained, and at the point of the initial visit, consent is sought from each patient to participate in our research program. Our program began with the initiation of a core AMS within the UAH (Stage I), progressed to the training of selected pharmacists (Stage II), and continues with the implementation of community (satellite) AMSs (Stage III). All stages include a comprehensive evaluation conducted by a third party, assessing both program-specific and system-level parameters. The three overlapping stages of the program are described below.


This is the abridged version of this article. The full version is available at: www.pharmacists.ca/ content/hcp/resource_ centre/cpj/cpj_mar_ apr06.cfm

Funded by: Alberta Health and Wellness, Health Innovation Fund (#272) 59

Stage I: Implementation of a core AMS Purpose: To establish a core AMS at the UAH in order to deliver care and to develop and test the program, as well as to serve as a training and support centre for subse• Bien que la recherche ait révélé que la quent phases of the program. warfarine prévient les accidents thromboOverview of the core clinic: emboliques, de nombreux patients ne Our AMS program began reçoivent que des traitements insuffisants. with the implementation of a • L’article décrit les méthodes appliquées core service within a quaterdans un service d’anticoagulation de nary care facility in order to l’Alberta. establish a benchmark for this • L’objectif du projet consiste à établir non-physician-managed servdes services communautaires d’anticoaguice. The program was devellation dirigés par des pharmaciens, qui se oped in close collaboration caractériseraient par leur grande accessibiwith a panel of medical lité et s’intégreraient à une infrastructure experts from several disciexistante. plines (internal medicine, cardiology, hematology, and medical administration). The core clinic developed policies and procedures and established a training base for future AMS pharmacists. Care was taken to ensure that these policies and procedures met local as well as national standards and to engage the physicians in the implementation to enhance rapport and ensure referrals. Operating the core at the UAH for one year allowed for refinement of procedures in order to foster efficient clinic function and establish a solid, diverse patient base. Administrative approval: Initiating a new program intended to be managed by non-physician practitioners required extensive consultation with key stakeholders. The Division of Cardiology was the starting point, followed by consultation with the Regional Health Authority (Capital Health), Regional Pharmacy Services, Regional Laboratory Services, the Medical Officer of Health, and the Patient Care Director for Ambulatory Clinics within Cardiology. Consultation with these individuals provided the necessary approvals and partnerships. Further, strong support was expressed by specialist physicians (cardiologists, internists, hematologists, neurologists, and emergency medicine physicians), both those practising at the UAH and their colleagues at other sites within the region. Consultations and strong letters of support were also obtained from the Faculty of Pharmacy and Pharmaceutical Sciences, the two pharmacy organizations within the province (one regulatory and one advocacy body), and the National Association of Pharmacy Regulatory Authorities. Clinic structure: This program was designed to be a voluntary referral-based service open to all physicians within the Capital Health Region. By signing

Points clés

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our referral form, the physician transfers the anticoagulation management to the AMS in accordance with our policies and procedures (Table 1). Patients with an accepted indication for therapy who are willing to provide informed consent and agree to participate in their own anticoagulation care are enrolled in our program. We intentionally placed few restrictions on referrals, as our goal was to provide a broad-based service for patients requiring warfarin and to establish a diverse patient mix. The core clinic appointed three medical directors, with representation across the key specialties of cardiology (WJT), general internal medicine (PH), and hematology (BR). The role of the medical directors is to approve clinic standard operating procedures and to serve as a resource for the pharmacists. Scope of practice for pharmacists: The program was designed to maximize the pharmacist’s ability to proactively and independently manage anticoagulant therapy. Pharmacists order and interpret laboratory testing applicable to anticoagulation management, perform all warfarin dosing adjustments, implement vitamin K for reversal of anticoagulant therapy (either for critical international normalized ratio [INR] management or preproceTABLE 1

Policies and procedures

Form 1: New patient referral form Appendices 1. Scope of practice for clinical pharmacists 2. Guidelines for the use of warfarin 3. Acceptance of referral letter 4. Anticoagulation management service introductory package 5. Hemorrhagic risk assessment 6. Patient responsibilities and adherence agreement 7. Patient assessment nomogram 8. Patient assessment guide 9. Warfarin maintenance dosing adjustment guide 10. Frequency of assessment guide 11. Physician information sheet on patient’s anticoagulant therapy 12. Ambulatory initiation of warfarin therapy 13. Guidelines for correction of overanticoagulation 14. Suggestions for anticoagulation management before and after dental procedures 15. Suggestions for anticoagulation management before and after invasive procedures 16. Tranexamic nasal gel for nosebleeds 17. Management of SQ low molecular weight heparin 18. Missed appointment slip 19. Anticoagulation management service termination letter


dural management), and initiate bridging therapy with low molecular weight heparin as deemed clinically appropriate. All laboratory results are available to the pharmacists through our regional laboratory database. Clinic operations: Virtually all the day-to-day operations of the program are performed by the pharmacists with the assistance of a secretary. Once a referral is received, the clinical pharmacists evaluate the indication for warfarin, the intensity of anticoagulation, and the completeness of information. The program has adopted the American College of Chest Physicians’ guidelines for anticoagulation management.1 Once the referral is accepted, the secretary contacts the patient and arranges an initial visit. If the AMS is unable to see the patient within a reasonable time interval, the referring physician is notified, as care is not transferred until the patient is seen. All patients are required to attend an initial visit during which a detailed history is taken, they receive extensive education, and the role of the AMS is clearly explained. We communicate the anticoagulation status of the patient to the referring physician every three months. The program has an on-call pharmacist to manage patients requiring weekend follow-up and to respond to critical INRs reported after hours. Current status: The core AMS has been operating for almost five years, since April 2001. The growth of this clinic has been limited only by staffing. The majority of referrals are from specialists. In general, patients referred to the core clinic have either been identified by the specialists as being poorly controlled (multiple subtherapeutic or “critical” INRs) or having suffered a thromboembolic/hemorrhagic event. In the second year of operation, the program was approached by the cardiac surgeons, and now all patients receiving mechanical valve implants at the UAH are automatically referred.

Stage II: Development of a training program Purpose: To develop an educational program to train pharmacists to establish and manage patients within a community-based satellite AMS. Application process: A call for applications to this program was sent to pharmacists through the provincial pharmacy regulatory body. Criteria for acceptance of sites included: 1. A collaborative environment, with practitioners being amenable to having standard operating procedures in place to provide a framework for clinical roles and decisions 2. Appropriate clinical coverage (two or more pharmacists per site)

3. Strong management support 4. The necessary infrastructure to operate the program (e.g., private counselling area, computer system) The application procedure required a general description of the pharmacists’ practice and the identification of a physician to fulfill the role of medical director for each satellite clinic. This individual was supportive of the scope of practice of the pharmacists within the program and served as a clinical resource (similar to the core AMS medical director model). Pharmacists were required to have a commitment from their employer for protected time to complete the AMS training program and to hold anticoagulation clinics three days per week. Pharmacists had to agree to manage patients for at least one year and to participate in the formal program evaluation. Once these commitments were satisfied, candidates were interviewed and successful applicants were invited to participate in the training program. Training program: The educational program (see box) was developed to provide a high level of clinical expertise in all aspects of anticoagulation management and to ensure the successful implementation and management of satellite AMSs. Throughout the four weeks spent at the core AMS,

Components of the training program 1. Web-based educational module (PHARMALearn.com —anticoagulation) This state-of-the-art, web-based, interactive educational program was developed in conjunction with the Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta. The intent with this module was to provide the learner with the foundation for anticoagulation management, upon which future training would build. 2. Experiential component A four-week “hands-on” practicum was provided at the core AMS. 3. Self-directed component Integrated into the practicum were several key therapeutic discussions. For each module, the learner was provided with objectives and required reading materials. The modules included an antithrombotic overview, venous thromboembolism, hypercoagulable states, atrial fibrillation, cerebrovascular accident, and valvular heart disease and replacement. The purpose of these discussions was to ensure the didactic knowledge attained by the learner was directly applicable to patients being managed.

the trainees were encouraged to reflect upon their own practice site and to modify policies and procedures, where appropriate, to suit their own practice setting. Current status: A total of 14 pharmacists have completed the training program. These pharmacists have diverse backgrounds and experience (ranging from new graduates to those having more


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than 20 years of experience) and work in diverse practice settings.

Stage III: Implementation and evaluation of satellite AMSs Purpose: To have pharmacists initiate and operate a satellite AMS at their practice site. Administrative approval: Administrative approval varied depending upon the location of the satellite AMS (e.g., regional health authorities for hospitalbased clinics). As with the core AMS, all satellite programs had collaborative support from physicians, and at least one physician agreed to fulfill the role of medical director. Clinic structure: The satellite clinic structure paralleled the core AMS in nearly all aspects. One urban community pharmacy is slightly different in that referrals are only taken from a medical clinic in close proximity to the pharmacy. This site does not have a single medical director but rather has the entire physician pool fulfill this role, relying on the on-call physician for after-hours queries. TABLE 2

Clinic operations: Each satellite clinic adapted the core’s policies and procedures to its own clinic operations. For example, community pharmacy programs are only able to conduct initial visits during times of double coverage with pharmacists. Rural sites typically only have one laboratory; therefore, reporting of test results occurs on designated days, which dictates most of the follow-up visits. Furthermore, each satellite was encouraged to determine, in collaboration with the physicians, the preferred reporting structure for laboratory results. The core AMS served as a resource to all satellite AMSs to address any operational or clinical queries. All AMSs within this program are using the same patient management software program, facilitating the ability to conduct program evaluation. Status: A total of 14 pharmacists have established seven satellite AMSs. An interesting cross-section of pharmacies will be assessed, including rural and urban community pharmacies, rural hospital pharmacies, and a continuing care facility located in an urban setting.

Program-specific evaluation

Program evaluation

Parameter

Data used in evaluation

Outcome

Adequacy of anticoagulation

INR documented in chart or obtained from lab

• Proportion of time spent within desired therapeutic INR range • Rate of critical INRs

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Rates of thrombosis & hemorrhage

Tracking of all emergency room visits and hospitalizations, discharge diagnoses, and applicable laboratory parameters

• Rate of major bleeding (defined as either hospitalization or emergency room visit, blood loss >2 g/L, or transfusion of ⱖ 2 units blood) • Rate of thromboembolism (defined as hospitalization or emergency room visit, clinical diagnosis given)

Cost-benefit analysis

Use of health care resources, survey of patients, cost of operating the AMS

The operating cost of the program on a per patient basis

Satisfaction

Postal survey of patients and survey of health care providers

Assessment of the expectations of an AMS and the opinions of the AMS (using a Likert scale ranging from “strongly agree” to “strongly disagree”)

Knowledge

Postal survey of patients

Answers to multiple choice questions grouped into four domains: general warfarin information, laboratory testing, warfarin safety, and factors affecting warfarin

Bleed risk

Patient-specific data upon referral and tracking of major bleeds

Evaluation of characteristics of patients having major bleeds relative to those not having major bleeds

The funding of the AMS program by Alberta Health and Wellness required evaluation by a third party. We have worked closely with the independent evaluators to ensure a comprehensive evaluation of the program. This evaluation consists of both project-specific parameters (patient outcomes) and system-level indicators (integration within the current health care infrastructure). Table 2 details several of the project-specific indicators that were identified. A more in-depth discussion of the project-specific and system-level evaluation is available in the online version of this article.

Discussion The proper usage and monitoring of anticoagulants is one of the largest known “care gaps” — a gap between what is known to be beneficial from clinical trials and real-world practice implementation. While AMSs have demonstrated efficacy in improving anticoagulant usage and monitoring, they have poor effectiveness because they are generally only provided to a small proportion of the population that could benefit from them.


Our goal was to create and evaluate a provincewide anticoagulation service that is widely accessible, of high quality, and integrated into an existing infrastructure. Our hypothesis was that the use of pharmacists practising in hospital and community settings, using a programmatic approach to implement anticoagulation services, would optimize patient outcomes while efficiently utilizing health care resources. Other unique features of the Alberta AMS program include a multidisciplinary administrative structure that includes a general internist, cardiologist, and hematologist in an arm’s length supervisory capacity; a scope of practice for the pharmacists that allows independent decisions regarding warfarin dosage changes and laboratory monitoring; a comprehensive training program for pharmacists; and a comprehensive evaluation strategy by an independent third party. This program may serve as a model of care for chronic disease management and continuing professional development. It allows for the tertiary care institution to act in partnership with outlying regions and the community, providing a training and support role. In the case of our program, it also bridges across five regional health authorities. Sustainability is always relevant to the discussion of any new program. In the case of the Alberta AMS program, one of the criteria for funding through the Health Innovation Fund was sustainability. In our case, the sustainability of the program will hinge upon the report of the third-party evaluation team. We are encouraged, as discussions

Pertinence quant à la pratique Pourquoi menons-nous cette étude ? • Pour démontrer hors de tout doute que les services communautaires d’anticoagulation fournis par le pharmacien renforcent la maîtrise de l’anticoagulation et améliorent l’évolution de l’état de santé des patients. • Pour concevoir un programme complet de formation sur la gestion de l’anticoagulation à l’intention des pharmaciens. Quelles sont les implications de cette étude quant à la pratique pharmaceutique ? • Cette étude à grande échelle devrait démontrer hors de tout doute que la prestation de services d’anticoagulation par les pharmaciens communautaires accroît la maîtrise de l’anticoagulation, constitue la préférence des patients et améliore l’évolution de leur état de santé.

for continuing the program into 2006 are ongoing within the respective regional health authorities. ■ Tammy J. Bungard, Stephen L. Archer, Wayne Tymchak, and Ross T. Tsuyuki are with the Division of Cardiology; Peter Hamilton is with the Division of General Internal Medicine; and Bruce Ritchie is with the Division of Hematology, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta. Contact: [email protected].

Relevance to practice Why are we doing this study? • To conclusively demonstrate that communitybased anticoagulation services provided by a pharmacist improve anticoagulation control and patient outcomes • To develop a comprehensive training program for pharmacists in anticoagulation management What does this mean for pharmacy practice? • It is anticipated that this large-scale study will conclusively demonstrate that provision of anticoagulation care by community-based pharmacists improves anticoagulation control, is preferred by patients, and improves outcomes.

Acknowledgements: The authors would like to acknowledge the support of Alberta Health and Wellness, the Capital Health Region, Dr. Leslie Gardner (independent evaluator), EPICORE Centre/Centre for Community Pharmacy Research and Interdisciplinary Strategies (COMPRIS) (for project management and data coordination), the Alberta College of Pharmacists, the Faculties of Medicine, Dentistry, and Pharmacy and Pharmaceutical Sciences, the AMS staff (Kirsten George-Phillips, Rene Breault, Amy Machnik), and the satellite clinic pharmacists (Cindy Jones, Guy Lacombe, Fern McNaughton, Tamara Bresee, Gladys Whyte, Sandra Leung, Tara Chmilar, Laurie Modien, Karen Schultz, Sylvie Druteika, John McVey, Blaine Colton).

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