Anticoagulation Management Services: Entering a New Era Edith A. Nutescu, Pharm.D., FCCP Key Words: anticoagulation management services, anticoagulation clinics, thrombosis programs, systematic anticoagulation management. (Pharmacotherapy 2010;30(4):327–329)
Vitamin K antagonists such as warfarin have been the gold standard for long-term anticoagulant treatment for more than 5 decades. Due to their narrow therapeutic index and to limit untoward complications such as bleeding and thrombosis, vitamin K antagonists require careful dosage adjustments and monitoring. Consequently, maximizing the efficacy and safety of vitamin K antagonists requires a meticulous and continuous balancing act.1 To this extent, a whole industry of structured models of oral anticoagulation management, such as anticoagulation clinics, has evolved over the last 20–30 years.2 It is estimated that 3000 anticoagulation clinics are in existence in the United States, providing care to approximately 30–40% of the patients receiving oral anticoagulation therapy. 2, 3 Although a large segment of patients treated with oral anticoagulation therapy are still managed by using the usual medical care model, it is expected that emerging national regulatory and quality measures from the Joint Commission and the National Quality Forum will lead to further expansion of systematic and coordinated anticoagulation management programs.4, 5 Historically, the goal of anticoagulation clinics has been to provide organized, systematic From the Department of Pharmacy Practice and Center for Pharmacoeconomic Research, College of Pharmacy, University of Illinois at Chicago, Chicago, Illinois. The opinions expressed in this editorial are those of the author and do not necessarily represent the position of Pharmacotherapy or the American College of Clinical Pharmacy. Invited editorials are not peer reviewed. For reprints, visit http://www.atypon-link.com/PPI/loi/phco. For questions or comments, contact Edith A. Nutescu, Pharm.D., FCCP, Department of Pharmacy Practice and Center for Pharmacoeconomic Research, College of Pharmacy, University of Illinois at Chicago, 833 South Wood Street, M/C 886, Chicago, IL 60612; e-mail:
[email protected].
management of anticoagulation therapy.1, 2 Most of these clinics are affiliated with hospitals or physician group practices, and clinical services in most of the clinics are provided by pharmacists (~60% of clinics), followed by nurses and, to a much lesser extent, physician assistants. 6, 7 Although the beneficial impact and value of pharmacist-managed anticoagulation clinics have been documented in the literature, data have been lacking to directly compare outcomes in anticoagulation clinics managed by various health providers and specialties (e.g., nurses vs pharmacists). Thus, consensus on the most effective anticoagulation clinic organizational structure and staffing model is lacking. When compared with usual medical care models, patients managed in anticoagulation clinics with pharmacist providers have improved anticoagulation control and reduced bleeding and thromboembolic event rates. 8–10 In addition, pharmacist-managed anticoagulation clinics have reported cost savings of $860–4072/patient-year of therapy8, 9 when compared with usual medical care. In this issue of Pharmacotherapy, Drs. Kelly Rudd and John Dier report one of the first studies to compare clinical and health utilization outcomes in three models of anticoagulation management: usual medical care by physician providers, an anticoagulation clinic managed by nurse providers, and an anticoagulation clinic managed by pharmacist providers. 11 The pharmacist-managed anticoagulation clinic achieved superior anticoagulation control and reduced anticoagulationrelated emergency room visits and hospitalizations, resulting in a significant financial benefit. These findings are consistent with those of a recently presented study that showed similar benefits of a pharmacist-managed anticoagulation
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clinic compared with a nurse-managed service.12 Over the last 2 decades, even though pharmacists have played a significant role in developing, implementing, and providing services, as well as documenting the value of anticoagulation clinics, controversy still surrounds which structure and staffing model in these clinics is the most effective. The lack of provider recognition by Medicare Part A and Part B for pharmacists has raised challenges in financial justification of pharmacists’ time for providing clinical services in anticoagulation clinics. Due to costcontainment measures and differences in salary scales, some health systems are reevaluating the cost of their anticoagulation clinic staffing structure and transition staffing from pharmacists to alternate health care practitioners (e.g., registered nurses, licensed practical nurses). The findings of Drs. Rudd and Dier support not only improved clinical and health care utilization outcomes in anticoagulation clinics managed by pharmacists, but also confirm that improved patient care can be achieved while reducing overall health care utilization costs.11 In determining future operational structure and staffing models in anticoagulation clinics, the overall economic impact to the health care system and the potential benefit of reducing litigation costs should be considered in addition to just factoring in basic personnel costs. As warfarin has been the sole oral anticoagulant available in the United States since the 1940s, most anticoagulation clinics have focused their services on warfarin monitoring, with a much smaller number of anticoagulation clinics specializing and offering management of a wider range of antithrombotic agents.2, 6, 7, 13 Many new oral anticoagulants are now in late-phase clinical development, with some even approved in Canada and Europe, and the introduction of these agents to the United States in the near future will have a significant impact on anticoagulation clinics and on daily clinical practice.14 The oral anticoagulants that are closest to market introduction in the United States are the direct factor-Xa inhibitors rivaroxaban and apixaban, and the direct thrombin inhibitor dabigatran. These agents are expected to gain initial indications for prevention and treatment of venous thrombosis, and stroke prevention in atrial fibrillation—all indications where warfarin is now used as the sole oral anticoagulant. Compared with warfarin, these novel oral anticoagulants offer the advantages of a wider therapeutic window and a more predictable dose response, thus eliminating
the need for routine dosage adjustments and monitoring in the majority of patients.14 The introduction of these agents into clinical practice may have significant impact not only on patient care, but may also affect the dynamics of anticoagulation clinics and the health care providers covering these services. A survey of U.S.-based anticoagulation providers indicated a 55% projected drop in patient volume in anticoagulation clinics after the introduction of novel oral anticoagulants. 7 The survey also predicted a 59% decline in laboratory-related drug monitoring and management activities. Most anticoagulation providers also felt that the introduction of the new oral anticoagulants will have a moderate-tosignificant impact on the scope of their clinical activities and may jeopardize the financial viability of their service.7 Thus, the introduction of novel oral anticoagulants will present both an opportunity and a threat. The process of care and structure of anticoagulation clinics will be required to adapt to incorporate management of novel anticoagulants and to the current safety, regulatory, and reimbursement environment.2, 6, 7, 13, 15, 16 It is expected that the anticoagulation clinics of the future will be retooling and broadening the scope of their services to include management of novel antithrombotic agents. Provision of coordinated care management anticoagulation models for existing anticoagulants has been endorsed by the National Quality Forum4 in conjunction with the Agency for Healthcare Research and Quality17 as one of 30 National Safe Practices for Better Health Care. In addition, the Joint Commission has released National Patient Safety Goals5 for anticoagulation therapy encompassing several existing anticoagulants. One of the Joint Commission elements of performance outlines the expectation for every accredited health care facility to have a coordinated anticoagulation management program. 5 Thus the anticoagulation clinics of the future will take the form of multidisciplinary, comprehensive outpatient thrombosis centers and inpatient thrombosis units.13–16 These centers and units will have to assume responsibility for managing patients with a variety of thrombotic disorders and anticoagulant therapies. In addition, these centers are expected to provide a host of functions and services beyond those currently performed by anticoagulation clinics. The emergence of novel antithrombotic agents will heighten the need for thrombosis experts with the knowledge and skill for managing a whole array of agents and related clinical issues. The
ANTICOAGULATION MANAGEMENT SERVICES: A NEW ERA Nutescu functions and services that will likely be provided by future thrombosis centers and units are the following2, 6, 7, 13, 15, 16: • Formulary management, input into the formulary process, and selection of antithrombotic agents • Monitoring on institutional outcomes on safety and clinical effectiveness of antithrombotic agents • Early identification of potential risk factors for thrombotic or hemorrhagic complications • Timely, appropriate intervention to avoid or minimize complications and maximize efficacy of antithrombotic therapy • Extensive patient education regarding awareness of disease states and recognition of signs and symptoms of bleeding and thrombosis • Antithrombotic therapy adherence management • Awareness and monitoring of potential antithrombotic-related adverse effects • Monitoring of special patient populations (e.g., pregnant, pediatric, elderly, renally impaired, obese, cancer) • Reversal of overanticoagulation • Periprocedure management of antithrombotic agents • Management of transitions between various antithrombotic agents • Coordination and oversight of patient selftesting and patient self-management programs • Patient triage, first-line access to health care • Development of clinical care guidelines, policies, protocols, and clinical pathways for antithrombotic agents • Education for health care providers regarding antithrombotic therapy • Research functions to incorporate and evaluate comparative effectiveness and safety aspects of novel antithrombotic therapeutic options In summary, traditional anticoagulation monitoring services will likely be short lived. The anticoagulation clinics of the future will be the ones that will expand to multidisciplinary comprehensive thrombosis programs (both inpatient and outpatient) that will focus on management of the whole spectrum of thrombotic diseases and on coordination of various antithrombotic therapies. These are the services
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that are also expected to meet current and future safety and quality regulations and requirements. For our profession, this transition presents great opportunities, and we are more than better equipped and should be ready to be at the forefront of these changes. References 1. Garcia DA, Witt DM, Hylek E, et al. Delivery of optimized anticoagulant therapy: consensus statement from the anticoagulation forum. Ann Pharmacother 2008;42(7):979–88. 2. Nutescu EA. The future of anticoagulation clinics. J Thromb Thrombolysis 2003;16(1–2):61–3. 3. Samsa GP, Matchar DB, Goldstein LB, et al. Quality of anticoagulation management among patients with atrial fibrillation: results of a review of medical records from two communities. Arch Intern Med 2000;160:967–73. 4. The National Quality Forum. Safe practices for better healthcare: a consensus report. Available from http://www. ahrq.gov/qual/nqfpract.pdf. Accessed January 10, 2010. 5. The Joint Commission. 2010 national patient safety goals. Available from http://www.jointcommission.org/patientsafety/ nationalpatientsafetygoals/. Accessed January 10, 2010. 6. Nutescu EA, Spinler SA, Dager WE, Bussey HI. Transitioning from traditional to novel anticoagulants: the impact of oral direct thrombin inhibitors on anticoagulation management. Pharmacotherapy 2004;24(10 pt 2):199S–202. 7. Nutescu EA, Pickard SA, Blackburn JC, Wittkowsky AK, Ansell J, Schumock GT. Impact of oral direct thrombin inhibitors on anticoagulation clinics. Pharmacotherapy 2004;24(9):1204–12. 8. Wilt VM, Gums JG, Ahmed OL, Moore LM. Outcome analysis of a pharmacist-managed anticoagulation service. Pharmacotherapy 1995;15:732–79. 9. Chiquette E, Amato MG, Bussey HI. Comparison of an anticoagulation clinic and usual medical care: anticoagulation control, patient outcomes, and health care costs. Arch Intern Med 1998;158:1641–7. 10. Witt DM, Sadler MA, Shanahan RL, Mazzoli G, Tillman DJ. Effect of a centralized clinical pharmacy anticoagulation service on the outcomes of anticoagulation therapy. Chest 2005; 127(5):1515–22. 11. Rudd K, Dier J. Comparison of two different models of anticoagulation management services with usual medical care. Pharmacotherapy 2010;30(4):330–8. 12. Nutescu EA, Bautista A, Gao W, et al. Quality of oral anticoagulation management in pharmacist vs nurse managed models of care. J Thromb Haemostasis 2009; July 1:P-MO-464. 13. Nutescu EA, Bauman JL. Shifting paradigms in oral anticoagulation management. J Cardiovasc Pharmacol Ther 2004;3: 149–50. 14. Garcia D, Libby E, Crowther MA. The new oral anticoagulants. Blood 2010;115(1):15–20. 15. Marongiu F, Barcellona D. The future of anticoagulation clinics: a journey to thrombosis centers? Haematologica 2005;90(3): 298–301. 16. Spyropoulos AC, Haire W. The clinical thrombosis center and clinical thrombologist: a new U.S. health systems paradigm for the management of venous thromboembolic disease. J Thromb Thrombolysis 2003;15(3):227–32. 17. Agency for Health Care Research and Quality. 30 safe practices for better health care: fact sheet. Available from http://www.ahrq.gov/qual/30safe.htm. Accessed January 10, 2010.
