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Author: Zachary R. Noel, PharmD, BCPS

Anticoagulants account for 5-10% of all medication errors that occur within the hospital.1 The Institute for Safe Medication Practices has long recognized anticoagulants as high-risk medications that require focused attention to minimize and prevent drug errors and adverse drug events.2 With the expanding number of approved anticoagulants, as well as increasing complexity of dosing for a growing number of indications, safe and effective anticoagulation practices within heath care organizations requires a system-based, structured management system to oversee and advance safe anticoagulation practices.1

One way to operationalize this is through the development of an anticoagulation stewardship program (ASP) (also referred to in the literature as hemostatic and antithrombotic stewardship or antithrombotic stewardship). Analogous to an antimicrobial stewardship program, ASPs involve a multidisciplinary approach to overseeing anticoagulant usage, including the implementation of policies and procedures to ensure safe medication practices, controlling drug and laboratory costs associated with anticoagulants, and education of both medical providers and patients. This blog will review the role of the pharmacist as part of ASPs as well as supporting literature.

What is an anticoagulation stewardship program and what is the role of the pharmacist?
Anticoagulation stewardship programs are a system-based team integrated into the healthcare organization and focused on ensuring safe and effective anticoagulation practices.1,3 ASPs use evidence-based standards of practice to synchronize processes, policies, and procedures and ensure provider education and competency as it pertains to anticoagulation. Although this structured approach is relatively new, and few health-systems have formally introduced it, as the complexity of anticoagulation grows, the role and demand for formal stewardship programs is ever-increasing.

Anticoagulation stewardship programs ideally involve a multidisciplinary team comprised of at least pharmacists and physicians. In many instances these programs are led by pharmacists.3,4 Some institutions have hired pharmacists to occupy these positions full-time, whereas others include other patient care activities in addition to their stewardship role. Physician collaborators are typically hematologists or cardiologists. Pharmacists are responsible for independently performing many of the functions outlined in Table 1. Some services, such as responding to inpatient consults, require physician collaborators to evaluate the patient in conjunction with the pharmacist.

What functions do anticoagulation stewardship programs perform?
Although the overarching role of ASPs are similar across health-systems, the exact functions vary considerably. The two main functions of ASPs are to surveil safe and effective anticoagulant use while reducing drug and laboratory costs associated with anticoagulants. Some institutions offer clinical consult services as well, including rounding on patients admitted to the hospital, leaving recommendations for anticoagulation management, and educating providers and patients (Table 1).

Table 1 – Functions of an Anticoagulation Stewardship Program

Cost Savings Initiatives

Oversight of thrombolytic agents (i.e., alteplase), factor products and reversal agents (i.e., recombinant factor VII, prothrombin complex concentrate, and idarucizumab), and, in some instances, blood products

Oversight of direct thrombin inhibitor usage, including heparin-induced thrombocytopenia laboratory diagnostics

Oversight of thrombophilia laboratory orders (e.g., Factor V Leiden, antiphospholipid syndrome)

Drug Safety Initiatives

Protocol development/synchronization and procedure review

Perioperative anticoagulation management

Oversight and monitoring of direct oral anticoagulant (DOAC) usage

Oversight of heparin utilization

Therapeutic drug monitoring of warfarin and enoxaparin

Therapeutic drug monitoring of direct thrombin inhibitors

Management of anticoagulation in high-risk patients (e.g., mechanical circulatory support devices)

Clinical Services Provided

Inpatient consult service for high-risk patients or challenging anticoagulation cases

Inpatient rounding

Patient education

Provider education

Therapeutic drug monitoring

Outpatient anticoagulation clinic

Transitions of care management (e.g., counseling, assessment of prior authorizations)

Documentation of recommendations in the electronic health record

 

What does the literature say about anticoagulation stewardship programs?
Unlike antimicrobial stewardship, there is relatively little peer-reviewed literature on ASPs. The earliest publications involving formal ASPs date back to 1999 and were limited to cost-effectiveness of pharmacist-led heparin and warfarin monitoring.6-7 As anticoagulation has evolved and become increasingly complex, recent publications have focused on a multidisciplinary approach to stewardship.

A 2015 publication highlighted the role of a multidisciplinary ASP involving post-graduate year 1 residents. Residents were involved with medication surveillance, including formal recommendations in conjunction with physician consultation. Oversight of direct thrombin inhibitors was a key service provided, and through the ASP the length of stay for patients being discharged on an anticoagulant was reduced from 7 to 5.6 days, resulting in a cost-savings of over $150,000 during the study period.

A 2016 publication by Dreijer, et al. describes the implementation of a multidisciplinary stewardship program involving a pharmacist, hematologist, pediatric hematologist, surgeon, cardiologist, pulmonologist, neurologist, case manager, outpatient anticoagulation manger, and quality assurance officer.3 Services included medication surveillance, patient counseling, medication reconciliation at discharge, and formal consultation for professional services when warranted. Data on cost-effectiveness and other outcomes are expected in 2018.

Another publication by Reardon, et al. describes the implementation of a multidisciplinary approach involving pharmacist oversight with an attending physician who serves as resource, reviews guidelines, and helps to resolve concerns or disparities in anticoagulation management on covering services.5 A medical director was also created to help guide long-term goals and initiatives of the stewardship program. The target areas identified were management of heparin-induced thrombocytopenia, management of factor products for hemophilia, and oversight and dosing of anticoagulation for extracorporeal membrane oxygenation and mechanical circulatory support. The authors report a savings of over $225,000 in one fiscal year alone, an outcome attributed primarily to the appropriate use of direct thrombin inhibitors.9

Conclusion
Anticoagulation stewardship programs are a multidisciplinary team-based approach to improving anticoagulation drug utilization habits, safety, and cost-effectiveness. Pharmacists play a vital role in leading and operationalizing stewardship programs. Formal ASPs are likely underutilized and, as anticoagulation grows in complexity, the role of the ASPs will likely expand.

 

 
Zachary R. Noel, PharmD, BCPS

Dr. Noel is an assistant professor in the Department of Pharmacy Practice and Science at the University of Maryland School of Pharmacy, and practices as a clinical pharmacy specialist in cardiology at the University of Maryland Medical Center in Baltimore, MD. Follow him on Twitter @ZacNoelCardsRx

References:

  1. Nutescu EA, et al. Delivery of Optimized Inpatient Anticoagulation Therapy: Consensus Statement from the Anticoagulation Forum. Ann Pharmacother. 2013;47:714-24.
  2. Institute for Safe Medication Practices. ismp.org. Accessed September 16, 2017.
  3. Dreijer AR, et al. Antithrombotic stewardship: a multidisciplinary team approach towards improving antithrombotic therapy outcomes during and after hospitalisation: a study protocol. BMJ Open. 2016;6: e011537.
  4. Phillips KW, Wittkowsky AK. Survey of pharmacist-managed inpatient anticoagulation services. Am J Health Syst Pharm. 2007;64(21):2275-2278
  5. Reardon DP, et al. Implementation of a Hemostatic and Antithrombotic Stewardship program. J Thromb Thrombolysis. (2015) 40:379–38.
  6. Mamdani MM, Racine E, McCreadie SM, et al. Clinical and economic effectiveness of an inpatient anticoagulation service. Pharmacotherapy. 1999;19(9):1064-1074.
  7. Dager WE, et al.Optimizationofinpatientwarfarin therapy:impactof daily consultation by a pharmacist-managed anticoagulation service. Ann Pharmacother. 2000;34(5):567-572.
  8. Padron M, et al. Development of an Anticoagulation Stewardship Program at a Large Tertiary Care Academic Institution. Journal of Pharmacy Practice. 2015, Vol 28(1) 93-98.
  9. Ritchie BM, et al. Treatment of Heparin-Induced Thrombocytopenia Before and After the Implementation of a Hemostatic and Antithrombotic Stewardship Program. J Thromb Thrombolysis. 42 (4), 616-622. 11 2016.
Anticoagulation Safety (Part 2 of 2): The Role of an Anticoagulation Stewardship Pharmacist

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