Standardizing periprocedural anticoagulation management: a stewardship initiative.

BACKGROUND: Study data indicates anticoagulant interruption peri-procedurally can increase the risk of anticoagulation-related bleeding and thrombosis. Management of anticoagulated patients during the peri-procedural period poses clinical challenges given the potential for thrombosis and bleeding in this complex, high risk population. As such, there is a need for enhanced emphasis on anticoagulated patient care throughout the peri-procedural period with the goal of optimizing patient safety and efficacy. PURPOSE: To operationalize an effective, efficient, comprehensive, and standardized anticoagulation management peri-procedural process housed within the electronic health record (EHR). DESIGN: The IPRO-MAPPP clinical decision support logic was adapted into a nurse-managed protocol to guide anticoagulation therapy use during the elective peri-procedural period at Bassett Medical Center, an Anticoagulation Forum Center of Excellence. A second phase of this initiative endorsed peri-procedural warfarin and bridging management by the Anticoagulation Management Service. RESULTS: Outcomes revealed 30-day hospital or emergency department admissions remained at or below 1% of the surgical patient population, and below the published national standards for both phases of implementation. Further, no emergent anticoagulation reversal agent use was attributed to peri-procedural care during the assessment period. CONCLUSIONS: The phased implementation of this Anticoagulation Stewardship initiative in elective peri-procedural anticoagulation management successfully describes the operationalization and demonstration of high-quality care and low provider practice variation from policy. The integration of clinical decision support systems, in consort with effective communication, via the EHR, provides stability, sustainability, and drives high quality care to optimize patient outcomes.

Barriers and motivators to national board certification as a certified anticoagulation care provider.

Professionals voice confusion between the distinctions of board certification and educational certificate courses, and note barriers and motivators in obtaining national anticoagulation board certification. To identify barriers vs. motivators in obtaining board certification and detail the differences in board certification and educational certificate courses, an IRB-approved electronic survey was sent to professionals completing the University of Southern Indiana (USI) Anticoagulation Therapy educational certificate course (n = 491) and existing Certified Anticoagulation Care Providers (CACP, n = 622). A total of 1049 surveys were delivered successfully, with a 26% response rate (USI = 62, CACP = 211.) Respondents identified as a nurse (n = 52, 19%), advanced practice nurse (n = 14, 5.1%), pharmacist (n = 206, 75.5%) or physician (n = 5, 1.8%). Overall, respondents indicated board certification via CACP has significant impact on patient/organizational outcomes (n = 118, 43.2%). Top motivators for board certification include personal accomplishment (n = 147, 53%) and professional growth (n = 139, 50.9%). Top barriers include lack of time to prepare (n = 102, 37.3%,) board certification exam cost (n = 95, 34.8%), and for CACP recertification, and requirement to recertify by examination (n = 74, 35.1%). Of board-certified respondents, 45.4% indicated they were not employed at an Anticoagulation Center of Excellence (ACE), 34.8% employed at an ACE and 16.8% were unsure of ACE status. Narrative comments were obtained and evaluated. Significant personal and professional barriers exist in completing, and subsequently maintaining, board certification in anticoagulation. This offers great insight for NCBAP to invoke changes to support clinicians and healthcare organizations in seeking and maintaining CACP credentialing, a component of ACE attainment.

Defining Minimum Necessary Anticoagulation-Related Communication at Discharge: Consensus of the Care Transitions Task Force of the New York State Anticoagulation Coalition.

BACKGROUND: Anticoagulated patients are particularly vulnerable to ADEs when they experience changes in medical acuity, pharmacotherapy, or care setting, and resources guiding care transitions are lacking. The New York State Anticoagulation Coalition convened a task force to develop a consensus list of requisite data elements (RDEs) that should accompany all anticoagulated patients undergoing care transitions. METHODS: A multidisciplinary panel of 15 anticoagulation experts voluntarily completed an iterative Delphi process. Resources were disseminated and deliberated via remote technology, with consensus achieved via blinded electronic polling. RESULTS: The panel reached consensus on a list of 15 RDEs for anticoagulation communication at discharge (the ACDC List). Consensus was rapidly achieved by the full panel on 13 elements, while 3 (2 of which were combined into 1 element) required multiple iterations and achieved consensus with votes from 8 available panelists. The elements encompassed a range of factors, including drug use and indications, previous exposure and duration of therapy, recent drug exposure and laboratory results and expectations for subsequent administration, therapy goals, patient education and comprehension, and expectations for clinical management. Twelve of the elements are applicable to any anticoagulant, and 3 are specific to warfarin. CONCLUSION: The ACDC List identifies specific pieces of clinical information that a panel of anticoagulant experts agree should be communicated to downstream providers for all anticoagulated patients undergoing care transitions. Additional study is needed to objectively evaluate the ability of existing care systems to communicate the elements and to assess possible relationships between communication of the elements and clinical outcomes.

Features of electronic health records necessary for the delivery of optimized anticoagulant therapy: consensus of the EHR Task Force of the New York State Anticoagulation Coalition.

BACKGROUND: Oral anticoagulants are prescribed to millions of Americans, and consequently are among the medications most likely to contribute to emergency department visits and hospitalizations. Although guidelines and consensus statements promote systematic approaches to therapy, anticoagulation (AC) management is often suboptimal. Electronic health records (EHRs) have the potential to improve safety and quality but have not yet incorporated specialized features necessary to optimize therapy. OBJECTIVE: To generate a comprehensive, consensus-based list of EHR features clinically necessary to deliver optimized AC management, provide a "language bridge" to accelerate incorporation of features into EHR systems, and suggest mechanisms for the objective evaluation of available EHRs. METHODS: A multidisciplinary panel of AC specialists utilized the framework of a previously published consensus statement to map outpatient AC management and developed a comprehensive array of sequential computer logic steps using a restricted language scheme. Logic steps were then translated into narrative descriptions of potential EHR features, which were refined through multiple group evaluations. A finalized list of proposed features was ranked according to perceived clinical necessity by physician, pharmacist, and nurse panelists in a blinded manner using a 5-point Likert scale. Features receiving no more than 1 dissenting opinion were included in a finalized list of clinically necessary features. RESULTS: The task force generated 78 recommended EHR features across 20 key discrete areas and 425 individual logic steps. All recommended features received Strongly Agree or Agree rankings regarding their perceived clinical necessity, and no feature received more than a single Disagree response. CONCLUSION: The incorporation of key AC-related features into existing EHRs or specialized AC management systems has the potential to systematize the delivery of optimal AC care by health care professionals at the point of care. Optimized AC management has the potential to reduce adverse drug events associated with anticoagulant therapy in the outpatient setting.

Increasing Hospital Pharmacist Clinical Competence in Intensive Pharmacotherapeutics Using a Novel Pharmacist Clinical Educational Program.

BACKGROUND: Intensive pharmacotherapeutics (IP) is the application of multiple evidence-based practices applied at a patient-specific level, creating the overall best treatment plan in medically complex patients. To practice at this level, a high level of clinical knowledge and competency is paramount. OBJECTIVE: The goal of the pharmacist clinical educational program was to develop an engaging, challenging, and interactive program, which was concise but intense, to improve pharmacists' clinical knowledge and critical thinking skills. METHODS: A 12-week educational series was developed and successfully implemented. The primary outcome was a comparison of the proportion of accepted clinical interventions per total number of medication orders reviewed by hospital pharmacists during and after the pharmacist clinical educational program to a 3-month baseline. The secondary outcome was to anonymously gauge participant satisfaction with the program. RESULTS: The proportion of accepted clinical interventions increased from 6.4% (at baseline) to 9.1% and 8.7% in the 3 months during and 3 months immediately after the educational program, respectively (P < .01). The overall acceptance rate for clinical interventions remained >90% for all periods. Approximately 94% of respondents (n = 16) indicated that the program met their educational needs. CONCLUSIONS: The development of a clinical educational program to engage, challenge, and incentivize pharmacists is an essential tool to elevate the practice of IP. By maximizing existing resources, programming can be provided in an efficient and cost-effective manner. As health systems continue to merge on a national level, the methods described here demonstrate a means to provide critical education for both clinical and organizational competency.

Assessing anticoagulation knowledge in patients new to warfarin therapy.

BACKGROUND: Warfarin is highly efficacious for the treatment and prevention of thromboembolic disorders. However, anticoagulation control has been a long-standing challenge, as patients' lack of knowledge of warfarin therapy is a predictor of nonadherence and compromised patient safety. OBJECTIVE: To ascertain whether hospitalized patients newly initiated on warfarin are provided adequate anticoagulation education during hospitalization, as measured at discharge, as well as determine whether there is a difference in the knowledge obtained by patients educated via a structured program versus those counseled by "usual care." METHODS: A prospective evaluation of warfarin education of inpatients new to warfarin therapy was performed at Bassett Medical Center, Cooperstown, NY. Patients who were admitted to the hospital and receiving warfarin for any given diagnosis, were >18 years of age and able to give informed consent, and spoke English were recruited. Patients with dementia or cognitive impairment, those who were pregnant, or those who had previously been on warfarin therapy were excluded. Recruited patients received warfarin education in the form of a structured program provided by a pharmacist or counseling by usual care during hospitalization. Prior to discharge, the Oral Anticoagulation Knowledge (OAK) test, a prevalidated tool used to measure warfarin knowledge, was administered to evaluate outcomes. Further warfarin education was provided posttest if necessary. RESULTS: The intervention group (n = 20) scored significantly higher on the OAK test than the usual care group (n = 20): 74% versus 55%, respectively (p = 0.004). CONCLUSIONS: This preliminary study demonstrated that there is a large amount of variability regarding patient knowledge of warfarin on discharge from an inpatient facility. A formalized inpatient warfarin education program may empower patients to achieve a larger degree of initial warfarin knowledge than those educated by usual care. Previous studies have demonstrated that this may improve adherence and subsequently increase long-term safety associated with oral anticoagulation. Larger, prospective, randomized studies are necessary to further evaluate patient education and safety outcomes.

Rash associated with rivaroxaban use.

PURPOSE: A case of a patient who developed a hypersensitivity reaction to rivaroxaban in the form of a diffuse, exanthematous rash is reported. SUMMARY: After starting rivaroxaban for treatment of cancer-associated deep vein thrombosis (DVT) with pulmonary embolism (PE), a 69-year-old Caucasian woman arrived at an oncology clinic with a diffuse, exanthematous (morbilliform) rash on her neck and torso, spreading to her upper and lower extremities. She reported that the symptoms started to develop about 48 hours after transitioning from subcutaneous enoxaparin to oral rivaroxaban. The patient's symptoms did not subside with diphenhydramine 25-50 mg orally every 6-8 hours. The patient was switched back to enoxaparin therapy for continued anticoagulation therapy. On day 5, rivaroxaban and diphenhydramine were discontinued. Oral dexamethasone 4 mg twice daily was initiated, and the patient transitioned from rivaroxaban to enoxaparin 1 mg/kg every 12 hours subcutaneously. On day 8, the rash had diminished considerably and was present only on her thighs. Analysis of the case using the adverse drug reaction probability scale of Naranjo et al. indicated that rivaroxaban was the probable cause of the hypersensitivity reaction. Four prior case reports of rivaroxaban hypersensitivity manifesting as a rash have been previously reported, with this being the first in a female and the first in a patient undergoing treatment of DVT and PE in the setting of active cancer. CONCLUSION: A 69-year-old Caucasian woman developed a diffuse, exanthematous rash on day 3 of rivaroxaban treatment. Symptoms abated after rivaroxaban discontinuation and treatment with dexamethasone.

Spontaneous Thyroid Hemorrhage on Chronic Anticoagulation Therapy.

Even though highly vascularized, the thyroid gland rarely has spontaneous bleeding. Bleeding into the thyroid gland can result in potentially lethal acute airway compromise. This case report describes an elderly patient on warfarin for atrial fibrillation, who presented with swelling on the right side of her neck causing acute airway obstruction. An urgent computed tomography of the neck showed an enlarging hemorrhage into the right lobe of the thyroid gland. She was initially intubated for airway protection and her anticoagulation was reversed to stop the bleeding. She was closely monitored in the intensive care unit. After an uncomplicated tracheal extubation and recovery, she was discharged and scheduled for an elective total thyroidectomy. We desire that physicians be aware of this rare, potentially lethal bleeding complication.

Methods for assessing drug-related anticholinergic activity.

The geriatric population is a large consumer of both prescription and over-the-counter drugs. Positive outcomes from drugs depend on the delicate interplay between therapeutic and adverse effects. This relationship becomes tortuous with simultaneous administration of several drugs. Numerous concomitant drug therapies may be essential for providing quality patient care but may also increase the possibility of an adverse drug event. Increasing sensitivity to drug effects in the geriatric population also creates concern over adverse effects. Drugs that possess anticholinergic properties are especially worrisome, as these properties may manifest as hazardous physiologic and psychological adverse drug events. Consequently, clinicians strive to minimize total drug exposure to agents possessing anticholinergic properties in elderly patients. A review of the literature revealed four methods that might help clinicians systematically reduce or eliminate potentially offending anticholinergic drugs. Each of the four has merits and limitations, with no ideal evidence-based approach used. Three of the four methods described have research utility; however, only one of the methods is clinically useful.

Possible Rivaroxaban Failure during the Postpartum Period.

Rivaroxaban, a factor Xa inhibitor, is a direct-acting oral anticoagulant (DOAC) indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for reducing the risk of DVT and PE recurrence. To our knowledge, no data are presently available to guide DOAC dosing in the postpartum period when pharmacokinetic and pharmacodynamic changes induced by pregnancy have an impact on drug clearance and increase hypercoagulability for a period of 6-8 weeks after delivery. We describe the case of a 35-year-old postpartum woman who presented to the emergency department with a diagnosis of a new multiple segmental PE 5 days after starting rivaroxaban therapy for a diagnosis of DVT. No precipitating cause, including noncompliance, was identified as a source of thrombosis embolization or extension. The patient was admitted, a heparin infusion was started for the management of PE, and rivaroxaban was discontinued. She was transitioned to enoxaparin 1 mg/kg (90 mg) subcutaneously every 12 hours the next day, bridged to warfarin, and discharged home on the overlapping regimen with close follow-up by the pharmacist-managed outpatient Anticoagulation Management Service. To our knowledge, this is the first case report of potential failure associated with rivaroxaban therapy in the postpartum period, possibly due to pharmacokinetic alterations seen in the postpartum period contributing to decreased drug exposure, yielding reduced anticoagulant efficacy. Clinicians should carefully weigh the risks and benefits of DOAC therapy in postpartum patients or other special populations requiring anticoagulation therapy. This report also highlights the need for further research identifying the impact of pharmacokinetic changes induced by special populations and the need to develop monitoring assays for such clinical situations.

New oral anticoagulants in the treatment of pulmonary embolism: efficacy, bleeding risk, and monitoring.

Anticoagulation therapy is mandatory in patients with pulmonary embolism to prevent significant morbidity and mortality. The mainstay of therapy has been vitamin-K antagonist therapy bridged with parenteral anticoagulants. The recent approval of new oral anticoagulants (NOACs: apixaban, dabigatran, and rivaroxaban) has generated significant interest in their role in managing venous thromboembolism, especially pulmonary embolism due to their improved pharmacokinetic and pharmacodynamic profiles, predictable anticoagulant response, and lack of required efficacy monitoring. This paper addresses the available literature, on-going clinical trials, highlights critical points, and discusses potential advantages and disadvantages of the new oral anticoagulants in patients with pulmonary embolism.

Comparison of two different models of anticoagulation management services with usual medical care.

STUDY OBJECTIVE: To evaluate the safety and economic impact of three models of anticoagulation management services: usual medical care, a nurse-managed service, and a pharmacist-managed service. DESIGN: Retrospective medical record review. SETTING: An eight-county health care system in central New York State. PATIENTS: Nine hundred ninety-six patients (age range 19-99 yrs) who were receiving warfarin therapy for at least 6 months and who had three or more international normalized ratio (INR) values reported during the 1-year study period; 489 patients (6243 INR values) were in the pharmacist-managed group, 307 patients (3618 INR values) were in the nurse-managed group, and 200 patients (3142 INR values) were in the usual care group. MEASUREMENTS AND MAIN RESULTS: All INR measurements were performed by the central laboratory or by on-site point-of-care testing. Data were queried from calendar year 2003 for the usual care and nurse-managed services and calendar year 2006 for the pharmacist-managed service. Anticoagulation indication, INR goal, baseline characteristics, and rates and costs of hospitalization and emergency department visits directly related to anticoagulation therapy were extracted from the medical record. If the INR goal was not documented, a range was assigned as appropriate from the American College of Chest Physicians anticoagulation guidelines. Markers of anticoagulation control--time in range (percentage of time a patient is maintained within their therapeutic range) and percentage of INR values in range--were calculated for each study group. Baseline characteristics were similar among all study groups. The pharmacist-managed service yielded the lowest rates of hospitalization and emergency department visits, with hospitalizations reduced by 56% versus nurse-managed service and 61% versus usual care (p<0.01). Emergency department visits were reduced by 78% in both the nurse-managed and usual care models (p<0.002). Based on visit rates, the pharmacist-managed service averted $141,277.34 in hospitalization costs and $10,183.76 in emergency department visit costs versus the nurse-managed service and $95,579.08 in hospitalization costs and $5511.21 in emergency department costs compared with the usual care model. CONCLUSION: Pharmacist-managed anticoagulation management services reduced the rates of anticoagulation-related emergency department visits and hospitalizations, with significant financial impact. Based on results of this study, a collaborative clinic using pharmacists, nurses, and physicians may be the optimal structure for an anticoagulation management service, with these results verified in future prospective randomized studies.