Reversal of direct oral anticoagulants: Guidance from the Anticoagulation Forum.

Two specific reversal agents for direct oral anticoagulants (DOACs) have been approved in the United States: idarucizumab for dabigatran reversal and andexanet alfa for apixaban and rivaroxaban reversal. Non-specific prohemostatic agents such as prothrombin complex concentrate (PCC) and activated PCC have also been used for DOAC reversal. The goal of this document is to provide comprehensive guidance from the Anticoagulation Forum, a North American organization of anticoagulation providers, regarding use of DOAC reversal agents. We discuss indications for reversal, provide guidance on how the individual reversal agents should be administered, and offer suggestions for stewardship at the health system level.

Guidance for the practical management of the heparin anticoagulants in the treatment of venous thromboembolism.

Venous thromboembolism (VTE) is a serious and often fatal medical condition with an increasing incidence. Despite the changing landscape of VTE treatment with the introduction of the new direct oral anticoagulants many uncertainties remain regarding the optimal use of traditional parenteral agents. This manuscript, initiated by the Anticoagulation Forum, provides clinical guidance based on existing guidelines and consensus expert opinion where guidelines are lacking. This specific chapter addresses the practical management of heparins including low molecular weight heparins and fondaparinux. For each anticoagulant a list of the most common practice related questions were created. Each question was addressed using a brief focused literature review followed by a multidisciplinary consensus guidance recommendation. Issues addressed included initial anticoagulant dosing recommendations, recommended baseline laboratory monitoring, managing dose adjustments, evidence to support a relationship between laboratory tests and meaningful clinical outcomes, special patient populations including extremes of weight and renal impairment, duration of necessary parenteral therapy during the transition to oral therapy, candidates for outpatient treatment where appropriate and management of over-anticoagulation and adverse effects including bleeding and heparin induced thrombocytopenia. This article concludes with a concise table of clinical management questions and guidance recommendations to provide a quick reference for the practical management of heparin, low molecular weight heparin and fondaparinux.

Integrating electronic health records in the delivery of optimized anticoagulation therapy.

Integration of accepted practice standards into electronic health record systems can facilitate standardization of anticoagulation care delivery and result in improved anticoagulation safety. However, the majority of commonly used electronic health record systems are lacking the specialized features necessary for optimal anticoagulation management. The Task Force on Electronic Health Records of the New York State Anticoagulation Coalition provides such a Consensus Statement in this issue of the journal. The Anticoagulation Forum endorses these recommendations and advises the electronic health record industry and health information technology programmers at the institutional level to adopt these recommendations in a comprehensive and timely manner.

The implementation cost of a safety-net hospital program addressing social needs in Atlanta.

OBJECTIVE: To describe the cost of integrating social needs activities into a health care program that works toward health equity by addressing socioeconomic barriers. DATA SOURCES/STUDY SETTING: Costs for a heart failure health care program based in a safety-net hospital were reported by program staff for the program year May 2018-April 2019. Additional data sources included hospital records, invoices, and staff survey. STUDY DESIGN: We conducted a retrospective, cross-sectional, case study of a program that includes health education, outpatient care, financial counseling and free medication; transportation and home services for those most in need; and connections to other social services. Program costs were summarized overall and for mutually exclusive categories: health care program (fixed and variable) and social needs activities. DATA COLLECTION: Program cost data were collected using a activity-based, micro-costing approach. In addition, we conducted a survey that was completed by key staff to understand time allocation. PRINCIPAL FINDINGS: Program costs were approximately $1.33 million, and the annual per patient cost was $1455. Thirty percent of the program costs was for social needs activities: 18% for 30-day supply of medications and addressing socioeconomic barriers to medication adherence, 18% for mobile health services (outpatient home visits), 53% for navigating services through a financial counselor and community health worker, and 12% for transportation to visits and addressing transportation barriers. Most of the program costs were for personnel: 92% of the health care program fixed, 95% of the health care program variable, and 78% of social needs activities. DISCUSSION: Historically, social and health care services are funded by different systems and have not been integrated. We estimate the cost of implementing social needs activities into a health care program. This work can inform implementation for hospitals attempting to address social determinants of health and social needs in their patient population.

Detection and identification of cytochrome P-450 2C9 alleles *1, *2, and *3 by high-resolution melting curve analysis of PCR amplicons.

High-resolution melting curve analysis using a fluorescent DNA binding dye can detect sequence variations in a closed-tube system without labeled primers or probes. We developed and verified a melting analysis assay for common single nucleotide polymorphisms of cytochrome P-450 (CYP) 2C9 that affect warfarin metabolism. We used this method to genotype 84 patients receiving warfarin. For wild-type, *1/*1, 50% fluorescence corresponded to a mean+/-SD of 87.17+/-0.05 degrees C, whereas *2/*2 was 0.4 degrees C lower. The *1/*2 melting curve was easily distinguished from *1/*1 and *2/*2 based on transition temperature and shape. Exon 7 showed a more complex melting curve; however, genotypes *1/*1, *1/*3, and *3/*3 were easily distinguishable. Melting curves were highly reproducible (SD of temperature for multiple fluorescence values 0.04 degrees C-0.11 degrees C; mean, 0.06 degrees C). Heterozygotes (*1/*2 or *1/*3) required significantly lower mean maintenance warfarin doses compared with wild-type (30.67 and 29.56 vs 42.81 mg/wk; P<.05). High-resolution melting analysis provides a simple and accurate method for genotyping of CYP2C9.