ABSTRACT
BACKGROUND: The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety. How do we best monitor effectiveness and safety of biosimilar products once approved by the FDA and used more extensively by patients? OBJECTIVE: To determine the feasibility of developing a distributed research network that will use health insurance plan and health delivery system data to detect biosimilar safety and effectiveness signals early and be able to answer important managed care pharmacy questions from both the government and managed care organizations. METHODS: Twenty-one members of the AMCP Task Force on Biosimilar Collective Intelligence Systems met November 12, 2013, to discuss issues involved in designing this consortium and to explore next steps. RESULTS: The task force concluded that a managed care biosimilars research consortium would be of significant value. Task force members agreed that it is best to use a distributed research network structurally similar to existing DARTNet, HMO Research Network, and Mini-Sentinel consortia. However, for some surveillance projects that it undertakes, the task force recognizes it may need supplemental data from managed care and other sources (i.e., a "hybrid" structure model). CONCLUSIONS: The task force believes that AMCP is well positioned to lead the biosimilar-monitoring effort and that the next step to developing a biosimilar-innovator collective intelligence system is to convene an advisory council to address organizational governance.
Subject(s)
Biosimilar Pharmaceuticals/adverse effects , Biosimilar Pharmaceuticals/therapeutic use , Data Collection/methods , Drug Approval , Humans , Pharmaceutical Services/organization & administration , United States , United States Food and Drug AdministrationABSTRACT
Patient engagement is increasingly seen as a potentially effective way to improve quality and lower costs in health care. We review and synthesize current research, including our work with patients' use of prescription medications, to explore whether and in what settings patient engagement may not be realistic or even necessary. Our commentary argues that a more tempered assessment of patient engagement is warranted for the following three reasons: Evidence of the effectiveness of interventions to increase patient engagement on health outcomes is not definitive; ongoing and sustained patient engagement conflicts with cognitive limitations that are the hallmark of basic human nature; and, in some settings, choice architecture and associated strategies provide a clear alternative for improving behavior and decisions without relying on ongoing engagement. We recommend the use of such strategies when possible, including the marriage of patient engagement strategies with choice architecture solutions.
Subject(s)
Choice Behavior , Patient Participation/methods , Delivery of Health Care/methods , Delivery of Health Care/organization & administration , Humans , Intention , Patient Participation/psychology , Quality ImprovementABSTRACT
Analisadores compactos, apropriados para testes em pacientes à mão, avaliam o hematócrito pela medida da condutividade do sangue não diluído. Nós avaliamos a exatidão do resultado de hematócrito de um determinado analisador (Instrumentation Laboratory BGE Analyzer) em comparação com um automático contador eletrônico de partículas (CEP) e volume de células sedimentadas (VCS) microhematócrito. Quando amostras (n = 34) de pacientes externos e de enfermaria foram analisadas por todos os três métodos, o analisador AEG estava de acordo com os dois hematócritos CEP e VCS (AEG = 1,00 VCS + 0,3%, Sy/x = 1,6% ; AEG = 1,04 CEP + 0,4%, Sy/x = 2,0%), indicando que todos os três métodos têm performances similares na maioria dos pacientes. Entretanto, um paciente com osmolalidade plasmática aumentada mostrou significante decréscimo nos hematócritos AEG e VCS em comparação ao método CEP. As diferenças nas medidas do hematócrito podiam ser reproduzidas pela adição de solutos ao sangue in vitro ou pela modificação de osmolalidade plasmática de ratos "in vivo". Amostras de pacientes submetidos a uma cirurgia cardíaca, cujo sangue tinha grandes mudanças na concentração de proteína, mostrou discrepância entre hematócritos pela condutividade e outros métodos; efeitos similares poderiam ser produzidos pelas mudanças na concentração de proteína ou pela adição "in vitro" de polietileno glicol. Nós concluímos que medidas de condutividade fornecem resultados exatos do hematócrito para sujeitos normais fisiologicamente, mas não para alguns pacientes sob cuidado intensivo e pacientes cirúrgicos.
