Distributed, Collaborative Intelligent Agents for Proactive Post-Marketing Drug S

描述(由申请人提供)：全国的医疗保健系统和保险公司根据有关药物的益处、风险和成本的证据，定期决定将哪些药物纳入或排除在其处方中。有效选择药物的一个主要障碍是缺乏关于药物，特别是新药安全性的充分公开信息。在医疗机构运行的计算机化系统可以在处方中引入新药后提供持续、主动的监测和及时识别潜在的安全问题，这是非常可取的。这样的系统可以导致更安全的药物使用政策，更具成本效益的处方决策，更好的医疗保健，以及更早发现药物不良反应(ADR)。这种技术对改善国家药物监测系统的影响将是显而易见的，因为ADR会使患者的医疗状况复杂化，增加发病率，并导致死亡(美国每年约有7000人死于ADR)。目前，将为这些决定提供依据的安全问题证据主要由FDA的上市后监控系统MedWatch(Tm)产生。MedWatch(Tm)是一个被动的系统，依赖于自愿、自发的报告。由于该系统受限于低报告率和缓慢积累足够的事件以进行关键分析，因此在识别和从市场上撤回问题药物或给它们贴上黑盒警告的标签方面会出现延误。这些延误导致了不必要的死亡率、发病率和医疗成本。 我们建议开发一种创新的基于团队的代理系统，名为ADRMonitor，用于主动监控和检测涉及医疗机构预期或潜在ADR的信号对。每个ADRMonitor用户(例如医生和药物安全官员)都将拥有他/她自己的软件代理，可以通过互联网访问，并扮演两个角色--帮助用户做出决策，以及与其他团队成员的代理合作。提出的方法的一个关键特征是，代理将持续自主地相互协作。他们预测队友的信息需求，并主动分享信息，以便及时向用户发出信号对的警报。 为了证明可行性，我们计划在这个为期两年的试点项目中开发ADRMonitor的原型，该项目将由我们的多学科团队合作承担。我们的初步设计和分析表明，所提出的方法是有前景的。这项拟议的工作是在这项研究工作的后期阶段开发更全面的ADRMonitor的关键的第一步，该系统将使用信号对来检测ADR，并将结果系统扩展到覆盖一个地区或全国的医疗保健。拟议的方法是一般性的，可以适用于其他重要应用，如生物恐怖主义监视。 与公共卫生相关：在医疗机构运行的计算机化系统可以在处方中引入新药后提供持续、主动的监测和及时识别潜在的安全问题，这是非常可取的。这样的系统可以导致更安全的药物使用政策，更具成本效益的处方决策，更好的医疗保健，以及更早发现药物不良反应(ADR)。这种技术对改善国家药物监测系统的影响将是显而易见的，因为ADR会使患者的医疗状况复杂化，增加发病率，并导致死亡(美国每年约有7000人死于ADR)。

DESCRIPTION (provided by applicant): Healthcare systems and insurers nationwide regularly make decisions regarding which drugs to include or exclude from their formularies based on evidence concerning benefits, risks, and costs of the medications. A major barrier to effective drug selection is the lack of sufficient published information on the safety of drugs, particularly new drugs. A computerized system operating at healthcare facilities that could provide continuous, active surveillance and timely identification of potential safety issues following the introduction of a new drug to a formulary is highly desirable. Such a system could lead to safer drug use policy, more cost-effective formulary decisions, better healthcare, and earlier detection of adverse drug reactions (ADRs). The implications of such technology for improving a national drug surveillance system will be apparent because ADRs can complicate the patient's medical condition, increase morbidity, and result in death (about 7,000 deaths per year in the U.S. were attributed to ADRs). At present, evidence on safety issues that would inform these decisions is generated primarily by the FDA's post-marketing surveillance system MedWatch(tm). MedWatch(tm) is a passive system that depends on voluntary, spontaneous reports. Because the system is limited by low reporting rates and the slow accumulation of sufficient events to enable a critical analysis, delays occur in the identification and withdrawal of problematic drugs from the market or labeling them with black box warnings. These delays have resulted in unnecessary mortality, morbidity, and costs of healthcare. We propose to develop an innovative team-based agent system, named ADRMonitor, for actively monitoring and detecting signal pairs implicating anticipated or potential ADRs at a healthcare facility. Each ADRMonitor user (e.g., physicians and drug safety officers) will have his/her own software agent that is accessible via the Internet and plays two roles -- assisting the user in his/her decision-making, and collaborating with agents of other team members. A key feature of the proposed approach is that the agents will continuously and autonomously collaborate with one another. They anticipate information needs of their teammates and share information proactively so that the users can be alerted timely about signal pairs. To demonstrate the feasibility, we plan to develop a prototype of ADRMonitor in this two-year pilot project, which will be undertaken collaboratively by our multidisciplinary team. Our preliminary design and analysis show the proposed methodology to be promising. The proposed effort represents a critical first step toward a subsequent development of a more comprehensive ADRMonitor in later phases of this research endeavor that would use the signal pairs to detect ADRs and expand the resultant system to cover healthcare in a region or across the country. The proposed methodology is general in nature and can be adapted for other important applications such as bioterrorism surveillance. PUBLIC HEALTH RELEVANCE: A computerized system operating at healthcare facilities that could provide continuous, active surveillance and timely identification of potential safety issues following the introduction of a new drug to a formulary is highly desirable. Such a system could lead to safer drug use policy, more cost-effective formulary decisions, better healthcare, and earlier detection of adverse drug reactions (ADRs). The implications of such technology for improving a national drug surveillance system will be apparent because ADRs can complicate the patient's medical condition, increase morbidity, and result in death (about 7,000 deaths per year in the U.S. were attributed to ADRs).