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

描述（由申请人提供）：全国范围内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包括或排除在处方中。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资料。非常需要在医疗机构中运行的计算机化系统，该系统可以在将新药引入处方后提供持续、主动的监测和及时识别潜在的安全问题。这样一个系统可能导致更安全的药物使用政策、更具成本效益的处方决策、更好的医疗保健和更早地发现药物不良反应（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，有关安全问题的证据主要由FDA的上市后监测系统MedWatch（tm）产生。MedWatch（tm）是一个依赖于自愿、自发报告的被动系统。由于该系统受到报告率低和事件积累缓慢的限制，无法进行批判性分析，因此在确定问题药物并将其从市场上撤出或在其上贴上黑框警告方面出现了延误。这些延误导致了不必要的死亡率、发病率和医疗费用。

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).