Signal Detection for Prescription Opioid Outbreaks

描述（由申请人提供）：本应用程序建立在inflexion对成瘾严重程度指数多媒体版本（ASI-MV）和其他资助的SBIRs进行的程序性研究的基础上，这些研究导致了ASI-MV连接的创建。这是全国各地药物滥用治疗中心的全国性公共卫生综合征监测网络，可以收集和汇总滥用药物的客户级数据，包括关于药物使用和滥用的特定产品数据，特别是阿片类镇痛药。ASI-MV连接能够跟踪和识别可能反映当地滥用受监测物质（包括可滥用药物）情况的“信号”。本应用程序的目的是(1)开发一个网站，提供ASI-MV Connect数据的验证和自动化，时间和地理空间信号检测；(2)为利益相关者提供持续的实时信号检测，如制药公司，FDA，以及州和地方公共卫生和刑事司法当局。据我们所知，没有其他现有的或竞争性的上市后监测系统利用最先进的综合征监测方法（如监测传染病或生物恐怖主义威胁的系统）在全国范围内搜索当地药物滥用的爆发。最近，FDA要求制药公司对可滥用或成瘾物质提出新的申请，制定风险最小化行动计划（称为RiskMAPs），其中通常包括上市后监督计划。白宫国家药物管制政策办公室建议建立药物爆发的早期预警和反应系统，进一步强调了公共卫生的重要性。ASI-MV Connect的全部商业和公共卫生潜力需要(1)研究以增强该领域的知识，了解哪些统计技术应该与药物使用数据一起使用，(2)展示药物滥用治疗中客户的药物使用自我报告数据如何反映当地社区的滥用率，以及(3)利益相关者可以访问一个易于使用的基于网络的工具，该工具可以实时持续地自动跟踪和报告多种感兴趣的药物信号。第一阶段将(1)探索利用ASI-MV Connect数据进行各种时间和地理空间信号检测方法的相对效率；(2)进行可行性现场测试，探索ASI-MV Connect数据与其他社区级药物滥用数据来源的关系；(3)开发和测试样本网站设计，向利益相关者群体(如药品风险管理人员、公共卫生当局、刑事司法当局)。这项工作的结果将是可发表的各种药物滥用信号检测方法的绩效研究，以及一个网站，该网站将成为真正的公共卫生工具，并允许利益攸关方实时获取全国各地的滥用率和信号。该系统将被认为对制药公司、DEA、FDA和其他公共卫生官员非常有价值。公共卫生相关性：我们合作过的许多制药公司对inflexion在风险管理领域的服务非常感兴趣。对于阿片类药物疼痛管理领域的公司来说，具有最先进信号检测能力的强大上市后监测计划对于获得监管机构的批准至关重要。这一工具为那些专注于药物滥用监测和信号检测的人提供了类似于监测传染病和生物恐怖主义威胁的卫生当局所获得的数据。这个系统应该被利益相关者认为是非常有价值的。因此，我们相信该产品具有巨大的商业可行性和公共卫生重要性。

DESCRIPTION (provided by applicant): This application builds on programmatic research conducted at Inflexxion regarding the Addiction Severity Index Multimedia Version (ASI-MV) and other funded SBIRs that have resulted in the creation of ASI-MV Connect. This is a national, public health syndromic surveillance network of substance abuse treatment centers around the country that allows the collection and aggregation of client-level data on substances of abuse, including product-specific data on use and abuse of pharmaceutical medications, especially opioid analgesics. ASI-MV Connect is capable of tracking and identifying "signals" that may reflect local outbreaks of abuse of monitored substances, including abusable pharmaceuticals. The aims of the present application are (1) to develop a website that presents validated and automated, temporal and geospatial signal detection of ASI-MV Connect data and (2) to make ongoing, real-time signal detection available to stakeholders, such as pharmaceutical companies, the FDA, as well as state and local public health and criminal justice authorities. No other existing or competitive post-marketing surveillance system of which we are aware utilizes state-of- the-art syndromic surveillance methods (such as systems that monitor infectious disease or bioterrorism threats) to search for local outbreaks of drug abuse across the country. Recent FDA requirements direct pharmaceutical companies making new applications for abusable or addictive substances to develop risk minimization action plans (called RiskMAPs), which typically include postmarketing surveillance programs. The public health import is further underscored by recommendations of the White House Office of National Drug Control Policy to develop an early warning and response system for drug outbreaks. The full commercial and public health potential of ASI-MV Connect requires (1) research to enhance the field's knowledge of which statistical techniques should be used with drug use data, (2) demonstration of how self-report data of drug use by clients in substance abuse treatment reflect abuse rates in local communities, and (3) an easy-to-use, web- based tool accessible to stakeholders that automatically tracks and reports signals of multiple drugs of interest in a real-time, ongoing manner. Phase I will (1) explore the relative efficiency of various temporal and geospatial methods of signal detection with ASI-MV Connect data, (2) conduct a feasibility field test to explore the relationship of ASI-MV Connect data to other sources of community level drug abuse data, and (3) develop and test sample website designs that present real-time signal detection information to stakeholder groups (e.g., pharmaceutical risk management personnel, public health authorities, criminal justice authorities). The result of this work will be publishable performance studies of various signal detection methods for drug abuse along with a website that will be a genuine public health tool and permit stakeholders real-time access to abuse rates and signals around the country. This system will be perceived as highly valuable to pharmaceutical companies, the DEA, the FDA and other public health officials. PUBLIC HEALTH RELEVANCE: Many of the pharmaceutical companies with which we have worked, are extremely interested in Inflexxion's services in the risk management area. For companies in the opioid pain management area, a strong postmarketing surveillance program with state-of-the-art signal detection capabilities is essential to obtaining approval by regulatory agencies. Such a tool makes available to those focused on substance abuse surveillance and signal detection, data similar to what is available to health authorities that monitor infectious disease and bioterrorism threats. This system should be perceived by stakeholders as highly valuable. Thus, we believe this product has enormous commercial viability and public health importance.