Neonatal Abstinence Syndrome: Risk of Drug Withdrawal in Opioid-Exposed Infants

描述（由申请人提供）：在过去十年中，美国阿片类止痛药（OPR）的销售和不良事件翻了两番。越来越多地使用和滥用有机磷农药影响到包括孕妇在内的广大人群。伴随着子宫内阿片类药物暴露的增加，新生儿戒断综合征（NAS）的发生率急剧增加，以至于在美国，每小时就有一名婴儿出生，有阿片类药物戒断的迹象。到2009年，超过13，500名婴儿出生时患有NAS，估计全国医疗保健支出为7.2亿美元。田纳西州在OPR处方数量上排名全国第二，NAS的增长速度是全国平均水平的三倍。尽管NAS迅速增加，但对根本原因知之甚少，导致所有阿片类药物暴露婴儿的医疗保健利用率低下。迫切需要进行研究，重点了解与发展NAS相关的因素，包括多种药物滥用、精神药物的联合处方和OPR处方模式。这项研究将通过改变产妇和处方者的行为，以及通过限制对不会发展NAS的阿片类药物暴露婴儿进行不必要的医院观察，更有效地利用医疗资源，为NAS的一级预防提供信息。该项目旨在：1）使用田纳西州医疗补助计划中大量婴儿的生命统计数据，管理数据，门诊药房数据，全州医疗记录审查和药物筛选数据来确定NAS的预测因素，2）确定产前阿片类药物处方模式是否与NAS相关，3）开发NAS的风险评估工具。这项研究包括来自田纳西州医疗补助计划的丰富数据，包括生命统计数据，门诊药房数据，医院管理数据和全州医疗记录审查。总的来说，将从超过10万名孕妇和1,000多名被诊断患有NAS的婴儿中获得数据。这一系列项目的成果将填补药物滥用、成瘾和NAS文献中的现有空白，这些文献将迅速传播，以告知临床医生和决策者。这种指导职业发展经验的总体目标是候选人成为一名独立的临床研究者，领导一个多学科研究计划，以改善物质暴露婴儿的护理和结果。为了实现这一目标，候选人将通过高级课程和预测建模，药物流行病学，领导力培训和实践经验方面的实践技能发展来加强他之前的研究培训，重点是怀孕和母婴公共卫生系统中的药物依赖治疗。在整个获奖期间，候选人将与多学科的导师和导师团队密切合作，包括儿科，妇产科，生物统计学，精神病学，精神病学， 重症监护医学，公共卫生和流行病学-实现他的职业目标和具体目标。

DESCRIPTION (provided by applicant): Over the last decade, sales and adverse events due to opioid pain relievers (OPRs) in the US have quadrupled. The increasing use and abuse of OPRs impacts a wide range of the population, including pregnant women. Concomitant with increased in utero opioid exposures, there has been a dramatic increase in the incidence of neonatal abstinence syndrome (NAS), such that in the US, one infant is born every hour with signs of drug withdrawal from opioids. By 2009, more than 13,500 infants were born with NAS accounting for an estimated $720 million in healthcare expenditures nationwide. The state of Tennessee ranks second in the nation in number of prescriptions written for OPRs and rates of NAS have grown three times faster than the national average. Despite the rapid increase in NAS, underlying causes are poorly understood, resulting in inefficient use of healthcare utilization for all opioid-exposed infants. There is a critical need for research focused on understanding factors associated with developing NAS, including poly-substance abuse, co- prescribing of psychotropic medications and OPR prescription patterns. This research will inform efforts aimed at primary prevention of the NAS through modifying maternal and prescriber behaviors and more efficient use of healthcare resources through limiting unnecessary hospital observation of opioid-exposed infants who will not develop NAS. This project aims to: 1) determine predictors of NAS using vital statistics, administrative data, outpatient pharmacy data, statewide medical record review and drug screen data in a large population of infants in the Tennessee Medicaid Program, 2) determine if antenatal opioid prescribing patterns are associated with NAS and 3) develop a risk assessment tool for NAS. This study includes a rich array of data from the Tennessee Medicaid program comprising vital statistics, outpatient pharmacy data, hospital administrative data and statewide medical record review. In total, data will be obtained from more than 100,000 pregnant women and more than 1,000 infants diagnosed with NAS. The result of this series of projects will fill an existing gap i the literature on drug abuse, addiction and NAS that will be rapidly disseminated to inform clinicians and policymakers. The overarching objective of this mentored career development experience is for the candidate to emerge as an independent clinical investigator leading a multidisciplinary research program to improve care and outcomes for substance-exposed infants. To accomplish this goal, the candidate will augment his prior research training with advanced coursework and practical skills development in predictive modeling, pharmaco-epidemiology, leadership training and practical experiences focused on substance dependency treatment in pregnancy and maternal and infant public health systems. Throughout the award period, the candidate will work closely with a multidisciplinary team of mentors and advisors-including experts in pediatrics, obstetrics and gynecology, biostatistics, psychiatry, neonatology, critical care medicine, public health, and epidemiology-to carry out his stated career objectives and specific aims.