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

描述(申请人提供)：在过去的十年里，阿片类止痛药(OPR)在美国的销售额和不良事件增加了四倍。口服避孕药的使用和滥用越来越多，影响了广泛的人口，包括孕妇。伴随着子宫内阿片类药物暴露的增加，新生儿禁欲综合征(NAS)的发生率急剧增加，以至于在美国，每小时就有一个婴儿出生时出现阿片类药物戒断的迹象。到2009年，超过13,500名出生时患有NAS的婴儿在全国范围内的医疗支出估计为7.2亿美元。田纳西州为OPR开出的处方数量在全国排名第二，NAS比率的增长速度是全国平均水平的三倍。尽管NAS迅速增加，但根本原因尚不清楚，导致所有接触阿片类药物的婴儿的医疗保健利用效率低下。迫切需要进行研究，重点了解与发展NAS相关的因素，包括多物质滥用、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，以及通过限制医院对不会发展为NAS的阿片类药物暴露婴儿的不必要观察，更有效地利用医疗资源，为旨在初级预防NAS的努力提供信息。该项目旨在：1)使用生命统计数据、管理数据、门诊药房数据、全州病历回顾和田纳西州医疗补助计划中大量婴儿的药物筛选数据，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有关；3)开发NAS的风险评估工具。这项研究包括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。总共将从10万多名孕妇和1000多名被诊断为NAS的婴儿那里获得数据。这一系列项目的成果将填补关于药物滥用、成瘾和非吸毒症的文献的现有空白，这些文献将迅速传播，以告知临床医生和政策制定者。这一有指导的职业发展经验的首要目标是应聘者成为一名独立的临床调查员，领导一个多学科研究计划，以改善对暴露于物质的婴儿的护理和结局。为了实现这一目标，候选人将加强其先前的研究培训，包括预测建模、药物流行病学、领导力培训和侧重于妊娠和母婴公共卫生系统物质依赖治疗的实践经验方面的高级课程和实践技能发展。在整个获奖期间，候选人将与一个由导师和顾问组成的多学科团队密切合作-包括儿科、妇产科、生物统计学、精神病学、新生儿学、 重症监护医学、公共卫生和流行病学--以实现他所宣称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.