Prescribed Opioid Safety in Children

儿童处方阿片类药物的安全性

• 批准号: 9197320
• 负责人: WAYNE A RAY
• 金额: $ 52.06万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9197320
• 关键词: 17 year old; Address; Admission activity; Adolescent; Adult; Affect; Age; Antidepressive Agents; Antipsychotic Agents; Attention; Benefits and Risks; Benzodiazepines; Caring; Central Nervous System Depressants; Cessation of life; Child; Childhood; Clinical; Code; Data; Decision Making; Diagnosis; Dose; Drug abuse; Emergency department visit; Epidemic; Evaluation; Hospitals; Incidence; Ingestion; Medicaid; Medical; Medical Records; Monitor; Opioid; Opioid Analgesics; Overdose; Oxycodone; Parents; Periodicity; Pharmaceutical Preparations; Poisoning; Population; Public Health; Retrospective cohort study; Risk; Safety; Sales; Severities; Tennessee; Testing; Therapeutic Uses; Toxic effect; Vulnerable Populations; computerized; novel; opioid use; population based; prescription opioid; programs; public health relevance; response; sound; trend

DESCRIPTION (provided by applicant): The epidemic of toxicity related to prescription opioid use among U.S. adults is thought to be related to drug abuse. Thus, the public health response has focused on programs to reduce non-medical uses. However, little attention has been given to the possibility of a parallel epidemic among children, particularly vulnerable to opioid toxicit. Preliminary Tennessee Medicaid data suggest this epidemic now possibly affects children: the proportion of children 2-17 years old prescribed opioid analgesics increased from 5% in 1996 to 11% in 2007, with a comparable trend in medical care possibly consistent with opioid toxicity. What is the appropriate public health response to this potential threat to the safety of children? Because children's prescriptions must be filled by a parent or guardian, non-medical use is less plausible, particularly for young children. For this reason, pediatric opioid toxicity is most likey to be an unintended consequence of therapeutic use, which would need to be considered as part of prescription risk-benefit evaluation. Thus, there is an urgent need to quantify the incidence of opioid toxicity in children to inform pediatric practitioners' decision-making. Furthermore, opioid prescribing practices associated with elevated risk need to be identified so these can be avoided when possible. Potentially hazardous practices include higher doses, high-potency opioids such as oxycodone, and concurrent central nervous system depressants. To address this unmet public health need, we will conduct a large retrospective cohort study in an estimated 500,000 Tennessee Medicaid children 2-17 years of age with 1,000,000 filled opioid prescriptions and 1400 confirmed cases of opioid toxicity. There are two specific aims: Aim 1. Quantify the incidence of toxicity related to prescription opioid use according to a) the child's age, b) toxicity severity, and c) whether or not the toxicity was related to therapeutic use. Aim 2 Test the hypothesis that opioid toxicity risk increases with: a) increased opioid dose, b) high-potency opioids, and c) concurrent use of other CNS-depressant drugs. These data on the risks of opioid medications increasingly used by children will provide a sound basis for altering pediatric practice to address a novel threat to the safety of this vulnerable population.

描述(申请人提供)：美国成年人中与处方阿片类药物使用有关的毒性流行被认为与药物滥用有关。因此，公共卫生反应的重点是减少非医疗用途的计划。然而，很少有人注意到在儿童中平行流行的可能性，特别容易受到阿片类药物毒物的影响。田纳西州医疗补助计划的初步数据显示，这种流行病现在可能会影响儿童：2-17岁儿童服用阿片类止痛药的比例从1996年的5%增加到2007年的11%，医疗保健方面的类似趋势可能与阿片类药物的毒性一致。对于这一对儿童安全的潜在威胁，适当的公共卫生对策是什么？因为儿童的处方必须由父母或监护人配药，非医疗用途的可能性较小，特别是对年幼的儿童。因此，儿童阿片类药物毒性最有可能是治疗使用的意外后果，这需要作为处方风险-效益评估的一部分来考虑。因此，迫切需要量化这种疾病的发生率。 阿片类药物在儿童中的毒性为儿科医生的决策提供信息。此外，阿片类药物 需要确定与风险升高相关的处方做法，以便在可能的情况下避免这些做法。潜在的危险做法包括更高剂量、高效力的阿片类药物，如羟考酮，以及同时服用的中枢神经系统抑制剂。为了解决这一未得到满足的公共卫生需求，我们将对大约500,000名田纳西州2-17岁的医疗补助儿童进行一项大型回溯性队列研究，其中包括1,000,000张填写的阿片类药物处方和1400例确诊的阿片类药物中毒病例。有两个具体目标：目的1.根据a)儿童的年龄，b)毒性的严重程度，以及c)毒性是否与治疗性使用有关，量化与处方阿片类药物使用有关的毒性发生率。目的2验证阿片类药物毒性风险增加的假设：a)增加阿片类药物剂量，b)高效力阿片类药物，c)同时使用其他中枢神经系统抑制药。这些关于儿童越来越多地使用阿片类药物的风险的数据将为改变儿科做法提供可靠的基础，以解决这一弱势群体的安全面临的新威胁。