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（由申请人提供）：被认为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，公共卫生响应的重点是减少非医学用途的计划。但是，很少有人注意到儿童平行流行的可能性，特别容易受到阿片类药物毒性的影响。田纳西州的初步医疗补助数据表明，这种流行病现在可能影响儿童：2-17岁的儿童处方药的比例从1996年的5％增加到2007年的11％，医疗保健的可比趋势可能与阿片类毒性一致。对儿童安全的这种潜在威胁的适当公共卫生反应是什么？由于必须由父母或监护人填写儿童处方，因此非医疗用途不太合理，尤其是对于幼儿而言。因此，小儿阿片类药物毒性最喜欢是治疗用途的意外结果，这需要被视为处方风险效力评估的一部分。因此，迫切需要量化 儿童的阿片类药物毒性通知小儿从业者的决策。此外，阿片类药物 需要确定与风险升高有关的规定做法，以便在可能的情况下避免使用这些方法。潜在的危险实践包括较高剂量，高功率阿片类药物，例如羟考酮和并发中枢神经系统抑制剂。为了满足这一未满足的公共卫生需求，我们将在估计有500,000名田纳西州医疗补助儿童2-17岁的田纳西州医疗补助儿童中进行大量回顾性队列研究，其中有1,000,000个填充的阿片类药物处方和1400例确认的阿片类药物毒性病例。有两个具体的目的：目标1。根据a）儿童年龄，b）毒性严重程度，量化与处方阿片类药物使用相关的毒性发生率，c）毒性是否与治疗用途有关。 AIM 2检验以下假设，即阿片类药物毒性风险随之增加：a）阿片类药物剂量增加，b）高功率阿片类药物，c）同时使用其他CNS抑郁剂药物。这些有关儿童越来越多使用的阿片类药物风险的数据将为改变小儿实践的良好基础，以应对对这种脆弱人群安全的新威胁。