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）：美国成人中与处方阿片类药物使用相关的毒性流行被认为与药物滥用有关。因此，公共卫生对策的重点是减少非医疗用途的方案。然而，很少有人注意到在特别易受阿片类药物毒性影响的儿童中平行流行的可能性。田纳西州医疗补助计划的初步数据表明，这种流行病现在可能会影响儿童：2-17岁儿童处方阿片类镇痛药的比例从1996年的5%增加到2007年的11%，医疗保健的类似趋势可能与阿片类药物毒性一致。对这种对儿童安全的潜在威胁，适当的公共卫生对策是什么？由于儿童的处方必须由父母或监护人填写，非医疗用途是不太合理的，特别是对年幼的儿童。因此，儿科阿片类药物毒性最有可能是治疗使用的非预期后果，需要将其视为处方风险-获益评价的一部分。因此，迫切需要量化 阿片类药物在儿童中的毒性，以告知儿科医生的决策。此外，阿片类 需要确定与高风险相关的处方做法，以便在可能的情况下避免这些做法。潜在危险的做法包括更高剂量，高效力阿片类药物，如羟考酮，和并发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，我们将对估计500，000名2-17岁的田纳西州医疗补助儿童进行一项大型回顾性队列研究，其中包括1，000，000份已填写的阿片类药物处方和1，400例阿片类药物毒性确诊病例。有两个具体目标：目标1。根据a）儿童年龄，B）毒性严重程度，以及c）毒性是否与治疗使用相关，量化与处方阿片类药物使用相关的毒性发生率。目的2检验阿片类药物毒性风险随以下因素而增加的假设：a）阿片类药物剂量增加，B）高效阿片类药物，和c）同时使用其他CNS-阿片类药物。这些关于儿童越来越多地使用阿片类药物风险的数据将为改变儿科实践提供坚实的基础，以解决对这一弱势群体安全的新威胁。