Promoting Safe Use of Pediatric Liquid Medications: A Health Literacy Approach

促进儿科液体药物的安全使用：健康素养方法

• 批准号: 8371575
• 负责人: Hsiang Yin
• 金额: $ 71.54万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-16 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8371575
• 关键词: Abbreviations; Accident and Emergency department; Adult; Antibiotics; Caregivers; Child; Childhood; Complex; Confusion; Development; Devices; Dose; Drug Labeling; Effectiveness; Event; Guidelines; Inpatients; Instruction; Knowledge; Label; Language; Link; Liquid substance; Literature; Maps; Measurement; Measures; Medical; Medication Errors; Medicine; Oral; Outpatients; Parents; Pediatrics; Pharmaceutical Preparations; Policies; Population; Randomized Controlled Trials; Recommendation; Reliance; Research; Risk; Role; Series; Source; Syringes; Text; United States Food and Drug Administration; Variant; design; dosage; efficacy testing; evidence base; federal policy; health literacy; improved; instrument; intervention effect; liquid formulation; literacy; milliliter; patient oriented; patient safety; prevent; research study; skills

DESCRIPTION (provided by applicant): Variable and poor-quality drug labeling has been cited as a leading cause of medication errors and adverse drug events. This is an especially important issue in pediatrics, as more than half of US children are exposed to one or more outpatient medications in a given week, and studies suggest that over half of caregivers make errors when dosing liquid medications for children. Administering pediatric medications is frequently a difficult task for parents, in large part due to reliance on liquid formulations requiing the use of confusing, and often complex, measurement devices. Use of different units of measurement (milliliter, teaspoon, and/or tablespoon units) with variations in associated abbreviations, and the variability of measuring devices (type, markings, capacity), are sources of parent confusion. Low health literacy is linked to caregiver misunderstanding. Despite high error and utilization rates for outpatient pediatric medications, research examining strategies to prevent medication errors have focused largely on adults and on inpatient populations. The ability to understand pediatric medication instructions is a critical health literacy and patient safety concern. Recently, the US Food and Drug Administration recognized the importance of this issue and released new guidelines to promote improved labeling and measuring devices for pediatric liquid medications. While these recommendations are an essential first step, evidence is needed to support the development of 'best practices' for designing optimal instructions and devices, especially for parents with limited literacy and/or limited English proficiency. Our stud objective is to identify evidence-based 'best practices' for labeling and dosing prescription and over-the-counter pediatric liquid medications in order to promote safe, appropriate use. A series of experiments will first be conducted to examine the efficacy of specific dosing and measurement strategies for improving parent understanding and use of pediatric liquid medications, including examining the impact of milliliter-only label instructions and devices, as well as the potential role for pictographic dosing diagrams. Findings will be merged with existing evidence-based health literacy 'best practices' for medication labeling to develop a comprehensive, patient-centered strategy for the labeling and dosing of pediatric liquid medications. The effectiveness of the patient-centered strategy will then be evaluated as part of a randomized controlled trial among English and Spanish-speaking parents whose children have been newly prescribed oral liquid antibiotics in a pediatric emergency department setting. Secondary aims of the study include extending the body of literature on health literacy and pediatric medication use, and generating a policy road map for achieving and implementing labeling and dosing standards for pediatric liquid medications. PUBLIC HEALTH RELEVANCE: Variable and poor-quality drug labeling has been cited as a leading cause of medication errors and adverse drug events, especially in the context of low health literacy. This is a particularly important issue in pediatrics, as more than half of US children are exposed to one or more outpatient medications in a given week, and studies suggest that over half of caregivers make errors when dosing liquid medications for children. Our study objective is to identify evidence-based strategies for labeling and dosing prescription and over-the- counter pediatric liquid medications in order to promote safe, appropriate use, as well as to inform state and federal policy standards.

描述（由申请人提供）：可变和低质量的药品标签被认为是导致用药错误和药物不良事件的主要原因。这在儿科中是一个特别重要的问题，因为超过一半的美国儿童在给定的一周内接触一种或多种门诊药物，研究表明，超过一半的护理人员在给儿童服用液体药物时犯了错误。对父母来说，管理儿科药物往往是一项艰巨的任务，这在很大程度上是由于对液体配方的依赖，需要使用令人困惑的、往往复杂的测量设备。使用不同的计量单位（毫升、茶匙和/或汤匙单位）以及相关缩写的变化，以及测量设备（类型、标记、容量）的变化，都是造成家长混淆的原因。低健康素养与看护者的误解有关。尽管门诊儿科药物的错误率和使用率很高，但研究预防药物错误的策略主要集中在成年人和住院患者身上。理解儿科用药说明的能力是一个关键的健康素养和患者安全问题。最近，美国食品和药物管理局认识到这个问题的重要性，并发布了新的指导方针，以促进改进儿童液体药物的标签和测量设备。虽然这些建议是必不可少的第一步，但需要证据来支持设计最佳指导和设备的“最佳实践”的发展，特别是对于读写能力和/或英语水平有限的父母。我们的研究目标是确定处方和非处方儿科液体药物的标签和剂量的循证“最佳实践”，以促进安全，适当的使用。首先将进行一系列实验，以检验特定剂量和测量策略的有效性，以提高家长对儿科液体药物的理解和使用，包括检查仅限毫升的标签说明和设备的影响，以及象形文字剂量图的潜在作用。研究结果将与现有的以证据为基础的卫生素养“最佳实践”药物标签相结合，以制定一个全面的、以患者为中心的儿科液体药物标签和剂量策略。以患者为中心策略的有效性将作为一项随机对照试验的一部分进行评估，研究对象是在儿科急诊科新开口服液体抗生素的英语和西班牙语家长。该研究的次要目标包括扩展关于卫生知识普及和儿科药物使用的文献，并为实现和实施儿科液体药物的标签和剂量标准制定政策路线图。