Global Medical Affairs, Clinical Research and Toxicology, McNeil Consumer Healthcare , Fort Washington, PA , USA.
Clin Toxicol (Phila). 2013 Dec;51(10):930-6. doi: 10.3109/15563650.2013.855314. Epub 2013 Nov 28.
Changes to regulations, packaging, and labeling and ongoing educational efforts are intended to support appropriate use of medicines. Yet annually poison centers receive > 500 000 reports of accidental or unsupervised exposure to medicines for children under 6 years of age.
To identify root (i.e., fundamental and preventable) causes of accidental unsupervised ingestions (AUIs), we designed a questionnaire and conducted a follow-up survey of caregivers who contacted McNeil Consumer Healthcare (McNeil) following an AUI by a child under 12 years of age.
Reports received between 1 October 2008 and 22 January 2009 were screened retrospectively for specific Medical Dictionary of Regulatory Activities (MedDRA) Preferred Terms relating to AUIs. Using the questionnaire, we collected information about the child, caregiver, medicines involved in AUI, management of AUI, and storage location of medicines.
Two hundred twenty reports met inclusion criteria and attempts to contact these caregivers were made throughout a 2-week period in March 2009; caregivers completed the questionnaire for 45 reports. All AUIs occurred in children under 7 years and 56% were boys. In 56% of AUI cases, the child involved was the intended recipient of the medicine; in 71%, a pediatric medicine was involved. Most AUIs occurred in the child's home; most caregivers reported not observing the AUI. Sixty percent of caregivers reported that the medicine involved in AUI was not in the normal storage location when AUI occurred. Among children involved in AUIs, 84% did not experience any symptoms. Seven children experienced mild, self-limiting symptoms which resolved. AUIs often occurred < 24 h after last therapeutic use when the medicine was removed from its normal storage location.
These new insights may help guide-targeted interventions and educational efforts to focus caregivers' attention to reengaging childproofing mechanisms and returning medicines to a secure location, high and out of sight, immediately after use.
法规、包装和标签的变化以及持续的教育工作旨在支持药物的合理使用。然而，每年中毒控制中心都会收到超过 50 万例 6 岁以下儿童意外或无人监督接触药物的报告。
为了确定意外无人监督摄入（AUI）的根本（即基本和可预防）原因，我们设计了一份问卷，并对接触 McNeil 消费者保健（McNeil）的护理人员进行了后续调查，这些护理人员在 12 岁以下儿童发生 AUI 后联系了 McNeil。
对 2008 年 10 月 1 日至 2009 年 1 月 22 日期间收到的报告进行回顾性筛选，以确定与 AUI 相关的特定监管活动医学词典（MedDRA）首选术语。使用问卷收集了有关儿童、护理人员、AUI 中涉及的药物、AUI 管理以及药物储存位置的信息。
220 份报告符合纳入标准，并于 2009 年 3 月的两周内尝试联系这些护理人员；45 份报告的护理人员完成了问卷。所有 AUI 均发生在 7 岁以下儿童中，其中 56%为男孩。在 56%的 AUI 病例中，所涉及的儿童是药物的预期接受者；71%涉及儿科药物。大多数 AUI 发生在儿童家中；大多数护理人员报告未观察到 AUI。60%的护理人员报告说，AUI 发生时，所涉及的药物不在正常储存位置。在发生 AUI 的儿童中，84%没有任何症状。7 名儿童出现轻微、自限性症状并自行缓解。AUI 通常发生在最后一次治疗性使用后 < 24 小时，当药物从正常储存位置取出时。
这些新的见解可能有助于指导有针对性的干预措施和教育工作，重点关注护理人员重新启用儿童防护机制，并在使用后立即将药物放回安全位置，放在高处且视线之外。
