title: New insights into root causes of pediatric accidental unsupervised ingestions of over-the-counter medications.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Global Medical Affairs, Clinical Research and Toxicology, McNeil Consumer Healthcare , Fort Washington, PA , USA.
authors.forename: Sandy
authors.initials: S
authors.lastname: Schoenewald
authors.forename: Stacey
authors.initials: S
authors.lastname: Ross
authors.forename: Leslie
authors.initials: L
authors.lastname: Bloom
authors.forename: Megha
authors.initials: M
authors.lastname: Shah
authors.forename: Joseph
authors.initials: J
authors.lastname: Lynch
authors.forename: Changshuan Lily
authors.initials: CL
authors.lastname: Lin
authors.forename: Mitesh
authors.initials: M
authors.lastname: Patel
authors.forename: Kathleen
authors.initials: K
authors.lastname: Boyle
authors.forename: Edwin
authors.initials: E
authors.lastname: Kuffner
mesh_terms: D017028:Caregivers; D002648:Child; D002675:Child, Preschool; D003625:Data Collection; D005260:Female; D006801:Humans; D008297:Male; D004366:Nonprescription Drugs / Q000506:poisoning*; D010372:Pediatrics; D011041:Poisoning / Q000453:epidemiology* / Q000517:prevention & control; D011795:Surveys and Questionnaires
chemical_list: D004366:Nonprescription Drugs