PMID- 23993129
OWN - NLM
STAT- MEDLINE
DCOM- 20131230
LR  - 20220316
IS  - 1097-6833 (Electronic)
IS  - 0022-3476 (Linking)
VI  - 163
IP  - 5
DP  - 2013 Nov
TI  - Root causes, clinical effects, and outcomes of unintentional exposures to 
      buprenorphine by young children.
PG  - 1377-83.e1-3
LID - S0022-3476(13)00817-2 [pii]
LID - 10.1016/j.jpeds.2013.06.058 [doi]
AB  - OBJECTIVE: To characterize the rates, root causes, and clinical effects of 
      unintentional exposures to buprenorphine sublingual formulations among young 
      children and to determine whether exposure characteristics differ between 
      formulations. STUDY DESIGN: Unintentional exposures to buprenorphine-containing 
      products among children 28 days to less than 6 years old were collected from the 
      Researched Abuse, Diversion, and Addiction-Related Surveillance System Poison 
      Center Program and Reckitt Benckiser Pharmaceuticals' pharmacovigilance system 
      from October 2009-March 2012. After adjustment for drug availability, negative 
      binomial regression was used to estimate average exposure rates. Root cause 
      assessment was conducted, and an expert clinician panel adjudicated causality and 
      severity of moderate to severe adverse events (AEs). RESULTS: A total of 2380 
      cases were reviewed, including 4 deaths. Exposures to buprenorphine-naloxone 
      combination film were significantly less frequent than exposures to buprenorphine 
      tablets (rate ratio 3.5 [95% CI, 2.7-4.5]) and buprenorphine-naloxone combination 
      tablets (rate ratio 8.8 [7.2-10.6]). The most commonly identified root causes 
      were medication stored in sight, accessed from a bag or purse, and not stored in 
      the original packaging. Among 536 panel review cases, the most common AEs 
      reported for all formulations were lethargy, respiratory depression, miosis, and 
      vomiting. The highest level AE severity did not differ significantly by 
      formulation. CONCLUSIONS: Unintentional exposure to buprenorphine can cause 
      central nervous system depression, respiratory depression, and death in young 
      children. Exposure rates to film formulations are significantly less than to 
      tablet formulations. Package and storage deficiencies contribute to unintentional 
      exposures in young children.
CI  - Copyright (c) 2013 Mosby, Inc. All rights reserved.
FAU - Lavonas, Eric J
AU  - Lavonas EJ
AD  - Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, 
      Denver, CO; Department of Emergency Medicine, University of Colorado School of 
      Medicine, Aurora, CO. Electronic address: eric.lavonas@rmpdc.org.
FAU - Banner, William
AU  - Banner W
FAU - Bradt, Pamela
AU  - Bradt P
FAU - Bucher-Bartelson, Becki
AU  - Bucher-Bartelson B
FAU - Brown, Kimberly R
AU  - Brown KR
FAU - Rajan, Pradeep
AU  - Rajan P
FAU - Murrelle, Lenn
AU  - Murrelle L
FAU - Dart, Richard C
AU  - Dart RC
FAU - Green, Jody L
AU  - Green JL
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130829
PL  - United States
TA  - J Pediatr
JT  - The Journal of pediatrics
JID - 0375410
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Tablets)
RN  - 40D3SCR4GZ (Buprenorphine)
SB  - IM
MH  - Administration, Sublingual
MH  - Analgesics, Opioid/adverse effects/poisoning
MH  - Buprenorphine/*adverse effects/*poisoning
MH  - Central Nervous System/drug effects
MH  - Child, Preschool
MH  - Cross-Sectional Studies
MH  - Drug Packaging
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Pharmacovigilance
MH  - Poison Control Centers
MH  - Registries
MH  - Regression Analysis
MH  - Retrospective Studies
MH  - Tablets
MH  - United States
OTO - NOTNLM
OT  - AE
OT  - Adverse event
OT  - MedDRA
OT  - Medical Dictionary for Regulatory Activities
OT  - RADARS
OT  - REMS
OT  - Researched Abuse, Diversion, and Addiction-Related Surveillance
OT  - Risk evaluation and mitigation strategies
OT  - URDD
OT  - Unique recipients of a dispensed drug
EDAT- 2013/09/03 06:00
MHDA- 2014/01/01 06:00
CRDT- 2013/09/03 06:00
PHST- 2013/04/19 00:00 [received]
PHST- 2013/05/29 00:00 [revised]
PHST- 2013/06/24 00:00 [accepted]
PHST- 2013/09/03 06:00 [entrez]
PHST- 2013/09/03 06:00 [pubmed]
PHST- 2014/01/01 06:00 [medline]
AID - S0022-3476(13)00817-2 [pii]
AID - 10.1016/j.jpeds.2013.06.058 [doi]
PST - ppublish
SO  - J Pediatr. 2013 Nov;163(5):1377-83.e1-3. doi: 10.1016/j.jpeds.2013.06.058. Epub 
      2013 Aug 29.