TY - JOUR
T1 - Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children
AU - Green, Jody L.
AU - Reynolds, Kate M.
AU - Banner, William
AU - Bond, G. Randall
AU - Kauffman, Ralph E.
AU - Palmer, Robert B.
AU - Paul, Ian M.
AU - Dart, Richard C.
N1 - Funding Information:
The authors wish to thank Heather Delva, Dr. G. Sam Wang, and the team of abstractors at RMPDC for their contributions in supporting data collection.The American Association of Poison Control Centers (AAPCC; https://aapcc.org) maintains the national database of information logged by the country’s regional Poison Centers (PCs) serving all 50 United States, Puerto Rico, and the District of Columbia. Case records in this database are from self-reported calls: they reflect only information provided when the public or healthcare professionals report an actual or potential exposure to a substance (e.g. an ingestion, inhalation, or topical exposure, etc.) or request information/educational materials. Exposures do not necessarily represent a poisoning or overdose. The AAPCC is not able to completely verify the accuracy of every report made to member centers. Additional exposures may go unreported to PCs and data referenced from the AAPCC should not be construed to represent the complete incidence of national exposures to any substance(s). REDCap is supported in part by NIH/NCRR Colorado CTSI Grant Number UL1 RR025780. Contents are the authors’ sole responsibility and do not necessarily represent official NIH views.
Funding Information:
This study is funded through an unrestricted grant provided by the Consumer Healthcare Products Association Pediatric Cough Cold Task Group to Denver Health Rocky Mountain Poison and Drug Center. The sponsor was not involved in the study design, data collection, or data analysis.
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/12/22
Y1 - 2018/12/22
N2 - Background: The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System. Methods: The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure). Results: A total of 7184 unique cases were identified from 27,597 detected reports. Of these, 6447 (89.7%) were evaluable. The data source with the highest volume of detected cases was news/media; however, only 0.3% of those cases were eligible for panel review and only 0.2% (24 out of 13,450 cases) were evaluable. The data source with the highest proportion of eligible and evaluable cases was NPDS with 7691 detected cases, 6113 (79.5%) eligible cases, and 5587 (72.6%) evaluable cases. Conclusions: The data sources utilized to evaluate the safety profile of pediatric CCMs yielded variable detection and evaluation rates, but overall provided a comprehensive look at exposures that otherwise cannot be studied in clinical trials. While this study suggests that each source made a valuable contribution and that evaluable cases are generalizable, improvements are needed in case completeness and accuracy to enhance the quality of postmarket safety evaluations.
AB - Background: The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System. Methods: The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure). Results: A total of 7184 unique cases were identified from 27,597 detected reports. Of these, 6447 (89.7%) were evaluable. The data source with the highest volume of detected cases was news/media; however, only 0.3% of those cases were eligible for panel review and only 0.2% (24 out of 13,450 cases) were evaluable. The data source with the highest proportion of eligible and evaluable cases was NPDS with 7691 detected cases, 6113 (79.5%) eligible cases, and 5587 (72.6%) evaluable cases. Conclusions: The data sources utilized to evaluate the safety profile of pediatric CCMs yielded variable detection and evaluation rates, but overall provided a comprehensive look at exposures that otherwise cannot be studied in clinical trials. While this study suggests that each source made a valuable contribution and that evaluable cases are generalizable, improvements are needed in case completeness and accuracy to enhance the quality of postmarket safety evaluations.
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U2 - 10.1186/s12874-018-0626-3
DO - 10.1186/s12874-018-0626-3
M3 - Article
C2 - 30577764
AN - SCOPUS:85058922523
SN - 1471-2288
VL - 18
JO - BMC Medical Research Methodology
JF - BMC Medical Research Methodology
IS - 1
M1 - 175
ER -