Abstract
BackgroundThe 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.MethodsThe 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).ResultsA 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.ConclusionsThe 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.
Highlights
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
Postmarket surveillance of products approved by the United States Food and Drug Administration (FDA) provides real-world patient and provider experience and allows for monitoring of the product outside the confines and protections of randomized controlled clinical trials
The available evidence regarding the efficacy and safety of an over-the-counter (OTC) monograph drug is often sparse, for children, due to the historical nature of products that have been readily available for decades and deemed as “generally recognized as safe and effective” by the FDA [5, 6]
Summary
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. Postmarket experience gives patients and providers confidence when expected safety profiles are supported with real-world data. This type of surveillance has played a critical role in discovering safety signals that were not detected pre-market and in extreme cases resulted in removal of unsafe prescription products from the market. A couple of well publicized examples of drug removal include that of rofecoxib [1] and Opana®.[2] While postmarket surveillance plays a critical role in patient safety, the methods by which data. The available evidence regarding the efficacy and safety of an over-the-counter (OTC) monograph drug is often sparse, for children, due to the historical nature of products that have been readily available for decades and deemed as “generally recognized as safe and effective” by the FDA [5, 6]
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