title: Pediatric post-marketing safety systems in North America: assessment of the current status.
abstract: OBJECTIVE
  It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use.
  
  
  METHODS
  We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety.
  
  
  RESULTS
  Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples.
  
  
  CONCLUSIONS
  Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics.
authors.affiliation: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Ann W
authors.initials: AW
authors.lastname: McMahon
authors.affiliation: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Gerold T
authors.initials: GT
authors.lastname: Wharton
authors.affiliation: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Renan
authors.initials: R
authors.lastname: Bonnel
authors.affiliation: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Mary
authors.initials: M
authors.lastname: DeCelle
authors.affiliation: Office of Pharmacovigilance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Kimberley
authors.initials: K
authors.lastname: Swank
authors.affiliation: Duke Clinical Research Institute, Duke School of Medicine, Durham, NC, USA.
authors.forename: Daniela
authors.initials: D
authors.lastname: Testoni
authors.affiliation: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Judith U
authors.initials: JU
authors.lastname: Cope
authors.affiliation: Duke Clinical Research Institute, Duke School of Medicine, Durham, NC, USA.
authors.forename: Phillip Brian
authors.initials: PB
authors.lastname: Smith
authors.affiliation: Office of Pharmacovigilance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Eileen
authors.initials: E
authors.lastname: Wu
authors.affiliation: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Mary Dianne
authors.initials: MD
authors.lastname: Murphy
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D057186:Comparative Effectiveness Research; D057225:Data Mining; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology*; D057286:Electronic Health Records; D006801:Humans; D009656:North America / Q000453:epidemiology; D061214:Patient Safety; D017891:Pharmacoepidemiology / Q000379:methods*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
keywords: FDA; Pediatrix; active surveillance; adalimumab; adverse events; cilastatin; drug safety; electronic medical record; etanercept; imipenem; infliximab; meropenem; octreotide; passive surveillance; pharmacoepidemiology; retrospective chart review