Subject(s)
Cardiology , Drug and Narcotic Control/organization & administration , Hypertension, Pulmonary , Pediatrics , Randomized Controlled Trials as Topic , Sildenafil Citrate , Cardiology/methods , Cardiology/standards , Child , Child Advocacy , Child Health/legislation & jurisprudence , Dose-Response Relationship, Drug , Drug Development/methods , Drug Development/standards , Humans , Hypertension, Pulmonary/drug therapy , Hypertension, Pulmonary/mortality , Mortality , Off-Label Use/legislation & jurisprudence , Outcome Assessment, Health Care/ethics , Outcome Assessment, Health Care/statistics & numerical data , Pediatrics/methods , Pediatrics/standards , Randomized Controlled Trials as Topic/ethics , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards , Sildenafil Citrate/administration & dosage , Sildenafil Citrate/adverse effects , Vasodilator Agents/administration & dosage , Vasodilator Agents/adverse effectsSubject(s)
Drug Development/legislation & jurisprudence , Health Policy/legislation & jurisprudence , Hypertension, Pulmonary/drug therapy , Pediatrics/legislation & jurisprudence , Phosphodiesterase 5 Inhibitors/therapeutic use , Sildenafil Citrate/therapeutic use , Vasodilator Agents/therapeutic use , Adolescent , Age Factors , Child , Child, Preschool , Drug Approval/legislation & jurisprudence , Government Regulation , Humans , Hypertension, Pulmonary/diagnosis , Hypertension, Pulmonary/physiopathology , Infant , Patient Safety/legislation & jurisprudence , Phosphodiesterase 5 Inhibitors/adverse effects , Policy Making , Risk Assessment , Risk Factors , Sildenafil Citrate/adverse effects , Treatment Outcome , United States , United States Food and Drug Administration/legislation & jurisprudence , Vasodilator Agents/adverse effectsABSTRACT
PURPOSE: 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.
