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Quality of published case reports on adverse drug reactions in children
  1. Piero Impicciatore,
  2. Valeria Iato,
  3. Vincent Sevoz,
  4. Massimiliano Mucci
  1. Safety Evaluation and Reporting, Worldwide Safety and Regulatory Operations, Pfizer Medical, Milan, Italy
  1. Correspondence to Piero Impicciatore, Safety Evaluation and Reporting, Worldwide Safety and Regulatory Operations, Pfizer Medical, Via Lorenteggio, 257, 20152 Milan, Italy; piero.impicciatore{at}pfizer.com

https://doi.org/10.1136/archdischild-2011-300294

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    In 2007, the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) released guidelines for publishing case reports on adverse drug reactions (ADRs). These guidelines describe what authors should consider when constructing an ADR case report for publication in terms of key information about the affected patient, administered drugs, reported reaction, causality assessment and implications for clinical practice.1

    In this study, we assessed the adherence to ISPE/ISoP guidelines for ADR case reports of paediatric patients published from January 2008 to December 2010 and entered in Pfizer's safety database. We also developed a case report quality score by assigning a value …

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    Footnotes

    • Competing interests None.

    • Provenance and peer review Not commissioned; externally peer reviewed.