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Letter
Adverse drug reactions in paediatric age: analysis of spontaneous reports and reasons for under-reporting in a Local Health Unit in Veneto region
  1. Eva Draghi1,
  2. Virginia De Rossi1,
  3. Umberto Gallo1,
  4. Riccardo Bertin2,
  5. Francesca Bano1
  1. 1Pharmaceutical Department, ULSS 6 Euganea Company, Padova, Veneto, Italy
  2. 2Italian Society for Clinical Pharmacy and Therapeutics, Turin, Italy
    1. Correspondence to Dr Riccardo Bertin; riccardo.bertin7{at}gmail.com

    https://doi.org/10.1136/ejhpharm-2024-004335

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      Under-reporting is still one of the main limits of pharmacovigilance. Several studies have pointed out the leading reasons across different healthcare settings: overconfidence in medicines, negligence in prescribing potentially harmful therapies for the patient, professional ambition to publish individual researches, uncertainties regarding event–drug correlation, fear of medical-legal retaliation, lack of interest and/or time, distrust in the pharmacovigilance system and insufficient knowledge on reporting procedures.1 2

      Regarding paediatric population, the role of post-marketing pharmacovigilance is essential because children, together with the frail elderly, are the least represented patient groups in registration studies. Moreover, due to the rapid physiological changes accompanying their growth and maturation, children may show important differences in their response to drugs compared with adults.3 4

      This study aimed to explore the knowledge of paediatricians operating …

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      Footnotes

      • Contributors All authors contributed to the study conception and design. Material definition was performed by ED, UG and FB. Data collection and analysis were performed by ED and VDR. The first draft of the manuscript was written by VDR, ED and RB and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. RB is the guarantor of this Contributorship Statement.

      • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

      • Competing interests None declared.

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