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Ultrasound contrast media in paediatric patients: is it an off-label use? Regulatory requirements and radiologist’s liability

Il mezzo di contrasto ecografico in età pediatrica: uso off-label? Presupposti normativi e responsabilità del radiologo

  • Paediatric Radiology / Radiologia Pediatrica
  • Published:
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Abstract

The use of ultrasound contrast media is yet to be validated in children. The rare reports in the scientific literature denote their “sporadic” and “experimental” use. Their most likely use is in the setting of off-label prescription of medications. As there are still no guidelines available in Italy for the off-label use of medications, we aim to define the duties, obligations and liability of ultrasound radiologists according to the laws in force.

Riassunto

L’utilizzo del mezzo di contrasto ecografico a tutt’oggi non risulta ancora validato in età pediatrica. Le rare segnalazioni nella letteratura scientifica ne riportano un impiego sporadico e sperimentale. La sua utilizzazione è probabilmente da considerarsi nell’ambito delle prescrizioni dei farmaci off-label. Poiché in Italia per l’impiego dei farmaci off-label non sono ancora disponibili linee guida specifiche, si cerca di definire, secondo la normativa vigente, gli adempimenti, gli obblighi e le responsabilità del medico ecografista.

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Authors and Affiliations

  1. Struttura Complessa di Radiologia, Azienda Ospedaliera Pediatrica “Santobono-Pausilipon”, Via Mario Fiore 6, 80129, Napoli, Italy

    F. Esposito & P. Oresta

  2. DAS Diagnostica per Immagini e Radioterapia, Università “Federico II”, Napoli, Italy

    M. Di Serafino, P. Sgambati & G. Vallone

  3. Studio legale associato “Mercogliano&Celestino”, Rossano, CS, Italy

    F. Mercogliano

  4. U.O. di Epatologia ed Ecointerventistica, ASL NA3, Ospedale S. Giovanni di Dio, Frattamaggiore, NA, Italy

    L. Tarantino

Authors
  1. F. Esposito
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  2. M. Di Serafino
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  3. P. Sgambati
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  4. F. Mercogliano
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  5. L. Tarantino
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  6. G. Vallone
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  7. P. Oresta
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Correspondence to F. Esposito.

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Esposito, F., Di Serafino, M., Sgambati, P. et al. Ultrasound contrast media in paediatric patients: is it an off-label use? Regulatory requirements and radiologist’s liability. Radiol med 117, 148–159 (2012). https://doi.org/10.1007/s11547-011-0718-1

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  • DOI: https://doi.org/10.1007/s11547-011-0718-1

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