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DI-107 Creation of an Italian network for the active surveillance of off-label drug prescriptions in paediatrics
  1. D Zanon1,
  2. G Schillani1,
  3. A Maestro1,
  4. R Paparazzo1,
  5. L Ronfani2,
  6. F Marchetti3,
  7. F Rovere1
  1. 1Institute for Maternal and Child Health IRCCS “Burlo Garofolo", Pharmacy and Clinical Pharmacology Unit, Trieste, Italy
  2. 2Institute for Maternal and Child Health IRCCS “Burlo Garofolo", Epidemiology and Biostatistics Unit, Trieste, Italy
  3. 3Azienda Ospedaliera of Ravenna, Department of Maternal and Child Health Unit, Ravenna, Italy


Background Many drugs currently on the market have no specific authorisation for use in children and are used outside the licensed indications (off-label use). Off-label use might be associated with an increased risk of adverse drug reactions (ADRs), therefore it is important to implement monitor it in order to provide more careful clinical surveillance of prescriptions. An online database could offer an active network of off-label drugs pharmacovigilance, helping paediatricians and hospital pharmacists in prescribing, assessment of efficacy, follow-up and collection of ADRs.

Purpose To create an Italian online network and offer it to hospital pharmacists collaborating with paediatricians, so that they may share optimal off-label prescription practice and monitor possible adverse drug reactions.

Materials and methods The project examined all off-label prescriptions and follow-ups of children aged 0–18 years in regional paediatric departments participating in a web-based Friuli-Venezia Giulia Italian region network developed in Hypertext Preprocessor (PHP), based on open-source tools. Physicians create an online prescription for each new patient, referencing the literature that supports the off-label use, recording the follow-up, and reporting any adverse reactions. The hospital pharmacist examines each off-label prescription in detail, and updates the relative off-label archive, integrating and reviewing literature references, and recording dispensing data of prescribed medications (date, amount and costs).

Results We started to set up the Regional Pharmacovigilance Network in March 2013 and it is now almost ready to be used.

Conclusions If pharmacists and paediatricians cooperate successfully in this project, it will allow more complete and thorough monitoring of off-label treatment, to better protect paediatric patients’ health.

No conflict of interest.

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