Despite European and American initiatives aiming to promote greater awareness and research in the paediatric population, these data demonstrate that there is still a high percentage of unlicensed or off-label drugs use in neonatology, underlining the need to stimulate scientific data collection by means of experimental studies or outcome research.

The use of unlicensed or off-label drugs use is common practice in NICU, with wide variation in local policies and newborn characteristics. Well-designed and -conducted pharmaceutical studies in newborns are needed to increase the number of licensed drugs, thereby reducing any risk for patients due to over- or under-treatment, and also legal issues for clinicians.

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Dislocation or wrong placement of central venous catheters into the pleural cavity is rare, but if undiagnosed, may cause major, sometimes life-threatening, complications (pneumothorax, hemothorax, infection, and migration) and accidental pleural effusion due to intravenous injection of fluids containing drugs (i.e. chemotherapy, antibiotics, parenteral nutrition, other). We report a rare case of pleural effusion consisting of chemotherapy (chemothorax) directly injected into the pleural cavity due to the wrong placement of a central venous catheter (Porth-A-Cath) in a woman with breast cancer. A multidisciplinary management consisting of antidote administration, followed by removal of the venous device and washing of the pleural cavity through video-assisted thoracic surgery (VATS), avoided any major complication related to the adverse event.