Paediatric palliative care and off-label drug use

Key words: Paediatric palliative care, Pain, Off-label drugs

Paediatric palliative care (PPC) aims to ensure the control of symptoms and the best possible quality of life for patients whose underlying disease, characterised by an unstoppable evolution and negative prognosis, no longer responds to specific treatments. The Italian Medicines Agency (Agenzia Italiana del Farmaco - AIFA) and the Italian Society of Palliative Care (Società Italiana di Cure Palliative - SICP), within a dedicated working group, wrote a document that collects the scientific evidence available to support the offlabel drugs that are more frequently used in adult and PPC. The goal is to certify the consolidated off-label use of these drugs (under the Law 648/96), in the absence of data from its pivotal clinical trials. The paper reports the conditions for this important work and presents the 10 drugs that are usually used off-label in PPC and in pain therapy. At present they are included in Law 648/96 and deemed essential to resolve, at least in part, the unavailability of medicines approved for use in this specific setting.