Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions : Comparative regulation framework of off label prescriptions in pediatrics: a review.

Background Off-label uses of medicines are common in pediatrics. The literature reports that at least one-third of children in hospital and up to 90% of newborns in neonatal intensive care units receive off-label prescriptions. Moreover, the lack of data on safety and efficacy in the pediatric population may sometimes increase the risk of adverse drug reactions. Objective This paper aims to (a) map the main gaps in the existing EU and US regulatory frameworks for pediatric drug development and off-label use and (b) propose potential solutions for further discussion. Conclusion The selected jurisdictions aim to limit off-label prescribing, but implementation levels generally seem low, including in pediatric settings. Subject to further research, we propose potential concerted actions and initiatives of international cooperation to fill this gap. In particular, regulators and pediatric societies could strengthen manufacturers' incentives to develop pediatric medicines, pediatricians' information about off-label uses, and patients' and parents' awareness.

An empirical study of healthcare providers and patients' perceptions of electronic health records.

This paper is the result of a legal and policy analysis of a statistical poll focused on the area of Livorno conducted by the LIDER-Lab of the Scuola Superiore Sant'Anna (Pisa, Italy). Information were gathered by submitting questionnaires to both healthcare providers and their patients. The scope was to evaluate the interest engendered by the application of technology on health data processing along with the needs, expectations and concerns of patients and healthcare providers. The paper leads to the main policy proposals of increasing financial investments in e-health (or at least preserve this area from the generalized budget constraints public health is suffering nowadays) and introducing incentives to use computers for general practitioners.