Abstract
BackgroundIn Italy, the utilization and the reimbursement of Growth Hormone (rGH) therapy by the National Health System (Servizio Sanitario Nazionale) are regulated by the “Note #39” included in the “Notes for the use of drugs” by the Italian Medicines Agency (AIFA), which are published in the Official Gazette, thus having the force of law. The “Note #39” establishes the diagnosis for which the reimbursement is granted and confirms the assignment of the national health surveillance on the use of GH therapy to the Italian National Institute of Health, requesting its computerization.AimThe aim of this work was to realize a dedicated electronic Clinical Report Form based on the mandatory data requested by the Note #39 and allowing the online reporting of the rGH prescriptions by the regional accredited centers.Results and ConclusionsThis interface is at the base of the national database of the Italian Registry of GH Treatment, which allows obtaining and managing correct and complete data to provide public health surveillance on GH therapy, both at national and local levels, necessary for policymakers decisions. In addition, this national database could be a useful instrument for improving knowledge about aspects of this treatment still under discussion.
Highlights
Recombinant growth hormone has been used since 1985 and is applied both in Growth Hormone (GH)-deficiency and in non-GH-deficiency diseases, such as Turner (TS) and Prader Willi (PWS) syndromes, chronic renal failure, children born Short for Gestational Age (SGA) and Idiopathic Short Stature in pediatric age
The aim of this work was to design a dedicated electronic Clinical Report Form (e-CRF) to obtain a national database on this treatment as foreseen by the Note #39, including the requested data and the permitted diagnosis and criteria, to realize a computerized RNAOC, useful to perform the national pharmacosurveillance on reimbursement of Growth Hormone (rGH) therapy through the collection of the medical prescriptions
The structures accredited to the RNAOC e-CRF are the Centers, such as hospitals/universities including one or more Operating Units (OU), and the Regions, consisting of the Regional Commission and the administrative figures
Summary
Recombinant growth hormone (rGH) has been used since 1985 and is applied both in Growth Hormone (GH)-deficiency and in non-GH-deficiency diseases, such as Turner (TS) and Prader Willi (PWS) syndromes, chronic renal failure, children born Short for Gestational Age (SGA) and Idiopathic Short Stature (in the USA, but not in Europe so far) in pediatric age. Results and Conclusions This interface is at the base of the national database of the Italian Registry of GH Treatment, which allows obtaining and managing correct and complete data to provide public health surveillance on GH therapy, both at national and local levels, necessary for policymakers decisions. This national database could be a useful instrument for improving knowledge about aspects of this treatment still under discussion.
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
