The TEDDY Network promotes the paediatric pharmacological research as well as adequate health policies, also through the actions of its Working Groups (WGs), addressing the most important needs of the paediatric research and providing open areas of discussion on specific topics of interest in the paediatric field.
Considering the high relevance of the topic of the off-label medicines use in paediatrics which is widespread in Europe and worldwide and considering that often there is no alternative treatments, TEDDY has dedicated an ad hoc WG on this issue. The main aim of this WG is to prepare a document to promote a paediatric medicine “good use” including off-label.
Among the main activities performed by this WG there are:
- The preparation of a comprehensive overview of the existing documents and recommendations on the issue of paediatric off-label medicines use;
- The preparation of a first draft of a paediatric informative guide, using a consensus approach (Delphi or similar) and based on the previous cited overview in which the most relevant aspects related to paediatric off-label use will be considered.
The first step to prepare this guidance has been the preparation of a brief survey collecting the WG members opinion on the document’ possible contents. WG Members were requested to participate to the consultation and agreed on: a. the document primary objective, b. the available data sources; c. the type of document; d. the topic relevance.
The TEDDY WG is now starting with a literature/available documents search on the major topics of interest and the analysis of the results will be done before to proceed with the draft of the consensus statement. After the internal consent, the document will be shared with medical experts, researchers, patients and regulatory people. Industry point of view will be also considered. This document will be primarily intended to provide patients, families and prescribers with the best guidance and tools based on as much evidence as possible, on the efficacious and safe off-label use of medicines in paediatric patients.
Further information about this and the other Working Groups are available at this link.