Information in summaries of product characteristics about use in children is limited and needs standardisation: a systematic analysis in Switzerland.

BACKGROUND

A considerable proportion of drugs administered to children are not authorised for this purpose, and consequently off-label use is common in paediatric care. Our aims were to quantify systematically the number of drugs authorised in Switzerland for use in children based on their current summary of product characteristics (SmPC) and to assess the quality of this information.

METHODS

We used natural language processing to screen all Swiss SmPCs, available in German language in the open-source drug database, for information about use in children. Based on the SmPCs of the most frequently used drugs in Swiss children's hospitals, 10 search terms were defined to retrieve this information.

RESULTS

Of the analysed 4214 drugs corresponding to 1553 active substances, 2322 (55.1%) drugs were authorised for use in children. In only 639 (15.2%) SmPCs, information about authorisation for children was found in the section 'Therapeutic indications'. 320 (13.8%) SmPCs of drugs authorised for use in children contained only verbal age indications such as 'children' and 'adolescents' without a clear definition of the age or an age range.

CONCLUSIONS

Most Swiss SmPCs contain information about children, but only a minority refer to an official indication. Even if some SmPCs clearly indicate that use in children is authorised, a clear statement of the age at which the drug may be administered is missing. Standardisation of information about use in children in SmPCs is needed.