An article published in the Drug and Therapeutics Bulletin discusses the functions of the Summary of Product Characteristics (SmPC) – considered by the European Commission to be a regulatory document (setting out the agreed position of the medicinal product as distilled during the course of the assessment process) and also a clinical document, giving healthcare professionals information on how to use the product effectively and safely.  The author argues that these functions are not necessarily the same and that ‘it is therefore appropriate to ask whether the SmPC acts primarily as a clinical reference or a regulatory one, particularly when new information on drug safety emerges’.

They note that the time taken to update an SmPC in light of new information is of concern, and they illustrate this with the recent advice outlined in a ‘Direct Healthcare Professional Communication’ letter (dated 2 November 2011), about the risk of dose-dependent QT interval prolongation with citalopram, which has resulted in changes to the dosing recommendations.  By the middle of January there had been no changes made to the SmPCs available online.  They go on to raise further issues that need to be addressed, including the citing of summarised study data with no way of identifying the full published version (if available) and their availability. 

The author concludes that “it should be a requirement that market authorisation holders update their products' SmPCs with essential safety data as soon as such data is made available.”