CPC-076 Internal Audit on the Labelling of Investigational Medicinal Products

Background The purpose of labelling is to protect persons who take part to biomedical research. It must enable the product and study to be identified and the drugs to be used safely. The decree of 24 May 2006 [1] sets out the information to be included on the labelling of investigational medical product (IMPs). Purpose To evaluate the regulatory conformity of the labelling of IMPs. Materials and Methods An assessment grid was established from the decree of 24 May 2006. This audit investigated the labelling of the primary or secondary packaging, according to the presentation, of 135 IMPs corresponding to 75 clinical trials. Results Of 135 labels analysed, only 11 (8.1%) bore all the information required by the legislation. On 3 labels, information didn’t appear in French. In more than 5% of the cases, information allowing identification of the product and the study and the good use of the drugs was absent from label. In other cases the following was missing: pharmaceutical form (15.4%), route of administration (15.3%), content of the active substance (11.6%), product identification (6.88%), clinical trial reference (6.88%), patient visit number (71.9%) and storage conditions (14.4%). 57.8% of the labels came in layers. Basic information was not present on the first layer in 26.1% of the cases for the pharmaceutical form, route of administration (55.9%), dosage (13.8%), product identification (11.7%) or storage conditions (45.8%). Conclusions In spite of important and rigorous regulation, we noted non-conformities in labelling with sometimes important omissions. The significant number of statements required to appear on the label leads sponsors to reduce font size and to present the labels in layers. This audit highlights that the significant amount of information on the label makes it difficult to read and can lead to medicines errors, especially in elderly patients. Reference Order of 24 May 2006 establishing the content for the labelling of investigational medicinal products published in France’s official journal on 30 May 2006. No conflict of interest.