Anti-cancer vials: identifiable?

4 October 2018

M.Gallard1 , J.Arcizet1, M.Laplace1, L.Jolly2, B.Dalifard1, B. Le Franc1 1 Unité de Reconstitution des Cytotoxiques (URC), service Pharmacie, GH La Rochelle Ré Aunis, France
2 Service Biomédical, GH La Rochelle Ré Aunis, France

The US has established a national drug code NDC (National Drug Code), mandatory on each primary packaging, especially for anticancer drugs. In 2007, the ANSM forced pharmaceutical companies to present a Datamatrix on all secondary packagings. From 12th February 2019, the serialization of the secondary packaging of drugs will be mandatory. In both cases, the presence of a unique identifier on the primary packaging is not mandatory.

The main objective is to assess the identification security of primary packaging for cancer drugs marketed in France in 2018. Secondly, to determine if there are suppliers offering this differentiation that can enhance the safety of preparations. To do this, we analyzed all of the cytotoxic vials recorded in the user database of the Drugcam® digital video tool in France. The evaluation criteria are: vial with a barcode or readable Datamatrix, vial with a GTIN (Global Trade Item Number) encoded in a barcode or readable Datamatrix.

322 different bottles are registered in the database (21 health facilities in France). One hundred vials have a bar code or Datamatrix (31%): 47 with GTIN encoded in a barcode or Datamatrix, and 53 have a bar code or Datamatrix but unusable. In total, 7 manufacturers (13.7%) supply vials with GTIN and only 15% of the vials are truly identifiable. Four out of fifty one manufacturers have a percentage of vials identified above 50% (Roche: 68.8%, Accord: 61.8%, Janssen Cilag: 57.1% and Arrow: 54.5%).

Nearly 90% of vials are not identifiable by barcode technology or Datamatrix if secondary packaging is removed. For decision support for selecting a generic cancer drug provider for this identification criterion, only 2 laboratories have this added value. Only 15% of products have discriminant identification. With the current stockouts, 4% of used foreign bottles are observed which implies new problems of identification and understanding of the labeling (language, pictogram...).

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