EU regulators mull on-pack QR codes for patient communication

Allowing QR codes on medicines packaging is being considered by European regulators, reflecting the shift towards digital communication between drugmakers and patients.

The move shows that EU regulators are on board with using on-pack codes in a way that extends beyond compliance with the drug authentication principles – based on 2D datamatrix codes - enshrined within the Falsified Medicines Directive.

According to a recent position paper, Europe’s Heads of Medicines Agencies’ Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) says the 2D codes that can be scanned by a smartphone could be useful as a means to provide product information for both prescription and over-the-counter medicines.

QR codes are a relatively old coding technology but have the explosion in smartphone use means more and more companies are using them to interact with customers. In the case of pharmaceuticals, this code would be included on the pharma packaging and link to webpages maintained by drug companies or the National Competent Authorities. The European Medicines Agency (EMA) issued guidance on using QR codes on packs in 2015.

The group says QR codes are not mandatory but any inclusion of a QR code would be automatically accepted by all Member States “without any further assessment, which is particularly of relevance in the case of mutual recognition (MRP) and decentralised (DCP) procedures” that form part of the marketing authorisation. The intention of including a QR code would have to be declared in marketing authorisation applications, however, the details of which the CMDh outlines in the position paper.

The CMDh has also agreed that elements that can be provided via a QR code include approved product and statutory information, and risk minimisation material such as education material.

But it goes on to say: “The inclusion of the QR code cannot replace the inclusion of the statutory information (e.g. printed package leaflet).” Rather the QR code would be a way to provide “updated information” on medicinal products, which may not be included on the printed leaflet.

“However, these discrepancies between the latest approved product information (linked via QR code) and the printed information for the patients/users (i.e. patient leaflet) could lead to confusion among the patients or even lead to potential misinterpretation of the product information for similar products in the case of health care professionals. Therefore, it is recognised that this issue should be advised to the users,” the CMDh says.

The Co-ordination Group also notes that some countries allow the QR code to link to additional information such as video content, and says the inclusion of such extra information should be managed and discussed nationally.

The position of the QR code is also discussed in the position paper. The CMDh says it should be included in the outer carton and/or package leaflet “if the legibility is not negatively affected by its inclusion”, and on the inner lid/inner flap of the carton in the case of small packages. Meanwhile, the URL linking to the QR code content should also be displayed along with the QR code “so that patents without a smartphone or device can still access the info via the web”.

The CMDh also notes that the inclusion of more than one QR code is not recommended.

The position paper only considers the use of QR codes for product information, and stresses that only 2D datamatrix codes can be used for manufacturing processing and as a safety feature under the falsified medicines legislation.

The CMDh notes that the FMD does not prohibit the placing of a QR code on drug packaging “as far as it is not used for the purposes of identification and authentication of medicinal products”.

The group, however, advises that companies wishing to include product information via a QR code should “wherever technically feasible, exploit the residual storage capacity of the 2D barcode data matrix [as required by the FMD] to include the information they would otherwise include in the QR code”.

The CMDh states: “This would minimise the number of visible barcodes on the packaging and reduce the risk of confusion as regard the barcode to be scanned for verifying the authenticity of the medicinal product.”