The e-Leaflet concept for pharmaceutical products

With the world moving forward towards digitalisation, we can use the e-leaflet in pharmaceutical products, in turn preventing trees, informs PB Gite, AGM- Packaging Development, Kopran

All of us know about global warming and the fact that lots of forests are destroyed and large number of trees are cut for paper mills. Worldwide, tons of wood pulp is used for making the paper pulp. Now, with the world moving forward towards digitalisation, we can use the e-leaflet in pharmaceutical products.

The leaflet is always being used for regulatory, clinical dosage and for doctor information. Moreover, leaflets are never read by patients or are not useful for them. Most of the leaflet dimension is large sized and contains huge text matter for regulatory market of Europe, US and South Africa. With the availability of Google search engine, people mostly use mobile phones and product information like category, dosage forms and pack sizes is readily available to them.

However, there are many hurdles for using leaflet along with products during packing. As leaflet size is too big, secondary packing like carton and outer shippers need to increase their sizes due to which transport cost is increased. For insertion of leaflet during packing of product, there are several types of equipment required like continuator machine, leaflet folder machine, booklet feeder and camera for detection of pharma code. Moreover, with the insertion of leaflet, productivity gets hampered during product packing.

QR codes can be used on various mobile device operating systems. These devices support URL redirection, which allows QR codes to send metadata to existing applications on the device. Many paid or free apps are available with the ability to scan the codes and hard link to an external URL.

QR Codes on promotional material serve as an excellent tool to drive traffic from print media to online content. But, it’s not just marketers who can benefit from QR Codes, but patients and healthcare professionals can also do the same.

A pharma company/medical group/healthcare company can use QR Codes to:

  • redirect audience to website
  • show them a video on subject-specific matter
  • provide detailed product information via PDF

There can be many other uses as well. One can use QR Codes on print media material such as flyers, newspapers, and magazines. QR Codes cannot only help with promotions, but also help curb the issue of wrong medication and fake medicines.

In Jan 2018, researchers at University of Copenhagen developed a new method to produce medicines. They produced a white edible material and used medicine to print a QR Code on it.

On scanning the QR Code, one will get all the information about the medicine. This can potentially help reduce the cases of wrong medication and even fake medicines.

The fact that QR Codes can be of great use has been acknowledged by the European Medicines Agency (EMA). They issued guidelines to pharmaceutical companies who wish to add a QR Code on to packaging or even on package leaflet of centrally-authorised medicinal products.

Some highlights from the EMA guidelines

  • Pharma companies can add a QR Code to the packaging material or package leaflet of centrally-authorised medicinal products. This can be as long as the linked information is useful to the patient and not promotional in any way
  • Pharma companies should inform the EMA of their intention to use QR Codes via a request. This can be made as part of the initial marketing authorisation application (pre-authorisation) or after authorising the medicinal product
  • A complete request/declaration form needs to be submitted to the EMA. It should have relevant information such as linked content, labelling mock-ups, and location of the QR Code
  • The QR Code can contain any information that is relevant to the patient and the product. And it can be in the form of a website, webpage, PDF document, video, or link to a mobile app. The information in the QR Code cannot be promotional
  • The information linked with the QR Code should be ‘additional’ information to patients and healthcare professionals. Also, it should not replace important statutory information such as the printed package leaflet
  • The location of the QR Code should not affect the readability of statutory information. Inclusion of several QR Codes on a single package in not recommended
  • The QR Code should be available in all the member states where marketing of the medicinal product is done. And the information should be available in all the EU official languages of those member states
  • Patients should have the option of either scanning a QR Code via a smartphone or entering a short URL in a web browser