Digital package leaflet
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Changes
All medicines have a package leaflet with important information. The package leaflet is available inside the pack and as a digital version online at felleskatalogen.no. The digital version is always up-to-date which increases patient safety.
Page contents
The paper package leaflet available inside the pack has clear limitations. Among other things, it takes a long time to update them: printing, packing and distribution, for example.
Benefits of the digital package leaflet
The main advantage of the digital package leaflet is that it’s always up-to-date. The digital version makes it possible to add useful information for patients, such as video with instructions for proper use. It’s easily accessible via mobile phone and computers, and scanning of the barcode printed on the pack takes you directly to the latest version of the package leaflet at felleskatalogen.no
How to find the digital package leaflet
You can find the digital version by scanning the barcode on the medicine pack. Follow these steps:
- Using your mobile phone, go to the website felleskatalogen.no
- Tap the icon in the search bar that looks like a QR code, or tap the Finn pakningsvedlegg (Find package leaflet) menu option
- A black screen with a red stripe is displayed
- Give the website access to your camera
- Scan the barcode with your camera
- The package leaflet is displayed
Use of digital package leaflets may bring many benefits.
Medicine distribution and multinational packs
The requirement for a Norwegian package leaflet in all medicine packaging may be a barrier against implementing multinational packs. NOMA therefore works towards a transition to digital package leaflets in Norway and the Nordic region.
A larger market for the packs sold in Norway will reduce vulnerability to medicine shortages and will make it more cost-effective to market products in Norway as well. Most medicine shortages are being solved at present by allowing sales of packs from other countries than Norway. With increased use of multinational packs, the number of shortages will probably decrease because the “foreign pack” will be identical to those sold in Norway.
Many medicines that are particularly suitable for children are not distributed in Norway due to the small market, making it unprofitable. With multinational packs, the additional cost to access the Norwegian market will be significantly reduced.
A digital format provides more options for supplementary information, such as video, images and illustrations, which is updated quickly and is cost-effective.
Reuse across different channels
In addition to the paper version in the pack, the European Medicines Agency (EMA) offers on its website the package leaflets in different EU languages as PDF documents. Pharmaceutical manufacturers and European pharmaceutical authorities have been pushing for these to be available in an open, structured data format, which enables access across different digital channels.
The national pharmaceutical product compendia in the Nordic region aim to make package leaflets available in all Nordic languages in a common European structured data format. In 2024, patients and healthcare professionals will be able to easily access package leaflets in all Nordic languages.
European cooperation
In Europe, work has been underway for a long time on an agreement for the development, availability, and use of electronic product information, also called ePI. This work is under the direction of the EMA. Full adoption of digital product information relies on changes in the law and the regulatory environment. Thus far, the EMA has prepared key principles on how this is to happen in Europe. See the key principles on the EMA website.
The adoption of the ePI is difficult because different European countries have different needs and different levels of digital maturity. European patient and healthcare personnel organisations have been critical of promoting digital versions, as many believe it will discriminate against the elderly population, who use medicines the most.
Regulatory changes
The European Commission is now working on extensive changes to EU pharmaceutical legislation. NOMA wants each member state to be able to decide whether and when it wants to use the digital package leaflet as a replacement for the paper version. If the EU’s new pharmaceutical legislation gives this opportunity, Norway will take the lead in introducing digital package leaflets.
Norway and the Nordic countries – digital literacy
In Norway and the Nordic countries, digital literacy is higher, and the infrastructure is better than in many other European countries. Almost everyone has access to the internet on their smartphones and/or computers. Digital information on medicine from Felleskatalogen is well known and is often used by Norwegian healthcare professionals and many patients. User surveys show that Felleskatalogen is the most widely used source of information on medicines in Norway. As of 22 January 2024, Felleskatalogen had 6,25 million site visits package leaflets in the last twelve months, corresponding to about 17 000 views per day.
Digital package leaflets are therefore ready to replace printed package leaflets in Norway and the Nordic countries.
On this basis, NOMA wants patients and healthcare professionals to use digital package leaflets as their first choice.