Paper inserts have long been included when a patient receives prescription medication, but what if that information could be provided – and always kept up to date – electronically? That’s a question the global biotech industry has been working on for several years, with countries like Japan, set to be first to make the change to digital.
The rationale is simple, according to the European Medicines Agency. “Unlike paper package leaflets contained in medicine packages, which are updated gradually as stocks of medicines turn over, it will be possible to rapidly update electronic patient information with the latest authorized information. Patients/consumers and healthcare providers using ePI can be fully confident that they hold the latest information about benefits, risks and use.”
A 2014 study found that more than half of patients said they read the paper insert information that comes with their medicines. Andrew Robinson, CSL Behring’s Head of Global Packaging Design & Artwork, said electronic information could give patients and health care professionals enhanced information that goes beyond what’s currently listed on the paper version.
“Of course, national and regional legislation has to be followed on which information can be provided in this way, to whom and in which format such as audio and video,” Robinson said. “ePI has a potential that is recognized but at the same time not yet clearly defined or quantified.
Shifting to electronic inserts also could give new efficiencies to the manufacture of products that change frequently such as influenza vaccine. Digital patient inserts could save weeks of time because packing could occur while regulators are reviewing the final leaflet information, instead of afterward. Global biotech CSL includes Seqirus, a leader in flu vaccines.
Prescription medicines, including packaging requirements, are regulated by separate countries with their own timelines for electronic patient information. One survey suggested Europe won’t make this change until around 2030.
Japan is leading the switch to digital and will do so next year, said Claude Morf, CSL Behring’s Packaging Design Manager.
“As of August 2023, the provision of paper leaflets with each pack will no longer be necessary or even allowed. We have been working very closely with our CSL Behring colleagues in Japan to ensure that we will be ready on time for this deadline,” he said.
It takes careful consideration and a risk assessment to remove the paper insert, which can play a role in stabilizing the medicine in the package, Morf said.
In Japan, the patient information on a traditional leaflet is uploaded to an agency site as part of the regulatory process. To provide the electronic version, the link to this site is included in the linear bar code that is already printed on the packs during the packaging process, Morf said. Singapore will be next to change the way information is supplied, he said, though CSL Behring will host the digital information there.
