The Patient Information Leaflet goes green

A recent paper published by the ANPI (Alliance to Modernize Prescription Information) titled "Creating E-Labelling Platforms: An Industry Vision" listed a number of very strong points for an industry-wide adoption of an eLeaflet (or e-labelling) solution that could replace the paper inserts in healthcare products packaging for the dissemination of approved product information.

Among the listed benefits of such a solution we have:

• Better readability and searchability: for some users it may be difficult to find information in the current paper format which, when unfolded to its full size, can be overwhelming to read and navigate due to the small font and large volume of text.

• Faster sharing of new information: safety updates can be circulated in a matter of days versus months. Paper versions can be significantly outdated due to the complexity of the supply chain (a typical update cycle for a paper-based Information Leaflet is 6 months).

• Customizable information: Opportu­nities to highlight, customize, and prioritize important changes in labelling in a timely manner and target the information for a specific patient population exist.

These would primarily benefit the patients by working towards a safer use of medicinal products and an enhanced overall patient safety.

But what are the benefits for the industry, if any ?

While a move from a paper-based leaflet to a digital one may prove dramatic for the companies that supply these paper products today and may see their revenues eroded or disappear as the new digital technology establishes itself in the market, for their customers (pharmaceutical and healthcare products companies) the move to a digital solution may mean double digits saving throughout the manufacturing process even today when the legislation still requires that a paper leaflet be present in the packaging in most countries (please note that actual legal requirements differ by country and by class which is determined by the requested marketing authorization).

The paper by ANPI highlights a huge savings potential in both direct and indirect costs (direct costs are related to the costs of the actual raw materials while indirect costs are associated to the whole of the manufacturing process).

Every year, millions of paper inserts are discarded without even being viewed. The elimination of paper and reduction of package sizes would contribute to our global efforts to reduce the industry overall environmental impact.

The professional labelling, i.e., labelling targeted to the Health Care Professionals which is required in most US drugs, is often discarded upon dispensing a product to the patient.

Besides when there is a labelling change, resources are required to ensure quality control, review graphic design, proofread and conduct final release of the printed labelling. In some regions, packs are destroyed in order to implement labelling changes within a legally prescribed timeline, adding to the waste. At times, the actual packaging configuration may need to be enlarged due to the increased size of the paper labelling.

With over 25B paper leaflets produced in Europe alone there are big opportunities to achieve substantial savings and save the planet at the same time.