Electronic Product Information Leaflets (ePIL)

TL;DR
  • Electronic Product Information is a digital version of the printed leaflet that comes with every prescription medication.
  • The main driver to digitize product information is increased patient safety.

What is Electronic Product Information?

Electronic Product Information (sometimes referred to as Electronic Product Information Leaflet or ePIL) is a digital version of the printed leaflet that comes with every prescription medication.

Like a printed leaflet, the ePIL covers important information like safety warnings, dosage and administration, adverse reactions, recent major changes and plenty more. But moving to a digital platform has many advantages that differentiate the ePIL from its printed counterpart.



Why digitize drug product information? 

To really understand the ePIL you need to understand the main reason for moving to a digital platform…  patient safety.

Patient safety is the number one driver for this transition to digitize product information. Let’s look at an example.

Adverse drug events (ADE’s) cause over 200,000 emergency room visits each year in the United States. That’s a lot of people who are being harmed by medicine that is prescribed to help them.

From allergic reactions and improper use to mixing multiple medications with unintended results, ADE’s are a real concern and should be minimized to maximize patient safety. And this is where Electronic Product Information steps in.

Instead of having a static leaflet, the Electronic Product Information can be interactive and tailored to each individual patient. The ePIL can recognize that a patient has already been prescribed a medication that does not mix well with the current one being prescribed.

There’s no way a doctor should be expected to memorize every potential harmful combination of prescription drugs. Wouldn’t it be great if our drugs “told” us if they were safe for us to take? That’s where Electronic Product Information is taking us.



How will Electronic Product Information work?

As there are different regulatory bodies throughout the world, there may be some variation in “how” an ePIL will need to be structured and vetted. In the United States, Structured Product Labeling (SPL) will be the standard format for creating and (especially) maintaining accurate ePILs.

The XML backed system has been in place for decades.