March 2024

In August 2023, the Axia Institute began connecting stakeholders in the pharmaceutical value chain to identify the challenges of the current landscape and collaborate on opportunities to find efficiencies in the supply chain and possibly improve patient health. It is widely known across the pharmaceutical value chain that moving to digital labeling and electronic leaflets (“e-leaflets”) would not only reduce the industry’s environmental footprint but also provide more accurate, real-time information to pharmacists and physicians.

Problems with the Package Insert

At the August meeting, four themes emerged; affecting every step of the healthcare value chain.

1. 1. Limited Accessibility When Needed: PIs are easy to misplace, sustain physical damage, and can contain outdated information. The PI provides valuable information a provider or pharmacist can pass on to the patient to increase prescription adherence.
   2. Lack of Patient Centricity: PIs are usually written in the primary language of the country where the product is developed, which is English in the US, which may not be the provider or pharmacist’s primary language. This leads to inconsistencies globally in format, terminology, tone, and content.
   3. Costly Operational Inefficiencies: Automated printing and labeling services have approximately a 25% waste rate due to poorly centered, loosely attached patient packs, etc. This inefficiency is costly and creates delays in distribution.
   4. Compliance Barriers: Changes in the information in paper pamphlets may take eight to twelve months to reach providers and patients, with significant risks to providers, pharmacists, and patient safety.

At the conclusion of the August meeting, stakeholders agreed to use these themes to build an end-to-end framework for e-leaflets across the drug value chain, with a primary goal of enhancing patient safety.

Big Pill to Swallow: Environmental Impact of Paper PI

Compliance with printing PIs for physicians and pharmacists in the United States requires about 90 billion sheets of paper a
year¹, or consider:

Water Use

10.6 billion gallons, 7.6 million washing machines operated for a year.

¹Source: Environmental Paper Network “EPN” Paper Calculator^TM, https://environmentalpaper.org/2023/09/ending-90-billion-sheets-the-environmental-impact-of-pharmaceutical-paper-waste/.

Define Vision & Mission
Emphasize improved medication information accessibility for enhanced patient safety. Set clear parameters to define the scope of the project.
Status: Approved Feb. 2024

Stakeholder Alignment
Collaborate with industry stakeholders to finalize goals, ensuring alignment for initiative success.
Status: Ongoing

Framework Development
Engage thought leaders to devise a robust framework and pilot program. Leverage learnings from the EU and other geographies.
Status: Ongoing – April 2024

Focused Approach
Target specific US healthcare domains, such as emergency room or operating room drugs, specialty drugs, and generics, before expanding globally.
Target Date: August 2024

Pilot Launch
Implement targeted pilot programs across drug categories to gather insights.
Anticipated Date: October 2024

Stakeholder Alignment
Collaborate with industry stakeholders to finalize goals, ensuring alignment for initiative success.
Status: Ongoing

Universal Framework
In-person. Develop a universally adaptable framework compatible with various drug brands.
Anticipated Date: April 2025

Stakeholder Engagement

The following companies and organizations have been, or continue to be, part of our collaboration.