Every year, the United States wastes billions of sheets of paper on an unexpected source: paper prescribing information attached to pharmaceutical bottles sent to healthcare providers.
Despite the existence of digital alternatives, outdated U.S. regulations still require drug manufacturers to transmit prescribing information on a paper label. The environmental and climate repercussions of this paper delivery system is considerable. Paper is a critical resource that should be used sustainably. Now that digital options are superior and widely embraced by prescribers, this pre-internet paper policy is outdated, inefficient, and egregiously wasteful.
Each year, approximately 90 billion sheets of paper are consumed in order to satisfy the current government regulations.*
The regulation to print prescribing information was written in 1962. It requires that printed labels be affixed to every pharmaceutical bottle sent by drug manufacturers to prescribers like pharmacists and physicians. To be clear, these are not the labels that patients receive with their medicine. These leaflets (not intended for patients) range from a few pages to over 100 pages and contain information on the drug’s chemical make-up, known side effects, and other details to assist in prescribing decisions.
To quantify the potential benefits and resource saving of modernizing this rule, we calculated the estimated environmental impact of the annual 90 billion sheets of paper using EPN’s Paper Calculator™ life cycle tool. Each year, this paper production and consumption consumes the equivalent of: **
- Wood = 1.8 million tons | over 10 million trees per year
- Greenhouse gas emissions = 8.5 billion pounds of CO₂ | the emissions of 750,000 cars per year
- Energy use = 12.3 million BTUs | 14.6 million residential refrigerators operated per year
- Water use = 10.6 billion gallons | 7.6 million clothes washers operated per year
- Solid waste = 585 million pounds | what 134 million people would generate per day
Unfortunately, this consumption of resources and emissions production go to waste. In today’s healthcare landscape, medical professionals overwhelmingly favor online resources, highlighting how this pre-internet policy falls short of meeting the current needs of healthcare providers. The process of updating printed prescribing information can take 8-12 months to navigate through the supply chain and reach pharmacists—often rendering them outdated by the time they arrive.
Furthermore, Food and Drug Administration (FDA)-approved online platforms for prescribing information already exist, and healthcare providers prefer using them over printed versions to make informed decisions for their patients. Notably, 94% of all prescriptions filled in the United States today are now e-prescriptions. So why are drug manufacturers still required to provide redundant, outdated printed versions of materials that are readily available online?
The FDA has long supported a transition to digital. In 2014, the FDA proposed a rule that would eliminate the paper requirement and create an electronic labeling system for distributing prescribing information electronically. However, lobbying by the paper industry and special interests groups has prevented the FDA from implementing that rule. Since 2015, Congress has blocked the FDA from finalizing its rule in every budget appropriations bill by prohibiting the use of funds for the shift.
In March 2023, the Prescription Information Modernization Act was introduced in the U.S. House of Representatives to strong bipartisan support—quickly gathering 24 co-sponsors from 15 states. This legislation would override the appropriations process and enable the FDA to move forward with its rule to allow drug manufacturers to transmit prescribing information electronically. Efforts are also underway to sponsor the bill within the Senate. On September 27, Senators Cory Booker (D-NJ) and Markwayne Mullin (R-OK) announced their introduction of the bipartisan legislation.
In May 2023, another positive development occurred when – for the first time – the House Appropriations Committee overseeing the FDA did not include language in their funding bill to prevent the FDA from promulgating its e-delivery rules.
Proponents are hopeful that the FDA’s rule can be successfully implemented in the next two years.
It’s time for Congress to align policies with the 21st century. Paper is a critical resource that should be produced and consumed sustainably. Given the broad support from medical professionals and a clear environmental imperative for action, safe and effective digital alternatives should pave the way for eliminating these outdated federal regulations mandating paper usage.
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