Every year, CSL uses around 65 million paper product information leaflets (PIs), which are folded as small as possible and inserted into the boxes accompanying each injectable treatment or vial of vaccine. The good news is that hard copy PIs are on their way to becoming a thing of the past in jurisdictions like Australia and Japan, which are leading the charge.
Their replacement, electronic PIs (ePIs) accessible online or via QR codes on the package, have the potential to change how important product information is provided and consumed. As part of CSL’s commitment to environmental sustainability, the global biotech company is working with regulators to advocate for a move to ePIs where possible. This has the potential to save bales of paper and thousands of trees.
“The benefits of ePIs for CSL include reduced packaging cost, complexity and waste, potential for reduced time to market, reduced environmental impact and the ability to produce small-batch products more efficiently,” said Warren Comerford, Head of Global Packaging for CSL, who is based at CSL Behring’s manufacturing facility in Broadmeadows, Australia.
PIs are a regulatory requirement and disclose relevant information such as what the treatment or vaccine is used for, what to know before administering it, how to administer it, possible side effects and how to store it properly.
Comerford says that in the context of injectables administered by health care professionals (HCPs), most end-users use online specialist reference sites to find the latest safety and product information. That means a good portion of hardcopy PIs end up unused and in the waste bin.
These small, folded papers can also cause delays and inconveniences in the supply chain. Comerford explained that each hard copy PI is specific to the country the product is going to and packaging cannot commence until the PI is finalized, regulator approved and printed. Once packaged for distribution, the copy can’t be changed or updated. That means packed identical products intended for one jurisdiction can’t readily be diverted to a different region, regardless of demand. In the case where a shared pack is available, the removal of the requirement for a market-specific leaflet provides greater flexibility with supply.
During the COVID-19 pandemic, and the race to provide fast, global access to billions of vaccinations, regulators around the world unanimously recognized the limitations of hard copy PIs and allowed the provision of ePIs. Comerford estimates that during the peak of the COVID-19 pandemic, ePIs for COVID-19 vaccines eliminated the need to harvest at least 270,000 trees.
He also says ePIs enabled several important innovations:
- Products from a single manufacturer could be packaged and distributed worldwide as soon as possible.
- Safety information can be updated in real time.
- PIs can be translated into multiple languages without delay.
- Clinicians can access, read and search information more easily.
After seeing the successful global test case for ePIs during the COVID-19 pandemic, CSL’s global packaging team worked with CSL’s Australian government relations team to explore the potential for changing to ePIs with the Therapeutic Goods Administration (TGA) - Australia's regulatory authority for therapeutic goods such as medicines, medical devices and diagnostic tests. After an industry and health care professional consultation, the TGA announced that, from September 2023, hard copy PIs would no longer be required for many boxed injectables for use by Australian heath care professionals (HCPs), where a history of safe use has been demonstrated.
“It was a red-letter day for me, a real career highlight,” Comerford said. “It offers us enormous productivity and efficiency improvements on the packing line and opens the pathway to further reform in terms of common packaging for smaller and common language markets.”
With Australia, Taiwan and some other southeast Asian markets making the move, Comerford is hoping regulators in European and North American markets will come on board.
“It’s a win-win-win” he says, “better for the users, better for the manufacturers and definitely better for the trees!”
