The past 18 months have yielded unprecedented challenges on a global scale, and the summer of 2021 has been no exception. From record heat waves and wildfires in North America to catastrophic flooding in central and western Europe, all while facing increased transmission of Delta and Delta plus variants of the current COVID pandemic, it is increasingly recognized that we live in a time of changing environment. It is becoming increasingly clear that the climate crisis is also a health crisis, and that while every sector has a role to play in protecting our environment, the imperative for the health sector is especially strong. In September 2019, Health Care Without Harm published Green Paper One,[i] which found that healthcare’s climate footprint is equivalent to 4.4% of global net emissions (two gigatons of carbon dioxide equivalent, based on 2014 data). To put the numbers into perspective, healthcare is polluting twice as much as the reviled aviation industry (1.9% of global net carbon dioxide equivalent emissions, according to 2016 data from Climate Watch).
As our world changes, governments, recognizing that the roots of a changing environment also increase opportunity for pandemics through zoonotic transmission as animals migrate to more suitable climates, have begun pandemic preparedness planning linked to preserving our environment and ensuring the sustainability of products consumed in society.[ii] The sustainability agenda is rooting in the global society and the healthcare industry is following suit. Leading pharma corporations all have well-defined strategies for product stewardship and environmental impact reduction. Pharmaceutical companies have recognized the need to adopt more sustainable approaches to product development, and several companies have stated aggressive goals to achieve carbon neutrality by 2030, establishing the integration of sustainability into all value chains and development of partnerships to achieve carbon neutrality goals as key priorities.[iii]
While development of more sustainable pharmaceutical formulations and production processes is one approach to achieving neutrality in the pharmaceutical industry, development of more sustainable delivery devices represents one of the largest means of improving the overall sustainability within the pharmaceutical industry. With rapid growth, the drug delivery market is expected to reach USD $900 Billion by 2025;[iv] the medical device industry is a notoriously high waste industry, and pharmaceutical and medical device companies are increasingly concerned with improving the sustainability of their product profiles. Consequently, there is a movement toward leveraging reusable devices, where possible and safe to do so, to improve the overall sustainability of the drug delivery market.
Life Cycle Assessment (LCA) is a standardized means of assessing the overall sustainability of a product, including those produced by the drug delivery industry. LCA is a methodology, utilizing one or more predetermined methods, to assess the environmental impact of a product or device through all stages of the product life cycle, and allows for external validation. As described in more detail in a recent edition of ONDrugDelivery, a variety of impact categories are calculated for each stage of the product life cycle, then combined to result in a normalization factor referred to as the “Environmental Indicator” (c.f. Figure 1).[v]
Using a comprehensive inventory of the required materials and energy across the value chain of the product, and calculating the corresponding environmental emissions, LCA assesses the cumulative potential environmental impact of the product being studied. The totality of product life cycle, from raw material extraction through product use and disposal, is studied in LCA, with environmental impact being a key metric and output of the final analysis.
A strength of LCA is that it is governed by standardized procedures, allowing a level of external validation and verification of the data. Recognized LCA procedures are found within the ISO 14000 series (i.e. environmental standards management) for (i) method principles and framework (ii) analysis requirements and guidelines.
The four phases of LCA (c.f. Figure 2) are completed in an iterative process, with results from the impact assessment and interpretation being leveraged as the basis for evaluating sustainability improvements in product innovation (i.e. Eco-Design). While not part of LCA as defined by ISO 14040, Eco-Design provides an important means of extrapolating data from the LCA to make meaningful product improvements in a systemic manner. The methodological framework for Eco-Design is initiated by identifying an impact reduction target, derived from the LCA, and using this to construct and define the goal and scope of the Eco-Design process. Once the goal and scope are defined, the product system functions of the proposed design are investigated, and it is determined which impact processes, previously defined in the LCA, are the most significant and realistic areas of improvement for the proposed product design. Proposed solutions to each area of improvement are ranked, allowing a structured method for product improvement recommendations. Finally, the Eco-Design process is completed by creating new and optimized product concepts and using the LCA to validate that the goals for impact reduction had been reached.
Turning back to the device industry, after oral medication, injectables represent the largest product delivery method in the pharmaceutical industry. Just in the home setting, over 7.8 Billion hypodermic needles are used each year by the nearly 13.5 Million people who self-inject medication outside a Healthcare setting. This combined figure represents a mixture of both manual hypodermic needles and autoinjectors. As for a manual syringe, the entirety of a conventional autoinjector device becomes hazardous waste after use with an expectation that it will be disposed in a sharps container and then incinerated. And although single-use autoinjectors, that have dominated the self-injection market for the past 15 years, offer advantages such as safety and ease of use that make them more suitable for self-administration, they can contribute a larger sustainability impact than a simpler device such as syringe.
The reusable Aria smart autoinjector, combines features from both reusable and disposable device formats to provide an innovative solution for self-injection that can address both usability and sustainability. Aria consists of a reusable power unit that replaces the spring in a disposable mechanical device but also provides device connectivity; and a removable cassette that contains the drug product, and is discarded after use. This innovative approach to autoinjector design was seen from its inception to offer several advantages over previous reusable and disposable autoinjector designs, including the potential of better sustainability given a reduction in the amount of material thrown away after each use. However, validating whether this shift in device approach leads to meaningful improvements in the overall environmental impact required further study. Life Cycle Analysis has provided an effective way to validate assumptions regarding sustainability improvements over current, disposable autoinjectors, and then to share the results with customers to allow them to assess the beneficial impact on their sustainability commitments.
[i] “Healthcare’s Climate Footprint”, https://noharm-global.org/sites/default/files/documents-files/5961/HealthCaresClimateFootprint_092319.pdf, accessed August 17, 2021.
[ii] “Coronavirus and Climate Change”, Harvard School of Public Health, https://www.hsph.harvard.edu/c-change/subtopics/coronavirus-and-climate-change/, accessed August 5, 2021.
[iii] “Sustainability”, Merck, https://www.emdgroup.com/en/sustainability.html, accessed August 5, 2021.
[iv] Size of the global drug delivery systems market in 2016 and a forecast for 2025”. Statista Research, October 2018.
[v]ODD article to submit 8/19/2021.