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toxicity and other measured impacts. Alternatively, replacing high
GWP propellants with HFC-152a would reduce climate change impact
by 90-92% while decreasing most other impacts by 28-82%. While
this suggests that a switch to HFC-152a is the correct choice, the reinclusion
of patient needs in the argument necessarily complicates
matters. Patients are not a one-size behemoth. Each one thinks and
acts differently than each other, and their reasons for needing an
inhaler and their ability to use the different types are just as unique.
For this reason, halting the use of DPIs would be just as problematic
as doing the same with pMDIs. Wherever possible, we must ensure
the availability of all therapies that successfully meet the needs of
individuals, because helping every patient is ultimately the mission of
this industry and each of us working within it.
Keeping Every Element in Focus
So, how can you balance regulatory proposals and all-or-nothing
solutions with patient centricity and a wide-lens view of environmental
impact? In part, the answer is in the question: A 40,000-foot view of
the environmental impact of your therapy that includes components,
compounds, and the manufacturing and shipping processes can
help you stay a step ahead. While you will still encounter unexpected
updates, evaluating your product holistically and being proactive
about decreasing its environmental impact gives you time to make
necessary adjustments while respecting the procedures meant to
keep patients safe. Start with aspects you know are ripe for regulatory
focus and anywhere you find yourself falling surprisingly short.
As discussed, current suggestions favoring a universal switch to
DPIs are well-meaning but short-sighted. It is, in fact, important for
the entire drug-delivery combination product industry to approach
environmental concerns with a holistic view that places the patient
at its center. This means acknowledging that the right device for
condition management and adherence is the right device for the
patient, whether that is a pMDI, a DPI, or something else entirely. In
practicality, this means that there will be a need for most options
(or versions thereof) currently on the market for the foreseeable
future, which in turn indicates that the only way to create truly green
therapies is to evaluate all environmental impacts of each therapy
and make adjustments. Without a single, simple answer for protecting
both patients and the environment, an all-of-the-above approach to
improvements is the most realistic path to a marketplace of green
therapies that meet individual needs.
References
1.
2.
3.
United States Environmental Protection Agency. Refrigerant Transition & Environmental
Impacts. 2023. Available online: https://www.epa.gov/mvac/refrigerant-transitionenvironmental-impacts
(accessed April 28, 2023).
NHS England and NHS Improvement, Delivering a 'Net Zero' National Health Service
(London: Skipton House, 2020).
Jeswani, H. K., & Azapagic, A. (2019). Life cycle environmental impacts of inhalers.
Journal of Cleaner Production, 237, [117733]. Available online: https://doi.org/10.1016/j.
jclepro.2019.117733 (Accessed May 2, 2023).
Author Biographies
As Vice President of Global Regulatory Affairs, Nicholas
Smalley leads Kindeva's global regulatory affairs
organization. Nicholas has held previous positions
in regulatory at 3M Health Care, Perrigo, UCB, and
Norton Healthcare Limited. He holds a B.A. in chemistry from
Loughborough University.
As Global Sourcing and Procurement Manager, Gareth
Knowling leads Kindeva's global sourcing and procurement
organization. Gareth has held previous positions in Quality,
Supplier Management and Process Engineering at 3M
Health Care. He holds a BSc (hons) in Polymer Materials Science from
University of Manchester Institute of Science and Technology.
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