Sustainability is a critical consideration for any sector operating in contemporary society.
The question of sustainability in pharmaceutical industry practices is important in considering the environmental impact of pharmaceutical production. While COVID-19 has dominated much of 2020’s attention, the issue of climate change has not disappeared.
2019 saw protests across the world calling for action to be taken against the rising greenhouse gases caused by human activity, causing temperatures and sea levels to rise and more regular extreme weather occurrences and changes to the natural environment. While there are actions individuals can take to reduce their carbon footprint, companies also need to play their part to ensure they are operating in a sustainable way that doesn’t negatively impact the environment.
Sustainability can be summarised as: “meeting the needs of the present without compromising on the needs of the future” [1] which takes into account the natural environment and the lives of other species as well as socio-economic considerations. Research indicates that pharmaceutical pollution is recognised as a threat to both ecosystems and human health across the globe. Examples of this include abnormal reproductive behaviour in fish and antimicrobial resistance.
More needs to be done to manage the way pharmaceuticals are produced without causing a detriment to the environment, or human health. The right Quality Management System (QMS) can help to examine and refine an organisations processes, reducing the risk of things going wrong and the subsequent exposure of chemicals to the natural environment.
The question of packaging
Packaging is an easy area to point the finger at in improving pharmaceutical sustainability. The use of quality management software will help you manage the design and development of packaging and cut down the amount you are using - designing sustainability within your product from the start. However, it’s not quite as simple as that. Safety is critical in the packaging of pharmaceutical products to ensure that medicines reach patients without contamination as well as in a manner that will protect vulnerable people. For example, having child proof caps on bottles.
Regulatory requirements also slow down the process of introducing new packaging materials. Clinical data on the materials themselves need to be provided for them to be approved. In many cases, there is a lack of relevant data on these materials to allow for sufficient investigation and approval. [2] The use of a QMS is a step towards collecting and managing this data effectively, as well as implementing risk management controls relating to sustainability, rather than focusing purely on compliance.
Waste prevention: protecting our water supply
The main criticism of the pharmaceutical industry is how medicines have caused pollution to the surrounding environment. Across the world, traces of pharmaceuticals have been found in surface water, soil, sewage and drinking water. For example:
- UK Water Industry Research published a report in 2014 found commonly used drugs present in 160 sewage systems. [3]
- The World Health Organisation (WHO) declared antimicrobial resistance a major threat to human health, predicting that it will cost 10 million lives each year by 2050. [4]
- A UNESCO study in 2017 found that only nine out of 118 types of pharmaceuticals were sufficiently removed from wastewater during the treatment process to a sufficient level. [3]
- Reproductive changes in male fish due to pharmaceutical pollution has affected 37 different species of fish based in lakes and rivers across the world in the past decade. [5]
Finding ways to reduce pharmaceutical waste in the production process, alongside implementing responsible waste management, is something that needs to be addressed in moving towards pharma sustainability and preventing environmental damage. Using a QMS can help to implement and improve these processes, allowing you to look at reducing the amount of waste produced and focus on the responsible management of waste. In turn, this will prevent chemical run offs being dumped into the water supply and polluting aquatic life.
In addition, using a risk-based approach to quality minimises the likelihood of something going wrong in the manufacturing process, subsequently reducing the waste and impact on the environment. Focusing on getting it right before the drug goes to market will not only prevent having to recall the product but will avoid the significant waste associated with a non-compliant batch of medicines.
[1] Report of the World Commission on Environment and Development: Our Common Future (1987)
[2] Packaging Europe: ‘Dispensing and pharma: Safety, security and sustainability’ https://packagingeurope.com/dispensing-and-pharma-safety-security-and-sustainability/
[3] Nordic Life Science News. ‘Pharma industry confronts growing problem of pharmaceutical waste’: https://nordiclifescience.org/pharma-industry-confronts-growing-problem-of-pharmaceutical-waste/
[4] World Health Organisation, ‘Antimicrobial resistance’: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
[5] National Geographic, ‘why are these fish growing eggs?’: https://www.nationalgeographic.com/news/2016/02/160203-feminized-fish-endocrine-disruption-hormones-wildlife-refuges/
Deborah Nicholson
New business and Enterprise sales for governance, risk and compliance software solutions with over 10 years working in the global Life Science sector. Deborah specialises in the pharmaceutical sector as well as contract manufacturing, CROs, university research, biotechnology, vets and rural sectors.