Pharmacovigilance (PV) is an essential aspect of drug development and usage that ensures the safety of medicines and vaccines. The pharma-healthcare industry has an environmental footprint, including active pharmaceutical ingredients (APIs) from medications, which become environmental pollutants through various routes. In recent years, the world has seen a surge in the demand for eco-friendly and sustainable practices to help protect both human and ecological health, resulting in the emergence of Ecopharmacovigilance (EPV), also known as environmental pharmacovigilance.
EPV is a new science, and it is still unclear what it entails in practice. A comparison between pharmacovigilance (PV) and EPV uncovered some parallels, but also some significant distinctions that must be carefully considered before any practical application of EPV. Determining cause and effect in the environment is the greatest issue, proving to be the most significant distinction.
To gain further insight on EPV in practice, its development in different countries, strategies companies have adopted, along with changing regulations and best practices will be detailed.
EPV in Practice
Researchers investigated what EPV may imply in practice. They discovered some practical measures that can be taken to assess environmental risks throughout the product life cycle—particularly after the launch of a novel medication—to ensure that risk evaluations and scientific knowledge of medicinal products in the surroundings remain scientifically and ecologically relevant.
These measures include:
The above will aid in identifying and managing any severe environmental concerns linked with pharmaceutical pollutants (PhP) released into the environment in a timely manner.
PV vs. EPV
There are significant contrasts between PV and EPV, as well as various problems that must be solved if EPV is to be effective in practice, especially in terms of linking cause and effect. While EPV is still in its early stages, researchers have highlighted several actions that may be taken to guarantee that risk evaluations and scientific knowledge of pharmaceuticals in the environment are possible and up to date.
The table below describes the difference between PV and EPV
EPV Regulations and Best Practices:
Many countries have updated their regulations and best practices to align with eco-friendly and sustainable practices.
Companies have also recognized the need to adopt EPV strategies:
Due to growing recognition of the need for more comprehensive and systematic approaches to EPV, regulatory agencies around the world are becoming more stringent in their requirements for assessing the environmental risks of pharmaceuticals.
Process Changes, Developments, and Improvements
Pharmaceutical companies are making process changes to minimize the environmental impact of drug production and usage. Some companies are using green chemistry processes to reduce the use of hazardous chemicals and minimize waste generation. Additionally, some are adopting digital solutions to reduce the need for paper-based processes, minimizing their carbon footprint.
Microplastic pollution: Researchers have found that microplastics (small particles of plastic found in the environment) can absorb and accumulate pharmaceuticals. This can lead to the release of drugs into the environment, resulting in harmful effects on aquatic organisms and the ecosystem. EPV is being used to monitor the impact of microplastic pollution on the environment and to develop strategies to reduce its impact. Companies are exploring the use of eco-friendly packaging materials to reduce plastic waste.
Antimicrobial Resistance (AMR): The use of antibiotics in both humans and animals can lead to the development of antimicrobial resistance (AMR), which is a major global health concern. EPV is being used to monitor the release of antibiotics into the environment and to assess the potential impact of these antibiotics on the development of AMR in bacteria.
Sustainable manufacturing: EPV is being used to promote sustainable manufacturing practices in the pharmaceutical industry. This includes the use of green chemistry, which aims to reduce the use of dangerous chemicals and waste as well as developing more sustainable packaging materials.
Other developments in EPV include the discovery of new analytical methods to detect pharmaceutical residues in the environment. Further, increased collaboration between regulatory agencies, academic researchers, and the pharmaceutical industry are helping to improve our understanding of the environmental risks of pharmaceuticals.
Developing a Sustainable Future
EPV, an important aspect of sustainable drug development and usage, is a rapidly evolving field that is receiving increased attention from regulatory agencies and pharmaceutical companies around the world. With greater demand for eco-friendly practices, many countries and pharmaceutical companies alike are updating their regulations and best practices. Although, most of the progress has been made in the regulation of Environmental Risk Assessment (ERA) for medicines in the United States, the European Union, and Canada.
An ecopharmacovigilance program is needed to ensure sustainability and minimize life cycle exposure hazards of a chemical society. Recent developments in EPV include increased awareness and recognition of the potential environmental risks of pharmaceuticals, as well as the development of new methodologies and tools to assess these risks. These developments are crucial for ensuring a sustainable future and protecting the environment.
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