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.
Also read: Addressing Environmental Contamination from Healthcare Industry with Ecopharmacovigilance
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:
- Maintaining a global EPV perspective
- Increasing the transparency and accessibility of ecological data for therapeutic purposes
- Monitoring emerging evidence on exposure and consequences in literature following the product’s debut to track environmental hazards
- Using Environmental Risk Management Plans (ERMPs) as a centralized resource to analyze and manage a drug’s hazards throughout its life cycle
- Conducting further studies, assessments, and monitoring of the environment when concerns arise
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
| Sr No | PV | EPV |
|---|---|---|
| 1 | PV is a highly regulated process. It is strictly controlled, with pharmaceutical firms subject to inspection and punitive disciplinary procedures in situations of noncompliance. | EPV is a novel concept and a developing field of science that is unregulated. |
| 2 | Exposure to prescribed drugs is restricted to identifiable individuals and a target population (human or veterinary) | All species in all environmental compartments might be exposed. It involves indirect human exposure. |
| 3 | The dose is known and defined by drug regimen; exposure levels can be measured. | The dose is not known but environmental concentrations of drugs and their by-products can be measured or predicted. Actual exposure levels are undetermined without comprehensive biological monitoring work. |
| 4 | Affected populations are regularly observed, and regular surveillance may be in place. | There is no routine surveillance for species in the ecosystem (unless they are threatened); however, certain fish plasma levels are tracked for scientific investigations. |
| 5 | Mostly, it is possible to discuss and clarify concerns with the patient directly. | It is not possible to immediately detect adverse environmental effects through discussion or interaction with the species of concern. Human involvement is necessary to analyze environmental impacts. |
| 6 | It may or may not be simple to associate/determine ADR with one specific drug or drug combination or a subset of patients. | If adverse environmental effects are observed, it might be challenging to determine their origin. Whether adverse impacts on species in the environment to a single cause, such as a single medication, combination of medications, or drug derivative. |
EPV Regulations and Best Practices:
Many countries have updated their regulations and best practices to align with eco-friendly and sustainable practices.
A timeline:
2014
- Researchers found that EPV in China is still in its early stages. However, efforts have been made by the Chinese government and specialists to regulate environmental drug pollution issues, including the implementation of associated laws and regulations, the discovery of the presence and behavioural patterns of drug waste in the environment, and the development of novel technologies to enhance the disposal’s outcomes.
2019
- The European Medicine Agency (EMA) published guidelines on environmental (soil, water, and air quality) risk assessment for pharmaceutical products for human and veterinary use. The guidelines provide the framework for evaluating the potential environmental impact of drugs during their entire lifecycle, from development to disposal. It aims to improve the evaluation of the potential environmental impact of medicinal products and to promote the sustainable use of these products.
2020
- The US Environmental Protection Agency (EPA) proposed a guideline for the eco-friendly disposal of prescription drugs. The guidelines aim to prevent environmental contamination from unused or expired drugs. EPA also announced a new strategy for evaluating the potential ecological risks of pharmaceuticals. The strategy includes the development of new testing methods and tools for assessing the effects of pharmaceuticals on aquatic organisms.
- In the US, Environmental Assessments (EAs) must be filed as part of some new drug applications (NDA), according to FDA rules in 21 CFR part 25. When a new medicine is submitted for the market, the FDA requires its manufacturer to complete an environmental risk assessment (ERA) that predicts the concentration in the environment. If the risk assessment finds that the concentration will be less than one part per billion, the medicine is considered safe. In contrast, in countries like New Zealand, Australia, and many other nations, there are currently no defined criteria/specific guidelines for pharmaceutical ERA. However, they are projected to have tight restrictions and legal requirements in the future.
- Health Canada published a new guidance document for the environmental risk assessment of human pharmaceuticals. The guidance provides recommendations on how to assess the potential ecological impact of a drug, as well as how to communicate this information to stakeholders.
- The Japanese Ministry of Health, Labour, and Welfare (MHLW) published new guidelines on the environmental risk assessment of pharmaceuticals. The guidelines include recommendations for testing methods and risk assessment procedures for evaluating the potential impact of drugs on aquatic and terrestrial ecosystems.
- Some countries, including Sweden and the Netherlands, have begun to develop national strategies for managing the environmental risks of pharmaceuticals.
- In India, EPV is still in its infancy as per the experts/researchers. It is not supported by enough data to reveal the information about pharmaceuticals found in the environment. The government of India has been investigating the amounts of minerals and heavy metals as contaminants and pollutants in the environment but has not achieved any major success in detecting pharmaceuticals as pollutants.
Companies have also recognized the need to adopt EPV strategies:
2020
- Novartis announced a new environmental sustainability strategy that includes a focus on EPV. The strategy includes measures to reduce the environmental impact of its pharmaceutical products, as well as to develop new products that are more environmentally friendly.
2021
- AstraZeneca announced a new environmental sustainability strategy that includes a focus on EPV. The strategy includes measures to reduce the environmental impact of its manufacturing processes and supply chain, as well as to develop new products that are more environmentally friendly.
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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