Pharmaceuticals in the environment (PiE)

We are committed to protecting human health and the environment by conducting business in an environmentally responsible and sustainable manner. We integrate principles of resource conservation, pollution prevention and environmental responsibility into our business processes, facilities, operations and products.

Trace amounts of pharmaceuticals have been found in the environment for decades, but with advancements in environmental monitoring, detection rates and the number of pharmaceuticals identified have increased. Pharmaceuticals mostly reach the environment through human use and excretion of medicines, improper disposal, and to a lesser extent through emissions occurring during manufacturing. The presence of PiE including in various environmental compartments has raised concerns from various stakeholders on the impact and potential long-term effects that PiE has on human health and the environment.

Risk management and continuous improvement

BMS believes risk management and continuous improvements in operations are essential to reducing PiE and takes proactive steps to mitigate risk. These include:

Working to ensure operations at our facilities are both environmentally responsible and protective of personal and public health and safety, starting by designing clean and efficient manufacturing processes, and routinely assessing existing facility operations.
Establishing Water Quality Guidelines for our Active Pharmaceutical Ingredients (APIs).
Conducting Environmental Fate/Effects Studies and Environmental Risk Assessments (ERAs) on APIs during development of new medicines to better understand and address potential environmental impacts, in compliance with applicable regulatory requirements

In addition, shifts in our portfolio to certain biologics (e.g., monoclonal antibodies) have produced new medicines that more readily biodegrade in the environment, further reducing impacts related to PiE.

Collaboration and innovation

BMS is committed to playing a role in addressing PiE-related issues and mitigating any impact that our business activities may have on the environment. Through our collaboration with industry partners, academic researchers, regulatory and environmental agencies, and our participation in initiatives led by trade associations, we work to further understand and proactively address the potential impacts on human health and the environment from PiE.

BMS believes that projects and collaborations guide critical contributions to advancing PiE efforts by conducting innovative research projects, developing manufacturing best practices, and providing pathways for future collaborative partnerships. BMS’s collaborations include:

The Inter-Association Initiative on Pharmaceuticals in the Environment (IAI PIE)—a broad collaborative effort that combines the expertise of the Association of the European Self Medication Industry (AESGP), The European Federation of Pharmaceutical Industries and Associations (EFPIA), and Medicines for Europe (formerly the European Generic and Biosimilar Medicines Association)—developed the Eco-Pharmaco-Stewardship (EPS) initiative which is leading the way toward better understanding and reducing potential environmental impacts from PIE.
BMS is currently participating in an Innovative Medicines Initiative (IMI) project, called Prioritization and Risk Evaluation of Medicines in the EnviRonment (PREMIER). The PREMIER project brings together a world-leading multi-disciplinary consortium composed of 25 partners from the public, private and government sectors, working to contribute to a sustainable future by proactively managing the environmental impact of medicines and improving the availability of environmental data for all stakeholders.

Education and awareness

BMS believes in creating awareness of PiE and supports initiatives that educate stakeholders including the public, as well as supply chain partners. Proper disposal of unused medications is an important component of reducing PiE, which is why BMS supports initiatives that encourage patients to dispose of their products responsibly.

BMS has worked closely with the Pharmaceutical Product Stewardship Group (PPSWG), an association focused on providing infrastructure, guidance, and subject matter expertise to support member compliance and improve awareness of existing pharmaceutical disposal options. As part of the PPSWG, the MyOldMeds website provides a way for patients to find a kiosk site near them to dispose of unwanted, unused, or expired medicines from households.

In Europe, BMS has supported #medsdisposal, a campaign led by a collaboration of associations including EFPIA dedicated to raising awareness and providing detailed information to patients on how to dispose of unused or expired medicines appropriately.

BMS also partners closely with the Pharmaceutical Supply Chain Initiative (PSCI), a collective effort established to help support and implement supply chain best practices aimed at reducing potential environmental impacts of discharges from supplier manufacturing, developing tools and resources to evaluate and improve operating practices.

Commitment to transparency

BMS recognizes that our responsibility to the environment continues once our products are launched. In addition to our actions and activities to address potential environmental impacts around PIE, we have also established an ecopharmacovigilance program which monitors products post-launch for environmental risks and tracks scientific literature for emerging data on exposure and effects.

BMS is committed to transparency in reporting the environmental fate/effects API data we collect and have made this information available to the public through iPiE*SUM and our company Safety Data Sheets (SDS).

Additionally, a public database containing environmental fate/effects data on APIs is an expected outcome of the PREMIER project.