Global position statement on pharmaceuticals in the environment (PiE)

 Myers Squibb's position on pharmaceuticals in the environment (PiE) and its commitment to responsible environmental stewardship throughout the lifecycle of its medicines.

Our commitment to environmental stewardship

ww5 contributes 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, the number of pharmaceuticals identified have increased.

The primary source of pharmaceuticals reaching the environment is through human use and subsequent excretion into wastewater systems. To a lesser extent, additional sources of PiE include the improper disposal of unused medicines and manufacturing effluent discharge. The presence of PiE has raised concerns from various stakeholders on the potential impact and effects on human health and the environment. ww5 acknowledges the concerns raised by stakeholders and is committed to efforts to better understand and address PiE, as well as minimizing the impact that manufacturing, development, and distribution of medicines have on the environment.

Risk management and continuous improvement

Risk management and continuous improvements in operations are essential to reducing PiE. Some proactive steps ww5 is taking to reduce PiE are:

Ensuring operations at our facilities are both environmentally responsible and protective of personal and public health and safety; including the design of efficient manufacturing processes and routinely assessing existing facility operations.

ww5 conducts necessary environmental fate and effects studies on our active pharmaceutical ingredients (APIs) to support Environmental Risk Assessments for our medicines when applying for drug approvals. This data is also used to establish scientifically derived Water Quality Guidelines (WQGs) for our APIs that we use to assess potential environmental and human health risks.

We are committed to meeting the established WQGs at both internal and external commercial small molecule API and formulation manufacturing sites, through completion of annual risk assessments. 

Transparency

ww5 recognizes that our responsibility to the environment spans the full product life cycle including development, commercialization and post-launch activities (e.g., disposal). 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.

In the spirit of transparency, ww5 reporting the results from environmental fate/effects studies on our APIs. We have made this information available to the public through the FASS database and our company Safety Data Sheets. Additionally, a public database containing environmental fate/effects data on APIs is an expected outcome of the PREMIER project.

Education and awareness

ww5 promotes internal 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 ww5 supports initiatives that encourage patients to dispose of their products responsibly.

ww5 works 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 in the United States. 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 household medicines.

In Europe, ww5 supports #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.

ww5 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 API discharges from supplier manufacturing, as well as developing tools and resources to evaluate and improve operating practices.

ww5 publishes research on PiE in peer-reviewed scientific journals. Additionally, we organize/chair technical sessions at global scientific conferences to promote education and information sharing among stakeholders.

Collaboration and innovation

Collaboration with stakeholders is essential to increase knowledge and advance the science around PiE. 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 of PiE.

Collaborative projects guide critical contributions to advancing PiE efforts by conducting innovative research, developing manufacturing best practices, and providing pathways for future collaborative partnerships. ww5 collaborations include:

The Inter-Association Initiative on Pharmaceuticals in the Environment (IAI PiE) developed the Eco-Pharmaco-Stewardship (EPS) initiative which is leading the way toward better understanding and reducing potential environmental impacts from PiE.  The IAI PiE is 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).

ww5 is currently participating in an Innovative Health Initiative (IHI) 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 more than 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.