Improving the sustainability profiles of our products and packaging has long been an integral part of our environmental goals. We are committed to enhancing our process to assure continuous improvement and meet applicable environmental, health and safety (EHS) standards throughout the product life cycle.
We require our manufacturing, R&D and distribution facilities to identify, evaluate and minimize the direct and indirect EHS impacts of our products to meet EHS standards and ours.
How We're Reducing Negative Environmental Impacts
- We removed polyvinyl chloride (PVC) from our bottles. Reduced the use of PVC in blister packaging for medicines and eliminated it in our packaging trays. We also make sure suppliers share our commitment. We continue to explore opportunities to eliminate PVC as technical alternatives become available.
- Global Packaging instituted the Sustainable Packaging Design Guideline. Simplified the ABILIFY (aripiprazole) insert which resulted in the following:
- 70 tons less paper used per year
- Fit 30% more product on a pallet leading to a 30% reduction of ocean containers
- Annual cost savings of more than $2,000,000
- Our Green Chemistry program helps scientists and engineers reduce energy consumption, hazardous materials and waste generation in manufacturing through the Process Greenness Scorecard.
Household Generated Sharps Management Plan
As some States have approved regulation for the management of Household Generated Sharps Wastes during the past years, Bristol-Myers Squibb Company has prepared a “Household Generated Sharps Management Plan” to support the safe collection and proper disposal of these waste sharps. Under various state sanctioned regulations, pharmaceutical manufacturers that sell or distribute a medication that is self-administered through the use of hypodermic needles or other self-injectable devices have to prepare and/or submit to these States, or the state responsible agency, a plan that describes how the manufacturer supports the safe collection and proper disposal of waste sharps.
These regulations require the manufacturer to post and maintain their plans on their respective web sites. Currently two states, California and Minnesota, have issued pharmaceutical manufacturer requirements for Household Generated Sharps management. For California, the plan must be submitted to the California Integrated Waste Management Board for posting, and also posted on Bristol-Myers Squibb Company web site. The State of Minnesota only requires that the plan is posted on the Bristol-Myers Squibb Company web site.
Sharp waste generated by self-administration of an injectable drug could occur throughout the United States. Bristol-Myers Squibb Company has been conducting several clinical trials in various States, some of which involve subcutaneous injection of our pharmaceuticals. These clinical trials are administered by third parties at clinical investigative sites, located throughout California, Minnesota and elsewhere. In each of these trials, the patients are provided injectable sharps to self-administer the medication in a home environment and puncture resistant containers for the safe collection of the used sharps. As an element of the clinical trial, patients are provided with instructions on the proper administration of the medicine and requested to return the used sharps materials to these investigative sites using the puncture resistant containers. The investigative sites ultimately dispose of these sharps and containers, in accordance with applicable regulatory requirements. These home-generated sharps materials are not expected to enter into the pertinent municipality trash cycle.
During 2011, Bristol-Myers Squibb Company initiated the commercial distribution of ORENCIA® (abatacept) that is self-injected at home. Under the Bristol-Myers Squibb Company “Household Generated Sharps Management Plan”, Bristol-Myers Squibb Company offers customers that utilize self-injectable sharps, guidance, instructions and/or recommendations on how to handle the used sharp and on how to properly dispose of these materials.
In addition, our product, ORENCIA® (abatacept), currently offers our customers the option to participate in a program, which allows for the safe disposal of needles, at no cost to the customer. The program mails participating customers an empty sharps container with a return mail-back box for when the sharps container is full. This sharps container mail-back program is managed by a third-party but is fully funded by Bristol-Myers Squibb Company.
The Bristol-Myers Squibb Company Sharps Management Program and some related reference guidance are available at the following Internet web site:
Additional Sharps disposal guidance for all states is available at the following web pages:
Biotechnology and Biosafety
Our facilities worldwide follow biosafety requirements set forth by the World Health Organization (WHO) Laboratory Biosafety Manual, the U.S. National Institutes of Health, and U.S. Centers for Disease Control and Prevention. We maintain comprehensive biosafety programs to protect our workers, site visitors, communities and the environment.
Our corporate directive on Biological Safety addresses the biosafety, biosecurity, and bioethical issues associated with our R&D and manufacturing work with biological materials. State of the art engineering controls, procedures and personal protective equipment are used to assure safety. We have a robust evaluation process to regularly monitor and improve our biosafety program and work practices.
- Each facility that uses biological materials has a Biosafety Officer
- Facility Biosafety Committees, some with community representation, meet to review projects, genetically modified organisms and biological materials and advise research staff on biosafety concerns.
- The Biological Assessment of Risk (BAR) process facilitates the management and communication of our use of biological materials by assigning a risk category.
Our Commitment to the Ethical Use and Humane Care of Animals in Research
We take seriously our responsibility for the ethical treatment of animals used in research.
Our mission to discover, develop and deliver innovative medicines has both a legal and ethical obligation to ensure their safety and efficacy prior to use in humans. Regulatory agencies around the world require that investigational medicines be thoroughly evaluated before approval for use in human clinical trials. Research or testing methods that include the use of animals are sometimes required, and will continue to be a component of our efforts. At the same time, providing high-quality humane animal care and developing alternatives to animal use are moral, scientific and legal necessities. We are committed to reducing our reliance on animal testing methods, and promoting the development, validation and use of non-animal testing models. We abide by the 3Rs principles of animal research and our scientists must give serious consideration to:
- Replace animal research and testing with other methods
- Reduce the number of animals used
- Refine procedures to enhance animal welfare
An Animal Welfare 3Rs Innovation Award is conferred annually to scientists who have implemented innovative methods while still obtaining valid results. We have consistently advanced our research methods and moved to a system that relies on a combination of in silico, in vitro and in vivo approaches.
We have a world-class imaging department that allows scientists to view the impact of experimental drugs on disease and assess the long-term effectiveness in a non-invasive manner. We have consistently provided funding to external organizations to support the development of alternatives to animal research.
When the use of animals is necessary, we provide the highest level of care that meets or exceeds local, national and international regulations, as well as our own internal standards.
The Bristol-Myers Squibb Animal Welfare Oversight Committee, which reports to our senior leadership team overseeing research, provides guidance on animal welfare policies and standards, clarifies the Company’s expectations for implementation of new regulations and guidelines related to animal care and use, and assures that the appropriate resources are available to support our programs. We routinely conduct internal Animal Welfare Practice audits at each of our animal facilities.
Our research sites seek and secure accreditation by the Association for the Assessment and Accreditation of Laboratory Care International, a private, nonprofit organization that promotes humane treatment of animals in science and is internationally recognized as the gold standard for research programs.
The Company’s Animal Care and Use Committees / Animal Ethics Committees review, approve and monitor all animal use, and perform audits and semiannual facility inspections and program reviews, to ensure the animals are healthy and cared for appropriately. We provide our animals with environmental enrichment to enhance their welfare and ensure quality veterinary care is available at all times.
Special training and development is provided to all employees who work in our animal research programs to ensure they demonstrate ethical and humane care and respect for all research animals. Safe and compassionate procedures for handling and caring for animals are in place at our facilities and disciplinary actions, up to and including termination, can be taken against employees who do not comply with our standards and procedures.
Contractors who carry out research for Bristol-Myers Squibb are also expected to apply the same care and ethical standards and accreditation requirements. We conduct an Animal Welfare Risk Assessment of contractors and regular inspections to ensure compliance with these standards.