Bristol-Myers Squibb provides consumers and distributors with information necessary to ensure the safe use, transportation, storage and disposal of our products.
Our products relate to health care, the labeling of which governments strictly regulate to ensure safe use. We follow the highest standards. We also have systems for tracking consumer comments and adverse reactions to our products. We use this feedback on our material safety data sheets, as appropriate. Bristol-Myers Squibb’s Regulatory Affairs Department follows policy development, collects data on labeling and ensures compliance with regulations.
Marketing and Advertising
Bristol-Myers Squibb is committed to compliance of our sales and marketing practices with all applicable requirements, including guidelines of the Office of the Inspector General with respect to sales of pharmaceutical products.
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 Manufacturers requirements for Household Generated Sharps management. For California, the plan must be submitted to the California Integrated Waste Management Board for posting, and posted on
Bristol-Myers Squibb Company web site. The State of Minnesota only requires that the plan is posted on Bristol-Myers Squibb web page.
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, 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, ORENCIA® currently offers our customers the option to participate in a complimentary program, which allows for both the safe disposal of needles and also patient convenience, at no cost to the customer. The complimentary program mails participating customers an empty sharp container followed by a return mail-back box when the sharps container is full. This sharps container mail-back program is managed by a third party but fully funded by Bristol-Myers Squibb Company.
In August of 2012, Bristol-Myers Squibb Company acquired Amylin Pharmaceuticals, LLC. The acquisition of Amylin Pharmaceuticals, LLC resulted in the expansion of the alliance between AstraZeneca and Bristol-Myers Squibb Company to incorporate the development and marketing of Amylin’s portfolio of products: Byetta® (exenatide), Bydureon® (exenatide extended-release) and Symlin® (pramlintide acetate), which also use self-injectable sharps. Patients utilizing a commercially supplied, self-injectable Amylin product receive Patient Prescribing Information, which includes Instructions For Use on the proper handling and disposal of waste sharps. The pamphlet also instructs patients on the basic disposal requirements.
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: