Product Responsibility
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.
Sharps Management Plan
As some States have approved regulation for the management of Household Generated Sharps Wastes during the past years, Bristol-Myers Squibb has prepared a Sharps Management Plan to support in the safe collection and proper disposal of waste sharps. Under various state sanctioned regulations, pharmaceutical manufacturers that sell or distribute a medication that is self administered at home through the use of hypodermic needles or other self-injectable devices have to prepare and submit to the State, or its 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 the plans on their respective Internet web sites. Currently two states have issued Sharps management regulations, California and Minnesota. For California, the plan must be submitted to the California Integrated Waste Management Board (Board) for posting, and posted on Bristol-Myers Squibb web site. The State of Minnesota only requires that the plan is posted on Bristol-Myers Squibb web page.
Bristol-Myers Squibb has been conducting several clinical trials in various States, which involve subcutaneous injection of our pharmaceuticals. These clinical trials are administered at clinical investigative sites located throughout California, Minnesota and other states by third parties. In each of these trials, the patients are provided injectable sharps to self-administer the medication in a home environment and also 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. Disposal of these sharps is coordinated by the clinical investigational site using the third party disposal contractors.
As of October 2011, Bristol-Myers Squibb initiated the commercial distribution of a medicinal product that will be self-injected at home. Under this Bristol-Myers Squibb Sharps Management Plan, Bristol-Myers Squibb will offer customers that utilize self-injectable sharps, instructions and/or recommendations on how to handle the used sharp and on how to properly dispose of these materials. In addition, customers may be chosen to participate in a program that offers an empty sharps container and return mail-back program, which allows for both the adequate disposal of needles and also patient convenience, at no cost to the customer. This sharps container mail-back program will be managed by a third party and fully funded by Bristol-Myers Squibb.
This Sharps Management Program and some related reference guidance are available at the following Internet web site:
http://www.bms.com/ourcompany/compliance_ethics/Pages/default.aspx
Additional Sharps disposal guidance for all states is available at the following web pages:
http://www.safeneedledisposal.org/
http://www.epa.gov/wastes/wyl/stateprograms.htm
http://www.epa.gov/wastes/nonhaz/industrial/medical/disposal.htm