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: