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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link="#0563C1" vlink="#954F72"><div class=WordSection1><p class=MsoNormal>Please post my response to the discussion on “Anyone using Cactus Sink? that has recently circulated.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>I am commenting on the discussion of the problem of how to legally dispose of pharmaceutical waste generated by patient care operations. <o:p></o:p></p><p class=MsoNormal>EPA and many states are disallowing the practice of flushing waste pharmaceuticals down the toilet or sink.<o:p></o:p></p><p class=MsoNormal>The DEA requires dispensed controlled drugs to be deemed Unrecoverable and Unusable with no guidance on what that means. The industry thus is in a holding pattern, waiting until DEA regulations are finalized and the term Unrecoverable and Unusable is defined. <o:p></o:p></p><p class=MsoNormal>Disposal facilities acceptance processes and operating permits require a detailed characterization and inventory describing the wastes that will be shipped <o:p></o:p></p><p class=MsoNormal>EPA requires Generators to ensure Hazardous Waste are identified and disposed of properly. Mixing of just 1 warfarin tablet with unused patient controlled drugs, even if it is rendered Unrecoverable and Unusable, makes the mixture a Hazardous Waste. If the mixture weighs more than 1 Kg., the Generator is now considered a fully regulated Large Quantity Generator of Hazardous Waste. <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Over the past several years, the healthcare industry has shown interest in a product called the Cactus Sink. Marketed as the ultimate answer to disposal of pharmaceutical waste generated by hospitals, the Cactus Sink manufacturer accurately describes its product as securely captures dispensed unused pharmaceutical waste and renders it acutely "unrecoverable and unusable" <through chemical fixation> This is an effective collection system but it has serious side effects with disposal abilities:<o:p></o:p></p><p class=MsoListParagraphCxSpFirst style='text-indent:-.25in;mso-list:l0 level1 lfo1'><![if !supportLists]><span style='mso-list:Ignore'>1.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>If there is no inventory maintained as to the contents and, after mixing, the contents cannot be verified. This makes the filled canisters very difficult, if not impossible to dispose of.<o:p></o:p></p><p class=MsoListParagraphCxSpMiddle style='text-indent:-.25in;mso-list:l0 level1 lfo1'><![if !supportLists]><span style='mso-list:Ignore'>2.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>How does the Hospital totally ensure that the device is used only for distributed controlled drugs and never contains any hazardous waste? Or DOT Hazardous Materials. If the canister and contents weigh more than 1 Kg. before being used, adding just 1 warfarin tablet (or other “P” Listed product dose) makes the hospital a Large Quantity Generator of Hazardous Waste<o:p></o:p></p><p class=MsoListParagraphCxSpMiddle style='text-indent:-.25in;mso-list:l0 level1 lfo1'><![if !supportLists]><span style='mso-list:Ignore'>3.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>There is yet to be a DEA approved method of making these controlled drugs "unrecoverable and unusable". Thus the Cactus claim is pre-mature at this time on stating their product does this. <o:p></o:p></p><p class=MsoListParagraphCxSpMiddle style='text-indent:-.25in;mso-list:l0 level1 lfo1'><![if !supportLists]><span style='mso-list:Ignore'>4.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>For arguments sake, let’s say a filled canister contains only unrecoverable and unusable patient distributed controlled drugs and no hazardous waste. This is now a Solid Waste requiring shipment to a Solid Waste Management facility. Reverse Distributors do not typically have a Solid Waste Management Permit and thus are prohibited from accepting Solid Waste. <o:p></o:p></p><p class=MsoListParagraphCxSpMiddle style='text-indent:-.25in;mso-list:l0 level1 lfo1'><![if !supportLists]><span style='mso-list:Ignore'>5.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>One of the main functions of Reverse Distributors is to arrange for the destruction of DEA Controlled Drug Substances transferred from a DEA Registrant’s inventory. Destruction requires approval for the waste by Incinerator based on a detailed inventory. Patient distributed controlled drugs are not the same as inventoried Controlled Drug Substances and are not accepted as they are already out of the pharmacy’s inventory. <o:p></o:p></p><p class=MsoListParagraphCxSpMiddle style='text-indent:-.25in;mso-list:l0 level1 lfo1'><![if !supportLists]><span style='mso-list:Ignore'>6.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>If a Reverse Distributor were to accept these canisters, what, if any, disposal facility would accept them without an inventory of the contents? <o:p></o:p></p><p class=MsoListParagraphCxSpMiddle style='text-indent:-.25in;mso-list:l0 level1 lfo1'><![if !supportLists]><span style='mso-list:Ignore'>7.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>How would the Reverse Distributor accept the canisters and adhere to their state’s Solid Waste Management rules? <o:p></o:p></p><p class=MsoListParagraphCxSpLast style='text-indent:-.25in;mso-list:l0 level1 lfo1'><![if !supportLists]><span style='mso-list:Ignore'>8.<span style='font:7.0pt "Times New Roman"'> </span></span><![endif]>The canister can be used for liquids. Many pharmaceutical products, particularly liquid preparations, meet the definition of a DOT Hazardous Material in Transportation (e.g. Excelon (rivastigmine) is DOT Toxic and flammables, corrosives and oxidizers are quite common pharmaceutical wastes ). While these may be shipped as a Consumer commodity ORMD as a medicine, there is no provision to mark those canisters that contain Hazardous Materials as ORMD and misusing ORMD for non-hazardous is a DOT violation too. Are there compatibility issues (e.g. mixing flammable and oxidizers) without proper classification by the user? <o:p></o:p></p><p class=MsoNormal>I do not mean to be negative about this product but Hospitals and Pharmacies are cautioned to be prudent in weighing these risks. Legal, safety, documentation and logistical requirements need to be in place before a workable disposal process can be achieved. The Cactus Sink is a great waste collection system but needs considerable effort to make it a viable solution for disposal of the wastes it collects. <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial","sans-serif"'>William G. Speenburgh<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial","sans-serif"'>World Class Environmental Resources, LLC<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial","sans-serif"'>(973) 770-2275 (Phone)<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial","sans-serif"'>(973) 219-5720 (cell)<o:p></o:p></span></p><p class=MsoNormal><o:p> </o:p></p></div></body></html>