Management of Pharmaceutical Wastes from Healthcare & Households. Rudy Vingris Product Manager PharmEcology Services Waste Management, Inc.

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1 Management of Pharmaceutical Wastes from Healthcare & Households Rudy Vingris Product Manager PharmEcology Services Waste Management, Inc.

2 Legal Disclaimer This presentation is solely for educational purposes and provides only a general description of various regulatory requirements. For a complete description, please consult the relevant federal and state regulatory statutes. Nothing in this presentation constitutes legal advice and you should not legally rely on any information provided in this presentation. We make no warranty, express or implied, with respect to such information and disclaim all liability resulting from any use or reliance of this information.

3 Drug Disposal: The Ideal Healthcare Facilities Required to segregate pharmaceutical waste into RCRA hazardous waste or California Hazardous waste Households Excluded from RCRA Hazardous Waste regulations federally Best Management Practice is incineration: waste-to-energy or regulated medical waste

4 Managing Waste Pharmaceuticals in California The Real RCRA Hazardous Pharmaceuticals Cal EPA s Department of Toxic Substances (DTSC) administers RCRA. Poorly Understood and Adopted California Hazardous Pharmaceuticals California Department of Public Health (DPH, formerly DHS) California Medical Waste Management Act Expanded Definition of Hazardous Waste Many Hospitals Have Complied Department of Public Health Strong Guidance: Discouraging Discharge of Pharmaceuticals to POTW Additional Concerns: DOT regulations & DEA Controlled Substances Act.

5 RCRA: The Defining Regulation Resource Conservation & Recovery Act Enacted in 1976, enforced by the EPA Federal regulation of the disposal of solid wastes Encourages the minimization of waste generation Defines hazardous waste Cradle to Grave tracking of hazardous waste Households are exempt Increased enforcement by federal & state agencies on healthcare providers.

6 Which Discarded Drugs Become RCRA Hazardous Waste? P-listed chemicals (acutely hazardous) Sole active ingredient; unused; empty containers Warfarin >0.3% (P001); Nicotine (P075); Epinephrine (base) (P042) Salts Exclusion but Cal Haz; Nitroglycerin (P081) Federal Exclusion but Cal Haz U-listed chemicals (toxic) Sole active ingredient; unused Chloral Hydrate (U034) & Controlled Substance IV Cyclophosphamide (U058) Chemotherapy Characteristic of hazardous waste Ignitability (>24% Alcohol, Aerosol Propellants) Toxicity (Heavy Metals, exceed TCLP Limits) Corrosivity (Primarily Compounding Chemicals) Reactivity (Medicinal Nitroglycerin Excluded)

7 California Hazardous Pharmaceutical Waste Expanded Definition of a Hazardous Waste in CA. Defines state hazardous waste Rx per California Medical Waste Management Act Primary applicable criteria: An LD50 of 2500 mg/kg or less Acute aquatic 96-hour LC50 < 500mg/liter Carcinogenicity, acute toxicity, chronic toxicity, bioaccumulative, persistence in the environment No complete list Practical solution: manage all non-rcra pharmaceuticals as Cal-Hazardous Mandated incineration at a regulated medical waste facility or approved alternative

8 Prohibition Against Sewering Any Drugs Memo from Jack McGurk, DHS, September 5 th, 2003 California Law prohibits the sewering of hazardous wastes. Federal Clean Water Act and California Porter-Cologne Waste Quality Act. Requires hospitals to obtain written permission to sewer any drugs Items usually acceptable for sewering include saline solutions, lactate, glucose, and added salts such as potassium and/or other electrolytes

9 Management Recommendations Type of Waste For Pharmaceutical Waste Color code Contents Treatment Container Method Red bag (nonpathology) Red Biohazardous (RMW) No Rx Autoclave/ Landfill Red sharps/ needlebox Red Biohazardous; needles, No Rx Autoclave/ Landfill Trace chemo Rx (non RCRA) Yellow Biohazardous & Trace Chemo RMW Incineration RCRA Toxic/ Ignitable Hazardous Rx Black RCRA & BMP Cal Hazardous Rx RCRA TSDF/Incinerat ion Cal Hazardous Rx White/Blue Cal Hazardous Rx RMW Incineration

10 Traditional Chemo Waste Containers Empty chemo vials, syringes, IVs, tubing, gowns, gloves,etc. Containment RCRA Hazardous Waste Containers Bulk chemo in vials, unused IV s, P, U. toxic D Non-Hazardous Waste Containers Cal Hazardous pharmaceuticals

11 Household Pharm Waste: The Real The public s desire to provide safe disposal options for unwanted medications is increasing Primary regulatory barrier: Controlled Substances Act ONLY Allows Transfers Between DEA Registrants Primary practical barrier: Sustainable funding One-day collection events provide immediate relief but only scratch the surface Need continuous services based at pharmacies and through mail-back options

12 Safe Drug Disposal Act of 2009 Pending Legislation Introduced into the House on February 25, 2009: HR 1191 Introduced into the Senate on June 24, 2009: S 1336 To amend the Controlled Substances Act to provide for the disposal of controlled substances by ultimate users and care takers through State take-back disposal programs To amend the Federal Food, Drug and Cosmetic Act to prohibit recommendations on drug labels for the disposal by flushing Secure & Responsible Drug Disposal Act of 2009 Introduced into the House on March 5, 2009: HR 1359 Introduced into the Senate on June 18, 2009: S To amend the Controlled Substances Act to enable consumer take-back programs DEA will not promulgate regulatory changes until legislation is passed

13 Drug Take-back Pioneers: Charting Unknown Territory How much consumer-generated drug waste occurs annually? What percentage of drugs dispensed is wasted? How much residual, historical waste is in the system that needs to be flushed out What is the most efficient method for collecting/processing drug waste How does efficiency correlate with convenience? What will the costs of each system be? Who should incur the costs?

14 What Should the Future Look Like: Defining Success What makes medication collection and treatment programs successful? 1) Accessible 2) Easy 3) Cost Effective 4) Sustainable

15 Accessible Programs must be accessible to a variety of ultimate users. 3 models Community Take-Back Typically one-day events Mail back For non-mobile populations Pharmacy Kiosk Permanent

16 Easy Programs and operating procedures must be easy for ultimate users and collection staff. Law enforcement involvement Currently required by Controlled Substances Act (CSA) Simple sorting process Controlled vs. Non-controlled Federal CSA rule change Could allow for additional forms of pharmacy take-back

17 Cost Effective Collection and treatment programs must show value for dollars spent. Cal-Hazardous waste disposal Medical Waste Incineration Waste-to-Energy Federal exclusion for household-generated hazardous wastes. California s position: Cal DTSC does not regulate residential hazardous wastes. Cal DPH regulates residential pharmaceutical waste when consolidated at a location regulated by the Cal MWMA.

18 Sustainable Funding Product Stewardship

19 What is Product Stewardship? Shared responsibility for the end-of-life management for products. Drives changes in product design, production and consumer behavior regarding cost of proper disposal What entity bears which costs and responsibilities Primary historical reference: Scott Cassel, Ex Dir, Product Stewardship Institute,

20 What Makes Drug Product Stewardship So Problematic? Hundreds of manufacturers/repackagers Consumer does not often have choice of products/brands Difficult to separate by origin Bring only those drugs manufactured by ABC drug manufacturer Controlled substance and other regulatory issues Concerns regarding diversion/safety Multiple distribution systems: retail pharmacy, mail-order, internet pharmacy, multi-national sources

21 Impact on Manufacturers Have a stake in reducing drug waste if costs of disposal must be built in to cost structure Potential reduction in sampling/move to vouchers Encouragement of lower introductory prescription limits/options Application of business process to increase efficiencies in take-back efforts Economies of scale emerge

22 Reasons for Retailers & Manufacturers to Participate Competitive Advantage: perceived as being green and leaders in sustainability efforts Reduction of Business Risk: getting out in front of multiple state legislative efforts to support a mutually agreed upon federal effort. (Rechargeable Battery Recycling Corporation) Company Leadership: Bold decision to lead Wal-Mart s packaging scorecard initiative

23 Common Elements: General Consensus Must accept all OTC, RX drugs; some include veterinary Manufacturer or Importer; retailer not included Target audience: consumers, including long term care facilities, other residential treatment centers, hospice Plan Required of Manufacturer(s): Renewal times differ Flexibility: Urban and rural/mail-back required in some; collection in cities of 10,000+ in others

24 Proposed Product Stewardship Bills Florida: HR 1357, SB 2650 Maine: HP0557, LD 821 Minnesota: HR 1217 Oregon: SB 598 Washington State: HR 1165, SB 5279 (duplicate) None have passed to date only a matter of time

25 What s Needed: Product Stewardship Model Language States are clearly adopting language from each other Washington State, Maine, Minnesota very influential Suggested Action Item: Draft model language that retains much of the acceptable common elements Involve industry in dialog Move the discussion to federal legislation with some state flexibility Use Federal Act to move hazardous pharmaceuticals into Universal Waste Rule (UWR) in tandem with EPA

26 Finding a Way Forward Determine cost efficiency for 3 scenarios: Community take-back Pharmacy kiosk Individual mailback Define cost efficiency By individual? by family unit? By prescription? By pound? Seek federal legislation which allocates funding based on agreed upon parameter Sales into the market? Volume into the market?

27 Questions? Contact information: Rudy Vingris Product Manager-PharmEcology Services WM Healthcare Solutions, Inc Main Street 1 City Center, Suite 1000 Houston, TX (cell)

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