Pharmaceutical Waste Initiatives: What Comes Next? ACPE # L05-P (0.1 CEU)

Transcription

1 Date: Monday, August 27, 2012 Time: 10:15 a.m. 11:15 a.m. Location: Colorado Convention Center Rooms Title: Speaker: Pharmaceutical Waste Initiatives: What Comes Next? ACPE # L05-P (0.1 CEU) Diane Darvey, PharmD, JD, Director, Federal & State Public Policy, NACDS, Richard Leahy, Vice President, Environmental, Health and Safety Compliance, Wal-Mart and Mike Stephenson, Senior Director, Environmental Health &Safety Compliance, Wal-Mart Learning Objectives: At the conclusion of this knowledge-based program, participants will be better able to: Compare and contrast the federal and state approaches to handling and disposal of pharmaceutical hazardous waste Discuss options for pharmacies to work with EPA to develop workable means for handling pharmaceutical hazardous waste Explain the different categories of pharmaceutical waste and the criteria that define the different levels of hazardous waste generations

2 Agenda 2 PHARMACEUTICAL WASTE INITIATIVES: WHAT COMES NEXT? Diane Darvey Director Federal and State Public Policy NACDS Richard Leahy Vice President EH&S Wal-Mart Stores, Inc. Mike Stephenson Sr. Director EH&S Wal-Mart Stores, Inc. Why is Pharmaceutical Waste an Issue? Retail Pharmaceutical Waste Program Example What Comes Next Discussion Why is Pharmaceutical Waste an Issue? 3 4 Pharmaceuticals found in surface, ground, and drinking water. Uncertain effects on human health and aquatic environment Diversion Prevention Protect human health and the environment Cradle to Grave framework for hazardous wastes (Subtitle C) Must be listed or characteristic to be a hazardous waste Solid waste generally left to States/local municipalities (Subtitle D) Currently no special rules for pharmaceuticals Fundamental requirements are: Make a waste Determination (Is it discarded and is it hazardous ) Count waste Ascertain generator status (CESQG, SQG, LQG, and HW) Arrange for proper disposal (status dependent) 5 6 Waste Subtitle C Generators Transporters Treatment, storage and disposal facilities (TSDFs) Household pharmaceutical HW exempt from federal RCRA Treated as solid waste e.g. trash BUT EPA recommends Household hazardous waste be treated as hazardous waste Not with lesser requirements for solid waste What is considered pharmaceutical HW? Listed in F, K, P or U lists OR Characteristics of hazardous waste Ignitable flash point, <140 degrees F Corrosive ph < 2 or > 12.5 Reactive explosive, water reactive, cyanide, or sulfide bearing waste Toxic will generate leachate containing heavy metals, solvents or pesticides Estimate: up to 10% of drugs are HW

3 7 8 P list Acute hazardous waste Toxicity in smaller amounts and shorter time E.g. warfarin, arsenic, epinephrine, nicotine, nitroglycerin U list Commercial chemical products E.g. warfarin, melphalan, mercury, phenol cyclophosphamide F list Manufacturing & industrial process wastes K list Wastes from specific industries What is NOT Waste Biohazardous waste, drugs Controlled Substances Act (CSA) Regulates Schedule I-V pharmaceuticals. Transfers of out-of-date, damaged, or otherwise unusable or unwanted Schedule I and II controlled substances should be transferred to Reverse Distributors via the DEA Form 222, while Schedule III V compounds may be transferred via invoice. Source: DEA Practitioner s Manual Requires security measures and reporting of significant loss or theft via DEA Form 106. Transfers to Reverse Distributors generally through common carrier. 9 State Regulation States are authorized to implement RCRA and State programs can be stricter than RCRA (Different vs Stricter) Some States have additional characteristics for designating Waste (e.g. California uses aquatic toxicity ) FL and MI classify pharmaceuticals as Universal Waste WA and MN have special pharmaceutical reverse distribution policies k,doc_view/gid, Traditional Management Framework for out-of-date, damaged, or otherwise unusable or unwanted pharmaceuticals: 3 rd Party Reverse Distributors established to manage manufacturer credit terms and product disposition. Retail Pharmacies/Healthcare facilities send all pharmaceuticals via common carrier to Reverse Distributor that evaluates pharmaceuticals for credit and management per manufacturer terms. In 2008, EPA stated Because unused or expired pharmaceuticals are being returned (via the reverse distributor) for possible manufacturer credit, they still have potential value to the pharmacy or hospital and are thus not considered wastes. 73 FR EPA attempted to add pharmaceuticals to the list of Universal Wastes by proposing a rule amendment in Withdrawn in Would have allowed streamlined management of hazardous pharmaceuticals Commenters expressed concern over tracking and incomplete coverage (i.e. non-hazardous pharmaceuticals) Several States now rethinking potential credit in favor of ultimate disposition to make discard determination (CO, MN) Reverse Distribution of consumer products, including pharmaceuticals, coming under greater scrutiny. Waste Enforcement Actions in California: Home Depot (2007) - $9.9 Million Walmart (2010) - $27.6 Million Target (2011) - $22.5 Million CVS (2012) - $13.75 Million Costco (2012) - $3.6 Million Walgreens sued in June 2012 seeking $60 Million Complaint appears to include individuals ( DOES 1-25 )

4 Pharmacy Waste Program Example Pharmacy Waste Program Example 17 Nationwide Reverse Distribution Program Model (except CO) Creditable In-date 18 Identification Manage as Waste Loose / Unidentified Pills Damaged / Leaking / Non-creditworthy Creditable and In-date = Valuable and Viable = Non-waste

5 What Comes Next? What Comes Next? About the proposed UWR, EPA stated on its website: the Agency has decided to develop another proposal for health care facility-specific regulations for the management of hazardous pharmaceutical wastes in order to provide a regulatory scheme that addresses the unique issues that hospitals, pharmacies and other health care-related facilities face. It is anticipated that the proposal will be available for public comment in Spring OIG reported that EPA has developed early guidance and completed Option Selection in April A holistic pharmaceutical waste management solution would address: All pharmaceuticals Controlled (State and federal) Non- Diversion protection Transportation, Tracking, and Reporting Appropriate Disposal Methods Consistency!!! What Comes Next One possible Solution? Secure Contain er THANK YOU! Form 222 equivalent or combined form: Controlled Non-Controlled Non- Generate Waste & Manage Properly