PHARMACEUTICAL WASTE UPDATE ON HANDLING AND DISPOSAL ASTSWMO MEETING August 11, 2011

PHARMACEUTICAL WASTE UPDATE ON HANDLING AND DISPOSAL ASTSWMO MEETING August 11, 2011

Pharmaceutical Waste Getting the attention it deserves Are there Federal, State and Local laws & regulations to comply with? Is the The Joint Commission raising the standards? How do we protect patients & staff? How do we protect the environment?

OVERVIEW OF PROGRAM What is RX waste? Generation, types, where? Current state of regulations and legislation Current state of waste disposal Healthcare hospitals Healthcare other Home generated waste RX Reverse Distribution DEA Opportunities Healthcare disposal Home generated wastes Best management practices In healthcare Home generated

WHAT IS RX WASTE?? Pharmaceutical waste is a drug that is generated: When the decision is made to discard an pharmaceutical product, it is no longer usable for intended purpose To be discarded for other reasons contamination, already dispensed and expiration Can be a hazardous waste, non-hazardous waste, controlled substance In healthcare setting or in the home

WHAT IS RX WASTE?? In healthcare it can become waste where pharmaceuticals are prepared, used or dispensed to patients Hospital Pharmacies (30%) Inpatient and Out-Patient Care Areas (70%) Types of Pharmaceutical Waste in Patient Care Areas: Partial vials (safety caps removed) Un-dispensed, pre-instilled IV s Hospital repacks Pre-filled syringes Partial syringes Discontinued meds Un-administered meds Patient prescriptions Physician RX samples

WHAT IS RX WASTE?? Non-Hazardous 92 % of WASTE NON- RCRA HAZARDOUS RX WASTE Compatible Hazardous RX 6% Non-Compatibles/Inhalers 2% Aerosols & Inhalers Oxidizers/Corrosives Controlled Substances 5% of total formulary Less than 1% hazardous Compatible Hazardous Waste Rx waste that CAN be placed in the same container without danger of a chemical reaction Non-Compatible Hazardous Waste Rx waste that CANNOT be placed in the same container with other Rx waste because it may cause a dangerous chemical reaction Non-Hazardous Waste Typically not regulated

WHAT IS RX WASTE?? Waste Generation Locations Pharmacy Oncology - Chemo All Other Patient Care Areas Medication Dispense Station Med Carts Med Rooms Soiled Utility Room Characteristic Hazardous Lantus Humalog Humulin N&R Novalog Flovent Taxol P Listed Epinephrine* Coumadin/Warfarin* U Listed Chemotherapy drugs Cytoxan Mutamycin RMW Non-Hazardous Abbokinase Recombivax Dual Waste Hazardous Regulated medical waste with RCRA hazardous drug Non - Compatible Silver Nitrate Glycopyrrolate * State Specific

CURRENT STATE OF REGS AND LEGS Agencies involved in Rx waste regulation: State Regulatory Agencies All of you! Environment Protection Agency (EPA) Resource Conservation and Recovery Act (RCRA) Department of Transportation (DOT) Drug Enforcement Agency (DEA) Publicly Owned Treatment Works (POTW) State Board of Pharmacies The Joint Commission (TJC) (non regulatory)

CURRENT STATE OF REGS AND LEGS FEDERAL LEGISLATIVE UPDATE Drug Free Water Act 2009 H.R. 276 and Water Quality Investment Act of 2009 HR 1262 January 2009 Task force on proper disposal of unused pharmaceuticals Primarily through Water Department Secure and Responsible Drug Disposal Act of 2010 S 3397 Passed in October 2010 Amended the controlled substances act to identify a way for ultimate user disposal Awaiting action by DEA Public meeting held January 19-20, 2011 for public opinion to move forward with new regulations Will only deal with ultimate user (home generated wastes)

CURRENT STATE OF REGS AND LEGS EPA Water: FEDERAL REGULATORY UPDATE Public comment requested in 2009 Task force regarding proper disposal of unused drugs in healthcare and the impact on water Best Management Practices for Unused Pharmaceuticals in Healthcare Facilities Draft Sept. 2010 Received many comments awaiting redraft to be released 2011 Office of resource Conservation and recovery (Solid and Hazardous Waste) Proposed Universal Waste Rule is being reconsidered due to public comments received EPA considering additional regulatory options for management and disposal of pharmaceuticals Controlled substances still remain a challenge

CURRENT STATE OF REGS AND LEGS STATE LEGISLATIVE UPDATE MAIN AREAS OF LEGISLATIVE ACTIVITY AT STATE LEVEL: Home Generated Pharmaceutical Waste Disposal and Take Back Programs Donation No Flush Water Studies

CURRENT STATE OF REGS AND LEGS STATE LEGISLATIVE UPDATE Home Generated Pharmaceutical Waste Disposal and Take Back Programs States currently still active: DE, IL, KS, MS, MA, NJ, NY, WA Passed awaiting action: IN, la, MD, NE, NH, OH, VT Components of programs vary Many have moved away from manufacturer responsibility Funding remains a challenge Many awaiting DEA action Donation and or reuse: States currently still active: IL, NH, NJ, NY, PA, VT Passed awaiting action: NM Many variations: donation typically back to state run operations (prisons, LTCF)

CURRENT STATE OF REGS AND LEGS STATE LEGISLATIVE UPDATE NO FLUSH CAMPAIGNS AND WATER STUDIES 9 states had some form of legislation however most did not go through. NJ and WA remain TX ended stakeholder group and made determination that there was no long term impact and felt current practices are acceptable

CURRENT STATE OF REGS AND LEGS STATE REGULATIONS: CA requires RX waste to be over classified as RMW and sent for incineration if they meet the CA hazardous definition. Some exceptions made for flushing MN requires proper management of wastes that fall under the MN Lethal definition. Some exceptions are made for controlled substance flushing WA interim enforcement rule healthcare has options for disposing and utilizing alternative management methods provided materials are incinerated. FL and MI Universal waste rule NY AG using RCRA regulations and regulatory authority discretion to enforce for non hazardous drug disposal requirements No recent activity Most states are dealing with pharmaceutical issues under regulated medical waste regulations (CO, PA)

CURRENT STATE OF WASTE DISPOSAL What Happens to Rx Waste Today?

CURRENT STATE OF WASTE DISPOSAL Compatible Rx waste that CAN be placed in the same container without danger of a chemical reaction Non-Compatible Rx waste that CANNOT be placed in the same container with other Rx waste because it may cause a dangerous chemical reaction Controlled Substances Retuned to pharmacy (for inventory control and return to reverse distributor) or witness wasted to sewer

CURRENT STATE OF WASTE DISPOSAL Waste is generated on different Units Waste must be identified and determined how a healthcare facility is going to manage these materials drug coding and sorting Provide a program and containers Reasons for non compliance: Training issues Time limitation Controlled substances Containment and storage Currently most hospitals good at P and U identification and segregation but have not done full categorization of full formulary

CURRENT STATE OF WASTE DISPOSAL HEALTHCARE Hospitals - Clinical care Mix of waste disposal from solid waste, collection and segregation, all hazardous waste, red bag, and flushing Mostly disposal via red bag and flushing Nursing homes, hospices, etc. Mostly disposal via red bag, solid waste and flushing Still awaiting DEA regulation changes HOME Flushing, solid waste Special waste instructions unrecognizable or undesirable and solid waste Take back programs where available DEA take back days 2 so far 3 rd scheduled October 29, 2011 Disposal still a challenge for law enforcement

RX REVERSE DISTRIBUTION Must determine if returnable for credit by the manufacturer May be returned directly to manufacturer May be returned through a reverse distribution company which sets up agreements with the manufacturers and follows through on policies set by the manufacturers Returned goods are products not waste Not a RX Waste Management Tool

CURRENT STATE OF DISPOSAL RISK TO HEALTHCARE FOR COMPLIANCE Hazardous waste determinations not done or incorrect Labeling of hazardous waste not done or incorrect HW down the drain - POTW Improper disposal of chemotherapy drugs Inadequate training for employees in HW management Not conducting proper weekly inspections of HW storage No or inadequate HW manifests Improper management of expired pharmaceuticals Lack of emergency contingency plan DEA Registration risk States have started to take action! JOINT COMMISSION INSPECTIONS Identification and Management of Regulated Hazardous Waste EPA Region 2

DEA OPPORTUNITIES Controlled Substances in Healthcare DEA regulated materials registrant to registrant transfer only DEA does not have a definition for waste as part of the statute Options for unused controlled substances: Controlled substances from the floors should be witness wasted at the floor level through flushing as directed by the manufacturer s packaging instructions and using the Form 41 for Destruction Controlled substances should be brought back down to the hospital pharmacy and documented to be transferred to a reverse distributor for final disposition using the 222 Inventory Form DEA does not consider the sharps containers, regulated medical waste or solid waste containers as a method of treatment or witness wasting. DEA does not define irreclaimable or irretrievable as a method of destruction. Many healthcare facilities are required to obtain POTW variances to flush

DEA OPPORTUNITIES Controlled Substances in the Home Considered an issue for both environmental reasons as well as for diversion control Take back programs are not allowed to take controlled substances due to current statutory requirements Patients look for ways to return all drugs and are not aware which drugs are considered controlled substances Registrants cannot accept CS from ultimate user Home generated RX 5-10% controlled substances (some studies showed higher) DEA bill has passed; awaiting regulatory changes Many programs continuing Mailback option difficult DEA is not in full support Many are still flushing or putting into undesirable materials to solid waste

BEST MANAGEMENT PRACTICES HEALTHCARE: Identification of RX waste hazardous/non-hazardous; continuous inventory maintenance Identification of regulations from individual states Determine program and method of compliance PHARMACY CODES COLOR CODES STICKERS

BEST MANAGEMENT PRACTICES HEALTHCARE: Education create simple methods for compliance for employees and train, train, train (and retrain!) Example: Color-Coded Containers Non- Hazardous Waste (Blue) Compatible Hazardous (Black) Non- Compatible Hazardous (Black) CS - Units send back to pharmacy in baggie/tray Implement program and track accumulation Ensure continued compliance with program dedicated resource Identify best management options for controlled substances HOSPITALS REALLY DO WANT TO DO THE RIGHT THING!!!

BEST MANAGEMENT PRACTICES HOME DEA take back programs and education Educate public to what are controlled substances so that those materials are clearly identified to stay out of take back programs thus allowing take back programs for other drugs possible. Coding, special labeling, warning

BEST MANAGEMENT PRACTICES REGULATORY Study impact of non-hazardous drugs today Majority of the drugs found in the studies are not considered hazardous waste today Steroids, antibiotics, hormones, vitamin supplements EPA Federally recognizes the need for changes in the regulations Regulate segregation and enforce at generator level encourage training and reinforcement of hospital compliance policies Regulate disposal today BMP for destruction is incineration (high temperature either municipal solid waste with air pollution control systems in place or regulated medical waste incinerators) EPA BMP for Healthcare to be reintroduced and finalized

CONCLUSION Lots of opportunity for improvement Compliance with RCRA improves as there is more awareness Movement towards proper disposal of non-rcra regulated materials properly Healthcare is wanting to do the right thing for their patients and the environment Generators of waste in the home are becoming more aware of proper disposal Conflicting regulations and statutory constraints continue to be a challenge Regulatory focus will ensure continuation proper disposal

PHARMACEUTICAL WASTE UPDATE Questions Thank you!!! SELIN HOBOY VP LEGISLATIVE AND REGULATORY AFFAIRS STERICYCLE, INC shoboy@stericycle.com 847-943-6685