EWS Alabama, Inc. Training Services www.ewsalabama.com 800 739 9156 October 2012
Healthcare RCRA Violations Slide courtesy of John Gorman, USEPA Region 2 2
Training Outline What is RCRA Why comply Why are medications hazardous waste Waste collection into containers Container markings, labels, profile names Collection & moving containers off floor Recordkeeping 3
Formulary 4
Managing Pharmaceutical Waste: Why is pharmaceutical waste management becoming such a high priority with state and federal regulatory agencies How does pharmaceutical waste management relate to The Joint Commission Standards How do the federal and state hazardous waste rules apply to waste pharmaceuticals How do Drug Enforcement Administration regulations interface with EPA rules? 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 6
Which Discarded Drugs Become RCRA Hazardous Waste? P listed chemicals Sole active ingredient; unused U listed chemicals Sole active ingredient; unused Characteristic of hazardous waste Ignitability Toxicity Corrosivity Reactivity 7
Examples of P Listed Pharmaceutical Waste Arsenic trioxide P012 Epinephrine base* P042 Nicotine P075 Nitroglycerin* * P081 Phentermine (CIV) P046 Physostigmine P204 Physostigmine Salicylate P188 Warfarin >0.3% P001 * Epinephrine salts excluded federally as of Oct. 16 th, 2007; stimulated by Colorado ** Excluded from the P list federally and in Colorado 8
Examples of U listed Pharmaceutical Waste Chloral Hydrate(CIV) U034 Streptozotocin U206 Chlorambucil U035 Lindane U129 Cyclophosphamide U058 Saccharin U202 Daunomycin U059 Selenium Sulfide U205 Diethylstilbestrol U089 Uracil Mustard U237 Melphalan U150 Warfarin<0.3% U248 Mitomycin C U010 9
RCRA Risk Management & Liability Civil and criminal liability Civil: State/USEPA enforcement Criminal: FBI, Attorney General, Grand Jury Corporate fines: $32,500/violation/day Personal liability: fines and/or imprisonment No statute of limitations Managers up through CEO liable http://www.epa.gov/compliance/resources/policies/criminal/exercise.pdf 10
Increasing USEPA Regulatory Activity Region 1(New England) Veterans Administration Hospital, White River, Vermont, August 5 th, 2005 cited and fined $372,254 for hazardous waste violations Region 2 (NY, NJ): North Shore University Hospital, Manhasset, NY fined $40,000 (July 2003) Nassau University Medical Center, East Meadow, NY fined $279,900 (Oct. 2003) Mountainside Hospital, Montclair, NJ fined $64,349 (Nov. 2003) Memorial Sloan Kettering Cancer Center, New York, NY, fined $214,420 11
The Joint Commission Standards: The Joint Commission has expanded their standards to include management of hazardous medications. Both the Environment of Care and Medication Management standards now require hospitals to appropriately manage the risks related to hazardous materials and waste. Standard EC 023 02 01 The hospital manages risks related to hazardous materials and waste. Standard MM 01 01 03 The hospital safety manages high-alert and hazardous medications. 12
What Departments Get Involved in Generating and Managing Pharmaceutical Waste? Pharmacy Environmental Services Nursing Staff Infection Control Safety Department Risk Management Materials Management Facility Management 13
Definition of Empty P List Containers of P listed chemicals are considered hazardous waste, unless they have been rinsed three times and the rinsate discarded as hazardous waste. U List Containers of U listed chemicals are empty only when All contents removed that can be removed through normal means And no more than 3% by weight remains 14
When in question about a non listed drug being hazardous? Drugs which may cause harm to human health or the environment Drugs meeting OSHA or NIOSH toxic criteria Drugs with LD50s at or below 50mg/kg Identified as Toxic on technical spec sheets BMP recommendation is to segregate into RCRA toxic hazardous waste containers. 15
Characteristic of Ignitability Aqueous Solution containing 24% alcohol or more by volume & flash point<140 F Non aqueous solutions with flash points <140 F Oxidizers Flammable aerosols Hazardous Waste Number: D001 Rubbing Alcohol Topical Preparations Injections 16
Characteristic of Corrosivity An aqueous solution having a ph < or = 2 or > or = to 12.5 Examples: Primarily compounding chemicals Hydrochloric Acid(HCL) Sodium Hydroxide Hazardous waste number: D002 17
Characteristic of Toxicity 40 chemicals which meet specific leaching concentrations of mg/l Must pass the toxicity characteristic leaching procedure (TCLP) All have D codes Examples of potential toxic pharmaceuticals: Arsenic m Cresol Barium Mercury (thimerosal) Cadmium phenylmercuric acetate Chloroform Selenium Chromium Silver Lindane 18
How Should RCRA Hazardous Waste be Handled? Profile waste streams into specific hazard class groups Maintain as few profiles as practical in department RCRA Hazardous Waste: Ignitable (D001) Confirm wastestream mixing before performance 19
How Can Controlled Substances Be Disposed? Must be rendered non recoverable Disposal double witnessed by two health care professionals Traditionally disposed down the drain Obtain permission from local POTW Reverse distribution offers some options Some hazardous waste vendors are also DEA registrants 20
Common Pharmaceutical Waste Stream Management Type of Waste Container Color code Contents Treatment Method Red bag (nonpathology) Red Biohazardous (RMW) Autoclave/ Landfill Red sharps/ needlebox Red Biohazardous; needles, etc. Autoclave/ Landfill Trace chemo Rx bin Yellow or White Bulk & Trace Chemo, needles, tubing Incineration Sewer POTW Unused IVs, tablets, etc. Wastewater Treatment Plant Municipal Trash bin Pharma/Rx packaging. Waste to Energy Burner 21
Pharmaceutical Waste Management Recommendations Type of Waste Container Color code Contents Treatment Method Red bag (non pathology) Red Biohazardous (RMW) Autoclave/ Landfill Red sharps/ needlebox Red Biohazardous; needles Autoclave/ Landfill Trace chemo Rx Yellow Trace Chemo Incineration RCRA Toxic Hazardous Rx Black RCRA & BMP Hazardous Rx RCRA TSDF RCRA Ignitable Hazardous Rx Black RCRA Hazardous Rx RCRA TSDF Non hazardous Rx White Non hazardous Rx Incineration 22
How Should Non hazardous Drugs be Handled, Stored and Disposed? BMPs strongly discourage sewering and landfilling of nonhazardous drugs Organization can minimize risks by adopting BMPs Possible exception: controlled substances due to difficulty in rendering non recoverable under Drug Enforcement Administration (DEA) regulations Consider segregating into AP Medical Pharmaceutical white container. Dispose at EWS Alabama that is permitted to accept nonhazardous pharmaceutical waste. 23
When Regulators Come Calling Who is notified first? Who will conduct the audit? Where are manifests, land ban forms and certificates located for viewing and inspection? Who will show satellite & storage areas to inspector? Who will provide answers to inspector? Contact personnel Pharmacy Emergency Services Resource & Compliance 24
Contacts Bob Blom, Director of Medical Services bobb@ewsalabama.com Patrick Sullivan, VP of Operations pats@ewsalabama.com Neil Craps, Sales Manager neilc@ewsalabama.com Nila Gorham, Inside Sales Customer Service Representative nilag@ewsalabama.com 25