Pharmaceutical Waste as Universal Waste Charlotte A. Smith, R. Ph., M.S. September 21, 2009 2009 ASHES Annual Conference September 20-24, 2009 Reno, NV
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. 2009 ASHES Annual Conference September 20-24, 2009 Reno, NV
Goals Describe legislative and regulatory activity regarding pharmaceutical waste Define the Universal Waste Rule and its application to waste pharmaceuticals Explore the implications and unintended consequences of adding Rx waste to the UWR Demonstrate how facilities are implementing their pharmaceutical waste programs
Drugs in Drinking Water & Healthcare Pharmaceutical Waste March 9, 2008 5-month inquiry discovered that drugs were detected in the drinking water supplies of 24 major metropolitan areas September 14, 2008 Majority of 5,700 hospitals and 45,000 long-term care facilities flush unwanted drugs down the drain and do not document amounts according to EPA survey Extrapolation of data from 14 representative facilities in Minnesota yielded an estimated total volume of 250 million pounds of drug waste annually, including packaging April 19, 2009 U.S. manufacturers, including major drugmakers, have legally released at least 271 million pounds of pharmaceuticals into waterways that often provide drinking water
Pending Legislation Drug Free Water Act of 2009 Introduced into the House on January 7, 2009: HR 276 Requires EPA to convene a Task Force regarding proper disposal of unused pharmaceuticals Safe Drug Disposal Act of 2009 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. 1292 To amend the Controlled Substances Act to enable consumer take-back programs
EPA s Clean Water Act Review Mandatory Survey Mandatory survey for Unused Pharmaceuticals Disposal in the Health Services Industry All companies that receive questionnaire must respond within 60 days Failure to respond may result in criminal fines, civil penalties, and other sanctions, as provided by law May require documentation of some disposed drugs for a 30 day period Potentially 3500 facilities will be sampled Includes a sample of hospitals, long term care facilities, hospices, and veterinary practices May be administered September through November, 2009 http://www.epa.gov/fedrgstr/epa-water/2008/august/day-12/w18606.pdf http://www.epa.gov/guide/304m/ www.epa.gov/ost/ppcp
EPA Just Took A Cost-of-Living Raise Civil Monetary Penalty Inflation Adjustment Rule Mandatory periodic increase in fines Authority to issue civil fines raised from $32,500 to $37,500 as of January 12, 2009 Avoids cost of doing business violations http://www.epa.gov/fedrgstr/epa- GENERAL/2009/January/Day-07/g31452.htm
EPA Proposal to Add Pharmaceuticals to Universal Waste Rule Federal Register publication Dec 2, 2008 Comments due March 4, 2009 http://www.epa.gov/fedrgstr/epa-waste/2008/december/day- 02/f28161.htm Information: http://www.epa.gov/epawaste/hazard/wastetypes/universal/phar m.htm Only applies to drug waste that meets the definition of RCRA hazardous waste Only intended for healthcare-type generators, not manufacturers Intent to streamline pharmaceutical waste management and encourage consumer take-back programs Estimated 18 months minimum for federal enactment; states may or may not adopt; Iowa and Alaska will be automatic
RCRA and Universal Waste Universal Waste is a subset of RCRA hazardous waste. Federal RCRA Hazardous Waste (includes some pharmaceuticals) Universal Waste Federal EPA: Batteries, Pesticides, Mercury- containing devices, Lamps (bulbs) Florida: RCRA Pharmaceuticals
Pioneer Rx Universal Waste States Michigan and Florida already have added pharmaceuticals to their universal waste rules Florida: https://www.flrules.org/gateway/view_notice.asp?id=6599121a: Michigan: 299:9228 http://www.state.mi.us/orr/emi/admincode.asp?admincode=single&a dmin_num=29909101&dpt=&rnghigh=29999999 Unintended consequences: Un-registered entities started taking custody of legend drugs Need to involve state boards of pharmacy, DEA
Florida Restricted Rx Drug Distributor: Destruction Required to take possession of an RX drug for destruction Transporters/warehouse operators (common carriers exempt) Security requirements of a wholesaler Audit trail and documentation: name, manufacturers, quantity Certificate of Destruction: weight/manner of destruction/ time,date, location Extremely difficult to comply
Which Discarded Drugs Become RCRA Hazardous Waste? P-listed chemicals Sole active ingredient; unused, and empty containers U-listed chemicals Sole active ingredient; unused Characteristic of hazardous waste Ignitability Toxicity Corrosivity Reactivity Ref: 40 CFR Part 261
Listed Hazardous Pharmaceutical Waste P-listed Chemicals Sole active ingredient Examples: Arsenic trioxide P012 Nicotine P075 Warfarin (conc. greater 0.3%) U-listed Chemicals Sole active ingredient Examples: Chloral Hydrate (CIV) U034 Cyclophosphamide U058 Lindane U129
Characteristic Hazardous Waste Ignitability: 24% alcohol, oxidizers, flammable propellants Corrosivity: ph 12.5 or 2 Toxicity: Heavy metals and other chemicals specifically listed with individual leaching concentrations prohibited Mercury, barium, selenium, chromium, etc. Reactivity: Nitroglycerin in finished dosage forms excluded federally and in most states
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 and D codes Containers of U listed chemicals or D codes are empty only when All contents removed that can be removed through normal means And no more than 3% by weight remains Example: Empty Cytoxan vial would be trace chemotherapy Epinephrine syringe exclusion expanded to other P and U-listed drugs federally by USEPA. Many states have accepted this exclusion. Ref: 40 CFR 261.7
General Goals of UWR To encourage resource conservation To improve implementation of current RCRA subtitle C hazardous waste regulatory program To separate UW from the municipal waste stream
Specific Reasons to Add Pharmaceuticals to UWR Generation of pharmaceutical waste at a large number of points in relatively small quantities across the facility Generation of hundreds of different types of pharmaceutical waste Industry concerns regarding waste determination, generator status of acutely hazardous waste, hazardous waste listings, and accumulation time limits
Justifications for UW Status Relatively low risk during accumulation & transport Generation in a wide variety of settings Generated by different types of personnel Hazardous pharmaceutical wastes currently being disposed in non-hazardous waste management systems Healthcare workers, etc. unfamiliar with or confused by RCRA Rulemaking intended to bring RCRA to attention of healthcare
Expectations Improved management of hazardous pharmaceutical wastes Regulatory burden for many Rx waste generators will decrease Proposal provides a solution to many of the issues facing healthcare facilities and other Rx hazardous waste generators
Differentiation of Pharmaceuticals from other Universal Wastes
Why Pharmaceuticals are NOT Analogous to Current UWR Items: Security Issues Legend Pharmaceuticals (Rx only) are deliberately restricted in their availability to the consumer AND within the supply chain due to their inherently dangerous status regarding human use The street value of non-controlled substances continues to climb due to increased drug costs and shrinking personal resources Waste pharmaceuticals continue to have value, including empty vials of IV admixtures that can be used for introducing counterfeit drugs back into the supply chain
Why Pharmaceuticals are NOT Analogous to Current UWR Items: Security Issues Pharmaceutical manufacture, transport, warehousing, distribution, sale, and disposal are regulated by multiple state and federal agencies FDA DEA State Boards of Pharmacy State Controlled Substance Boards
Why Pharmaceuticals are NOT Analogous to Current UWR Items: Security Issues Pharmaceutical manufacture, distribution, sales, dispensing, and disposal has a long history of evolving regulations 1906 Food and Drugs Act 1914 Harrison Narcotic Act 1938 Federal Food, Drug and Cosmetic Act 1951 Durham-Humphrey Amendment (Rx only) 1968 Bureau of Narcotics and Dangerous Drugs 1973 Drug Enforcement Administration created 1988 Prescription Drug Marketing Act (PDMA) 1996 Comprehensive Methamphetamine Control Act 2004 Anabolic Steroid Control Act
Why Pharmaceuticals are NOT Analogous to Current UWR Items: Closed Loop System of Distribution Due to concerns regarding handling, storage, and counterfeiting, FDA and state regulatory authorities have multiple requirements, e.g.: Licensure (distributors & rev. distributors) Inspections Background checks Physical security Criminal penalties Pedigrees Forward supply chain (manufacturers, distributors) working hard to develop further security measures
Why Pharmaceuticals are NOT Analogous to Current UWR Items: OSHA Issues Handling and sorting of hazardous materials such as chemotherapy agents can cause a significant risk to employees NIOSH Hazardous Drug Alert http://www.cdc.gov/niosh/docs/2004-165/ ASHP Guidelines on Handling Hazardous Drugs http://www.ashp.org/doclibrary/bestpractices/ ASHPGuidelinesHandlingHazardousDrugs.as px
Small Quantity Handlers Accumulates less than 5,000 kg (11,000 lbs) of all UW Not required to notify EPA of activities or obtain an ID number Minimal training requirements Not required to track shipments No control or oversight and no way for other regulatory agencies to identify SQHUWs
Large Quantity Handlers Accumulates 5,000 kg (11,000 lbs) or more of UW at any time Must send written notification to EPA and receive an ID number May re-evaluate annually Employees trained on proper waste handling and emergency procedures Not required to keep training records Shipping records: name, address of UWH; quantity of each type of UW; date of receipt of UW No notification back to the original generating handler of final disposal
Unintended Consequences: No Chain of Custody Small Quantity Handlers would be completely unreported and unregulated by EPA or any other interested party Waste pharmaceuticals, and their packaging, could be re-introduced into the supply chain through secondary wholesalers or sold directly onto the black market or inappropriate disposal No chain of custody for SQHUW or LQHUW would assure appropriate destruction due to loss of the 6-part manifest
Unintended Consequences: Loss of Manifest How is receipt and destruction assured? What if a shipment, or partial shipment, is diverted? How will UW handlers and transporters manage state differences? Can a shipment get marooned in transit? Common carrier until it reaches a non-uwr state; wrong carrier, no manifest
Economic Impact Current waste disposal practices: (est. 80% of hospitals) Sewering no documented costs Autoclave/landfill minimal costs absorbed in normal operating costs Suggested practice of managing all Rx waste as universal waste Fee differential as large as 5x to 10x between municipal or regulated medical incineration and RCRA hazardous waste incinerator Municipal: $.19/lb - $.50/lb RCRA: $.95/lb - $4.95/lb
Percentage of RCRA & PharmE Haz in 149 Hospitals, 2008
Percentage of Hazard Categories in 149 Hospitals (2008) 97% Toxic or Ignitable
Weekly Volumes of 55 gal drums: 16 Non-haz; 4-5 Haz Photos courtesy of Abbott Northwestern Hospital
Healthcare Homerun! Removing P-listed waste from generator calculations is primary benefit Reduction in storage, employee training, and notification requirements are excellent Only need to evaluate inventory initially and upon receipt of new RCRA drugs
Tailoring the UWR for Pharmaceuticals Apply UWR for in-house management of waste pharmaceuticals at relatively small quantity waste generators such as distributors, pharmacies, hospitals, clinics, long term care facilities, veterinary clinics, other primary care facilities
Tailoring the UWR for Pharmaceuticals Require full identification and manifesting of pharmaceutical waste at the point of shipment to the final disposal site IF sorting/re-packaging occurs at a transfer station, full RCRA and HAZWOPER training and employee protection requirements should apply
Benefits of Tailored System Primary concern of healthcare facilities is alleviated: need to document P-listed waste to justify generator status and fear of increasing generator status Cradle-to-grave tracking system is maintained for both environmental and diversion reasons Employee safety is enhanced by reducing additional sorting in-transit
Burning Question: Should I Wait for the NO! UWR to Develop My System? It will take a MINIMUM of 18 months for a new rule to adopted; probably 2011 It will take YEARS for each state to adopt either the federal version or their own version of the UWR Hazardous waste will still need to be identified and manifested when traveling through states that have not adopted the UWR Your organization will still need to segregate hazardous waste to avoid premier disposal charges
Approaches to Pharmaceutical Waste Management Model I: Automatic Sorting Device Model 2: Data Applied to Dispensing Software Model 3: Stickers Applied Manually Model 4: Centralizing Segregation Model 5: Managing All Drug Waste As Hazardous
Considering the Optimal Management Options Need to label items that need segregation in a manner that makes it easy for pharmacy and nursing personnel Shelf stickers in pharmacy Data Applied to Dispensing Software and/or Message inserted into Pyxis, etc. and MAR (Medication Administration Record) and/or Stickers Applied Manually
Labeling the Pharmacy Shelves Avery Standard Shipping labels #5164
Label Alert: PYXIS Medications dispensed by the PYXIS medication station P, U, D, or HD a pop-up alert to properly dispose of the medication For example: Courtesy Lahey Clinic Medical Center, Burlington, MA Pyxis alert: THIS DRUG IS A FEDERAL HAZARDOUS WASTE TYPE (specifies P, U, D) DISPOSE >TRACE IN BLACK CONTAINER OR RETURN TO PHARMACY
IV / Medication Label Alert: P, U, D, HD Courtesy Lahey Clinic Medical Center, Burlington, MA
Labeling & Containers Items identified by PharmE Inventory Analysis Marked with black labels Special Disposal Required Coded in Pyxis dispensing machine also Shelf stickers in pharmacy Black hazardous waste containers SPECISPECIAL DISPOSAL REQUIRED Courtesy North Memorial Health Care
Example: D Type Hazard Insulin Containing M-Cresol A used syringe of this type of insulin An empty insulin vial A half empty insulin vial An outdated insulin vial RETURN TO PHARMACY Courtesy Lahey Clinic Medical Center, Burlington, MA
NEW Hazardous Waste Containers YELLOW Soft Hamper Trace/Soft Chemo/Bio Gowns, Gloves, Chux and soiled linens, ONLY) YELLOW HARD CONTAINER Trace / Sharps Syringes or Sharps Trace amounts of Chemo / Biotherapy; ONLY Empty syringes, IV bags, tubing P, U, D, HD, BLACK CONTAINER BULK (Larger than TRACE) amounts of Chemo Chemo-Spill products Courtesy Lahey Clinic Medical Center, Burlington, MA
Examples of Hazardous Pharm Waste Satellite Accumulation
Hazardous Pharmaceutical Waste Storage Accumulation
Creating a Hazardous Waste Profile Work with hazardous vendors to create a certified hazardous waste profile of all toxic & ignitable drug waste, including ignitable aerosols Ship commingled as UN3248, Waste Medicine, Liquid, Flammable,Toxic, n.o.s., 3 (6.1), PG II Ship any corrosive acids/bases or oxidizers separately
Non-Hazardous Pharmaceutical Waste Managed through nonhazardous incineration as a Best Management Practice Courtesy North Memorial Health Care
Examples of Non-Hazardous Pharmaceutical Waste Collection & Storage
Goals Re-visited Legislative and regulatory activity AP articles House & Senate legislation Universal Waste Rule Definition and application to Rx waste Implications and unintended consequences Loss of scrutiny and cradle to grave tracking OSHA handling concerns Demonstrate how facilities are implementing their pharmaceutical waste programs Manual and electronic labeling Satellite and storage accumulation 2009 ASHES Annual Conference September 20-24, 2009 Reno, NV
Summary Expect increased attention to be focused on pharmaceutical waste management Don t wait for rule changes the risk is now! Protect your organization and your community Avoid crisis mode!
Resources NIOSH Hazardous Drug Alert http://www.cdc.gov/niosh/docs/2004-165/#sum ASHP Guidance on Handling Hazardous Drugs http://www.ashp.org/s_ashp/bin.asp?cid=6&did=5420&doc=file.pdf OSHA Technical Manual http://www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.html Practice GreenHealth (fka Hospitals for a Healthy Environment) http://www.practicegreenhealth.org/ Pharmaceutical waste webpage: http://www.h2e-online.org/hazmat/pharma.html Healthcare Education Resource Center (HERC) Blueprint on Pharmaceutical Waste Management (Revised) http://www.hercenter.org/hazmat/tenstepblueprint.pdf WM Healthcare Solutions, PharmEcology Services www.pharmecology.com FAQs, state and federal waste regulations, subscription search engine PharmE Waste Wizard identifies RCRA hazardous waste plus NIOSH hazardous drugs, among additional criteria
QUESTIONS? Charlotte A. Smith, R. Ph., M.S. Director, PharmEcology Services WM Healthcare Solutions www.pharmecology.com 414-292-3959 csmith@pharmecology.com