Pharmaceutical Waste as Universal Waste

Transcription

1 Pharmaceutical Waste as Universal Waste Charlotte A. Smith, R. Ph., M.S. September 21, ASHES Annual Conference September 20-24, 2009 Reno, NV

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 ASHES Annual Conference September 20-24, 2009 Reno, NV

3 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

4 Drugs in Drinking Water & Healthcare Pharmaceutical Waste March 9, 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

5 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 To amend the Controlled Substances Act to enable consumer take-back programs

6 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,

7 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 GENERAL/2009/January/Day-07/g31452.htm

8 EPA Proposal to Add Pharmaceuticals to Universal Waste Rule Federal Register publication Dec 2, 2008 Comments due March 4, /f28161.htm Information: 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

9 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

10 Pioneer Rx Universal Waste States Michigan and Florida already have added pharmaceuticals to their universal waste rules Florida: Michigan: 299: dmin_num= &dpt=&rnghigh= Unintended consequences: Un-registered entities started taking custody of legend drugs Need to involve state boards of pharmacy, DEA

11 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

12 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

13 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

14 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

15 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

16 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

17 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

18 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

19 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

20 Differentiation of Pharmaceuticals from other Universal Wastes

21 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

22 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

23 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

24 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

25 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 ASHP Guidelines on Handling Hazardous Drugs ASHPGuidelinesHandlingHazardousDrugs.as px

26 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

27 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

28 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

29 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

30 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

31 Percentage of RCRA & PharmE Haz in 149 Hospitals, 2008

32 Percentage of Hazard Categories in 149 Hospitals (2008) 97% Toxic or Ignitable

33 Weekly Volumes of 55 gal drums: 16 Non-haz; 4-5 Haz Photos courtesy of Abbott Northwestern Hospital

34 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

35 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

36 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

37 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

38 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

39 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

40 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

41 Labeling the Pharmacy Shelves Avery Standard Shipping labels #5164

42 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

43 IV / Medication Label Alert: P, U, D, HD Courtesy Lahey Clinic Medical Center, Burlington, MA

44 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

45 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

46 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

47 Examples of Hazardous Pharm Waste Satellite Accumulation

48 Hazardous Pharmaceutical Waste Storage Accumulation

49 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

50 Non-Hazardous Pharmaceutical Waste Managed through nonhazardous incineration as a Best Management Practice Courtesy North Memorial Health Care

51 Examples of Non-Hazardous Pharmaceutical Waste Collection & Storage

52 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

53 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!

54 Resources NIOSH Hazardous Drug Alert ASHP Guidance on Handling Hazardous Drugs OSHA Technical Manual Practice GreenHealth (fka Hospitals for a Healthy Environment) Pharmaceutical waste webpage: Healthcare Education Resource Center (HERC) Blueprint on Pharmaceutical Waste Management (Revised) WM Healthcare Solutions, PharmEcology Services FAQs, state and federal waste regulations, subscription search engine PharmE Waste Wizard identifies RCRA hazardous waste plus NIOSH hazardous drugs, among additional criteria

55 QUESTIONS? Charlotte A. Smith, R. Ph., M.S. Director, PharmEcology Services WM Healthcare Solutions