Pharmaceutical Waste Management

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1 Pharmaceutical Waste Management Firouzan Fred Massoomi, Pharm.D., FASHP Pharmacy Operations Coordinator Nebraska Methodist Hospital Omaha, Nebraska USA

2 The Pharmaceutical-Water Paradigm Defined by WHO as an emerging contaminant for drinking-water Defined by US EPA as an emerging contaminant affecting human an ecological health 100,000 tons of drugs consumed annually 70% increase in drug consumption Finite source of Clean water Sources: WHO; KNAPPE; IMS 2011

3 March & September 2008 œ Health facilities flush 250 million pounds of drugs a year DEA implicated as major hurdle for proper disposal March 03, 2011 œ Integrity of the world water supply From toilets to tap œ 10% of household water comes from toilets Source: USA Today

4 Large Geographical Survey US Geological survey œ streams, waterways œ 80% contaminated Primary contaminants œ Antibiotics œ Anti-convulsants œ Mood stabilizers œ Cholesterol lowering agents œ Analgesics œ Reproductive hormones

5 Environmental Effects Steroid plant discharge and intersex wild gudgeons œ France Ethinyl estradiol feminization of male fish œ Canada, US, EU New gene splicing identification œ medaka fish + jelly fish gene Dicofenac vulture deaths œ Pakistan, India Source: New Scientist 2011 Source: Nature 2011

6 Which Pharmacy Class Did We Learn This In?

7 US Regulatory Bodies for RX Wastes Public Safety Public Safety Public Safety Public Safety US Environmental Protection Agency œ 1976 Resource Conservation Act (RCRA) œ Federal & State Specific Regulations Local Publicly Owned Treatment Works (POTWs) œ Permission has to be granted to dump/pour œ Local Regulations Occupational Safety and Health Agency œ Hazard Communication Standard 29 CFR part œ Hazardous Waste Operations and Emergency Response Standard (29 CFR ) Drug Enforcement Agency œ Controlled Substances Act of 1984 œ NO SPECIFIC guidance on destruction only accountability

8 Regulatory Bodies for RX Wastes Public Safety Public Safety Department of Transportation œ HAZWOPER from OSHA œ Hazardous Waste Transportation regulations Food and Drug Administration œ 27 drugs with package insert disposal recommendations œ Assisted White House policy for public disposal Examination Bodies for RX Wastes

9 Pending Legislation Drug Free Water Act of 2009 œ EPA Task Force regarding proper disposal of unused drugs Safe Drug Disposal Act of 2009 œ œ Amend 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 PASSED œ To amend the Controlled Substances Act to enable consumer take-back programs œ STATES MUST APPROVE FIRST! Slide courtesy of Charlotte Smith

10 How did the EPA get involved? Creation of EPA 1970 œ Prior to loose standards on disposal regulations œ Lack of environmental protection Cuyahoga River, OH Fire History 1949, 1951, 1952x3, 1961, 1969 EPA's mission is to protect human health and to safeguard the natural environment air, water, and land upon which life depends

11 What Drug Waste is Regulated? Solid Waste Disposal Act of 1965 œ encourage environmentally sound methods for disposal of household, municipal, commercial, and industrial refuse œ 1976 Resource Conservation and Recovery Act (RCRA) Clean Air Act 1991 œ Regulated-out hospital based incinerators Hooker Chemical company -dumped 20,000 tons -contaminated water and soil $400mil to clean-up What was the real cost?

12 US EPA Guidance to Healthcare Healthcare only œ Hospitals, long term care, clinics Estimated 12 million pounds No guidance on disposal Projected best practice document in 2012 Source: US EPA 2008

13 P-listed Drug, vials and packaging EPA Defined Hazardous Drugs U-listed Drug only P012 Arsenic Trioxide U034 Chloral Hydrate U010 Mitomycin C P042 P075 P081 P204 P188 Epinephrine Nicotine Nitroglycerin Physostigmine Physostigmine salisylate U035 Chlorambucil U044 Cloroform U058 Cyclophosphamide U059 Daunomycin U075 Dichlorodifluromethane U089 Diethylstilbestrol U182 U188 U200 U201 U202 U205 Paraldehyde Phenol Reserpine Resorcinol Saccharine Selenium P046 Phentermine U122 Formaldehyde U206 Streptozocin P001 Warfarin >0.3% U129 Lindane U237 Uracil Mustard U150 U151 Melphalan Mercury U248 Warfarin <0.3%

14 Exemptions are State Specific EPA guidance on exemptions Nitroglycerin Federal Register: May 16, 2001 (Volume 66, Number 95) Epinephrine Salts USEPA Memo Dated 10/07/2007 States who do NOT allow exemptions Nitroglycerin Epinephrine salts Connecticut Connecticut Hawaii Hawaii Maine New York exempted 7/15/09 Michigan Washington *Florida, Michigan, Minnesota, Washington

15 EPA Defined Hazardous Drugs D-Listed Characteristic Chemical Waste Ignitability (D001) Corrosivity (D002) Reactivity (D003) Toxicity NOTE: primary drug may not be what is listed! D004 Arsenic 5 mg/l Dual D005 Barium 100 mg/l Oral D007 Chromium 5 mg/l TPN D024 M-Cresol 200 mg/l Insulin D013 Lindane 0.4 mg/l D009 Mercury 0.2 mg/l Vaccine D101 Selenium 1 mg/l TPN D011 Silver 5 mg/l Creams Source:

16 Current Practice Drug Waste Process Expired drugs Reverse Distributor Special Drug Waste: Devices/Gases Biohazardous waste Autoclauve Empty IV Bags/Drug Packaging Hospital Non- hazardous Wastes Controlled Substances? Chemotherapy hazardous Wastes Medical Waste Incinerator RCRA Segregated hazardous Wastes IV & Irrigation Solutions: NO Drugs RCRA Incinerator Massoomi 2011 Water Treatment Plant

17 Risk Management & Liability Civil and criminal liability œ Civil & Criminal: State/USEPA enforcement Personal liability œ fines and/or imprisonment Corporate fines œ $37,500 per violation/day Eastern Kansas Health Care System August 18, 2009 œ What $51,501 civil penalty & $482,069 supplemental project œ Violations No hazardous waste determinations No proper hazardous waste containers No documentation of inspection of hazardous waste storage No documentation of personnel training Unpermitted on-site incineration of hazardous waste Unlawful shipping of hazardous waste

18 Healthcare RCRA Violations Breakout of RCRA Violations from Hospital Disclosures Container Management 21% UST 2% Generator Requirements 12% ID of HW 23% General Facility Standards 16% Accumulation Time 2% Manifest 6% Universal Waste 18% Slide courtesy of John Gorman, USEPA Region 2

19 DOT Manifest for Transport Standard US form Page 1 œ Main form (left) Page 2 œ Designated Facility to Generator State Page 3 œ Designated Facility to Generator Copy Page 4 œ Designated Facility Copy Page 5 œ Transporter" copy Page 6 œ Generator s Initial Copy

20 N=343 Rx Directors

21 EPA s Current Status No Health-system survey Guidance Document: Best Management Practices for Unused Pharmaceutical At Health Care Facilities Modeled off of H2E publication? Draft; Aug 26, 2010 Publication 2012? Universal Waste Rule proposal update œ Not to be.. Source: Meghan Hessenauer, US EPA Office of Water, Nov,2011

22 Pharmaceutical Waste Team Primary œ œ œ œ œ œ Hospital administration Pharmacy Lead Nursing Lead Risk Management Environmental Services Physicists Secondary œ œ œ œ œ Infection Control Safety Officer Facility Management Purchasing leads Pharmaceuticals Surgical supplies Central supplies Physician office managers

23 Think of All Areas Where Drugs Are Handled 310 Patient Rooms 52 Pyxis Stations 28 Med refrigerators 26 Surgical suites 15 Infusion chairs 12 Hospital clinics 5 MRI suites 7 CT suites 2 Anesthesia rooms 2 Pharmacies 459 Total Locations

24 Non-hazardous Pharmacy Waste œ œ Sewered Plain IV fluids Plain Irrigations œ œ Landfill Packaging (Non-P listed) Empty vials Medical Hazardous Waste Incineration RCRA Hazardous Incineration (Waste to Energy)

25 Biohazard Sharps Containers Unused pharmaceuticals should not be disposed of with biohazardous waste œ Autoclaving œ Heat to 180º F If used send to a medical waste incinerator œ Heat to 500º to 900º F Draft: Guidance Document: Best Management Practices for Unused Pharmaceutical At Health Care Facilities: EPA-821-R ; Aug 26, 2010

26 Controlled Substance Waste Mandatory ACCOUNTABILITY! No definition of waste No distinction between expired, contaminated controlled substances and saleable product Accountability required of all controlled substances Most US hospitals Sewer this waste Reverse Distributors to be DEA Registrants to remove Source: Mark W. Caverly, Chief; DEA Office of Diversion Control

27 Aerosolized Drug Products Highly specialized drug delivery devices œ Varying international regulations Puncture PRIOR to incineration Triple rinsing prior to landfill Rinsate disposed of properly

28 Anesthesia Gases Anesthetic gases are green house gases 5% of gases used by patient Global Warming Potentials Nitrous Oxide: 289x Desflurane: 3714x Isoflurane: 1401x Sevoflurane: 349x Gases liquefied and purified œ FUTURE: resale of products Source: Laura Brannen, BLUE

29 Medicinal Leeches and Maggots Biohazardous Waste

30 Formulary Assessment of Waste Collaborative formulary assessment œ NIOSH Appendix A & IARC œ State and Federal regulations œ Waste hauler process DRUG - GENERIC (BRAND) CLASS OF MEDICATION ROUTES/ FORMS COMPANY PREGNANCY CATEGORY MSDS BSC HAZ CLASS (1-4) WASTE STREAM Aldesleukin (Proleukin) ONC INJ Chrion C YES Yes Class 1 YELLOW N Alemtuzumab (Campth) ONC INJ Berlex C YES Yes Class 1 YELLOW N Alitretinoin (Panretin) Altretamine (Hexalen) Retinoid ONC TOPICAL, GEL Ligand D YES ORAL, CAPSUL E MGI D YES Yes, if altered Class 1 YELLOW N Yes, if altered Class 1 YELLOW N RCR A Y/N œ Continuous assessment of Risk and Stream

31 N=343 Rx Directors

32 Model I Manual Sorting of Regulated Waste Entire inventory has been manually analyzed œ New drugs have to added to the system Items are labeled œ During receiving process or electronically Regulated drugs are dispensing in colored bag Used with permission: Leslie Durrant, R.Ph., BCPS

33 Model II Electronic Devices for RX Waste EcoREX Smart Sink Automatic Sorting System Barcode segregation Alerts staff when full Completes DOT manifests Solid and liquid wastes Renders unusable unrecoverable Tamper evident, notification Wall mount, COW mount ONLY for collection of all wastes

34 Model III Centralizing Segregation All pharmaceutical waste is collected in hazardous waste containers Mixed waste is removed to the central hazardous waste storage accumulation area Sorting is done by hazardous waste vendor or trained hospital staff based on an analysis of the inventory NOTE: the generator (HOSPITAL) is liable for contracted employee harm Source: Charlotte A. Smith, R. Ph., M.S.,

35 Model IV Managing All RX Waste as Hazardous One Container for collection Easiest Need to sort out characteristic wastes œ Toxic, Corrosive, Ignitable, Reactive Storage space issues

36 Current Practice Drug Waste Process Expired drugs Reverse Distributor Special Drug Waste: Devices/Gases Biohazardous waste Autoclauve Empty IV Bags/Drug Packaging Hospital Non- hazardous Wastes Controlled Substances? Chemotherapy hazardous Wastes Medical Waste Incinerator RCRA Segregated hazardous Wastes IV & Irrigation Solutions: NO Drugs RCRA Incinerator Massoomi 2011 Water Treatment Plant

37 Proper Hazardous Drug Waste Disposal Poster Example Segregate the wastes of Drugs & Dispose of in appropriate containers SHARPS Red Container BIOHAZARDOUS Red Container Hazardous Yellow Container RCRA HAZARDOUS Black Container Non-Regulated Trash Sharps BioHaz CHEMO RCRA Trash -Needles -Broken Glass -Ampules -Other sharps -Non-Chemo vials -IVIG vials/bags -Albumin vials/bags -Blood factor vials -Syringes -IV Bags and Tubing -Empty Chemo vials -Chemo packaging < boxes, PIs> -Chemo mats not involved with spills -Chemo Gloves -PhaSeal devices ALL partial Chemo Dose vials Drugs on EPA P & U list 1.Chlorambucil 2.Cyclophosphamide 3.Daunomycin 4.Melphalan 5.Mitomycin C 6.Streptozotocin 7.Arsenic Trioxide 8.Idarubicin 9.Carmustin including Gliadel 10.Uracil mustard 11.Anything used 4 chemo spill Everythi ng El se N O T contaminated 1.Packaging 2.IV wraps 3.Syringe packaging 4.PhaSeal packaging 5.Gauzes 6.Gowns 7.Masks 8.Paper 9.Labels, etc. Contact Service Center for questions: XXX-XXX-XXXX

38 Assessment of Compliance Trash Rounds Staff Processes Check Streams Random audits for compliance 1. Check staff knowledge 2. Check waste containers 3. Track quantities 4. Track costs 5. Document process and results

39 N=343 Rx Directors

40 Future Waste Considerations Disposable drug delivery device wastes Genotargeted drug wastes Drug loaded Adenovirus wastes Nanotechnology drug wastes

41 Pharmaceutical Waste Management Firouzan Fred Massoomi, Pharm.D., FASHP Pharmacy Operations Coordinator Nebraska Methodist Hospital Omaha, Nebraska USA

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