Firouzan ‘Fred’ Massoomi, Pharm.D., FASHPPharmacy Operations Coordinator
Nebraska Methodist HospitalOmaha, Nebraska USA
Pharmaceutical Waste Management
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 1993-2003
§ Finite source of Clean water
Sources: WHO; KNAPPE; IMS 2011
§ March & September 2008ú Health facilities flush 250 million pounds of drugs a year DEA implicated as major hurdle for proper disposal
§ March 03, 2011ú Integrity of the world water supply “From toilets to tap”ú 10% of household water comes from toilets
Source: USA Today
Large Geographical Survey
§ US Geological surveyú 1999 -2000
§ 139 streams, waterwaysú 80% contaminated
§ Primary contaminantsú Antibioticsú Anti-convulsantsú Mood stabilizersú Cholesterol lowering agentsú Analgesicsú Reproductive hormones
Environmental Effects
§ Steroid plant discharge and intersex wild gudgeonsú France
§ Ethinyl estradiol feminization of male fishú Canada, US, EU
§ New gene splicing identificationú medaka fish + jelly fish gene
§ Dicofenac vulture deathsú Pakistan, India
Source: Nature 2011
Source: New Scientist 2011
US Regulatory Bodies for RX Wastes
§ Occupational Safety and Health Agencyú Hazard Communication Standard 29 CFR part 1910–1200ú Hazardous Waste Operations and Emergency Response
Standard (29 CFR 1910.120)
Public Safety
§ Drug Enforcement Agencyú Controlled Substances Act of 1984ú NO SPECIFIC guidance on destruction only accountability
§ US Environmental Protection Agencyú 1976 Resource Conservation Act (RCRA)ú Federal & State Specific RegulationsPublic Safety
Public Safety
Public Safety
§ Local Publicly Owned Treatment Works (POTWs)ú Permission has to be granted to dump/pourú Local Regulations
Regulatory Bodies for RX Wastes
Public Safety
§ Department of Transportationú HAZWOPER from OSHAú Hazardous Waste Transportation regulationsPublic Safety
§ Food and Drug Administrationú 27 drugs with package insert disposal recommendationsú Assisted White House policy for public disposal
Examination Bodies for RX Wastes
Pending Legislation§ Drug Free Water Act of 2009ú EPA Task Force regarding proper disposal of unused drugs
§ Safe Drug Disposal Act of 2009ú Amend Controlled Substances Act to provide for the disposal of
controlled substances by ultimate users and care takers through State take-back disposal programs
ú 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 – PASSEDú To amend the Controlled Substances Act to enable consumer
take-back programsú STATES MUST APPROVE FIRST!
Slide courtesy of Charlotte Smith
How did the EPA get involved?
§ Creation of EPA 1970ú Prior to loose standards on
disposal regulationsú Lack of environmental protection
§ EPA's mission is to protect human health and to safeguard the natural environment— air, water, and land—upon which life depends
Cuyahoga River, OH
Fire History1949, 1951, 1952x3,1961, 1969
What Drug Waste is Regulated?§ Solid Waste Disposal Act of 1965ú “encourage environmentally sound methods for disposal
of household, municipal, commercial, and industrial refuse”
ú 1976 Resource Conservation and Recovery Act (RCRA)
§ Clean Air Act 1991ú Regulated-out hospital based incinerators
$400mil to clean-upHooker Chemical company-dumped 20,000 tons-contaminated water and soil
What was the real cost?
US EPA Guidance to Healthcare
§ Healthcare onlyú Hospitals, long term care,
clinics
§ Estimated 12 million pounds
§ No guidance on disposal
§ Projected best practice document in 2012
Source: US EPA 2008
EPA Defined Hazardous Drugs
U010 Mitomycin C
U182 Paraldehyde
U188 Phenol
U200 Reserpine
U201 Resorcinol
U202 Saccharine
U205 Selenium
U206 Streptozocin
U237 Uracil Mustard
U248 Warfarin <0.3%
http://www.access.gpo.gov/nara/cfr/waisidx_05/40cfr261_05.html
P012 Arsenic Trioxide
P042 Epinephrine
P075 Nicotine
P081 Nitroglycerin
P204 Physostigmine
P188 Physostigmine salisylate
P046 Phentermine
P001 Warfarin >0.3%
U034 Chloral Hydrate
U035 Chlorambucil
U044 Cloroform
U058 Cyclophosphamide
U059 Daunomycin
U075 Dichlorodifluromethane
U089 Diethylstilbestrol
U122 Formaldehyde
U129 Lindane
U150 Melphalan
U151 Mercury
P-listed U-listedDrug, vials and packaging Drug only
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 saltsConnecticut ConnecticutHawaii HawaiiMaine New York – exempted 7/15/09Michigan Washington
*Florida, Michigan, Minnesota, Washington
D-Listed Characteristic Chemical Waste
D004 Arsenic 5 mg/L DualD005 Barium 100 mg/L OralD007 Chromium 5 mg/L TPND024 M-Cresol 200 mg/L InsulinD013 Lindane 0.4 mg/LD009 Mercury 0.2 mg/L VaccineD101 Selenium 1 mg/L TPND011 Silver 5 mg/L Creams
Source: www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr261_00.html
EPA Defined Hazardous Drugs
•Ignitability (D001)•Corrosivity (D002)•Reactivity (D003)•Toxicity
NOTE: primary drug may not be what is listed!
Hospital
Medical Waste Incinerator
Reverse Distributor
Water Treatment Plant
Biohazardous waste
Chemotherapy ‘hazardous’ Wastes
RCRA Segregated ‘hazardous’ Wastes
Current Practice Drug Waste Process
Expired drugs
Massoomi 2011©
RCRA Incinerator
Non-‘hazardous’ Wastes Controlled Substances?
IV & Irrigation Solutions: NO Drugs
Empty IV Bags/Drug Packaging
Autoclauve
Special Drug Waste: Devices/Gases
Risk Management & Liability§ Civil and criminal liabilityú Civil & Criminal: State/USEPA enforcement
§ Personal liabilityú fines and/or imprisonment
§ Corporate finesú $37,500 per violation/day
§ Eastern Kansas Health Care System August 18, 2009ú What $51,501 civil penalty & $482,069 supplemental projectú Violations
ñ No hazardous waste determinationsñ No proper hazardous waste containersñ No documentation of inspection of hazardous waste storageñ No documentation of personnel trainingñ Unpermitted on-site incineration of hazardous wasteñ Unlawful shipping of hazardous waste
Healthcare RCRA ViolationsBreakout of RCRA Violations from Hospital Disclosures
GeneratorRequirements 12%
ID of HW 23%
Universal Waste18%
General FacilityStandards 16%
ContainerManagement 21%
UST 2%
Accumulation Time2% Manifest 6%
Slide courtesy of John Gorman, USEPA Region 2
DOT Manifest for TransportStandard US form§ Page 1ú Main form (left)
§ Page 2ú “Designated Facility to
Generator State § Page 3 ú “Designated Facility to
Generator Copy” § Page 4ú “Designated Facility Copy”
§ Page 5ú “Transporter" copy
§ Page 6ú “Generator’s Initial Copy”
http://www.pneac.org/hazwastemanifest/manifest_video/manifest.html
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
ú Not to be..
Source: Meghan Hessenauer, US EPA Office of Water, Nov ,2011
Pharmaceutical Waste Team
§ Primaryú Hospital administrationú Pharmacy Leadú Nursing Leadú Risk Managementú Environmental Servicesú Physicists
§ Secondaryú Infection Controlú Safety Officerú Facility Managementú Purchasing leads Pharmaceuticals Surgical supplies Central supplies
ú Physician office managers
Think of All Areas Where Drugs Are Handled
310 Patient Rooms52 Pyxis Stations28 Med refrigerators26 Surgical suites15 Infusion chairs12 Hospital clinics5 MRI suites7 CT suites2 Anesthesia rooms2 Pharmacies
459 Total Locations
Non-hazardous Pharmacy Waste
Seweredú Plain IV fluidsú Plain Irrigations
Landfillú Packaging (Non-P listed)ú Empty vials
Medical Hazardous Waste Incineration RCRA Hazardous Incineration
(Waste to Energy)
Biohazard Sharps Containers
§ “Unused pharmaceuticals should not be disposed of with biohazardous waste”ú Autoclavingú Heat to 180º F
§ If used send to a medical waste incineratorú Heat to 500º to 900º F
Draft: Guidance Document: Best Management Practices for Unused PharmaceuticalAt Health Care Facilities: EPA-821-R-10-006; Aug 26, 2010
Controlled Substance WasteMandatory 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
Aerosolized Drug Products
§ Highly specialized drug delivery devicesú Varying international regulations Puncture PRIOR to incineration Triple rinsing prior to landfill Rinsate disposed of properly
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 ú FUTURE: resale of products
Source: Laura Brannen, BLUE
Medicinal Leeches and Maggots
Biohazardous Waste
Formulary Assessment of Waste
§ Collaborative formulary assessment ú NIOSH Appendix A & IARCú State and Federal regulationsú Waste hauler process
ú Continuous assessment of Risk and Stream
DRUG - GENERIC (BRAND)
CLASS OF MEDICATION
ROUTES/ FORMS COMPANY
PREGNANCY CATEGORY MSDS BSC
HAZ CLASS
(1-4)WASTE STREAM
RCRA Y/N
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) Retinoid
TOPICAL, GEL Ligand D YES
Yes, if altered Class 1 YELLOW N
Altretamine (Hexalen) ONC
ORAL, CAPSULE MGI D YES
Yes, if altered Class 1 YELLOW N
Model IManual Sorting of Regulated Waste
§ Entire inventory has been manually analyzed ú New drugs have to added to the system
§ Items are labeledú During receiving process or electronically
§ Regulated drugs are dispensing in colored bag
Used with permission: Leslie Durrant, R.Ph., BCPS
Model IIElectronic Devices for RX Waste
§ Automatic Sorting System§ Barcode segregation§ Alerts staff when full§ Completes DOT manifests
www.carefusion.com
§ Solid and liquid wastes§ Renders unusable unrecoverable§ Tamper evident, notification § Wall mount, COW mount§ ONLY for collection of all wastes
EcoREX™ Smart Sink™
www.cactusllc.net
Model IIICentralizing 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 harmSource: Charlotte A. Smith, R. Ph., M.S.,
Model IVManaging All RX Waste as Hazardous
§ One Container for collection
§ Easiest
§ Need to sort out characteristic wastes ú Toxic, Corrosive, Ignitable, Reactive
§ Storage space issues
Hospital
Medical Waste Incinerator
Reverse Distributor
Water Treatment Plant
Biohazardous waste
Chemotherapy ‘hazardous’ Wastes
RCRA Segregated ‘hazardous’ Wastes
Current Practice Drug Waste Process
Expired drugs
Massoomi 2011©
RCRA Incinerator
Non-‘hazardous’ Wastes Controlled Substances?
IV & Irrigation Solutions: NO Drugs
Empty IV Bags/Drug Packaging
Autoclauve
Special Drug Waste: Devices/Gases
Proper Hazardous Drug Waste DisposalPoster Example
Segregate the wastes of Drugs & Dispose of in appropriate containers
SHARPSRed Container
BIOHAZARDOUSRed Container
HazardousYellow Container
RCRA HAZARDOUSBlack 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 list1.Chlorambucil 2.Cyclophosphamide3.Daunomycin4.Melphalan 5.Mitomycin C6.Streptozotocin7.Arsenic Trioxide8.Idarubicin9.Carmustin including Gliadel10.Uracil mustard 11.Anything used 4 chemo spill
Everything Else NOT contaminated
1.Packaging2.IV wraps3.Syringe packaging4.PhaSeal packaging5.Gauzes6.Gowns 7.Masks 8.Paper9.Labels, etc.
Contact Service Center for questions: XXX-XXX-XXXX
Assessment of Compliance
Trash Rounds
Random audits for compliance1. Check staff knowledge2. Check waste containers3. Track quantities 4. Track costs
5. Document process and results
Staff Processes Check Streams
Future Waste Considerations
§ Disposable drug delivery device wastes§ Genotargeted drug wastes§ Drug loaded Adenovirus wastes§ Nanotechnology drug wastes
Firouzan ‘Fred’ Massoomi, Pharm.D., FASHPPharmacy Operations Coordinator
Nebraska Methodist HospitalOmaha, Nebraska USA
Pharmaceutical Waste Management
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