Firouzan ‘Fred’ Massoomi, Pharm.D., FASHP
Pharmacy Operations Coordinator Nebraska Methodist Hospital
Omaha, Nebraska USA [email protected]
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
§ March & September 2008
ú Health facilities flush 250 million pounds of drugs a year
DEA implicated as major hurdle for proper disposal
§ March 03, 2011
ú Integrity of the world water supply “From toilets to tap”
ú 10% of household water comes from toilets
Large Geographical Survey
§US Geological survey
ú 1999 -2000 §139 streams, waterways
ú 80% contaminated §Primary contaminants
ú Antibiotics ú Anti-convulsants ú Mood stabilizersú Cholesterol lowering agents
ú Analgesics
Environmental Effects
§
Steroid plant discharge and
intersex wild gudgeons
ú France
§
Ethinyl estradiol feminization
of male fish
ú Canada, US, EU
§
New gene splicing
identification
ú medaka fish + jelly fish gene
§
Dicofenac vulture deaths
ú Pakistan, India
Source: Nature 2011
US Regulatory Bodies for RX Wastes
§
Occupational Safety and Health Agency
ú Hazard Communication Standard 29 CFR part 1910–1200
ú Hazardous Waste Operations and Emergency Response
Standard (29 CFR 1910.120)
Public Safety
§ Drug Enforcement Agency
ú Controlled Substances Act of 1984
ú NO SPECIFIC guidance on destruction only accountability
§
US Environmental Protection Agency
ú 1976 Resource Conservation Act (RCRA)
ú Federal & State Specific Regulations
Public Safety
Public Safety
Public Safety
§
Local Publicly Owned Treatment Works (POTWs)
ú Permission has to be granted to dump/pour
Regulatory Bodies for RX Wastes
Public Safety
§
Department of Transportation
ú HAZWOPER from OSHA
ú Hazardous Waste Transportation regulations
Public Safety
§
Food and Drug Administration
ú 27 drugs with package insert disposal recommendations
ú Assisted White House policy for public disposal
Pending Legislation
§ Drug Free Water Act of 2009
ú EPA Task Force regarding proper disposal of unused drugs
§ Safe Drug Disposal Act of 2009
ú 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 – PASSED
ú To amend the Controlled Substances Act to enable consumer take-back programs
ú STATES MUST APPROVE FIRST!
How did the EPA get involved?
§
Creation of EPA 1970
ú
Prior to loose standards on
disposal regulations
ú
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 History
1949, 1951, 1952x3, 1961, 1969
What Drug Waste is Regulated?
§
Solid Waste Disposal Act of 1965
ú
“encourage environmentally sound methods for disposal
of household, municipal, commercial, and industrial
refuse”
ú
1976 Resource Conservation and Recovery Act
(RCRA)
§
Clean Air Act 1991
ú
Regulated-out hospital based incinerators
$400mil to clean-up
Hooker Chemical company -dumped 20,000 tons
-contaminated water and soil
US EPA Guidance to Healthcare
§
Healthcare only
ú Hospitals, long term care, clinics
§
Estimated 12 million
pounds
§
No guidance on disposal
§
Projected best practice
document in 2012
EPA Defined Hazardous Drugs
U010 Mitomycin C U182 Paraldehyde U188 Phenol U200 Reserpine U201 Resorcinol U202 Saccharine U205 Selenium U206 StreptozocinU237 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-listed
Drug, vials and packaging Drug onlyExemptions 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
D-Listed Characteristic Chemical Waste
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: www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr261_00.htmlEPA Defined Hazardous Drugs
•Ignitability (D001) •Corrosivity (D002) •Reactivity (D003) •Toxicity
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
Risk Management & Liability
§
Civil and criminal liability
ú
Civil & Criminal: State/USEPA enforcement
§
Personal liability
ú
fines and/or imprisonment
§
Corporate fines
ú
$37,500 per violation/day
§
Eastern Kansas Health Care System
August 18, 2009
ú
What $51,501 civil penalty & $482,069 supplemental project
ú
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
Healthcare RCRA Violations
Breakout of RCRA Violations from Hospital Disclosures
Generator Requirements 12% ID of HW 23% Universal Waste 18% General Facility Standards 16% Container Management 21% UST 2% Accumulation Time 2% Manifest 6%
DOT Manifest for Transport
Standard US form
§
Page 1
ú Main form (left)
§
Page 2
ú “Designated Facility to Generator State §Page 3
ú “Designated Facility to Generator Copy” §Page 4
ú “Designated Facility Copy”
§
Page 5
ú “Transporter" copy
§
Page 6
ú “Generator’s Initial Copy”
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..
Pharmaceutical Waste Team
§ Primary ú Hospital administration ú Pharmacy Lead ú Nursing Lead ú Risk Management ú Environmental Services ú Physicists § Secondary ú Infection Control ú Safety Officer ú Facility Management ú Purchasing leads Pharmaceuticals Surgical supplies Central suppliesThink 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
Non-hazardous Pharmacy Waste
Sewered
ú Plain IV fluids
ú Plain Irrigations
Landfill
ú Packaging (Non-P listed)
ú Empty vials
Medical Hazardous Waste Incineration
RCRA Hazardous Incineration
Biohazard Sharps Containers
§
“Unused pharmaceuticals
should not be disposed of with
biohazardous waste”
ú
Autoclaving
ú
Heat to 180º F
§
If used send to a medical
waste incinerator
ú
Heat to 500º to 900º F
Draft: Guidance Document: Best Management Practices for Unused Pharmaceutical At Health Care Facilities: EPA-821-R-10-006; Aug 26, 2010
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
Aerosolized Drug Products
§
Highly specialized drug delivery devices
ú
Varying international regulations
Puncture PRIOR to incineration
Triple rinsing prior to landfill
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
Medicinal Leeches and Maggots
Formulary Assessment of Waste
§
Collaborative formulary assessment
úNIOSH Appendix A & IARC
ú
State and Federal regulations
úWaste 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 RCR A 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, CAPSUL E MGI D YES Yes, if
Model I
Manual Sorting of Regulated Waste
§ Entire inventory has been manually analyzed
ú New drugs have to added to the system
§ Items are labeled
ú During receiving process or electronically
§ Regulated drugs are dispensing in colored bag
Model II
Electronic 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™
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
Model IV
Managing All RX Waste as Hazardous
§
One Container for collection
§
Easiest
§
Need to sort out characteristic
wastes
ú Toxic, Corrosive, Ignitable, Reactive
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
Proper Hazardous Drug Waste Disposal
Poster Example
Segregate the wastes of Drugs & Dispose of in appropriate containers
SHARPS Red Container
BIOHAZARDOUS
Red Container Yellow ContainerHazardous
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
Everything Else NOT contaminated 1.Packaging 2.IV wraps 3.Syringe packaging 4.PhaSeal packaging 5.Gauzes 6.Gowns 7.Masks 8.Paper 9.Labels, etc.
Assessment of Compliance
Trash Rounds
Random audits for compliance 1. Check staff knowledge 2. Check waste containers 3. Track quantities
4. Track costs
5. Document process and results
Future Waste Considerations
§
Disposable drug delivery device wastes
§
Genotargeted drug wastes
§
Drug loaded Adenovirus wastes
Firouzan ‘Fred’ Massoomi, Pharm.D., FASHP
Pharmacy Operations Coordinator Nebraska Methodist Hospital
Omaha, Nebraska USA [email protected]
