Transcript Pharmaceutical Waste: A Waste Stream Whose Time has Come

Pharmaceutical Waste
June 2010
Wendi Shafir
Environmental Protection Agency Region 9
415-972-3422
[email protected]
Key Issues to Cover Today
 Pharmaceuticals in the Environment
 US Geological Survey Study
 How do they get there ?
 Health /Environmental Impacts
 Current Requirements for Managing Pharms
 What is pharmaceutical waste?
 Regulations
 Identification
 Management
 Resources
Pharmaceuticals in the News
Medical facilities making uncontrolled releases of
controlled drugs into water
By JEFF DONN | AP National Writer 12:36 PM EDT, September 14, 2008
MINNEAPOLIS (AP) _ In a frustrating quirk in government policy, the most tightly controlled drugs — like painkilling narcotics prone to
abuse — are the ones that most often elude environmental regulation when they become waste.
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Drugs in Water
 In surface and ground sources of drinking
water
 Endocrine disruptors found in waterways
receiving wastewater
 Detrimental effects on aquatic species
 May have an impact on human health
 Antibotic resistance
 Water quality degradation
 Nationwide survey
 139 streams in 30 states, analyzed for 95 compounds
 86% of compounds in at least one stream sample
 Widespread: One or more found in 80% of stream samples
 13% of streams had more than 20 compounds
* http://toxics.usgs.gov/pubs/OFR-02-94/index.html
How do they get into the water?
 Sewers
 Excretion
 Flushing unwanted medicines
 “Wasting” meds into sinks
 Landfills – thrown in trash
 Leachate goes to wastewater plants, released to rivers,
ocean
 Animal waste flows into waterways
 Industrial discharge
So, what’s the problem?
 Endocrine Disruptors – act at very low dose
 Antibiotic Resistance
 Toxicity
 Environmental Degradation
 Lack of confidence in water supply
Sources of Endocrine Disrupting Chemicals
(EDCs)
Industrial
chemicals
Pharmaceuticals
Endocrine
Disrupting
Synthetic
and natural
hormones
Chemicals
Personal care
products
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Pesticides,
herbicides,
fungicides
Endocrine System
What are Endocrine Disruptors ?
 Any chemical –- that disrupts (or mimics) the normal
balance of hormones, with particular focus on estrogen
 Interfere with normal function of the endocrine system
(thyroid, adrenals, ovaries, testes)
 Affect reproduction, development, and behavior
 Active at VERY low dose
 Multi-generational effects
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Antibiotic Resistance
 1999: Ampicillin-resistant bacteria
found in every U.S. river tested
 Samples containing the highest levels
of antibiotics also contained bacteria
with greatest resistance
 DNA that helps make germs resistant to
medicines increasingly appearing as a
pollutant in the water,
 even treated drinking water
 Decreases effectiveness of antibiotics
What is Pharmaceutical Waste?
What is Pharmaceutical Waste?
May include, but is not limited to:
 expired drugs;
 patients’ personal medications;
 waste materials containing excess drugs ( IV bags, tubing, vials,
etc.)
 drugs that can no longer be used;
 containers that held drugs;
 drugs that are intended to be discarded; and
 contaminated garments, absorbents and spill cleanup material.
How is it regulated ?
 Resource Conservation & Recovery Act- RCRA, mostly
 Enforced by EPA, state and local agencies
 Federal regulation - hazardous waste disposal
 Encourages minimization of waste generation
 Defines “hazardous waste”
 “Cradle to Grave” tracking of hazardous waste
 Households are exempt
 Not all pharms are hazardous waste
Understanding the Regulations
Defining Hazardous Wastes:
 Listed (F, K, P and U)- lists of actual wastes – includes some
meds
 Characteristic Waste: exhibit these characteristics
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Ignitability
Corrosivity
Reactivity
Toxicity
 Also Radioactives – other reguations
P-Listed Pharmaceutical Waste
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
P-Listed Pharmaceutical Waste
 Arsenic trioxide
 Epinephrine
 Nicotine
 Nitroglycerin*
 Phentermine (CIV)
 Physostigmine
 Physostigmine Salicylate
 Warfarin >0.3%
P012
P042
P075
P081
P046
P204
P188
P001
*Nitroglycerin in finished dosage forms excluded federally
and in many states for reactivity; must evaluate for ignitability
Copyright © 2005 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Common U-Listed Pharmaceuticals:
 Chloral Hydrate (CIV)
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

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U034
Chlorambucil (chemo) U035
Chloroform
U044
Cyclophosphamide (chemo)
U058
Daunomycin (chemo)
U059
Dichlorodifluromethane U075
Diethylstilbestrol(chemo) U089
Formaldehyde
U122
Hexachlorophene
U132
Lindane
U129
Melphalan (chemo)
U150
Mercury
U151
 Mitomycin C (chemo)
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U010
Paraldehyde (CIV)
U182
Phenacetin
U187
Phenol
U188
Reserpine
U200
Resorcinol
U201
Saccharin
U202
Selenium sulfide
U205
Streptozotocin (chemo) U206
Trichloromonofluromethane
U121
 Uracil mustard (chemo)
 Warfarin <0.3%
U237
U248
U-Listed Pharmaceutical Waste
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Characteristic of Ignitability
 Aqueous Solution
containing 24% alcohol or
more by volume & flash
point<140° F.
 Hazardous Waste
Number: D001
 Rubbing Alcohol
 Topical Preparation
 Injections
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Characteristic of Corrosivity
 An aqueous solution having a pH < or = 2
or > or = to 12.5
 Examples: Primarily compounding
chemicals
 Glacial Acetic Acid
 Sodium Hydroxide
 Hazardous waste number: D002
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Characteristic of Toxicity
 Approximately 40 chemicals which meet
specific leaching concentrations
 Examples of potential toxic pharmaceuticals:
 Arsenic
 Barium
 Cadmium
 Chloroform
 Chromium
 Lindane
m-Cresol
Mercury
(thimerosal)
Selenium
Silver
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Examples of Pharmaceuticals
Exhibiting the Characteristic of
Toxicity
Heavy Metals: Selenium,
Chromium and Silver
Preservatives: thimerosal & m-cresol
Characteristic of Reactivity
 Meet eight separate criteria identifying
certain explosive and water reactive
wastes
 Nitroglycerin formulations are exempted
federally as of August 14, 2001 under FR: May
16, 2001. Many states have adopted
exemption. Must still be evaluated for
ignitability.
 Hazardous Waste Number:
D003
Copyright © 2005 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Pharm Waste in California
 Proper pharmaceutical waste management is a highly
complex new frontier in healthcare
 Hospital pharmacies typically stock between 2,000 and
4,000 different items
 Very difficult to correctly identify and manage waste
 California Only pharmaceuticals handled under MWMA
What can we do?

Pollution Prevention



Control at source
Can implement & reduce
loading in near term
Product stewardship
Overview of Pharmaceutical Disposal: Hospitals
 Radioactives
 special handling
 RCRA hazardous waste
 must be hauled off as hazardous waste
 California Only pharmaceuticals
 handled under MWMA
 Solid Waste – not hazardous as defined by regs
 some flexibility
 May be best to dispose of as hazardous waste
RCRA Risk Management
& Liability
 Civil and criminal liability
 Civil: State/USEPA enforcement
 Criminal: FBI, Attorney General, Grand Jury
 Corporate fines: $32,500 per violation/day
 Personal liability: fines and/or imprisonment
 No statute of limitations
 Managers up through CEO
Copyright © 2005 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Minimizing Pharm Waste examples
 Minimize inventory
 Rotate inventory - use oldest stock first
 Centralized disposal of physician’s samples
 Prevent free samples- use voucher option
 Avoid unnecessary prescriptions, especially
antibiotics-Note pharmacy has very little
control
 Use pharmacy reverse distribution
Managing Pharm Waste
 Sewering
 Hazardous
 Chemo
 Radioactive
 MUST Develop Comprehensive System
Managing Pharmaceutical Waste
 A 10-Step Blueprint for Healthcare Facilities
Revised August, 2008
Good reference – to develop plan
California version available
Green Team
 Pharmacy
 Environmental
 Nursing
 Administration
 Safety
 Education
 Purchasing
 Risk Management
Recommended Disposal Strategy
RCRA Hazardous
RCRA Hazardous
Waste
IV bags with
salts/nutrients
Sewer
Everything Else
Medical Waste
What Pharms Can Be Sewered?
 Up to individual POTWs – sewer authority
 Generally okay to sewer solutions in IV
bags containing only:
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saline solution
lactate (i.e, Ringer’s)
nutrients such as glucose (I.e., D5W)
vitamins
potassium
other salts and electrolytes
Chemotherapy Waste – Special Handling
 Nine chemotherapy agents listed hazardous waste
 Medical waste hauler protocols for “Chemo Waste”
 Empty vials, syringes, IV’s
 Treated as infectious medical waste preferably through regulated
medical waste incineration
 If not empty, place into Haz Waste container
 “Empty” for U-listed waste means all contents removed
that can be removed through normal means and no more
than 3% by weight remains
 3 ml allowance in common practice is a misunderstanding of the
definition of “RCRA empty”
Copyright © 2005 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Chemotherapy Agents: Many Not Regulated as
Hazardous waste
 Over 100 chemotherapy agents not regulated by EPA
 Examples:
 Alkylating agents: Cisplatin, Thiotepa
 Antimetabolites: Fluorouracil, Methotrexate
 Hormonal (antiandrogen): Lupron® (leuprolide)
 Hormonal (antiestrogen): Tamoxifen
 Mitotic Inhibitor: Taxol® (paclitaxol)
Copyright © 2005 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Trace Chemotherapeutic Waste
 “RCRA empty” but have held any chemotherapy or been
potentially exposed to chemotherapy
 avoid autoclaving or microwaving of items which may be
contaminated at molecular level w/ chemotherapy
 Requires incineration at an RMW incinerator; may be
infectious such as used needles
 IV tubes primed and flushed with saline before being removed
from patient can be managed as trace chemotherapeutic
waste, reducing the volume of hazardous waste generated,
reducing contamination of PPE, and lessening employee
exposure
Copyright © 2005 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
How Can a RCRA Hazardous
Waste Be Identified?
 Web-based databases enabling search by product for
waste management recommendations
 Search by NDC, product or generic name, active
ingredient
 Recommendations citing federal regulations and
recommended waste streams
 State regulation alerts if more stringent than
federal
 Risk Management alerts based on professional
knowledge (e.g. chemotherapy agents not
regulated at the state or federal level)
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Where Should a RCRA
Hazardous Waste Be Stored?
 Hazardous Waste Storage
Accumulation Site:
 Same locked area as
mercury, xylene,
formaldehyde, lab
chemicals
 Maximum storage time:
90 or 180 days based on
generator status
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
RCRA Hazardous
Wastes Must Be
Properly Labeled!
How Should a RCRA
Hazardous Waste Be Disposed?
 Either contract with a hazardous waste
broker or develop internal expertise for:
 Lab packing
 Manifest preparation
 Land ban preparation
 Contract with a federally permitted RCRA
hazardous waste incineration facility (TSDF:
Treatment, Storage & Disposal Facility)
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
What About Non-Hazardous Drugs?
 Segregate into a non-red, non-yellow
container, such as beige or white with blue
top (California Pharmaceutical Waste)
 Label “Non-hazardous Pharmaceutical Waste
– Incinerate Only”
 Dispose at a regulated medical waste or
municipal incinerator that is permitted to
accept non-hazardous pharmaceutical waste
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
Reverse Distribution
 For pharmaceuticals – not available for most other
hazardous substances
 "Reverse distribution" - expired pharms can be returned to
the manufacturer for credit by pharmacies, not by
consumers
 Not to be used as a “waste management system.”
 Exclusion applies only to bona fide returns for credit, and
not to broken containers, spilled contents, compounding
leftovers, unused IVs, etc.
Take Home Messages
 Pharmaceuticals at detectable levels in many U.S.
surface waters!
 First manage for P2, then dispose of properly.
 Pharmacists not always conversant in waste
regulations (and may need support).
 EPA Resource Conservation & Recovery Act
regulations carry significant liability, comparable to
Drug Enforcement Administration
What About Household Pharms?
 Non-controlled substances
 May be able to take to a household hazardous
waste roundup – check with your county
 or treat as below
 Controlled substances
 Render unpalatable – pepper, turmeric, other
strong spices
 Remove labeling, duct tape shut
 Mix with undesirable trash and put out with
regular trash right before pickup
 NO DRUGS DOWN THE DRAIN
Copyright © 2004 by PharmEcology Associates, LLC.
Additional information available at: www.pharmecology.com
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
• 2008 10-Step Blueprint for Health Care Facilities Pharmaceutical waste
http://www.hercenter.org/hazmat/tenstepblueprint.pdf
 U.S. Geological Survey
http://pubs.acs.org/cgi-bin/jtextd?esthag/36/6/html/es011055j.html
• Classifying Pharmaceutical Waste at California Healthcare
Facilities
• http://www.sfenvironment.org/downloads/library/euticaldispos
alinformation.pdf
Resources
• Classifying Pharmaceutical Waste at California Healthcare
Facilities
• http://www.sfenvironment.org/downloads/library/euticaldi
sposalinformation.pdf