Transcript Managing Pharmaceutical Waste Stanford Hospital & Clinics

Managing Waste
Chemotherapeutic Agents:
What to Know and
What to Find Out
H2E Teleconference
March 11, 2005
Eydie Pines
[email protected]
Charlotte Smith
[email protected]
Know the Lingo
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Cytotoxic
Antineoplastic
Chemotherapeutic
Biohazardous
• Refers to infectious waste, Blood Borne
Pathogens Act
• In Pharmacy circles, often used to refer to
agents which are hazardous to living systems,
such as chemotherapy drugs
• Need to correct this misconception and use the
term only for infectious waste
Chemotherapeutic Agents:
The Regulatory Players
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OSHA Hazard Communication Standard
• OSHA Technical Manual Section 6, Chapter 2, Appendix VI: 2-1
• Lists hazardous drugs
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NIOSH Hazardous Drug Alert
• Recently released comprehensive new guidelines for total life
cycle management of OSHA “Hazardous Drug”
• Identifies “hazardous waste” and need for appropriate disposal
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EPA RCRA
• Only 9 chemotherapy drugs “listed” as hazardous waste in
1976
• None added to the list to keep up with drug development
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State RMW Regulations
• May include trace chemotherapy
 Treated as infectious medical waste through regulated
medical waste incineration
NIOSH Hazardous Drug Alert
• Preventing Occupational Exposures to
Antineoplastic and Other Hazardous Drugs in
Healthcare Setting
• Recognizes risks to employees
• Recommends engineering controls,
administrative controls, and personal
protective equipment
• Provides waste disposal guidelines
• http://www.cdc.gov/niosh/docs/2004-165/
• Appendix A provides a starting list of
hazardous drugs under OSHA (not to be
confused with hazardous waste under EPA)
Chemotherapeutic Drugs:
Here, There and Everywhere
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75% of pharmacy areas and 65% of
administration areas demonstrated some level of
contamination
Contamination was generally higher in the
pharmacy than in the administration areas
Locations adjacent to handling areas were also
contaminated.
Conner TH, Anderson RW, Surface contamination
with antineoplastic agents in six cancer center
treatment centers in Canada and the United
States. AMJ Health-System Pharm 1999: 561427-32.
New Study Reveals
Chemotherapy on Vials
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Documents external contamination on
vials from manufacturers
Supports requiring personnel who check in
or handle chemotherapy containers to
wear appropriate personal protective
equipment
Conner TH, Sessink JM et al, Surface
contamination of chemotherapy drug vials
and evaluation of new vial-cleaning
techniques: Results of three studies. AMJHealth-System Pharm 2005: 62-475-84
Beyond the Obvious: Where
Chemo Wastes are Generated
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Operating Room
• Mitomycin eye drops, bladder irrigant (U listed)
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Med-Surg Floors
• Immunosuppressives, eg. Rheumatoid arthritis
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Methotrexate (Not listed)
Cyclophosphamide (U listed)
Emergency Department
• Ectopic pregnancy
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Methotrexate
Examples of Chemotherapy
Dosage Forms
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Tablets/Capsule
• Chlor-am'-bu-cil, U035 Leukeran®
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Vial – Powder
• Cyclophosphamide U058
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Cy-clo-phos´-pha-mide, Cytoxan®, Neosar®
• Melphalan
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U150
Mel´-phal-an,
Vial – Liquid
Alkeran®
• Fluorouracil (Not listed)
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Fluor-o-ur’-a-cil, 5FU, Adrucil®
Ampule – Liquid
• Arsenic Trioxide P012
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Trisenox®
The Dispensing Instrument
Matters
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Syringes
• EPA Hotline guidance exempts epinephrine syringe that has
been injected into a patient and is therefore infectious waste;
exclusion was extended verbally to other P and U listed drugs
in a used syringe – open to interpretation
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IV Sets
• IV bags that are not empty and can be separated from patient
exposed sharp without exposing the employee should be managed as
RCRA hazardous waste
• IV bags that are not empty and can NOT be separated from patient
exposed sharp without exposing the employee should be managed as
both RCRA hazardous waste and RMW
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Vials
• Vials that are not empty should be managed as RCRA hazardous waste
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Tablets
• Unused tablets should be managed as RCRA hazardous waste
Arsenic Trioxide: The Only
P-Listed Chemo Waste
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Consider all containers that have held arsenic
trioxide to be hazardous waste
• RCRA empty for P-listed drugs requires triple rinsing of
the container – not practical
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Over 1 kg (2.2 lbs) of P waste in a calendar
month results in large quantity generator status
Weights of P-listed drug waste must be combined
with any other P-listed waste generated at the
facility in a given month
If an IV set containing P-listed wastes is also
considered infectious waste, it may have to be
managed by a facility permitted to handle both
hazardous waste and RMW
Chemotherapy Agents: Many Are
Not Regulated by RCRA
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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)
Some Chemotherapy Drugs May
Also Be Ignitable
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Aqueous Solution containing 24%
alcohol or more by volume & flash
point<140° F.
Hazardous Waste Number: D001
Example: Paclitaxel Inj contains
49.7% ethanol
Dispose in ignitable container
Trace Chemotherapeutic Waste
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A term used to define items which are RCRA
empty but which have held any chemotherapy or
been potentially exposed to chemotherapy
To avoid autoclaving or microwaving of items
which may be contaminated at the molecular
level with undetected chemotherapy
Requires incineration at an RMW incinerator; may
be infectious such as used needles
IV tubes primed with saline by the pharmacy 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
Discarding Contaminated Personal
Protective Equipment and Spill Clean
Up Material
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Personal Protective Equipment (PPE)
and spill clean up material
contaminated with P- or U-listed
waste must be managed as
hazardous waste
Traditional Trace Chemo
Waste Containers
New Hazardous
Waste
Containers
Bulk chemo in vials,
unused IV’s, P, U, toxic D and
associated spill clean up materials
DOT approved
Hospitec
Empty vials,
syringes, IVs,
tubing, gowns,
gloves,etc.
Kendall
Treatment Technologies: Regulated
Medical (Infectious) Waste Incinerators
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Permitted by the state to accept
pathology waste, infectious waste
and sharps, trace chemo waste
Regulated under the Clean Air Act
Lower temperature, less controls
than RCRA permitted hazardous
waste incinerators
Ash disposed of in a municipal (nonhazardous) landfill
Characteristic and Listed
Hazardous Waste: Toxic
Regulation:
• P,U,D hazardous RX
(non-chemo)
• Bulk chemo vials,
IV bags
• Chemo and haz spill
materials
• Investigational drugs
Resource Conservation
& Recovery Act
Acronym:
RCRA
Contents:
Toxic Hazardous Waste
Treatment:
Purpose:
Final
Disposition:
Incineration at a RCRA
hazardous waste incinerator
Destroy chemical
compound entirely
Lined hazardous waste landfill
Characteristic Hazardous
Waste: Ignitable
Regulation:
• D001 Ignitable
hazardous RX
Resource Conservation
& Recovery Act
Acronym:
RCRA
Contents:
Ignitable Hazardous Waste
Treatment:
Incineration at a RCRA
hazardous waste incinerator
Purpose:
Final
Disposition:
Destroy chemical
compound entirely
Lined hazardous waste landfill
Treatment Technologies:
Hazardous Waste Incinerators
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Permitted by USEPA, known as a Treatment,
Storage and Disposal Facility (TSDF)
High temperature, molecular bonds broken
Pollutants scrubbed, emits only water vapor, ash
stored in a lined, hazardous waste landfill
Authorized to accept the “worst of the worst”
hazardous chemicals, shipped on a 5-part
manifest
Examples:
• Clean Harbors/Safety Kleen
• Heritage
• Onyx
• Teris
Combination Wastes:
Infectious and Hazardous
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If IV bag chemo drug has been hung, is not completely
used and can be separated from patient exposed sharp or
catheter without exposing the employee, remove and
incinerate IV set as RCRA hazardous waste
If chemo residue cannot be removed safely, states differ on
regulatory requirements
• Florida – may dispose as biohazardous, infectious waste
• Minnesota – must dispose as hazardous waste; may be
considered infectious
Engineering controls are making this scenario less frequent
Clean Harbors is permitted to incinerate combination
wastes at their RCRA/RMW facility in Deer Park, Texas and
Aragonite, Utah
P-listed Arsenic Trioxide is likely to be both a hazardous and
infectious waste
Satellite Accumulation
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At the point of generation
Need only a Hazardous Waste (Toxic) or
(Ignitable) label
May need signage indicating it is Satellite
Accumulation based on state requirements
Need to keep covered when not in use
Can accumulate up to 1 quart of P listed
waste; 55 gallons of U and mixed waste
Have 3 days to move when limit is
reached
No other time limit involved
Storage Accumulation
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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
• Additional regulatory
requirements
Hazardous
Waste Label
Storage Capacity and Location
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Does your existing hazardous waste
storage facility have sufficient capacity for
the chemotherapeutic waste stream and
other hazardous drug waste?
Is the storage accumulation area well
removed from patient traffic areas?
Consider how waste will be transported
from point of generation to storage
accumulation area
Manifesting Toxic
Chemotherapeutic Wastes
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Approach # 1
• Document all listed P and U drugs that may be
used in the organization
• Have this list pre-certified by the waste vendor
as a bulk shipment, rather than a lab pack
• List all waste codes on the manifest regardless
of contents
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Approach #2
• Document exactly which P and U listed drugs
are deposited in a particular container
• List only those waste codes on the manifest
• Very time consuming, but required in
Minnesota in particular
Manifesting Ignitable
Chemotherapeutic Wastes
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Segregated into RCRA Ignitable waste
container
May combine with other ignitable drug
wastes
Manifest using the D001 code for
ignitability
If a P or U listed drug is involved, list the
waste code in the shipping name along
with the proper DOT ignitable shipping
name
Federal Waste
Generator Status
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Large Quantity Generator (LQG):
generates more than 1000 kg/month of
hazardous waste or >1 kg/month “P”
listed waste.
Small Quantity Generator
(SQG):Generates <1000 kg/month but
>100 kg/month of hazardous waste & <
or = 1 kg/month “P” listed waste.
Conditionally Exempt Small Quantity
Generator (CESQG):Generates < or =
100 kg haz waste/month, < or = 1kg P
listed waste/month
OSHA HAZWOPER* Training
Requirements
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If not Large Quantity Generator, general
awareness training and specific work
training sufficient
For Large Quantity Generator, need
appropriate levels of HAZWOPER training
for employees handling and transporting
hazardous waste
http://www.osha.gov/pls/oshaweb/owadis
p.show_document?p_table=STANDARDS&
p_id=9765
*Hazardous Waste Operations and Emergency Response 1920.120
Discovering Waste Minimization
Opportunities
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Is the pharmacy disposing of opened
chemo drugs before the expiration
date?
Is the pharmacy priming the IV tube
with saline?
Does the nursing staff flush the IV
tube with saline before it is removed
from the patient?
Questions for Nursing, Pharmacy
and Housekeeping Staff
• How often are IV bags partially used?
• Do the IV bags have sharps or catheters attached?
• Are the IV tubes primed with saline by the
pharmacy?
• Are the IV tubes flushed with saline before being
removed from the patient?
• How often are gowns changed?
• How many trace chemotherapy containers are
currently being generated?
• Are opened vials of chemotherapeutic agents
disposed of prior to their expiration date?
• How often are opened expired chemotherapeutic
drugs discarded?
Managing to the Highest Standard
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Treat all bulk chemotherapy waste
(greater than trace amounts) as
RCRA hazardous waste
• Easier to implement – no lists or sorting
required
• The right thing to do for human health
and the environment
• Complies with the RCRA statutory
definition of hazardous waste
References
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www.pharmecology.com
Pharmaceutical Waste: http://www.h2eonline.org/tools/chem-pharm.htm
RCRA On-Line http://www.epa.gov/rcraonline/
NIOSH Hazardous Drug Alert:
http://www.cdc.gov/niosh/docs/2004-165/
Pharmaceuticals and Personal Care Products as
Environmental Pollutants:
http://www.epa.gov/nerlesd1/chemistry/pharma/index.
htm
Containers
• Hospitec: Christopher Hahn, (561) 833-2296,
[email protected]
• Kendall: Mike Liscio, (508) 261-8493,
[email protected]