Beruflich Dokumente
Kultur Dokumente
Pharmaceutical Waste
H2E Teleconference
September 12, 2003
Charlotte A. Smith, R. Ph., M.S.
President
csmith@ pharmecology.com
www.pharmecology.com
262-814-2635
Copyright © 2003 by PharmEcology Associates, LLC
Pharmaceutical Waste:
A Waste Stream Whose
Time has Come
Concept of “Green Pharmacy” Gaining Attention
"Cradle-to-Cradle Stewardship of Drugs for
Minimizing Their Environmental Disposition
While Promoting Human Health.”
Dr. Christian Daughton, Chief, Environmental
Chemistry Branch, USEPA National Exposure Research
Laboratory
I. Rationale for and Avenues toward a Green Pharmacy;
II. Drug Disposal, Waste Reduction, and Future
Directions,
http://www.h2e-online.org/tools/chem-pharm.htm
Increasing Regulatory Activity
EPA Region 2 auditing 480 hospitals in 2003; Rx waste
included; link from H2E to Region 2 website
http://www.h2e-online.org/tools/chem-hwm.htm
States beginning to focus on management of waste
pharmaceuticals
Florida
Washington State
California
Minnesota
Michigan
Intersecting regulatory agencies
EPA, DEA, OSHA, State Boards of
Pharmacy
H2E and Hazardous Pharmaceuticals
Initial involvement while at Capital Returns, Inc., Rx
reverse distributor, 1999-2000
Worked on Chemical Minimization Committee with
Catherine Zimmer, Minnesota Technical Assistance
Program (MnTAP)
http://www.h2e-online.org/pubs/chemmin/pharmacy.pdf
Contributed to prioritization tool by reviewing all drug
products in CRI database
http://www.h2e-online.org/pubs/chemmin/chappf.pdf
USGS Water Quality Study*
First nationwide reconnaissance of occurrence of
pharmaceuticals, hormones, other organic
wastewater contaminants
139 streams in 30 states, analyzed for 95 different
OWCs
82 of the 95 detected in at least one sample
One or more OWCs found in 80% of stream
samples
13% of sites had more than 20 OWCs
*http://toxics.usgs.gov/pubs/OFR-02-94/index.html
Below the Dose/Response Curve:
Endocrine Disruptors
Endocrine Disruptors: chemicals that interfere with the
normal function of the endocrine system (glands including
thyroid, adrenals, ovaries, testicles)
Mimic hormone, trigger identical response, block a
hormone
Do not follow the normal dose/response curve
Active at much lower doses, especially in the fetus and
newborn
Estradiols, progesterone, testosterone
Lindane
Low sperm counts(50% reduction since 1939)
Infertility
Genital deformities
Hormonally triggered human cancers
Neurological disorders in children
Hyperactivity
Attention deficit
Developmental & reproductive
problems in wildlife
Pharmaceuticals Entering
the Waste Stream
Wastage of Raw Materials from Manufacturing
Process
Wastage at the Distributor/
Pharmacy/Healthcare Facility
Wastage at the LTCF or other residential
facility
Expired Pharmaceuticals
Wastage at the Consumer Level
Metabolites Entering Wastewater
When is an Outdated Drug
a Waste?
At the time and place the decision is made to
discard it
Two EPA guidance letters to the industry:
Merck & Co., 1981
BFI Pharmaceutical, 1991
Enables shipping of potentially creditable outdates
to a reverse distributor as product
PROHIBITS the shipping of waste-like items,
such as unused IVs, partial vials
Reverse Distribution:
Current Scenarios
Decision to discard is made at the pharmacy
By pharmacy
By a contracted company
Pharmacy (hospital) becomes the waste
generator
Decision to discard is made at the reverse
distributor
Reverse Distributor becomes the waste
generator
Where Have Waste Drugs
Gone in the Past?
Primarily concerned with rendering drugs
unrecoverable
Not in dumpsters, municipal trash
Compounding residues
Liquids
Leachate
Copyright © 2002 by PharmEcology™ Associates, LLC
How is Pharmaceutical Waste Generated
at the Healthcare Facility?
IV Preparation
General Compounding
Spills/Breakage
Partially Used Vials/Syringes
If Contaminated, Biohazardous
Empty vials,
syringes, IVs,
tubing, gowns,
gloves,etc.
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
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
Characteristic of Toxicity
federal
Risk Management alerts based on professional
Spills
RCRA Hazardous Waste: Ignitable (D001)
Hospitec has developed a dedicated hazardous waste
containment system
Can also use hazardous waste buckets available from
brokers and disposal firms
Recommended Additional Pharmaceutical Waste Streams
HAZARDOUS WASTE HAZARDOUS WASTE
- TOXIC - IGNITABLE NON-HAZARDOUS
NON-INFECTIOUS RX
MUNICIPAL
Hazardous waste MEDICAL INCINERATOR
broker and transporter WASTE PERMITTED
INCINERATOR FOR SPECIAL
WASTE
Ash Ash
FEDERALLY PERMITTED
HAZARDOUS WASTE INCINERATOR
(HIGH TEMPERATURE, SCRUBBERS)
NON-HAZARDOUS LANDFILL
Ash
• Packaging • IV’s • P-listed • D-listed Ignitable • Vials • Gowns All waste • Non-chemo
• Empty bottles - D5W • U-listed - Collodion - Empty • Gloves pharmaceuticals vials
• Paper - NaCl • D-listed toxic - Oxidizers • Syringes/Needles • Goggles NOT hazardous - Empty
• Plastic • Controlled (Heavy metals) - Ignitable - Empty • Tubing including • Non-chemo
• Chemo agents compressed • IV’s • Wipes antibiotics, IV’s syringes/
• Food waste, etc. Substances?
(residue, bulk) gas - Empty needles
• Antibiotics? • Chemo spill clean up - Empty
• Hazardous spill clean up
• Risk management:
• Recycle as • Check with - Antivirals
much paper, municipal water - Others
glass, plastic treatment plant MUNICIPAL
as possible for limits,
MEDICAL WASTE INCINERATOR AUTOCLAVE/
recommendations
INCINERATOR PERMITTED MICROWAVE
• Use shredder
where patient FOR SPECIAL
privacy is an FEDERALLY PERMITTED WASTE
issue HAZARDOUS WASTE
INCINERATOR (HIGH
TEMPERATURE, SCRUBBERS)
Ash Ash Shredded (?)
Ash
NON-HAZARDOUS LANDFILL
LINED HAZARDOUS
WASTE LANDFILL
Leachate
Copyright © 2002 by PharmEcology™ Associates, LLC
Where Should RCRA Hazardous
Waste Be Stored?
Hazardous Waste Yellow Hazardous
Storage Waste Label
Accumulation Site:
Same locked area as
mercury, xylene,
formaldehyde, lab
chemicals
Maximum storage
time: 90 or 180 days
based on generator
status
How Should 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)
How Can Hazardous RX
Waste Generation Be Minimized?
Inherent limitations on substitution of a less
hazardous drug since the hazardous nature of the
chemical often provides the therapeutic effect
Tighter inventory control to reduce outdate
generation, both original manufacturers’
containers and repacks
Single dose vials vs. multiple dose vials
Patient specific oral syringes vs. 10 cc. repacks
(e.g. choral hydrate for pediatric use)
Reformulation of heavy metal concentration,
especially mercury and m-cresol as preservatives
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
Where to Begin?
Purchase appropriate containers for collecting
toxic and ignitable hazardous waste
Pilot bulk and residue chemotherapy segregation
in the pharmacy and on the oncology unit
Extend the program to all units that handle any
chemotherapy agents (methotrexate and
cyclophosphamide used in other units)
Begin identifying other P, U and D hazardous
wastes
Train all relevant staff on the reasons for the new
system
Jump-Starting the Process
Electronic formulary review service
Send PharmEcology Associates your drug formulary
information
We compare it to our database of over 107,000 drug
items
You receive back a list of which drugs are hazardous
waste or risk management hazardous waste
On-site review
A one or two day visit to your facility followed by an
Action Plan and Findings and Recommendations
Benefits of a Comprehensive
Hazardous Waste Disposal Plan
JCAHO Environment of Care Performance
Improvement Initiative
New 2004 Standards – see both