[Pharmwaste] Chemo drugs
Jim Mullowney
jmullowney at pharma-cycle.com
Wed Apr 18 14:32:41 EDT 2018
Hello Charlotte,
Good to hear from you and I agree with you completely, trace chemotherapy
waste is not a Hazardous waste and is treated as "Trace Chemotherapy waste",
not general trash but not a hazardous waste. Not sure where the
misunderstanding came from but it most likely was my fault.
I am attaching a letter I wrote to the USP committee last week that may have
been a source of the confusion. Very few Hazardous Drugs are Hazardous
Wastes and unassimilated Hazardous Drugs contained in urine, sweat, vomit
and feces are NOT hazardous wastes and USP 800 has little to do with the
EPA, except for the handful or so that are regulated. The dangers still
exist and don't go away because the EPA does not regulate them and those
working with the Hazardous Drugs and the patient waste should be aware of
the dangers. OSHA and FDA still apply.
Hope this helps.
Jim Mullowney, President
Pharma-Cycle, LLC.
Associate Member American Society of Clinical Oncology
Member of the American Chemical Society
<mailto:jmullowney at pharma-cycle.com> jmullowney at pharma-cycle.com
(617) 755-0883
From: Smith, Charlotte [mailto:csmith32 at wm.com]
Sent: Wednesday, April 18, 2018 2:10 PM
To: Ed Gottlieb; pharmwaste at lists.dep.state.fl.us
Cc: Mullowney, Jim
Subject: RE: Chemo drugs
With all due respect, I have carefully re-read the final USP General Chapter
<800> Handling Hazardous Drugs and I do not find any reference to the
requirement to dispose of trace chemotherapy as a hazardous waste. The
chapter repeatedly refers to the complying with EPA regulations, which do
not currently address trace chemotherapy waste. There is one reference to
disposal in a container appropriate for trace contaminated HD waste and also
a reference to "HD containers" but that is a hazardous drug container, not
necessarily a hazardous waste container. It is also my understanding that
the current version available from USP is the final version with no
additional drafts being contemplated. There is often confusion between a
hazardous drug and a hazardous waste, but the definitions are very
different.
Best regards,
Charlotte A. Smith, RPh, MS
Senior Regulatory Advisor
PharmEcology Services, WM Sustainability Services
csmith32 at wm.com
Waste Management
P.O. Box 1654
Brookfield, WI 53008-1654
Cell 713-725-6363
Waste Management's Sustainability Services teams work with you to devise a
strategy that will help achieve your environmental goals while benefitting
your financial objectives. Find out more at
<http://www.wmsustainabilityservices.com/> www.wmsustainabilityservices.com
From: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf
Of Ed Gottlieb
Sent: Monday, April 9, 2018 1:43 PM
To: pharmwaste at lists.dep.state.fl.us
Cc: Mullowney, Jim <jmullowney at pharma-cycle.com>
Subject: [EXTERNAL] [Pharmwaste] Chemo drugs
New info from Jim Mullowney below. Contact him for more information:
jmullowney at pharma-cycle.com
Unofficial draft of the updated USP [set standards, publish International
Pharmacopoeia] "General Chapter <800> on Hazardous Drugs, handling in
healthcare settings" states that materials with trace amounts of Hazardous
Drugs must be discarded as a Hazardous Waste. This includes items
contaminated in the medical care facility and patient-care environment,
which can include the home.
Problem Chemotherapy Drugs That Are Excreted at High Concentrations & Can
Damage Others at Ultra-low Doses1
Generic Name Other Names Excretion
Administered Dose
%
Danger Period Dose/Weight Amount
Actinomycin D Dactinomycin, Cosmenogen 30% 7 Days ?
50 ug/Kg ? 4 mg
Bleomycin Blenoxane 60-70% 1 Day
? 50 units (mg)/Kg ? 4000 mg
Carboplatin Paraplatin 65-75% 1 Day
? 12 mg/Kg ? 960 mg
Cisplatin Platin 13-17% 1
Day ? 3.3 mg/Kg ? 264 mg
Cyclophosphamide Endoxan, Cytoxan, Neosar, Procytox, Revimmune
5-25%
1 Day ? 50 mg/Kg ? 4000 mg
Dacarbazine DTIC, DTIC-Dome 40% 1 Day
? 4.5 mg/Kg ? 360 mg
Daunorubicin HCl Cerubidine 65% 3 Days
? 1.5 mg/Kg ?120 mg
Doxorubicin Adriamycin, Rubex, Doxil, Caelyx, Myocet
45-55%
5 Days ? 2.5 mg/Kg ? 200 mg
Epirubicin Ellence, Pharmorubicin 55% 4 Days
? 40 mg/Kg ? 3200 mg
Etoposide Eposin, Etopophos, Vepesid, VP-16 45% 5 Days ?
3.3 mg/Kg ? 264 mg
Floxuridine Fdur 20% 1
Day ? 0.6 mg/Kg ? 48 mg
Fludarabine Fludara 40-60% 1 Day
? 0.83 mg/Kg ? 66.4 mg
Fluorouracil 5-FU, Adrucil, Carac, Efudix, Efudex, Fluoroplex
7-20%
1 Day ? 12 mg/Kg ? 960 mg
Idarubicin Zavedos, Idamycin 20% 8 Days
? 0.4 mg/Kg ? 32 mg
Ifosfamide Mitoxana, Ifex 12-18% 1 Day
? 40 mg/Kg ? 3200 mg
Irinotecan Camptosar, Campto 25-50% 2 Days
? 11.7 mg/Kg ? 936 mg
Mitomycin Mitosol 10% 1
Day ? 0.67 mg/Kg ? 53.6 mg
Mitoxantrone 24%
5 Days ? 0.47 mg/Kg ? 37.6 mg
Oxaliplatin Eloxatin 35%
1 Day ? 2.8 mg/Kg ? 224 mg
Methotrexate Trexall, MTX, Amethopterin 80-90% 1 Day ?
15 mg/Kg ? 1200 mg
Temozolomide Temodar 18% 7 Days
? 50 mg/Kg ? 4000 mg
Topotecan Hycamtin 70 -75% 9
Days ? 0.05 mg/Kg ? 4 mg
Restricted use
Arsenic trioxide Trisenox 15% 1
Day ? 15 mg/Kg ? 1200 mg
Clofarabine 49-60%
1 Day ? 1.7 mg/Kg ? 138 mg
Melphalan Alkeran 10-15%
1 Day 6 mg 6 mg
Teniposide Vumon 4-12% 5
Days ? 8.3 mg/Kg ? 666 mg
Valrubicin Valstar 99%
1 Day 800 mg 800 mg
1. Information summarized from the Drug Package Inserts - information
required by the FDA from pharmaceutical companies before each drug is
approved for use in humans.
2. Estimated percent of drug dose that exits patient's body as parental drug
or active metabolite as well as excretion period.
3. Doses will vary depending on disease and doctors' recommendations. See
individual Drug Inserts for more details.
4. Where needed, converted from mg/m2 to mg/Kg
Ed Gottlieb
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY 14850
(607) 273-8381 <tel:(607)%20273-8381>
fax: <tel:(607)%20273-8433> (607) 273-8433
_____
Recycling is a good thing. Please recycle any printed emails.
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