[Pharmwaste] Pharmwaste Digest, Vol 147, Issue 7

Edward Krisiunas ekrisiunas at gmail.com
Thu Apr 19 09:14:13 EDT 2018


Good the day:

Jim is addressing an issue - management of the excretions from patients
which is a risk to staff and family members. The 1985 OSHA guidance does
not address waste disposal of these items as much as protecting oneself
from exposure as well as being aware that metabolites may be present.
Musgrave et al published data in 1992 regarding the presence of metabolites
in excretions   - nothing new here but how should this waste be managed is
the issue...

<800> does not specifically address this issue to Jim's point and his
letter to USP  - there is no definition for HD waste or trace in the
glossary - it refers you to state and federal regulations.

In the attached commentary/replies to questions in 2016, USP is asked to
define trace and declines as they state it is beyond the purview if the
committee ( search for the term "trace")..it comes up several times.

Regards,

Ed Krisiunas

On Thu, Apr 19, 2018 at 8:54 AM, <pharmwaste-request at lists.dep.state.fl.us>
wrote:

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> Today's Topics:
>
>    1. Re: Chemo drugs (Jim Mullowney)
>    2. FREE PSI webinar: "Global Best Practices for Drug Take-Back
>       Programs"? 6/7/2018 (Vivian Futran Fuhrman)
>
>
> ---------- Forwarded message ----------
> From: Jim Mullowney <jmullowney at pharma-cycle.com>
> To: "'Smith, Charlotte'" <csmith32 at wm.com>, "'Ed Gottlieb'" <
> EGottlieb at cityofithaca.org>, <pharmwaste at lists.dep.state.fl.us>
> Cc:
> Bcc:
> Date: Wed, 18 Apr 2018 16:26:54 -0400
> Subject: Re: [Pharmwaste] Chemo drugs
>
> Sorry about that again, I looked up my email and I should have said
> Hazardous Drug,  Section 3 Table 1 of USP 800
>
>
>
> Patient-care activities ∙ Handling body fluids (e.g., urine, feces, sweat,
> or vomit) or body-fluid-contaminated clothing, dressings, linens, and other
> materials
>
>
>
>
>
>
>
> Jim Mullowney, President
>
> Pharma-Cycle, LLC.
>
> Associate Member American Society of Clinical Oncology
>
> Member of the American Chemical Society
>
> jmullowney at pharma-cycle.com
>
> (617) 755-0883
>
>
>
>
>
>
>
> *From:* Smith, Charlotte [mailto:csmith32 at wm.com]
> *Sent:* Wednesday, April 18, 2018 3:31 PM
> *To:* Jim Mullowney; 'Ed Gottlieb'; pharmwaste at lists.dep.state.fl.us
> *Subject:* RE: RE: Chemo drugs
>
>
>
> Thank you, Jim, for your clarification. It’s important that we keep the
> definitions clear and concise so healthcare facilities can operationalize
> in compliance and still be cost-effective.
>
>
>
> 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
> www.wmsustainabilityservices.com
>
>
>
>
>
>
>
>
>
> *From:* Jim Mullowney [mailto:jmullowney at pharma-cycle.com]
> *Sent:* Wednesday, April 18, 2018 1:33 PM
> *To:* Smith, Charlotte <csmith32 at wm.com>; 'Ed Gottlieb' <
> EGottlieb at cityofithaca.org>; pharmwaste at lists.dep.state.fl.us
> *Subject:* [EXTERNAL] RE: Chemo drugs
>
>
>
> 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
>
> jmullowney at pharma-cycle.com
>
> (617) 755-0883
>
>
>
>
>
>
>
> *From:* Smith, Charlotte [mailto:csmith32 at wm.com <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
> www.wmsustainabilityservices.com
>
>
>
>
>
>
>
>
>
> *From:* Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us
> <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
> fax: (607) 273-8433
>
>
> ------------------------------
>
> *Recycling is a good thing. Please recycle any printed emails. *
>
>
> ---------- Forwarded message ----------
> From: Vivian Futran Fuhrman <vivian at productstewardship.us>
> To: "pharmwaste at lists.dep.state.fl.us" <pharmwaste at lists.dep.state.fl.us>
> Cc:
> Bcc:
> Date: Thu, 19 Apr 2018 12:54:11 +0000
> Subject: [Pharmwaste] FREE PSI webinar: "Global Best Practices for Drug
> Take-Back Programs"– 6/7/2018
>
> Good Morning,
>
>
>
> PSI is holding a free webinar, *Global Best Practices for Drug Take-Back
> Programs*, on *June 7, 11am - 12:30pm EDT (8am PDT / 5pm CEST)*. This is
> the third in a four-webinar global series that will connect stakeholders
> worldwide and launch an ongoing dialogue about best practices for safely
> managing waste pharmaceuticals.
>
>
>
> The 90 minute webinar will feature speakers from Canada, the United
> States, France, and Sweden who will share their program best practices. The
> presentations will be followed by a 45 minute question/answer session. The
> entire webinar will be held in English.
>
>
>
> More details and a link to register can be found online:
> https://productstewardship.site-ym.com/events/EventDetails.aspx?id=1096126.
>
>
> We hope to see you there!
>
>
>
> Best,
>
> Vivian
>
>
> *______________________________ Vivian Fuhrman, Ph.D.*
>
> Sr. Associate for Policy and Programs
>
>
> *Product Stewardship Institute, Inc. *29 Stanhope St., 3rd Floor, Boston,
> MA 02116
> P: (617) 236-4771 F: (617) 236-4766
> www.productstewardship.us
> vivian at productstewardship.us
>
> *The Product Stewardship Institute, Inc. is an equal opportunity provider
> and employer.*
>
>
>
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-- 


Ed Krisiunas, MT(ASCP), MPH
President
WNWN International
PO Box 1164
Burlington, Connecticut
06013
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1-860-675-1311 (F)
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