[Pharmwaste] Pharmwaste Digest, Vol 147, Issue 7

Jim Mullowney jmullowney at pharma-cycle.com
Sat Apr 21 16:01:45 EDT 2018


Good afternoon Ed,

 

Thank you for the clarification. I do have one point to make, you refer to metabolites in the excretion.

I am talking about the raw drug in its original form and with its original strength and its original dangers and its continuing liability to those involved including the Chief Pharmacist (WHO) and the Management team (USP 800). This liability and danger continues with the drug before, during and after administration including into the home and family members.

USP does issue guidance on how to handle the waste from Hazardous drugs, it does not exclude the hazardous drug after it has passed through the patient and specifically defines the post patient waste as a danger. Section 3 table 1

Patient-care activities • Handling body fluids (e.g., urine, feces, sweat, or vomit) or body-fluid-contaminated clothing, dressings, linens, and other materials 

 

The metabolites are another issue and sometimes more dangerous. The example I like to use Cyclophosphamide a U listed EPA hazardous waste (U058), the first metabolite is Acrolein a P listed EPA hazardous waste (P003) and Phosphamide mustard (gas). 

 

The battle of wording is for the lawyers, the dangers are the same to the Pharmacist as they are to the Nurse and the families, septic systems and water systems.

 

I would remind everyone that we are talking about non-dose dependent chemicals where there is no safe level of exposure, I have attached the OSHA, Niosh, Joint Commission letter.

 

Section 7.6 of USP 800 

Chemotherapy gloves and sleeve covers (if used) worn during compounding must be carefully removed and discarded immediately into a waste container ap-proved for trace contaminated waste inside the C-PEC or contained in a sealable bag for discarding outside the C-PEC. 

 

That being said, Ed 

 

We need a meeting, thinking Mystic CT.

 

 

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: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Edward Krisiunas
Sent: Thursday, April 19, 2018 9:14 AM
To: pharmwaste
Subject: Re: [Pharmwaste] Pharmwaste Digest, Vol 147, Issue 7

 

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  <http://www.wmsustainabilityservices.com/> 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] 
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. 



---------- 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
 <http://www.productstewardship.us/> www.productstewardship.us
 <mailto:vivian at 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
1-860-675-1217 (O)
1-860-675-1311 (F)
1-860-839-3993 (M)
SKYPE - Boutiquewaste

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