[Pharmwaste] FW: USP 800 and unassimilated drugs

Jim Mullowney jmullowney at pharma-cycle.com
Mon Apr 9 11:40:16 EDT 2018


Good Morning All,

Please read the email below regarding United Stated Pharmacopeia (USP) 800
and unassimilated hazardous drugs. This regulation will be enforceable
December 1, 2019 and has been adopted by California already.

 

From: Jim Mullowney [mailto:jmullowney at pharma-cycle.com] 
Sent: Monday, April 9, 2018 11:32 AM
To: 'gsdavid2 at ncsu.edu'
Cc: Compounding SL Account (CompoundingSL at USP.org);
patricia.kienle at cardinalhealth.com
Subject: FW: USP 800 and unassimilated drugs

 

Good Morning Gigi and USP.

Could you acknowledge receipt of this email and present to the Compounding
Expert Committee

 

From: Jim Mullowney [mailto:jmullowney at pharma-cycle.com] 
Sent: Monday, April 9, 2018 11:10 AM
To: 'gsdavid at ncsu.edu'
Cc: Compounding SL Account (CompoundingSL at USP.org)
Subject: USP 800 and unassimilated drugs

 

Gigi Davidson
April 9, 2018

Chair, Compounding Expert Committee.

United States Pharmacopeia 

12601 Twinbrook Parkway

Rockville, MDE 20852

 

 

Dear Gigi,

Chapter 800, hazardous drug handling in healthcare settings does actually
identify contact with unassimilated hazardous drugs in body fluids as
potential opportunities of exposure to hazardous drugs in healthcare
settings. This is defined in section 3, table 1.

This would define unassimilated drugs from certain treatments as hazardous
drugs. In some cases, up to 90% of the drug is in the bodily fluids. I have
attached a list of hazardous drugs that are excreted heavily in the urine
and feces as well as the sweat and saliva, they all happen to be
chemotherapy drugs. See attachment 1.

This would put human waste contaminated with cytotoxic chemotherapy drugs
under regulation by USP 800, and would also apply to a patients clothing,
bedding and anything the patient came in contact with during the excretion
time. Due to the amount of unassimilated drug in the urine and feces the
bodily fluids should be collected during the excretion time and disposed of
as bulk chemotherapy waste and the contaminated clothing and bedding should
be disposed of as trace chemotherapy waste.

Human waste contaminated with certain cytotoxic chemotherapy drugs are
covered in the following manner in USP 800 in various sections.

1.       Introduction and scope. This section applies to hazardous drug
handling including unassimilated drugs in human waste and includes home
healthcare workers. It is important to note that most cytotoxic drugs are
administered in the hospital on an outpatient basis or administered in the
patient's home. It is still the responsibility of the administrator to
control the human waste excreting from the patient for 24 to 48 hours as
also stated by the World Health Organization.

2.       List of hazardous drugs. This list constantly changing and is
currently adding 20 or so new hazardous drugs. It is the responsibility of
the administrator to know which of these drugs are a hazard post patient and
to apply necessary containment.

3.       Types of exposure.  Under this section handling bodily fluids
(e.g., urine, feces, sweat and vomit) or body fluid contaminated clothing,
dressing, linens and other materials are a source of exposure and therefore
are considered hazardous drugs and are regulated under USP 800.

4.       Responsibilities of personnel handling hazardous drugs. The World
Health Organization places the responsibility of controlling hazardous drugs
including human waste containing cytotoxic chemotherapy drugs on the chief
pharmacist. It also states that the control of cytotoxic waste should be
paid for by the entities that pay for healthcare

5.       facilities and engineering controls. As we agree that certain
contaminated human wastes are still hazardous drugs, engineering controls
should be put in place to protect the workers and the environment including
containment of the urine and feces as well as the linens and the patients
clothing.

6.       Environmental quality and control. The same controls apply to the
unassimilated chemotherapy drugs and many wipe samples have been taken
around toilets and bathrooms clearly showing the need for control. The
hazardous drugs referenced in this section are all cytotoxic chemotherapy
drugs that are heavily excreted. Data on the excretion rates and times can
be found in attachment 1. Cyclophosphamide, ifosfamide, methotrexate,
fluorouracil and platinum containing drugs are all heavily excreted with
methotrexate estimated at 90%. This information is readily available from
the drug package insert and from the Food and Drug Administration.

7.       Personal protective equipment. This section would apply to
personnel handling the patient, the linens and all human waste containing
unassimilated hazardous drugs. All PPE should be treated as trace
chemotherapy waste and as stated by the World Health Organization. The human
waste from certain unassimilated cytotoxic chemotherapy drugs must be
collected and disposed of to prevent potential environmental disaster. The
human waste collected would not be considered trace chemotherapy waste as
some of the drugs are concentrated in the urine and feces.  Please see
attachment 2, a review of the World Health Organization's Blue Book on
Healthcare waste management as it pertains to Hazardous Drugs.



 

8.       Hazard communication program. The section would apply to
unassimilated hazardous drugs that are excreted by the patient and the
information must be communicated to personnel handling the patient, linens
and clothing as well as collecting the human waste.

9.       Personnel training. The section would apply to unassimilated
hazardous drugs as well.

10.   Receiving. The section would not apply to post patient hazardous
drugs.

11.   Labeling, packaging, transport and disposal. Unassimilated cytotoxic
chemotherapy drugs are covered under this section. It should be noted that
used personal protective equipment should be considered trace chemotherapy
waste and the collected urine, feces and vomit should be considered bulk
chemotherapy waste and handled under strict Department of Transportation
regulations as well as OSHA guidelines.

12.   Dispensing final dosage forms. This section would not apply to
unassimilated hazardous drugs.

13.   Compounding. This section would not apply to Unassimilated hazardous
drugs.

14.   Administering. Under this section used PPE should be handled as trace
chemotherapy waste and unused IV bags should be considered bulk chemotherapy
waste and handled appropriately.

15.   Deactivating, decontaminating, cleaning and disinfecting. This section
would apply to unassimilated cytotoxic chemotherapy drugs and areas where
the patient is after infusion for 24 to 48 hours. In most cases this is the
patient's home. Contaminated clothing and linens are treated as trace
chemotherapy waste and collected urine and feces are treated as bulk
chemotherapy waste and handled under OSHA and department transportation
regulations.

16.   Spill control. Release of bodily fluids containing cytotoxic
chemotherapy drugs would be considered under this section and appropriately
all spill materials must be disposed of as a hazardous waste.

17.   Documentation and standard operating procedures. All SOP's must take
into consideration the unassimilated drugs that pass through the patient's
body. This section applies to unassimilated cytotoxic chemotherapy drugs.

18.   Medical surveillance. Healthcare workers that handle unassimilated
hazardous drugs would fall into this category and would include nurses
collecting the unassimilated drugs contained in the urine and feces of the
patient as well as home health care providers.

 

 

I would like to see a clarification by the United States pharmacopeia that
takes into consideration the 27 unassimilated hazardous drugs. I would be
happy to go over this with the Compounding Expert Committee

 

Sincerely

 

 

 

 

 

                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 

TED Talk https://youtu.be/zX6OsvzZdOw?t=4 

 

 

 

 

 

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