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Volume 13, Issue 4 Winter 2011 Wasting Narcotics: Just What is Allowed and Recommended by DEA and WA Ecology? 1 Managing Patient Urine/ Chemotherapy Drug Waste 2 Hospitalwastemgmt.com Has a New Look! 3 Storing Flammable Materials 3 Most Common Ecology Inspec- tion Citation? Labeling! 4 Inside this issue: Hospital Waste Our firm… H ospital Waste Man- agement is committed to assisting healthcare facilities in complying with hazardous material management and waste disposal regulations and better managing their wastes. Our clients are hospitals, clinics, and medical labs. Our services include con- ducting dangerous, solid, radio- active, and regulated medical waste audits; risk assessment; hazmat audits; developing waste management plans for Joint Commission compliance; haz- mat emergency response train- ing; and annual dangerous waste and Pollution Prevention reporting. Our e-mail address is: Al- [email protected]. For past Hospital Waste issues, check our website at http:// www.hospitalwastemgmt.com. “Helping Hospitals Manage Waste” Wasting Narcotics: Just What is Al- lowed and Recommended by DEA and Washington Ecology? Hospital Waste Management P harmaceutical waste management has been an evolving field in Washington over the past nearly 10 years. Most generators of pharmaceutical waste know that Washington’s Department of Ecology (Ecology) has taken enormous interest in the management of this waste stream and promulgated several policies and rules for hospitals as a result. The management of unwanted con- trolled substances, however, is still very much the responsibility of the U.S. Drug Enforcement Agency (DEA). When Ecol- ogy developed its recent Interim Enforce- ment Policy: Pharmaceutical Waste in Health Care, the DEA declined to engage in the policy development process. As a result, what DEA rec- ommends for the dis- posal and management of controlled substanc- es doesn’t concur with the intent of Ecology’s policy. Ecology regards nearly all pharmaceuti- cal waste as dangerous waste and would like to see it all incinerated. When phar- maceutical waste is disposed of in the sewer, compounds often are not decom- posed during wastewater treatment and end up in our surface waters, including streams, rivers, ponds and Puget Sound. Many pharmaceutical compounds can cause mutagenesis, influence fauna sex ratios and mimic hormones when present in chronic, sub-therapeutic concentrations. DEA is concerned with the potential for diversion and abuse of unwanted con- trolled substances by people and does not allow this waste stream to be accumulated and stored onsite unless it is under lock- and-key. DEA recommends that unwanted con- trolled substances be wasted down the san- itary sewer or, if security provisions can be implemented, it can be accumulated and hauled away by a reverse distributor for destruction or credit. How should your facility manage con- trolled substance waste? The truth is that the DEA has much more power in this matter than Ecology. Although Ecology is not pleased with the practice of wast- ing unwanted controlled substances into the sani- tary sewer, they accept this as a reasonable policy for healthcare providers at the moment. Ecology would like to see more hospitals securing unwanted con- trolled substances for destruction by their reverse distributors. Someday DEA and Ecology will, hopefully, work together and concur on a policy that will both deter diversion and abuse but also keep this pharmaceutical waste stream out of our environment. But not now. Wasting unwanted controlled substances down the sewer is still an appropriate policy for now, until the DEA and Ecolo- gy can one day agree upon a better policy.

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Page 1: Hospital Waste Management Wasting Narcotics: Just · PDF fileHospital Waste Management 17629 N.E. 138th Street Redmond, WA 98052-1226 Hospital Waste is published quarterly for hospital,

Volume 13, Issue 4 Winter 2011

Wasting Narcotics: Just What is Allowed and Recommended by DEA and WA Ecology?

1

Managing Patient Urine/Chemotherapy Drug Waste

2

Hospitalwastemgmt.com Has a New Look!

3

Storing Flammable Materials 3

Most Common Ecology Inspec-tion Citation? Labeling!

4

Inside this issue:

Hospital Waste

Our firm…

H ospital Waste Man-agement is committed

to assisting healthcare facilities in complying with hazardous material management and waste disposal regulations and better managing their wastes. Our clients are hospitals, clinics, and medical labs.

Our services include con-ducting dangerous, solid, radio-active, and regulated medical waste audits; risk assessment; hazmat audits; developing waste management plans for Joint Commission compliance; haz-mat emergency response train-ing; and annual dangerous waste and Pollution Prevention reporting.

Our e-mail address is: [email protected]. For past Hospital Waste issues, check our website at http://www.hospitalwastemgmt.com.

“Helping Hospitals Manage Waste”

Wasting Narcotics: Just What is Al-lowed and Recommended by DEA

and Washington Ecology?

Hospital Waste Management

P harmaceutical waste management has been an evolving field in

Washington over the past nearly 10 years. Most generators of pharmaceutical waste know that Washington’s Department of Ecology (Ecology) has taken enormous interest in the management of this waste stream and promulgated several policies and rules for hospitals as a result.

The management of unwanted con-trolled substances, however, is still very much the responsibility of the U.S. Drug Enforcement Agency (DEA). When Ecol-ogy developed its recent Interim Enforce-ment Policy: Pharmaceutical Waste in Health Care, the DEA declined to engage in the policy development process. As a result, what DEA rec-ommends for the dis-posal and management of controlled substanc-es doesn’t concur with the intent of Ecology’s policy.

Ecology regards nearly all pharmaceuti-cal waste as dangerous waste and would like to see it all incinerated. When phar-maceutical waste is disposed of in the sewer, compounds often are not decom-posed during wastewater treatment and end up in our surface waters, including streams, rivers, ponds and Puget Sound. Many pharmaceutical compounds can cause mutagenesis, influence fauna sex

ratios and mimic hormones when present in chronic, sub-therapeutic concentrations.

DEA is concerned with the potential for diversion and abuse of unwanted con-trolled substances by people and does not allow this waste stream to be accumulated and stored onsite unless it is under lock-and-key.

DEA recommends that unwanted con-trolled substances be wasted down the san-itary sewer or, if security provisions can be implemented, it can be accumulated and hauled away by a reverse distributor for destruction or credit.

How should your facility manage con-trolled substance waste?

The truth is that the DEA has much more power in this matter than Ecology. Although Ecology is not pleased with the practice of wast-ing unwanted controlled substances into the sani-tary sewer, they accept this as a reasonable policy for healthcare providers at

the moment. Ecology would like to see more hospitals securing unwanted con-trolled substances for destruction by their reverse distributors.

Someday DEA and Ecology will, hopefully, work together and concur on a policy that will both deter diversion and abuse but also keep this pharmaceutical waste stream out of our environment. But not now.

Wasting unwanted controlled substances down the sewer is still an appropriate policy for now, until the DEA and Ecolo-gy can one day agree upon a better policy.

Page 2: Hospital Waste Management Wasting Narcotics: Just · PDF fileHospital Waste Management 17629 N.E. 138th Street Redmond, WA 98052-1226 Hospital Waste is published quarterly for hospital,

Hospital

Waste

“Helping Hospitals Manage Waste”

Publisher: Alan B. Jones, Ph.D.

Hospital Waste Management 17629 N.E. 138th Street

Redmond, WA 98052-1226

Hospital Waste is published quarterly for hospital, clinical, and medi-cal laboratory waste managers.

Hospital Waste Management is committed to serving the Healthcare Industry by assisting hospitals in manag-ing their waste. Hospital Waste aims to broadcast information about waste regulations and waste manage-ment initiatives and to provide helpful hints and general waste information to healthcare waste managers.

If this newsletter has reached you in error, please notify the Editor by phone, fax, or e-mail. If you wish to be placed on our quarterly mailing list, please con-tact the Editor. For past issues and an index of articles, check our website at http://www.hospitalwastemgmt.com.

This newsletter is copyrighted by Alan B. Jones. Reprints are en coura ged wi th acknowledgement to Alan B. Jones, Ph.D. Please send any letters or comments to:

Alan B. Jones, Editor Hospital Waste

17629 N.E. 138th Street Redmond, WA 98052-1226

Ph: (425) 883-0405 Fax: (425) 895-0067

E-mail: [email protected] http://www.hospitalwastemgmt.com

Our Editorial Policy While every effort was made during the development of this newsletter to insure accuracy, we make no warranties or cer-tifications. We encourage you to contact the references listed in the articles or Alan B. Jones for further information about any topic mentioned in this news-letter.

PAGE 2 HOSPITAL WASTE VOLUME 13 , ISSUE 4

F ollowing bladder cancer sur-gery an OR team may instill a

patient’s bladder with chemotherapy drug for a short period of time (30 minutes). The mix is then voided by the patient or drawn off into a Foley bag. How should the mix of urine and chemotherapy drug be managed? What PPE and other precautions should be taken for staff protection?

Common sense tells us that the mix is definitely toxic because the chemo drug has not been metabolized. The University of Washington Medical Center has determined that the con-centration of chemotherapy drug mixed with the patient’s urine is be-low the toxicity threshold for danger-ous waste. A common cocktail is M-VAC, a combination of methotrexate, vinblastine, doxorubicin & cisplatin.

Does the domestic sewage exclu-sion (DSE) rule apply in this case, causing it to designate as just sewage and not dangerous waste? And what role does the potential exposure of hazardous materials to staff and PPE play in a bladder installation proce-dure?

Although Washington’s Depart-ment of Ecology (Ecology) has not issued a formal rule, technical infor-mation memorandum, or policy on this waste stream, a careful reading of the Domestic Sewage Exclusion rule can assist you in designating this waste.

Ecology’s DSE rule1 derives direct-ly from the federal rule. It’s defined as “Any mixture of domestic sewage and other wastes that passes through a sewer system to a publicly owned treatment works (POTW) for treat-ment … This exclusion does not ap-ply to the generation, treatment, stor-age, recycling, or other management of dangerous wastes prior to discharge into the sanitary sewage system.”

If the patient is able to excrete the urine/chemotherapy drug mix directly into a toilet or is discharged after sur-

gery and voids the mix at home, the ex-clusion rule definitely applies—i.e., the mix designates as sewage. The drug has also been used for its intended purpose.

If the patient voids the urine/chemo mix into a bedpan, this uncontained waste would pose a potential for staff hazmat exposure if an effort is made to capture the waste. It’s best to flush this waste into the sewer and treat the waste as if the patient had voided into a hard-plumbed toilet.

But if the urine/chemotherapy drug mix is drawn off into a Foley bag by a nurse without entering the sewage sys-tem, then the DSE does not apply. The urine/chemotherapy drug mix should be captured and managed as dangerous waste or biohazardous/trace chemo waste unless you can verify that (1) the toxicity is below the threshold for desig-nation or (2) the drug is the M-VAC cocktail that the UWMC has determined is below the designation threshold. The Foley bag is a containment system that will largely prevent hazmat exposure to staff and allow the waste to be safely hauled offsite for incineration.

This same issue is becoming more common for procedures infusing chem-otherapy drug in pleural and peritoneal cavities following surgery.

The likelihood is perhaps greater that a hospital would be cited for not pro-tecting its staff from hazardous material exposure than improper management of the waste, however.

Labor & Industries is currently devel-oping a rule on hazardous drugs (WAC 296-62-500, Part R Hazardous Drugs) that is expected to be issued January 1, 2012. The new rule, if enacted as cur-rently written, will require the following during a bladder installation:

1. Two pairs of gloves, the outer pair being chemotherapy gloves ex-tending over the cuff of the gown;

2. Gowns of polyethylene-coated polypropylene with a closed front,

(Continued on page 3, Managing Urine/Chemo)

Managing Patient Urine/Chemo Waste

Page 3: Hospital Waste Management Wasting Narcotics: Just · PDF fileHospital Waste Management 17629 N.E. 138th Street Redmond, WA 98052-1226 Hospital Waste is published quarterly for hospital,

PAGE 3 HOSPITAL WASTE VOLUME 13 , ISSUE 4

long sleeves, and elastic or knit cuffs; and

3. A full face shield. Under the proposed rule, gloves must

be changed every 30 minutes and gowns every 2 to 3 hours or when damaged.

Staff working with hazardous drugs must also receive training and annual medical monitoring commensurate with their potential exposure to the drugs. The rule will apply to all staff handling hazardous drugs, from receiving to healthcare providers and environmental services staff.

A healthcare safety expert has esti-mated the cost under the new L&I rule to provide medical monitoring for those who will have the most severe potential for exposure to hazardous drugs as $600 per staff annually, although it’s not en-tirely clear what chemicals or effects must be monitored.

1 WAC 173-303-071(3)(a)(ii) Domestic sew-age

(Continued from page 2: Managing Urine/Chemo)

O ne of the most common questions I’m asked as a

hazmat consultant is either “How do I store flammable materials?” or “How much flammable material can I store?”

The questions do not have simple answers. The nearly universal refer-ence authority for these questions is the International Fire Code (IFC)—although a notable exception is Seat-tle, which has its own fire code. Other than Seattle, all municipalities in Washington refer to the IFC.

IFC 3404.3.2—Liquid Storage Cabinets, covers the details of suita-ble storage cabinets for these materi-als. Generally, flammable liquid storage cabinets can be either metal (18 g. and double-walled) or wood (at least 1” exterior grade plywood), labeled (FLAMMABLE—KEEP FIRE AWAY), doors must be self-closing, the bottom shall be liquid-tight to a height of 2”, and the com-bined total quantity of liquids shall not exceed 120 gallons. There are additional design constraints noted in the IFC.

The allowable storage volumes of flammable liquids depends upon the flash point of the materials: the low-er the flash point, the less material can be stored within a given fire control area. Materials are classi-fied by their flash points (f.p.) and their boiling points (b.p.):

• Class IA—f.p. < 73° and b.p. < 100°

• Class IB—f.p. < 73° and b.p. > 100°

• Class IC—73° < f.p. > 100° • Class II—100° < f.p. > 140° • Class IIIA—140° < f.p. > 200° • Class IIIB—f.p. > 200°

Fire control areas are defined by separation with a 1-hour fire wall.

Hospitals are generally Group I Occupancy facilities (where people are physically unable to leave with-

out assistance) and allowable vol-umes of flammable liquids are not-ed in the IFC in Table 2703.1.1(1): Maximum Allowable Quantity Per Control Area of Hazardous Materi-als Posing a Physical Hazard.

Allowable storage volumes for different classes of flammable Class IA, IB and IC) and combustible (Classes II and III) liquids in a sin-gle fire control area in an appropri-ate storage cabinet for a Group I Occupancy facility are:

• Class IA—30 gallons • Class IB & IC—120 gallons • Class II—120 gallons • Class III—330 gallons

Additional storage regulations apply to explosives, gases, solids, oxidizers, pyrophorics and water reactive materials.

If you are responsible for the storage of hazardous materials of any kind at your hospital you should have an electronic copy of the IFC and become familiar with it. There are many conditions and possibly applicable regulations for your particular flammable storage situation which cannot be listed here.

The latest version of the IFC is 2009. The IFC is copyrighted and can be purchased either online or on a CD for $70 to $85 depending up-on the format. The IFC can be pur-chased from a number of different vendors on the internet.

Small containers of flammable liquids that are in regular use by staff can be left on countertops and desks if they are properly labeled. These include Instant Hand Sanitiz-er, rubbing alcohol, Tincture of Benzoin, spray drape adhesive, lub-ricants like Teflon spray, and other aerosol containers.

HospitalWasteMgmt.Com Has a New Look!

O ur website, http://www.hospital wastemgmt.com, has a brand

new look. It’s still a bit rough around the edges and is definitely under con-struction, but you can search articles on healthcare waste and hazardous material management and download newsletter issues now much more easily than under the old site architecture.

If you need information on managing a healthcare waste stream or hazardous material or a regulation, try looking at our website. There’s a searchable index of 275 articles on our website. You can easily download one or more .pdf copies of newsletters with the articles you need. Most newsletter issues are just a few hundred kilobytes and download quick-ly.

Of course, if you need to know what services we offer, that’s on the website, also!

Storing Flammable Materials

Page 4: Hospital Waste Management Wasting Narcotics: Just · PDF fileHospital Waste Management 17629 N.E. 138th Street Redmond, WA 98052-1226 Hospital Waste is published quarterly for hospital,

Alan B. Jones, Ph.D. Hospital Waste Management 17629 N.E. 138th Street Redmond, WA 98052-1226

Phone: 425-883-0405 Fax: 425-895-0067 E-mail: [email protected] http://www.hospitalwastemgmt.com

“Helping Hospitals Manage Waste”

TO:

Hospital Waste

be secured from public access and the door labeled (visible from 25 ft.) with: “Danger—Unauthorized Personnel Keep Out” and an NFPA diamond label (a generally acceptable healthcare NFPA dan-gerous waste storage area label would be Red Diamond=4, Blue Diamond=3, Yellow Diamond=0 and White Diamond=blank);

• Containers of spent fluorescent lamps must be labeled with “Universal Waste—Fluorescent Lamps”;

• Containers of spent dry cell batteries must be labeled with “Universal Waste—Dry Cell Batteries”;

• All containers of dangerous waste in satellite accumulation areas must be labeled with “Chemical Hazardous Waste” and the type of waste in the container (e.g., methanol, xylene). This in-cludes chemotherapy drug waste containers;

• Containers of the Special Waste (solid, corrosive dangerous waste) generated by anesthesiologists during surgery including SodaSorb, Baralyme, and Carbolime; and

• Empty containers that once contained dangerous waste cannot continue to bear a label (i.e., it must be removed or destroyed).

Inspect your facility regularly for proper container and door la-bels.

Most Common Ecology Inspection Citation? Labeling!

A necdotal evidence from the most recent Washing-ton State Healthcare Safety Council seminar sug-

gests that the most common Ecology inspection citation at hospitals is the lack of appropriate labels. Several hospital safety officers commented on their experiences with Ecol-ogy inspectors who have visited their facilities recently.

Ecology inspects hospitals for compliance with the Dangerous Waste Regulations (WAC 173-303), amongst other, generally minor, issues. These citations may or may not be accompanied by fines. The overwhelming majority of the citations these hospitals received dealt with improp-er or missing labels for dangerous waste.

Where are labels required in a hospital according to the Dangerous Waste Regulations?

• Containers of dangerous waste must be labeled with the date, the name of the contents, the hazard (e.g., flam-mable, toxic) and the words “Chemical Hazardous Waste” when they enter your primary dangerous waste accumula-tion area;

• The primary dangerous waste accumulation area must