Implementing a Pharmaceutical Waste Management System Compliance and Pollution Prevention Workshop Kansas City December 6th, 2007 John Brenna, R. Ph.

Implementing a Pharmaceutical Waste Management System Compliance and Pollution Prevention Workshop Kansas City December 6th, 2007 John Brenna, R. Ph. Hospital Consultant PharmEcology Associates, LLC Copyright © 2007 by PharmEcology Associates, LLC

Copyright 2007 PharmEcology Associates, LLC
Goals To develop a better understanding of the regulatory and environmental reasons for managing pharmaceutical waste more stringently To review the definitions of a hazardous waste as they apply to waste pharmaceuticals To explore implementation models for the management of hazardous pharmaceutical waste Copyright 2007 PharmEcology Associates, LLC

Who Are the Regulators? USEPA & 10 Regions Office of Solid Waste, Hazardous Waste Division Office of Water Authorized State Hazardous Waste Programs Every state except Iowa and Alaska Local Publicly Owned Treatment Works (POTWs) Must meet federal effluent guidelines The Joint Commission Primary accrediting body for many hospitals Federal funding dependent on accreditation Any discharge to the surface waters or municipal wastewater treatment plants (“POTWs”) must comply with the more stringent of the technology-based standards (“effluent guidelines”) and local site specific effluent limitations (“local limits”). Copyright 2007 PharmEcology Associates, LLC

USGS Water Quality Study*
First nationwide reconnaissance of occurrence of pharmaceuticals, hormones, other organic wastewater contaminants – March, 2002 139 streams in 30 states, analyzed for 95 different OWCs 82 of the 95 detected in at least one sample One or more OWCs found in 80% of stream samples 13% of sites had more than 20 OWCs Minnesota Study: Found 79 out of 92; 23 were pharmaceuticals * Copyright 2007 PharmEcology Associates, LLC

Below the Dose/Response Curve: Endocrine Disruptors
Endocrine Disruptors: chemicals that interfere with the normal function of the endocrine system (glands including thyroid, adrenals, ovaries, testicles) Mimic hormone, trigger identical response, block a hormone Do not follow the normal dose/response curve Active at much lower doses, especially in the fetus and newborn Estradiols, progesterone, testosterone Lindane One of the things we need to understand is that we just don’t have the ability at POTWs to remove many of these pharmaceuticals from the waste stream. The POTW is set up to remove solid materials and to destroy bacteria, not necessarily to remove chemicals. One question people often ask, though, is ‘why do we have to worry about this when the chemicals are present in such tiny amounts in the water?’ The reason is this concept of endocrine disruptors, which are chemicals that interfere with the normal function of the endocrine glands. We are talking about the major glands of the body, such as the thyroid, the adrenals and the reproductive system. These endocrine disruptors can mimic the effects of the normal hormones, or can trigger an identical response, or block the hormones so they can’t respond as they should. The result is shown is animal tests, where we have seen an increased feminization of newborns, lower sperm counts, and increases in various types of cancer. It’s not surprising that the female hormones, estrogens and progesterone and the male testosterone would have this effect, but we also find that other drugs like Lindane which is used to kill lice, are actually estrogen mimics, so when a body sees lindane, it thinks of it as being estrogen. A good example would be a woman in her first trimester, who uses lindane to kill lice on her other children—This could certainly impact that developing fetus. I understand that lindane is actually banned in California. Copyright 2007 PharmEcology Associates, LLC

Copyright © 2007 by PharmEcology Associates, LLC
The Faroes Statement 200 environmental scientists from five continents met at the Faroes Islands in the North Atlantic –May 24, 2007 Warned of fetal exposure to toxic substances resulting in “fetal programming” to the 2nd and 3rd generation Lifelong effects: obesity, diabetes, cancers, ADHD, Parkinson’s, Alzheimer’s, reduced immune system “The dose makes the poison” replaced by “The timing makes the poison” New approach to testing of chemicals strongly advocated; 80% of major chemicals never tested for damage to early development Toxicologists, pediatricians, epidemiologists, warned that when fetuses and newborns encounter various toxic substances, growth of critical organs and functions can be skewed, making these children susceptible to diseases later in life, and could perhaps even pass those altered traits on to their own children. Many governments, including US have said there is little evidence to support concerns about most toxic residue in air, food or water sources. But these scientists are urging govts to revise regulations to take into account these subtle effects on fetal and infant development. They said that ‘given the ubiquitous exposure to many environmental toxicants, there needs to be a renewed effort to prevent harm. Such prevention should not wait for detailed evidence on individual hazards. For centuries the basic rule of toxicology is that ‘the dose makes the poison’. Now the scientists say “the timing makes the poison”– in other words, when a toxic exposure occurs is as important as how much people are exposed to. And a fetus is extraordinarily susceptible in the intrauterine environment. Organs and systems affected can include the brain, immune system, reproductive, cardiovascular. The big question is what effect these products might have on chronically exposed plants, animals and people. Christian Daughton states that because the concentrations are so small, the immediate effects might be too subtle to notice, but because the exposure is constant the long term cumulative effect could be insidious. Copyright © 2007 by PharmEcology Associates, LLC

"When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically." Wingspread Conference, Racine, WI 1998 The Precautionary Principle is not something new, similar philosophies have been around for centuries, but at the Wingspread Conference in Wisconsin in 1998, 32 scientists from around the world met to further define that. As formulated here, the principle of precautionary action has 4 parts: People have a duty to take anticipatory action to prevent harm. (As one participant at the Wingspread meeting summarized the essence of the precautionary principle, "If you have a reasonable suspicion that something bad might be going to happen, you have an obligation to try to stop it.") The burden of proof of harmlessness of a new technology, process, activity, or chemical lies with the proponents, not with the general public. Before using a new technology, process, or chemical, or starting a new activity, people have an obligation to examine "a full range of alternatives" including the alternative of doing nothing. Decisions applying the precautionary principle must be "open, informed, and democratic" and "must include affected parties." Copyright 2007 PharmEcology Associates, LLC

Preliminary 2008 Effluent Guidelines Program Plan (Pre-publication version) Published in Federal Register Oct. 18th, 2007 Major pollutants of concern in discharges include pharmaceuticals and endocrine-disrupting compounds (EDCs) Focus area: Unused pharmaceuticals Physician offices, long-term care facilities, veterinary care services, hospitals and clinics Soliciting data, information, and comments on a variety of questions relating to disposal of unused pharmaceuticals The major environmental law governing surface water discharges is the Clean Water Act (CWA). The CWA also requires EPA to “promulgate pretreatment standards for pollutants not susceptible to treatment by POTWs or that would interfere with the operation of POTWs Identification of any policies, procedures or guidelines that govern the disposal of unused pharmaceuticals from hospitals, nursing, long-term care, re-habilitation, and personal care facilities, and veterinary care facilities. Identification of the main factors that drive current disposal practices and any barriers preventing the reduction or elimination of unused pharmaceuticals to wastewater treatment plants and/or surface waters. - In particular, EPA solicits comment on the extent that the Controlled Substances Act (21 U.S.C. § 801 et. seq.) complicates the design of an efficacious solution to drug disposal EPA solicits data on how municipal wastewater treatment plants are currently controlling disposal of unused pharmaceuticals via wastewater. Quantitative information or tracking sheets for the past year on the disposal of unused pharmaceuticals via the toilet, drain, or sewer, from hospitals and long-term care facilities. Information on any best management practices (BMPs) that are available to control or eliminate the disposal of unused pharmaceuticals to wastewater treatment plants. Qualitative and quantitative data on the effectiveness and annualized costs of BMPs that health service facilities use to control or eliminate the discharge of unused pharmaceuticals from their wastewater. EPA is also interested in obtaining information on the current costs (including labor) associated with disposal of unused pharmaceuticals. Copyright 2007 PharmEcology Associates, LLC

EPA’s Clean Water Act Review of the Management of Unused Pharmaceuticals for the Health Services Industrial Sector What is the Scope of the Study? Highlight good voluntary practices on an industry that may have significant discharges of consequence to the environment Focus include unused or expired pharmaceutical discharges to municipal wastewater treatment plants from hospitals, long-term care facilities, and veterinarians What are They Studying? Current industry practices, guidance and regulatory requirements Source, and pass through or inhibition, associated with these discharges at municipal wastewater treatment plants Schedule: CY2007: Complete data collection for identifying current industry practices, existing guidance/requirements, and possible BMPs FY2008: Estimate pollutant loadings, identify possible best practices for controlling pollutant discharges and associated costs, and final report. What is the Scope of the Study? Looking to highlight good voluntary practices on an industry that may have significant discharges of consequence to the environment Focus is primarily on Mercury discharges from dentists Unused or expired pharmaceutical discharges to municipal wastewater treatment plants from hospitals, long-term care facilities, and veterinarians What are We Studying? Current industry practices, guidance and regulatory requirements Source, and pass through or inhibition, associated with these discharges at municipal wastewater treatment plants Current Efforts – Unused Pharmaceuticals Outreach to better understand the issues surrounding pharmaceutical discharges from long-term care facilities, hospitals, and veterinarians Within EPA, Other Federal Agencies, and Industry Groups Identifying current management of unused pharmaceuticals at long term care facilities, hospitals, and veterinarians Summarizing federal, local, and regional requirements, guidance, and voluntary initiatives Copyright 2007 PharmEcology Associates, LLC

Increasing USEPA Regulatory Activity
Region 1(New England) Veterans Administration Hospital, White River, Vermont, August 5th, 2005 cited and fined $372,254 for hazardous waste violations Region 2 (NY, NJ): North Shore University Hospital, Manhasset, NY fined $40,000 (July 2003) Nassau University Medical Center, East Meadow, NY fined $279,900 (Oct. 2003) Mountainside Hospital, Montclair, NJ fined $64,349 (Nov. 2003) Memorial Sloan Kettering Cancer Center, New York , NY, fined $214,420 Copyright 2007 PharmEcology Associates, LLC

Additional USEPA Regional Activity
Region 3: PA, VA, WV, DE, MD, DC Located in Philadelphia, sponsored workshops in 2006 Region 4: KY, TN, NC, SC, FL, GA, MS, AL Inspections in GA, AL, possibly additional states Region 5: OH, IN, IL, WI, MN, MI Site visits to hospitals in MN and WI Region 7: IA, MO, KS, NE Sponsored seminars in 2006 & 2007; have been inspecting hospitals in Kansas City and St. Louis Region 8: ND, SD, MT, WY, UT, CO Sponsored SD DENR workshop Region 9: AZ, NV, CA Inspecting hospitals in California Copyright 2007 PharmEcology Associates, LLC

Relationship to The Joint Commission Standards: Environment of Care
Standard EC.3.10 The organization manages its hazardous materials and waste[1] risks. [1] Hazardous materials (HAZMAT) and waste: Materials whose handling, use, and storage are guided or regulated by local, state, or federal regulation. Examples include OSHA’s Regulations for Bloodborne Pathogens (regarding the blood, other infectious materials, contaminated items which would release blood or other infectious materials, or contaminated sharps), the Nuclear Regulatory Commission's regulations for handling and disposal of radioactive waste, management of hazardous vapors (such as glutaraldehyde, ethylene oxide, and nitrous oxide), chemicals regulated by the EPA, Department of Transportation requirements, and hazardous energy sources (for example, ionizing or non-ionizing radiation, lasers, microwaves, and ultrasound.) Copyright 2007 PharmEcology Associates, LLC

OSHA Hazardous Drugs NIOSH Hazardous Drug Alert Hazardous drugs as defined by OSHA/NIOSH intersect but are not the same as EPA hazardous wastes ASHP Guidelines on Handling Hazardous Drugs Deal primarily with OSHA employee exposure issues but also refer to required or recommended hazardous pharmaceutical waste management practices The NIOSH hazardous drug alert has been published for a couple of years now. Are you acting on it’s recommendations in pharmacy and nursing? NIOSH is the research arm of OSHA and even though the alert is only recommendations, OSHA can take that and use it under its common duty clause, so it does need to be taken seriously. It talks about--- all the way from bringing drugs into the facility, through handling and all the way to proper disposal. And it identifies the items considered hazardous in a new list which it calls Appendix A. And recently the ASHP published a new guideline for hospital pharmacies called the Guidelines on Handling Hazardous Drugs, which closely follows the NIOSH Alert. The important thing about that is that over the years, ASHP guidelines have become the standard of practice in hospital pharmacy. So these are all things to keep in mind as we go through the rest of this. Copyright 2007 PharmEcology Associates, LLC

Hazardous Drugs vs. Hazardous Waste Where OSHA & EPA Meet
EPA TOXIC HAZARDOUS DRUG EXAMPLES OSHA HAZARDOUS DRUGS EPA HAZARDOUS WASTE Genotoxicity Teratogenicity - Reproductive toxicity - Carcinogenicity - Organ toxicity at low doses Examples: - Chemotherapy agents - Endocrine disruptors - Arsenic trioxide - Cyclophosphamide - Mitomycin Melphalan P&U Listed Examples: - Epinephrine base - Warfarin - Nicotine Characteristic Examples: - Formulations containing greater than or equal to 24% alcohol Formulations containing heavy metals - Strong acids & bases EPA IGNITABLE HAZARDOUS DRUG EXAMPLES - Paclitaxel - Valrubicin - Etoposide Copyright 2007 PharmEcology Associates, LLC

How is Pharmaceutical Waste Generated at the Healthcare Facility?
IV Preparation General Compounding Spills/Breakage Partially Used Vials Partially Used Syringes/IVs If Contaminated, Biohazardous Discontinued, Unused Preparations Unused Repacks (Unit Dose) Patients’ Personal Medications Outdated Pharmaceuticals Copyright 2007 PharmEcology Associates, LLC

When is an Outdated Drug a Waste?
At the time and place the decision is made to discard it Two EPA guidance letters to the industry: Merck & Co., 1981 BFI Pharmaceutical, 1991 Enables shipping of potentially usable outdates to a reverse distributor as product PROHIBITS the shipping of waste-like items, such as unused IVs, partial vials, expired repacks, samples Hospital is liable for using due diligence in selecting a vendor I want to take a minute to discuss outdated drugs and we will look at it more closely when we tour the pharmacy. The EPA put out two letters, one to Merck in 1981, and one to BFI pharmaceuticals, a reverse distributor, in In them they stated that they would consider an outdated drug to remain a product until the decision was made to discard it based on the idea that it was potentially returnable for credit. I think they also had the rather naïve idea that these drugs would be recycled but we all know that doesn't really happen. So that means you can send outdates in the original manufacturer’s packaging to your reverse distributor if you feel its potentially going to get you some returned credit. What you can’t do is send waste-like items, for which you know you can’t receive credit. Items like unused IVs, unit dose repacks, partial vials, ointment tubes and things like that. Reverse distribution was never intended to be a waste management system. Some of the reverse distributors didn’t help any one by advertising that they would take anything. That was unfortunate because they crossed the line and now it’s going to get tighter. Note the first line in this slide. It becomes waste at he time and place the decision is made to discard it. Copyright 2007 PharmEcology Associates, LLC

RCRA: The Defining Regulation
Resource Conservation & Recovery Act Enacted in 1976, enforced by the EPA Federal regulation of the disposal of solid wastes Encourages the minimization of waste generation Defines “hazardous waste” “Cradle to Grave” tracking of hazardous waste Copyright 2007 PharmEcology Associates, LLC

RCRA Risk Management & Liability
Civil and criminal liability Civil: State/USEPA enforcement Criminal: FBI, Attorney General, Grand Jury Corporate fines: $32,500/violation/day Personal liability: fines and/or imprisonment No statute of limitations Managers up through CEO liable Copyright 2007 PharmEcology Associates, LLC

Healthcare RCRA Violations
Slide courtesy of John Gorman, USEPA Region 2 Copyright 2007 PharmEcology Associates, LLC

Which Discarded Drugs Become RCRA Hazardous Waste?
P-listed chemicals Sole active ingredient; unused; and empty containers U-listed chemicals Sole active ingredient; unused Characteristic of hazardous waste Ignitability Toxicity Corrosivity Reactivity Copyright 2007 PharmEcology Associates, LLC

Examples of P-Listed Pharmaceutical Waste
Arsenic trioxide P012 Epinephrine base* P042 Nicotine P075 Nitroglycerin** (weak) P081 Phentermine (CIV) P046 Physostigmine P204 Physostigmine Salicylate P188 Warfarin >0.3% P001 *Salts excluded federally as of Oct. 16th, 2007; States may or may not accept this position ** Excluded from the P list federally and in a number of states Copyright 2007 PharmEcology Associates, LLC

Examples of P-Listed Pharmaceuticals
Copyright 2007 PharmEcology Associates, LLC

Examples of U-listed Pharmaceutical Waste
Chloral Hydrate(CIV) U034 Chlorambucil U035 Cyclophosphamide U058 Daunomycin U059 Diethylstilbestrol U089 Melphalan U150 Mitomycin C U010 Streptozotocin U206 Lindane U129 Saccharin U202 Selenium Sulfide U205 Uracil Mustard U237 Warfarin<0.3% U248 Copyright 2007 PharmEcology Associates, LLC

Characteristic of Ignitability
Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F Non-aqueous solutions with flash points <140 ° F Oxidizers Flammable aerosols Hazardous Waste Number: D001 Rubbing Alcohol Topical Preparations Injections What about other drugs? Some may be ignitable. This is more important than the toxic characteristic. For DOT, ignitability takes precedence over characteristic waste. You can dilute during normal use, but you can’t dilute if you are doing it to “treat” ignitability. Copyright 2007 PharmEcology Associates, LLC

Characteristic of Corrosivity
An aqueous solution having a pH < or = 2 or > or = to 12.5 Examples: Primarily compounding chemicals Glacial Acetic Acid Sodium Hydroxide Hazardous waste number: D002 Copyright 2007 PharmEcology Associates, LLC

Characteristic of Toxicity
40 chemicals which must be below specific leaching concentrations Must pass the Toxicity Characteristic Leaching Procedure (TCLP) Must evaluate IVs, such as TPN (total parenteral nutrition)– may come out of regulation due to dilution Examples of potential toxic pharmaceuticals: Arsenic m-Cresol Barium Mercury (thimerosal, Cadmium phenylmercuric acetate) Chromium Selenium Lindane Silver Copyright 2007 PharmEcology Associates, LLC

Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity
Heavy Metals: Selenium, Chromium and Silver Preservatives: thimerosal & m-cresol Copyright 2007 PharmEcology Associates, LLC

Characteristic of Reactivity
Meet eight separate criteria identifying certain explosive and water reactive wastes Nitroglycerin formulations may be considered excluded federally from the P081 listing as non-reactive as of August 14, 2001 under FR: May 16, 2001, unless they exhibit another characteristics, such as ignitability. Many, but not all states, have adopted the federal exclusion for nitroglycerin. Waste must still be evaluated for ignitability. Hazardous Waste Number for reactives: D003 Copyright 2007 PharmEcology Associates, LLC

Chemotherapy Agents: Many Are Not Regulated by RCRA
Eight chemotherapy agents are U-listed; one is P-listed About 100 chemotherapy agents not regulated by EPA Examples: Alkylating agents: Cisplatin, Thiotepa Antimetabolites: Fluorouracil, Methotrexate Hormonal (antiandrogen): Lupron® (leuprolide) Hormonal (antiestrogen): Tamoxifen Mitotic Inhibitor: Taxol® (paclitaxol) Copyright 2007 PharmEcology Associates, LLC

Two Types of Chemotherapy Waste
Trace Chemotherapy Waste Medical waste hauler protocols for “Chemo Waste” Empty vials, syringes, IV’s Treated as infectious medical waste preferably through regulated medical waste incineration “Bulk” Chemotherapy Waste If not empty, should be placed into Hazardous Waste container Copyright 2007 PharmEcology Associates, LLC

Definition of “Empty” “P” List Containers of “P” listed chemicals are considered hazardous waste, unless they have been rinsed three times and the rinsate discarded as hazardous waste. “U” List Containers of “U” listed chemicals are empty only when All contents removed that can be removed through normal means And no more than 3% by weight remains Example: “Empty” Cytoxan vial would be “trace” chemotherapy NOTE: the “3 mil exclusion: is a myth and a misunderstanding of the 3% by weight rule. The “3% solution exclusion” is also a myth. Make it easy. If a drug is on the NIOSH hazardous drug alert, manage it as HW For containers: If it’s Arsenic Trioxide or other P listed waste, the container is HW If it’s all other chemo drug, the container is trace chemo If not a chemo drug, the container is solid waste. Copyright 2007 PharmEcology Associates, LLC

What Is PharmE Hazardous® Waste?
Drugs which may cause harm to human health or the environment and need to be managed according to BMPs NIOSH Hazardous Drug Alert Appendix A The US Department of Health and Human Services National Toxicology Program's Report on Carcinogens (11th Edition) Drugs with LD50s at or below 50mg/kg Endocrine disruptors BMP recommendation is to segregate at least chemo agents into RCRA toxic hazardous waste containers and to dispose of other agents through incineration Copyright 2007 PharmEcology Associates, LLC

Federal Waste Generation Status
Large Quantity Generator (LQG): generates more than 1000 kg/month of hazardous waste or >1 kg/month “P” listed waste. Small Quantity Generator (SQG):Generates <1000 kg/month but >100 kg/month of hazardous waste & < or = 1 kg/month “P” listed waste. Conditionally Exempt Small Quantity Generator (CESQG) : Generates < or = 100 kg haz waste/month, < or = 1kg P listed waste/month Copyright 2007 PharmEcology Associates, LLC

Documenting Generator Status
Large quantity generator: no need to record P waste separately. Small quantity generator or CESQG: need to segregate all P-listed including empty containers and document weights per calendar month Cannot exceed 1 kg or 2.2 lbs/month for any given month Copyright 2007 PharmEcology Associates, LLC

How Should RCRA Hazardous Waste be Handled?
Need one or two new waste streams in Pharmacy, certain Patient Care Areas, Oncology Clinics RCRA Hazardous Waste: Toxic P, U, toxic Ds, (all Chemotherapy Residues, Chemo Spills) RCRA Hazardous Waste: Ignitable (D001) May be able to combine these into one waste stream based on state and waste vendor requirements Copyright 2007 PharmEcology Associates, LLC

New Hazardous Waste Containers Traditional Chemo Waste Containers
Bulk chemo in vials, unused IV’s, P, U. toxic D Empty vials, syringes, IVs, tubing, gowns, gloves,etc. Covidien/Kendall Copyright 2007 PharmEcology Associates, LLC

How Should RCRA Hazardous Waste Be Disposed?
Either contract with a hazardous waste broker or develop internal expertise for: Labeling Waste profiling Manifest preparation Land ban preparation Contract with a federally permitted RCRA hazardous waste incineration facility (TSDF: Treatment, Storage & Disposal Facility) Copyright 2007 PharmEcology Associates, LLC

How Should Non-hazardous Drugs be Handled, Stored and Disposed?
BMPs strongly discourage sewering and landfilling of non-hazardous drugs Organization can minimize risks by adopting BMPs Possible exception: controlled substances due to difficulty in rendering non-recoverable under Drug Enforcement Administration (DEA) regulations Consider segregating into white Covidien container with blue top Label “Incinerate Only” Dispose at a regulated medical waste incinerator or municipal incinerator that is permitted to accept non-hazardous pharmaceutical waste Copyright 2007 PharmEcology Associates, LLC

A Quick Primer on Incinerators
Municipal Permitted to burn municipal “garbage” Usually not permitted to handle infectious waste May be permitted to handle non-hazardous pharmaceuticals, with certain volume restrictions Medical Waste Permitted by USEPA and the state to accept pathology waste, red bag and red sharps waste, trace chemo waste May be permitted to accept non-hazardous pharmaceutical waste Hazardous Waste Permitted by USEPA, known as a Treatment, Storage and Disposal Facility (TSDF) High temperature, molecular bonds broken Authorized to accept the “worst of the worst” hazardous chemicals, shipped on a 6-part Uniform Manifest Copyright 2007 PharmEcology Associates, LLC

Common Pharmaceutical Waste Stream Management
Type of Waste Container Color code Contents Treatment Method Red bag (non-pathology) Red Biohazardous (RMW) + Rx Autoclave/ Landfill Red sharps/ needlebox Biohazardous; needles, etc. + Rx Trace chemo Rx Yellow or White Bulk & Trace Chemo, needles, tubing RMW Incineration Sewer Unused IVs, tablets, etc. Wastewater Treatment Plant Municipal Trash Unused ointments, etc. Copyright 2007 PharmEcology Associates, LLC

Pharmaceutical Waste Management Recommendations
Type of Waste Container Color code Contents Treatment Method Red bag (non-pathology) Red Biohazardous (RMW) No Rx Autoclave/ Landfill Red sharps/ needlebox Biohazardous; needles, No Rx Trace chemo Rx Yellow or White Biohazardous & Trace Chemo RMW Incineration RCRA Toxic Hazardous Rx Black RCRA & BMP Hazardous Rx RCRA TSDF RCRA Ignitable RCRA Hazardous Rx Non-hazardous Rx White/Blue Copyright 2007 PharmEcology Associates, LLC

Satellite Accumulation
Segregated, labeled and contained in areas where it is generated Available in all units in which hazardous waste is generated & must be under the control of the operator Label each container as “Hazardous Waste” with the appropriate waste stream noted No time limit to fill the container No more than 55 gallons of U listed and characteristic waste or 1 quart of P listed waste may be accumulated Must be moved to storage accumulation within 3 days after these quantities are reached (federal regulations) Some states are stricter Copyright 2007 PharmEcology Associates, LLC

Storage Accumulation Hazardous Waste Storage Accumulation Site: Provides a safe and secure storage area for hazardous waste while it awaits shipping. Same locked area as mercury, xylene, formaldehyde, lab chemicals Maximum storage time: 90 days if LQG; 180 days if SQG Copyright 2007 PharmEcology Associates, LLC

What Departments Get Involved in Managing Pharmaceutical Waste?
Pharmacy Nursing Infection Control Environmental Services Safety Facility Management Risk Management Materials Management Copyright 2007 PharmEcology Associates, LLC

Considering the Optimal Management Options
Need to label items that need segregation in a manner that makes it easy for pharmacy and nursing personnel Shelf stickers in pharmacy Data Applied to Dispensing Software and/or Message inserted into automated dispensing machines, etc. and MAR (Medication Administration Record) and/or Stickers Applied Manually Copyright 2007 PharmEcology Associates, LLC

Getting Implementation Done: Choosing a Model
Model 1: Automated sorting device In development Model 2: Labeling electronically Model 3: Labeling manually Model 4: Central collection and sorting Model 5: Manage all as hazardous waste Copyright 2007 PharmEcology Associates, LLC

Model 2: Electronic Labeling
Entire inventory is analyzed Shelf stickers in pharmacy Data is entered into the dispensing software at the NDC or “pneumonic” level Label prints with pre-determined code HW1, RCRA1, Black Bin, etc. Nursing staff are trained on waste segregation based on codes Black “satellite accumulation” containers in soiled utility rooms Hybrid Model: North Memorial Health Care Programmed automated dispensing machines (e.g., Pyxis) Copyright 2007 PharmEcology Associates, LLC

Model 3: Manual Labeling of Hazardous Waste
Entire inventory is analyzed Shelf stickers in pharmacy Items are stickered upon dispensing Nursing staff are trained on waste segregation based on stickers Black “satellite accumulation” containers in soiled utility rooms Model program: North Memorial Health Care Copyright 2007 PharmEcology Associates, LLC

North Memorial Health Care Robbinsdale, MN
SPECIAL DISPOSAL REQUIRED Copyright 2007 PharmEcology Associates, LLC Photos courtesy of North Memorial Health Care

Model 4: Centralizing Segregation
All pharmaceutical waste is collected in hazardous waste containers in the pharmacy and in the nursing units The mixed waste is removed to the central hazardous waste storage accumulation area Sorting is done by hazardous waste vendor or trained hospital staff based on an analysis of the inventory Hazardous waste and related items are manifested and disposed as such Model: Abbott Northwestern Hospital Copyright 2007 PharmEcology Associates, LLC

Abbott Northwestern Hospital Minneapolis, MN
Copyright 2007 PharmEcology Associates, LLC

Model 5: Managing All Pharmaceutical Waste as Hazardous
Easiest, most expensive May still need to sort out ignitables Still need to do analysis of inventory to determine waste codes for manifesting Hybrid Model: UW Health, Madison, WI All tablets/capsules/solids hazardous IVs hazardous if RCRA, PharmE Hazardous® (BMP) Copyright 2007 PharmEcology Associates, LLC

Summary Managing hazardous pharmaceutical waste is an emerging and rapidly evolving management area Several implementation models are available and more may evolve Successful implementation will require an interdisciplinary team committed to moving forward The rewards include cost-effective compliance and evidence of a commitment to environmental excellence Copyright 2007 PharmEcology Associates, LLC

Resources NIOSH Hazardous Drug Alert ASHP Guidance on Handling Hazardous Drugs OSHA Technical Manual Hospitals for a Healthy Environment Pharmaceutical waste webpage: Managing Pharmaceutical Waste: A 10-Step Blueprint for Health Care Facilities In the United States: PharmEcology Associates, LLC FAQs, state and federal waste regulations, subscription search engine PharmE™ Waste Wizard identifies RCRA hazardous waste plus NIOSH hazardous drugs, among additional criteria Pharmaceuticals and Personal Care Products as Environmental Pollutants: Copyright 2007 PharmEcology Associates, LLC

Pharmaceutical Waste Management
In which waste container should you discard each of the following items? What is the appropriate waste stream designation for each? How should each item be destroyed? Copyright 2007 PharmEcology Associates, LLC

Partial vial of paclitaxel
Black hazardous waste container– ignitable RCRA Hazardous Waste Federally permitted Treatment, Storage and Disposal Facility Copyright © 2007 by PharmEcology Associates, LLC

Yellow chemotherapy container Regulated Medical Waste Incinerate only
Used chemo gown Yellow chemotherapy container Regulated Medical Waste Incinerate only Copyright © 2007 by PharmEcology Associates, LLC

Empty arsenic trioxide ampule
Black hazardous waste container – toxic RCRA Hazardous Waste Federally permitted Treatment, Storage and Disposal Facility Copyright © 2007 by PharmEcology Associates, LLC

Contents of spill kit after a hazardous spill clean-up
Black hazardous waste container – toxic RCRA Hazardous Waste Federally permitted Treatment, Storage and Disposal Facility Copyright © 2007 by PharmEcology Associates, LLC

Partial Methotrexate IV
Black hazardous waste container – toxic Best Management Practice RCRA Hazardous Waste Federally permitted Treatment, Storage and Disposal Facility Copyright © 2007 by PharmEcology Associates, LLC

Ziplock bag used to transport chemo

Needle & syringe used in IV chemo preparation

Implementing a Pharmaceutical Waste Management System Compliance and Pollution Prevention Workshop Kansas City December 6th, 2007 John Brenna, R. Ph.

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Implementing a Pharmaceutical Waste Management System Compliance and Pollution Prevention Workshop Kansas City December 6th, 2007 John Brenna, R. Ph.

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