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![Page 1: Identifying and Managing Hazardous Pharmaceutical Waste MIRT Meeting May 15, 2002 Charlotte A. Smith, R. Ph., M.S. President 414-258-8359 csmith@ pharmecology.org.](https://reader036.fdocuments.in/reader036/viewer/2022081519/56649ceb5503460f949b61d9/html5/thumbnails/1.jpg)
Identifying and Managing Hazardous Pharmaceutical Waste
MIRT Meeting May 15, 2002
Charlotte A. Smith, R. Ph., M.S.
President
414-258-8359
csmith@ pharmecology.org
262-814-2635
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Founded Capital Returns, Inc. in 1991Pharmaceutical reverse distributorLarge quantity hazardous waste generatorApplied RCRA definitions item by itemDesignated over 400,000 itemsPioneered seminars to the regulated industrySold Capital Returns, Inc. in 1997Affiliated as Chief Regulatory Advisor
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Development of Knowledge and Systems to Minimize the Destructive Impact of Pharmaceutical Waste on the Environment
To Insure Compliance with State and Federal Regulations in a Cost Effective Manner
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Pharmaceuticals Enteringthe Waste Stream
Wastage of Raw Materials from Manufacturing Process
Wastage at the Distributor/ Pharmacy/Healthcare Facility
Wastage at the LTCF or other residential facilityExpired PharmaceuticalsWastage at the Consumer LevelMetabolites Entering Wastewater
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How is Pharmaceutical Waste Generated at the Healthcare Facility?
IV PreparationGeneral CompoundingSpills/BreakagePartially Used Vials/Syringes
If Contaminated, BiohazardousDiscontinued, Unused PreparationsUnused Repacks (Unit Dose)Discontinued Indated PharmaceuticalsPatients’ Personal MedicationsOutdated Pharmaceuticals
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Pharmaceutical Industry’s Unique Challenges
Substitution of less toxic chemicals usually not possible
Lack of application of EPA regulations to finished dosage forms
No readily retrievable source of information on specific products
Lack of knowledge of environmental regulations and the need to comply
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RCRA Risk Management & Liability
Civil and criminal liability Civil: State/USEPA enforcement Criminal: FBI, Attorney General, Grand Jury
Corporate fines: $27,500 per violation/dayPersonal liability: fines and/or
imprisonmentNo statute of limitations Managers up through CEO
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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 creditable outdates to a reverse distributor as product
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History of Pharmaceutical Reverse Distribution
1987: Prescription Drug Marketing Act made returns processing by wholesalers & manufacturer reps more difficult
Late 1980’s, early 1990’s: Several entrepreneurs entered marketplace Hospital oriented Retail oriented Manufacturer oriented
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Demographics of DEA Registered Reverse Distributors: 38 Facilities
in 20 States* Illinois 6 Florida 6 Georgia 5 Tennessee 2 Arizona 2 New Jersey 2 New York 2 North Carolina 1 Indiana 1 Iowa 1
Michigan 1 Missouri 1 Washington 1 Pennsylvania 1 Wisconsin 1 California 1 Delaware 1 Texas 1 Ohio 1 Utah 1
* 2000 DEA FOIA List of Registrants
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Process OverviewIndustry Distribution/Reverse Distribution Model
ManufacturersWholesalers, Distributors
Pharmacies, Institutions,
other indirects
Return3rd party
processors
Mfg.3rd party
processors
Incinerator
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Reverse Distribution: Current Scenarios
Decision to discard is made at the pharmacy/wholesaler By pharmacy/wholesaler personnel By a contracted company Pharmacy/wholesaler becomes the waste
generatorDecision to discard is made at the reverse
distributor Reverse Distributor becomes the waste
generator
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Benefits of Reverse Distribution as an Industry
Development of core competency in receipt, handling, shipment of returnable items
Results in millions of dollars being returned to healthcare industry
Development of core competency in management of waste pharmaceuticals, RCRA and non-hazardous
Reduces likelihood of inappropriate disposal by healthcare industry
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Case Study: Capital Returns, Inc.
20% to 30% of products received are non-returnable based on manufacturers’ policies and become waste at CRI
10% of non-returnable items are characterized as hazardous waste
2% to 3% of all returns received become hazardous waste
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The Returns Industry Association
Association of pharmaceutical reverse distributors established in May, 1998
Criteria includes a DEA registration to handle controlled substances in schedules II through V
RIA provides a unified voice for the industry,and a commitment to high quality standards and protection of the environment
Development of Guidelines for Minimum Regulatory Standards
Proposed development of Education & Certification Program
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Federal and State Regulatory Agencies Governing
Reverse Distribution
EPA FDADEA
DOT OSHA
State EnvProtection
State Board of Pharmacy
DOH,Controlled Substance
Board
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David Jenkins Executive Director
703-787-8574 [email protected]
www.returnsindustry.com
RIA Contact Information
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Which Discarded Drugs Become Hazardous Waste?P-listed chemicals
Sole active ingredientU-listed chemicals
Sole active ingredientCharacteristic of hazardous waste
Ignitability Toxicity Corrosivity Reactivity
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P-Listed Chemicals
Acutely hazardousLD50 < 50mg/kgSole active ingredientNo concentration thresholdCause entire formulation to be hazardous Weight of container/solvent included>1 kg/month (2.2 lbs) = Large Quantity
Generator
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Examples of P-Listed Pharmaceutical Waste
Arsenic P012Epinephrine P042Nicotine P075Nitroglycerin P081Physostigmine P204Physostigmine Salicylate P188Warfarin >0.3% P001
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U-Listed Waste
May be U-listed due to toxicity, ignitability, corrosivity, reactivity
Pharmaceuticals U-listed primarily due to toxicity
Sole active ingredientOver 100 kg/month (220 lbs) = Small
Quantity Generator
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Examples of U-listed Pharmaceutical Waste
Chloral Hydrate(CIV) U034
Chlorambucil U035
Cyclophosphamide
U058
Daunomycin U059
Melphalan
U150
Mitomycin C U010
Streptozotocin U206
Lindane U129
Saccharin U202
Selenium Sulfide U205
Warfarin<0.3% U248
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Chemotherapy WasteSeven chemotherapy agents are U-listedWaste protocols for “Chemo Waste”
Empty vials, syringes, IV’s Treated as infectious medical waste through
autoclaving and landfilling or low temperature incineration
If not empty, should be placed into Hazardous Waste container
“Empty” means all contents removed that can be removed through normal means
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Characteristic of Ignitability
Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F.
A Liquid having a flash point <140° F.An ignitable compressed gas (certain
aerosols)An oxidizerHazardous Waste Number: D001
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Examples of Ignitable Discarded Pharmaceuticals
Rubbing AlcoholParegoric (CIII)Cleocin T Topical SolutionRetin A GelListerine MouthwashErythromycin Topical SolutionSilver Nitrate (oxidizer) Collodion Based Preparations
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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
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Characteristic of Toxicity
Approximately 40 chemicals which meet specific leaching concentrations
Examples of potential toxic pharmaceuticals:Arsenic m-CresolBarium Mercury (thimerosal)Cadmium phenylmercuric acetate)Chloroform Selenium Chromium SilverLindane
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Evaluation of Thimerosal Toxicityper Merck Index, Twelfth Edition:
Thimerosal (C9H9HgNaO2S) mol. wt. 404.82
C 26.70%H 2.24%Hg 49.55%Na 5.68%O 7.90%S 7.92%
1:1000 Solution:Thimerosal may be used as a preservative in aconcentration of 1:1000, which means, by definition, 1gram in 1000ml of solution.Since thimerosal is 49.55% mercury (see above):1g thimerosal x 49.55% = 0.4955g mercury.
So: 1g thimerosal = 0.4955g Hg =1000ml 1000ml
495.5mg Hg = 495.5mg Hg . 1000ml 1 liter
The regulatory limit for mercury is 0.2mg . 1 liter
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Characteristic of Reactivity
Meet eight separate criteria identifying certain explosive and water reactive wastes
Nitroglycerin formulations are considered exempt as of August 14, 2001 under FR: May 16, 2001. States must still adopt.
Hazardous Waste Number: D003
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Applicable USEPA Interpretative Letters & Hotline
ResponsesEpinephrine Residue in Syringe not P042
Hotline December 1994
Discarded Nitroglycerine Pills are P081 Hotline September 1993; Modified Aug 14, 2001?
Disposal of CESQG hazardous waste Hotline August 1999
Anti-Neoplastic Agents January 30, 1986 April 25, 1988
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Washington State
State-only Dangerous Waste
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Services National and Regional Seminars to Raise
Awareness Confidential On-Site Reviews of Current
Practices, Possible Areas of Concern Implementation Assistance in Developing
Compliant Systems Web-based PharmEcology Wizard
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The PharmEcology™ WizardWeb-based database enabling search by product for waste
management recommendationsSearch by NDC, product or generic name, active ingredient
Recommendations citing federal regulations and recommended waste streams
State regulation alerts if more stringent than federal Risk Management alerts based on professional
knowledge (e.g. chemotherapy agents not regulated at the state or federal level)
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The PharmEcology WizardPrototype
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2-2576-5
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Readi-Cat
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Future Considerations
Identify which hazardous wastes as defined present a real threat at levels normally seen in pharmaceuticals
Establish a relationship between professional pharmacy organizations and USEPA, state environmental regulatory agencies
Work towards exemptions from and expansion of RCRA where appropriate
Work towards consistent standards of enforcement
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Resources
www. ourstolenfuture.org www. lindane.org/world/environment/water www. h2e-online.org “Safely Managing Hazardous Materials and Hazardous
Waste,” ASHP Clinical Midyear, 2001, Handouts on CD-Rom
RCRA On-Line www.epa.gov/rcraonline RCRA Hot Line 1-800-424-9346 Improper Discard of Toxic Drugs Hurts Environment,
Leads to Fines, AJHP, Vol 58, #17 September 1, 2001 pp 1576-1578.
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Resources
www. pharmecology.org Go to link to article “Bad Medicine” January 2001
Your Risks in Handling Outdated and Unusable Drugs: A Guide to JCAHO and Regulatory Standards. Capital Returns, Inc., 1998 Call 1-800-950-5479
A Guide on Hazardous Waste Management for Florida’s Pharmacies, www. floridacenter.org.
Guidelines for Reverse Distributors: Minimum Federal Regulatory Standards, www.returnsindustry.com
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Appendix
Endocrine Disruptors:
Emerging Contaminants
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Cause for Concern?
Endocrine Disruptors: chemicals that interfere with the normal function of the endocrine system
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 newbornEstradiols, testosterone, progesteroneLindane
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USGS Water Quality Study*First nationwide reconnaissance of occurrence of
pharmaceuticals, hormones, other organic wastewater contaminants
139 streams in 30 states, analyzed for 95 different OWCs
82 of the 95 detected in at least one sampleOne or more OWCs found in 80% of stream
samples13% of sites had more than 20 OWCs*http://toxics.usgs.gov/pubs/OFR-02-94/index.html
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Location of 139 Stream Sampling Sites: USGS, 1999 - 2000
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Drug Residues In Ambient Water: Initial Surveillance in New Mexico*
NM Environment DepartmentScientific Laboratory DivisionDrug detection limits into low ppt (10 ng/L)Test included Darvon, Dilantin, Prozac other
antidepressants, prednisone, estrogens, caffeine, tamoxifen
8 sites positive, 16 negativeNext study will include antibiotics, lipid-regulators,
and cardiovascular pharmaceuticals* http://www.nmenv.state.nm.us/gwb/drugs.html
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New Mexico Drug Residue Sampling
Red = Positive
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California has tested for lindane, reported contamination levels, banned
use on humans for lice and scabies*
*www.lindane.org/world/environment/ water/national.htm
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Our Stolen Future:How Endocrine Disruptors May
Be Threatening Our Lives and Survival
Seven years synthesizing research on endocrine-disrupting chemicals
Extensive databaseEstrogen mimics, blockage of
testosterone, disruption of thyroid hormones
www.ourstolenfuture .org
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Generations at Risk: Reproductive Health and the
EnvironmentTed Schettler, MD. Gina Solomon, MD,
Maria Valenti, Annette HuddleReproductive Physiology and
ToxicologyReproductive and Developmental Effects
of Selected Substances and Human Exposure
A Guide to Investigating Environmental Threats
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Low sperm counts InfertilityGenital deformitiesHormonally triggered human cancersNeurological disorders in children
Hyperactivity Attention deficit
Developmental & reproductive problems in wildlife
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Early Warnings
Copenhagen, Denmark: 1992 Review of 61studies by Niels Skakkeback,
University of Copenhagen Average human male sperm counts dropped by
almost 50% between 1939 and 1990 Incidence of testicular cancer jumped Undescended testicles and shortened urinary
tracts rising among young boys
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Early Warnings DES (Diethylstilbestrol)
Used in the 1950’s - early 1970’s to prevent miscarriages - potent estrogenic
Resulted in daughters of mothers given DES developing clear-cell cancer of the vagina, other reproductive effects
Sons not studied well, but indications of reproductive abnormalities, testicular cancer
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Early Warnings
Steady 1% a year increase in breast cancer
rates since WWIIExposure during prenatal period critical51 synthetic chemicals now identified as
hormone disruptors; at least half are persistant and resist natural decomposition
Mother’s breast milk is contaminated
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Identification of Endocrine Related Pharmaceuticals
EstrogensProgesteronesTestosteronesCorticosteroidsGlucosteroidsThyroid
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Identification of Pharmaceuticals as Endocrine Disruptors*
Chloroform: ReproductiveKetoconazole: Reproductive
Nizoral®Lindane: Estrogen/AndrogenMalathion: Thyroid
Ovide®Permethrin: Androgen mimic
Elimite®, Acticin®, Nix®*http://www.ourstolenfuture.org/Basics/chemlist.htm* Generations at Risk: Reproductive Health and the
Environment
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Identification of Pharmaceuticals as Endocrine Disruptors*
Nonylphenol: EstrogenResorcinol: ThyroidArsenic: Glucocortocoid
Trisenox®, Atrivex®
Mercury: Reproductive/Thyroid Thimerosal, Mersol®, Aeroaid®
*http://www.ourstolenfuture.org/Basics/chemlist.htm
Generations at Risk: Reproductive Health and the Environment
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