Pharmaceutical Waste June 2010 Wendi Shafir Environmental Protection Agency Region 9 415-972-3422...

Pharmaceutical WasteJune 2010

Wendi ShafirEnvironmental Protection Agency Region 9

[email protected]

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Key Issues to Cover Today

Pharmaceuticals in the EnvironmentUS Geological Survey StudyHow do they get there ?Health /Environmental Impacts

Current Requirements for Managing PharmsWhat is pharmaceutical waste?RegulationsIdentificationManagement

Resources

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Pharmaceuticals in the News

Medical facilities making uncontrolled releases of controlled drugs into waterBy JEFF DONN | AP National Writer 12:36 PM EDT, September 14, 2008

MINNEAPOLIS (AP) _ In a frustrating quirk in government policy, the most tightly controlled drugs — like painkilling narcotics prone to abuse — are the ones that most often elude environmental regulation when they become waste.

Drugs in WaterIn surface and ground sources of drinking

water

Endocrine disruptors found in waterways receiving wastewaterDetrimental effects on aquatic speciesMay have an impact on human health

Antibotic resistance

Water quality degradation

Nationwide survey

139 streams in 30 states, analyzed for 95 compounds

86% of compounds in at least one stream sampleWidespread: One or more found in 80% of stream samples

13% of streams had more than 20 compounds

* http://toxics.usgs.gov/pubs/OFR-02-94/index.html

How do they get into the water?Sewers

ExcretionFlushing unwanted medicines“Wasting” meds into sinks

Landfills – thrown in trashLeachate goes to wastewater plants, released to rivers, ocean

Animal waste flows into waterways

Industrial discharge

http://www.google.com/imgres?imgurl=http://www.animalaid.org.uk/images/manure.png&imgrefurl=http://www.animalaid.org.uk/h/n/NEWS/news_veggie/ALL/1597//&usg=__65l_QVrUqX9a1tRH4vLhj087Kkg=&h=200&w=200&sz=13&hl=en&start=8&um=1&itbs=1&tbnid=ScaRe1jzVDnVdM:&tbnh=104&tbnw=104&prev=/images?q=cow+manure&um=1&hl=en&client=firefox-a&rls=org.mozilla:en-US:official&tbs=isch:1

So, what’s the problem?

Endocrine Disruptors – act at very low dose

Antibiotic Resistance

Toxicity

Environmental Degradation

Lack of confidence in water supply

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Sources of Endocrine Disrupting Chemicals (EDCs)

Industrial chemicals

Personal care products

Pesticides,

herbicides, fungicides

PharmaceuticalsSynthetic

and natural hormonesEndocrine

Disrupting

Chemicals

Endocrine System

What are Endocrine Disruptors ?Any chemical –- that disrupts (or mimics) the normal

balance of hormones, with particular focus on estrogen

Interfere with normal function of the endocrine system (thyroid, adrenals, ovaries, testes)

Affect reproduction, development, and behavior

Active at VERY low dose

Multi-generational effects

Antibiotic Resistance

1999: Ampicillin-resistant bacteria found in every U.S. river tested

Samples containing the highest levels of antibiotics also contained bacteria with greatest resistance

DNA that helps make germs resistant to medicines increasingly appearing as a pollutant in the water, even treated drinking water

Decreases effectiveness of antibiotics

What is Pharmaceutical Waste?

What is Pharmaceutical Waste?

May include, but is not limited to:

expired drugs;

patients’ personal medications;

waste materials containing excess drugs ( IV bags, tubing, vials, etc.)

drugs that can no longer be used;

containers that held drugs;

drugs that are intended to be discarded; and

contaminated garments, absorbents and spill cleanup material.

How is it regulated ?Resource Conservation & Recovery Act- RCRA, mostly

Enforced by EPA, state and local agenciesFederal regulation - hazardous waste disposalEncourages minimization of waste generation

Defines “hazardous waste”

“Cradle to Grave” tracking of hazardous waste

Households are exempt

Not all pharms are hazardous waste

Understanding the Regulations

Defining Hazardous Wastes:

Listed (F, K, P and U)- lists of actual wastes – includes some meds

Characteristic Waste: exhibit these characteristics

IgnitabilityCorrosivityReactivityToxicity

Also Radioactives – other reguations

P-Listed Pharmaceutical Waste

Copyright © 2004 by PharmEcology Associates, LLC. Additional information available at: www.pharmecology.com

P-Listed Pharmaceutical Waste

Arsenic trioxide P012Epinephrine P042Nicotine P075Nitroglycerin* P081Phentermine (CIV) P046Physostigmine P204Physostigmine Salicylate P188Warfarin >0.3% P001


*Nitroglycerin in finished dosage forms excluded federally and in many states for reactivity; must evaluate for ignitability

Common U-Listed Pharmaceuticals:

Chloral Hydrate (CIV) U034 Chlorambucil (chemo) U035 Chloroform U044 Cyclophosphamide (chemo)

U058 Daunomycin (chemo) U059 Dichlorodifluromethane U075 Diethylstilbestrol(chemo) U089 Formaldehyde U122 Hexachlorophene U132 Lindane U129 Melphalan (chemo)U150 Mercury U151

Mitomycin C (chemo) U010 Paraldehyde (CIV) U182 Phenacetin U187 Phenol U188 Reserpine U200 Resorcinol U201 Saccharin U202 Selenium sulfide U205 Streptozotocin (chemo) U206 Trichloromonofluromethane

U121 Uracil mustard (chemo) U237 Warfarin <0.3% U248

U-Listed Pharmaceutical Waste


Characteristic of Ignitability

Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F.

Hazardous Waste Number: D001

Rubbing Alcohol Topical Preparation Injections


Characteristic of Corrosivity

An aqueous solution having a pH < or = 2 or > or = to 12.5

Examples: Primarily compounding chemicalsGlacial Acetic AcidSodium Hydroxide

Hazardous waste number: D002


Characteristic of Toxicity

Approximately 40 chemicals which meet specific leaching concentrations

Examples of potential toxic pharmaceuticals:ArsenicBarium CadmiumChloroformChromiumLindane


m-CresolMercury

(thimerosal)Selenium Silver

Preservatives: thimerosal & m-cresol

Heavy Metals: Selenium, Chromium and Silver

Examples of Pharmaceuticals Exhibiting the Characteristic of

Toxicity

Characteristic of Reactivity

Meet eight separate criteria identifying certain explosive and water reactive wastes

Nitroglycerin formulations are exempted federally as of August 14, 2001 under FR: May 16, 2001. Many states have adopted exemption. Must still be evaluated for ignitability.

Hazardous Waste Number: D003


Pharm Waste in California

Proper pharmaceutical waste management is a highly complex new frontier in healthcare

Hospital pharmacies typically stock between 2,000 and 4,000 different items

Very difficult to correctly identify and manage waste

California Only pharmaceuticals handled under MWMA

What can we do?

Pollution Prevention Control at source Can implement & reduce

loading in near term

Product stewardship

Overview of Pharmaceutical Disposal: Hospitals

Radioactives special handling

RCRA hazardous waste must be hauled off as hazardous waste

California Only pharmaceuticals handled under MWMA

Solid Waste – not hazardous as defined by regs some flexibility May be best to dispose of as hazardous waste

RCRA Risk Management & Liability

Civil and criminal liabilityCivil: State/USEPA enforcementCriminal: FBI, Attorney General, Grand Jury

Corporate fines: $32,500 per violation/day Personal liability: fines and/or imprisonmentNo statute of limitations Managers up through CEO


Minimizing Pharm Waste -examples

Minimize inventory

Rotate inventory - use oldest stock first

Centralized disposal of physician’s

samples

Prevent free samples- use voucher option

Avoid unnecessary prescriptions,

especially antibiotics-Note pharmacy has

very little control

Use pharmacy reverse distribution

Managing Pharm Waste

Sewering

Hazardous

Chemo

Radioactive

MUST Develop Comprehensive System

Managing Pharmaceutical Waste

A 10-Step Blueprint for Healthcare FacilitiesRevised August, 2008

Good reference – to develop plan

California version available

Green TeamPharmacyEnvironmentalNursingAdministrationSafetyEducationPurchasingRisk Management

Recommended Disposal Strategy

Everything Else

RCRA Hazardous

Waste

RCRA Hazardous

Sewer

IV bags with salts/nutrients

Medical Waste

What Pharms Can Be Sewered?Up to individual POTWs – sewer authority

Generally okay to sewer solutions in IV bags containing only:saline solutionlactate (i.e, Ringer’s)nutrients such as glucose (I.e., D5W)vitaminspotassiumother salts and electrolytes

Chemotherapy Waste – Special Handling

Nine chemotherapy agents listed hazardous waste

Medical waste hauler protocols for “Chemo Waste”Empty vials, syringes, IV’sTreated as infectious medical waste preferably through regulated

medical waste incineration

If not empty, place into Haz Waste container

“Empty” for U-listed waste means all contents removed that can be removed through normal means and no more than 3% by weight remains3 ml allowance in common practice is a misunderstanding of the

definition of “RCRA empty”


Chemotherapy Agents: Many Not Regulated as Hazardous waste

Over 100 chemotherapy agents not regulated by EPAExamples:

Alkylating agents: Cisplatin, ThiotepaAntimetabolites: Fluorouracil, MethotrexateHormonal (antiandrogen): Lupron® (leuprolide)Hormonal (antiestrogen): TamoxifenMitotic Inhibitor: Taxol® (paclitaxol)


Trace Chemotherapeutic Waste“RCRA empty” but have held any chemotherapy or been

potentially exposed to chemotherapyavoid autoclaving or microwaving of items which may be

contaminated at molecular level w/ chemotherapyRequires incineration at an RMW incinerator; may be

infectious such as used needlesIV tubes primed and flushed with saline before being removed

from patient can be managed as trace chemotherapeutic waste, reducing the volume of hazardous waste generated, reducing contamination of PPE, and lessening employee exposureCopyright © 2005 by PharmEcology Associates, LLC.

Additional information available at: www.pharmecology.com

How Can a RCRA Hazardous Waste Be Identified?

Web-based databases enabling search by product for waste management recommendations

Search by NDC, product or generic name, active ingredientRecommendations citing federal regulations

and recommended waste streams State regulation alerts if more stringent than

federalRisk Management alerts based on

professional knowledge (e.g. chemotherapy agents not regulated at the state or federal level)


Where Should a RCRA Hazardous Waste Be Stored?

Hazardous Waste Storage Accumulation Site:Same locked area as

mercury, xylene, formaldehyde, lab chemicals

Maximum storage time: 90 or 180 days based on generator status


RCRA Hazardous Wastes Must Be

Properly Labeled!

How Should a RCRA Hazardous Waste Be Disposed?

Either contract with a hazardous waste broker or develop internal expertise for:Lab packingManifest preparationLand ban preparation

Contract with a federally permitted RCRA hazardous waste incineration facility (TSDF: Treatment, Storage & Disposal Facility)


What About Non-Hazardous Drugs?

Segregate into a non-red, non-yellow container, such as beige or white with blue top (California Pharmaceutical Waste)

Label “Non-hazardous Pharmaceutical Waste – Incinerate Only”

Dispose at a regulated medical waste or municipal incinerator that is permitted to accept non-hazardous pharmaceutical waste


Reverse DistributionFor pharmaceuticals – not available for most other

hazardous substances

"Reverse distribution" - expired pharms can be returned to the manufacturer for credit by pharmacies, not by consumers

Not to be used as a “waste management system.”

Exclusion applies only to bona fide returns for credit, and not to broken containers, spilled contents, compounding leftovers, unused IVs, etc.

Take Home Messages

Pharmaceuticals at detectable levels in many U.S. surface waters!

First manage for P2, then dispose of properly.

Pharmacists not always conversant in waste regulations (and may need support).

EPA Resource Conservation & Recovery Act regulations carry significant liability, comparable to Drug Enforcement Administration

What About Household Pharms?

Non-controlled substancesMay be able to take to a household

hazardous waste roundup – check with your county

or treat as below Controlled substances

Render unpalatable – pepper, turmeric, other strong spices

Remove labeling, duct tape shutMix with undesirable trash and put out with

regular trash right before pickup NO DRUGS DOWN THE DRAIN


Resources• NIOSH Hazardous Drug Alert

http://www.cdc.gov/niosh/docs/2004-165/#sum

• ASHP Guidance on Handling Hazardous Drugshttp://www.ashp.org/s_ashp/bin.asp?CID=6&DID=5420&DOC=FILE.PDF

• OSHA Technical Manualhttp://www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.html

• 2008 10-Step Blueprint for Health Care Facilities Pharmaceutical wastehttp://www.hercenter.org/hazmat/tenstepblueprint.pdf

U.S. Geological Surveyhttp://pubs.acs.org/cgi-bin/jtextd?esthag/36/6/html/es011055j.html

• Classifying Pharmaceutical Waste at California Healthcare Facilities• http://www.sfenvironment.org/downloads/library/euticaldispos

alinformation.pdf

http://www.cdc.gov/niosh/docs/2004-165/#sum

http://www.ashp.org/s_ashp/bin.asp?CID=6&DID=5420&DOC=FILE.PDF

http://www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.html

http://pubs.acs.org/cgi-bin/jtextd?esthag/36/6/html/es011055j.html

http://www.sfenvironment.org/downloads/library/euticaldisposalinformation.pdf


Resources• Classifying Pharmaceutical Waste at California Healthcare

Facilities• http://www.sfenvironment.org/downloads/library/euticaldi

sposalinformation.pdf



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