Firouzan ‘Fred’ Massoomi, Pharm.D., FASHPPharmacy Operations Coordinator

Nebraska Methodist HospitalOmaha, Nebraska USA

Fred.Massoomi@nmhs.org

Pharmaceutical Waste Management

The Pharmaceutical-Water Paradigm§ Defined by WHO as an emerging contaminant

for drinking-water

§ Defined by US EPA as an emerging contaminant affecting human an ecological health

§ 100,000 tons of drugs consumed annually

§ 70% increase in drug consumption 1993-2003

§ Finite source of Clean water

Sources: WHO; KNAPPE; IMS 2011

§ March & September 2008ú Health facilities flush 250 million pounds of drugs a year  DEA implicated as major hurdle for proper disposal

§ March 03, 2011ú Integrity of the world water supply “From toilets to tap”ú 10% of household water comes from toilets

Source: USA Today

Large Geographical Survey

§ US Geological surveyú 1999 -2000

§ 139 streams, waterwaysú 80% contaminated

§ Primary contaminantsú Antibioticsú Anti-convulsantsú Mood stabilizersú Cholesterol lowering agentsú Analgesicsú Reproductive hormones

Environmental Effects

§ Steroid plant discharge and intersex wild gudgeonsú France

§ Ethinyl estradiol feminization of male fishú Canada, US, EU

§ New gene splicing identificationú medaka fish + jelly fish gene

§ Dicofenac vulture deathsú Pakistan, India

Source: Nature 2011

Source: New Scientist 2011

Which Pharmacy Class Did We Learn This In?

US Regulatory Bodies for RX Wastes

§ Occupational Safety and Health Agencyú Hazard Communication Standard 29 CFR part 1910–1200ú Hazardous Waste Operations and Emergency Response

Standard (29 CFR 1910.120)

Public Safety

§ Drug Enforcement Agencyú Controlled Substances Act of 1984ú NO SPECIFIC guidance on destruction only accountability

§ US Environmental Protection Agencyú 1976 Resource Conservation Act (RCRA)ú Federal & State Specific RegulationsPublic Safety

Public Safety

Public Safety

§ Local Publicly Owned Treatment Works (POTWs)ú Permission has to be granted to dump/pourú Local Regulations

Regulatory Bodies for RX Wastes

Public Safety

§ Department of Transportationú HAZWOPER from OSHAú Hazardous Waste Transportation regulationsPublic Safety

§ Food and Drug Administrationú 27 drugs with package insert disposal recommendationsú Assisted White House policy for public disposal

Examination Bodies for RX Wastes

Pending Legislation§ Drug Free Water Act of 2009ú EPA Task Force regarding proper disposal of unused drugs

§ Safe Drug Disposal Act of 2009ú Amend Controlled Substances Act to provide for the disposal of

controlled substances by ultimate users and care takers through State take-back disposal programs

ú To amend the Federal Food, Drug and Cosmetic Act to prohibit recommendations on drug labels for the disposal by flushing

§ Secure & Responsible Drug Disposal Act of 2009 – PASSEDú To amend the Controlled Substances Act to enable consumer

take-back programsú STATES MUST APPROVE FIRST!

Slide courtesy of Charlotte Smith

How did the EPA get involved?

§ Creation of EPA 1970ú Prior to loose standards on

disposal regulationsú Lack of environmental protection

§ EPA's mission is to protect human health and to safeguard the natural environment— air, water, and land—upon which life depends

Cuyahoga River, OH

Fire History1949, 1951, 1952x3,1961, 1969

What Drug Waste is Regulated?§ Solid Waste Disposal Act of 1965ú “encourage environmentally sound methods for disposal

of household, municipal, commercial, and industrial refuse”

ú 1976 Resource Conservation and Recovery Act (RCRA)

§ Clean Air Act 1991ú Regulated-out hospital based incinerators

$400mil to clean-upHooker Chemical company-dumped 20,000 tons-contaminated water and soil

What was the real cost?

US EPA Guidance to Healthcare

§ Healthcare onlyú Hospitals, long term care,

clinics

§ Estimated 12 million pounds

§ No guidance on disposal

§ Projected best practice document in 2012

Source: US EPA 2008

EPA Defined Hazardous Drugs

U010 Mitomycin C

U182 Paraldehyde

U188 Phenol

U200 Reserpine

U201 Resorcinol

U202 Saccharine

U205 Selenium

U206 Streptozocin

U237 Uracil Mustard

U248 Warfarin <0.3%

http://www.access.gpo.gov/nara/cfr/waisidx_05/40cfr261_05.html

P012 Arsenic Trioxide

P042 Epinephrine

P075 Nicotine

P081 Nitroglycerin

P204 Physostigmine

P188 Physostigmine salisylate

P046 Phentermine

P001 Warfarin >0.3%

U034 Chloral Hydrate

U035 Chlorambucil

U044 Cloroform

U058 Cyclophosphamide

U059 Daunomycin

U075 Dichlorodifluromethane

U089 Diethylstilbestrol

U122 Formaldehyde

U129 Lindane

U150 Melphalan

U151 Mercury

P-listed U-listedDrug, vials and packaging Drug only

Exemptions are State Specific

§ EPA guidance on exemptions  Nitroglycerin Federal Register: May 16, 2001 (Volume 66, Number 95)

  Epinephrine Salts USEPA Memo Dated 10/07/2007

§ States who do NOT allow exemptions

Nitroglycerin Epinephrine saltsConnecticut ConnecticutHawaii HawaiiMaine New York – exempted 7/15/09Michigan Washington

*Florida, Michigan, Minnesota, Washington

D-Listed Characteristic Chemical Waste

D004 Arsenic 5 mg/L DualD005 Barium 100 mg/L OralD007 Chromium 5 mg/L TPND024 M-Cresol 200 mg/L InsulinD013 Lindane 0.4 mg/LD009 Mercury 0.2 mg/L VaccineD101 Selenium 1 mg/L TPND011 Silver 5 mg/L Creams

Source: www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr261_00.html

EPA Defined Hazardous Drugs

•Ignitability (D001)•Corrosivity (D002)•Reactivity (D003)•Toxicity

NOTE: primary drug may not be what is listed!

Hospital

Medical Waste Incinerator

Reverse Distributor

Water Treatment Plant

Biohazardous waste

Chemotherapy ‘hazardous’ Wastes

RCRA Segregated ‘hazardous’ Wastes

Current Practice Drug Waste Process

Expired drugs

Massoomi 2011©

RCRA Incinerator

Non-‘hazardous’ Wastes Controlled Substances?

IV & Irrigation Solutions: NO Drugs

Empty IV Bags/Drug Packaging

Autoclauve

Special Drug Waste: Devices/Gases

Risk Management & Liability§ Civil and criminal liabilityú Civil & Criminal: State/USEPA enforcement

§ Personal liabilityú fines and/or imprisonment

§ Corporate finesú $37,500 per violation/day

§ Eastern Kansas Health Care System August 18, 2009ú What $51,501 civil penalty & $482,069 supplemental projectú Violations

ñ No hazardous waste determinationsñ No proper hazardous waste containersñ No documentation of inspection of hazardous waste storageñ No documentation of personnel trainingñ Unpermitted on-site incineration of hazardous wasteñ Unlawful shipping of hazardous waste

Healthcare RCRA ViolationsBreakout of RCRA Violations from Hospital Disclosures

GeneratorRequirements 12%

ID of HW 23%

Universal Waste18%

General FacilityStandards 16%

ContainerManagement 21%

UST 2%

Accumulation Time2% Manifest 6%

Slide courtesy of John Gorman, USEPA Region 2

DOT Manifest for TransportStandard US form§ Page 1ú Main form (left)

§ Page 2ú “Designated Facility to

Generator State § Page 3 ú “Designated Facility to

Generator Copy” § Page 4ú “Designated Facility Copy”

§ Page 5ú “Transporter" copy

§ Page 6ú “Generator’s Initial Copy”

http://www.pneac.org/hazwastemanifest/manifest_video/manifest.html

N=343 Rx Directors

EPA’s Current Status

No Health-system survey

Guidance Document: Best Management Practices for Unused Pharmaceutical At Health Care Facilities  Modeled off of H2E publication?  Draft; Aug 26, 2010  Publication 2012?

§ Universal Waste Rule proposal update

ú Not to be..

Source: Meghan Hessenauer, US EPA Office of Water, Nov ,2011

Pharmaceutical Waste Team

§ Primaryú Hospital administrationú Pharmacy Leadú Nursing Leadú Risk Managementú Environmental Servicesú Physicists

§ Secondaryú Infection Controlú Safety Officerú Facility Managementú Purchasing leads  Pharmaceuticals  Surgical supplies  Central supplies

ú Physician office managers

Think of All Areas Where Drugs Are Handled

310 Patient Rooms52 Pyxis Stations28 Med refrigerators26 Surgical suites15 Infusion chairs12 Hospital clinics5 MRI suites7 CT suites2 Anesthesia rooms2 Pharmacies

459 Total Locations

Non-hazardous Pharmacy Waste

Seweredú Plain IV fluidsú Plain Irrigations

Landfillú Packaging (Non-P listed)ú Empty vials

Medical Hazardous Waste Incineration RCRA Hazardous Incineration

(Waste to Energy)

Biohazard Sharps Containers

§ “Unused pharmaceuticals should not be disposed of with biohazardous waste”ú Autoclavingú Heat to 180º F

§ If used send to a medical waste incineratorú Heat to 500º to 900º F

Draft: Guidance Document: Best Management Practices for Unused PharmaceuticalAt Health Care Facilities: EPA-821-R-10-006; Aug 26, 2010

Controlled Substance WasteMandatory ACCOUNTABILITY !

§ No definition of “waste”§ No distinction between expired, contaminated

controlled substances and saleable product

§ Accountability required of all controlled substances

§ Most US hospitals Sewer this waste

§ Reverse Distributors ­ to be DEA Registrants to remove

Source: Mark W. Caverly, Chief; DEA Office of Diversion Control

Aerosolized Drug Products

§ Highly specialized drug delivery devicesú Varying international regulations  Puncture PRIOR to incineration  Triple rinsing prior to landfill  Rinsate disposed of properly

Anesthesia Gases

§ Anesthetic gases are green house gases § 5% of gases used by patient§ Global Warming Potentials

  Nitrous Oxide: 289x  Desflurane: 3714x  Isoflurane: 1401x  Sevoflurane: 349x

§ Gases liquefied and purified ú FUTURE: resale of products

Source: Laura Brannen, BLUE

Medicinal Leeches and Maggots

Biohazardous Waste

Formulary Assessment of Waste

§ Collaborative formulary assessment ú NIOSH Appendix A & IARCú State and Federal regulationsú Waste hauler process

ú Continuous assessment of Risk and Stream

DRUG - GENERIC (BRAND)

CLASS OF MEDICATION

ROUTES/ FORMS COMPANY

PREGNANCY CATEGORY MSDS BSC

HAZ CLASS

(1-4)WASTE STREAM

RCRA Y/N

Aldesleukin (Proleukin) ONC INJ Chrion C YES Yes Class 1 YELLOW N

Alemtuzumab (Campth) ONC INJ Berlex C YES Yes Class 1 YELLOW N

Alitretinoin (Panretin) Retinoid

TOPICAL, GEL Ligand D YES

Yes, if altered Class 1 YELLOW N

Altretamine (Hexalen) ONC

ORAL, CAPSULE MGI D YES

Yes, if altered Class 1 YELLOW N

N=343 Rx Directors

Model IManual Sorting of Regulated Waste

§ Entire inventory has been manually analyzed ú New drugs have to added to the system

§ Items are labeledú During receiving process or electronically

§ Regulated drugs are dispensing in colored bag

Used with permission: Leslie Durrant, R.Ph., BCPS

Model IIElectronic Devices for RX Waste

§ Automatic Sorting System§ Barcode segregation§ Alerts staff when full§ Completes DOT manifests

www.carefusion.com

§ Solid and liquid wastes§ Renders unusable unrecoverable§ Tamper evident, notification § Wall mount, COW mount§ ONLY for collection of all wastes

EcoREX™ Smart Sink™

www.cactusllc.net

Model IIICentralizing Segregation

§ All pharmaceutical waste is collected in hazardous waste containers

§ 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

§ NOTE: the generator (HOSPITAL) is liable for contracted employee harmSource: Charlotte A. Smith, R. Ph., M.S.,

Model IVManaging All RX Waste as Hazardous

§ One Container for collection

§ Easiest

§ Need to sort out characteristic wastes ú Toxic, Corrosive, Ignitable, Reactive

§ Storage space issues

Hospital

Medical Waste Incinerator

Reverse Distributor

Water Treatment Plant

Biohazardous waste

Chemotherapy ‘hazardous’ Wastes

RCRA Segregated ‘hazardous’ Wastes

Current Practice Drug Waste Process

Expired drugs

Massoomi 2011©

RCRA Incinerator

Non-‘hazardous’ Wastes Controlled Substances?

IV & Irrigation Solutions: NO Drugs

Empty IV Bags/Drug Packaging

Autoclauve

Special Drug Waste: Devices/Gases

Proper Hazardous Drug Waste DisposalPoster Example

Segregate the wastes of Drugs & Dispose of in appropriate containers

SHARPSRed Container

BIOHAZARDOUSRed Container

HazardousYellow Container

RCRA HAZARDOUSBlack Container

Non-Regulated Trash

Sharps BioHaz CHEMO RCRA Trash-Needles

-Broken Glass

-Ampules

-Other sharps

-Non-Chemo vials

-IVIG vials/bags

-Albumin vials/bags

-Blood factor vials

-Syringes

-IV Bags and Tubing

-Empty Chemo vials

-Chemo packaging< boxes, PIs>

-Chemo mats not involved with spills

-Chemo Gloves

-PhaSeal devices

ALL partial Chemo Dose vials

Drugs on EPA P & U list1.Chlorambucil 2.Cyclophosphamide3.Daunomycin4.Melphalan 5.Mitomycin C6.Streptozotocin7.Arsenic Trioxide8.Idarubicin9.Carmustin including Gliadel10.Uracil mustard 11.Anything used 4 chemo spill

Everything Else NOT contaminated

1.Packaging2.IV wraps3.Syringe packaging4.PhaSeal packaging5.Gauzes6.Gowns 7.Masks 8.Paper9.Labels, etc.

Contact Service Center for questions: XXX-XXX-XXXX

Assessment of Compliance

Trash Rounds

Random audits for compliance1. Check staff knowledge2. Check waste containers3. Track quantities 4. Track costs

5. Document process and results

Staff Processes Check Streams

N=343 Rx Directors

Future Waste Considerations

§ Disposable drug delivery device wastes§ Genotargeted drug wastes§ Drug loaded Adenovirus wastes§ Nanotechnology drug wastes

Firouzan ‘Fred’ Massoomi, Pharm.D., FASHPPharmacy Operations Coordinator

Nebraska Methodist HospitalOmaha, Nebraska USA

Fred.Massoomi@nmhs.org

Pharmaceutical Waste Management