The Proper Place for Pharmacy Waste

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The Proper Place for Pharmacy Waste

• Keeping pharmaceuticals out of our waterways

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K-States Pollution Prevention Institute (PPI)

• PPI staff operate Small Business Environmental
  Assistance Program or SBEAP
• Program services are
• Site visits
• Hotline
• Workshops
• Newsletters
• Multimedia (cover air permits, haz waste, and
  water regulations, integrating pollution
  prevention)
• Free
• Confidential
• H2E Champion

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Pharmacy waste management

• Supported by Bureau of Water at KDHE
• Target audience is LTC facilities
• Research, outreach and technical assistance
• Hotline [phone]
• Site visits
• Seeking professional input for solutions

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Web cast objectives

• Understand the environmental impacts related to
  pharmacy waste management.
• Identify practices that contribute to the
  problem.
• Alternative pharmacy waste management
  requirements and/or the best management
  practices.
• Identify available resources related to
  pharmaceutical waste management questions.

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Pharmacy waste management, an emerging issue

• The water connection
• Becky Gagnon-Lewis
• Why is this an issue?
• What pharmaceuticals are regulated RCRA
• Hierarchy of Rx waste management
• Resources
• Questions and answers

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Pharmaceuticals emerging contaminants in the
wastewater utility
Synthetic or naturally occurring chemicals or
microorganisms Not commonly monitored in the
environment Potential to enter the environment
and cause known or suspected adverse ecological
and/or human health effects May be new chemicals
OR Release may have occurred for a long time, but
only recently recognized as a potential problem
OR New use of existing chemicals
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Pharmaceuticals, Hormones, and other emerging
contaminants study in US Streams Study

• One or more of the following chemicals were found
  in over 80 of the streams sampled downstream of
  WWTPs
• 17alpha Ethynyl Estradiol (16)
• - Median concentration 73 ng/l
• -(Effects at as low as 1 ng/l may result in
  feminization of male fish)
• Acetaminophen (24)
• Steroids and hormones (16)
• Diltiazem (blood pressure medication) (13)
• Codeine (11)
• Antibiotics and antimicrobials (10)
• Ibuprofen (10)

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Risks associated with pharmaceutical disposal
down the drain

• Wastewater Plants are biological processes
  designed to treat domestic human waste - cannot
  treat or remove pharmaceutical chemicals
• May kill beneficial bacteria responsible for
  breaking down waste in sewage plants and damage
  septic systems contaminate water and aquatic
  life in surrounding environment OR
• Pass through the treatment plant and enter the
  receiving stream aquatic environment

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Why should we care?

• Increasing Attention to Emerging Contaminants,
  particularly pharmaceuticals
• Media
• Public
• Non-Governmental Organizations
• Potential Impacts to Organisms at low
  concentrations
• Persistence in the Environment Bioaccumulation
• Chronic Toxicity
• Endocrine Disruption
• Regulatory Control?

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Potential regulatory control

• Pharmaceutical Manufacturers already regulated by
  EPA Effluent Guidelines
• 2008 EPA Effluent Guideline Study
• Proposed Guidelines may include discharge
  restrictions for Health care facilities
• http//www.epa.gov/EPA-WATER/2007/October/Day-30/w
  21310.pdf

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What is the concern?

• Drugs are designed to be biologically active
• Life-long trace level exposures
• Impact on aquatic life
• Exposure (minute concentration) through our
  drinking water sources
• Action preventionis key

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Never down the drain
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What practices are harmful?

• Any drain disposal practices need to be
  eliminated
• Direct conduit to the our rivers and water bodies
• Eliminate land filling when possible
• What about DEA restrictions on controlled
  substances?

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NEW KDHE Guidance

• New technical guidance document at
  http//www.kdheks.gov/waste/guidance/sw07-01.pdf
• For residents and non-regulated hazardous waste
  generators, like nursing homes
• Hospital are generally regulated under RCRA
• KS Board of pharmacy has similar guidance on
  their Web site at http//www.kansas.gov/pharmacy/f
  aq.html

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Waste management hierarchy

• New KDHE guidance
• Waste minimization
• Reverse distribution
• Collection events or programs
• Incineration
• Hazardous waste landfill
• Render non-recoverable and landfill
• Sanitary sewer (last resort option for disposal)

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Emerging issue for healthcare

• Hospitals, larger sources, just now beginning to
  recognize this as an issue
• EPA is beginning to inspect them
• Most are considered regulated under the hazardous
  waste regulations (RCRA)
• Hospitals for a Healthy Environment Workshop and
  Trade Show
• Dec 6, 2007 in KC, Kansas

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What types of pharmaceuticals are RCRA hazardous
or regulated wastes?

• The reason we administer these drugs in
  controlled measures, is the same reason we need
  to managed them carefully when discarded

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What is RCRA

• Resource Conservation Recovery Act
• Hazardous waste regulation
• Generator has cradle to grave responsibility
• Most LTC facilities do not fall into the
  regulatory category of generators, so they have
  options for land filling RCRA wastes
• Caution facilities linked to hospitals

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Categories of RCRA Hazardous Wastes

• Listed Wastes
• U-listed toxic
• P-listed - acutely hazardous
• Characteristic Wastes
• Specific measurable properties
• Ignitable
• Corrosive
• Reactive
• Toxic

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P-Listed Wastes

• P-Listed Wastes
• Sole active ingredient
• Unused drug has not been given to a patient
• Empty Containers
• Must be triple rinsed to be RCRC empty
• Rinsate managed as hazardous waste
• Rinsing generally not practical for
  pharmaceutical waste
• Generally easier to manage container as hazardous
  waste

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Examples of P-Listed Pharmaceutical Waste

• Arsenic trioxide P012
• Epinephrine (non-salts) P042
• Nicotine P075
• Nitroglycerin P081
• Phentermine (CIV) P046
• Physostigmine P204
• Physostigmine Salicylate P188
• Warfarin 0.3 P001
• Excluded from the P list federally and in a
  number of states if in final dosage forms,
  including Kansas

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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

Chemotherapy agents
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Characteristic Hazardous Waste

• Ignitable
• Aqueous solutions with 24 or more alcohol and a
  flashpoint less than 140F
• Non-aqueous drug formulations with flashpoint
  less than 140 F
• Strong oxidizers
• Potassium permanganate and silver nitrate
• Compressed gases

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Characteristic Hazardous Waste

• Corrosive
• pH of less than or equal to 2 (highly acidic)
• pH greater than or equal to 12.5 (highly basic)
• Reactive
• Toxic
• 10 of the 40 Toxicity Characteristic (TC)
  chemicals and heavy metals are found in drug
  formulations
• Silver, barium or other metals compounds

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Regulated levels

• Based on monthly waste generation
• P-Listed waste regulated at 2.2 lbs/month
• Others regulated at 55 lbs/month
• Categories of generators in KS
• SQG
• KSG
• EPAG

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Are long-term care facilities regulated under
RCRA?

• Most LTC facilities do not generate enough
  hazardous waste total to be regulated hazardous
  waste generators.
• Most are non-regulated SQGs.
• SQG have disposal options
• Reverse distribution, collection programs, the
  landfill and only as a last resort (with written
  approval), the sewer.

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SQGs in Sedgwick County

• Can use the Household Hazardous Waste program
  services
• Contact 316-6607464 in Sedgwick county
• Can not take controlled substances

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Pharm waste regulators

• KDHE under RCRA
• Just detailed regulatory level
• Kansas Department on Aging
• Board of Pharmacy
• Concurs with KDHE and DEA guidelines
• Drug Enforcement Agency
• Judy Williams, DEA contact for BOP
• 21 CFR 1307.21

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Code of Federal Regulations

• DISPOSAL OF CONTROLLED SUBSTANCES
• Section 1307.21 Procedure for disposing of
  controlled substances.
• (a) Any person in possession of any controlled
  substance and desiring or required to dispose of
  such substance may request assistance from the
  Special Agent in Charge of the Administration in
  the area in which the person is located for
  authority and instructions to dispose of such
  substance. The request should be made as follows
  
• (1) If the person is a registrant, he/she shall
  list the controlled substance or substances which
  he/she desires to dispose of on DEA Form 41, and
  submit three copies of that form to the Special
  Agent in Charge in his/her area or

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Can a long term care facility (LTCF) return a
residents unused controlled substance medication
to a pharmacy?

• Answer No. There are no provisions in the
  Controlled Substances Act for a DEA registrant
  (i.e., retail pharmacy) to acquire controlled
  substances from a non-registrant (i.e., resident
  of a LTCF). Most long term care facilities are
  not licensed by their respective state to handle
  controlled substances and therefore are not
  registered with DEA. Long term care facilities
  act in a custodial capacity, holding controlled
  substances that, pursuant to a prescription, have
  been dispensed to and belong to the resident of
  the LTCF. Federal laws and regulations make no
  provisions for controlled substances that have
  already been dispensed to patients, regardless of
  the packaging method, to be returned to a
  pharmacy for further dispensing or disposal.
• http//www.deadiversion.usdoj.gov/faq/general.htm
  5

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Can an individual return their controlled
substance prescription medication to a pharmacy?

• Answer No. An individual patient may not return
  their unused controlled substance prescription
  medication to the pharmacy. Federal laws and
  regulations make no provisions for an individual
  to return their controlled substance prescription
  medication to a pharmacy for further dispensing
  or for disposal. There are no provisions in the
  Controlled Substances Act or Code of Federal
  Regulations (CFR) for a DEA registrant (i.e.,
  retail pharmacy) to acquire controlled substances
  from a non-registrant (i.e. individual patient).
• The CFR does have a provision for an individual
  to return their unused controlled substance
  medication to the pharmacy in the event of the
  controlled substance being recalled or a
  dispensing error has occurred.
• An individual may dispose of their own controlled
  substance medication without approval from DEA.
  Medications should be disposed of in such a
  manner that does not allow for the controlled
  substances to be easily retrieved. In situations
  where an individual has expired, a caregiver or
  hospice staff member may assist the family with
  the proper disposal of any unused controlled
  substance medications.

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Controlled substances disposal

• Non-RCRA or KDHE regulated
• DEA approval of land fill option
• BOP approval of land fill option
• Kansas Department on Aging

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Pharmacy Services

• Caryl Gill, RN, BSN
• Kansas Department on Aging
• December 13, 2007

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Pharmacy ServicesCFR 483.60, F425

• Pharmaceutical Services
• A facility must provide pharmaceutical services
  to meet the needs of each resident.
• What constitutes Pharmaceutical Services
• Definition of Disposition
• Services of a licensed pharmacist
• Procedures addressing the disposition of
  medications

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State Regulations

• Accountability and disposition
• KAR 28-39-156 (f)-Nursing Facilities
• KAR 28-39-156 (f)(3) Role of the
  pharmacist-Nursing Facilities
• KAR 28-39-247(f)(5)-Assisted Living and
  Residential Health Care
• KAR 28-39-436 (f)(5)-Home Plus
• KAR 28-39-282(f)(5)-Adult Day Care

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http//www.kslegislature.org/supplemental/2008/SN2
578.pdf
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http//www.kansas.gov/pharmacy/Newsletters/March20
06.pdf
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Waste minimization opportunities

• Use return processors
• Ask what is being wasted?
• Shelf life 1 year
• Minimize samples that might expire
• Work with doctors and suppliers to control
  inventory and decrease waste
• Eliminate drain disposal practices

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Spread the word to others

• Nurses
• Safety committees
• Pharmacy set policy and training
• Patients
• Share guidance or posters

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Resources

• HERC pharmacy waste guidance http//www.hercenter.
  org/hazmat/pharma.cfm
• Blue print http//www.h2e-online.org/docs/h2epharm
  ablueprint41506.pdf
• Pharmaceutical waste webpage
• http//www.h2e-online.org/hazmat/pharma.html
• BOP newsletters - http//www.kansas.gov/pharmacy/N
  ewsletters/March2006.pdf
• Your pharmacist

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Kansas resource

• Pollution Prevention Institute
• Technical assistance
• Confidential
• Free
• 800-578-8898 ask for Nancy
• Question and Answer period operator assisted