Download Pharmacy Waste Web cast presentation

The Proper Place for
Pharmacy Waste
Keeping pharmaceuticals out of
our waterways
K-State’s Pollution Prevention
Institute (PPI)
• PPI staff operate Small Business
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Environmental Assistance Program or
SBEAP
Program services are
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Site visits
Hotline
Workshops
Newsletters
Multimedia (cover air permits, haz waste, and
water regulations, integrating pollution prevention)
– Free
– Confidential
• H2E Champion
www.sbeap.org 800-578-8898
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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 800-578-8898
– Site visits
• Seeking professional input for solutions
www.sbeap.org 800-578-8898
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Web cast objectives
• Understand the environmental impacts related
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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.
www.sbeap.org 800-578-8898
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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
www.sbeap.org 800-578-8898
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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
www.sbeap.org 800-578-8898
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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%)
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- 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%)
www.sbeap.org 800-578-8898
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Risks associated with pharmaceutical
disposal down the drain
• Wastewater Plants are biological processes
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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
www.sbeap.org 800-578-8898
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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?
www.sbeap.org 800-578-8898
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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/Day30/w21310.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: prevention…is key
www.sbeap.org 800-578-8898
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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?
www.sbeap.org 800-578-8898
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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/faq.ht
ml
www.sbeap.org 800-578-8898
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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)
www.sbeap.org 800-578-8898
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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
www.sbeap.org 800-578-8898
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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
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
www.sbeap.org 800-578-8898
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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
www.sbeap.org 800-578-8898
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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
www.sbeap.org 800-578-8898
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Examples of P-Listed
Pharmaceutical Waste
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Arsenic trioxide
Epinephrine (non-salts)
Nicotine
Nitroglycerin*
Phentermine (CIV)
Physostigmine
Physostigmine Salicylate
Warfarin >0.3%
P012
P042
P075
P081
P046
P204
P188
P001
* Excluded from the P list federally and in a number of states if in
final dosage forms, including
Kansas
www.sbeap.org
800-578-8898
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Examples of U-listed
Pharmaceutical Waste*
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Chloral Hydrate(CIV)
U034
Chlorambucil *
U206
U035
• Streptozotocin
• Lindane
Cyclophosphamide*
U058
• Saccharin
U202
Daunomycin*
U059
• Selenium Sulfide
U205
Diethylstilbestrol*
U089
U237
Melphalan*
U150
• Uracil Mustard*
Mitomycin C *
U010
• Warfarin<0.3%
U248
U129
*Chemotherapy agents
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Characteristic Hazardous Waste
• Ignitable
– Aqueous solutions with 24% or more alcohol
and a flashpoint less than 140°F
– 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
www.sbeap.org 800-578-8898
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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
www.sbeap.org 800-578-8898
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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.
www.sbeap.org 800-578-8898
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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
www.sbeap.org 800-578-8898
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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
resident’s 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 nonregistrant (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
www.sbeap.org 800-578-8898
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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
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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.
www.sbeap.org 800-578-8898
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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
www.sbeap.org 800-578-8898
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Pharmacy Services
Caryl Gill, RN, BSN
Kansas Department on Aging
December 13, 2007
www.sbeap.org 800-578-8898
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Pharmacy Services
CFR 483.60, F425
• Pharmaceutical Services
• A facility must provide pharmaceutical
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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
www.sbeap.org 800-578-8898
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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
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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/SN2578.pdf
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http://www.kansas.gov/pharmacy/Newsletters/March2006.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
www.sbeap.org 800-578-8898
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Spread the word to others
• Nurses
• Safety committees
• Pharmacy – set policy and training
• Patients
• Share guidance or posters
www.sbeap.org 800-578-8898
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www.sbeap.org 800-578-8898
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Resources
– HERC pharmacy waste guidance
http://www.hercenter.org/hazmat/pharma.cfm
– Blue print http://www.h2e-
online.org/docs/h2epharmablueprint41506.pdf
– Pharmaceutical waste webpage:
• http://www.h2e-online.org/hazmat/pharma.html
– BOP newsletters -
http://www.kansas.gov/pharmacy/Newsletters/March2006.pdf
– Your pharmacist
www.sbeap.org 800-578-8898
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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
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