Transcript Pharmaceutical Waste & EPA Updates: New Focus/New Solutions

Pharmaceutical Waste & EPA
Updates: New Focus/New Solutions
13th Annual Pharmacy Purchasing
Networking Conference
August 18th, 2009
Charlotte A. Smith, R. Ph., M.S.,HEM
Director, PharmEcology Services
Waste Management Healthcare Solutions, Inc.
Legal Disclaimer
This presentation is solely for educational purposes and provides only a
general description of various regulatory requirements. For a complete
description, please consult the relevant federal and state regulatory
statutes. Nothing in this presentation constitutes legal advice and you
should not legally rely on any information provided in this presentation.
We make no warranty, express or implied, with respect to such
information and disclaim all liability resulting from any use or reliance of
this information.
Agenda
• Regulatory update: What’s happening on
Capitol Hill
• RCRA 101: How hazardous waste regulations
apply to discarded pharmaceuticals
• Implementing a cost-effective system for
managing pharmaceutical waste
Pop Quiz
• Is pharmaceutical waste ending up in red
sharps containers in your patient care units?
• Are any unused IVs or other compounded
prescriptions being disposed of down the
drain?
• Are waste pharmaceuticals like warfarin and
lindane, considered hazardous by EPA, being
combined with non-hazardous pharmaceutical
waste?
Pop Quiz
• What about items containing 24% alcohol?
• Or any items that contain mercury
preservatives, such as vaccines, or eye and ear
preparations?
• Are vials and IVs containing unused
chemotherapy agents like Cytoxan being
disposed of in chemo waste containers?
What’s Driving New Regulatory
Initiatives?
Drugs in Drinking Water &
Healthcare Pharmaceutical Waste
• March 9, 2008
– 5-month inquiry discovered that drugs were detected in the drinking water
supplies of 24 major metropolitan areas
• September 14, 2008
– Majority of 5,700 hospitals and 45,000 long-term care facilities flush unwanted
drugs down the drain and do not document amounts according to EPA survey
– Extrapolation of data from 14 representative facilities in Minnesota yielded an
estimated total volume of 250 million pounds of drug waste annually, including
packaging
• April 19, 2009
– U.S. manufacturers, including major drugmakers, have legally released at least 271
million pounds of pharmaceuticals into waterways that often provide drinking
water
Pending Legislation
• Drug Free Water Act of 2009
– Introduced into the House on January 7, 2009: HR 276
– Requires EPA to convene a Task Force regarding proper disposal of unused pharmaceuticals
• Safe Drug Disposal Act of 2009
– Introduced into the House on February 25, 2009: HR 1191
– Introduced into the Senate on June 24, 2009: S 1336
– To amend the Controlled Substances Act to provide for the disposal of controlled
substances by ultimate users and care takers through State take-back disposal programs
– 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
– Introduced into the House on March 5, 2009: HR 1359
– Introduced into the Senate on June 18, 2009: S. 1292
– To amend the Controlled Substances A ct to enable consumer take-back programs
EPA’s Clean Water Act Review
Mandatory Survey
• Mandatory survey for Unused Pharmaceuticals Disposal in the
Health Services Industry
– All companies that receive questionnaire must respond within 60
days
– Failure to respond may result in criminal fines, civil penalties, and
other sanctions, as provided by law
– May require documentation of some disposed drugs for a 30 day
period
• Potentially 3500 facilities will be sampled
• Includes a sample of hospitals, long term care facilities, hospices,
and veterinary practices
• May be administered September through November, 2009
•
•
•
http://www.epa.gov/fedrgstr/EPA-WATER/2008/August/Day-12/w18606.pdf
http://www.epa.gov/guide/304m/
www.epa.gov/ost/ppcp
EPA Proposal to Add Pharmaceuticals
to Universal Waste Rule
• Federal Register publication Dec 2, 2008 – Comments due March 4, 2009
– http://www.epa.gov/fedrgstr/EPA-WASTE/2008/December/Day02/f28161.htm
– Information:
http://www.epa.gov/epawaste/hazard/wastetypes/universal/pharm.h
tm
• Only applies to drug waste that meets the definition of RCRA hazardous
waste
• Only intended for healthcare-type generators, not manufacturers
• Intent to streamline pharmaceutical waste management and encourage
consumer take-back programs
• Estimated 18 months minimum for federal enactment; states may or may
not adopt; Iowa and Alaska will be automatic
RCRA and Universal Waste
“Universal Waste” is a subset of RCRA
hazardous waste.
Federal EPA: Batteries,
Pesticides, Mercurycontaining devices,
Lamps (bulbs)
Federal RCRA
Hazardous
Waste (includes
some
pharmaceuticals)
Universal Waste
Florida: RCRA
Pharmaceuticals
Pioneer Rx Universal
Waste States
 Michigan and Florida already have added
pharmaceuticals to their universal waste rules
 Florida: https://www.flrules.org/Gateway/View_notice.asp?id=6599121a:
 Michigan: 299:9228
http://www.state.mi.us/orr/emi/admincode.asp?AdminCode=Single&Admin
_Num=29909101&Dpt=&RngHigh=29999999
 Unintended consequences:
– Un-registered entities started taking custody of
legend drugs
– Need to involve state boards of pharmacy, DEA
Expectations
• Improved management of hazardous
pharmaceutical wastes
• Regulatory burden for many Rx waste generators will
decrease
• Proposal provides a solution to many of the issues
facing healthcare facilities and other Rx hazardous
waste generators
RCRA:
Risk Management & Liability
• Civil and criminal liability
– Civil: State/USEPA enforcement
– Criminal: FBI, Attorney General, Grand Jury
• Corporate fines: $37,500/violation/day
• Personal liability: Fines and/or
imprisonment
• No statute of limitations
• Managers up through CEO liable
http://www.epa.gov/compliance/resources/policies/criminal/exercise.pdf
You’re Chance to Shine!
Mix & Match Exercise
The “All-Seeing Eye”
holds the clues!
Which Discarded Drugs Become RCRA
Hazardous Waste?
•
P-listed chemicals
–
•
U-listed chemicals
–
•
Sole active ingredient; unused, and empty containers
Sole active ingredient; unused
Characteristic of hazardous waste
–
–
–
–
Ignitability
Toxicity
Corrosivity
Reactivity
Ref: 40 CFR Part 261
Examples of P-Listed Pharmaceutical Waste
•
•
•
•
•
•
•
•
•
•
Arsenic trioxide
Epinephrine base*
Nicotine
Nitroglycerin** (weak)
Phentermine (CIV)
Physostigmine
Physostigmine Salicylate
Warfarin >0.3%
P012
P042
P075
P081
P046
P204
P188
P001
*Salts excluded federally as of Oct. 15th, 2007; Many states have adopted this
position.
** Excluded from the P list federally and in many states.
Examples of U-listed
Pharmaceutical Waste
•Chloral Hydrate(CIV) U034
•Streptozotocin
U206
•Chlorambucil
U035
•Lindane
U129
•Cyclophosphamide
U058
•Saccharin
U202
•Daunomycin
U059
•Selenium Sulfide
U205
•Diethylstilbestrol
U089
•Uracil Mustard
U237
•Melphalan
U150
•Warfarin<0.3%
U248
•Mitomycin C
U010
Characteristic of Ignitability
•Aqueous Solution containing 24%
alcohol or more by volume & flash
point<140° F
•Non-aqueous solutions with flash
points <140 ° F
•Oxidizers
•Flammable aerosols
•Hazardous Waste Number: D001
•Rubbing Alcohol
•Topical Preparations
•Injections
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
Characteristic of Toxicity
• 40 chemicals which must be below specific
leaching concentrations
• Must pass the Toxicity Characteristic Leaching
Procedure (TCLP)
• Must evaluate IVs, such as TPN – may come
out of regulation due to dilution
•
•
•
•
•
•
Examples of potential toxic ingredients of pharmaceuticals:
Arsenic
m-Cresol
Barium
Mercury (thimerosal,
Cadmium
phenylmercuric acetate)
Chromium
Selenium
Lindane
Silver
Characteristic of Reactivity
•
Meet eight separate criteria identifying certain
explosive and water reactive wastes
•
Nitroglycerin formulations may be considered
excluded federally from the P081 listing as nonreactive as of August 14, 2001 under FR: May
16, 2001, unless they exhibit another
characteristics, such as ignitability.
•
Most states have adopted the federal exclusion
for nitroglycerin. Waste must still be evaluated
for ignitability.
•
Hazardous Waste Number for reactives: D003
Chemotherapy Agents: Many Are Not
Regulated by RCRA
• About 100 chemotherapy agents not regulated by
EPA
• Examples:
–
–
–
–
–
Alkylating agents: Cisplatin, Thiotepa
Antimetabolites: Fluorouracil, Methotrexate
Hormonal (antiandrogen): Lupron® (leuprolide)
Hormonal (antiestrogen): Tamoxifen
Mitotic Inhibitor: Taxol® (paclitaxol)
Three Types of
Chemotherapy Waste
• Trace Chemotherapy Waste (yellow)
– Medical waste hauler protocols for “Chemo Waste”
– Empty vials, syringes, IV’s, gowns, gloves, ziplock bags
– Treated as infectious medical waste through regulated
medical waste incineration
• “Bulk” Chemotherapy Waste (black)
– If not empty, should be placed into RCRA Hazardous
Waste container
• Spill Clean-up (black)
– Manage as RCRA Hazardous Waste
Definition of “Empty”
•
“P” List
Containers of “P” listed chemicals are considered hazardous waste,
unless they have been rinsed three times and the rinsate discarded as
hazardous waste.
•
“U” List and D codes
Containers of “U” listed chemicals or D codes are empty only when
•
All contents removed that can be removed through normal
means
•
And no more than 3% by weight remains
•
Example: “Empty” Cytoxan vial would be “trace” chemotherapy
•
Epinephrine syringe exclusion expanded to other P and U-listed drugs federally
by USEPA. Many states have accepted this exclusion.
Ref: 40 CFR 261.7
Specific Reasons to Add Pharmaceuticals to
UWR
• Generation of pharmaceutical waste at a
large number of points in relatively small
quantities across the facility
• Generation of hundreds of different types
of pharmaceutical waste
• Industry concerns regarding waste
determination, generator status of acutely
hazardous waste, hazardous waste listings,
and accumulation time limits
Differentiation of Pharmaceuticals
from other Universal Wastes
Why Pharmaceuticals are NOT Analogous to
Current UWR Items: Security Issues
• Legend Pharmaceuticals (Rx only) are deliberately
restricted in their availability to the consumer AND
within the supply chain due to their inherently “
dangerous” status regarding human use
• The street value of non-controlled substances
continues to climb due to increased drug costs and
shrinking personal resources
• Waste pharmaceuticals continue to have value,
including empty vials of IV admixtures that can be used
for introducing counterfeit drugs back into the supply
chain
Why Pharmaceuticals are NOT Analogous to
Current UWR Items: Security Issues
• Pharmaceutical manufacture, transport,
warehousing, distribution, sale, and
disposal are regulated by multiple state
and federal agencies
– FDA
– DEA
– State Boards of Pharmacy
– State Controlled Substance Boards
Why Pharmaceuticals are NOT Analogous to
Current UWR Items: OSHA Issues
• Handling and sorting of hazardous materials
such as chemotherapy agents can cause a
significant risk to employees
–
–
–
–
NIOSH Hazardous Drug Alert
http://www.cdc.gov/niosh/docs/2004-165/
ASHP Guidelines on Handling Hazardous Drugs
http://www.ashp.org/DocLibrary/BestPractices/AS
HPGuidelinesHandlingHazardousDrugs.aspx
Unintended Consequences:
Loss of Manifest
• How is receipt and destruction assured?
• What if a shipment, or partial shipment, is
diverted?
• How will UW handlers and transporters
manage state differences?
– Can a shipment get “marooned” in transit?
– Common carrier until it reaches a non-UWR state;
wrong carrier, no manifest
Economic Impact
• Current waste disposal practices: (est. 80% of
hospitals)
– Sewering – no documented costs
– Autoclave/landfill – minimal costs absorbed in normal operating costs
• Suggested practice of managing all Rx waste as
universal waste
– Fee differential as large as 5x to 10x between municipal or regulated
medical incineration and RCRA hazardous waste incinerator
– Municipal: $.19/lb - $.50/lb
– RCRA: $.95/lb - $4.95/lb
Percentage of RCRA & PharmE Haz ® in
149 Hospitals, 2008
PharmE® Inventory Analysis
Average for 149 Facilities
Fed Haz, 88 ,
4%
Non
Hazardous,
2,030 , 86%
Fed Haz
PharmE Hazardous
Non Hazardous
PharmE
Hazardous,
235 , 10%
PharmE Hazardous®
Drug Criteria Examples
•
NIOSH Hazardous Drug Alert Appendix A
•
OSHA Technical Manual Section 6, Chapter 2, Appendix VI: 2 -1
•
The US Department of Health and Human Services National Toxicology Program's
Report on Carcinogens (11th Edition)
•
Other chemotherapy agents not already listed as RCRA hazardous
•
Additional drugs meeting OSHA or NIOSH criteria
•
Drugs with LD50s at or below 50mg/kg
•
Endocrine disruptors
Weekly Volumes of 55 gal drums:
16 Non-haz; 4-5 Haz
Photos courtesy of Abbott Northwestern Hospital
Healthcare Homerun!
• Removing P-listed waste from generator calculations
is primary benefit
• Reduction in storage, employee training, and
notification requirements are excellent
• Only need to evaluate inventory initially and upon
receipt of new RCRA drugs
Tailoring the UWR for Pharmaceuticals
• Apply UWR for in-house management
of waste pharmaceuticals at relatively
small quantity waste generators such as
distributors, pharmacies, hospitals,
clinics, long term care facilities,
veterinary clinics, other primary care
facilities
Tailoring the UWR for Pharmaceuticals
• Require full identification and manifesting of
pharmaceutical waste at the point of shipment to the
final disposal site
• IF sorting/re-packaging occurs at a transfer station,
full RCRA and HAZWOPER training and employee
protection requirements should apply
Benefits of Tailored System
• Primary concern of healthcare facilities is
alleviated: need to document P-listed waste to
justify generator status and fear of increasing
generator status
• Cradle-to-grave tracking system is maintained
for both environmental and diversion reasons
• Employee safety is enhanced by reducing
additional sorting in-transit
Burning Question: Should I Wait for the UWR to
Develop My System?
• NO!
– It will take a MINIMUM of 18 months for a new rule to adopted;
probably 2011
– It will take YEARS for each state to adopt either the federal version or
their own version of the UWR
– Hazardous waste will still need to be identified and manifested when
traveling through states that have not adopted the UWR
– Your organization will still need to segregate hazardous waste to avoid
premier disposal charges
Approaches to Pharmaceutical
Waste Management
• Model I: Automatic Sorting Device
• Model 2: Data Applied to Dispensing
Software
• Model 3: Stickers Applied Manually
• Model 4: Centralizing Segregation
• Model 5: Managing All Drug Waste As
Hazardous
Performing a Drug
Inventory Review
• Perform initial inventory review
–
–
–
–
Obtain drug specific data from purchasing records
Identify ingredients
Determine RCRA hazardous waste code
Make Best Management Practice determinations
• Document decision making process
• Keep the review current
Maintaining the Inventory
PharmE® Waste
Wizard
Web-based annual
subscription
service.
Waste
classifications,
including container
recommendations
& MSDSs
Assessing Current Practices
• Performing department reviews
– Quantitative volumes/weights of discarded drugs difficult to obtain
– Informal but well documented interview process in pharmacy and
nursing units can determine current medication disposal practices
• Schedule units in advance
– Emphasize “no wrong answer” approach
• Utilize data from automated dispensing
machines
• Conduct a frequency analysis, especially for
drugs which become hazardous waste
Considering the Optimal Management Options
– Need to label items that need segregation in a
manner that makes it easy for pharmacy and
nursing personnel
– Shelf stickers in pharmacy
– Data Applied to Dispensing Software and/or
– Message inserted into Pyxis, etc. and MAR
(Medication Administration Record) and/or
– Stickers Applied Manually
Labeling the Pharmacy Shelves
• Avery Standard Shipping labels #5164
Label Alert: PYXIS
Courtesy Lahey Clinic Medical Center, Burlington, MA
•Medications dispensed
by the PYXIS medication
station
–P, U, D, or HD a pop-up alert to
properly dispose of the medication
For example:
Pyxis alert:
THIS DRUG IS A FEDERAL HAZARDOUS
WASTE TYPE (specifies P, U, D)
DISPOSE >TRACE IN “BLACK” CONTAINER
OR RETURN TO PHARMACY
IV / Medication Label Alert:
P, U, D, HD
Courtesy Lahey Clinic Medical Center, Burlington, MA
Labeling & Containers
•Items identified by
PharmE Inventory
Analysis
–Marked with black labels
–“Special Disposal Required”
–Coded in Pyxis dispensing
machine also
•Black hazardous waste
containers purchased
Courtesy North Memorial Health Care
from Covidien
SPECISPECIAL
DISPOSAL REQUIRED
Selecting the Right Waste Vendor(s)
•
For RCRA hazardous waste, vendor must be permitted by EPA as a treatment,
storage and disposal facility (TSDF)
– Request a copy of their notification
•
Insure your current vendor can handle all new waste codes
– Provide them with all P, U and D codes
•
Ask for a waste profile to be generated to enable manifesting without
documenting each item in each container
•
Ask if vendor can pre-certify the items and combine ignitables with toxics to
simplify waste segregation
•
Determine if you will have special needs, such as hazardous controlled substances
or mixed hazardous/regulated medical waste streams
Creating a Hazardous
Waste Profile
• Work with hazardous vendors to create a
certified hazardous waste profile of all toxic &
ignitable drug waste, including ignitable aerosols
• Ship commingled as UN3248, Waste Medicine,
Liquid, Flammable,Toxic, n.o.s., 3 (6.1), PG II
• Ship any corrosive acids/bases or oxidizers
separately
Percentage of Hazard Categories in 149
Hospitals (2008)
97% Toxic or Ignitable
PharmE® Database
Summary of Actual Federally Hazardous
Products
Ignitable, 22.2
, 25%
Toxic
, 58.1 , 66%
Toxic
Ignitable
Ignitable Aerosol
Corrosive Acid
Oxidizer
Corrosive Base
Ignitable
Aerosol, 4.8 ,
6%
Corrosive
Acid
,
0.2 , 0%
Oxidizer
, 0.1 , 0%
Corrosive
Base
, 0.1 , 0%
Ignitable
Oxidizer, 2.3 ,
3%
Conducting a Pilot Program
• Pilot the program in the pharmacy first
– Requires shelf stickers on drugs that become hazardous
waste
– Introduces concept to pharmacy staff
• Consider inpatient and/or outpatient oncology and
cardiac ICU next
• Find nursing “champions” within the system
Examples of Hazardous Pharm Waste
Satellite Accumulation
Hazardous Pharmaceutical Waste
Storage Accumulation
Non-Hazardous Pharmaceutical Waste
•Managed through nonhazardous incineration as
a Best Management
Practice
Courtesy North Memorial Health Care
Examples of Non-Hazardous Pharmaceutical
Waste
Collection & Storage
Develop Policies and Procedures
• Complete pilots to determine best methods to
use
• Develop policies and procedures applicable to the
entire facility
– Be sure to involve all stakeholders
• Consider developing a pharmaceutical waste flow
chart and/or pictorial diagrams for each area
• Be sure to update spill management plans to
include non-chemo hazardous waste
Launching the Program
• Educating and training staff
– Notify the entire facility of the timetable for training and roll out
– Train all shifts immediately before their units/department is to begin
waste segregation
– Stick with the timetable!
• Take advantage of Safety Fairs, Nursing Education
Expos, or other hospital-wide events for a general
introduction
• Involve nursing educators initially, with new hires,
and for annual training
Example: “D” Type Hazard
Insulin Containing M-Cresol
•A used syringe of this
type of insulin
•An empty insulin vial
•A half empty insulin vial
RETURN TO
•An outdated insulin vial
Courtesy Lahey Clinic Medical Center, Burlington, MA
PHARMACY
NEW Hazardous Waste Containers
YELLOW
“Soft” Hamper
Trace/Soft Chemo/Bio
 Gowns, Gloves, Chux and
soiled linens, ONLY)
YELLOW HARD
CONTAINER
Trace / Sharps
 Syringes or Sharps
 Trace amounts of Chemo /
Biotherapy; ONLY Empty syringes,
IV bags, tubing
Courtesy Lahey Clinic Medical Center, Burlington, MA
P, U, D, HD,
BLACK CONTAINE
 BULK (Larger than TRACE)
amounts of Chemo / Bio
Chemo-Spill products
Summary
• Expect increased attention to be focused on
pharmaceutical waste management
• Don’t wait for rule changes – the risk is now!
• Protect your organization and your community
• Avoid crisis mode!
Resources
•
NIOSH Hazardous Drug Alert
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•
ASHP Guidance on Handling Hazardous Drugs
–
•
http://www.practicegreenhealth.org/
Pharmaceutical waste webpage: http://www.h2e-online.org/hazmat/pharma.html
Healthcare Education Resource Center (HERC)
–
–
•
http://www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.html
Practice GreenHealth (fka Hospitals for a Healthy Environment)
–
–
•
http://www.ashp.org/s_ashp/bin.asp?CID=6&DID=5420&DOC=FILE.PDF
OSHA Technical Manual
–
•
http://www.cdc.gov/niosh/docs/2004-165/#sum
Blueprint on Pharmaceutical Waste Management (Revised)
http://www.hercenter.org/hazmat/tenstepblueprint.pdf
WM Healthcare Solutions, PharmEcology Services

–
–
www.pharmecology.com
FAQs, state and federal waste regulations, subscription search engine
PharmE™ Waste Wizard identifies RCRA hazardous waste plus NIOSH hazardous drugs, among
additional criteria
QUESTIONS?
Charlotte A. Smith, R. Ph., M.S.
Director, PharmEcology Services
WM Healthcare Solutions, Inc.
www.pharmecology.com
414-292-3959
[email protected]
Copyright 2007 PharmEcology Associates, LLC