Transcript Presentation - Product Stewardship Institute

PHEDERAL PHARMACEUTICAL
ALPHABET SOUP
DOT • EPA • DOJ • FDA • USPS • ONDCP • CSA
Federal Touchstones for
State Medicine Return Policy
The 5th National Product Stewardship Forum and the 2009 Northwest Hazardous Materials
Conference for Household and Small Business Programs Hyatt Olive 8 Hotel ~ Seattle,
WA June 1-4, 2009
Presented By: David Stitzhal
Northwest Product Stewardship Council & Full Circle Environmental, Inc.
Overview
• There is a lot going on federally
that interacts with state policy
development and program
design for management of
unwanted medications.
Overview
• There is a lot going on federally that interacts with
state policy development and program design for
management of unwanted medications.
• Pharmaceuticals -- more than
most products at end-of-life -are regulated, or otherwise
overseen, by several federal
agencies and statutes.
Overview
• There is a lot going on federally that
interacts with state policy development
and program design for management of
unwanted medications.
• Pharmaceuticals -- more than most
products at end-of-life -- are regulated or
otherwise overseen by several federal
agencies and statutes.
• This presentation provides a
snapshot of issues from a handful
of federal agencies.
Overview
• There is a lot going on federally that
interacts with state policy development
and program design for management of
unwanted medications.
• Pharmaceuticals -- more than most
products at end-of-life -- are regulated or
otherwise overseen by several federal
agencies and statutes.
• This presentation provides a snapshot of
issues from a handful of federal agencies.
• Some substantial progress has
already been made against
seemingly intractable obstacles.
DEPARTMENT OF TRANSPORTATION
– Once you have collected unwanted medications
through a take-back program, you have to ship
them for disposal.
More specifically……
• Household hazardous waste that is pharmaceutical waste
should be shipped under:
Medicine, solid/ liquid, toxic, n.o.s. (not otherwise specified),
division 6.1 or Consumer Commodity ORM-D (if in the
original consumer package) defined in 49 CFR 173.144.
ORM-D includes medications. The volume limit for ORM-D is
66 lbs.
– Unpackaged medicine, solid/liquid, toxic, n.o.s. had a
shipping limit of 11 lbs (solid).
–
Progress:
– For mixed pills that had been taken out of their
consumer packaging (loose pills) the PH:ARM
take-back program in Washington was using the
DOT designation of “Medicine, Solid, Toxic, Not
Otherwise Specified”.
Progress:
– For mixed pills that had been taken out of their
consumer packaging (loose pills) the PH:ARM
take-back program in Washington was using the
DOT designation of “Medicine, Solid, Toxic, Not
Otherwise Specified”.
– Materials shipped under this designation had
been limited to 11 lbs (about 1/3 of a 5 gallon
bucket).
Progress:
– For mixed pills that had been taken out of their
consumer packaging (loose pills) the PH:ARM
take-back program in Washington was using the
DOT designation of “Medicine, Solid, Toxic, Not
Otherwise Specified”.
– Materials shipped under this designation had
been limited to 11 lbs (about 1/3 of a 5 gallon
bucket).
– DOT has removed that special provision from 3
medicine shipping names. The 11 pound limit no
longer applies. (We changed a federal reg.!)
Drug Enforcement Administration
• The Primary Roadblock:
Drugs specified by the Controlled
Substances Act can not currently be
accepted by anyone other than the
DEA or law enforcement officials.
Drug Enforcement Administration
• The Primary Roadblock: Drugs specified by the
Controlled Substances Act can not currently be
accepted by anyone other than the DEA or law
enforcement officials.
• The public doesn’t know which drugs
are controlled substances.
Drug Enforcement Administration
• The Primary Roadblock: Drugs specified by the
Controlled Substances Act can not currently be
accepted by anyone other than the DEA or law
enforcement officials.
• The public doesn’t know which drugs
are controlled substances.
• There are challenges with arranging
for law enforcement presence, and
they arguably should not be spending
their time collecting used medication.
Drug Enforcement Administration
• The Primary Roadblock: Drugs specified by the
Controlled Substances Act can not currently be
accepted by anyone other than the DEA or law
enforcement officials.
• The public doesn’t know which drugs are
controlled substances.
• There are challenges with arranging for
law enforcement presence, and they
arguably should not be spending their
time collecting used medication.
• It is inefficient and impractical to collect
controlled’s and other medication
separately.
Change on the
Horizon
• The DEA – through an Advance Notice of Proposed Rulemaking (ANPRM)
issued January 21, 2009 -- has solicited opinions and responses to a set of
questions for input on managing unwanted medications.
• The PSI Regulatory Workgroup (under the National Pharmaceuticals
Dialogue) helped organize joint and individual agency comments to the
ANPRM.
• REMINDER: There are limited legal options for collecting controlled
substances from the public.
• Law enforcement presence at collection sites.
• Mail-back to authorized law enforcement receiver, such as the DEA program in
Maine.
Proposed Inslee Bill
• Representative Inslee (D-WA) [with Representative Moran (D-VA)]
introduced a bill to establish the Safe Drug Disposal Act of 2009.
• Purpose: “To amend the Controlled Substances Act to provide for
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 disposal by flushing…”
• Referred to two Subcommittees: Energy & Commerce and
Judiciary. No hearings currently scheduled.
Safe Drug Disposal Act of 2009
H.R. 1191
(proposed)
• 2/25/2009--Introduced. Amends the Controlled
Substances Act:
(1) authorizes an ultimate user or care taker to dispose of a
controlled substance in accordance with a prescribed state
program;
(2) includes five model state programs providing for such
disposal through delivery to a designated facility; and
(3) allows a state to work with the Attorney General to
devise an alternative disposal program that is consistent
with this Act.
Safe Drug Disposal Act 2009
(continued)
Requires each such program to:
(1) enact state legislation as a prerequisite to its adoption and
implementation;
(2) protect the public safety;
Safe Drug Disposal Act 2009
(continued)
Requires each such program to:
(1) require a state to enact legislation as a prerequisite to its adoption and implementation;
(2) protect the public safety;
(3) allow disposal of controlled substances through persons
other than law enforcement personnel;
(4) incorporate environmentally sound practices for disposal;
(“by means other than flushing down a public or private
wastewater treatment system or disposing in a municipal
solid waste landfill”)
Safe Drug Disposal Act 2009
(continued)
Requires each such program to:
(1) require a state to enact legislation as a prerequisite to its adoption and implementation;
(2) protect the public safety;
(3) allow disposal of controlled substances through persons other than law enforcement personnel;
(4) incorporate environmentally sound practices for disposal; (“by means other than flushing down a public or
private wastewater treatment system or disposing in a municipal solid waste landfill”)
(5) be cost-effective;
(6) include convenient take-back options for urban and rural
locations; and
(7) not restrict the funding a state may use to implement it.
Food & Drug Administration
• FDA worked with the White House Office of
National Drug Control Policy (ONDCP) to
develop consumer guidance for proper
disposal of prescription
drugs.http://www.fda.gov/consumer/updates/drug_disposal062308.h
tml
• There is no requirement that disposal
information be included or excluded in the
labeling.
Current FDA Guidance:
• Flush these: Actiq (fentanyl citrate), Daytrana Transdermal
Patch (methylphenidate), Duragesic Transdermal System
(fentanyl), OxyContin Tablets (oxycodone), Avinza Capsules
(morphine sulfate), Baraclude Tablets (entecavir) Reyataz
Capsules (atazanavir sulfate), Tequin Tablets (gatifloxacin),
Zerit for Oral Solution (stavudine), Meperidine HCl Tablets,
Percocet (Oxycodone and Acetaminophen), Xyrem (Sodium
Oxybate), Fentora (fentanyl buccal tablet)
Flush-recommended drugs are mostly
controlled substances.
FDA is concerned about diversion.
Recent Triumphs
• Through work growing out of the PSI National
Dialogue, the FDA changed the priority order of
their recommendations for drug disposal.
1)Don’t flush (except for the listed drugs)
2)Use take-back programs
3)Adulterate
4)Seal and dispose
A Sample of Remaining Issues
• Fentanyl patches (on the flush list) are a
problem for wastewater treatment plants and
on-site septic systems.
• Many groups are advocating for a no-flush
policy for all medications.
EPA, THE UNIVERSAL
WASTE RULE and RCRA
What is the Universal Waste Rule?
The universal waste rule (UWR) streamlines hazardous
waste management standards for certain designated
hazardous wastes, which are referred to as universal
wastes (UW).
Why have a
Universal Waste Rule?
A universal waste is still a hazardous waste, but the
generator requirements are simplified in order to:
• Promote the collection of these wastes;
• Promote the proper recycling, treatment or
disposal of these wastes; and
• Reduce the burden on businesses.
27
What Are the Current Federal Universal Wastes?
• Batteries, pesticides, mercury-containing equipment
(MCEs), and lamps
What Are the Current Federal Universal Wastes?
• Batteries, pesticides, mercury-containing equipment (MCEs),
and lamps
• Why are these wastes special?
 Compared to other hazardous wastes, these wastes are
relatively low-risk during accumulation and transport.
 They are frequently generated in a wide variety of settings.
 They are generated by a vast community
 Present in significant volumes in non-hazardous waste
management systems (e.g., household trash).
So what about unwanted medicines and the
Universal Waste Rule?
• To answer this we have to take a side trip to RCRA, the
Resource Conservation and Recovery Act.
RCRA
30
So what about unwanted medicines and the
Universal Waste Rule?
• To answer this we have to take a side trip to RCRA, the Resource
Conservation and Recovery Act.
• Currently, hospitals that generate pharmaceutical
wastes on RCRA’s so-called P- and U-lists (e.g.,
warfarin, physostigmine, and chemotherapy drugs)
are classified as hazardous waste generators.
However, these lists have not been updated since
RCRA was written in the 1970’s, despite dramatic
expansion of the universe of pharmaceuticals.
31
So what about unwanted medicines and the
Universal Waste Rule?
• To answer this we have to take a side trip to RCRA, the Resource
Conservation and Recovery Act.
• Currently, hospitals that generate pharmaceutical wastes on RCRA’s P- and
U-lists (e.g., warfarin, physostigmine, and chemotherapy drugs) are
classified as hazardous waste generators. However, these lists have not
been updated since RCRA was written in the 1970’s, despite dramatic
expansion of the universe of pharmaceuticals.
• Some pharmaceuticals have ingredients with
characteristics that cause them to ‘designate’ as
hazardous waste when disposed, even if they are not
on the P or U lists.
32
So what about unwanted medicines and the
Universal Waste Rule?
•
•
•
To answer this we have to take a side trip to RCRA, the Resource Conservation and
Recovery Act.
Currently, hospitals that generate pharmaceutical wastes on RCRA’s P- and U-lists (e.g.,
warfarin, physostigmine, and chemotherapy drugs) are classified as hazardous waste
generators. However, these lists have not been updated since RCRA was written in the
1970’s, despite dramatic expansion of the universe of pharmaceuticals.
Some pharmaceuticals have ingredients with characteristics that cause them to
‘designate’ as hazardous waste when disposed, even if they are not on the P or U lists.
• Note: pharmaceutical waste generated by households is
exempt from the state Dangerous Waste and the federal
RCRA rules. However, local jurisdictions responsible for
municipal waste management may disallow household
hazardous waste from regular solid waste, septic, or sewer
disposal routes, as in the case of Snohomish County, Kitsap
County, and the City of Seattle.
• EPA, Pharmaceuticals and U-Waste:
http://www.epa.gov/waste/hazard/wastetypes/universal/pharm.htm
33
So what about unwanted medicines and the
Universal Waste Rule?
•
•
•
•
To answer this we have to take a side trip to RCRA, the Resource Conservation and Recovery Act.
Currently, hospitals that generate pharmaceutical wastes on RCRA’s P- and U-lists (e.g., warfarin,
physostigmine, and chemotherapy drugs) are classified as hazardous waste generators. However,
these lists have not been updated since RCRA was written in the 1970’s, despite dramatic expansion
of the universe of pharmaceuticals.
Some pharmaceuticals have ingredients with characteristics that cause them to ‘designate’ as
hazardous waste when disposed, even if they are not on the P or U lists.
Note: pharmaceutical waste generated by households is exempt from the state Dangerous Waste
and the federal RCRA rules. However, local jurisdictions responsible for municipal waste
management may disallow household hazardous waste from regular solid waste, septic, or sewer
disposal routes, as in the case of Snohomish County, Kitsap County, and the City of Seattle.
• “Approximately 4-5 percent of pharmaceutical products
designate under the federal RCRA regulations as hazardous
waste. If RCRA P and U lists were updated to include
comparable products developed in the last 30 years, the
number of products designating as hazardous waste would
approach 15%.” Charlotte Smith, Founder of PharmEcology
• EPA, Pharmaceuticals and U-Waste:
http://www.epa.gov/waste/hazard/wastetypes/universal/pharm.htm
34
Reasons to Manage all Consumer TakeBack Drugs Under the U-Waste Rules
and as Hazardous Waste
• Nursing homes could dispose of medicines with
a U-Waste reverse distributor.
• Best management practice for the environment.
Reasons to Manage all Consumer TakeBack Drugs Under the U-Waste Rules
and as Hazardous Waste?
• Nursing homes could dispose of medicines with a
U-Waste reverse distributor.
• Best management practice for the environment.
• Meets the intent of RCRA.
• Too difficult to separate into hazardous
and non-hazardous during collection.
Reasons to Manage all Consumer TakeBack Drugs Under the U-Waste Rules
and as Hazardous Waste?
• Nursing homes could dispose of medicines with a U-Waste reverse
distributor.
• Best management practice for the environment.
• Meets the intent of RCRA.
• Too difficult to separate into hazardous and non-hazardous during
collection.
• Tighter security and tracking to prevent
diversion.
• Most medicines in Washington State
designate as state only dangerous waste
(hazardous waste).
UNITED STATES
POSTAL SERVICE
• Issues include:
– Postal regulations vis-à-vis drug mailback programs.
– Cost of mailers and postage.
– Management of controlled
substances (align with other reg’s).
– Options for viable/ legal recipients
(e.g. DEA agents; deputized haz.
waste incinerators; reverse
distributors).