Update on King County’s
Secure Medicine Return Regulations
Margaret Shield, Policy Liaison
Local Hazardous Waste Management Program in King County
NW NAHMMA June 24, 2014
1
Why medicine take-back?
To protect our kids, families, and environment from leftover
medicines in our homes.
About one-third of medicines sold go unused each year –
roughly 33 million containers of medicines in WA.
Public Safety - reduce the amount of drugs available for misuse
and
Environmental Protection - keep waste medicines out of our
waterways and water supplies
Epidemic: Responding to America’s Prescription
Drug Abuse Crisis
2013 National Drug Control Strategy:
1.
Education of health providers and the public.
2.
Expand prescription monitoring programs.
3.
4.
Safe drug disposal – increase return/take-back and
disposal programs.
Effective enforcement to address
“pill mills” and “doctor shopping.”
3
Voluntary Medicine Take-Back Programs
Secure AND environmentally sound…
Some Law
Enforcement:
Some
Pharmacies:
can accept all
medicines,
including
controlled
substances.
cannot accept
controlled
substances
(currently).
Secure
Tracking &
Storage
Safe Disposal
by High
Temperature
Incineration
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National Prescription Drug
Take-Back Days
DEA-coordinated events in spring & fall
Results from Washington Events:
April 2014 – 16,677 pounds
Oct. 2013 – 14,508 pounds
April 2013 – 14,992 pounds
Sept. 2012 – 13,057 pounds
April 2012 – 13,426 pounds
Oct. 2011 – 9,502 pounds
April 2011 – 8,535 pounds
Sept. 2010 – 8,931 pounds
Barriers to a Comprehensive Medicine Takeback System in King County
• Challenges in collection of controlled substances –
help coming from new DEA regulation. (hopefully SOON!)
• Convenience and access – too few drop-off sites; too
much of county and state unserved.
• Financing – lack of dedicated & adequate funding; very
limited funding for education & promotion.
• Lack of an efficient system – no county-wide or statewide coordination.
6
DEA’s Proposed Rule
for Secure & Responsible Drug Disposal Act of 2010
New federal regulations for take-back of controlled drugs.
Draft rule published in Dec. 2012.
Waiting for final rule….STILL!
What we expect in final rule:
3 take-back methods allowed under
specific security protocols.
(1) Collection receptacles (i.e. drop-off boxes) and
(2) mail-back programs may be operated by DEA approved
retail pharmacies, drug manufacturers, drug distributors,
reverse distributors, and law enforcement.
(3) Take-back events may be conducted by law enforcement only.
7
Product Stewardship Approaches for
Medicine Take-back
Pharmaceutical manufacturers provide
medicine return systems
in B.C., Manitoba, Ontario,
France, Spain & Mexico.
“Product stewardship”
The product producer has the greatest responsibility and ability to
minimize adverse impacts of their product throughout lifecycle.
Other stakeholders, such as suppliers, retailers, and consumers
also share responsibility.
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Product Stewardship Legislation for Pharmaceuticals
in the U.S.
Federal: 2011 legislation (HR 2939 – Slaughter). No action taken.
States: legislation proposed in 9 states in recent years - CA, FL,
ME, MD, MN, NY, OR, PA, WA. None have passed yet.
Counties:
• 2010 - San Francisco, City & County considered ordinance.
Legislation tabled when PhRMA and Genentech agreed to
provide grants for city-operated program.
• July 2012 - Alameda County, CA passed a Safe Drug Disposal
Ordinance.
• June 2013 - King County Board of Health, WA passed Secure
Medicine Return Regulations.
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www.KingCountySecureMedicineReturn.org
Taylor Watson
Program
Implementation
Manager
10
King County’s Secure Medicine Return Regulation
•
Drug manufacturers whose medicines are sold in or into King County are
required to finance and provide a county-wide secure medicine return
system.
•
Collection system requirements for secure drop boxes in retail
pharmacies or law enforcement offices throughout county. Or periodic
collection events or prepaid return mailers.
•
Prescription and over-the counter medicines will be accepted. From
residential sources, not clinical or business.
•
Collected medicines must be securely handled, transported and disposed
according to federal & state laws and policies.
•
Public Health-Seattle & King County and LHWMP provide oversight to
ensure safety and compliance.
11
Timelines: Pharmaceutical Stewardship Laws in Two
Counties & Industry’s Commerce Clause Lawsuits
Alameda County, CA Safe Drug Disposal Ordinance
http://www.acgov.org/aceh/safedisposal/
July 2012
Dec. 2012
Aug. 2013
Nov. 2013
Ordinance passed
Federal lawsuit filed by 3 pharmaceutical associations
(PhRMA, GPhA, BIO)
Northern CA District Federal Judge rules in favor of
Alameda County.
Pharmaceutical associations appeal verdict to Ninth
Circuit Federal Court
King County, WA Secure Medicine Return Regulation
June 2013
Nov. 2013
Rule & Regulation passed
Federal lawsuit filed by 4 pharmaceutical associations
(PhRMA, GPhA, BIO, CHPA)
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What is the Commerce Clause?
Article 1, Section 8 of U.S. Constitution
 empowers Congress to regulate interstate
commerce.
“Dormant” Commerce Clause
 legal doctrine inferred from the Commerce Clause
 state and local governments may not unduly
interfere with interstate commerce.
13
Initial Ruling in Alameda County’s Lawsuit
U.S. District Court for the Northern District of California ruled in
favor of Alameda County’s Safe Drug Disposal ordinance:
 Does not discriminate against out-of state entities in the manner
prohibited by the dormant Commerce Clause.
 Does not directly regulate interstate commerce in the manner
prohibited by the dormant Commerce Clause.
Alameda County has “adequately shown that the Ordinance serves
a legitimate public health and safety interest, and that the
relatively modest compliance costs producers will incur
should they choose to sell their products in the county do not
unduly burden interstate commerce.”
14
Pharma Industry Associations Appeal
To Ninth Circuit
15
What
is
King
County
doing
to
implement
the
law?
Ag

Explaining the Regulations, including official notifications




Developed website & email list for interested stakeholders
Contacting obligated entities through certified mail
Consultation & technical assistance
Identifying drug producers

Drug Wholesalers required to provide list of producers to county

164 drug producers complied with a Dec. 1, 2013 deadline by providing a
“Notice of Intent to Participate in a Stewardship Plan”

Agreement with industry to extend Compliance Deadlines. King
County’s 2014 compliance deadlines have beeen extended pending decision
on Alameda lawsuit in Ninth Circuit.

Developing a fee schedule for recovery of agency costs for plan review
and oversight. Adopted by Board of Health on May 15, 2014.
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“This is about saving even just one life…if we can
dispose of cans and bottles and oil from our car
properly, why can’t we dispose of something
the size of a dime that can kill you?”
‒
Bernard Strain, whose teenage son Timothy died
last year after accidentally taking prescription
methadone pills that had been sitting in a
medicine cabinet.
New York Times, September 24, 2010
www.KingCountySecureMedicineReturn.org
To receive email updates subscribe to:
http://bit.ly/securemeds
www.TakeBackYourMeds.org
WA Medicine Take-back Sites &
Product Stewardship Information:
Margaret Shield
Local Hazardous Waste Management Program
206-477-6238 margaret.shield@kingcounty.gov
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Where are WA Medicine Take-back Sites?
Look it up at www.TakeBackYourMeds.org
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WA Secure Medicine Return Bill
Requires drug companies selling medicines
to pay for and provide a secure statewide
take-back program.
 Supported by Take Back Your Meds
Coalition
 Opposed by pharmaceutical industry
Drug companies should step up to disposal problems
Feb. 7, 2012
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Examples of Producer Stewardship Programs for
Take Back of Other Hazardous Products







Electronic Waste
Mercury lights (CFLs & Fluorescent tubes)
Rechargeable Batteries
Paint
Auto Switches
Mercury Thermostats
Cell Phones
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