Transcript Controlled Substance Act

PH:ARM – Pharmaceuticals from
Households: A Return Mechanism
Controlled Substance Act: Regulatory Barriers for A Pilot Waste
Management Program
April 18, 2008
Stan Jeppesen, Pharm.D.
Investigator
Washington State Board of Pharmacy
Regulatory Barriers
• DOT-Department of Transportation
• EPA – Environmental Protection Agency
• Regional Air Board permitting Agencies
• USPS - U.S. Postal Service
• DEA – Biggest hurdle & focus of this presentation
DEA Regulatory Issues
• Concerned with Controlled Substance
Medications (Narcotics)
• ~ 5-15% of Prescription Drugs
• Examples - Percocet, Morphine, Diazepam,
OxyContin, Xanax, Vicodin
Controlled Substance Act
• Does not allow a patient to return Controlled
Substances to pharmacist, doctor,
manufacturer or wholesaler
• Dispensing only on Prescriptions – (leaves the
DEA system)
DEA Regulatory Barriers
The Controlled Substance Act creates a
closed inventory system –
• If not a DEA Registrant -Controlled Substances can only
be transferred to law enforcement
• Does not allow patients to return Controlled Substances to
anyone (pharmacy, doctor, manufacturer, take-back
program) OTHER than law-enforcement
DEA Regulations
• DEA regulations were written before the need of
take-back program were conceived.
• DEA regulations do NOT acknowledge the
presence of waste or the need for proper disposal
PH:ARM Pilot Goals
• To make it easier to dispose of medicines
than to buy
• Locate the take back in the most convenient
location - surveys point to the the pharmacy
• Create one secure system to collect all
unwanted drugs.
What We’ve Learned from Other Countries
Existing programs in British Columbia, Australia, Europe :
• Collect high volumes of pharmaceuticals
• Are pharmacy based
• Collect Narcotics along with all other pharmaceuticals.
• Do not restrict collection due to DEA transfer restrictions
British Columbia Program
PH:ARM’s Combination Approach
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•
•
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Follow DEA Rules in “Spirit and Intention”
Address the concerns of the WABOP
Accomplish PH:ARM’s Goals
Provide security suitable for Controlled Substances
• THEN PH:ARM asked the DEA to Waive pertinent
DEA Regulations for the Pilot program
PH:ARM’s work with the DEA
• Met with the DEA in Portland and Seattle
• Provided detailed protocols, under oversight of the WA
State Board of Pharmacy, as requested by the DEA
• Conceptualized the attributes of secure containers to
address DEA security concerns
The PH:ARM Pilot Model
• Specially designed secure collection containers
• Allows for direct patient deposit of drug material.
• Drug material is NOT given to facility personnel.
• System allows for collection of Controlled and
non-Controlled material in one secure container.
The PH:ARM Pilot Model – con’t
• The system allows for complete tracking of the secure
containers (and the materials inside).
• Does NOT require item inventory of collected material.
• Utilizes existing wholesaler-distributors and retail
businesses to provide the transportation and secure
storage of collected materials.
DEA Waiver Request
Wash. Board of Pharmacy submitted request to the DEA
in March 2007 for a waiver to DEA regulations. The
request included:
• Detailed protocols describing collection and disposal
of drugs by Group Health
• Many letters of support, incl. those of Governor
Gregoire, Atty. Gen. McKenna, Senators Cantwell &
Murray, & WA State Dept of Health.
DEA Waiver Request, con’t
• No response from the DEA
• PHARM sent a letter to the DEA, announcing that the pilot
would begin without officially accepting Controlled Substances
• DEA wrote to U.S. Senators Patty Murray and Maria Cantwell
– Waiver is not possible
• DEA acknowledges this is a problem – working to change
regulations
• But, legislative changes may be needed to the C.S.A.
The Maine Approach
• Until waivers are obtained, programs can use a U.S.
Postal Service (USPS) mailer for Controlled
Substances
• State of Maine is piloting this system – mailing
Controlled Substances to a law enforcement office
• Maine also obtained a waiver from USPS regulations
Summary
• The DEA is working to change its regulations (No one disputes the need).
• PHARM is pioneering a pragmatic solution for the
secure collection and disposal of drug waste.
• Manufacturers may have the political clout to get the
pragmatic regulatory changes needed to develop a
secure and effective national take-back programs.