PH:ARM

1
PHARM 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

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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

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DEA Regulatory Issues

• Concerned with Controlled Substance
• Medications (Narcotics)
• 5-15 of Prescription Drugs
• Examples - Percocet, Morphine, Diazepam,
  OxyContin, Xanax, Vicodin

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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)

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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

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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

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PHARM 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.

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What Weve 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

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British Columbia Program
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PHARMs Combination Approach

• Follow DEA Rules in Spirit and Intention
• Address the concerns of the WABOP
• Accomplish PHARMs Goals
• Provide security suitable for Controlled
  Substances
• THEN PHARM asked the DEA to Waive pertinent DEA
  Regulations for the Pilot program

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PHARMs 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

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The PHARM 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.

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The PHARM Pilot Model cont

• 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.

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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.

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DEA Waiver Request, cont

• 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.

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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

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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.