1. 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

2. 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

3. DEA Regulatory Issues Concerned with Controlled Substance Medications (Narcotics) ~ 5-15% of Prescription Drugs Examples - Percocet, Morphine, Diazepam, OxyContin, Xanax, Vicodin

4. 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)

5. 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

6. 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

7. 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.

8. 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

9. British Columbia Program

10. PH:ARM’s Combination Approach 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

11. 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

12. 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.

13. 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.

14. 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.

15. 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.

16. 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

17. 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.