a5be103b001882d6c24cb61e1420f818.ppt
- Количество слайдов: 17
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, Oxy. Contin, 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 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 • • 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 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. Mc. Kenna, 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.