Medication Take Back Programs and the DEA Regulations

Transcription

1 Medication Take Back Programs and the DEA Reglations Jeanie Jaramillo-Stametz, PharmD Director, Medication Cleanot Managing Director, Texas Panhandle Poison Center Assistant Professor, Texas Tech University Health Sciences Center, School of Pharmacy

2 My Backgrond 2001 gradate of Tx Tech School of Pharmacy Completed drg information residency in 2002 Began position as director of poison center in 2003 Started med take back program in 2009 To date, have condcted 49 med take back events across the Texas panhandle Non-controlled sbstances = 32,245 ponds Controlled sbstances = 2,231 ponds Sharps = 1,792 ponds

3 Objectives Review the DEA rles regarding medication take-back programs Determine reqirements for law enforcement presence at take-back events Discss srveys and otcome measres as they pertain to take-back programs Develop a strategy for gaining law enforcement assistance

4 Medication Take Back Rles & Reglations to Consider State Board of Pharmacy Law Enforcement Environmental Reglations Department of Transportation Federal vs. State Whichever is more strict is typically the one to apply In many cases, there are no rles/regs specific to take back programs

5 Drg Enforcement Administration Code of Federal Reglations Part 1300

6 I am not a representative of the DEA. The views presented here are my views and interpretations only, and do not necessarily represent those of the DEA.

7 DEA Rles Rles related to medication take back and disposal are based on the Controlled Sbstances Act (Title 21 United States Code) Code of Federal Reglations: Part 1317 Disposal ( tml)

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9 Part Disposal Sbpart A is for registrants (pharmacies, reverse distribtors, etc. that are registered with DEA) Sbpart B is for disposal from ltimate sers and other non-registrants (this is relevant to most take-back programs) Who is eligible to collect controlled sbstances from nonregistrants? (2) Federal, State, tribal, or local law enforcement when in the corse of official dties and prsant to How do we fit into this? We operate in conjnction with local law enforcement (not secrity gards or secrity teams, bt certified peace officers)

10 Part Disposal Collection by law enforcement Federal, State, tribal, or local law enforcement may collect controlled sbstances from ltimate sers sing the following methods: Take back events in accordance with Law enforcement that condcts a take back event shold maintain any records of removal, storage, or destrction consistent with that agency s recordkeeping reqirements for illicit controlled sbstances evidence

11 Take Back Events Any person may partner with law enforcement to hold a collection take-back event in accordance with this section Law enforcement will appoint a law enforcement officer employed by the agency to oversee the collections (and) shall maintain control and cstody of the collected sbstances from the time the sbstances are collected from the ltimate ser ntil secre transfer, storage, or destrction Only those controlled sbstances listed in Schedle II, III, IV, or V may be collected Only persons entitled to dispose of an ltimate ser decedent s property may transfer sch sbstances to law enforcement dring the take-back event.

12 Where to find more details Title 21 of the CFR is brief The fll docment can be fond at: 9/ /disposal-of-controlled-sbstances This docment is primarily in Q & A format Answers many qestions related to specifics of take back events

13 Can we inventory items accepted at take-back events? J. Prohibition on Handling, Sorting, and Inventorying Inner Liner Contents and Mail-Back Package Contents (8 Isses) Prsant to , law enforcement may contine to condct take-back events when a law enforcement officer maintains control and cstody of collected sbstances at takeback events and only the ltimate ser transfers controlled sbstances to law enforcement control and cstody. However, non-law enforcement personnel may assist the law enforcement officer, and the final rle does not prohibit healthcare professionals from volntarily polling ltimate sers abot the sbstances they are discarding or from assisting ltimate sers to separate pharmacetical controlled sbstances from non-controlled sbstances dring the disposal process, and inventorying the non-controlled sbstances.

14 Frthermore, nothing in this rle prohibits law enforcement from partnering with athorized collectors or other entities to inventory or sort sbstances that have been collected by law enforcement provided that the collected sbstances remain nder the control and cstody of law enforcement. This final rle in (b) reqires that law enforcement maintain control and cstody of the collected sbstances from the time the sbstances are collected ntil secre transfer, storage, and destrction has occrred. Therefore, if law enforcement opts to inventory or sort collected sbstances within their possession, law enforcement shold provide adeqate secrity to prevent diversion or theft of controlled sbstances within their possession and control as a reslt of, or dring, inventorying or sorting

15 Approach to Law Enforcement Have a clear plan before yo make contact Be prepared to ask for what yo need 1 certified peace officer to provide oversight and maintain control & cstody of controlled sbstances; additional officers? Are yo willing to pay for officers? Will they need to remove collections at conclsion of event? Everything vs. jst controlled sbstances Hold ntil DEA can pick p

16 Can we condct crbside srveys? the final rle does not prohibit healthcare professionals from volntarily polling ltimate sers abot the sbstances they are discarding. Gidance from individal DEA representatives varies and some state that information shold not be collected, however, according to the rle, this is not prohibited

17 Why srvey? Why collect data? Many programs need otcome measres to report to fnding agencies Weight collected Srvey data Inventory Collected data can help facilitate change on a broad scale

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20 Qestions? Contact Information Jeanie Jaramillo-Stametz (806)