REGULATORY REQUIREMENTS DEA LICENSED PHYSICIANS FOR. Pierce County EMS Meeting January 4, 2012

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1 REGULATORY REQUIREMENTS FOR DEA LICENSED PHYSICIANS Pierce County EMS Meeting January 4, 2012 Ruth Carter Group Supervisor Seattle Field Division Drug Enforcement Administration

2 OFFICE OF DIVERSION CONTROL To prevent, detect, and investigate the diversion of controlled substances from legitimate sources while Ensuring an adequate and uninterrupted supply for legitimate medical and scientific purposes

3 CLOSED SYSTEM OF DISTRIBUTION Investigations Established Schedules Recordkeeping Requirements Registration Security Requirements ARCOS

4 TOPICS Distribution Regulations Security Requirements Potential Actions by DEA

5 FEDERAL REGULATIONS Every person who dispenses a controlled substance shall be registered CFR (a) A separate registration is required for each principle location CFR (a) DEA Registrations are based, in part, on active state licenses

6 FEDERAL REGULATIONS The CFR & CSA do not specifically mention EMS EMS can obtain controlled substances by: Practitioner DEA Registration Hospital DEA Registration

7 FEDERAL REGULATIONS Practitioner DEA Registration Under control of Practitioner Controlled Substances provided to EMS vehicle(s) Practitioner responsible for: Receipt, Storage, Dispensing, and Security Practitioner must register at each location where: Controlled Substances are received and stored Restocking of EMS vehicles

8 FEDERAL REGULATIONS Hospital DEA Registration Example #1 - Extension EMS Vehicle owned & operated by Hospital EMS Vehicle stocked by Pharmacy or ER Considered extension of Hospital Pharmacy

9 FEDERAL REGULATIONS Hospital DEA Registration Example #2 - Agreement Private EMS Service enters into a formal written agreement with a Hospital Private EMS Service to act as Hospital s Agent Hospital supplies each EMS vehicle with a kit Replenishment as deemed necessary

10 DISPENSING Recordkeeping Requirements Inventory Acquisition Distribution Security

11 INVENTORY

12 INVENTORY 21 CFR (a) A complete and accurate record of all controlled substances on hand Must contain: The name of the substance The finished form of the substance (10mg tab) The # of units in each container (100 tab bottle) The # of containers (Four 100-tab bottles)

13 INVENTORY 21 CFR (a) Must contain BOB or COB CII Separate from CIII-V Initial Inventory First date to engage in dispensing Biennial Inventory At least once every two years

14 INVENTORY EXAMPLE DEA Biennial Inventory (Schedule II) January 1, 2012 (BOB) Dr. John Doe / DEA Registration #AB List of all Schedule II Controlled Substances The name of the substance The finished form of the substance (10mg tab) The # of units in each container (100 tab bottle) The # of containers (Four 100-tab bottles)

15 ACQUISITION

16 ACQUISITION Schedule II drugs via DEA Form-222 Must record units received & date received 21 CFR Power of Attorney Form Authorization to issue DEA Form CFR No Pre-Signed DEA Forms-222

17 ACQUISITION Schedule III-V drugs via Invoices Name, address, and DEA # of purchaser Must record units received & date received 21 CFR (d)

18 ACQUISITION EXAMPLE Date: January 1, 2012 From: Hospital ABC / DEA Registration #YZ Address: 123 Front Street, Tacoma, WA To: Dr. John Doe / DEA Registration #AB Address: 789 Back Street, Tacoma, WA List of all Schedule III-V Controlled Substances

19 ACQUISITION DEA Registrants can not accept controlled substances from patients Physicians can not write prescriptions for office stock 21 CFR (b)

20 DISTRIBUTION Dispensing Administering Transfers Theft and/or Loss Destruction / Returns Has Elvis left the building?

21 DISPENSING 21 CFR (c) General Dispensing Records: Name of the Substance Finished Form (10mg tab) & Number of Units Name & Address of the Patient Date of Dispensing Number of Units Dispensed Name or Initials of the Dispenser

22 ADMINISTERING 21 CFR (d) Must Keep Administering Records If: Regularly engage in administration & Charge patients either separately or together with other professional services

23 TRANSFERS DEA Registration is location specific Transfers / Distribution: Must be Registrant to Registrant Must be on invoice or DEA Form-222 Must be entire stock bottle Must be less than 5 percent of yearly stock

24 THEFT AND/OR LOSS 21 CFR (b) Theft and Loss Reports The registrant shall notify DEA, in writing Within one business day of discovery The registrant shall complete, and submit, DEA Form-106 regarding the loss or theft DEA Diversion Website

25 THEFT AND/OR LOSS

26 DESTRUCTION Unwanted / Expired / Tainted (Stock) Return to Vendor Reverse Distributor (Fee Based) Drug Destruction Must have DEA Authorization Must Keep Required Records

27 DESTRUCTION Waste (Patient Specific) Must Be Documented in Logs **Common Method of Diversion ** Best Practice Specific staff witness waste At least one witness / Initials on log

28 SECURITY

29 SECURITY 21 CFR (a) All registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances 21 CFR (b) Controlled substances shall be stored in a securely locked, substantially constructed cabinet

30 SECURITY Best Practices Limited Access to Controlled Substances Electronic safes Unique code / staff specific Time stamp capability

31 SECURITY 21 CFR Employees have an obligation to report drug diversion. Employers shall implement policy 21 CFR Employees who divert subject themselves to criminal prosecution.

32 SECURITY Best Practices Provide EMS Staff with: CFR & CFR Meet with EMS Staff regarding Diversion and potential consequences Employment Licensing State Prosecution Federal Prosecution

33 VIOLATIONS NOTED BY SEATTLE DEA Principle locations not registered with DEA Not maintaining proper records Tampering / Diversion Fentanyl vial contained saline (patient harm) Unfettered access to ordering No review of records by Registrant

34 POSSIBLE DEA ACTION Criminal charges Administrative sanctions Suspension / Revocation / MOA / Letters Civil fines $10,000 - $25,000 per violation of CFR / CSA

35 QUESTIONS?

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37 DOMESTIC DIVERSION OFFICES Division Offices Field Offices 21 Divisions 81 DEA Offices

38 DOMESTIC DIVERSION OFFICES Seattle Diversion Office Group Supervisor Ruth Carter Main Line Fax Line