1. Controlling Controlled Substances Russell Griffin McKinney Fire / EMS EMS Coordinator

2. Why are we here?

6. What is a controlled substance? A controlled substance is a drug or chemical whose manufacture, possession and use are regulated by a government. The Drug Enforcement Administration is responsible for suppressing illegal drug use and distribution by enforcing the Controlled Substances Act.

7. Controlled Substances Act Enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The CSA is the legal basis by which the manufacture, importation, possession, and distribution of certain drugs are regulated by the federal government of the United States.

9. Scheduled Drugs Schedule 1 – Highly Addictive – No Medical Use Schedule 2 – Highly Addictive – Medical use with extreme restrictions Schedule 3 – Moderate Potential for Abuse Schedule 4 – Lower Potential for Abuse in relation to drugs in Schedule 3 Schedule 5 – Lower Potential for Abuse in relation to drugs in Schedule 4

10. Schedule I GHB Cannabis Heroin Peyote PCP China White 119 Total Listed Substances with DEA

11. Schedule II Dilaudid Demerol Methadone Ritalin Percocet Fentanyl Morphine 64 Total listed Substances with DEA

12. Schedule III Anabolic Steroids Codeine – some preparations Ketamine 68 Total listed Substances with DEA

13. Schedule IV Xanax Stadol Librium Valium Ativan Versed Ambien 65 Total listed Substances with DEA

14. Schedule V 7 Total listed Substances with DEA

17. The LAW Who really governs controlled substances? Who really enforces controlled substances? Where can we find rules? Where can we find regulations? Commonly “unknown” questions and answers regarding controlled substances.

18. The State of Texas Texas Department of Public Safety –Issues Texas “Controlled Substances License” –Conduct investigation regarding diversion –Texas Rangers Texas Controlled Substances Act –Similar to Federal Act Texas Department of State Health Services –Controlled substances are not specifically addressed under Texas Administrative Code Title 25, Part 1, Chapter 157 - EMS

19. The Federal Government Drug Enforcement Agency –Office of Diversion Control –Dallas Field Division – 5 Offices –Investigation, Enforcement of Drug Diversion at the Federal level. –Excellent resource, however attention not specifically drawn towards EMS.

20. Where are the Rules???? Code of Federal Regulations (CFR) –Title 21 (Food and Drug) –Chapter 2 (DEA and DOJ) –Part 1300 – 1399

21. True or False ? In Texas, are we required to “double lock” our narcotics?

22. Rules to Know Part 1301.75 – Physical Security Controls –Controlled substances listed in schedules II-V shall be stored in a securely locked, substantially constructed cabinet. –However, practitioners may disperse such substances throughout the stock of non- controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

23. Rules to Know Part 1301.91 – Employee responsibility to report drug diversion –It is the position of DEA that an employee who has knowledge of drug diversion by a fellow employee has an obligation to report such information to a responsible security official of the employer.

26. Rules to Know Part 1304.04 – Maintenance of records and inventories. –Records must be kept for up to two years from the date of such inventory of record for inspection and copying by authorized by the Administrator. –Records must be kept at the registered location and available for inspection.

27. Rules to Know Part 1305 – Order Forms –Rules Regulation DEA Form 222 –Persons entitled to order –Rules regarding Power of Attorney –Procedures for obtaining –Procedures for executing –Procedure for endorsing –Unaccepted or defective forms –Lost or Stolen Forms –Preservation of Forms –Return of unused Forms –Cancellation and Voiding of order forms

28. Rules to Know Part 1307.21 – Disposing of controlled substances –This part refers to expired substances. –This portion is typically unknown to EMS. –Requires direct communication with local Special Agent in Charge.

29. Disposal of Controlled Substances Part 1307.21 –Section (a) any person who requires destruction of a controlled substance may request assistance from the regional Special Agent in Charge!!! –Section (a-1) complete DEA Form 41 and submit in triplicate to the regional office two weeks prior to the scheduled destruction.

32. Disposal of Controlled Substances Part 1307.21 –Section (b) The Special Agent in Charge shall authorize and instruct the applicant to dispose of the controlled substance in one of the following means: –Section (b-1) by transfer to a person registered under the Act and authorized to possess the substance. (Reverse Distributor) –Section (b-2) by delivery to an agent of the administration or the nearest office. (Agent) –Section (b-3) by destruction in the presence of an agent of the Administration or other authorized person. (Police)

33. Disposal of Controlled Substances Part 1307.21 – Section (b-1) “Authorized person” = Reverse Distributor Commercial Business Several across the U.S. Must be DEA “accredited” Most won’t mess with little fish. i.e. – EMS They process your scheduled substances and issue you a DEA 222 form for Schedule II.

34. Disposal of Controlled Substances Part 1307.21 – Section (b-3) Destruction in the presence of an agent or one person who is authorized. Local Police Department EPA only allows incineration EPA will not allow wasting down a sink, trash can, biohazard box, concrete, evaporation …

35. New Rules !!!!! Texas Department of Public Safety Narcotics Division

36. Texas Narcotics – New Rules New Rules – Still in Review EMS and Medical Director Registration Geographic Registration 3 Diversion Inspectors

38. Anatomy of Diversion December 21 st – 24th, 2005 –Expired controlled substances within our main storage facility were noticed to have damaged seals. –Immediately reported, and inspection began. –All controlled substances were pulled and replaced –Random samples sent for analysis

39. Anatomy of Diversion January 9 th – 10 th, 2006 –Lab report – “all vials have been diluted or completely replaced with saline.” –63 Total Tampered Products –Internal investigation immediately began with McKinney PD, coordinated with DEA, DSHS, Texas Rangers etc… –Interviews began and confession was received on Jan 10 th

40. Anatomy of Diversion After action- –Were diluted or replaced controlled substances live on our ambulances? –Were patients administered diluted or replaced controlled substances during routine patient care. –6 – Month Retroactive case study began evaluating all patients who received controlled substances. –Did a patient suffer a non-desired outcome from possibly receiving tampered medication.

41. Anatomy of Diversion Weak Points – Where we failed –Mass storage of expired controlled substances. –Medication packaging and preparation. –Crew education regarding seals. –MICU Security. –Main warehouse security. –Documentation –Lack of familiarization with State / Federal law. –Random retroactive verification process.

42. The Old System

43. The New System “DEA Approved”

56. Questions ?

57. Thank YOU! Russell Griffin EMS Coordinator Office : 972-547-2869 Email : rgriffin@mckinneytexas.org