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

Controlling Controlled Substances

Russell Griffin

McKinney Fire / EMSEMS Coordinator

Why are we here?

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.

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.

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

Schedule I

• GHB• Cannabis• Heroin• Peyote• PCP• China White

• 119 Total Listed Substances with DEA

Schedule II

• Dilaudid• Demerol• Methadone• Ritalin• Percocet

• Fentanyl• Morphine

• 64 Total listed Substances with DEA

Schedule III

• Anabolic Steroids• Codeine – some

preparations • Ketamine

• 68 Total listed Substances with DEA

Schedule IV

• Xanax• Stadol• Librium• Valium• Ativan• Versed• Ambien

• 65 Total listed Substances with DEA

Schedule V

• 7 Total listed Substances with DEA

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.

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

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.

Where are the Rules????

• Code of Federal Regulations (CFR)– Title 21 (Food and Drug)– Chapter 2 (DEA and DOJ)– Part 1300 – 1399

True or False ?

• In Texas, are we required to “double lock” our narcotics?

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.

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.

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.

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

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.

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.

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)

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.

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 …

New Rules !!!!!Texas Department of

Public SafetyNarcotics Division

Texas Narcotics – New Rules

• New Rules – Still in Review• EMS and Medical Director Registration• Geographic Registration• 3 Diversion Inspectors

Anatomy of Diversion

• December 21st – 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

Anatomy of Diversion

• January 9th – 10th, 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 10th

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.

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.

The Old System

The New System“DEA Approved”

Date # Vehicle # Box # Pouch # Seal # Key Medic / EMT Medic / EMT Captain

McKinney / Fire EMS Daily Controlled Substances Log

McKinney Fire Department Controlled Substance Accountability Form

Date: __________ Station: __________ Shift: A B C

Medic Unit: __________ Box: __________ Pouch: _________

Broken Seal # : __________ New Seal # : __________ Fentanyl : Exp-________ Lot-_________ Morphine : Exp- ________ Lot- _________ Fentanyl : Exp-________ Lot-_________ Morphine : Exp- ________ Lot- _________ Fentanyl : Exp-________ Lot-_________ Morphine : Exp- ________ Lot- _________ Fentanyl : Exp-________ Lot-_________ Morphine : Exp- ________ Lot- _________ Fentanyl : Exp-________ Lot-_________ Morphine : Exp- ________ Lot- _________

Versed : Exp-__________ Lot-___________ Versed : Exp-__________ Lot-___________ Versed : Exp-__________ Lot-___________ Versed : Exp-__________ Lot-___________ Versed : Exp-__________ Lot-___________

Paramedic 1: ___________________ Paramedic 2: ____________________

Captain: _________________________

Concentrations of controlled substances

Morphine 10mg/1cc Versed 10mg/2cc Fentanyl 100mcg/2cc

The individuals who sign this form attest to a visual inspection of all controlled substances located in the pouch stated above. Completion of this form also attests to the lack of evidence that the controlled substances in the pouch are damaged and that all tamper evident seals appear secured under visual inspection when the pouch was sealed. This form remains with the controlled substances until they are used, or expiration check day. When a new form is created the old form is sent to the EMS Coordinator.

McKinney Fire Department Controlled Substance Usage / Waste Form

Date: __________ Station: __________ Shift: A B C

Medic Unit: __________ Box: __________ Pouch: _________

Run Number : ____________________ Pt. Destination: ___________________

Controlled Substance: _________________ Lot # : ________________

Amount Administered : ____________ Amount Wasted : ___________

Controlled Substance: _________________ Lot # : ________________

Amount Administered : ____________ Amount Wasted : ___________

Reason for wasted portion : ________________________________________________________________________________________________________________________________________________________________________________________________________________________

Paramedic #1: ______________________ Paramedic #2: _______________________

Concentrations of controlled substances

Morphine 10mg/1cc Versed 5mg/5cc Versed 5mg/1cc Fentanyl 100mcg/2cc

Questions ?

Thank YOU!

• Russell Griffin• EMS Coordinator• Office : 972-547-2869• Email : [email protected]