Printable PDF: VTH Controlled Substance Surveillance Program Policy PDF

Policy

The University of Illinois Veterinary Teaching Hospital (VTH) must comply with both state and federal regulations. The use, storage, and disposal of controlled substances are regulated by the U.S. Drug Enforcement Administration (DEA) in the Code of Federal Regulations (CFR) Title 21, Part 1300-1308, by the Illinois Controlled Substance Act [720 ILCS 570)] and the Illinois Department of Financial & Professional Regulation (IDFPR) requirements. Failure to comply with the requirements of this program may result in disciplinary action, clinical appointment termination, or reports to the DEA field office and IDFPR.

The University of Illinois mandates participation in the VTH Controlled Substance Surveillance Program for all College of Veterinary Medicine DEA registrants, authorized agents, and authorized users. The program was created to help those with access to controlled substances remain compliant with both state and federal regulations.  

Activities conducted at or sponsored by the Veterinary Teaching Hospital involving controlled substances must be conducted by Registrants, Authorized Agents, or Authorized Users. Individuals accessing these substances must pass screening, complete training, and operate under the direction of a compliant registrant.

All participants must comply with all applicable Federal and State laws and regulations, VTH and University policies, procedures, and guidance related to controlled substances.

Non-compliance with the VTH Controlled Substance Surveillance Program may result in disciplinary action from the College of Veterinary Medicine, removal from clinics, and suspension of permissions for controlled substance activities, including Cubex access. Additionally, failure to follow Illinois and Federal controlled substance regulations could lead to administrative penalties, civil fines, revocation of licenses or registrations, and criminal prosecution.

Guidelines:

The VTH Controlled Substance Surveillance Program Manager will maintain oversight and compliance of the VTH Registrant, Authorized Agents, Authorized Users, and all clinical controlled substance activities, including students on rotation.

DEA Registrant

The responsible individual (VTH Hospital Director or Chief of Staff) who holds the state license and DEA registration for controlled substances used for VTH patient care and authorized activities. This individual is ultimately responsible for all activities that fall under the terms of their license and registration.

The registrant will undergo a screening process with the DEA and the State of Illinois before being granted a license and registration.

Authorized Agents

An individual affiliated with the University who has access to the secured location (e.g., Cubex, lockbox, ambulatory bag, etc.) in addition to the ability to handle the controlled substance. An authorized agent is an individual who has the complete trust of the DEA registrant and is authorized by the registrant to oversee the dispensing and control of the substances in the absence of the DEA registrant. If they have power of attorney and follow the ordering procedures described by the program, an agent may order controlled substances on behalf of the registrant.

To become an authorized agent, a screening process¹ must be completed, which includes a screening questionnaire and background check.

In the VTH, the following roles are considered authorized agents:

• Veterinary Technicians
• Animal Care Technicians (Service Aides)²
• House officers
• Faculty clinicians with a VTH appointment³
• Veterinary students working in the Medication Dispensary or as WMC team leaders
• Pharmacists
• Pharmacy Technicians
• Medication Dispensary Office Support Specialist
• Medication Dispensary Coordinator

Compliance Requirements:

• Controlled Substance Questionnaire – completed every 3 years.
• Controlled Substance Training Module – completed every 3 years.
• Active background check within the previous 5 years – performed every 5 years after that

Authorized Users

An individual who has the ability to handle controlled substances under a registrant’s license but does not have physical access to the secured location containing the bulk quantities of controlled substances. The DEA registrant or authorized agent dispenses single doses of controlled substances to the authorized user for immediate administration.

To become an authorized user, a screening process¹ must be completed, which includes a screening questionnaire.

In the VTH, the following roles are considered authorized users:

• Veterinary Assistants
• Veterinary students by the start of their 3^rd year curriculum (who aren't already authorized agents)
• Client Services Representatives (CSRs) and CSR student workers
• Storekeepers
• Locum clinicians

Compliance Requirements:

• Controlled Substance Questionnaire – completed every three years.
• Controlled Substance Training Module – completed every three years.

¹ Concerns from an Authorized Agent or User’s questionnaire and flagged background checks will be reviewed case-by-case by the VTH Controlled Substance Surveillance Program Manager, DEA Registrant, HR, and the individual’s supervisor.

² Animal Care Technicians (Service Aides) are required to complete additional training in dosage calculations and controlled substances handling prior to being granted independent access to controlled substances (e.g., Cubex). Approval is determined on a case-by-case basis by the DEA Registrant in consultation with the individual’s supervisor and/or service head.  

³ Faculty clinicians with a VTH appointment are automatically authorized to prescribe, thus assigned as Authorized Agents.  

Procedure: 

1. Authorized Agents and Authorized Users must maintain compliance with respective mandates. The VTH Controlled Substance Surveillance Program Manager will monitor the compliance status of Authorized Agents and Authorized Users and send notifications to the Agents and Users when needed.
   1. Authorized Agents and Authorized Users must complete the requirements by the deadline stated by the VTH Controlled Substance Surveillance Program Manager. Supervisors may be contacted when deadlines are approaching.  
   2. Background checks for Authorized Agents are performed at hire or implementation of the VTH Controlled Substance Surveillance Program, and approximately every 5 years after that. The VTH Controlled Substance Surveillance Program Manager will notify the Authorized Agent(s) and initiate a background check request with HR.

Definitions: 

Controlled Substance: A drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of Title 21 USC Controlled Substances Act. This term does not include distilled spirits, wine, malt beverages, or tobacco.

DEA Registrant (VTH):  The DEA license holder under whom controlled substances are purchased by the Medication Dispensary for VTH use. This individual is ultimately responsible for all activities that fall under the terms of their license and registration.

Drug Enforcement Agency (DEA): The Federal and State Agency responsible for overseeing the Controlled Substances Act (CSA) and affiliated rules.

Illinois Department of Financial and Professional Regulation (IDFPR): The Illinois state government code department that, through its operational components, oversees the regulation and licensure of various licensed professions and is charged with enforcing standards of professional practice and protecting the rights of Illinois residents in their transactions with regulated industries.

Veterinary Teaching Hospital (VTH): The collective clinical services of the Large Animal Clinic, Midwest Equine, the Small Animal Clinic, and the Veterinary Medicine South Clinic. This does not include the Medical District Veterinary Clinic (MDVC).

VTH Controlled Substance Surveillance Program Manager: The person working within the Veterinary Teaching Hospital (VTH) who implements the oversight program for all clinical controlled substance activities, including students on rotation.