Category: Controlled Substances
Number: SOP-001-CS
Date of Last Review: 11/1/2023
Next Review Date: 11/2024

Printable PDF: Notifying the DEA Registrant of Controlled Substance Questions and Concerns SOP-001-CS

Purpose/ Applicability:

To define the process of responding to controlled substance-related communication that is initially received by Medication Dispensary Staff.

Scope:

This SOP applies to all controlled substance–related communication received by Medication Dispensary staff.

Associated Policy: Notifying the DEA Registrant of Controlled Substance Questions and Concerns Policy

Procedure:

1. The Pharmacy Coordinator will determine which controlled substance–related communication is addressed by Medication Dispensary Staff versus sent to the VTH Controlled Substance Surveillance Program Manager based on the following principles.
   1. Communication pertaining to controlled substances relevant to daily staffing activities with the Medication Dispensary will be addressed by Medication Dispensary Staff at the direction of the Pharmacy Coordinator.
      
      
   2. When controlled substances are/may be lost or missing, the situation will be shared with the VTH Controlled Substance Surveillance Program Manager after due diligence has been completed or within 12 hours of the determination that a controlled substance is not readily accounted for.  Context must be provided regarding the situation and what has been done so far. This should include the following:
      1. Summary of the issue and the names of those involved and if they are an Authorized Agent or Authorized User.
      2. A description of what has been reviewed (e.g., transaction logs, security camera footage, etc.) and the result of those reviews.
      3. Hypothesis of what may have occurred and the level of confidence in that hypothesis.
      4. Recommendations for next steps and if reporting to the DEA may be required.
         
         Based on the information provided, the VTH Controlled Substance Surveillance Program Manager will pursue additional investigation, if necessary, in accordance with POL-005-CS and SOP-005-CS (Controlled Substance Discrepancy Resolution) and make a final recommendation to the VTH DEA Registrant on reporting to the DEA and/or CVM HR personnel. If reporting is necessary, it will be done in accordance with POL-006-CS and SOP-007-CS Controlled Substance Theft and Loss Reporting.
         
         
   3. Communication regarding questions about controlled substance regulations and hospital policy including but not limited to appropriate licensing requirements, expiration and renewal, potential misuse, and compliance with the UIUC Policy on the Use of Controlled Substances will be addressed by the Pharmacy Coordinator through review of policies and SOPs. If there is not sufficient documentation of appropriate action in approved policies/SOPs, then the question will be shared with the VTH Controlled Substance Surveillance Program Manager to make an appropriate determination or involve the VTH DEA Registrant if necessary. The VTH Controlled Substance Surveillance Program Manager and the VTH DEA Registrant will consider the following as appropriate/necessary when making a determination:

1. 1. 1. Review of applicable laws and regulations.
      2. Consultation with DEA Field Agents.
      3. Consideration of risk.

Definition(s):

• Authorized Agent: A person authorized by the DEA registrant to have access to controlled substances in quantities larger than a single dose. In the VTH, this includes but is not limited to Medication Dispensary Staff, Veterinary Technicians, Clinicians, and WMC Team Leaders.
• Authorized User: A person authorized by the DEA registrant to have access to single doses of controlled substances for administration and/or transport but do not have access to stock bottles. In the VTH, this includes but is not limited to Veterinary Students in all four years of the DVM program, Affiliate Year Students, and Veterinary Assistants. 
• Automated Dispensing Cabinet (ADC): The drug dispensing cabinet used within the VTH. (E.g., Cubex and Omnicell).
• 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.
• Controlled Substance-Related Communication: Any communication (verbal or written) that pertains to a controlled substance.
• Controlled Substance Surveillance Program Manager: The person working within the Division of Research Safety (DRS) who is responsible for implementing the oversight program for controlled substance use in research.
• Drug Enforcement Agency (DEA): The Federal and State Agency responsible for overseeing the Controlled Substance Act (CSA) and affiliated rules.
• DEA Registrant: The DEA license holder under whom controlled substances are purchased by the Medication Dispensary for VTH use.
• Transaction Logs: Documentation pertaining to controlled substance access, administration, and wasting. This includes but is not limited to Automated Dispensing Cabinet (ADC) logs, paper logs, and patient charts.
• Medication Dispensary Staff: Pharmacists, pharmacy technicians, pharmacy students, and veterinary students working or completing a rotation in the Medication Dispensary.
• Pharmacy Coordinator: The pharmacist acting as the Pharmacist in Charge (PIC). This person is responsible for the oversight of all Medication Dispensary operations ensuring all legal requirements are met.
• UIUC Policy on the Use of Controlled Substances: Campus Administrative Manual (CAM) policy governing the use and oversight of controlled substances in all University activities. Compliance with this policy is overseen by a Controlled Substance Surveillance Program Manager in conjunction with the Division of Research Safety (DRS), and the VTH Controlled Substance Surveillance Program Manager.
• 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 is responsible for implementing the oversight program for all clinical controlled substance activities, including students on rotation.

Applicable Regulations:

Federal

• 1301.91 Employee responsibility to report drug diversion: “…an employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer… A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area.”
• 1301.92 Illicit activities by employees: “…employees who possess, sell, use or divert controlled substances will subject themselves not only to State or Federal prosecution for any illicit activity, but shall also immediately become the subject of independent action regarding their continued employment…”
• 1301.76 (b) Other security controls for practitioners: “The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft…” Form must be submitted electronically.
• 1301.76 (b) (1-6) Determining if a loss is significant: “When determining whether a loss is significant, a registrant should consider, among others, the following factors:
  • The actual quantity of controlled substances lost in relation to the type of business;
  • The specific controlled substances lost;
  • Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
  • A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and if known,
  • Whether the specific controlled substances are likely candidates for diversion;
  • Local trends and other indicators of the diversion potential of the missing controlled substance.”