Category: Controlled Substances
Number: SOP-007-CS
Date of Last Review: 11/1/2023
Next Review Date: 11/2024

Printable PDF: Controlled Substance Theft and Loss Reporting SOP-007-CS

Purpose/ Applicability:

To describe the process of determining if a controlled substance discrepancy is significant with regards to the requirement of reporting a theft/loss, and to describe the theft/loss reporting process.

Scope:

This applies to all controlled substance discrepancies within the VTH. This does not apply to MDVC.

Associated Policy: Controlled Substance Theft and Loss Reporting Policy

Procedure:

Determining Significance of Controlled Substance Discrepancies

1. When a controlled substance discrepancy cannot be resolved as described in SOP-005-CS, this is considered a theft/loss of controlled substance, and significance of this loss must be determined.
2. The VTH Controlled Substance Surveillance Program Manager should run a report of all resolved discrepancies over the past 3 months to determine if there are trends with discrepancies involving the drug in question. Document any trends noted.
   1. Trends that should be considered include frequency, location, and employee involvement of unresolved discrepancies for the drug in question, instances of overfill being documented, and whether calculated hub loss is consistently well beyond the volume of any discrepancies.
   2. Consider whether noted trends have been consistent throughout the past 3 months or if there has been a change from one month to the next.
3. The VTH Controlled Substance Surveillance Program Manager should run a report showing all dispensations of the drug in question from the location in question over the past 1-3 months with duration determined by frequency of dispensing (i.e., high frequency of use, evaluate the past month; low frequency of use, evaluate the past three months).
   1. Remove all known errors from the data.
   2. Determine the average volume dispensed per dose, the minimum volume dispensed, and the maximum volume dispensed during the time period evaluated.
4. The VTH Controlled Substance Surveillance Program Manager should consider drug-specific characteristics of the drug in question. These include the concentration, control schedule, volume required for human effect, and diversion potential/motivation based on public health/news trends.
5. Once the evaluated described in steps 1-4 is complete, the VTH Controlled Substance Surveillance Program Manager should summarize the results of each step and their significance to the discrepancy in question and provide a final recommendation of if the loss is significant. The information in the summary should be designed to support the final recommendation. This documentation must be provided to the VTH DEA Registrant.
   1. Maintain documentation of this evaluation and the resulting recommendation as much of the information can be reused for future evaluation and the determined cutoff for significance will likely remain consistent (e.g., drug characteristics, average dose volume and volume ranges, etc. will likely remain consistent over time.)
6. The VTH DEA Registrant will review the summary and recommendation provided by the VTH Controlled Substance Surveillance Program Manager and make a final determination on if the drug loss is significant.

Reporting Significant Theft/Loss of Controlled Substances

1. When the VTH DEA Registrant determines an unsolved discrepancy is significant, they must notify IDFPR and the IL DEA field agent as well as complete a DEA Form 106 electronically.
   1. IDFPR and the IL DEA field agent must be notified within 1 business day of discovering a loss that is likely significant. This notification should include available information at that time. If the investigation is not yet completed, a follow up email must be sent at the conclusion of the investigation. This will either be the communication described in step 4 under Completing DEA Form 106, or a notification that it was determined no theft/loss occurred, so a DEA Form 106 will not be forthcoming.
      1. The current IDFPR contact is Janelle Kirby (Janelle.Kirby@illinois.gov).
      2. The current IL DEA field agent is Scott Garriott (Scott.M.Garriott@dea.gov).
   2. The DEA Form 106 must be completed at the conclusion of the investigation if a theft/loss has actually occurred. If no resolution can be identified, this is considered a loss.
      
      

Completing DEA Form 106

1. Access DEA Form 106 at https://apps.deadiversion.usdoj.gov/TLR/.
2. Follow the directions for completing the form and enter all required information.
3. Once the form is completed, print a copy to maintain with the controlled substance records, and save a PDF file to send to IDFPR and IL DEA contacts.
   1. Attach any relevant documents to the Form 106 being filed.
4. Email IDFPR and the IL DEA field agent to notify them a DEA Form 106 was submitted and provide a copy of the submitted form.
   1. If not already provided, the email notification should include a summary of what occurred and why it was determined to be significant. Also include any guesses on what may have occurred and plans to prevent future issues.

Definition(s):

• 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 Form 106: The DEA form used for reporting theft or loss of a controlled substance. This form must be completed online.
• DEA Registrant: The DEA license holder under whom controlled substances are purchased by the Medication Dispensary for VTH use.
• Discrepancy: A difference in the actual amount of drug on hand compared to the amount expected based on transaction logs.
• Drug Enforcement Agency (DEA): The Federal and State Agency responsible for overseeing the Controlled Substance 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.
• Significant Controlled Substance Discrepancy: A controlled substance discrepancy that is of a quantity which warrants reporting to the DEA as a theft/loss. The amount that constitutes a significant discrepancy is dependent on the drug and should be determined in consideration of the concentration, typical use volume, volume required for human effect, and diversion potential. VTH-specific data should also be considered such as average volume/dose, range of volume/dose, and histocial and recent discrepancy trends for the drug in question.
• 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 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

• 1301.76 (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…”
• 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."
• 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 toa 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 continue employment…”
• 1304.04 (a) Recordkeeping duration: "…every inventory and other records required to be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employees of the Administration."

State

• 3100.360 (d) Record and inventorying requirements generally: “After a loss or theft of controlled substances, a licensee shall conduct an approximate count inventory with a start date of the last inventory for the controlled substance that was either lost or stolen.”
• 3100.360 (e) Record and inventorying requirements generally: "In every instance that a licensee is required by 21 CFR 1301.76 to file with the DEA a Report of Theft or Loss of Controlled Substances (Form 106), a copy shall be sent to the Division within one business day after submission to the DEA, along with the printed name of the person who signed the form. Failure to do so may result in discipline of the licensee. This information should be sent to the Drug Compliance Unit of the Division."