Controlled Substance Theft and Loss Reporting Policy

Printable PDF: Controlled Substance Theft and Loss Reporting Policy

Intent and Scope

The intent of this policy is 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 requirements. This applies to all controlled substance discrepancies within the VTH. This does not apply to MDVC.

Policy

When a controlled substance discrepancy cannot be resolved, this is considered a theft/loss of a controlled substance, and significance of this loss must be determined. All significant controlled substance discrepancies that cannot be accounted for must be reported to IDFPR and DEA inspectors within 24 hours of discovery. If the investigation is completed within a definitive resolution to the discrepancy, a DEA Form 106 is completed electronically. The VTH DEA Registrant has the final say on if a controlled substance discrepancy is considered significant with regards to requiring reporting. This determination should be made in consult with the VetMed Controlled Substance Surveillance Program Manager. If employee diversion is identified or suspected, it is the responsibility of the VTH DEA Registrant to involve HR.

Guidelines:

• Controlled substance discrepancies must be reviewed and resolved/addressed in accordance with POL-005-CS and SOP-005-CS (Controlled Substance Discrepancy Resolution).
• Discrepancies of potential significance must be brought to the attention of the DEA Registrant in accordance with POL-001-CS and SOP-001-CS (Notifying the DEA Registrant of Controlled Substance Questions and Concerns).
• Whether a discrepancy is significant or not is dependent on the drug, concentration, typical use volume, volume required for human effect, and diversion potential (e.g., street value, controlled substance schedule, etc.). When determining if a loss is significant, the VetMed Controlled Substance Surveillance Program Manager should consider VTH-specific data such as average volume/dose, range of volume/dose, and historical and recent discrepancy trends for the drug in question.
• The VTH DEA Registrant is responsible for submitting a DEA Form 106 when warranted. This should be done in consult with the VetMed Controlled Substance Surveillance Program Manager if feasible.
• All submitted DEA Forms 106 must be maintained at the VTH for at least five years with all other controlled substance documentation.

Associated SOP: Controlled Substance Theft and Loss Reporting (SOP-007-CS) 

Definitions (if applicable)

• 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 historical 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).
• VetMed Controlled Substance Surveillance Program Manager: The person working within the College of Veterinary Medicine (CVM) who is responsible for implementing the oversight program for all clinical activities including students on rotation.

Regulations (if applicable)

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."