Controlled Substance Discrepancy Resolution Policy
Implementation Date: 10/24/2023
Date of Last Review: 11/12/2023
Next Review Due: 11/2024
Reviewed by VetMed Controlled Substance Surveillance Program Manager & VTH Director: 11/2023
Reviewed by VTH Board: N/A
Reviewed by Legal Counsel: N/A
Reviewed by Biosecurity Subcommittee: N/A
Printable PDF: Controlled Substance Discrepancy Resolution Policy
Intent and Scope
The intent of this policy is to describe the process of investigating, resolving, and documenting controlled substance discrepancies. This applies to all controlled substance discrepancies identified within the VTH. This does not apply to MDVC.
All controlled substance inventory discrepancies will be addressed by a pharmacist within one business day of discovery. The pharmacist addressing the discrepancy will review all relevant logs including but not limited to ADC transaction logs, paper logs, order and receipt history, patient records, prescription records, and ADC stocking history. If the cause of the discrepancy cannot be identified with full confidence based on logs, camera footage will be reviewed to assist in identifying the cause of the discrepancy.
The reason for the discrepancy must be documented and maintained for a minimum of five years. If the discrepancy was created in the ADC system, the resolution documentation will be added to the notes when the discrepancy is resolved. If the discrepancy is associated with an item outside the ADC system, the resolution will be documented on the drug log associated with that vial. Any discrepancies that cannot be documented by one of those two methods, will be documented on the Discrepancy Resolution Spreadsheet maintained within the VTH Medication Dispensary.
When trends are identified that show either a particular person, service, or cause of the discrepancy, the Pharmacy Coordinator and the VetMed Controlled Substance Surveillance Program Manager will work with the VTH DEA Registrant to identify an appropriate method of addressing the trend through retraining, process improvements, and/or disciplinary action as appropriate.
- Controlled substances will be cycle counted as outlined in SOP-002-CS (Drug Kit Use, Inventory and Stocking), SOP-003-CS (Ambulatory Bag Use, Inventory and Stocking), and SOP-006-CS (Maintaining the Automated Dispensing Machine (Cubex).
- Controlled substance discrepancies will be communicated to the VTH DEA Registrant as outlined in POL-001-CS and SOP-001-CS (Notifying the DEA Registrant of Controlled Substance Questions and Concerns).
- Controlled substance discrepancy resolution will be reviewed monthly by the VetMed Controlled Substance Surveillance Program Manager as outlined in POL-004-CS (VTH DEA Registrant Responsibilities).
- Failure to accurately document all discrepancy resolutions may result in failure to meet the Federal Regulations regarding employee responsibility to report drug diversion. The regulations are Title 21 CFR Chapter II Drug Enforcement Administration, Department of Justice Parts 1301.91, 1301.92, and 1301.76(b) which are described below.
Associated SOP: Controlled Substance Discrepancy Resolution (SOP-005-CS)
Definitions (if applicable)
- Automated Dispending 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.
- 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.
- Discrepancy Resolution Spreadsheet: An Excel document for tracking controlled substance discrepancies and their eventual resolution when documentation on the transaction log (paper log or ADC log) is not feasible. The document is a required controlled substance record and as such, must be maintained for a minimum of five years.
- 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.
- 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.
- 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).
- 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)
- 1301.71 (a) Security requirements generally: "All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances…"
- 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…”
- 1301.91 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 continued 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."
- 1304.21 (a, b, e) General recordkeeping requirements: "...Shall maintain, on a current basis, a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him/her…Separate records shall be maintained by a registrant for each registered location...In addition to any other recordkeeping requirements, any registered person that destroys a controlled substance...shall maintain a record of destruction on a DEA Form 41. The records shall be complete and accurate and include the name and signature of the two employees who witnessed the destruction. Except, the destruction of a controlled substance dispensed by a practitioner for immediate administration at the practitioner's registered location, when the substance is not full exhausted, shall be properly recorded...and such record need not be maintained on a DEA Form 41."
- 1304.22 (a2i,ii,iv,vii,ix) (c ) Required records: "…For each controlled substance in finished form, the name of the substance, each finished form and the number of units or volume of finished form in each commercial container, the number of units of finished forms and/or commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the name, address, and registration number of the person from whom the units were acquired, the number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed, the number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant, including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed...the number of units or volume of such finished form disposed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume disposed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser.”
- 720 ILCS 570/201 (h) Security requirements generally: "Persons registered with the Drug Enforcement Administration to manufacture or distribute controlled substances shall maintain adequate security and provide effective controls and procedures to guard against theft and diversion…"
- 3100.310 (a) Security requirements generally: “All applicants and licensees shall provide effective controls and procedures to guard against theft and diversion of controlled substances…”
- 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 (f) Record and inventorying requirements duration: “Every licensee shall keep a suitable book, file or electronic record keeping system in which shall be preserved for a period of not less than 5 years, [all prescription dispensing information].”