Drug Kit Use, Inventory, and Stocking Policy

Implementation Date: 8/2023

Date of Last Review: 8/2023

Next Review Due: 8/2024

 

Reviewed by VTH Director & Pharmacy Coordinator: 8/2023

Reviewed by VTH Board: N/A

 

Reviewed by Legal Counsel: N/A

Reviewed by Biosecurity Subcommittee: N/A

Subject to modification by the VTH Director without approval.

Intent and Scope

The intent of this policy is to describe the storage, inventory, proper use, and restocking of drug kits containing one or more controlled substances for VTH use to ensure compliance with all DEA requirements and the UIUC Policy on the Use of Controlled Substances. This policy applies to all drug kits containing one or more controlled substances for use by a VTH service/clinician. This does not apply to MDVC or drug kits that do not contain any controlled substances.

Policy

All drug kits are ordered or assembled by the VTH Medication Dispensary staff and stocked into the Automated Dispensing Cabinet (ADC) for removal immediately prior to anticipated need. The amount of controlled substance used from each kit must be logged accurately and completely on the log sheet accompanying the kit prior to returning the kit to the Medication Dispensary or ADC.

With the exception of Large Animal Anesthesia kits (small kit, large kit, and junior surgery kit), drug kit contents will be charged to the service that requested the kit when initially stocked/restocked at the current ward stock markup. Large Animal Anesthesia kits are charged to the service when obtained. The service is responsible for adding the appropriate charge to the patient account for each individual use. A patient charge must be entered using a code that specifically identifies the drug/combination used and quantity used. Covering the cost within another charge or using a non-specific medication or ward stock charge is not acceptable. Charges are not needed for junior surgery patients, but drugs used, and doses administered must be appropriately documented in the medical record.

After each use, the kit will be checked by a Medication Dispensary staff member. The kit may be checked by a pharmacy technician, or a pharmacist and a double check is required from the opposite role. Student workers are not permitted to check or double check kit contents. After the double check, the kit must be held up to the Medication Dispensary security camera prior to being returned to the ADC. It is the responsibility of the person that checks the kit to ensure that charges corresponding to each log have been entered correctly.

Guidelines

• Drug kits are to be removed from the ADC immediately prior to intended use. If being transported for off-site use, then they must be promptly secured in an approved ambulatory bag.
• While outside of the ADC, controlled drug vials must be maintained and accessed only by Authorized Agents. The Authorized Agent is responsible for ensuring accurate logs of each use are maintained. Authorized Users are only permitted to handle prepared doses.
• Drug kits are to be returned to the Medication Dispensary and handed to a Medication Dispensary staff member immediately after the need has passed. After hours, kits are to be returned to the ADC they were obtained from. If the kit cannot be returned to ADC, the on-call pharmacist should be contacted for direction on appropriate next steps.
• Drug kits ordered from outside sources (e.g., ZooPharm) must be ordered under the VTH’s designated DEA Registrant.

Associated SOP: SOP-002-CS Drug Kit Use, Inventory, and Stocking

Definitions (if applicable)

• 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.
• DEA Registrant: The DEA license holder under whom controlled substances are purchased by the Medication Dispensary for VTH use.
• Drug Enforcement Agency (DEA): The Federal and State Agency responsible for overseeing the Controlled Substance Act (CSA) and affiliated rules.
• Drug Kit: A combination of 2 or more drugs designed to be mixed and/or are consistently used in combination. This includes but is not limited to MK, MK2, BAM, TKX, Junior Surgery kits, and LA Anesthesia kits. This does not include ambulatory drug bags.
• Medication Dispensary Staff: Pharmacists, pharmacy technicians, pharmacy students, and veterinary students working or completing a rotation in the Medication Dispensary.
• 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 Division of Research Safety (DRS), and the VetMed 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 Medical District Veterinary Clinic (MDVC).

Regulations (if applicable)

Federal

• 1304.04 (f) (1-2) Recordkeeping method: "Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant: and Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant."
• 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 dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser.
• 1317.90 (a) and 1317.95 (d) (1-2) Destruction of controlled substances: "All controlled substances to be destroyed by a registrant or caused to be destroyed by a registrant…shall be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations and shall be rendered non-retrievable.
  • If the controlled substances are destroyed at a registrant's registered location utilizing an on-site method of destruction, the follow procedures shall be followed:
    • Two employees of the registrant shall handle or observe the handling of any controlled substance until the substance is rendered non-retrievable; and
    • Two employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable."
• 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) Physical security controls for practitioners: "Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet."