Subject to modification by the VTH Director without approval.

Printable PDF: Ambulatory Bag Use, Inventory, and Stocking Policy

Intent and Scope

The intent of this policy is to describe the storage, inventory, proper use, and restocking of ambulatory bags 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 ambulatory bags containing one or more controlled substances for use by a VTH service/clinician. This does not apply to MDVC.

Policy

All ambulatory bags are prepared and restocked by the Medication Dispensary staff and then either stocked in the ADC or secured in the Medication Dispensary until needed. The amount of each controlled substance used from each ambulatory bag must be logged accurately and completely on the log sheet accompanying the vial prior to returning the bag to the Medication Dispensary or ADC.

Ambulatory bag contents will be charged to the service that requested the bag when initially stocked/restocked at the current ward stock markup. 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 shelter medicine patients, but drugs used, and doses administered must be appropriately documented in the medical record.

Weekly each bag will be checked by a Medication Dispensary staff member. The bag 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 bag contents. After the double check, the bag will either be stocked into an ADC or secured in the controlled substance storage closet in the Medication Dispensary. It is the responsibility of the person who checks the bag to ensure that charges corresponding to each log have been entered correctly.

Guidelines

• Ambulatory bags are to be removed from the ADC or picked up from the Medication Dispensary immediately prior to intended use and returned to that location after the need has passed.
• While outside of the ADC/Medication Dispensary, 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.
• While the bag is outside of the ADC/Medication Dispensary, it must be in the possession of an Authorized Agent or securely affixed to a locked vehicle at all times.
• If the Medication Dispensary is closed and the bag cannot be returned to the ADC, the on-call pharmacist should be contacted for direction on appropriate next steps.
• It is the responsibility of the service to ensure the ambulatory bag is delivered to the Medication Dispensary at least once every 7 days for a check and when additional drug is needed. This should be done when the bag can be left for multiple hours prior to the next anticipated need.
• When stocking/restocking the Zoomed ambulatory bag, controlled substances will be transferred from the VTH DEA license to the VMSC DEA license utilizing a DEA Form 222 (CII drugs) or a transfer by invoice form (CIII – V drugs).

Associated SOP: SOP-003-CS Ambulatory Bag Use, Inventory, and Stocking

Definitions (if applicable)

• Ambulatory Bag: A locked bag or box containing controlled substances assigned to a hospital service for use when treating VTH patients of that service at locations other than the VTH. Bags are stocked with a limited amount of drug to meet the needs of that service’s usual patients. Additional drugs can be added and removed based on anticipated need.
• 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."
• 1301.12 (a) Separate registrations for separate locations: "A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person."
• 21 USC 822 (e)(2) Separate registration exemption for ambulatory: "…a registrant who is a veterinarian shall not be required to have a separate registration in order to transport and dispense controlled substances in the usual course of veterinary practice at a site other than the registrant's registered principal place of business or professional practice, so long as the transporting and dispensing is located in a State where the veterinarian is licensed to practice veterinary medicine and is not a principal place of business or professional practice."

State

• 720 ILCS 570/302 (d) Separate registration for separate locations: "A separate registration is required at each place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances, or purchases, stores, or administers euthanasia drugs. Persons are required to obtain a separate registration for each place of business or professional practice where controlled substances are located or stored. A separate registration is not required for every location at which a controlled substance may be prescribed."