Ambulatory Bag Use, Inventory, and Stocking SOP

Category: Controlled Substances
Number: SOP-003-CS
Date of Last Review: 8/2023
Next Review Date: 8/2024

Purpose/ Applicability:

To describe the procedures for inventory, 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.

Scope:

This SOP applies to all ambulatory bags containing one or more controlled substances for use by a VTH service/clinician. This does not apply to MDVC.

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

 

Definition(s):

• 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.
• Hospital Information System (HIS): The computer system used to maintain electronic patient records and statements.
• Medication Dispensary Staff: Pharmacists, pharmacy technicians, pharmacy students, and veterinary students working or completing a rotation in the Medication Dispensary.
• 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.
• 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).

Applicable Regulations:

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."

 

Procedure:

Ordering/Restocking

1. When a VTH service determines that a controlled drug (or several controlled drugs) will need to be transported offsite for treating VTH patients, a service representative will notify the Pharmacy Coordinator to discuss the need for an ambulatory bag. This notification should indicate if this will be a one-time/short term need or an ongoing need.
   1. After an initial decision is made to stock, reordering or increased PAR levels can be communicated to a Medication Dispensary staff member.
2. Established ambulatory bags will be restocked by Medication Dispensary staff as needed to maintain the quantities indicated below. Stocking will occur during weekly checks and in-between checks if a service representative indicates that additional drug is needed.
   1. Farms Bag: (3) unreconstituted vials of Telazol; (3) 10ml vials of ketamine; (4) 100ml vials of euthanasia solution; and (1) 10ml vial of butorphanol

 

1. 2. ZooMed Bag: (1) 10ml vial midazolam; (2) 10ml vials ketamine; (1) 10ml vial butorphanol; (1) 10ml vial alfaxalone; (1) 1ml vial buprenorphine; (1) 1ml vial hydromorphone 10 mg/ml; (1) 10ml vial dexmedetomidine; (1) 10ml vial atipamezole; (1) 20ml vial Propoflo28; (1) 1ml vial naloxone; and (2) 10ml vials flumazenil

 

2. 3. MWE Bags (1 bag per doctor): (3) 10ml vials butorphanol; (5) 100ml vials euthanasia solution; (3) 10ml vials ketamine; and (2) 10ml vials midazolam

 

3. 4. Shelter Medicine Bag: (4) unreconstituted vials of Telazol; (2) 10ml vials of butorphanol; (2) 10ml vials of Simbadol; (1) 100ml vial of euthanasia solution; (1) box of Zorbium 0.4mg; and (1) box of Zorbium 1 mg

 

Stocking

1. Ambulatory bags are stocked into the ADC by the ‘each’. Therefore, the quantity available in the ADC should reflect the number of kits (either 1 or 0 depending on if the kit is checked out).

 

Use

1. When a kit is needed/anticipated to be needed, an authorized user with ADC access will remove the kit. The following applicable patient should be used when removing an ambulatory bag. Note: If these patients aren’t found, switch to the inactive list and search again.
   1. Farms Bag: Farms Bag LAC
   2. ZooMed Bag: Zoo Medicine Bag
   3. MWE Bags (stocked under the doctor’s name): MWE Kit
   4. Shelter Medicine: Shelter Medicine Bag
2. Once the ambulatory bag has been removed from the ADC, it is the responsibility of the person that removed it to ensure that it is maintained securely and returned appropriately with all logs completed at the conclusion of use.
   1. Maintaining securely means that it is under the supervision of an authorized user at all times and that authorized agents are only given access to prepared doses and not full vials. If not in the immediate possession of an authorized user, it must be securely attached inside a locked university vehicle.
   2. Completed log means that the attached log sheet is filled out for each dose withdrawn. Each line entry counts as 1 stick for purposes of calculating hub loss, so each vial stick should have its own log entry. Ideally all fields are completed. However, at a minimum, a patient identifier (e.g., MR#), volume withdrawn, date, initials of the person drawing up/administering the dose, calculated amount remaining, and initials of a witness must be included for each draw.
      1. If a dose is drawn up and not administered or only partially administered, a note with the amount to be wasted must be noted by the log entry. The drug waste shall be labeled with the drug name and a patient identifier and returned to the Medication Dispensary with the ambulatory bag.
   3. Ambulatory bags are to be returned to the ADC or to the Medication Dispensary and handed to a Medication Dispensary staff member immediately after the need has passed. After hours, ambulatory bags are to be returned to the ADC they were obtained from utilizing the return function. If the bag cannot be returned to ADC, the on-call pharmacist should be contacted for direction on appropriate next steps. It is not acceptable for ambulatory bags to be stored overnight in a vehicle or offsite. The only exception is the on-call clinician may store the bag in their assigned locked vehicle (securely attached to the vehicle) while on call if it’s reasonable to expect that controlled substances may be required on an emergency call and returning to the VTH prior to the call is not practical.

Weekly Ambulatory Bag Checks

1. When checking ambulatory bags, a Medication Dispensary staff member (pharmacist or technician) will complete the following steps for each controlled substance contained within the bag for which the tamper packaging is no longer securely intact:
   1. Check that each log sheet entry is complete and that the math for the amount remaining is correct. Make any necessary corrections and/or contact those involved in bag use to obtain missing data when needed.
   2. Verify that waste returned was indicated on the log sheet as wasted. If waste returned and log sheet do not match, make necessary corrections and/or contact those involved in bag use to obtain clarification and make necessary corrections.
      1. Log waste in the Medication Dispensary waste log, obtain a witness and dispose of in the RxDestroyer.
   3. Draw up amount remaining and create a log sheet entry to document that amount. Return the drug to the vial. If vial leaks during drawing, ensure that is noted next to the log entry.
      1. The log sheet entry needs to include the date, “Med Dispensary draw”, the amount remaining in the vial, and the initials of the person doing the draw.
         1. The amount remaining that is documented on the log sheet should be determined in consideration with overfill. Instead of taking the log sheet quantity up due to overfill, the log sheet should be allowed to go negative. This better facilitates monitoring trends in relation to use of overfill.
            1. If the actual amount drawn is less than indicated on the last log sheet entry: Enter the amount remaining as the actual amount withdrawn.
            2. If the actual amount drawn is more than indicated on the last log sheet entry: Enter the amount remaining as the last logged amount (assuming calculations are correct).
         2. If the actual amount remaining is less than the amount indicated on the last log entry, calculate acceptable hub loss as “number of log entries since last draw x 0.05ml”. Indicate acceptable hub loss next to the actual draw entry.
            1. If hub loss does not account for the full discrepancy, and the vial isn’t leaking, notify the PIC for further direction. The PIC will follow procedures as described in POL-001-CS and SOP-001-CS.
   4. For empty vials, close out the log sheet with the following steps, and dispose of the empty vial in a DRS med waste bucket.
      1. Draw a diagonal line through the space remaining on the log.
      2. Below the line write “0 ml returned” and sign and date by this amount. This notation replaces the need for a log entry as described above.
      3. File the used log sheet by stapling the yellow log sheet to the white portion in the log sheet binder.
   5. Restock as needed (see above for restocking points). When restocking, ensure each vial is given a yellow log sheet and the log sheet number is written on the vial. Charge drugs being restocked to the service ward stock account.
      1. For the Zoomed bag, any controlled substances stocked must be documented appropriately to transfer them from the VTH DEA registration to the VMSC DEA registration. For CII drugs, a VMSC DEA Form 222 will be used. For CIII-V drugs, a transfer by inventory form will be used.
   6. Place each drug into a tamper evident bag with the drug name written on the front. If a vial will be expiring within the next 2 months, write the expiration date on the bag. Prior to closing each tamper bag, the bag contents should be double checked by the opposite role (pharmacist or technician).
   7. Lock the bag and return it to the ADC or secure it in the Medication Dispensary. If secured in the Medication Dispensary, the bag may only be picked up by an Authorized Agent.

 

Expiring Out/Disposing of Drug

1. When a bag contains a controlled substance that is expired, close out the log sheet for that vial using the following process.

1. 1. Draw a diagonal line through the space remaining on the log.
   2. Below the line write “___ml returned and wasted on DEA Form 41” and sign and date by this amount. The ml returned and wasted should be the actual amount remaining.
   3. File the used log sheet by stapling the yellow log sheet to the white portion in the log sheet binder.
   4. Complete a DEA Form 41 parts A, B1, C, and D.

2. After obtaining a witness signature on the DEA Form 41, dispose of the drug in the RxDestroyer.
3. File the DEA Form 41 in the appropriate location.