Drug Kit Use, Inventory, and Stocking SOP

Category: Controlled Substances
Number: SOP-002-CS
Date of Last Review: 8/2023
Next Review Date: 8/2024

Purpose/ Applicability:

To describe the procedures for inventory, 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.

Scope:

This SOP 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.

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

Definition(s):

• 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."

Procedure:

Ordering/Restocking

1. When a VTH service determines that a drug kit not currently stocked is needed, a service representative will notify the Pharmacy Coordinator to discuss stocking.
   1. After an initial decision is made to stock, reordering or increased PAR levels can be communicated to the Medication Dispensary staff member responsible for placing orders.
2. For drug kits obtained from outside sources (e.g., ZooPharm) such as MK, MK2, and BAM kits, an office stock order is placed under the VTH designated DEA Registrant for shipping to the Medication Dispensary.
3. With the exception of requests to order/stock additional drug kits, kits will be restocked/reordered by Medication Dispensary staff as follows:
   1. BAM Kit: When the current kit is empty/almost empty or expired a single replacement will be reordered from ZooPharm and charged to the Farms service.
   2. MK and MK2 Kits: When the current kit is empty/almost empty or expired a single replacement will be reordered from NexGen Pharmaceuticals and charged to the Farms service.
   3. TKX Kit: Individual components will be restocked when quantities on hand drop below the following to ensure there are sufficient ingredients stocked to prepare a new vial. The components will be charged to the Farms service.
      1. Ketamine: 2.5 ml
      2. Xylazine: 2.5 ml
      3. Telazol (unreconstituted): 1 vial
   4. Large Animal Anesthesia Kits: Three small kits will be maintained in the ADC, and two large kits will be maintained in the Medication Dispensary. Each kit will be restocked to round to the amounts indicated below. For example, if a small kit is returned with 43 ml of ketamine and 46 ml of midazolam remaining, it will have 2 vials (20 ml) of ketamine added, but no additional midazolam added.
      1. Small kits: 60 ml ketamine and 50 ml midazolam
      2. Large kits: 120 ml ketamine and 60 ml midazolam
   5. Junior Surgery Kits: The following kits will be maintained in the ADC while junior surgery is in session. It is the responsibly of the technician(s) overseeing the use of these kits to notify the Medication Dispensary prior to the start of junior surgery and once junior surgery has ended. Each kit will be restocked to round to the amounts indicated below.
      1. Large Animal Junior Surgery Kit: (12) 10 ml vials of Ketamine, (6) 10 ml vials of midazolam, and (1) 10 ml vial of butorphanol.
      2. Small Animal Junior Surgery Anesthesia Kit: (2) 20 ml vials of Hydromorphone 2mg/ml, (1) 10 ml vial of Simbadol, and (1) 10ml vial of ketamine.
      3. Small Animal Junior Surgery Kit: (1) 10ml vial of dexmedetomidine, (1) 10ml vial of butorphanol, (1) 10ml vial of ketamine, and (2) 10ml empty sterile vials.

Receiving/Stocking

1. For kits ordered from outside sources, they will be received by Medication Dispensary staff in the same manner as other controlled substances. A pharmacist will unpack and sign the packing slip to indicate the amount received was the amount indicated. The paperwork will be filed with all other controlled substance packing slips. A second person will stock the kit into the ADC.
   1. If the kit is not going into a general use ADC immediately, it will be stocked in the Medication Dispensary ADC as a backstock item.
   2. Prior to stocking in the ADC, either the pharmacist receiving the kit or the person stocking it will create a yellow log sheet by completing all fields on the white portion, writing the sheet number on the kit and each vial within the kit, and then initialing to indicate who prepared the sheet. Kits sourced from outside the VTH will have one yellow sheet per kit.
2. Kits are stocked into the ADC by the ‘each’. Therefore, the quantity available in the ADC should reflect the number of kits. For most kits, each kit will be contained within its own bag.
   1. For TKX, the number of kits is the number of Telazol vials (reconstituted or unreconstitued) in the ADC.
   2. The person stocking kits into the ADC should ensure that each kit is accompanied by a log sheet and the kit has the log sheet number written on it.
      1. For the large animal junior surgery kit, each vial within the kit will have “jrsx” written on it and the yellow sheets for each drug will indicate what type of junior surgery kit it is in the service blank.
         1. Large animal junior surgery kit will have one log sheet per drug. Small animal junior surgery kits will have one log sheet per vial.
      2. Large animal anesthesia kits (small and large) will have the kit number written on each vial and the kit number indicated at the top of the yellow sheet. These kits will have one yellow sheet per drug.
      3. TKX will have one yellow sheet per vial of Telazol with the yellow sheet number written on the vial.
   3. When stocking into the ADC, the correct expiration date should be entered. Expiration dates are as follows.
      1. Kits obtained from outside the VTH: The beyond use date (BUD) stated on the packaging.
      2. TKX: If all Telazol is unreconsituted, then use the earliest manufacturer expiration date of any ingredient in the bin. If a Telazol vial is reconstituted, then use 30 days from the date of reconstitution or the earliest manufacturer expiration date of any ingredient in the bin, whichever is sooner.
      3. All other kits: Earliest expiration date of any vial within the kit.
         
         

Use

1. When a kit is needed/anticipated to be needed, an authorized user with ADC access will remove the kit. If the kit will be used on more than one patient, or the specific patient is unknown, the following patients can be used. Note: If these patients aren’t found, switch to the inactive list and search again.
   1. TKX: TKX Kit LAC
   2. SA Junior Surgery Kit: SAC Junior Surgery Kit
   3. SA Anesthesia Junior Surgery Kit: Junior Surgery Anesthesia Kit
   4. LA Anesthesia Kit (small): LAC Anesthesia Kit (this patient should always be used for this type of kit)
   5. LA Anesthesia Kit (large): This kit is not maintained in the ADC and needs to have a prescription entered and pinned by a doctor prior to picking up from the Medication Dispensary. The prescription should be entered under the Large Animal Anesthesia service account in the HIS.
2. Once the kit 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 a completed log 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.
   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 kit.
   3. 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 utilizing the return function. If the kit cannot be returned to ADC, the on-call pharmacist should be contacted for direction on appropriate next steps.

Inventory/Cycle Counting

1. The Medication Dispensary staff member stocking the ADC will do a daily (M-F) cycle count of all kits accessed since the last cycle count.
   1. Cycle counting the kits will involve verifying the number of kits actually present matches the number expected as well as ensuring that any open kits have not been used since the last Medication Dispensary check.
      1. Kits that have been used and not checked by the Medication Dispensary will be brought back for checking.
   2. During the cycle count, expiration dates will also be checked to ensure nothing is expired and the soonest expiration date is reflected in the expiration date indicated by the ADC.
2. When checking kits, a Medication Dispensary staff member (pharmacist or technician) will complete the following steps for each controlled substance contained within the kit:
   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 kit 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 kit 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. (Log sheet entry is not needed for large animal anesthesia and junior surgery kits or for completely empty vials.)
         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. Ensure each open vial has an expiration date sticker added with the expiration date indicated. (This step can be skipped for kits obtained from outside).
      1. Ketamine: 28 days
      2. Midazolam: 28 days
      3. Butorphanol: 120 days
      4. TKX: 30 days
   6. Reorder/restock as needed (see above for reorder/restocking points).
   7. All kits except LA animal junior surgery and anesthesia kits should be double checked, showed to the Medication Dispensary security camera, and returned to the ADC at this point. For large animal kits (anesthesia small and large and junior surgery) continue to next steps.
   8. For large animal anesthesia and junior surgery kits, the log sheets are closed out at each kit check. Complete the following steps to close out all used logs for the kit.
      1. Draw a diagonal line through the space remaining on the log.
      2. Below the line write “___ml returned” and sign and date by this amount. The ml returned should be the actual amount remaining. 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.
   9. Restock the kit as needed based on the intended quantity ensuring the kit number is written on each vial.
   10. Ensure all open vials have an expiration date sticker.
   11. Start a new log sheet as described above.
   12. At this point the kit should be double checked, showed to the Medication Dispensary security camera, and returned to the ADC (LA junior surgery kit, and LA anesthesia small kits) or the controlled drug storage closet (LA anesthesia large kit).

Expiring Out/Disposing of Drug

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