Category: Controlled Substances
Number: SOP-006-CS
Date of Last Review: 10/24/2023
Next Review Date: 10/2024

Printable PDF: Maintaining the Automated Dispensing Machine (Cubex) SOP-006-CS

Purpose/ Applicability:

To describe the process for Medication Dispensary staff maintaining the automated dispensing cabinets (ADCs) throughout the VTH.

Scope:

This applies to all Medication Dispensary staff performing administrative functions in the ADCs located within the VTH. This includes stocking, cycle counts of controlled and non-controlled drugs, assigning and de-assigning drawers and medications, and other administrative functions as assigned.

Associated Policy: N/A

Procedure:

Stocking Cubex Machines

1. Cubex machines will be stocked based on the morning purchase order that is automatically emailed to the VTHPharmacy@vetmed.illinois.edu email address.
2. If the order does not come through, it can be manually printed on the mycubex.com website.
   • Type demand into the search bar and it will pull the report up OR
   • Under reports à  run report à  (change report category to) purchasing à  restock demand, c60.
3. Appropriate stock of the medications noted on the report shall be pulled, recorded on the sheet, and checked by a pharmacist.
   • The pharmacist will sign and date the report; the report shall be stored in the Cubex binder.
4. One re-stock should be completed in the morning for all the Cubex machines.
   • Additional stocking may be required for:
     • Medications that are prepared in the cleanroom.
     • Drug kits and ambulatory bags that need to go into the Cubex once checked/refilled (e.g., ZM, MWE)
     • Medications that are in the storeroom order and are needed urgently.
     • ** LAC Anesthesia Kits **
       • During the week, a single kit can be left out and kept in the closet for restocking the next day.
       • For weekends, all kits need to be stocked in the Cubex.
5. While doing the stocking, the technician will also complete cycle counts (discussed below)
   • Drugs must be stocked using the stocking function. It is not acceptable to stock a drug through the cycle count function.
6. For VMSC: A stock transfer form needs to be appropriately filled out for all controlled substances.
   • A DEA 222 form must be completed for C-IIs under the appropriate clinician / DEA number.
     • Gene Pavlovsky @ 2100 S Goodwin Ave
7. For WMC: The medication needs to be charged out under the “WMC Ward Stock” account and a stock transfer form needs to be appropriately filled out for all controlled substances; the medication should be charged prior to the pharmacist check to ensure that it is done.
   • A DEA 222 form must be completed for C-IIs under the appropriate clinician / DEA number.
     • Stephany Lewis @ 2100 S Goodwin Ave
8. Any controlled substances that are restocked in the Medication Dispensary from VMSC or WMC must have a stock transfer form appropriately filled out.
   • A DEA 222 form must be completed for C-IIs under the appropriate clinician / DEA number.    
     • Scott Austin @ 1008 W Hazelwood Drive
   • WMC charges will need to be refunded to WMC Ward Stock account.
   • Controlled substances must not be transferred from VMSC/WMC to another VTH Cubex machine outside of the Medication Dispensary.
9. Medications from VMSC that require wasting must be completed using the VMSC license information, a DEA form 41, and a sign-off by a VMSC clinician/technician.

Cubex Cycle Counts

1. The Cubex machines must be appropriately cycle counted when stocked.
   • Non-controlled substances that have been accessed since the last cycle count shall be cycle counted at least weekly at each machine.
     • Amounts of drug loss that cannot be accounted for by a potential stocking error or hub loss should be charged out to the appropriate service.
   • Controlled substances that have been accessed since the last cycle count shall be cycle counted daily on each machine.
     • If any controlled substance appears to be a different quantity/volume than what is listed, it must be drawn up and adjusted accordingly. There must not be any multi-dose vial controlled substance adjustments made unless there was an actual draw completed or only full vials remaining.
   • The Medication Dispensary Cubex must be completely cycle counted at least monthly.

Assigning / De-assigning Drugs

1. In order to assign a drug, a code must be appropriately made for the Cubex item and have a linked code created in the HIS.
2. Controlled substances must be assigned to individual bins.
3. When medications are removed, they must be de-assigned from the location.
   • Do NOT cycle count the medication out if removing the full quantity.
   • Expire the medication, if needed.
4. When assigning a drug, the minimum and maximum must be added as well as the current stock on hand.
5. After assigning a drug / adding the medication, cycle count the medication to ensure that it was appropriately added to the machine.
6. The only CBX codes (pharmacy use only codes) that should be assigned should be in the Medication Dispensary Cubex for medications that are dispensed pursuant to prescriptions entered into the HIS. All other drugs should be assigned using billable codes.

Expired Medications

1. All multi-dose vials must be stickered with an “expiration date” sticker once punctured.
2. It is the responsibility of the technician completing Cubex to ensure date opened stickers are written on all open vials of medication and calculate the expiration date.
   • If an open vial of medication is found without an expiration date, the assumption can be made that it was opened the previous day, and the expiration date would be “X” days from the previous day. E.g., found a vial on 1/2/20XX and it has an expiration of 28 days, so expires 1/29/20XX.
3. When cycle counting, it is expected that the soonest expiration date in Cubex will be updated to reflect the date of the currently open vial(s).
4. All expired non-controlled drugs will be brought back to the Medication Dispensary for disposal. All expired controlled substances must be disposed of at the address from which they are obtained (i.e., VTH expired controlled substances must be disposed at the Medication Dispensary, VMSC expired controlled substances must be disposed at the VMSC).
   • Controlled substances from the Cubex are to be logged on a DEA Form 41.
     • VTH non-patient medications shall be expired using the DEA Form 41 with the VTH address and DEA number.
     • VMSC non-patient medications shall be expired using the DEA Form 41 with the VMSC address and DEA number.
     • Note that both forms should have the method of destruction listed as “Rx Destroyer”. The destruction address must reflect the location of the Rx Destroyer used (i.e., VTH address for VTH drugs and VMSC address for VMSC drugs).
5. If large vials of medication are found to expire out consistently, the Pharmacy Coordinator can determine if it is appropriate to continue using them (cheaper medications), repackage the vial into smaller sizes (longer expiration date products e.g., acepromazine), or remove the medication from the Cubex.
   • Currently repackaged medications:
     • Acepromazine
     • Aranesp (darbepoetin)
     • Butorphanol – syringes
     • Enoxaparin
     • Furosemide
     • Insulin (for clients)
     • Methadone
     • PF Morphine
     • Procainamide

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.
• 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.
• Cycle Count:
• DEA Form 41: The DEA form used for destroying controlled substances that have not been logged out for use on a specific patient.
• DEA Form 222: The paper DEA form used for ordering CI and CII drugs. This is used when CSOS is not used.
• 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.
• Discrepancy: A difference in the actual amount of drug on hand compared to the amount expected based on transaction logs.
• 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.
• 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).

Applicable Regulations:

Federal

• 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."
• 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."
• 1305.03 and 1305.04 (b) DEA Form 222 Requirement: "Either a DEA Form 222 or its electronic equivalent…is required for each distribution of a Schedule I or II controlled substance…" "An order for Schedule I or II controlled substances may be executed only on behalf of the registrant named on the order and only if his or her registration for the substances being purchased has not expired or been revoked or suspended."
• 1305.06 (a) (c) Persons entitled to fill CII orders: "An order for Schedule I and II controlled substances, whether on a DEA Form 222 or an electronic order, may be filled only by a person registered with the DEA as a manufacturer or distrubotr of controlled substances…except for the following. A person registered with DEA to dispense the substances, or to export the substances, if he/she is discontinuing business or if his/her registration is expiring without reregistration, may dispose of any Schedule I or II controlled substances in his/her possession with a DEA Form 222 or an electronic order. A person registered to dispense Schedule II substances may distribute the substances to another dispenser with either a DEA Form 222 or an electronic order only in the circumstances described in 1307.11."
• 1305.12 (a-d) Executing DEA Forms 222: "A purchaser must prepare and execute a DEA Form 222 by use of a typewriter, computer printer, pen, or indelible pencil. Only one item may be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must be noted on that form at the bottom of the form, in the space provided. The name and address of the supplier from whom the controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any form. The supplier's DEA registration number may be entered by the purchaser or the supplier. Each DEA Form 222 must be signed and dated by a person authorized to sign an application for registration or a person granted power of attorney to sign a Form 222. The name of the purchaser, if different from the individual signing the DEA Form 222, must also be inserted in the signature space."
• 1305.13 (a, b, d, e) Procedure for filling DEA Forms 222: "A purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. The copy retained by the purchaser may be in paper or electronic form. A supplier may fill the order, if possible and the supplier desires to do so, and must record on the original DEA Form 222 its DEA registration number (if not previously entered by the purchaser) and the number of commercial or bulk containers furnished on each item and the date on which containers are shipped to the purchaser. The supplier must retain the original DEA Form 222 for the supplier's files. Any supplier who is not required to report to ARCOS (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail or email. The copy must be forwarded at the close of the month during which the order is filled. The purchaser must record on its copy of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser."
• 1307.11 (a)(1)(i-iv) Distribution by dispenser to another practitioner: "A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner for the purpose of general dispensing by the practitioner to patients provided that, the practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance; the distribution is recorded in accordance with 1304.22(c), an order form is used as required in 1305, and the total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year."
• 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."

State

• 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…"
• 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."
• 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…”