Category: Controlled Substances
Number: SOP-008-CS
Date of Last Review: 12/1/2023
Next Review Date: 12/2024

Printable PDF: VTH Ward Stock Controlled Substances SOP (SOP-008-CS)

Purpose/ Applicability:

To describe the process for maintaining approved ward stock controlled substances.

Scope:

This applies to the services that have approved ward stock controlled substance plans as described below and in POL-008-CS.

Associated Policy: VTH Ward Stock Controlled Substances Policy POL-008-CS

Procedure:

Radiation Oncology

1. A butorphanol 10 mg/mL 50 mL vial and three alfaxalone 10 mg/mL 10 mL vials will be maintained in the lockbox mounted to the wall in the radiation oncology treatment area. 
2. Lockbox access will be managed by the VTH Controlled Substance Surveillance Program Manager using Cartrak software. Only pharmacists, pharmacy technicians, and Radiation Oncology-associated authorized agents will be permitted to have lockbox access.
   1. Radiation Oncology is responsible for providing notification when a new employee needs lockbox access. Before granting access, the VTH Controlled Substance Surveillance Program Manager will verify the employee is approved as an authorized agent. Once verified, the employee will be set up with a 4-digit pin of their choice.
   2. The VTH Controlled Substance Surveillance Program Manager will review submitted Exit Forms and remove lockbox access as applicable.
3. When additional drug is needed, it will be ordered utilizing a ward stock order form with a radiation oncology clinician signature next to each controlled drug being ordered. The signing clinician must be an approved authorized agent.  Drugs should be ordered when 5-10% of the original volume remains.
   1. Once the order is received by the Medication Dispensary Staff, the drug will be charged to Radiation Oncology with a 10% markup over the purchase price in the HIS and pulled from the Medication Dispensary Cubex machine using the ‘Ward Stock’ patient. The doctor for the Cubex transaction should be the clinician who signed the order.
   2. A paper log (i.e., yellow sheet) will be completed for each vial of drug ordered.
      1. The service should be listed as ‘Rad Onc’
      2. The last name of the clinician who signed the order and the Rx# for charging in the HIS should be written on the log sheet. The log sheet should then be initialed by the person who completed it.
      3. The log sheet number must be written on the vial it is attached to.
   3. Ward stock order forms that include controlled substance orders must be maintained for at least 5 years with other controlled substance records.
4. Once filled and paired with a paper log sheet, the controlled substance may be picked up from the Medication Dispensary by an authorized agent in the Radiation Oncology service.
   1. When the drug is picked up, the Medication Dispensary Staff member will indicate the drug name, and log sheet number as well as the Radiation Oncology service on the controlled substance pickup log. The authorized agent picking up the drug will sign and date the log.
   2. Immediately after picking up the drug, the authorized agent will secure the drug in the Radiation Oncology lockbox.
5. Radiation Oncology is responsible for entering charges for the controlled drugs used. Charges must be entered using individual charge codes for each controlled substance. These should be codes that were created specifically for Radiation Oncology ward stock charging.
6. The VTH Controlled Substance Surveillance Program Manager will complete quarterly audits of the drugs stored in the lockbox to ensure logs are accurate and all drug is accounted for.
   1. Each quarter, all controlled substances contained in the Radiation Oncology lockbox will be measured in a syringe and compared to the totals recorded on the yellow sheet corresponding to the stock bottle.  Stock bottles may also be brought back to the dispensary when empty for reconciliation.
   2. Any discrepancies will be investigated using lockbox access from the Cartrak software as well as SANDI records, medication administration records, etc.

Wildlife Medical Clinic (WMC)

1. Buprenorphine (300 mcg/ml), euthanasia solution (390 mg/ml), midazolam (5 mg/ml), butorphanol (10 mg/ml), alfaxalone (10 mg/ml), Simbadol (1.8 mg/ml), hydromorphone (10 mg/ml), tramadol tabs (50 mg), and tramadol suspension (20 mg/ml) will be maintained in the VMSC ADC for use in WMC patients and ambassador animals only.
2. ADC access will be managed by Medication Dispensary staff in the same manner as other ADC access. Only pharmacists, pharmacy technicians, and authorized agents associated with WMC (including WMC team leaders) will have access.
   1. It is the responsibility of WMC to provide notification when a new employee needs Cubex access. Prior to giving access, the VTH Controlled Substance Surveillance Program Manager will verify the employee has been approved as an authorized agent. Once verified, the employee will be set up with appropriate permissions. WMC Team Leaders are provided access only to WMC drugs.
   2. The VTH Controlled Substance Surveillance Program Manager will review submitted Exit Forms and remove Cubex access as applicable.
   3. During the yearly turnover of WMC Team Leaders (end and beginning of school year), the VTH Controlled Substance Surveillance Program Manager will work with the WMC Director to determine which students no longer need Cubex access for WMC drugs.
3. Documentation of all drug access will be maintained in the ADC system utilizing the temp patient function for patients who do not have an account in the VTH HIS. WMC personnel are responsible for ensuring each drug administered is recorded correctly (dose, volume, date, time, witness) in the WMC HIS system (RaptorMed).
   1. When a WMC patient or ambassador animal needs a controlled substance and does not have a corresponding HIS account, the person removing the drug will use the ‘Add Patient’ function at the Cubex machine.
      1. The patient’s WW number will be entered for the identification.
      2. The next business day, a pharmacist will ‘match’ the temp patient in the Cubex system. If the patient has previously been entered or has an HIS account, the temp patient will be matched to this. If the patient is not found, a new patient will be created in the Cubex system to match the temp patient with.
4. Drug stocking and auditing will be done in accordance with SOP-006-CS (Maintaining the Automated Dispensing Machine (Cubex)).

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.
• 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.
• Exit Form: The electronic form submitted by the supervisor when an employee has or will be ceasing employment in their current VTH role.
• Hospital Information System (HIS): The computer system used to maintain electronic patient records and statements.
• 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).
• VTH Controlled Substance Surveillance Program Manager: The person working within the Veterinary Teaching Hospital (VTH) who is responsible for implementing the oversight program for all clinical controlled substance activities, including students on rotation.
• Ward Stock: Drugs sold by the Medication Dispensary to a VTH service for the purposes of storing in their service-specific area for treating patients of that service. The service is responsible for ensuring charging practices are appropriate for recovering the cost of the ward stock.

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."
• 1304.04 (a) Recordkeeping duration: "…every inventory and other records required to be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employees of the Administration."
• 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 (2i, 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 disposed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume disposed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser."
• 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 distributor 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."
• 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."

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…”
• 3100.360 (f) Record and inventorying requirements duration: “Every licensee shall keep a suitable book, file or electronic record keeping system in which shall be preserved for a period of not less than 5 years, [all prescription dispensing information].”