Implementation Date: 12/14/2023

Date of Last Review: 12/14/2023

Next Review Due: 12/13/2024

 

Reviewed by VTH Controlled Substance Surveillance Program Manager & VTH Director: 12/2023

Reviewed by VTH Board: N/A

 

Reviewed by Legal Counsel: N/A

Reviewed by Biosecurity Subcommittee: N/A

Printable PDF: VTH Ward Stock Controlled Substances Policy POL-008-CS

Intent

To describe when controlled substances for VTH patient care may be maintained as ward stock.

Scope

This applies to all controlled substances maintained as ward stock by VTH services. As of the last review, only the Wildlife Medical Clinic (WMC) and Radiation Oncology are approved to have controlled substance ward stock.

• This does not apply to drug kits (See POL-002-CS and SOP-002-CS for drug kit information.)
• This does not apply to ambulatory bags (See POL-003-CS and SOP-003-CS for ambulatory bag information.)

Policy

Ward stock is used to provide access to necessary medications for patient care that cannot be feasibly obtained through normal VTH channels within a reasonable amount of time given the drug, indication, volume, and service location. Controlled substance ward stock is limited to situations approved by the VTH Controlled Substance Surveillance Program Manager in consultation with the VTH DEA Registrant. Approval of controlled substance ward stock requires a plan to be in place for how that ward stock will be maintained and used by the service with Medication Dispensary oversight as appropriate. Approved controlled substance ward stock plans must be summarized in this policy and documented in detail in the associated SOP (SOP-008-CS).

Guidelines:

• Radiation Oncology
  • A butorphanol 10 mg/mL 50 mL vial and three alfaxalone 10 mg/mL vials will be maintained in the lockbox mounted to the wall in the Radiation Oncology treatment area.
  • 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.
  • Documentation of all drug access will be maintained using paper logs (i.e., yellow sheets). When a vial is empty, the empty vial and completed log will be returned to the Medication Dispensary.
  • All drugs are charged to the service at the time they are provided for ward stock, and the service is responsible for charging appropriately using billing codes in the HIS linked to each individual drug.
  • When an additional drug is needed, it will be ordered utilizing a ward stock order form with a radiation oncology clinician's 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.  Ward stock order forms that include controlled substance orders must be maintained for at least 5 years with other controlled substance records.
  • 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. The controlled substance pickup log will be signed at the time the drug is picked up. Immediately after picking up the drug, the authorized agent will secure the drug in the Radiation Oncology lockbox.
  • 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.

• WMC
  • 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 (20mg/ml) will be maintained in the VMSC ADC for use in WMC patients and ambassador animals only.
  • 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.
  • Documentation of all drug access will be maintained in the ADC system utilizing the temp patient function for patients that do not have an account in the VTH HIS. WMC personnel are responsible for ensuring each drug administered is recorded correctly in the WMC HIS system (RaptorMed).
  • Additional drug(s) will be provided based on ADC stocking practices. When additional drug(s) are stocked, they will be charged to WMC and transferred by invoice or Form 222 to the DEA Registration of the WMC Director.
  • Drug volumes will be monitored by pharmacists and pharmacy technicians in the same manner as other ADC-controlled substances.

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

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 drugs 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.
• 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 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.
• 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.

Regulations (if applicable)

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].”