Designation of Hazardous Areas

Implementation Date: 11/2021

Date of Last Revision: 6/24/2023

Next Review Due: 6/23/2026

 

Reviewed by VTH Administrative Team: 11/2021

Reviewed by VTH Board: N/A

 

Reviewed & Approved by Hospital Director: 11/2021

Reviewed by Biosecurity Subcommittee: N/A

Subject to modification by the VTH Director without approval.

Policy

The intent of this policy is to provide the procedure to define areas for the receiving, unpacking, and storage of hazardous drugs (Groups 1, 2, and 3 on the NIOSH list). This refers to all hazardous drugs on the NIOSH list (Groups 1, 2, and 3) that are stored, prepared, and administered within the VTH and Medication Dispensary

Designated areas must be available for hazardous drug receipt and unpacking – including chemotherapeutics –, the storage of hazardous drugs, non-sterile compounding of hazardous drugs, and sterile compounding of hazardous drugs.   Locations and bins for designated hazardous waste must also be available.

Guidelines

Receipt and Unpacking

1. Receipt and handling of all hazardous drugs should be completed wearing appropriate PPE.
2. Receipt of shipping containers containing Group 1 drugs (antineoplastics) will be received in the designated back area of the Dispensary. Once the packing slip is read and is known to contain antineoplastics, the shipping container will be taken to the Cleanroom door. Once the Dispensary staff is prepared to enter Cleanroom, the drug will be removed from the shipping container and taken inside Cleanroom. Drugs will be unpackaged and placed in designated labeled bins for storage.
   1. If shipping containers that contain antineoplastic drugs are damaged, they will be transferred to the negative pressure cleanroom sterile compounding hood.
3. Receipt of shipping containers containing Group 2 and 3 drugs will be received in the designated back area of the Dispensary. Items will be unpackaged, and any hazardous drugs will be delivered immediately to the designated labeled bin for storage.

 

Storage

1. Antineoplastics requiring manipulation and HD APIs must be stored separately from non-hazardous drugs and should be stored in an externally ventilated, negative pressure room with at least 12 air changes per hour, as consistent with USP guidelines.
2. Refrigerated antineoplastics must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH, as consistent with USP guidelines.
3. Non-antineoplastic, reproductive risk only and final dosage forms of antineoplastic HD can be stored with other inventory but should be denoted with appropriate auxiliary labels on the medication bin.
4. Non-sterile drugs should not be stored in sterile compounding areas, if possible, to prevent increased traffic to these areas.
   
   

Miscellaneous

1. A sign designating the entrance to the sterile hazardous compounding/drug handling area must be clearly visible. This area must be away from an area where food/drink is consumed.
2. Access to designated receiving area must be restricted to authorized personnel.
3. A spill kit must be accessible in all hazardous drug areas where it will be received and stored.

Procedure (if applicable)

Definitions and abbreviations (if applicable)

• NIOSH : National Institute of Occupational Health and Safety
• HD : Hazardous Drug
• ACPH : Air Changes Per Hour
  • Air change rate is measured of the air volume that is added to or removed from a space in one hour, divided by the volume of the space
• API : Active Pharmaceutical Ingredient
  • Any substance or mixture of substances intended to be used in the compounding of drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.
• PPE : Personal Protective Equipment
• USP : United States Pharmacopeia
  
  

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.