“Research has shown that vial contamination from drug manufacturers is a real issue, which is why you must assume that all HD containers and packaging contain some trace contamination.”

Joseph Coyne, RPh

Educating staff on the risk of exposure and the need for practicing proper receiving procedures upon receipt of hazardous drugs (HD) to your facility will begin the mitigation of risk to everyone in the HD exposure lifecycle.

Receiving and Storage.

Receiving:

The organization must establish standard operating procedures for receiving HDs. HDs should be received from the supplier in impervious plastic to segregate them from other medications and to permit safe receipt. HDs must be transported to the HD storage area immediately after unpacking. Personal protective equipment (PPE), including chemotherapy gloves, must be worn when unpacking HDs. A spill kit must be accessible in the receiving area. The entity must enforce policies that include a tiered methodology, starting with visual examination of the shipping container for signs of damage or breakage, such as visible stains from leakage or sounds of broken glass.

Storage:

HDs must be stored to prevent spillage or breakage if the container falls. Do not store HDs on the floor. In regions prone to specific types of natural disasters, such as, earthquakes, the storage approach must meet applicable safety precautions, such as secure shelves with raised front lips. Antineoplastic HDs requiring manipulation, other than counting or repackaging of final dosage forms, and every HD active pharmaceutical ingredient must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. These HDs must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH). Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy.

Sterile and non-sterile HDs may be stored together, but to minimize traffic into sterile compounding areas, HDs used for non-sterile compounding should not be stored in areas designated for sterile compounding.

Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH; for example, storage room, buffer room, or containment segregated compounding area (C-SCA). If a refrigerator is positioned in a negative pressure buffer room, an exhaust located adjacent to the refrigerator’s compressor and behind the refrigerator should be considered to minimize the environmental impact of any particles generated by the device.

Transport:

HDs that require transporting must be labeled, stored, and handled in accordance with applicable federal, state, and local regulations. HDs must be transported in containers that minimize the possibility of breakage or leakage. Pneumatic tubes must not be used to transport any liquid HDs or any antineoplastic HDs due to the potential for breakage and contamination.

When shipping HDs to locations outside the entity, the entity must consult the Transport Information on the Safety Data Sheet (SDS). The entity must ensure that labels and accessory labeling for the HDs include storage instructions, disposal instructions, and HD category information in a format that is consistent with the carrier’s policies.

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