05-10-2017 07:25 PM
So far, the only antineoplastic HD we have that is refrigerated is Alkeran 2mg tabs. We stock and dispense them without manipulation. For non-refrigerated antineoplastics, it appears that we can receive, store and dispense them in neutral pressure, as long as we aren't doing any manipulations. Am I reading USP 800 correctly, in that just becuase Alkeran needs refrigeration, we would have to build a negative pressure room for the refrigerator for this one product? Can anyone explain why refrigeration makes this necessary. Or, am I missing something?
Thanks very much
06-08-2017 02:13 PM
Thanks for your patience. My read of USP <800> is the Alkeran, if you are not doing anything to it to generate an occupational exposure (nothing is done to its final dosage form) can be stored with other inventory. It could be stored in a refrigerator in the main pharmacy, ideally in a separate tote that identifies it as a hazardous drug with precautions. You need to develop an entity safe handling policy.
The chapter says: "Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any HD API 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."
Hope this helps.
06-08-2017 03:21 PM - edited 06-08-2017 03:51 PM
Thanks for the reply. I'm concerned with the first sentence in the final paragraph in that same section (5.2 Storage) that says: Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH [e.g., storage room, buffer room, or containment segregated compounding area (C-SCA)]. I thought that maybe refrigerated items get more stringent storage requirements because they are usually liquids and subject to breakage/spills. On the other hand, if taken at face value the sentence in question means that there is no way to store refrigerated final dosage forms of antineoplastic HDs in patient care areas without a negative pressure room to locate the refrigerator in. My feeling is that the wording of the sentence will need to be changed for better clarity in a future revision of USP 800 and that your interpretation is correct.
Any further thoughts on this?
Thank you very much
06-09-2017 01:30 PM
The need for a separate refrigerator are for those antineoplastic HDs that are segregation. The first part of the section exempts drugs like the Alkeran. Hope this helps.