HEPARIN 25000 UNITS/500 ML (PREMIX)

We have had similar shortages over the last couple years here in USA (west coast) for the manufacturers Hospira, Baxter, and B-Braun. I currently have B-Braun. We also have a secondary compounding company PharMEDIUM that does a lot of other various products, so just including one of theirs (5,000 units/1000mL) but they do make numerous other concentrations.

Our current Heparin is 25,000 units/500 mL D5W (50 units/mL). While it is in a non-PVC and DEHP bag it does not necessarily have to be. I have also been to another local hospital using 25,000 units/250 mL D5W (100 units/mL). A couple weeks ago we were out of our manufactured 5,000 units/1000 mL NS bags so we had to batch ourselves. See image of those. I strongly suggest making safety stickers for “high alert” meds such as HEPARIN ADDED, and placing them on the bags, otherwise if the main compounded label were to fall off the bag could look like a plain bag and get mistakenly used in a busy situation.

When I run out, I do batch compounding using 500 mL D5W bags to match our usual product, and using heparin of 1000 units/mL concentration (adding 25 mL total to the bag). We have had to make our own heparin 25,000 unit/500 mL bags in batches about 10 times in the last 6 months.

I will write a short compounding formula with notes below….

COMPOUNDED STERILE PRODUCT: Heparin 25,000 units/500 mL D5W bag (when premix is out of stock)

PROCEDURE: remove 25 mL of D5W from the 500 mL bag, then add 25 mL of 1,000 units/mL (25,000 units) into the bag for a total volume of 500 mL. Of note, these solutions can be made in NS.

EXPIRATION: 30 hours room temp or 9 days refrigerated (797 medium risk BUD when making from multiple vials and/or multiple punctures to the bag’s port).

STABILITY NOTES: Many concentrations ranging from 1 unit/mL to 500 unit/mL have been studied and reported stable at both the room temp and refrigerated stability beyond the USP 797 BUD’s but must keep to those 797 maximums. Some of these studies confirmed physical stability of the compounded formulations up to 12 months in either D5W or NS at fridge and room temps. This very stable physical stability is also also evident by the product’s availability as a manufactured premix with expiration dates out 2 years in some cases. While the actual 50 unit/mL or 100 unit/mL concentrations being used are not specifically listed in this first reference by Bing, those concentrations are within the ranges studied and of course, available already as premixes with long stabilities so this should give confidence to make them yourself if you have to. If you do not have a place to store them, or just have low volume of use, then only make each one when needed.

LABELING: standard batching label with lot numbers, HEPARIN ADDED sticker, any additional alert stickers per local policy.

REFERENCES REVIEWED: (and attached)
Bing’s Extended Stability for Parenteral Drugs 2013 (see multiple references within the entry)
Lexi-Comp Heparin Monograph 2017
Trissel’s Handbook of Injectable Drugs 2017 (not attached)

https://mega.nz/file/GwJDQKYS#SAQeLti4ovlsf5N8dbtm3u4Bli1hqRKOnD-TYeHDgCw