Jerry talks about the problem with storing medications in plastic syringes and potency loss. Recently the FDA notified ASHP that no plastic syringe is approved for use as a final storage device. Jerry discusses the issue and how it will impact pharmacies in the near future.
Host: Jerry Fahnri, Pharm.D.
Articles discussed in podcast:
Initial Reaction to FDA Stance on Syringes As Standalone Storage Container [JerryFahrni.com]
No Syringe Is Approved as a Standalone Storage Container, FDA Says [ASHP]
ISMP Comments On BD Syringe Potency Issue [ISMP]
Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning [FDA Alerts]
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones
5 thoughts on “JerryFahrni.com Podcast | Episode 6: Stability of CSPs in Syringes”
I work in a large tertiary care pediatric hospital where we prepare IV doses in syringes in 24 hour batches for all hospitalization units (no ER or OR, though). We also prepare 1st doses on demand in the clean room. Not for all drugs, mind you, but for as much as we can given our resources. We prepare almost no syringes more than 24 hours in advance. It’s definitely feasible. What would be catastrophic is a directive to use syringes immediately after filling in all cases. That would be a major drug safety problem.
I agree with your assessment, that is having to prepare all syringes for immediate use. This is especially true in situations like yours. I have to think that the FDA and syringe manufacturers will do something in the near future to improve the situation, but only time will tell. And as you know, nothing in healthcare moves fast.
What strikes me as interesting in all of this, is how the syringe companies, who are profiting from the sale of their syringes, all of a sudden appear to be oblivious as to how their syringes are being used by hospital pharmacies. Prepackaging medications, both oral and injectable, into plastic syringes is NOT a new hospital pharmacy practice. This is a little like the Zig Zag cigarette paper company claiming that they were not aware that their papers were being used to smoke marijuana. Really…???
The company that should have known about this issue more than any other company is Baxter, the maker of the IntelliFill syringe-filling robot. This robot has been around for approximately 15 years and it uses a dedicated, bandoleer-type syringe system to prepackage BULK supplies of injectable syringes. There is no question that these syringes are for the sole purpose of long-term drug storage. Yet, the response I got back from Baxter was that they don’t have any data on the stability of drugs in their syringe system and that customers using this system should do their own testing. Obviously, that statement was written by their lawyers.
Bottom line, buyer beware. Don’t depend on your vendor to help you out. You’re on your own. Also, I wouldn’t expect the FDA to provide any assistance on this issue either. From the FDA perspective, the syringes on the market were never intended from drug storage in the first place.
Back in the “old days” when the concept of unit-dose was catching on (1970’s), we prepared all of our extemporaneous (i.e., not available from vendors) unit-dose preparations (e.g., oral syringes, injectable syringes) on a daily basis based upon demand. I guess that was the right thing to do. Preparing these doses in larger quantities (i.e., more than daily need) was done for convenience and efficiency, apparently without consideration of the packaging’s effect on drug potency during storage.
Nothing is simple any more. I highly recommend that you make sure “retirement” is on your Bucket List…
I’m with you on this one, Ray. It’s interesting that everyone became ignorant in the blink of an eye. I have to believe that companies like Baxter have data for the storage of medications in syringes that come from their IntelliFill. I also have to believe that BD was aware of how their syringes were being used.
As for just-in-time dosing, that’s going to give people headaches. Facilities have worked long and hard improving processes, and this certainly isn’t going to help. I spoke to the pharmacy operations manager at a large hospital yesterday, and they’re scratching their heads. They don’t know what to do, or how to handle this new statement from the FDA.
Retirement has been on my bucket list for a while, but I don’t see it in my immediate future.