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BD vs FDA: only the PATIENT loses in this battle.

BD vs FDA: only the PATIENT loses in this battle.
January 31, 2018 Seth DePasquale
In 503B, FDA, Sterile Compounding

Known Knowns

In 2015, the FDA alerted the public to a loss of potency of medications if they’ve been compounded and then stored in certain BD syringes. Unbeknownst to both BD and the FDA compounders and repackagers have been using these beyond what they were intended for (“FDA has cleared these syringes as medical devices for general purpose fluid aspiration and injection only.”). The most alarming reports come from the use of fentanyl being stored in these syringes. It’s not uncommon to see fentanyl used in a PCA pump which is made for syringes. However, depending on the potency (or lack of potency) from batch to batch, the very next syringe that may have full potency could potentially be lethal for that patient.

It’s also not uncommon to see compounding pharmacies that make intrathecal medications store their formulations in a syringe to be shipped where it’s needed. I would think the majority of the time these are used fairly quickly from the time they are made (within 72 hours) but cannot say that for sure in every scenario. What is known is that sometime in 2015 BD switched their “formula” for making the stoppers inside some of their syringes which is what caused all of these alerts.

Below is a trail of letters from BD and the FDA in chronological order:

07-31-15-letter

07-31-15-letter-technical-update

8-18-15 FDA-medwatch-report

09-01-15-letter

In November of 2015, BD announced that it would be releasing 3 and 5 mL syringes that had the original stopper (potentially one that wouldn’t cause drugs to lose potency?):

November 3rd 2015 – 3mL and 5mL Syringe Launch Customer Letter

Known Unknowns

What we don’t know is whether there was ever any syringe that has been made by BD (or anyone else for that matter who produces syringes using polypropylene, latex free elastomer and silicone) that doesn’t cause medications to lose potency when used as a storage device. Given they were never intended for this use in the first place no one has done studies on this.

Here’s a technical data sheet on the materials used to produce their syringes:

BD Disposable Technical Datasheet 03-14 MSS0507

Unknown Unknowns

While this is battled out between BD, the FDA and various compounding facilities both large and small the only ones really losing in all of this is the patient. Pragmatically speaking, there’s not really an easy solution to this problem. VERY hypothetically speaking, if tomorrow a law came out banning the use of syringes for storing medications what could we do? Patients still need medications, and the supply chain that’s been providing these compounds cannot just re-tool a new solution overnight (there are some fairly large 503Bs involved). The only immediate thought that comes to mind would be to package in vials when they’re being compounded and at the point of administration repackage into a syringe for immediate use. However, even this solution would have to have all of the pieces in place: a facility that is able to package in vials that will not degrade the preparations (have stability studies been performed on this situation?) and at the point of administration a health care provider would need access to a cleanroom or compounding area to repackage into a syringe (unless used immediately?).

The next potential solution would be to lower the beyond use dates of these compounded medications. However, this also might be a little unreasonable given the demand and need for large quantities that need to be mass produced and shipped all over the country. This is not a simple problem to fix. The most surprising aspect of all of this is that 2 1/2 years have gone by since the public first became aware of this problem and yet it seems like no solution is in sight. This happens to be one of those cases where what we don’t know, may actually hurt us (or worse, our patients).

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About the author:

Seth DePasquale is a pharmacist and co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.

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