Have you heard the news? The United States Food & Drug Administration (FDA) last month issued guidance on the pharmaceutical industry’s practice of over-filling single-dose vials. The official report is titled, “Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.” Kudos to Indian media for the tip.
“Why would over-filling be a problem?” one might ask. Well…apparently because idiots are allowed to handle and administer vaccines, and they think it’s totally okay to take the leftovers and dump them together into one vial until there’s enough for another single dose.
And if you’re the inquisitive type, you’re now probably thinking that’s not a fantastic idea, but are curious as to why. I’m here to tell you.
The FDA actually has an overfill requirement. It’s intended to ensure the proper dosage by accounting for viscosity and the amount of product that sticks to the inside of the vial or is otherwise not able to be taken up by a syringe.
The United States Pharmacopeia (USP) General Chapter <1> Injections provides that each container of an injectable product is filled with a volume that slightly exceeds the content indicated in the labeling. The excess volumes are meant to be sufficient to permit withdrawal and administration of the labeled volumes. FDA regulations at 21 CFR 201.51(g) provide that for drugs in ampules or vials that are intended for injection, the declaration of net quantity of contents on the label is considered to express the minimum quantity of contents and further requires that variation above the stated measure must comply with the excess volumes set forth in USP. USP General Chapter <1151> Pharmaceutical Dosage Forms provides excess volume recommendations for mobile and viscous liquids in a range of fill volumes, noting that the excess volumes recommended are usually sufficient to permit withdrawal and administration of the labeled volumes. Allowable excess volume may also be referred to as “overfill,” but should not be confused with “overage,” which is addressed in a separate guidance. Generally, an applicant should not declare the amount of overfill on the container label.
But apparently, our Pharma Phriends either just eyeball the volume or put in a little extra for kicks. Additional background, from the FDA report:
Injectable vial misuse, including unsafe handling and injection techniques, has led to vial contamination and an increased risk of bloodborne illness transmission between patients.
Inappropriate excess volume and labeled vial fill sizes are two factors that may contribute to unsafe handling and injection practices by consumers and health care providers. FDA has been concerned about these issues and is publishing this guidance to clarify its regulatory requirements and recommendations.
So, they are acknowledging that healthcare providers routinely mishandle vaccines so as to require regulatory guidance, and that such mishandling leads to vial contamination and spread of disease. But wait–there’s more!
FDA becomes concerned when the excess volume in a vial is greater or less than the USP recommended amount without appropriate justification. Such excesses and deficiencies may result in medication errors and may lead to misuse of leftover drug product or pooling of vials to obtain a single dose.
Got that? Pooling of vials? You could put it that way, or you’re perfectly welcome to quote me: THEY ARE DUMPING THE LEFTOVERS TOGETHER INTO A BIOLOGY EXPERIMENT TO TRY OUT ON THE NEXT UNWITTING KID WHO’S BEING INJECTED BY FORCE.
Now, why this is problematic:
1. The purpose of single-dose vials is to limit the potential for fungal growth that is a concern with multi-dose vials, as they are exposed to oxygen, multiple punctures, excessive handling, temperature fluctuation and other factors.
2. The purpose of thimerosal is to prevent fungal growth inside the vial. The New York Times told us this in 2012.
3. They quit putting thimerosal in single-dose vials, thinking that healthcare professionals might use their brains and NOT POOL THE LEFTOVERS.
4. Fungi in vaccine vials reactivate live, attenuated viruses, immunosuppress the victim, and ultimately cause the disease the vaccine is meant to prevent, plus brain damage. See loads of citations here: https://badlymeattitude.files.wordpress.com/2015/06/fungus.pdf
5. Doctors are not taught this information, nor do most of them seem to have any interest in learning it in order to be better at their job, which happens to be FIRST DO NO HARM.
Are you pissed off yet? How about if I tell you this is totally unenforceable? Look, the FDA even says so:
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word ‘should’ in Agency guidances means that something is suggested or recommended, but not required.
Now are you pissed off? The FDA is admitting this is a problem that causes adverse events and spread of disease, and all they do is issue a flaccid opinion–“current thinking.” Wonderful. They think. Currently. And whom is their current thinking directed toward? The pharmaceutical manufacturers, of course. Our phriends who think it’s phun to phill the vials really really phull. And who tells the doctors what to think? The pharmaceutical manufacturers’ reps, of course.
NOW are you pissed off? The FDA totally gets what’s going on here, and nobody–NOBODY–in the entire agency has the guts to make a meaningful statement or take a meaningful action. They’ve taken the coward’s way out, essentially saying: “Hey, Pharma, you might not wanna put too much in there, cuz, you know, like, the doctors, they might wanna save a buck and make a kamikaze out of the dregs.” It’s done out of fear; out of a need to cover for their inadequacy, or worse, their collusion.