Category: fospropofol

Propofol Under Lock Down

Our friends at the DEA have turned their attention to propofol and are seriously considering listing it as a controlled substance.  After the untimely death of the pop star Michael Jackson, the drug enforcement watchdog has been under pressure to classify the milky stuff as a controlled substance.

From Pharmacy Practice News:

The agency is circulating a proposed rule that would classify propofol as a Schedule IV substance, putting it in the same category as midazolam, diazepam, lorazepam and the sleeping aid zolpidem, according to a DEA official familiar with the decision. Schedule IV drugs “are known to produce euphoric moods as adverse events and have histories of abuse” in the United States and abroad.

Ironically the propofol pro-drug fospropofol was listed as a controlled substance in 2009.  What this means for the anesthesia provider?  Prepare to account for every mL of the milk of amnesia.  Not sure what role this decision will play in the shortage. My hope is for an alternative…soon (see previous post).

See ASA position on scheduling of propofol here.

FYI (and mine):

Schedule I 
a category of drugs not considered legitimate for medical use. Included are heroin, lysergic acid diethylamide (LSD), and marijuana.

Schedule II
a category of drugs considered to have a strong potential for abuse or addiction but that also have legitimate medical use. Included are opium, morphine, and cocaine.

Schedule III
a category of drugs that have less potential for abuse or addiction than Schedule I or II drugs and have a useful medical purpose. Included are short-acting barbiturates and amphetamines.

Schedule IV
a medically useful category of drugs that have less potential for abuse or addiction than those of Schedules I, II, and III. Included are diazepam and chloral hydrate.

Schedule V
a medically useful catiegory of drugs that have less potential for abuse or addiction than those of Schedules I through IV. Included are antidiarrheals and antitussives with opioid derivatives.

Sep 17, 2010 | 0 comments View Post

Journal Watch: Anesthesia Drugs of the Future

Am excellent review article appears in this months British Journal of Anesthesia entitled “New Drugs and Technologies, Intravenous Anaesthesia is on the Move (Again)”. Its an excellent summary of the drugs we have, whats wrong with them and what is in development.

I’ve previously mentioned some of the drugs in the article like MOC-Etmoidate and fospropofol. I have since had the (dis)pleasure of using the latter with some interesting results…painful rectal itching and/or burning(!). Severe enough to make my never touch the stuff again. The mechanism is unclear at this time and I’m not sure I really care.

The benzo and propofol reformulations seem to have little advantage in my humble opinion.  My money is on one of the etomidate analogues to replace propofol as the one induction agent to rule all induction agents.  Article also contains an interesting discussion on the financial aspects of the drug development process.  Enjoy.

Sep 14, 2010 | 0 comments View Post

Invasion of the Anestho-bot!

I’ve previously chronicled the impending take-over by laryngoscope-wielding automatons here. CRNA jokes aside (!), I was intrigued by a new medical device that recently received an approvable letter by an FDA advisory panel: Sedasys is a device designed to deliver anesthesia, sans anesthesia provider:

Developed by Ethicon Endo-Surgery, a division of Johnson & Johnson, Sedasys combines a drug delivery system with sensors to monitor heart rate, blood pressure, oxygen saturation and other patient data. The machine is designed to be used by a team of nurses and physicians, although not necessarily anesthesiologists, for patients requiring light or moderate sedation. In submissions to the FDA, the company estimated than anesthetists participate in about 25% of all endoscopies.

The “who-pushes-what-drug-where” debate rages on. The development of fos-propofol was a non-event for the GI docs trying to push us out. This seems to me to have the same fate in store for it. I say so because of the following conversation:
Dr Endoscopist: “You are going to be sedated by a machine today”
Patient: “Ok, what if I stop breathing…like MJ?”
Dr Endoscopist:”I’ll have 911 on speed dial, don’t you worry!”
Ok so I exaggerate. The literature seems split on the issue depending on which special interest is doing the publishing, so in this instance I’m going to side with the anesthesia providers. I don’t discount the role technology can play in our practice, just keep the robots away from me and my loved ones please.

Aug 15, 2009 | 0 comments View Post

Permission granted, but not for all.


After much wrangling on anesthesia safety and labeling the propofol pro-drug fospropofol has been approved by the FDA.  

Fospropofol is a water-soluble prodrug of propofol, metabolized by the liver altering the pharmacokinetics to produce a slower peak effect and longer duration.  All of the problems associated with the lipid emulsion are assumed to be null and void with this formulation (pain on injection, bacterial contamination, hyperlipidemia etc..).
Fospropofol was designed for procedural sedation and was championed by the endoscopists as a “safer” alternative to propofol.  Thanks to the ASA’s stern warning letter to the FDA, the labeling requiring the presence of an anesthesia provider remains, and the safety of patients having their insides examined remains with us.
No info on when it’ll be ours for the sedating.

Jan 01, 2009 | 0 comments View Post