The Propofol Availability Conundrum
What does the lack of propofol availability mean to you as a practicing anesthesiologist?
Over the last 6-8 months, our profession has been besieged by many different forces making our job to provide our comprehensive level of high quality anesthesia services very difficult. Our focus is always to make sure our patients have the best and safest experience that is available to them for their surgical and therapeutic procedures.
In addition to numerous drug shortages, we have been engaged with having our voices heard with regards to the healthcare reform initiatives and Medicare payment policy issues.
As many of you know, over the last few months the sedative-hypnotic, propofol, a mainstay for practicing anesthesia personnel has been difficult if not impossible to attain. Numerous production interruptions and decisions by manufacturers to leave the market have severely hampered our clinical options. The American Society of Anesthesiologists has been constantly updating the anesthesia community and working closely with the FDA (Federal Drug Administration) to overcome these severe propofol shortages. Just last week Teva announced it was no longer going to produce propofol and Hospira has recalled numerous lots of its propofol. APP who markets and produces generic propofol/Diprivan and Fresenius Propoven is really the only viable option at this point. What was a very affordable and readily available drug is now not so inexpensive and not so available.
Anesthesiologists and anesthetists function in many practice settings from the operating room to the endoscopy suites and beyond. We are resourceful clinicians and have been challenged to provide the best and safest pharmaceutical options to our patients. There have been anecdotal increased utilizations of Pentothal and ketamine for use with inductions as well as the use of etomidate has been on the increase. The costs and availability of these drugs has also been altered as well. Brevital is even being used as well.
Precedex which is traditionally an ICU drug and now has an application as a MAC sedation agent (monitored anesthesia care) is an option; but the costs are fairly prohibitive compared to generic propofol and it too has characteristics that make it cumbersome to use in various clinical settings.
These drugs are not so easily available and have been universally displaced by the overwhelming use of propofol. What other options exist? Most recently in November of 2009, Eisai introduced Lusedra (fospropofol) which was approved as a sedative-hypnotic for use as MAC sedation in diagnostic and therapeutic procedures. It is a prodrug form of propofol and thus has different pharmacodynamics and pharmacokinetics. It is a viable option that provides a consistent level of propofol-like sedation with a single bolus injection.
We continue to utilize benzodiazepenes and narcotics to balance our delivery of care to our patients but there are a few alternatives that may have a role in our toolbox. Anesthesia providers take pride in the quality of the care in which they provide their patients.
We can revisit some of the older drugs which we have almost uniformly dismissed; or we have the option of learning new medications and using our clinical acumen to take our profession and the care of our patients to an even greater level.
Just my thoughts,
Stanford Plavin MD
President Ambulatory Anesthesia of Atlanta LLC
Board Vice Chair: Preventing Colorectal Cancer.org
DrP@propofolshortage.com
For more information check out the following sites:
www.preventingcolorectalcancer.org
www.fda.gov/Drugs/DrugSafety/Drugshortages/ucm207290.htm
Seems like a real clinical problem. What is the anesthesia community doing with big business to make things better?
ReplyDeleteWho is most affected.? do patients seem to know about what is going on when they go in for an operation.
ReplyDeleteJim in Spokane