2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC133
Submitter : Dr. Peter Bailey Date & Time: 11/01/2005 04:11:11
Organization : University of Rochester
Category : Health Professional
Issue Areas/Comments
I have been involved in matters concerning sedation by non-anesthesiologists for about 20 years. I have been and remain to date on the ASA task force that promulgates the guidelines on sedation by non-anesthesioloigsts which are widely used and I am the sedaiton officer for my entire hospital. My research contributions to this area are well cited.

I am dismayed and frustrated by the tone and content of the ongoing controversy. Points that I would like to briefly mention to highlight what I feel are important matters are:
1. We need to remember how far we have come. There were many deaths (86 in one report in 1990 in the journal Anesthesiology summarizing the FDA database) when midazolam was first used by non-anesthesiologists in the late 1980's. We have all learned a lot. I can no find no credible peer reviewed reports of deaths with sedation with propofol when adminsitered by non-anesthesiologists. The difference between what happened with midazolam in the past and now with propofol is quite notable. Does the FDA know of any sedation related deaths with propofol?
2. It is a primary principle in anesthesia and pharmacology that it is the how a drug is used not what the drug is, that largely determines clinical safety. While propofol certainly can be used as an induction agent, and thus cause hypotension and apnea, so can midazolam for that matter. Indeed midazolam inductions in anesthesia are well described. The fact is, with propoer education and training (not equating to a residency) clinicians can learn to safely and effectively employ propofol in their practice to advantage. The drug is very short acting, a very desirable and potentially safe feature. It leaves patients feeling rather 'well' and it has mild antiemetic properties. The key concerning safe and effective use of propofol for sedation is to assure proper education and training as well as practice setting and standards of care (e.g. those consistent with a deep sedation practice).
3. With somewhere close to 200,000,000 sedations provided every year for all sorts of procedures and tests in the USA there will never be the anesthesia trained manpower to provide all this care nor should there be.
4. Not only are many drugs used safely 'off-label' to the benefit of patients, but numerous practices, such as echocardiography, are practiced by clinicians other than those in the specialty from which the practice arose. Thus, cardiac anesthesiologists practice transesophageal echocardiography, again to the benefit of many patients, and quality is built through inter-specialty efforts to assure adequate education, training and practice standards. I am certain this joint effort was not painless but it is working.

The arguments which focus on the issue of propofol use by others than those trained in anesthesia care as a practice which threatens the integerity of a specialty or patient safety seem more like exagerrations. Some of the comments and rhetoric I have seen sound like the controvery is more over politics and economics and not patient safety. Where is the data that patients are harmed, rather than helped? Where is the collegial cooperation to do what is best for patients? Where is the national coordinated effort of multiple specialties defining standards of education, training and competency and high quality care rather than participating in polarizing rhetoric?

I believe that patients deserve better than this and that they would be better served by a different discourse and direction in this matter.


Peter Bailey, MD
Professor, Anesthesiology
University of Rochester