ASA/FDA Propofol Availability Call
Chicago —
(November 5, 2009)
In response to numerous inquiries about the availability of certain
anesthesia induction agents including, propofol and thiopental as well
as etomidate and methohexital, the ASA, in cooperation with the U.S.
Food and Drug Administration (FDA) and the American Society of
Health-System Pharmacists (ASHP) will hold a conference call on Friday, November 6, 2009 from 12:00 pm to 1:00 pm (EST) to provide an update on the current situation.
During
this call, members will hear the latest information directly from FDA
officials, and will have the opportunity to raise specific concerns and
ask questions.
Call Details
Date: Friday, November 6, 2009
Time: 12:00 pm to 1:00 pm (EST)
Call in number: (877) 633-3156
Conference Code: 40467450
Participants will include:
| From FDA |
|
| Curtis Rosebraugh, M.D. |
Director, Office of Drug Evaluation II |
| Bob A. Rappaport, M.D. |
Director, Division of Anesthesia, Analgesia and Rheumatology Products (DAARP) |
| Rigoberto Roca, M.D. |
Deputy Director, DAARP |
| Bindi Nikhar, M.D. |
Medical Team Leader for Anesthesia |
| Arthur Simone, M.D. |
Medical Officer |
| Amra Slakovic-Mcclanen, M.D. |
Clinical Reviewer |
| Valerie Jensen, R.Ph. |
Drug Shortage Coordinator |
| Parinda Jani |
Chief, Project Management Staff |
| Allison Meyer |
Project Manager |
| |
|
| From ASA |
|
| Alexander Hannenberg, M.D. |
President |
| Arnold Berry, M.D. |
Vice-President for Scientific Affairs |
| Chip Amoe, JD, MPA |
Assistant Director, Federal Affairs |
| |
|
| From ASHP |
|
| Bona Benjamin, BS Pharm |
Director for Medication Use Quality Improvement |
Message for those unable to participate:
ASA and ASHP have been in close contact with the FDA and are working
with the agency to address concerns about the simultaneous supply
problems that are occurring with multiple induction agents in some
parts of the country. According to the FDA’s Director of the Division
of Anesthesia, Analgesia and Rheumatology Products in the Center for
Drug Evaluation and Research, the FDA Drug Shortage Program is
continuing to monitor the propofol and thiopental supply situation and
is working with manufacturers to ensure that adequate product remains
available. Currently the Agency believes that there is an adequate
supply of propofol available between the three major suppliers (APP,
Hospira and Teva) with an increase in supply likely to occur as early
as next week, although some limited availability with certain
presentations may still exist for a few weeks. See the ASA website for
the latest update.
The
ASA, ASHP and FDA encourage anesthesiology departments and purchasing
managers to continue ordering product at historic levels and to not
engage in additional bulk ordering that could lead to diminished supply
for others. If your practice or hospital is experiencing difficulty
obtaining product, please contact the FDA’s Drug Shortage Group at for assistance.
For those who may miss the call, a recording of the meeting will be available on the ASA website following the call.
THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS
Anesthesiologists: Physicians providing the lifeline of modern medicine. Founded in 1905, the American Society of Anesthesiologists is an educational, research and scientific association with 46,000 members organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.
For more information on the field of anesthesiology, visit the American Society of Anesthesiologists Web site at www.asahq.org. For patient information, visit LifeLineToModernMedicine.com
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