2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC183
Submitter : Dr. Louis La Luna Date & Time: 12/13/2005 09:12:08
Organization : Berks Center for Digestive Health
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am a gastroenterologist practicing in Berks County PA near Reading. We currently have a contract with an anesthesia provider (including anesthesiologists and CRNAs) who administer propofol to patients in our facility. I am writing to voice my opinion regarding the proposed removal from the labeling of restrictions on who can administer propofol. I feel strongly that propofol should be administered by trained professionals. Because there are no reversal agents for this anesthetic, it is crucial that a formally educated and trained anesthesia provider, with primary and sole responsibility for advanced airway support and resuscitative support, be responsible for its administration. Experience administering this medication, as well as observing and treating common and rare untoward events, is a long process. I understand, furthermore, that there are several professional organizations who recognize the risks involved with Propofol and the need for advanced training to administer the drug. They include: American Society of Anesthesiologists? (ASA), American Association of Nurse Anesthetists? (AANA), Joint Commission on Accreditation of Health Organizations (JCAHO), American Association of Accreditation for Ambulatory Surgical Facilities (AAAASF), and the Boards of Nursing in 12 States. The state of Pennsylvania also recognizes the potential dangers associated with administering this drug and is poised to mandate that endoscopy centers using this medication be classified as ?class-C? facilities which, according to the AAAASF, requires an anesthesiologist or CRNA to administer the drug. The possible risk for bad patient outcomes in the ambulatory setting cannot be ignored. In the interest of patient safety and quality of care, it is my opinion that your committee should deny this petition for a label change.