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Executive Summary

STUART DIPRIVAN "DEAR DOCTOR" EMPHASIZES SINGLE-USE and alerts anesthesiologists and hospital pharmacists to a contamination potential from improper administration of the I.V. anesthetic drug. The July 6 letter observes that "recent reports of clusters of postoperative fevers and infections have been associated with the administration of Diprivan (propofol) Injection." Investigations of those reports by the company, the Centers for Disease Control and FDA, the letter reports, "suggest that these adverse reactions are the result of failure by hospital personnel to adhere to aseptic techniques leading to the contamination of Diprivan." The letter was sent by the ICI subsidiary in response to an article in the June 29 Centers for Disease Control Morbidity and Mortality Weekly Report. That report described four clusters of postoperative infections in 24 patients who received Diprivan in hospitals in California, Illinois, Maine and Michigan. The CDC report said its investigators had concluded that in each case "contamination of propofol was extrinsic (i.e., contaminated during manipulation after receipt from the manufacturer) and not intrinsic (i.e., contaminated at the time of manufacture)." Stuart reports that Diprivan has now been used "commercially in an estimated 650,000 patients in the US and over 10 mil. patients worldwide." That use experience "supports the conclusion that in situations where aseptic techniques are employed contamination of Diprivan has not been a problem," Stuart's "Dear Doctor" letter maintains. The product has been on the market in the U.S. since November of last year. At each of the hospitals investigated as a result of the contaminations, the CDC found, "aseptic technique was not observed during preparation of the propofol for use during infusion; syringes...used in the infusion pump were usually used on multiple patients." In one case, portions of the drug remaining in the infusion pump at the completion of one surgery were used in the next procedure. The CDC also established that "at each of the hospitals investigated, different lots of propofol were used, and cultures of previously unopened ampules from each hospital were sterile," according to the MMW report. Stuart's "Dear Doctor" letter explains that the vehicle for Diprivan is "a soybean fat emulsion and contains no antimicrobial preservatives. Strict aseptic techniques must always be maintained during handling, because the vehicle is capable of supporting rapid growth of microorganisms." Stuart has also sent out a revised package insert containing more specific instructions for handling and administering the I.V. anesthetic together with the "Dear Doctor" letter. The revised insert contains new reminders on maintaining aseptic techniques and the potential for microorganism contamination under both the warnings and the dosage and administration sections. "As with all sterile products, failure to follow aseptic handling procedures may result in microbial contamination causing fever and/or other adverse consequences which could lead to life-threatening illness," the dosage and administration section states. The labeling's new handling instructions now read "Diprivan Injection should be drawn in to sterile syringes immediately after ampules are opened. Administration should then commence without extended delay. Diprivan is intended as a single-use parenteral product. Diprivan should be prepared for single patient use only and any unused portions should be discarded at the end of the surgical procedure."

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