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Don't confuse new liposomal doxorubicin with conventional doxorubicin


From the October 9, 1996 issue

Problem:A death was reported which may be related to the accidental administration of the new liposomal form of doxorubicin instead of the conventional doxorubicin hydrochloride actually prescribed. Doxil® (liposomal doxorubicin, SEQUUS Pharmaceuticals) is indicated only for AIDS-related Kaposi's sarcoma while doxorubicin hydrochloride (Adriamycin®, Rubex®) is used in leukemias, lymphomas, as well as breast, ovarian, and other forms of cancer. The plasma clearance of the liposomal form is significantly reduced compared to free doxorubicin. Standard doses of the liposomal product are 20 mg/m2 given at 21 day intervals compared to doses of 60 to 75 mg/m2 every 21 days for conventional drug.

Several dispensing errors took place in a hospital where pharmacy personnel were unaware of the new liposomal form and where the drug was not on the hospital's formulary. The drug was specially ordered as a non-formulary item for a patient with Kaposi's sarcoma, but the patient's physician later decided not to use it. Since it was non-formulary, liposomal doxorubicin was not listed in the computer order entry system and had no set storage location within the pharmacy. It was placed on a pharmacy shelf alongside the conventional product. The pharmacy had been experiencing shortages of conventional doxorubicin hydrochloride, and it was common to see products from various manufacturers in different vial sizes, including both solution and lyophilized forms. Thus, pharmacy technicians and pharmacists did not notice the change in vial size and appearance which might have been noticed if the shortages had not been occurring. Generic name similarity between the two products, and the fact that they both provide clear, red solutions when doses are prepared in IV bags, may also have contributed to the mix-up. Before the error was discovered, three patients each received the wrong product. Two suffered no injuries, but one patient later died. However, it could not be determined with certainty whether or not the error contributed to the death.

Safe Practice Recommendation: An important reason for the drug formulary review process is that it provides an important window of opportunity for staff education when new products are introduced. However, a systematic process for educating staff about new drugs must also be in place in other circumstances, such as use of non-formulary agents. Since hospitals treating AIDS patients are likely to be using liposomal doxorubicin, clinical staff must be aware of the availability and proper use of this drug, including factors that differentiate it from doxorubicin hydrochloride. For non-formulary items, many hospitals establish special storage areas to separate new drugs and provide staff with notification of their status and availability. The manufacturer should also consider steps that could be taken to help differentiate their product from conventional doxorubicin. For example, the word "liposomal" could be listed much more prominently on Doxil® package labels. Hospitals with supplies of Doxil® should consider adding auxiliary labels to the containers to help assure that all staff can differentiate this item from doxorubicin hydrochloride. [P,N,T]

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