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| Discovered date | Reporting criterion | Title | Description | LER | |
|---|---|---|---|---|---|
| ENS 56310 | 14 December 2022 08:00:00 | Agreement State | Two Under Doses and Contaminated Individual | The following information was provided by the Washington Office of Radiation Protection via email: This is an event report involving two patients and a technologist (which occurred on 12/14/2022). The first patient was being treated for prostate cancer with the radiopharmaceutical PLUVICTO (lutetium-177 vipivotide tetraxetan). The apparatus that is normally used for administering the radiopharmaceutical was not available due to supply chain issues, so a similar apparatus where the infusion vial would be pressurized was used instead. Unfortunately, the radiopharmaceutical began to leak out of the rubber septum of the vial and into the shielded storage container. As soon as the leak was identified, the pump was stopped and the case was aborted, resulting in the dosage delivered being less than the prescribed dose by more than twenty percent. 200 millicuries had been prescribed, but only 129 millicuries was administered to the patient. There may have been too much pressure in the vial, which forced the liquid out of the pierced septum near the needles. The patient will continue receiving the remainder of their planned treatments. The effects and appropriate response to missing a partial dose will be discussed with the care team and the drug manufacturer. (The typical recommended treatment is 200 millicuries every six weeks for up to six doses.) The licensee will use a different administration method and apparatus that uses a syringe pump instead of a pressurized vial. The second patient was being treated for prostate cancer with the radiopharmaceutical PLUVICTO (lutetium-177 vipivotide tetraxetan). The apparatus that is normally used for administering the radiopharmaceutical was not available due to supply chain issues, so a similar apparatus where the infusion vial would be pressurized was used instead. Unfortunately, radiopharmaceutical began to leak out of the rubber septum of the vial and into the shielded storage container. As soon as the leak was identified, the pump was stopped and the case was aborted, resulting in the dosage delivered being less than the prescribed dose by more than twenty percent. 200 millicuries had been prescribed, but only 121 millicuries was administered to the patient. There may have been too much pressure in the vial, which forced the liquid out of the pierced septum near the needles. Due to a cancellation, on the next day (12/15/2022) a dose of PLUVICTO was available and after consultation with the patient, the nuclear medicine team including other authorized users, and the referring physician, it was agreed to inject a partial dose so that the full 200 millicuries originally prescribed would be delivered. The clinical team agreed on the medical necessity and safety of this fractionated administration. The second infusion was completed without incident and was well tolerated by the patient. At the manufacturer's web site in the prescribing information for PLUVICTO, a few options are given for administering PLUVICTO. None of those options involve pressurizing the vial of PLUVICTO. This does not appear to be a good practice, and appears to have resulted in the leak. Unfortunately, one of the technologists involved in the cleanup of the radiopharmaceutical spills (from the leaking vials) had contamination on his hand that he and radiation safety staff were unable to remove. The Washington State Department of Health has asked for additional details on how the contamination occurred, the radiation readings, and dose estimates, and suggested contacting the U.S. Department of Energy's Radiation Emergency Assistance Center / Training Site for help with dose calculations, decontamination advice, and advice on any additional medical care that the technologist may need in the future because of his radiation dose. Washington Report Number: WA-23-002 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. |