ENS Event | |
|---|---|
14:30 Sep 28, 2023 | |
| Title | Possible Misadministration |
| Event Description | The following information was provided by the Kentucky Department for Public Health and Safety, Radiation Health Branch (KY RHB) via email:
KY RHB was notified on 9/29/2023, by a representative from the University of Kentucky that two patients were scheduled for treatment with Lu-177, one with commercially available Lu-177 dotatate (Lutathera) and one under a research protocol also using Lu-177 dotatate but distributed under an investigational new drug label. Both vials contained the same drug and differed only in their label for distribution / intended use. The nuclear medicine technologist prepared and administered Lu-177 dotatate from the vial labeled for research to the standard of care patient instead of the correct (commercial) vial. The patient received the correct amount of drug (prescribed activity), the correct chemical form (identical Lu-177 dotatate) by the correct route of administration as intended for their treatment. However, since the drug was dispensed from the vial distributed under the investigational new drug application intended for the research study patient, KY RHB considers this to meet the reporting requirements in Part 35 for a medical event. The physician was informed, the patient was informed, and no harm is anticipated as a result of this incident. Additional notifications have also been made as required considering the involvement of investigational drug product and the Institutional Review Board. The incident remains under evaluation and investigation for corrective actions. 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. |
| Where | |
|---|---|
| University Of Kentucky Lexington, Kentucky (NRC Region 1) | |
| License number: | 202-049-22 |
| Organization: | Kentucky Dept Of Radiation Control |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+20.42 h0.851 days <br />0.122 weeks <br />0.028 months <br />) | |
| Opened: | Russell Hestand 10:55 Sep 29, 2023 |
| NRC Officer: | Lawrence Criscione |
| Last Updated: | Oct 2, 2023 |
| 56765 - NRC Website | |
University Of Kentucky with Agreement State | |
WEEKMONTHYEARENS 578872025-08-22T05:00:00022 August 2025 05:00:00
[Table view]Agreement State Medical Event ENS 568162023-10-23T05:00:00023 October 2023 05:00:00 Agreement State Possible Dose Misadministration ENS 567652023-09-28T14:30:00028 September 2023 14:30:00 Agreement State Possible Misadministration ENS 457162010-02-23T15:45:00023 February 2010 15:45:00 Agreement State Agreement State Report - Gamma Knife Treatment to Wrong Location ENS 450112009-04-22T14:00:00022 April 2009 14:00:00 Agreement State Agreement State - Medical Misadministration ENS 411612004-10-22T19:00:00022 October 2004 19:00:00 Agreement State Agreement State Report ENS 400562003-06-23T20:30:00023 June 2003 20:30:00 Agreement State Agreement State Report 2025-08-22T05:00:00 | |