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Up & Atom

The US Nuclear Regulatory Commission’s (NRC’s) Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a meeting on March 30 to discuss a variety of topics of interest, including recent trends in radiopharmaceuticals, the scope of “patient intervention” as occurrences that are not Medical Events. Below are some items of potential interest from these discussions.

Trends in Radiopharmaceuticals

The ACMUI anticipates new positron emission tomography (PET) radiotracers to become available in the next few years in major clinical settings of cardiology, neurology, and oncology. In addition, the ACMUI believes that theranostics (the combination of using one radioactive drug to diagnose and a second radioactive drug to deliver therapy to treat the main tumor and any metastatic tumors) will continue to grow with the clinical introduction of prostate-specific membrane antigen (PSMA)-based agents for imaging and radioligand therapy of prostate cancer.

Medical Event/Patient Intervention

The ACMUI’s Subcommittee on Medical Events and Patient Intervention articulated the contours of the term “patient intervention”[1] as among occurrences that are not reportable as Medical Events. The subcommittee proposed that “patient intervention” should include intentional or “voluntary” physical actions taken by the patient (such as refusing to continue with a prescribed course of treatment) and unintentional or “involuntary” actions resulting from the anatomical or physiological conditions of the patient (such as the onset of other underlying medical diseases and disorders that interfere with the prescribed treatment).

Notwithstanding the subcommittee’s proposal that “patient intervention” be treated as non-reportable, the ACMUI noted that medical events resulting from patient intervention should still be reported internally, as required by a licensee’s policies and procedures. A representative from the NRC’s Office of General Counsel also participated in the discussion and questioned whether the subcommittee’s proposal was consistent with the NRC’s definition of “Medical Event” and the related reporting requirements.

Frequency of Medical Events

The NRC Medical Radiation Safety Team summarized and analyzed the medical events that occurred between 2014 and 2019. In so doing, the team identified the types of procedures during which those events occurred and the root and contributing causes of many of those events. Interestingly, although the number of therapeutic procedures nationwide has remained roughly constant in recent years, the number of medical events has increased between 2017 and 2019 (43 in 2017, 48 in 2018, and 56 in 2019). 10 CFR § 35.3045 identifies the circumstances in which a licensee must submit a report to the NRC in connection with medical uses of isotopes. The failure to submit reports in accordance with that section could result in civil penalties and the revocation of the underlying license, among other adverse consequences, depending on the facts underlying the failure to do so. As we noted previously, the NRC recently issued guidance to licensees in response to, among other factors, licensees’ failure to identify and report Medical Events.

Medical-use licensees are subject to NRC and agreement state inspections and enforcement actions, both of which may be time consuming and costly. We will continue to monitor and report issues related to medical uses of radioisotopes.

[1] Unanticipated events that occur during a properly performed clinical procedure that result from actions taken by the patient that could not have been reasonably prevented, or from an anatomical or physiological condition of the patient.