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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

The US Nuclear Regulatory Commission (NRC) and state agencies oversee the possession and use of radiopharmaceuticals and medical devices containing radioisotopes. In this regard, the NRC recently issued two information notices in response to medical events arising from the administration of radiopharmaceuticals.

The first, Information Notice 2019-11, alerts medical-use licensees to four strontium (Sr)-82/rubidium (Rb)-82 generator elution events that resulted in patients receiving concentrations of Sr-82 and Sr-85 in excess of regulatory requirements. The IN describes four separate events in which approximately 90 patients were administered Rb-82 chloride for cardiac imaging that contained Sr-82 and Sr-85 concentrations in excess of the regulatory limits identified in 10 CFR § 35.204.

In evaluating these events, the NRC found as follows:

  • Operators did not regularly perform breakthrough tests, and their failure to do so caused several patients to receive doses in excess of the medical event criteria.
  • Operators failed to switch the scale on the dose calibrator from millicuries to microcuries before measuring the decayed vial. Doing so masked the Sr-82 and Sr-85 breakthrough and led to multiple overexposures, though none in excess of the medical event criteria.
  • An operator used Ringer’s lactate intravenous fluid instead of sterile saline as the eluent, causing patients to receive doses 5 to 10 times greater than the medical event criteria.
  • An operator used Ringer’s lactate intravenous fluid instead of sterile saline as the eluent, although no patient received a dose in excess the medical event criteria.

The NRC attributed the overexposures to human error and failure to follow applicable procedures, and stressed the need to heed all warnings associated with the use of Sr-82/Rb-82 generators and the performance of breakthrough tests.

The second, Information Notice 2019-12, identifies recent medical events involving the administration of Y-90 microspheres. These medical events resulted from a variety of causes, such as errors with the written directive; clogging and kinking in the catheters causing the administration of a reduced amount of microspheres to the patient; and treatment to the wrong part of the body.

Of the reported medical events,

  • seven events involved a dose or activity going to the target organ that exceeded the written directive by more than 20% as a result of human error;
  • twenty-seven events involved blockages of the microspheres in the delivery system, either from kinks or dents in the catheter or clumping of the Y-90 microspheres in the catheter; and
  • eight events involved treatment to the wrong location covered by, among other things, administrative error.

In evaluating these events, the NRC stressed the importance of (1) having a signed and dated written directive as described in the Y-90 microsphere licensing guidance document; (2) reviewing the written directive before administering Y-90 microspheres; and (3) developing, implementing, and maintaining written procedures to provide high confidence that each administration is in accordance with the written directive.

Depending on the circumstances of a particular overexposure, licensees may be required to report to both the NRC and the US Food and Drug Administration. In addition, such an overexposure could trigger an investigation under hospital or related standard operating procedures, and may be reportable to the hospital accreditation and/or state licensing authorities, the hospital compliance program, and facility insurers.

Lawyers in our nuclear, FDA, and healthcare practices have experience assisting licensees in the wake of such events and related regulatory compliance matters more broadly. Please reach out to the authors if you have any questions or need assistance on these matters.