I am a patient, know a patient, or am a patient advocate

Point 1 – NRC should protect patients

• Patients count on the NRC policies to protect them when radiation is being used medically.
• In the August 3, 2020 Federal Register (65 FR 47654) the NRC explains their current Medical Use Policy Statement. The NRC “has a role assuring accurate delivery of radiation doses and dosages to patients and has rejected the notion that NRC should not regulate patient radiation safety.”
• Extravasations are, by definition, the inaccurate delivery of radiation doses. Significant extravasations can harm patients.
• Extravasations are currently exempted from reporting as medical events because of the NRC 1980 policy, which we now know is incorrect. Therefore, extravasations should not be treated any differently than other medical events.
• The NRC is not meeting their own Medical Use Policy Statement—they need to make extravasations reportable events.

Point 2 – Patients and their doctors need to know

• Extravasations can irradiate patient tissue with high doses and affect their care.
• Many nuclear medicine patients are predisposed to an increased radiosensitivity at lower radiations doses due to factors like obesity, diabetes, and prescribed chemotherapy and other drugs.
• Patients should know when something goes wrong with their medical procedure.

Point 3 – NRC needs to follow the evidence

• The NRC advisory committee made recommendations regarding extravasations that were unsupported by scientific evidence.
• The NRC advisory committee ignored patient safety with their recommendation to retain the exemption policy.

NRC Topic: Injection Quality Monitoring

Q1: How frequently does radiopharmaceutical extravasation occur?

The frequency of the potential medical events should not dictate medical event reporting. Did the NRC consider the frequency of other types of medical events or occupational exposures when determining reporting requirements?

Medical literature suggests that diagnostic extravasations happen at least 15% of the time.

A recent poster presented at a scientific session showed a major medical center extravasated 13% of their initial Lutathera therapy patients.

A review of the 2008 and 2009 ACMUI transcripts supports the medical literature. ACMUI members suggested extravasations happen all the time.

Q2: Do you know of any extravasations that have resulted in harm to patients? If so and without including information that could lead to the identification of the individual, describe the circumstances, type of effect harm, and the impacts.

A review of the NRC website indicates that medical event reporting does not necessarily indicate patient harm. The website says “Medical event reporting may indicate potential problems in a medical facility’s use of radioactive materials. It does not necessarily result in harm to the patient.”

The petition and other communications with the NRC cite references to medical literature and cases that show patient harm. Additionally, the FDA has had adverse events reports associated with extravasations.

Clinicians cannot know when patients have been harmed. Harm from radiation to tissue may not show up for months or years and the literature suggests that the nuclear medicine community does not routinely perform dosimetry or follow extravasated patients.

Additional imaging/radiation or performing unnecessary procedures on patients due to extravasations harms patients.

Q3: For medical use licensees, does your facility currently monitor for radiopharmaceutical extravasation? If so, why and how do you monitor? If not, why not?

N/A

Q4: Do you expect that monitoring for extravasation and reviewing the results would improve radiopharmaceutical administration techniques at medical use licensee facilities? If so, how? If not, why not?

Monitoring a process is the first step in understanding and improving the process.

Quality improvement processes have already been proven to reduce the frequency of extravasation in chemotherapy and contrast CT injections/infusions.

In 2019, the world’s largest nuclear medicine injection quality improvement project was published. It demonstrated that nuclear medicine centers who follow a quality improvement process significantly improved their extravasation rates.

The Mammography Quality Standards Act (MQSA) that Congress passed in the 1990’s ensured monitoring and improved mammography quality. The extravasation issue is no different.

Q5: Do you believe an NRC regulatory action requiring monitoring and review of extravasation would improve patient radiological health and safety? If so, how? If not, why not?

There is documentation that extravasations have been present since the beginning of nuclear medicine. However, the frequency remains high. The frequency cited by ACMUI members in 2008 and 2009 continued to be supported by data published since then. This indicates that the community has neither had the tools nor a mandate to improve nuclear medicine administrations. Regulatory action and public reporting will drive quality improvement efforts that will lead to reduced frequency.

50 peer-reviewed publications indicate how extravasation can negatively affect patient images and ensuing care. Reducing extravasations will reduce these negative effects.

The nuclear medicine community has stated that irradiating patient tissue with 1.0 Sv dose equivalent leads to adverse tissue reactions. Reducing extravasations will reduce the number of patients irradiated with high doses.

NRC Topic: Medical Event Classification and Reporting Criteria

Q1: Are there any benefits, not related to medical techniques, to monitoring and reporting certain extravasations as medical events? What would be the burden associated with monitoring for and reporting certain extravasations as medical events?

Patients expect their nuclear medicine procedures to be done properly and would have peace of mind knowing they can trust their imaging results.

Patients would want to know that their nuclear medicine centers monitor injections for extravasation.

Patients need to know if they have unintentionally been irradiated with high doses. Extravasations may negatively affect their diagnosis or treatment and they should be followed for delayed radiation injuries. This is no different than any other situations when patients accidentally receive high radiation exposures.

Patients should not have to pay for a procedure that was not done properly.

Patients sometimes care for young children. They should know if they have radiation remaining in their arm after their nuclear medicine procedure.

Patient safety should trump the minimal burden associated with monitoring and reporting. Patients do not want their extravasation to be ignored because someone does not want to fill out a form.

It is well understood that some centers do not routinely extravasate today. Therefore, the burden of monitoring injections must not be high. Centers that do not routinely extravasate will have no additional reporting burden.

For facilities that do extravasate, the burden should not outweigh the benefits to patients. When these facilities correct their extravasations issue, they will have no reporting burden.

Q2: If the NRC were to require that licensees report certain extravasations as medical events (recorded in NMED), what reporting criteria should be used to provide the NRC data that can be used to identify problems, monitor trends, and ensure that the licensee takes corrective action(s)?

The NRC should collect similar data to that collected for other medical events. Extravasations that exceed 0.5 Sv to tissue should be reported.

The ratio of significant extravasations to administrations would provide important information for understanding how a facility administers radioactive material. Centers that are not improving their reportable extravasation ratio should warrant closer scrutiny by the NRC.

Q3: If the NRC requires reporting of extravasations that meet medical event reporting criteria, should a distinction be made between reporting extravasations of diagnostic and therapeutic radiopharmaceuticals? If so, why? If not, why not?

It does not matter to a patient whether the high dose from an extravasation results from a diagnostic or therapeutic radiopharmaceutical.

The petition cites many cases of diagnostic extravasation which exceeded 0.5 Sv to tissue and references many therapeutic extravasations that must have exceeded the reporting limit. Both should be reported.