Highlights
- •diagnostic procedures involving I-131 sodium iodide or Ga-67 citrate SPECT/CT
- •therapeutic and theranostic procedures except Y-90 radioembolizations
- •instances when the wrong type or quantity of radiopharmaceutical was administered
- •instances where more than a single CT acquisition is obtained with the embryo/fetus in the FOV
- •instances where additional radiologic exams have been performed that may result in a total effective dose equivalent to the embryo/fetus of 50 mSv
Abstract
The Supreme Court of the United States (SCOTUS) decision on Dobbs v Jackson Women's Health Organization overturned a 49-year-old federal recognition of abortion rights and drastically altered a long-established risk-benefit analysis for pregnant or potentially pregnant patients in nuclear medicine. In this current legal landscape, the collection/documentation of reproductive health information (RHI) must be reduced and, in our brief communication, we outline how to do just that.
Keywords
1. Introduction
Radiation exposure to pregnant or potentially pregnant patients (PPPPs) has been a complex topic for physicians and other medical providers for over one hundred years. In the field of nuclear medicine (NM), there are many types of radiopharmaceuticals involved in diagnosing and treating diseases including heart disease, thyroid disease, neurodegenerative brain disease, infections, inflammatory conditions, cancer and other conditions that must all be individually considered,
1.
and the list of available radiopharmaceuticals is rapidly growing. The scientific understanding of radiobiological effects continues to advance. Public perceptions and concerns are ever-changing. Regulatory and accreditation requirements are constantly evolving. Amidst this landscape, on June 24, 2022, the Supreme Court of the United States (SCOTUS) issued a final decision in Dobbs v Jackson Women's Health Organization that overturned the 49-year-old federal recognition of abortion rights established by Roe v Wade and drastically altered a long-established risk-benefit analysis for PPPPs in NM.2. Reproductive health information in nuclear medicine
In most diagnostic NM applications (including positron emission tomography (PET)), the benefits of the diagnostic test should be carefully weighed against the risks of exposing a developing embryo/fetus. In these applications, the (stochastic) risk is usually a small theoretical increase in the probability of developing cancer later in life, but (pre-Dobbs) substantial enough that inquiring PPPPs if they are or could be pregnant was always reasonable. In therapeutic NM applications, again the benefits must outweigh the risks; however, the risks of NM therapies to a developing embryo/fetus are generally considered high enough to definitively exclude pregnancy by either a urine or blood test.
2.
In a post-Dobbs legal environment, medical professionals must first consider how best to minimize the directly adverse effects of antiabortion laws on patients and provide quality reproductive health care within legal limits.
3.
, - Harris L.H.
Navigating loss of abortion services—a large academic medical center prepares for the overturn of Roe v. Wade.
N Engl J Med. 2022 May 11; https://doi.org/10.1056/NEJMp2206246
4.
However, a second important consideration for clinicians and healthcare facilities is how best to protect their patients and themselves from having reproductive health information (RHI) used to incriminate them.- Spector-Bagdady K.
- Mello M.M.
Protecting the privacy of reproductive health information after the fall of roe v wade.
In JAMA Health Forum. 2022 Jun 3; 3 (pp. e222656-e222656) (American Medical Association)https://doi.org/10.1001/jamahealthforum.2022.2656
3.
, - Harris L.H.
Navigating loss of abortion services—a large academic medical center prepares for the overturn of Roe v. Wade.
N Engl J Med. 2022 May 11; https://doi.org/10.1056/NEJMp2206246
4.
This second consideration is what has the potential to impact NM so severely.- Spector-Bagdady K.
- Mello M.M.
Protecting the privacy of reproductive health information after the fall of roe v wade.
In JAMA Health Forum. 2022 Jun 3; 3 (pp. e222656-e222656) (American Medical Association)https://doi.org/10.1001/jamahealthforum.2022.2656
The results of all patient histories and laboratory tests regarding RHI are ultimately placed into the patient's electronic medical record (EMR). The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) protects such individually identifiable health information from disclosure without the patient's approval, but there are important exceptions, which “include reporting child abuse or neglect to an ‘appropriate government authority’; responding to a court order, subpoena, or discovery request for information relating to a lawsuit; and giving information to law enforcement officials ‘as required by law.’”
4.
Thus, HIPAA may not protect patients or providers from incrimination in abortion cases for RHI collected in NM.- Spector-Bagdady K.
- Mello M.M.
Protecting the privacy of reproductive health information after the fall of roe v wade.
In JAMA Health Forum. 2022 Jun 3; 3 (pp. e222656-e222656) (American Medical Association)https://doi.org/10.1001/jamahealthforum.2022.2656
Simply put, SCOTUS' Dobbs decision has significantly changed the risk associated with collecting RHI for PPPPs. By law, NM clinicians and radioactive material (RAM) licensees are required to report embryonic/fetal doses above 50 mSv (10 CFR § 35.3047), which corresponds to a small (0.5%) increased risk of any adverse effects (childhood cancer or malformation).
5.
, 6.
In these rare occurrences of embryonic/fetal doses above 50 mSv, 10 CFR § 35.3047 requires notifying the pregnant individual, their referring physician, and the United States Nuclear Regulatory Commission (NRC) or agreement state. However, there is no other regulation or requirement, aside from internal policies and procedures, that requires RHI be collected or documented for PPPPs in NM. Considering that Dobbs now opens patients and clinicians to potential incrimination in abortion cases, NM departments must reconsider the risk-benefit analysis of collecting and documenting RHI information for PPPPs.3. Embryonic/fetal risks in nuclear medicine
The vast majority of diagnostic NM procedures result in much less than 50 mSv to a developing embryo/fetus at any stage.
6.
The primary exception is I-131 sodium iodide where thyroidal uptake in the fetus may result in partial or complete ablation.5.
Likely the next most concerning type of radiopharmaceutical administration would be Ga-67 citrate which would result in 38 mSv to a 3-month-old fetus. Even some therapeutic NM procedures may result in fetal doses well below 50 mSv. Y-90 radioembolization, for example, would likely only result in 2 mSv to an embryo/fetus.7.
Embryonic/fetal doses from computed tomography (CT) scans obtained for diagnostic, localization, or attenuation-correction purposes must also be considered. A whole-body F-18 fluorodeoxyglucose (FDG) PET/CT scan, for example, should consider the approximate dose to the embryo/fetus to be about 25 mSv if directly in the imaging field of view (FOV). This must be added to the radiopharmaceutical dose contribution, which may result in a total effective dose equivalent (TEDE) of about 33 mSv– again well below the 50 mSv notification threshold in 10 CFR § 35.3047. It's likely acceptable to estimate the approximate embryonic/fetal CT dose to also be about 25 mSv, or less, for any SPECT/CT scan where the embryo/fetus is again directly exposed in the FOV.
PET/MRI is another growing hybrid imaging modality in NM and there is a persistent concern among a small minority of radiology professionals regarding the safety of non-ionizing radiation for PPPPs. However, the first clinical MRI scanners were installed in the early 1980s and there have since been no observed adverse effects on an embryo or fetus.
8.
For this reason, the non-ionizing imaging modalities of MRI and ultrasound have always been preferred for PPPPs.Again, stochastic risks are the primary radiation safety concern for PPPPs in NM and 50 mSv is the regulatory threshold that triggers reporting. Additional concerns include “prenatal death, intrauterine growth restriction, small head size, mental retardation, and organ malformation”,
6.
but these risks will occur with less than 0.1% frequency at 50 mSv and 0.2% frequency at 100 mSv. Without any radiation at all, these effects occur in about 4% of pregnancies – 20 times higher than any potential increased risk at 100 mSv. Radiosensitivity of the conceptus varies with gestational age, but again these quantifications of risk reflect the worst-case scenario at any stage.Taking all of this into account in the post-Dobbs legal environment, from a radiation safety perspective, RHI should consequently only be collected and documented in NM for the following:
- •diagnostic procedures involving I-131 sodium iodide
- •diagnostic Ga-67 citrate SPECT/CT
- •therapeutic and theranostic procedures except Y-90 radioembolizations
- •instances when the wrong type or quantity of radiopharmaceutical was administered
- •instances where more than a single CT acquisition is obtained with the embryo/fetus in the FOV
- •instances where additional radiologic exams have been performed that may result in a TEDE to the embryo/fetus of 50 mSv
Outside of these procedures/instances, the clinical utility of RHI in NM radiation safety decisions is now eclipsed by the risk of it being used to incriminate and limiting access to potentially life-saving care.
We must also consider that 10 CFR § 35.75 additionally requires licensees to provide patients with discharge instructions if the dose to any other individual may exceed 1 mSv, and it is possible that in a post-Dobbs legal environment that this may be applied to PPPPs. This regulation is currently commonly applied to nursing mothers in consideration of nursing infants but never (to date) an embryo or fetus. This interpretation may change in the future and could inappropriately limit PPPPs access to care, but it is something that must be considered as a post-Dobbs possibility. The NRC would ultimately be responsible for overseeing such a proposed change in the established interpretation and would hopefully reject it. NM clinicians should therefore assume the status quo on the interpretation of 10 CFR § 35.75 and reduce RHI collection as discussed above. If there were a change in the status quo, the NRC would be required to issue a notice to all licensees before any changes.
4. Considerations for staff and the need for stronger privacy laws
A separate topic is RHI collected for the radiation safety of pregnant or potentially pregnant staff. In this regard, 10 CFR § 20.1208 requires that the dose to a declared pregnant worker not exceed 5 mSv over the entire course of gestation and 10 CFR § 20.1502 requires that declared pregnant workers be issued personnel dosimetry if the dose to the embryo/fetus is likely to exceed 1 mSv. It is vital that workers be aware that they do not need to declare their pregnancy to their employer in any way. If they do choose to declare, it must be in writing along with the estimated date of conception. Workers may also choose to undeclare their pregnancy at any time and this must also be in writing. Radiation safety personnel should be open to discussing these concerns with staff and, as with PPPPs, similarly reduce RHI collection/documentation where possible.
Stronger federal privacy laws are ultimately needed to fully protect patients, providers, and facilities. However, NM providers must acknowledge that SCOTUS' Dobbs decision has already drastically altered routine practice. Even in states that protect women's reproductive rights, there is the obvious possibility of pregnant patients having a NM procedure in one such state and later requiring an abortion in another state. Regulatory and accreditation agencies hold clinicians and healthcare facilities to their own internal policies but considering the minimal to non-existent risks to PPPPs for the vast majority of NM procedures, RHI collection and documentation is now only clinically or administratively warranted in the select cases discussed above. So if internal policies and procedures uniformly require collecting RHI, then they should be changed immediately. Failure to do so puts patients' health in jeopardy and increases their risk of incrimination along with that of providers' and healthcare facilities'.
Data statement
Not applicable.
Funding
The authors have no sources of funding to declare.
Declaration of competing interest
The authors declare no conflict of interest.
References
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- Protecting the privacy of reproductive health information after the fall of roe v wade.In JAMA Health Forum. 2022 Jun 3; 3 (pp. e222656-e222656) (American Medical Association)https://doi.org/10.1001/jamahealthforum.2022.2656
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Article info
Publication history
Published online: January 02, 2023
Accepted:
December 20,
2022
Received in revised form:
December 9,
2022
Received:
August 1,
2022
Identification
Copyright
© 2023 Elsevier Inc. All rights reserved.
