Prioritizing Health and Radiation Safety in Radiopharmaceutical Therapy

wallnerThis post was contributed by Paul E. Wallner, DO, FACR, chair of the ad hoc workgroup on NRC training and experience requirements for the ACR Commission on Government Relations-Federal Regulatory Committee

The U.S. Nuclear Regulatory Commission (NRC) is exploring the idea of reducing training and experience (T&E) requirements for physicians authorized to use therapeutic radiopharmaceuticals regulated under 10 CFR Part 35, Subpart E (“Unsealed Byproduct Material—Written Directive Required”). The controversial concept would involve less comprehensive T&E pathways to authorized user (AU) eligibility for clinicians without the appropriate ABR, ABNM or AOBR board certification or the currently specified alternate pathway. The target audience would be referring clinicians who, for whatever reason, do not wish to refer their patients to the radiopharmaceutical therapy experts.

Supporters of weakened 10 CFR 35.390 AU T&E prerequisites—primarily commercial entities that manufacture or supply therapeutic radiopharmaceuticals—suggest there is a shortage of AUs, creating rural access problems. They argue that unitized dose delivery systems negate the need for physicians to have radiation and nuclear materials expertise. Such arguments are unsubstantiated, anecdotal and often conflicted.

With approximately a thousand trainees in the traditional pipelines of nuclear medicine, radiation oncology and nuclear/diagnostic radiology, demand for radionuclide therapy AUs under Subpart E will be adequately covered for the foreseeable future. With many considerations influencing treatment and referral decisions, it is unlikely that expanding the AU population with inadequately-trained clinicians would create additional points of access in rural areas. Rather, it is more likely that large facilities already licensed by NRC or the Agreement States for these uses would be disrupted internally. This concept would circumvent radiation best practices and cancer care standards while fostering an environment of financially-motivated utilization, thereby reducing the quality and safety of radiopharmaceutical therapy.

As a member of ACR’s Federal Regulatory Committee (FRC), I have chaired an ad hoc workgroup responsible for leading the College’s response. The workgroup consists of leaders and volunteers from ACR’s Commission on Government Relations, Commission on Radiation Oncology, Commission on Nuclear Medicine and Molecular Imaging, and Commission on Medical Physics-Government Relations Committee. Over the past year, we provided testimony to NRC’s federal advisory committee, wrote letters to NRC staff and leaders, collaborated with likeminded professional organizations, and met face-to-face with NRC’s Commissioners to educate them about our community’s concerns.

On January 29, 2019, ACR submitted public comments answering specified questions from NRC and asking the agency to not pursue regulatory revisions to reduce the aforementioned T&E requirements for individuals without appropriate board certification. The NRC staff and Commissioners intend to make a decision later this year on whether or not to open up the rulemaking process. Moving forward, ACR will continue to work to promote the best interests of patients and the public on this important health and radiation safety issue.

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Engaging Medical Students and Residents to Choose Pediatric Radiology

drsouthardThis post was contributed by Richard N. Southard, MD, Vice Chairman of Clinical Operations, Director of CT and Cardiac Imaging, Co-Director of the 3-D Innovation Lab at Phoenix Children’s Hospital

To address the on-going physician shortage in Medicine in general, radiology specifically, and my chosen subspecialty of pediatric radiology especially, I need insight about the young adults, medical students and residents whom we are trying to recruit.

These medical students and residents are late Generation Y/Millennials (born 1981-1994), and early Generation Z (born 1995-2012). This technologically savvy generation grew up with computers, and despite being able to instantaneously “connect” via social media, they still seek out and value being with friends and experiences. They also value social equality, want to make a positive impact in a supportive workplace and desire a stable future.

In an article discussing the factors influencing subspecialty choice among residents, Arnold, et al [2009], questioned radiology trainees about their motivations and perceptions of the subspecialty fields when selecting radiology fellowships. Leading factors for the residents were areas of strong personal interest, advanced multi-modality imaging, intellectual challenge, marketability and enjoyable resident rotations. Financial compensation was relatively unimportant.

I completed a pediatric internship and residency before going into radiology. The aspects of pediatric medicine which appeal to me are working with kids, interacting with families, making a positive impact on pediatric care, and the challenges of a multitude of diseases. Pediatric radiology today still has a wonderful blend of patient and family interaction; general to subspecialized clinician interaction; advanced imaging modalities such as ultrasound, MRI, CT, and Nuclear Medicine; and cutting edge hardware and software technologies such as elastography, musculoskeletal ultrasound and interventions, the latest MRI techniques, dual-energy Spectral CT, 3-D modelling and volumetrics, molecular imaging and PET/SPECT/CT. My daily work involves supportive colleagues, an incredible breadth and depth of technology and a large number of disease processes to consider. Pediatric radiology affords me the ability to be a subspecialist and a generalist at the same time, and it is never boring.

Many residents select their subspecialties prior to their 3rd and 4th years, and rotating residents at children’s hospitals typically are in the later stages of training, leaving us at a disadvantage in recruiting bright residents into pediatric radiology fellowships. How to address this problem?

There is need to engage medical students and residents through earlier elective rotations, radiology lectures in medical school or clubs, developing active department research opportunities for medical students and residents and social media such as daily cases on Instagram. One could attract pediatric residents who already show a strong interest in pediatric care into radiology by showing them a welcoming patient-friendly work environment that maintains personal interactions, and our role as an active care team member positively impacting children’s health. The radiology profession is technologically advanced and intellectually challenging, and the multiple imaging modalities are becoming more advanced.

Given the shortage of, and great need for, pediatric fellowship trained radiologists in both private practice and academic settings, these skills remain highly marketable. Compensation and benefits, and flexible work environments, remain good for radiologists.  The role we imagers play in the diagnosis and delivery of health care is both meaningful and rewarding. In my opinion, radiology is the perfect job for today’s medical students and residents to consider.

  • How are you engaging medical students to pursue a career in pediatric radiology, or another subspecialty?
  • Have you been leveraging the new resource, RadInfo 4 Kids, in your practice?

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TMIST Helps Expand Participation in Clinical Trials

Etta Pisano 16May17_0002 headshotThis post was contributed by Etta Pisano, MD, FACR, principal investigator of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST).

Criticisms of some large clinical trials include that the research was confined to large academic centers and that patient populations lacked sufficient representation from underserved communities.

The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is taking steps to avoid such pitfalls. I recently explained to ACR-RBMA Practice Leaders Forum attendees how their practice or department can benefit by take part in TMIST. The response was fantastic!

It appears many freestanding or outpatient imaging facility leaders have rarely been approached to take part in a large study. That is a shame.

While we thank — and are proud of — all the large institutions taking part in TMIST (and we want more to take part), we are also seeking a mix of facility types to demonstrate that trial results are applicable across care settings.

pisano at podium wide

ACR-RBMA Practice Leaders Forum

TMIST participation can also empower your practice to offer the latest care to underserved populations and expand minority and rural resident participation in clinical trials.

Sites receive $500 for the recruitment of each woman to the study and the submission of the data on the first round of screening, plus $150 for data submitted after each additional TMIST-required screening mammogram.

What makes TMIST different from most other federally funded trials is that for uninsured women recruited to the study who qualify for charity care at a participating facility, the site also receives $138 for each TMIST screening mammogram (on top of the $500 and $150 mentioned above).

pisano at podium tight

This is a new and rare opportunity — one that I am proud to say TMIST can offer to practices.

TMIST seeks to identify groups of women in which tomosynthesis may outpace digital mammography at reducing advanced cancer development. TMIST would also create the world’s largest bio-repository to tailor future risk-based screening policy.

I encourage you to get involved in shaping the future of breast cancer screening by participating in TMIST. Decision makers rarely update policy without such a randomized, controlled trial.

Now is the time to get involved.

Email — we will answer your questions and walk you through how to get started.

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