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The medical isotope shortage and why it matters, explained

March 9, 2018

    This month, a Canadian supplier will discontinue production of a critical isotope widely used for SPECT studies, which has sparked widespread concern about an impending shortage.

    The supplier, Chalk River, runs a nuclear reactor that processes molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m), which is the primary isotope used for these exams. Chalk River is the only North American supplier, and their exit leaves only six suppliers globally.

    Chalk River's closure impacts an already fragile international supply chain. Currently, the United States ships uranium to one of the suppliers, primarily located in Europe. These nuclear reactor plants extract Mo-99 and then ship it back to the United States, where specialized pharmacies process the parent isotope into Tc-99m. From there, the isotope is delivered to hospitals around the country for use in SPECT studies.

    Plans for US manufacturing underway

    Former President Barack Obama in 2013 signed legislation to allow American companies to begin manufacturing medical isotopes. This decision was driven by the limited supply volumes, in addition to other factors, such as fears that terrorists would intercept U.S. uranium shipments to make dirty bombs.

    American companies are responding to this call to action. Last month, FDA and the Nuclear Regulatory Commission (NRC) allowed a Wisconsin-based company, NorthStar Medical Radioisotopes, to use their RadioGenix System for production of Tc-99m. The radioisotope separation platform extrapolates Tc-99m from non-uranium based Mo-99. Importantly, this announcement allows for the only domestic supply of non-uranium based Mo-99.

    Additionally, a second Wisconsin company, SHINE Medical Technologies, is in the process of building a nuclear accelerator capable of producing Mo-99. Aided by $25 million in federal funds, the company plans to develop 50,000 weekly doses of this isotope by 2020. But, before they can shift isotope production to American soil, they must navigate the lengthy and costly nuclear regulatory process, which has already delayed their original 2015 goal.

    Implications for imaging leaders

    While it's important to remain aware of the potential shortage, some industry leaders, such as the Nuclear Energy Agency, urge leaders not to raise the alarm. Existing suppliers assure that they've accounted for isotope shortages and will take precautions to minimize impacts.

    Regardless, there are steps imaging leaders can take to prepare for potential shortages:

    • Predict potential no-show patients: Although no-shows are less likely among patients scheduled for SPECT studies, one missed appointment results in costly supply waste. Tc-99m has a short shelf life of six hours, meaning there's a small timeframe to administer the imaging agent. If a patient misses an appointment, the wasted isotope could cost the hospital $500. To avoid this problem, consider increasing the frequency of SPECT appointment reminders leading up to the exam.
    • Shift patients to an alternative scan: If isotope deliveries are delayed, technologists are unable to perform SPECT studies and risk delaying patient care. If a delay is anticipated, consider shifting the patient to a different exam, such as a PET/CT.

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