HealthCare Business News recently caught up with Tiffany Olson to discuss supply chain issues in the radiopharmaceutical industry.

HCB News: There have been molybdenum-99 (Mo-99) supply interruptions in the past. Does the supply chain in the U.S. look stable now, or are there weaknesses to keep an eye on?
Tiffany Olson: When I started in the radiopharmaceutical industry in 2013, I was astonished at the complexity of the supply chain. It truly impacts the business, and industry as a whole, more than I’ve seen in other industries in which I’ve worked. Technetium-99m (Tc-99m) is the daughter of molybdenum-99 (Mo-99) and is used in approximately 80 percent of the nuclear medicine procedures worldwide. Tc-99m has become the principal radioisotope used for medical diagnostic imaging because of the manageable half-life, low radiation exposure to patients and health care providers and clarity of images provided. Tc-99m is critical to how physicians make diagnoses and direct patient care, and we are therefore dedicated to managing the complicated dynamics in the Mo-99 supply chain.

Many factors combine to make the current supply chain for Mo-99 complex, including:
• The short half-life of Mo-99 at 66 hours, and Tc-99m at six hours.
• The U.S. does not have a domestic source of Mo-99, which can create difficult transportation and customs issues.
• The advanced age of most of the international reactors creates concern.

The Mo-99 supply shortage in 2009 created an impetus for the industry to focus on enhancing the reliability of supply. Over the last several years, the industry has increased outage reserve capacity and added extra targets at current reactors. Generator manufacturers, downstream to reactors, have diversified their supply chains and incorporated multi-source agreements for Mo-99. Industry groups such as the Organisation for Economic Co-operation and Development (OECD) are meeting with groups to ensure reactor maintenance schedules are coordinated. Mo-99 production has become more reliable with these additional reactors and processing capacity. We continue to monitor these conditions closely, and feel confident in the plans the industry has in place to minimize interruptions and ensure continuous supply for patients.

HCB News: How can nuclear pharmacies and nuclear medicine departments help optimize the use of Tc-99m and ensure patients continue to have access to important radiopharmaceuticals in case of a shortage?
TO: Improving the reliability of the Mo-99 supply chain doesn’t end with the reactors and generator manufacturers. Recall that necessity is the mother of invention, and nuclear pharmacies and nuclear medicine departments learned from prior Mo-99 shortages. Nuclear pharmacists are passionate about providing patients access to these critical diagnostic tools, and have adapted from the challenges of prior shortages. To optimize Tc-99m in the event of a shortage, nuclear pharmacies manage discretional orders of Tc-99m and, if necessary, engage in a triage process. Nuclear pharmacies have also become more efficient with their use of Mo-99/Tc-99m generators. Software applications have helped nuclear medicine departments simplify ordering and optimize deliveries. Nuclear medicine departments also use software and analytics to optimize patient scheduling.

HCB News: You raised the issue of the U.S. not having a domestic supply of Mo-99. How is this progressing?
TO: Cardinal Health and others in the industry are closely following these projects for the creation of a domestic Mo-99 supply. We need continued support from the U.S. government to assist commercial entities in establishing a reliable domestic supply of Mo-99.

In January 2013, the American Medical Isotope Production Act (AMIPA) was enacted to help establish a reliable domestic supply of LEU Mo-99. Making gains in this area, in December 2016, the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) announced that it entered into follow-on cooperative agreements with three commercial entities to establish a reliable domestic source of molybdenum-99 that will be produced without the use of highly enriched uranium (HEU).

HCB News: When will conversion to low enriched uranium (LEU) become mandatory? What does that mean to the industry?
TO: Since 1978, the International Atomic Energy Agency and U.S. Department of Energy have led focused programs to convert research reactors from using HEU to LEU to reduce the potential risk of terrorists accessing HEU. In 2007, 140 research reactors were using HEU fuel, and in 2016, this number was down to 74 research reactors using HEU. This includes eight reactors in the U.S. HEU continues to be used in producing Mo-99, as fuel for reactors and as targets. However, many producers utilize LEU fuels in their reactors, but continue to rely on HEU targets.

The National Nuclear Security Administration (NNSA) also works with international Mo-99 producers to convert their facilities to LEU targets. The goal is to eliminate the use of HEU in civilian applications worldwide, including in research reactors and medical isotope production facilities. It is key for the government to invest in these programs, otherwise the timelines will be very drawn out.

HCB News: What is the state of the radiopharmaceutical market today and what does the near-term future look like?
TO: We continue to see solid demand for myocardial perfusion imaging (MPI) due to the prevalence of cardiovascular disease and MPI’s ability to assist a physician in determining a course of action.

In 2016, we saw new radiopharmaceutical products enter the market, and this brings a sense of optimism to the industry as we continue to provide patients and health care providers effective tools to diagnose and treat patients. The pipeline for radiopharmaceuticals is a strong indication pharmaceutical manufacturers continue to invest in our industry.

The radiopharmaceutical industry is full of passionate individuals focused on improving patient care. I believe that through continued investment in research through public and private organizations, along with government grants, we’ll continue to see new developments that will grow our industry. The IDEAS study is a great example of financial investment from both industry and government to advance diagnosis and treatment.

HCB News: What other dynamics are impacting the radiopharmaceutical industry?
TO: We continue to be optimistic about therapeutic radiopharmaceuticals in the drug development pipeline. The unique aspects of radioisotopes, combined with new pharmaceuticals, make this a cutting-edge area that will truly improve patient care.


We continue to experience industry changes of acquisitions and divestitures. This year Cardinal Health acquired North American rights to Lymphoseek® from Navidea. We are thrilled with how the integration is moving, and are driven by the goal of providing continued access of the product to our hospital and clinic customers who have found great value in using Lymphoseek®.

HCB News: What do you anticipate from President Trump’s administration and shifting political landscape?
TO: Our fundamental strategy at Cardinal Health remains consistent. We’ll continue to operate with patient and employee safety as a top priority, and remain focused on value-based care, controlling costs and emphasizing disease prevention and improved patient outcomes.