Last week, we received news of an industry-wide shortage on vital radiopharmaceuticals, Tc-99m and Mo-99, due to international reactors being shut down for scheduled and unscheduled maintenance. While we believe the shortage will be temporary – leading to supply challenges for the next few weeks – the production of Tc-99m and Mo-99 are currently delayed.
This incident is the latest in similar events that continue to expose the fragility of the nuclear supply chain. This year, I attended the OECD-HLG meeting and sat on a panel at the UPPI meeting where the challenges faced in radiopharmaceutical manufacturing were discussed. The fragile nature of producing radiopharmaceuticals can present a strain on the nuclear supply chain causing downstream effects on both the supply and the future cost of product acquisition.
As part of standard planned maintenance of international nuclear reactors, a plant may suspend or delay production of a radioisotope because of a need to adequately maintain compliance with regulatory or product compliance standards. If there is any unplanned maintenance it could cause global supply challenges while other international reactors work at full capacity to supply the global market; or it could cause an inadvertent shut down.
In this most recent event, U.S. commercial nuclear pharmacy providers experienced a reduction in their supply of raw material Mo-99 and I-131 because two nuclear reactors were temporarily shut down. These interruptions in production translate to one thing—nuclear pharmacies not receiving essential raw radioactive materials to prepare the radiopharmaceutical doses for health care organizations to perform necessary diagnostic tests for their patients.
So what is one to do when raw material for medical isotopes are in short supply for nuclear pharmacies? The answer lies in finding creative ways to work through this issue when there’s a break within the nuclear supply chain. Here are some steps you can take to be prepared when a shortage occurs within your nuclear medicine department:
- Consult with your nuclear pharmacy on when to place orders. During a supply shortage, health care organizations should check with the nuclear pharmacy for the days when the Tc-99m activity is the highest and their delivery schedules can best accommodate. Communication with the nuclear pharmacy is key to ensuring you will have the right radiopharmaceutical with the highest radioactivity to safeguard diagnostic efficacy.
- Order ahead. Plan to order unit doses of Tc-99m when the bulk material is known to face a cutback. When supply is interrupted, Tc-99m bulk doses are typically the first to be cut by your nuclear pharmacy.
- Substitute Tc-99m for Thallium 201 in the interim. During a shortage, consult with the ordering physician about substituting Thallium 201 for Tc-99m for a cardiac imaging study. This is another area of opportunity where providers could implement an extensive communication with nuclear pharmacies to ensure the adequate supply of Thallium is also available to meet demand.
- Adjust office hours. Because certain radiopharmaceuticals are unavailable during a shortage, it is critical to consider if extending your office hours to account for patient reschedules later in the week is a viable option for your organization. This may give the supply chain time to rebound and later in the week your nuclear pharmacy should have better insight on which days Tc-99m radiopharmaceutical will be in greater abundance.
As seen this week, disruptions in the supply chain can happen for a variety of reasons. Whether it’s a reactor going offline for scheduled maintenance or a plant halting production until a reactor passes inspection, the nuclear supply chain is interrupted causing nuclear pharmacies to be in short supply of a much-needed radiopharmaceutical compound containing Tc-99m. However, as I think about the main takeaway from this short-lived incident, I cannot express enough that communication and adaptability are the critical elements to ensuring supply is able to be replenished in the market. These materials are not easy to stockpile since they are radioactive and decay rapidly.
Therefore, if providers can work side by side with their nuclear pharmacy partners, nuclear pharmacies will work diligently to ensure that providers can continue to receive critical isotopes during this shortage. I recommend you work with your department to understand the impact of when the product will be back in full supply and consider adjusting your patient scheduling as required.
If you are interested in learning more about some of the other challenges that impact the various nuclear supply chains, read more in my recently authored white paper, “Can the SPECT Nuclear Imaging Modality Be Sustained?”
About the author. In her role as senior portfolio executive of radiopharmaceutical distribution sourcing, Leah Gannon looks to identify opportunities to help health care organizations achieve their cost-reduction initiatives and increase their operational efficiencies by offering competitively bid contracts and cost-savings solutions. In addition to her in-depth technical expertise, she possesses a keen understanding of the market dynamics related to radiopharmaceuticals.