Contact us | Sign in | A A A | U.S.A. U.S.A. (Change) - English

The Mo-99 Global Shortage: A closer look at
industry challenges

Date: September-2009

The Mo-99 supply chain
Key variables that impact supply
When there is a “break” in the supply chain
What is Cardinal Health doing to address this issue?
Future state

The Mo-99 supply chain

Molybdenum (Mo-99) is the key isotope used in the production of technetium generators and its supply chain has always been delicately balanced to meet world-wide technetium demand. While this delicate balance has been somewhat temperamental in the past, recent months have been particularly challenging. Used in 80 percent of nuclear medicine procedures, technetium is critically important in nuclear medicine with over 50,000 patients being imaged in the U.S. every day and tens of thousands of patients internationally. The limited production capability of Mo-99 is a recurring, global issue that impacts the nuclear medicine industry’s ability to effectively diagnose and treat patients on a daily basis. The challenge is real. For a better understanding of how and why Mo-99 shortages occur, here is a closer look at the components of the Mo-99 supply chain.

When the supply chain is working at optimal levels, below is the standard process for producing Mo-99.

Step 1: Reactors
Only five reactors are used to produce the world’s supply of Mo-99 and two of these five reactors are responsible for approximately 64 percent of the world’s supply, Canada (NRU) and The Netherlands (HFR). The other reactors make up an additional 21 percent combined and are located in Belgium (BR2), France (OSIRIS) and South Africa (Safari). A sixth reactor in Australia (OPAL), the first low enriched uranium (LEU) reactor, is coming online in the future and is considering assisting in this global shortage issue.

Step 2: Processors
Product is shipped to processing facilities where it is purified and then shipped to manufacturing facility where it is incorporated into the Mo-99 (technetium) generator.

Step 3: Generators
The output from these international reactors in turn supports the production of technetium generators from Covidien and Lantheus; the only two FDA-registered and approved generator manufacturers in the U.S.

Step 4: Nuclear pharmacy
Cardinal Health and other nuclear pharmacies use the generators to compound and dispense technetium-based products.

Step 5: Delivery to customer
Once the product has passed through all channels of the supply chain, it is finally delivered to a nuclear medicine facility for administration to the patient.

As you can see, the supply chain has many steps and involves several variables that allow the industry to collectively provide you and your patients with the products used for the critical detection and treatment of disease.

Back to Top

Key variables that impact supply

Aging reactors
The reactors became operational over 40-50 years ago and had a lifespan of approximately 30 years. Therefore, maintenance issues are frequent and can be difficult to repair or prevent, often impacting Mo-99 supply, without warning.

No reactors in the U.S.
As indicated in the process above, there are only five nuclear reactors producing medical isotopes in the world, and none of them are in the U.S., meaning 100 percent of the U.S. supply is imported. Based on the market demand, the top producing reactors, NRU (~ 31 percent) and HFR (~ 33 percent), are the primary sources for U.S. product.

Back to Top

When there is a “break” in the supply chain

So, what happens when one of the reactors goes down? If one of the main reactors, HFR or NRU, is unable to produce Mo-99, the availability of Mo-99 is severely diminished because the other existing reactors cannot ramp up to meet the world’s supply. This is the situation that has developed over the past several months.

In early-May 2009, the NRU reactor in Chalk River, Ontario, shutdown due to a heavy water leak which was discovered during routine maintenance after a regional power outage. This issue impacted the ability of nuclear pharmacies across the nation to obtain product from Lantheus. Based on an announcement in late-May by the Atomic Energy of Canada Limited (AECL), it stated the leak could take up to three months to repair. With now approximately31 percent of the world’s supply unavailable, the remaining reactors began ramping-up processes to increase their output. Below is a representation of how the supply chain was impacted when the NRU reactor shut down.


After the NRU reactor shut down

In early-June 2009, the NRU reactor leak was still under investigation. Meanwhile, the HFR reactor in The Netherlands announced a planned shutdown in early-July with routine maintenance also scheduled in mid-July, which will last about four weeks. This means approximately 64 percent of the world’s supply is impacted. Other reactors supplying the industry further continued to gear up to increase supply during this time in an effort to offset supply disruptions caused by the largest reactors being off-line. Below is a representation of the supply chain after the HFR reactor shut down.


After the HFR reactor shut down

The above graphics represent the true complexities of the Mo-99 supply chain. While the industry works diligently to keep supply near normal levels, reactors that are not producing at capacity still have an effect on the ability to meet the national demand for technetium radiopharmaceuticals.  As a result, dramatic shortfalls in supply and increasing Mo-99 costs are expected.

Back to Top

What is Cardinal Health doing to address this issue?
Supply issues are an industry issue - world-wide - not just a Cardinal Health issue. Cardinal Health participated in the International Atomic Energy Agency (IAEA) workshop that was hosted by the Nuclear Energy Agency of France in February 2009. The objective was to improve coordination of maintenance and down time of the five reactors to minimize disruption to the Mo-99 supply chain. The long-term goal is to develop new, consistent supply sources and Cardinal Health will continue to be actively involved with the IAEA to help achieve this goal.

Additionally, to prepare for these shortages, Cardinal Health does the following: 1.) diversifies its purchases of technetium generators across both manufacturers (Covidien and Lantheus) to improve reliability and address shortage issues and 2) drives efficiencies across our network of 150+ pharmacies to minimize waste and maximize the availability of technetium. We will continue to diligently manage every aspect of our operations to increase efficiencies and minimize waste and to provide our customers with frequent communications and updates to keep them apprised of supply conditions. We also ask that our customers take an active role in working with their local Cardinal Health pharmacy to efficiently manage their tech requirements use as well.

Back to Top

Future state
Mo-99 supply is a global crisis. It is real. But, the issue has created high visibility and has spurred new investment opportunities and ideas to improve our industry.

  • The American Medical Isotopes Production Act (AMIPA) was introduced by Representatives Markey and Upton to speed up the overall development efforts in the U.S. looking to provide $163 million over the next five years for a domestic Mo-99 supply. 
  • University of Missouri Research Reactor in Columbia is looking at modifying the reactor to product Mo-99 in three years at an estimated cost of $50 million.
  • Babcock & Wilcox Co. is planning to build a reactor to product medical isotopes and estimates five to six years for construction.
  • Two companies (one in Washington and one in Winnipeg, Canada) are exploring the use of linear accelerators to produce Mo-99 with the advantages of requiring less shielding and unlike a reactor, an accelerator can be easily shut down in case of an emergency.
  • While these are short-term fixes, there are long-term efforts underway to improve the availability of the supply of radioisotopes from within the U.S. As we look forward to the coming months ahead, we as an industry will continue to be challenged with shortages in Mo-99 supply. We need to continue to be more efficient in how we schedule, order and dose the patients we serve. Cardinal Health remains committed to the nuclear medicine industry and are working with suppliers to help ensure you have a reliable supply of technetium and to assist you through times of shortages.

    Please pass this information along to others in your facility who may be interested in understanding the Mo-99 supply shortages.

    Back to Top

    Be sure to check out future issues of TheLink: your connection to nuclear medicine safety for monthly updates, tips and reminders regarding the Mo-99 supply chain. For additional questions regarding the supply chain or safety-related information, please send an email to
    TheLink@cardinalhealth.com.

    References

    1. Written Testimony of Council of Radionuclides and Radiopharmaceuticals (CORAR). September 9, 2009.
    2. Society of Nuclear Medicine. Fast Facts on the Worldwide Medical Isotope Crisis. June 15, 2009. http://interactive.snm.org/index.cfm?PageID=8803&RPID=6313

    Disclaimer: Any reader of this document is cautioned that Cardinal Health makes no representation, guarantee, or warranty, express or implied as to the accuracy and appropriateness of the information contained in this document, and will bear no responsibility or liability for the results or consequences of its use.

    Feedback: TheLink