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Medical isotopes: time to secure supplies?
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Special Report: International Medical isotopes: time to secure supplies?
www.thelancet.com/oncology Vol 9 November 2008
essential to help maximum patient access to medical isotopes when the already fragile ⁹⁹Mo supply chain is impacted by unscheduled maintenance at multiple reactors”, says JoAnna Schooler (Covidien, Hazelwood, MO, USA). None of the measures has been able to make up the shortfall in Europe or guarantee a continuous supply. The activity of ⁹⁹mTc generators delivered over the past 2 months has fluctuated from 75% to 25% of normal. Provision of radionuclides used for extreme pain relief in patients with bone metastases, including strontium-89 and samarium153, has also been affected. The variability of supply has been difficult, says Donagh O’Sullivan (Mater Misericordiae, Dublin, Ireland). “We cannot keep making appointments for outpatients, only for them to be cancelled, rescheduled, and then cancelled again”, he comments. Departments have harvested ⁹⁹mTc from generators more often than usual and rescheduled scans to make the most of source activity. “The generator typically arrives overnight on Friday or the early hours of Saturday morning, so it is very efficient to start using it on a Saturday”, says Fred Verzijlbergen (St Antonius Hospital, Nieuwegein, Netherlands). Tests that need the high doses of ⁹⁹mTc (eg, bone scans and parathyroid scans) are done immediately after the generator is delivered, says Adil AlNahhas (Imperial College Healthcare NHS Trust, London, UK). Less demanding scans (eg, thyroid imaging) are done as the generator’s activity drops. Global supplies have been affected before—maintenance at the Canadian reactor overran for several weeks last year—and the fear is that problems will recur. “We are dependent on reactors that are between 40 and 50 years old”, warns Jean-Pierre Cabocel (Association of Imaging Producers and Equipment
Suppliers, Brussels, Belgium). “As they get older, they need more maintenance and there are more unplanned shutdowns, so our exposure to this type of problem is growing.” Doctors believe that collaboration is needed between the organisations producing radionuclides. The three European reactors that generate ⁹⁹Mo already synchronise operating cycles to ensure that at least one is always online. However, the number of days that each reactor operates, and commitments to non-medical projects, means there is little room for manoeuvre. The reactors in Canada and South Africa are not typically involved in the discussions. The European Association of Nuclear Medicine is lobbying for an upgrade of existing facilities or construction of new reactors devoted to the production of medical radionuclides. This latter demand is unlikely in the near future. A Canadian reactor project producing only medical isotopes was cancelled due to design problems. Plans to replace the HFR with a new reactor in 2016 are dependent on co-funding from scientific research grants.
Paula Gould
David Parker/Science Photo Library
The High Flux Reactor (HFR) in the Netherlands, one of three nuclear reactors in Europe that makes medical radionuclides, announced on Oct 14, 2008, that it would not restart until mid February. The prolonged Europewide shortage of key radioisotopes has prompted doctors to lobby for a new European reactor dedicated to medical applications. One of the main products affected is technetium-99m (⁹⁹mTc), a radioisotope used to detect metastatic spread on bone scans, to assess kidney, thyroid, and parathyroid function, and, to diagnose some breast cancers. ⁹⁹mTc is formed from the radioactive decay of molybdenum-99 (⁹⁹Mo), a byproduct of uranium-235 fission. It is delivered weekly to hospitals and clinics as a ⁹⁹Mo “generator” that ⁹⁹mTc is extracted from. The ⁹⁹mTc supply chain has been hit hard by the unexpected closure of the HFR. The stoppage in late August due to a technical problem overlapped with planned maintenance shutdowns at the other two reactors making ⁹⁹Mo. To make matters worse, it also coincided with the temporary closure of the Institut des Radioéléments (IRE) in Fleurus, Belgium, one of two plants in Europe responsible for extracting ⁹⁹Mo from irradiated uranium targets. European production of ⁹⁹Mo is now up and running again, albeit at decreased strength. Supplies have been supplemented by surplus material from reactors in Canada and South Africa, and sites in France and Belgium. New agreements have been struck between suppliers of ⁹⁹mTc generators and operating reactors allowing their sources of ⁹⁹Mo to be switched. “Collaborations that quickly address hurdles such as transport licenses, marketing authorisations, and changes in technical facilities, that require the approval of multiple authorities, in timeframes of only hours or days, are
Technetium-99m can be extracted from a molybdenum-99 generator
1027
Special Report: International Medical isotopes: time to secure supplies?
www.thelancet.com/oncology Vol 9 November 2008
essential to help maximum patient access to medical isotopes when the already fragile ⁹⁹Mo supply chain is impacted by unscheduled maintenance at multiple reactors”, says JoAnna Schooler (Covidien, Hazelwood, MO, USA). None of the measures has been able to make up the shortfall in Europe or guarantee a continuous supply. The activity of ⁹⁹mTc generators delivered over the past 2 months has fluctuated from 75% to 25% of normal. Provision of radionuclides used for extreme pain relief in patients with bone metastases, including strontium-89 and samarium153, has also been affected. The variability of supply has been difficult, says Donagh O’Sullivan (Mater Misericordiae, Dublin, Ireland). “We cannot keep making appointments for outpatients, only for them to be cancelled, rescheduled, and then cancelled again”, he comments. Departments have harvested ⁹⁹mTc from generators more often than usual and rescheduled scans to make the most of source activity. “The generator typically arrives overnight on Friday or the early hours of Saturday morning, so it is very efficient to start using it on a Saturday”, says Fred Verzijlbergen (St Antonius Hospital, Nieuwegein, Netherlands). Tests that need the high doses of ⁹⁹mTc (eg, bone scans and parathyroid scans) are done immediately after the generator is delivered, says Adil AlNahhas (Imperial College Healthcare NHS Trust, London, UK). Less demanding scans (eg, thyroid imaging) are done as the generator’s activity drops. Global supplies have been affected before—maintenance at the Canadian reactor overran for several weeks last year—and the fear is that problems will recur. “We are dependent on reactors that are between 40 and 50 years old”, warns Jean-Pierre Cabocel (Association of Imaging Producers and Equipment
Suppliers, Brussels, Belgium). “As they get older, they need more maintenance and there are more unplanned shutdowns, so our exposure to this type of problem is growing.” Doctors believe that collaboration is needed between the organisations producing radionuclides. The three European reactors that generate ⁹⁹Mo already synchronise operating cycles to ensure that at least one is always online. However, the number of days that each reactor operates, and commitments to non-medical projects, means there is little room for manoeuvre. The reactors in Canada and South Africa are not typically involved in the discussions. The European Association of Nuclear Medicine is lobbying for an upgrade of existing facilities or construction of new reactors devoted to the production of medical radionuclides. This latter demand is unlikely in the near future. A Canadian reactor project producing only medical isotopes was cancelled due to design problems. Plans to replace the HFR with a new reactor in 2016 are dependent on co-funding from scientific research grants.
Paula Gould
David Parker/Science Photo Library
The High Flux Reactor (HFR) in the Netherlands, one of three nuclear reactors in Europe that makes medical radionuclides, announced on Oct 14, 2008, that it would not restart until mid February. The prolonged Europewide shortage of key radioisotopes has prompted doctors to lobby for a new European reactor dedicated to medical applications. One of the main products affected is technetium-99m (⁹⁹mTc), a radioisotope used to detect metastatic spread on bone scans, to assess kidney, thyroid, and parathyroid function, and, to diagnose some breast cancers. ⁹⁹mTc is formed from the radioactive decay of molybdenum-99 (⁹⁹Mo), a byproduct of uranium-235 fission. It is delivered weekly to hospitals and clinics as a ⁹⁹Mo “generator” that ⁹⁹mTc is extracted from. The ⁹⁹mTc supply chain has been hit hard by the unexpected closure of the HFR. The stoppage in late August due to a technical problem overlapped with planned maintenance shutdowns at the other two reactors making ⁹⁹Mo. To make matters worse, it also coincided with the temporary closure of the Institut des Radioéléments (IRE) in Fleurus, Belgium, one of two plants in Europe responsible for extracting ⁹⁹Mo from irradiated uranium targets. European production of ⁹⁹Mo is now up and running again, albeit at decreased strength. Supplies have been supplemented by surplus material from reactors in Canada and South Africa, and sites in France and Belgium. New agreements have been struck between suppliers of ⁹⁹mTc generators and operating reactors allowing their sources of ⁹⁹Mo to be switched. “Collaborations that quickly address hurdles such as transport licenses, marketing authorisations, and changes in technical facilities, that require the approval of multiple authorities, in timeframes of only hours or days, are
Technetium-99m can be extracted from a molybdenum-99 generator
1027