Nuclear Medicine Challenges in Ukraine
Ukraine lacks its own production of radiopharmaceuticals to meet the needs of its citizens. Most radiopharmaceuticals (except for a small portion used in diagnostics) and 100% of the related equipment are imported. The full-scale invasion of Ukraine by russia has further complicated supply routes, leading to longer waiting times for patients requiring medicines and diagnostic or treatment preparations. The State Enterprise “Ukrainian State Industrial Enterprise IZOTOP” (USIE IZOTOP) has repeatedly addressed these issues during their presentations. In May 2024, they unveiled a Concept for the Development of Nuclear Medicine in Ukraine. This initiative focuses on establishing domestic production of RPs for diagnosing and treating oncological conditions, as well as detecting cardiovascular, endocrine, nephrological, neurological, and other diseases.
To understand the current challenges facing nuclear medicine in Ukraine, including issues with the supply of radioisotopes, the establishment of supply chains, and diversification of supply routes, the Uatom.org Editorial Board interviewed Iryna Novikova, Head of the Multidisciplinary Clinical Diagnostic Laboratory at the Municipal Non-Commercial Enterprise of the Kharkiv Regional Council “Regional Clinical Hospital”, Leonid Vasyliev, Medical Director of the Grigoriev Institute for Medical Radiology, Ph.D. in Medicine, and Senior Researcher, and Mykola Bodnar, Head of the Department of Radionuclide Diagnostics and Treatment at the Lviv Regional Oncology Treatment and Diagnostic Center and a radiation therapist.
– Please tell us what challenges the field of nuclear medicine in Ukraine faces today.
Leonid Vasyliev: Unfortunately, the level of development of nuclear medicine in Ukraine is incomparable with that of developed countries. The annual number of radionuclide diagnostic manipulations in Ukraine is in the thousands, whereas in developed countries, it reaches millions. The number of radiological centers in Ukraine is less than the number of regions. Several modern positron emission tomography (PET) centers are located only in Kyiv. The range of radiopharmaceuticals for diagnostics and therapy in Ukraine is insufficient, totaling fewer than ten. The main problem is the lack of centralized procurement of radiopharmaceuticals, as was the case in the past. Perhaps a new mechanism for developing the healthcare system will help solve this problem in the future.
Currently, there is only one organization in Ukraine that supplies isotope products to radiation centers – USIE IZOTOP. This enterprise does not produce isotope products but only supplies them. Despite the existence of several nuclear physics centers in Ukraine (Kharkiv and Kyiv) and numerous promises and state programs, the production of domestic radiopharmaceuticals has not been established. Theoretically, nuclear physicists know how to produce certain radionuclides, but they are unable to meet the stringent requirements for medical isotopes. There are no specialists in radiochemistry, nuclear pharmaceuticals, or related fields, and, unfortunately, Ukrainian universities do not train such specialists. However, such expertise is essential for the further development of nuclear medicine.
Mykola Bodnar: The main problem in nuclear medicine is the limited choice of radiopharmaceuticals. In Ukraine, there is no wide range of modern radiopharmaceuticals, and those available have certain restrictions on drug dosage. For example, we have radioactive iodine intended for treatment, but it is currently impossible to obtain diagnostic activities of radioiodine due to the lack of registration in Ukraine as a medicinal product.
Another major issue is that most equipment in Ukraine is obsolete – essentially yesterday’s equipment. Most hospitals are equipped with gamma cameras, only a few clinics have modern SPECT systems, and even fewer have SPECT/CT.
Among other challenges is the cost of modern radiopharmaceuticals. For instance, the cost of therapy with 89-Strontium was approximately $1,500. Alternative therapy for bone metastases with Lutetium-177 PMSA, which is only available abroad, costs $6,000. Lutetium-177-DOTATATE therapy for neuroendocrine tumors starts at $17,000. This raises the question of how many patients in Ukraine can afford such expensive treatments.
Iryna Novikova: I can only speak from the perspective of laboratory diagnostics. There is a problem that not only our institution faces – the equipment is outdated. Of course, it works and passes inspections, but in my opinion, it already requires modernization. We are currently using Gamma-12 equipment that was supplied back in 1986. In 2019, the device failed, and we contacted our supplier, who provided us with a replacement device for use. The replacement Gamma-12 was manufactured in the same year, but it had not been used and was still operable. Thus, the device is currently functional, but I believe the equipment still needs to be updated. If updating the device is not feasible, perhaps modern alternative methods of laboratory diagnostics should be considered, and discussions held with management about the direction in which to move forward.
– There are about 140 radioisotopes used in nuclear medicine, including Technetium-99m, Iodine-131, Lutetium-177, Fluorine-18, etc. In which procedures does your hospital use radioisotopes?
Iryna Novikova: We work with radiation sources containing Iodine-125. We perform thyroid hormone tests, including thyroid-stimulating hormone (TSH), free and total triiodothyronine, free and total thyroxine, thyroglobulin antibodies (TgAb), and thyroid peroxidase antibodies (TPOAb).
Leonid Vasyliev: In the practice of our nuclear medicine department, as in most centers, the following radiopharmaceuticals are used: Technetium-99m pertechnetate in combination with various organotropic sets (skeleton, kidneys, liver, thyroid gland), Iodine-131, Samarium-153, and Strontium-89. These radiopharmaceuticals are foreign-made, predominantly from Poland.
In our practice, skeletal examinations to detect metastases are most frequently performed, as well as functional examinations of the kidneys, liver, and thyroid gland. For nearly 100 years, our department has been performing radionuclide therapy with Iodine-131 for both malignant and benign thyroid tumors. We also use Samarium-153 to treat bone metastases, which, in our opinion, is highly effective in alleviating pain syndrome in cancer patients with bone metastatic disease. Unfortunately, for various reasons, we are unable to use Lutetium-177 to treat prostate cancer.
Mykola Bodnar: In our center, we work with Technetium-99m and Iodine-131.
Until recently, we used Strontium-89 to treat bone metastases. However, in June, the production of Strontium-89 was halted in Poland (National Centre for Nuclear Research, Radioisotope Centre POLATOM) because the global focus has shifted to Lutetium-177. This presents a problem, as Ukraine does not currently have access to this radioisotope, despite Lutetium-177 being the primary radiopharmaceutical for radionuclide therapy.
Additionally, the production of Hippuran-131I, also manufactured by POLATOM, which some clinics used for kidney diagnostics (renoscintigraphy), has been discontinued.
– Russia’s full-scale invasion of Ukraine has resulted in airspace closure, causing a problem with the supply of radioisotopes. Has this become a critical issue for patients at your hospital, and how did you resolve the problem of a shortage of radioisotopes, if such a problem occurred?
Leonid Vasyliev: Indeed, the war with russia negatively impacted the state of nuclear medicine, especially at the initial stage. However, USIE IZOTOP developed its own transport infrastructure, which allowed regular deliveries of radiopharmaceuticals to Ukraine to resume. Owing to the active efforts of USIE IZOTOP, this did not become a critical issue for cancer patients. This contrasts with the early 1990s, when, following the collapse of the USSR, the supply of radiopharmaceuticals was suspended for several years, leading to a significant increase in mortality among thyroid cancer patients.
Iryna Novikova: As of today, we have concluded contracts with USIE IZOTOP, which are being fulfilled on time. This ensures that we have radiation sources for all planned tests. The full-scale invasion has not affected the supply of radioisotopes in any way.
Mykola Bodnar: Before the full-scale invasion, we used Samarium-153 to treat bone metastases. We previously sourced Samarium-153 from Uzbekistan, but we lost the opportunity to use this drug after ceasing cooperation due to the lack of air traffic.
At the beginning of the full-scale invasion, there was, of course, a problem with the shortage of radioisotopes for patients. The supply of radioisotopes was stopped, and our patients had to go abroad for treatment. This was due to the introduction of martial law in Ukraine, which made the supply of nuclear materials impossible. However, I was one of the initiators of restoring the supply, as radioisotopes are medical radiopharmaceuticals, not nuclear materials. It was agreed with USIE IZOTOP that the supply of radiopharmaceuticals would not be subject to this restriction, and thus the supply was successfully restored. For about two months, we were unable to work, but then we resumed our activities. Currently, logistics is organized using land transport, and we receive supplies by road. Road transport supply is stable and well-established, so we currently have no problems with the delivery of radiopharmaceuticals.
– Another problem was related to the supply of most radioisotopes from russia. How did you manage to solve this issue and diversify supply routes?
Iryna Novikova: We did not use russian-made radioisotopes even before the full-scale war. Instead, we sourced radioisotopes from the Czech Republic, produced by Beckman Coulter. Therefore, nothing has changed for us.
Leonid Vasyliev: It should be noted that USIE IZOTOP has taken an active role in establishing the production of domestic radiopharmaceuticals. They initiated the state program for production at their own facilities.
Mykola Bodnar: I would like to emphasize that since Ukraine’s independence, we have not received radioisotopes from russia. However, diversification of radioisotope suppliers remains a very important issue. All the radiopharmaceuticals we currently have are obtained from a single manufacturer – POLATOM. If their reactor breaks down or undergoes maintenance, the supply is halted. For instance, last year, there were times when we did not receive radiopharmaceuticals due to their modernization efforts. Therefore, having an alternative manufacturer of radiopharmaceuticals would be beneficial for ensuring the stability of radioisotope supplies.
This autumn, there were global issues with the supply of technetium due to a reactor breakdown in the Netherlands – a major producer of molybdenum for the world. Consequently, we also faced problems with the supply of technetium generators, as the supply was limited. Hence, having alternatives is always advantageous.
– With what organizations and in what areas do you cooperate at the national level? Are there any international programs to support nuclear medicine in Ukraine? Which ones do you participate in?
Iryna Novikova: Even before the full-scale invasion, specialists from the laboratory’s radioimmunology department were invited to conferences and actively participated in them.
Mykola Bodnar: At present, we do not participate in international programs supporting nuclear medicine. However, seven years ago, under the World Bank program, we received modern equipment, which we continue to use. As for training in nuclear medicine or radiopharmaceuticals, it depends entirely on the independent initiative of our specialists.
Leonid Vasyliev: Unfortunately, the war has deprived us of such opportunities. However, there is hope and plans for the future to propose an international project under the auspices of the IAEA.
It should be noted that the European Association of Nuclear Medicine (EANM) actively supports our doctors by providing free access to thematic training courses and annual EANM congresses. Leveraging these opportunities, our specialists present scientific reports at the European level and enhance their professional skills. The main topics of these reports focus on complications and the personalization of treatment for our patients.
Our scientists have also participated in the SAMIRA study (under the auspices of the IAEA and the European Association of Nuclear Medicine). The primary goal of this study was to implement the legal framework of Euratom and the EU for the therapeutic use of radiopharmaceuticals, aiming for simplification, leniency, and a reduction in bureaucratic procedures.
However, outdated equipment and the limited availability of diagnostic and therapeutic radiopharmaceuticals restrict our doctors and scientists from fully engaging in international programs. I believe the most effective form of training is “on-the-job training”, involving new therapeutic and diagnostic radiopharmaceuticals, modern equipment, and the opportunity to apply new knowledge directly in our department.
Uatom.org Editorial Board