Nuclear Medicine in Jordan Therapeutic Radiopharmaceuticals - PowerPoint by rF74o0K


									   Nuclear Medicine in Jordan
Therapeutic Radiopharmaceuticals
       19-23 October 2009 Manila, Philippines

                   Kusai Al-Muqbel, MD
           American Board in Nuclear Medicine
   Assistant Professor-Jordan University of Science and
    Nuclear Medicine Facilities in
• There are 8 hospital-based nuclear medicine
• There are 3 private nuclear medicine clinics.
• Most of them have single and/or dual head
  gamma cameras.
• There are 3 PET/CT scanners.
• There are two coincidence gamma cameras for
  PET acquisition.
• There is one baby cyclotron
       Manufacturing in Jordan
• F18-FDG is the only radiopharmaceutical
  manufactured in Jordan.
• One baby cyclotron is available in military
  medical services in Amman.
Imported Radiopharmaceuticals
•   Tc-99m Generators
•   Cold pharmaceutical kits
•   Ready SPECT radiopharmaceuticals
•   Therapeutic radiopharmaceuticls
   Radiopharmacy QC equipment
         Status in Jordan
• They are not available in hospital hot labs
• They are not required by local licensing
  body for initial and renewal licensing of hot
• Licensing body in Jordan is “Jordan
  Atomic Energy Commission”.
    Radiopharmacy QC in Jordan
• No QC procedures are being performed
  since they are not required by local atomic
  energy commission licensing.
 Therapeutic Radiopharmaceutical
        Activity in Jordan
• Ablation of thyroid gland in
  hyperthyroidism with I131
• Ablation of remnant thyroid tissue in
  thyroid cancer with I131
• Treatment of metastatic thyroid cancer
  with I131
• Bone pain treatment with
  radiopharmaceuticals (Sm153, Re186,
        Source of Therapeutic
• Imported from outside (Syria, Turkey,
  Poland, Hungary and UK)
• It is administered as an out patient for
  doses of 30 mCi and less.
• It is administered as an inpatient for doses
  > 30 mCi.
• Documentation of the process is according
  to hospital policy and JAEC regulations.
• Radiation protection instructions are
       Bone pain Treatment
• Limited cases (10-15 cases per year).
• Confined to cancer patients with bone
  metastatic disease associated with bone
• Radiopharmaceuticals used are P32,
  Sm157 or Re186.
• Oncologists are still in doubt about the
  benefits of these radiopharmaceuticals in
  cancer patients.
• The high price of those
  radiopharmaceuticals is a major problem
  for its utilization in clinical practice.
• Non-availability of these
  radiopharmaceuticals on spot is another
  problem (days and weeks are needed for
  the dose to reach the patient).
• Patient fears and concerns about the
            What we need
• Cheaper products
• Trials supported by research grants to
  involve as many patients as possible.
• Direct involvement of oncologists and
  other clinicians in such procedures (for
  cancer and non-cancer cases).
            What we need
• Continuous nuclear physician training on
  the clinical indications of such
• Patient education on the safety of nuclear
  medicine products and applications.
    RAS 2013: Good Radiopharmacy
    Practice and good Manufacturing
• Jordan participated in “meeting on the Future
  Direction and Work Planning for Implementation
  Good Radiopharmacy Practices and GMP”
  4/2007 China.
• Re-arrangement of our hot lab
• Better documentation of all processes
  involved in hot lab while reconstituting cold
  kits and dispensing radiopharmaceuticals.
• Writing the hospital policies dealing with
  radioactive materials in a way compatible
  with JCIA.
• Staff education on the policies.
• One physicist was sponsored for
  advanced education on medical physics to
  improve the hot lab performance.
• On going plan to upgrade our hot lab
  equipments including daily QC
Recommendations from practicing
      nuclear Physician
• The governments should be involved more
  in improving the quality of Radiopharmacy
  practice in the member states.
    Suggestions from practicing
        nuclear Physician
• Trained pharmacist is available in local
  atomic energy commission.
• Hot lab QC equipments should be part of
• Trained pharmacist or equivalent person is
  in charge for the hot lab.
• The hot lab QC records should be
  checked before license renewal.
         Country survey (Jordan)
1. List the most common (at least the top 3) therapeutic procedures being
   done in your institution/country.
• ANS: # 1-Thyroid ablation (hyperthyroidism and thyroid cancer
         # 2 - Bone pain treatment with radionuclides
         # 3 ___________________________
1.1.    What radiopharmaceutical agents are being used most commonly?
       ANS: (for Procedure # 1) Radioactive iodine I131
              (for Procedure # 2)Radioactive Phosphorus (P32), Radioactive
   rhenium Re186
             (for Procedure # 3) _ _______________________
1.2.    What is the estimated number of cases done/year?
        ANS: (for Procedure # 1) __500-1000 for the whole country
              (for Procedure # 2) ___10______________________
             (for Procedure # 3) _________________________
2. What is the source of these therapeutic
   radiopharmaceuticals? (Please check Yes/No)
2.1. Produced within the country. YES? _____ NO? _x____
2.1.1. If produced within the country, what are the processes involved
   in the manufacture; Q/A, Q/C, etc?
   ANS: _____________________________________________
2.2. Imported from other countries. YES? __x___ NO? _____
2.2.1. If imported, from which country/ies?
        ANS: Syria, Turkey, Holland,
2.2.2.    If imported and comes as finished product, what interventions
   are still needed?
• ANS: training on dispensing QC (radiopharmacy)
3. What are the costs per therapeutic procedure (in US$) in your country?
   ANS: (Procedure #1) US$_400-1000
          (Procedure #2) US$_2000-3000
         (Procedure #3) US$______________
4. What training is provided to the personnel currently doing/assisting in the
   ANS: clinical indications, radiation protection, preparation for dose
    administration, training on dose administration, inpatient monitoring.
5. Are there governmental or institutional requirements which constrain the
    use of therapeutic radiopharmaceuticals (e.g. stringent regulations, approval
    delays, reporting, etc)? Please elaborate.
   ANS: Radiation protection regulations by the government
           Clinical indications by institutions
6. What therapeutic procedure/s do you think should be made available in your
    country? Why is it / are they not available?
   ANS: Yttrium-90(90Y) ibritumomab tiuxetan (ZevalinR)
         It is not available because of its cost

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