Competency: 12

Details

Plan production of a range of radioactive medicinal products.

Considerations

• Legislative framework, including Medicines (Administration of Radioactive Substances) Regulations 1978, Ionising Radiation (Medical Exposure) Regulations 2000.
• Local procedures for prescription and authorisation of administration of radioactive medicinal products.
• Normal diagnostic reference levels for administration and dosage, their calculation, and acceptable variances for diagnostic purposes.
• Radionuclides used in nuclear medicine:
  • the relationships between their physical properties, their clinical applications, and their strengths and weaknesses;
  • the radiopharmaceutical chemistry of these radionuclides;
  • the influence of these chemical properties on the biodistribution of their radiopharmaceuticals;
  • the different formulations used in nuclear medicine; properties and preparation;
  • radiopharmaceutical kits and reagents used therein.
• The principles of radionuclide generators, their design and operation, including the molybdenum-99/technetium-99m generator system and other generators in routine use.
• Indications and implications of radioactive contamination.
• Risk associated with production of radiopharmaceuticals, including radiation protection, and the requirements for relevant control measures.
• Requirements for storage conditions and shelf life of radioactive and non-radioactive medicinal products.
• Expected performance, limitations and calibration of equipment, including dose calibrators and isolators, and range of tests to be undertaken.
• The importance of physical environmental monitoring and the required testing frequency.
• Aseptic techniques and their application.
• Corrective action to be taken in the event of spillage, breakage damage, or contamination, and the implications of these events.
• Need for appropriate diluents, limitations and consequences of over- dilution and the need for unsuitable containers.
• Basic radiopharmaceutical chemistry.
• Radiation hygiene and safe working in radiopharmaceutical preparation.
• Automation in radiopharmaceutical preparation.
• Potential medicine interactions with radiopharmaceuticals and interventions that may affect radiopharmaceutical performance or the outcome of a patient investigation or treatment.
• The mechanisms by which commonly used radiopharmaceuticals localise in their target tissues.
• Problems that may arise during the preparation and clinical use of radiopharmaceuticals and know how to identify and solve them where appropriate.
• Sources of reference information on all aspects of radiopharmaceuticals.
• EU Good Manufacturing Practice (GMP).
• Standard operating procedures (SOPs).
• Mathematical principles and calculations for pharmaceutical science.
• Documentation for preparation and release of radioactive medicinal products, including:
  • master formula and manufacturing method
  • batch manufacturing records
  • batch packaging records
  • SOPs, log books, etc.
  • special records, e.g. sterilisation, product release, clinical trials, exception/deviation reports, etc.
  • cross-contamination monitoring
  • cleaning schedules
  • materials management documents, etc.
  • exception/variation reporting.
• Cyclotrons and the production of positron emission tomography (PET) radiopharmaceuticals.
• The general principles of PET imaging.
• The organisation of a PET radiopharmacy.
• PET radiopharmaceuticals and their production.
• Clinical indications for the use of PET.

Relevant learning outcomes