Module - Radiopharmacy

Work-based learning outcomes

  1. Obtain a detailed knowledge of the quality system used in radiopharamaceutical production, including production facilities and radiopharmaceutical quality control
  2. Advise on best practice in the use of a radionuclide calibrator
  3. Apply radiation safety practice and regulatory compliance in the context of a radiopharmacy

Work-based Competencies

Learning outcome Title Knowledge
1 1,3

Advise colleagues on the use of radiopharmaceuticals

  • Information needs of colleagues
  • Risks associated with the handling, storage, preparation and use of radiopharmaceuticals
  • Protocols and procedures for preparation and issue of radiopharmaceuticals
2 1,3

Access sources of information on the design requirements for the production  of radiopharmaceuticals

  • Requirements for facilities, equipment, training and environment
  • Good Manufacturing Practice requirements
  • MHRA recommendations
  • National and international guidance
3 3

Critically review environmental and personal monitoring including which tests are performed and frequency of testing

  • Sources of contamination
  • Viable contamination monitoring
  • Particle counting methods and limits
  • Process validation
4 1,3

Comply with relevant quality assurance requirements associated with radiopharmaceuticals

  • Describe requirements for quality systems, including specification, document control, validation, monitoring, change control, error analysis, risk assessment and corrective and preventative action (CAPA)
  • The risks for patients, staff and public associated with non- compliance
5 2

Perform commissioning tests on radionuclide calibrators

  • Range of tests performed – linearity, accuracy and precision
  • Range of radionuclides used and relative response of calibrator
6 2

Perform periodic quality control tests on radionuclide calibrators and recommend procedures for optimisation of  measurements

  • Range and frequency of tests performed, including the accuracy of radionuclide calibrators against a secondary standard instrument for a range of radionuclides (including Technetium-99m, Iodine-131 and Fluorine-18)
  • Derivation of calibration factors for geometric corrections
  • Use of filters (eg copper filters for I-123)
7 2

Use radionuclide calibrators for the measurement of therapeutic activities of radionuclides

  • Measurement errors for beta-emitting radionuclides
  • Use of calibrators for other therapeutic agents
8 3

Review compliance of radiopharmacy procedures against relevant radiation regulations and guidance

  • Legislation covering radiation safety of the staff, public and patients; transport of radioactive materials and radioactive waste management as it applies to a radiopharmacy

Work-based assessment

Complete 1 Case-Based Discussion(s)
Complete 1 of the following DOPS and/or OCEs
Type Title
DOPS Perform a molybdenum breakthrough test and analyse the result
DOPS Perform a Chemical purity test and analyse the result
DOPS Perform a linearity measurement on a Radionuclide calibrator
DOPS Set up a radionuclide calibrator to measure I 123 using a copper filter.
OCE Advise colleagues in the use of a Radionuclide calibrator
OCE Explain to colleagues the principle of a molybdenum generator
OCE Discuss the precautions required in the preparation of radiopharmaceuticals in the radiopharmacy.
DOPS Elute a Tc-99m generator