Radiopharmacy 1 (SPE203)

10 credits

Aim of this module

This rotation will enable trainees to gain skills and experience of Radiopharmacy and apply underpinning knowledge through introduction to the practice of Radiopharmacy. Trainees will follow the patient pathway and gain knowledge and understanding of the use of radiopharmaceuticals in clinical practice. Trainees will be expected to perform some routine radiopharmacy procedures and develop and build their professional practice.

  1. Use the correct local procedures for entering and leaving the different types of controlled area within the department.
  2. Monitor an area for possible radioactive contamination and decontaminate the area if necessary.
  3. Operate a molybdenum-99/technetium-99m generator.
  4. Prepare a technetium-99m labelled radiopharmaceutical from a ‘kit’ using appropriate radiation safety precautions.
  5. Calculate and draw up the volume of the preparation required to administer a (nominal) dose.
  6. Complete the documentation that would normally be used to record these activities in the radiopharmacy.
  7. Measure the radiochemical purity of a prepared radiopharmaceutical such as technetium-99m labelled methylene diphosphonate (MDP) using a miniaturised two-system thin-layer chromatography (TLC) assay.
  8. Perform a constancy, linearity and geometry calibration check on an isotope assay calibrator.
  9. Assist in the preparation and administration of an iodine-131 therapy dose.
Number Work-based learning outcome Title Knowledge
1 1

Perform changing procedures for entering and leaving radiopharmacy manufacturing, dispensing and blood labelling areas

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2 1

Perform successful broth transfer test

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3 2

Select and check the meters for contamination monitoring by checking the power supply and background levels

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4 2

Perform reference source checks and understand the need for reporting deviations from the norm

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5 2

Perform and document monitoring for radioactive contamination in accordance with local protocol

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6 3

Calculate the expected theoretical technetium-99m yield of the generator

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7 3

Elute the generator

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8 3

Measure the radioactivity of the eluate and calculate the elution efficiency

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9 3,6

Perform a molybdenum breakthrough assay and complete documentation

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10 4,6

Prepare a technetium-99m labelled radiopharmaceutical from a ‘kit’ using appropriate radiation safety precautions and complete documentation

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11 5

Calculate the volume of the preparation required to administer a (nominal) dose:

  • immediately
  • 4 hours later
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12 7,6

Measure the radiochemical purity of a prepared radiopharmaceutical such as technetium-99m-labelled methylene    diphosphonate   (MDP) using a miniaturised two-system thin-layer chromatography (TLC) assay

  • Calculate percentage purity and see if it meets the required specification
  • Repeat the assay towards the end of the shelf life of the material
  • Complete the documentation to record these activities
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13 8

Perform a constancy, linearity and geometry calibration check on an isotope assay calibrator

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14 9

Observe and assist in the administration of 131 I therapy for benign and malignant disease of the thyroid gland

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15 9

Identify the protocol to be used and confirm appropriate authorisation and justification for the therapy procedure observed. 

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16 9

Assist in the patient preparation, including pre-administration checks including medication for the therapy procedure observed.

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17 9

Assist in delivering specific patient and patient carer information, including radiation protection instructions, following administration for the therapy procedure observed.

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You must complete
1 Case-based discussion(s)
1 of the following DOPS / OCEs
Assessment Title Type
Operate a 99Mo 99mTc generator under GMP conditions DOPS
Measure the radiochemical purity of a prepared radiopharmaceutical by a suitable chromatographic technique at two time points during its shelf life DOPS
Select an appropriate contamination monitor Calibrate it and then perform monitoring for contamination DOPS
Explain to a patient the mode of operation of a therapeutic radionuclide therapy OCE
Explain to colleagues the principles of a generator and discuss the method of its commercial manufacture at a GMP facility OCE
Observe the administration and subsequent imaging of patients prepared from this type of product and noting its impact on management OCE
Undertake and document radiopharmacy personnel monitoring following a production run OCE
Prepare a 99mTc radiopharmaceutical from a kit using appropriate aseptic technique and precautions DOPS

Important information

The academic parts of this module will be detailed and communicated to you by your university. Please contact them if you have questions regarding this module and its assessments. The module titles in your MSc may not be exactly identical to the work-based modules shown in the e-portfolio. Your modules will be aligned, however, to ensure that your academic and work-based learning are complimentary.

Learning Outcomes

  1. Discuss the role of the Clinical Scientist in Clinical Pharmaceutical Sciences in ensuring the safety of the patient, particularly related to the manufacture and quality control with reference to key patient care
  2. Discuss the UK regulatory requirements that apply to the design and operation of radiopharmacies and the different possible solutions to these requirements
  3. Recognise the different types of radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use
  4. Describe the types of activities normally undertaken in a hospital radiopharmacy
  5. Describe the ways in which radiopharmaceuticals are prepared
  6. Describe how the principles of quality assurance are routinely applied in a radiopharmaceutical production system
  7. Explain the nomenclature, principles and mechanisms of atomic reactions
  8. Describe the design and principles of particle accelerators and nuclear reactors and their relevance for production of radionuclides used in nuclear medicine
  9. Describe in both qualitative and quantitative terms the interactions of radiation with biological systems and discuss the relative risks of nuclear medicine procedures compared with other potentially hazardous life events
  10. Describe the principles of the most important types of radiation detectors used in nuclear medicine together with the way in which they are normally employed
  11. Describe the structure of the atom, the most important means of radioactive decay of unstable nuclei and the types of radiation emitted
  12. Recognise the radionuclides used in nuclear medicine and discuss the relationships between their physical properties, their clinical applications, and their strengths and weaknesses
  13. Describe the radiopharmaceutical chemistry of these radionuclides and discuss the influence of these chemical properties on the biodistribution of their radiopharmaceuticals
  14. List the different formulations used in nuclear medicine; describe their properties and the way in which these formulations are prepared; discuss the significance of the development of radiopharmaceutical kits and describe the function of the various reagents used therein

 

Indicative Content

Clinical Pharmaceutical Science in key patient and care pathways

  • Diagnosis using radioactive materials
  • Treatment relevant to the patient and care pathway, including chemotherapy
  • Treatment using radioactive materials
  • The role of regulation, Good Manufacturing Practice, aseptic techniques and quality assurance in ensuring patient safety

Radiopharmacy 1

  •  UK regulatory requirements that apply to the design and operation of radiopharmacies and the different possible solutions to these requirements
  • Radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use
  • Activities normally undertaken in a hospital radiopharmacy
  • Radiopharmaceuticals preparation
  • Quality assurance in radiopharmacy in particular, and describe the most important means of control of aseptic preparation and how the principles of quality assurance are routinely applied in a radiopharmaceutical production system
  • Nomenclature, principles and mechanisms of atomic reactions
  • The design and principles of particle accelerators and nuclear reactors and their relevance for production of radionuclides used in nuclear medicine
  • Qualitative and quantitative terms the interactions of radiation with biological systems,
  • Relative risks of nuclear medicine procedures compared with other potentially hazardous life events
  • The principles of the most important types of radiation detectors used in nuclear medicine together with the way in which they are normally employed
  • The structure of the atom, the most important means of radioactive decay of unstable nuclei and the types of radiation emitted therefrom
  • 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