Radiopharmacy 2 (SPE223)

15 credits

Aim of this module

This module will enable the trainee to consolidate their experience in radiopharmacy and act independently as part of the team preparing routine radioactive medicinal products within a quality assured and safe environment for use in patients for diagnosis and treatment

  1. Order, receive, unpack and store radioactive materials following local procedures, and prepare packages for transport of a radiopharmaceutical by road.
  2. Review and work within the pharmaceutical quality management system, including audit, error reporting, change control, deviations and risk assessments.
  3. Perform the normal daily preparation of radiopharmaceuticals and advise nuclear medicine services/service users on a range of issues, including the requirements for cessation of breastfeeding prior to administration of radiopharmaceuticals.
  4. Perform a range of procedures in the radiopharmacy, including the radio- labelling of white blood cells, preparation and administration of an iodine-131 therapy dose and measurement of glomerular filtration rate (GFR).
  5. Perform quality assurance tests of equipment used in the preparation and quality control of radiopharmaceuticals.
  6. Investigate unusual clinical findings in patient scans to determine any possible relationship to administered radiopharmaceuticals and report findings, maintaining patient confidentiality, assessing whether unusual clinical findings affect the validity of the patient scan due to radiopharmaceutical defects or medicines interactions.
  7. Investigate adverse medicines reactions and explain the likely inter- relationship between patient symptoms or reaction, or reaction and administered radiopharmaceutical.
  8. Assess and interpret radiopharmaceutical in-process and end products quality test results, e.g. high-performance liquid chromatography (HPLC), thin-layer chromatography (TLC), pyrogen tests, etc.
Number Work-based learning outcome Title Knowledge
1 1

Order, receive, unpack and store radioactive materials following local procedures.

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2 1

Calculate the transport index.

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3 1

Package an excepted package for transport of radioactive materials to the correct standards, including completion of documentation and labelling.

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4 1

Package a type A package for transport of radioactive materials to the correct standards, including completion of documentation and labelling.

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5 2

Work safely in the radiation environment.

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6 2

Critically appraise the radiopharmacy quality management system, demonstrating how this meets the requirements for a manufacturer’s (‘specials’) licence granted by the Medicines and Healthcare products Regulatory Agency (MHRA) and Good Manufacturing Practice (GMP).

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7 2

Perform a risk assessment for the introduction of a new product.

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8 2

Perform and document internal quality audits.

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9 2

Critically appraise the requirements for complying with radiation safety legislation, the Medicines Act (Radioactive Substances) 1978 and environmental permitting.

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10 2

Write and disseminate standard operating procedures (SOPs) for the quality management system for the preparation and quality control of radiopharmaceuticals.

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11 3

Verify prescription and/or order for a range of radioactive medicinal products.

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12 3

Plan production of a range of radioactive medicinal products.

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13 3

Prepare the working environment for manufacture and dispensing of a range of radioactive medicinal products.

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14 3

Prepare a range of radioactive medicinal products.

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15 3

Dispense aliquots of a range of radioactive medicinal products for immediate use.

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16 3

Prepare a prescribed range of radioactive medicinal products from raw materials.

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17 3

Observe the manufacture of radiopharmaceuticals containing positron-emitting radionuclides.

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18 3

Complete the release of a range of radioactive medicinal products suitable for clinical use under supervision.

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19 3

Advise nuclear medicine services/service users on a range of issues, including on the requirements for cessation of breastfeeding prior to administration of radiopharmaceuticals.

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20 4

Assist and perform white cell labelling using either technetium- 99m or indium-111.

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21 4

Prepare and administer an iodine- 131 therapy dose.

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22 4

Observe a range of therapeutic administrations.

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23 4

Dispense radioactive material for the measurement of glomerular filtration rate (GFR).

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24 4

Spin, pipette and count samples. Calculate the result and compare to normal range.

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25 5,8

Perform quality assurance tests of equipment used in the preparation and quality control of radiopharmaceuticals.

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26 5,8

Undertake radiochemical purity testing, interpret and report on the results.

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27 6,7

Critically appraise the impact of the radiopharmaceutical production process on the quality of clinical outcomes.

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28 6,7

Review an adverse reaction to a radiopharmaceutical administration and the subsequent incident investigation.

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29 6,7

Review the adjuvant medicines used in nuclear medicine, their role and impact on the clinical outcome.

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30 6,7

Review the potential medicine interactions and interventions that may affect radiopharmaceutical performance or the outcome of a patient investigation or treatment.

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You must complete
3 Case-based discussion(s)
2 of the following DOPS / OCEs
Assessment Title Type
Assist directing staff with a physical monitoring test eg DOP, particle counting, air flow, pressure differentials and tabulate the results for the unit DOPS
Select an appropriate contamination monitor. Calibrate it and then perform monitoring for contamination DOPS
Investigate a diagnostic imaging study that has an unexpected biodistribution in order to ascertain a causal relationship with the administered radiopharmaceutical. Report your findings to your colleagues OCE
Observe the administration and subsequent imaging of patients prepared from this type of product and noting its impact on management OCE

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 Radiopharmacy in the diagnosis  and treatment of disease using radiopharmaceuticals, including the contribution to patient management and patient-centred care.
  2. Discuss the regulations controlling transport of radioactive materials in the UK and describe the means taken to comply with these regulations.
  3. Explain the mechanisms by which commonly used radiopharmaceuticals localise in their target tissues.
  4. Describe those problems that might arise during the preparation and clinical use of radiopharmaceuticals and know how to identify and solve them where appropriate.
  5. Describe the possibilities for interactions both desired and undesirable between radiopharmaceuticals and other medications.
  6. Access and evaluate sources of reference information on all aspects of radiopharmaceuticals.
  7. Describe the general principles of positron emission tomography (PET) imaging and the organisation of a PET radiopharmacy, and list the products most commonly used therein together with their clinical indications.
  8. Describe the types of procedures routinely employed in  hospital radiopharmacy management.
  9. Explain the quality control parameters that determine the quality of radiopharmaceuticals.
  10. Describe the analytical methods by which these parameters are measured.
  11. Discuss the significance of the development of radionuclide generators for nuclear medicine, and the principles of their design and operation, describe  the molybdenum-99/technetium-99m generator system and give examples of other generators in routine use.
  12. Discuss the importance of radiation hygiene and safe working in radiopharmaceutical preparation.
  13. Discuss the need for automation in radiopharmaceutical preparation and the possible ways in which this might be achieved.
  14. Discuss the physical and chemical properties required of a therapeutic radiopharmaceutical and list the products approved for general use in nuclear medicine together with their clinical applications.
  15. Describe the functions of the different cell types routinely labelled in nuclear medicine, outline the most significant points in the labelling procedures used and list the most common clinical indications for these radiopharmaceuticals.

Indicative Content

  • Regulations controlling transport of radioactive materials in the UK and the means taken to comply with these regulations
  • The mechanisms by which commonly used radiopharmaceuticals localise in their target tissues
  • Problems that might arise during the preparation and clinical use of radiopharmaceuticals and know how to identify and solve them where appropriate
  • Interactions, both desired and undesirable, between radiopharmaceuticals and other medications
  • Sources of reference information on all aspects of radiopharmaceuticals
  • 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
  • Routine procedures used in hospital radiopharmacy management
  • The organisational and financial aspects of a commercial radiopharmacy
  • The relative advantages of commercial and non-commercial systems
  • Quality control parameters that determine the quality of radiopharmaceuticals
  • The analytical methods by which quality control parameters are measured
  • The principles of radionuclide generators, their design and operation, including the molybdenum-99/technetium-99m generator system other generators in routine use
  • Radiation hygiene and safe working in radiopharmaceutical preparation
  • Automation in radiopharmaceutical preparation
  • Physical and chemical properties of therapeutic radiopharmaceuticals
  • Therapeutic radiopharmaceutical products approved for general use in nuclear medicine, together with their clinical applications
  • The functions of the different cell types routinely labelled in nuclear medicine
  • Cell labelling procedures
  • Clinical indications for cell labelling