Radiopharmacy 1

Module details

Title

Radiopharmacy 1

Type

Rotation

Module code

SPE203

Credits

10

Requirement

Compulsory

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.

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 1	Competency Perform changing procedures for entering and leaving radiopharmacy manufacturing, dispensing and blood labelling areas	Action View
# 2	Learning outcome 1	Competency Perform successful broth transfer test	Action View
# 3	Learning outcome 2	Competency Select and check the meters for contamination monitoring by checking the power supply and background levels	Action View
# 4	Learning outcome 2	Competency Perform reference source checks and understand the need for reporting deviations from the norm	Action View
# 5	Learning outcome 2	Competency Perform and document monitoring for radioactive contamination in accordance with local protocol	Action View
# 6	Learning outcome 3	Competency Calculate the expected theoretical technetium-99m yield of the generator	Action View
# 7	Learning outcome 3	Competency Elute the generator	Action View
# 8	Learning outcome 3	Competency Measure the radioactivity of the eluate and calculate the elution efficiency	Action View
# 9	Learning outcome 3,6	Competency Perform a molybdenum breakthrough assay and complete documentation	Action View
# 10	Learning outcome 4,6	Competency Prepare a technetium-99m labelled radiopharmaceutical from a ‘kit’ using appropriate radiation safety precautions and complete documentation	Action View
# 11	Learning outcome 5	Competency Calculate the volume of the preparation required to administer a (nominal) dose: immediately 4 hours later	Action View
# 12	Learning outcome 7,6	Competency 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	Action View
# 13	Learning outcome 8	Competency Perform a constancy, linearity and geometry calibration check on an isotope assay calibrator	Action View
# 14	Learning outcome 9	Competency Observe and assist in the administration of 131 I therapy for benign and malignant disease of the thyroid gland	Action View
# 15	Learning outcome 9	Competency Identify the protocol to be used and confirm appropriate authorisation and justification for the therapy procedure observed.	Action View
# 16	Learning outcome 9	Competency Assist in the patient preparation, including pre-administration checks including medication for the therapy procedure observed.	Action View
# 17	Learning outcome 9	Competency Assist in delivering specific patient and patient carer information, including radiation protection instructions, following administration for the therapy procedure observed.	Action View

Assessments

You must complete:

• 1 case-based discussion(s)
• 1 of the following DOPS/ OCEs:

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

Learning outcomes

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.

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

Activities

• Assist in normal daily preparation of radiopharmaceuticals and critically evaluate how they contribute to the diagnosis and management of patient care
• Observe radiopharmaceutical administration(s) and subsequent imaging of the patient(s) and reflect on the importance of imaging to the diagnosis and management of patient care
• Observe a nuclear medicine reporting session and discuss the impact of imaging on patient care with their supervisor
• Observe the preparation of an iodine-131 therapy dose and the administration to the patient and critically evaluate how radionuclide therapy impacts on patient management
• Produce a professional portfolio which cumulatively records/provides evidence of: skills, knowledge and understanding, ability to use reflective practice, and personal and professional development