Module - Radiopharmacy 2 (SPE223)

STP

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

Work-based learning outcomes


  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.

Work-based Competencies


Learning outcome Title Knowledge
1 1

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

  • Calculation of the required activity.
  • Storage of radioactive materials and pharmaceutical kits.
  • Documentation required.
  • Environmental Permitting Regulations 2011.
  • Safe handling of radioactive materials.
  • Security of radioactive materials.
  • Routine procedures used in hospital radiopharmacy management.
  • The organisational and financial aspects of a commercial radiopharmacy.
2 1

Calculate the transport index.

  • Carriage of Dangerous Goods and Pressure Vessel (Amendment) Regulations 2001.
  • Accord européen relatif au transport international des marchandises Dangereuses par Route (ADR).
  • Design, type testing and types of packaging.
  • Labelling and documentation requirements.
  • Calculation of transport index.
  • Environmental Permitting Regulations 2011.
  • Safe handling of radioactive materials.
  • Security of radioactive materials.
  • Documentation requirements.
3 1

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

  • Carriage of Dangerous Goods and Pressure Vessel (Amendment) Regulations 2001.
  • Accord européen relatif au transport international des marchandises Dangereuses par Route (ADR).
  • Design, type testing and types of packaging.
  • Labelling and documentation requirements.
  • Calculation of transport index.
  • Environmental Permitting Regulations 2011.
  • Safe handling of radioactive materials.
  • Security of radioactive materials.
  • Documentation requirements.
4 1

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

  • Carriage of Dangerous Goods and Pressure Vessel (Amendment) Regulations 2001.
  • Accord européen relatif au transport international des marchandises Dangereuses par Route (ADR).
  • Design, type testing and types of packaging.
  • Labelling and documentation requirements.
  • Calculation of transport index.
  • Environmental Permitting Regulations 2011.
  • Safe handling of radioactive materials.
  • Security of radioactive materials.
  • Documentation requirements.
5 2

Work safely in the radiation environment.

  • Safe working practices.
  • Local radiation safety rules.
  • Administration of Radioactive Substance Advisory Committee (ARSAC) certificates.
  • Environmental permits.
  • Critical incident reporting.
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).

  • Quality assurance, including management and organisational aspects.
  • Quality risk management.
  • Quality management systems.
  • Quality audits: participation in internal and external audits and inspections, follow-up and reporting, including relevant aspects of clinical governances, controls assurance standards, risk management/assessment and critical point analysis
  • The role of the qualified person.
  • Quality system review.
  • BS5750, ISO 9000.
  • Laboratory of Government Chemist (LGC) and Pharmassure schemes of intra-laboratory quality assurance.
  • Governance and controls assurance, risk management and critical point control analysis.
  • United Kingdom Accreditation Service.
  • EU Good Manufacturing Practice (GMP).
  • International Good Manufacturing Practice (GMP) guidelines and standards.
  • Quality assurance and technical information database.
  • Defective products, complaints and recall procedure.
  • Inter-relationships between disciplines involved in quality assurance.
  • Royal Pharmaceutical Society hospital standards.
  • Documentation.
  • Authorisation, control and indexing the documentation.
  • Updating and version control.
  • Pharmaceutical formulation and processes.
  • Properties of excipients and ingredients in pharmaceutical products.
  • Key chemical and physical reactions involved in the preparation, stabilisation and degradation of medicinal products.
  • Mathematical principles and calculations for pharmaceutical sciences.
  • 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.
  • Radiation safety in radiopharmacy.
7 2

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

  • Quality assurance, including management and organisational aspects.
  • Quality risk management.
  • Quality management systems.
  • Quality audits: participation in internal and external audits and inspections, follow-up and reporting, including relevant aspects of clinical governances, controls assurance standards, risk management/assessment and critical point analysis
  • The role of the qualified person.
  • Quality system review.
  • BS5750, ISO 9000.
  • Laboratory of Government Chemist (LGC) and Pharmassure schemes of intra-laboratory quality assurance.
  • Governance and controls assurance, risk management and critical point control analysis.
  • United Kingdom Accreditation Service.
  • EU Good Manufacturing Practice (GMP).
  • International Good Manufacturing Practice (GMP) guidelines and standards.
  • Quality assurance and technical information database.
  • Defective products, complaints and recall procedure.
  • Inter-relationships between disciplines involved in quality assurance.
  • Royal Pharmaceutical Society hospital standards.
  • Documentation.
  • Authorisation, control and indexing the documentation.
  • Updating and version control.
  • Pharmaceutical formulation and processes.
  • Properties of excipients and ingredients in pharmaceutical products.
  • Key chemical and physical reactions involved in the preparation, stabilisation and degradation of medicinal products.
  • Mathematical principles and calculations for pharmaceutical sciences.
  • 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.
  • Radiation safety in radiopharmacy.
8 2

Perform and document internal quality audits.

  • Quality assurance, including management and organisational aspects.
  • Quality risk management.
  • Quality management systems.
  • Quality audits: participation in internal and external audits and inspections, follow-up and reporting, including relevant aspects of clinical governances, controls assurance standards, risk management/assessment and critical point analysis
  • The role of the qualified person.
  • Quality system review.
  • BS5750, ISO 9000.
  • Laboratory of Government Chemist (LGC) and Pharmassure schemes of intra-laboratory quality assurance.
  • Governance and controls assurance, risk management and critical point control analysis.
  • United Kingdom Accreditation Service.
  • EU Good Manufacturing Practice (GMP).
  • International Good Manufacturing Practice (GMP) guidelines and standards.
  • Quality assurance and technical information database.
  • Defective products, complaints and recall procedure.
  • Inter-relationships between disciplines involved in quality assurance.
  • Royal Pharmaceutical Society hospital standards.
  • Documentation.
  • Authorisation, control and indexing the documentation.
  • Updating and version control.
  • Pharmaceutical formulation and processes.
  • Properties of excipients and ingredients in pharmaceutical products.
  • Key chemical and physical reactions involved in the preparation, stabilisation and degradation of medicinal products.
  • Mathematical principles and calculations for pharmaceutical sciences.
  • 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.
  • Radiation safety in radiopharmacy.
9 2

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

  • Quality assurance, including management and organisational aspects.
  • Quality risk management.
  • Quality management systems.
  • Quality audits: participation in internal and external audits and inspections, follow-up and reporting, including relevant aspects of clinical governances, controls assurance standards, risk management/assessment and critical point analysis
  • The role of the qualified person.
  • Quality system review.
  • BS5750, ISO 9000.
  • Laboratory of Government Chemist (LGC) and Pharmassure schemes of intra-laboratory quality assurance.
  • Governance and controls assurance, risk management and critical point control analysis.
  • United Kingdom Accreditation Service.
  • EU Good Manufacturing Practice (GMP).
  • International Good Manufacturing Practice (GMP) guidelines and standards.
  • Quality assurance and technical information database.
  • Defective products, complaints and recall procedure.
  • Inter-relationships between disciplines involved in quality assurance.
  • Royal Pharmaceutical Society hospital standards.
  • Documentation.
  • Authorisation, control and indexing the documentation.
  • Updating and version control.
  • Pharmaceutical formulation and processes.
  • Properties of excipients and ingredients in pharmaceutical products.
  • Key chemical and physical reactions involved in the preparation, stabilisation and degradation of medicinal products.
  • Mathematical principles and calculations for pharmaceutical sciences.
  • 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.
  • Radiation safety in radiopharmacy.
10 2

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

  • Quality assurance, including management and organisational aspects.
  • Quality risk management.
  • Quality management systems.
  • Quality audits: participation in internal and external audits and inspections, follow-up and reporting, including relevant aspects of clinical governances, controls assurance standards, risk management/assessment and critical point analysis
  • The role of the qualified person.
  • Quality system review.
  • BS5750, ISO 9000.
  • Laboratory of Government Chemist (LGC) and Pharmassure schemes of intra-laboratory quality assurance.
  • Governance and controls assurance, risk management and critical point control analysis.
  • United Kingdom Accreditation Service.
  • EU Good Manufacturing Practice (GMP).
  • International Good Manufacturing Practice (GMP) guidelines and standards.
  • Quality assurance and technical information database.
  • Defective products, complaints and recall procedure.
  • Inter-relationships between disciplines involved in quality assurance.
  • Royal Pharmaceutical Society hospital standards.
  • Documentation.
  • Authorisation, control and indexing the documentation.
  • Updating and version control.
  • Pharmaceutical formulation and processes.
  • Properties of excipients and ingredients in pharmaceutical products.
  • Key chemical and physical reactions involved in the preparation, stabilisation and degradation of medicinal products.
  • Mathematical principles and calculations for pharmaceutical sciences.
  • 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.
  • Radiation safety in radiopharmacy.
11 3

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

  • 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.
12 3

Plan production of a range of radioactive medicinal products.

  • 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.
13 3

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

  • 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.
14 3

Prepare a range of radioactive medicinal products.

  • 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.
15 3

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

  • 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.
16 3

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

  • 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.
17 3

Observe the manufacture of radiopharmaceuticals containing positron-emitting radionuclides.

  • 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.
18 3

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

  • 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.
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.

  • Requirements/implications for cessation of breastfeeding prior to administration of radiopharmaceuticals.
  • Potential medicine interactions and interventions that may affect radiopharmaceutical performance or the outcome of a patient investigation or treatment.
  • When an undesired patient radiation exposure may arise from either misadministration or maladministration of a radiopharmaceutical.
  • Suitability and formulation of non-radioactive medicines used to enhance nuclear medicine studies.
  • Administration of medicines for the protection of organs from unwanted radiation exposure.
20 4

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

  • The functions of the different cell types routinely labelled in nuclear medicine.
  • Cell labelling procedures.
  • Clinical indications for cell labelling.
  • Aseptic techniques for labelling blood products.
  • SOPs.
21 4

Prepare and administer an iodine- 131 therapy dose.

  • Therapeutic radiopharmaceutical products approved for general use in nuclear medicine together with their clinical applications.
22 4

Observe a range of therapeutic administrations.

  • Therapeutic radiopharmaceutical products approved for general use in nuclear medicine together with their clinical applications.
23 4

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

  • Clinical indications for measuring glomerular filtration rate (GFR).
  • Dilution of stock solutions.
  • Preparation and dispensing of radioactive medicinal products used in measuring GFR.
  • Normal ranges.
  • Good Manufacturing Practice.
  • Methods of measuring radioactivity in in-vitro samples.
  • Radiation detectors used in radiopharmacy, including calibration.
24 4

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

  • Clinical indications for measuring glomerular filtration rate (GFR).
  • Dilution of stock solutions.
  • Preparation and dispensing of radioactive medicinal products used in measuring GFR.
  • Normal ranges.
  • Good Manufacturing Practice.
  • Methods of measuring radioactivity in in-vitro samples.
  • Radiation detectors used in radiopharmacy, including calibration.
25 5,8

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

  • Control of quality and the role of the quality controller.
  • Techniques and instrumentation:
    • thin-layer chromatography (TLC)
    • high-performance liquid chromatography (HPLC)
    • gas chromatography
    • ion separation chromatography
    • endotoxin and pyrogen testing (theory)
    • pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
  • Product testing:
    • purchased medicines
    • raw materials
    • final products.
26 5,8

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

  • Control of quality and the role of the quality controller.
  • Techniques and instrumentation:
    • thin-layer chromatography (TLC)
    • high-performance liquid chromatography (HPLC)
    • gas chromatography
    • ion separation chromatography
    • endotoxin and pyrogen testing (theory)
    • pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
  • Product testing:
    • purchased medicines
    • raw materials
    • final products.
27 6,7

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

  • Radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use.
  • Nuclear medicine examinations, including PET, their indications, clinical use and impact on patient management.
  • Adjuvant medicines used in nuclear medicine, their role and impact on the clinical outcome.
  • Potential medicine interactions and interventions that may affect radiopharmaceutical performance or the outcome of a patient investigation or treatment.
28 6,7

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

  • Radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use.
  • Nuclear medicine examinations, including PET, their indications, clinical use and impact on patient management.
  • Adjuvant medicines used in nuclear medicine, their role and impact on the clinical outcome.
  • Potential medicine interactions and interventions that may affect radiopharmaceutical performance or the outcome of a patient investigation or treatment.
29 6,7

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

  • Radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use.
  • Nuclear medicine examinations, including PET, their indications, clinical use and impact on patient management.
  • Adjuvant medicines used in nuclear medicine, their role and impact on the clinical outcome.
  • Potential medicine interactions and interventions that may affect radiopharmaceutical performance or the outcome of a patient investigation or treatment.
30 6,7

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

  • Radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use.
  • Nuclear medicine examinations, including PET, their indications, clinical use and impact on patient management.
  • Adjuvant medicines used in nuclear medicine, their role and impact on the clinical outcome.
  • Potential medicine interactions and interventions that may affect radiopharmaceutical performance or the outcome of a patient investigation or treatment.

Work-based assessment


Complete 3 Case-Based Discussion(s)
Complete 2 of the following DOPS and/or OCEs
Type Title
DOPS 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
OCE 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