|Title||Radiopharmaceuticals and Radiopharmacy|
By the end of this module the Clinical Scientist in HSST will be able to analyse, synthesise, critically evaluate and apply their expert knowledge of the scientific, technical and clinical principles underpinning the production and use of safe and efficacious radiopharmaceutical products. They will be able to apply knowledge and understanding to a wide range of routine and more complex technical and clinical situations in a manner that is consistent with the role and responsibilities of a Consultant Clinical Scientist. They will also be able to seek and critically evaluate evidence from a variety of sources and analyse their responses to normal or unusual circumstances, consistently demonstrating the professional attributes and insights required of a Consultant Clinical Scientist.
Knowledge and understanding
By the end of this module the Clinical Scientist in HSST will be able to analyse, synthesise, critically evaluate and apply expert knowledge of radiopharmaceuticals and radiopharmacy in the following areas:
- The scientific, technical and clinical principles of radiopharmacy:
- physical and chemical properties of radiopharmaceuticals;
- production of artificial radionuclides used in medicine, including cyclotrons, nuclear reactors and radionuclide generators;
- applications of radiopharmaceuticals and their place in the patient pathway;
- radiopharmaceutical production techniques, including the use of pre- prepared non-radioactive kits and automated synthesis modules;
- radioactive labelling of blood cells;
- patient safety, adverse effects of radiopharmaceuticals, interactions of radiopharmaceuticals with other medications;
- radiation dosimetry in diagnostic and therapeutic nuclear medicine;
- modifications that need to be made to a pharmaceutical production facility to make it suitable for the production of radiopharmaceuticals;
- legislation and guidance that applies to the design and operation of a radiopharmacy, including pharmaceutical and radiation safety, transport, quality management and radioactive waste.
- The production of pharmaceutical products:
- theory and practice of pharmaceutical design, manufacturing, assembly, preparation, packaging and dispensing;
- principles of sterilisation, including irradiation, filtration, gas, moist and dry heat;
- licensed products, unlicensed products, ‘specials’ and investigational medical products;
- procedures for the release and recall of pharmaceutical products;
- routes for obtaining manufacturing authorisation;
- the role of the Qualified Person (QP).
- The principles of aseptic techniques in the manufacture and dispensing of pharmaceutical products:
- microbiological basis of aseptic manufacture, including relevant microorganisms;
- principles of aseptic manipulation;
- function and monitoring of clean air facilities, including laminar flow cabinets and isolators;
- cleaning regimens and personnel requirements.
- Quality management in radiopharmacy:
- quality management framework, including quality management systems, quality assurance and quality control;
- quality measures and techniques for radiopharmaceutical products, clean air facilities and aseptic production techniques;
- techniques and instruments in a pharmaceutical quality control laboratory;
- quality control regimens for different aseptic facilities;
- statistical analysis and reporting of the results of quality control tests.
Technical and clinical skills
By the end of this module, through the critical application of knowledge and understanding, the Clinical Scientist in HSST will have mastered a wide range of technical skills related to radiopharmaceuticals and radiopharmacy. In addition, they will be able to identify suboptimal areas of practice and recommend improvements. They will:
- Lead an effective and efficient radiopharmacy service:
- prepare and dispense a wide range of radiopharmaceuticals for clinical diagnostic and therapeutic use, keeping detailed records at all stages of the process;
- prepare labelled blood cells;
- develop, review and update standard operating procedures for the preparation of radiopharmaceuticals;
- implement and supervise a comprehensive radiation monitoring programme, including contamination and personnel dosimetry, regularly review the results and take corrective action as required;
- specify, procure and implement a radiopharmacy information technology system;
- give expert advice on the design, construction, commissioning and decommissioning of radiopharmacy facilities;
- synthesise and evaluate the management of systems for the storage and disposal of radioactive waste and provide advice and expertise regarding the required facilities.
- Lead the production of pharmaceutical products:
- perform a range of procedures to safely manufacture, store and distribute medicinal products, in accordance with the requirements of Good Manufacturing Practice (GMP) and local standard operating procedures;
- perform pharmacovigilance risk assessments;
- evaluate internal and external auditing of suppliers and manufacturers.
- Lead within an aseptic environment:
- undertake aseptic manipulations and transfers;
- supervise procedures to ensure the quality of processing, labelling, storage and dispensing prior to the release of aseptically prepared products;
- supervise the training and monitoring of aseptic services personnel to ensure competence and compliance with relevant standards;
- evaluate procedures for the reporting of errors and exceptions;
- commission clean air facilities after maintenance, modification, or installation;
- implement validations of facilities, processes and operator performance.
- Implement and lead quality assurance programmes within the framework of a quality management system:
- perform a comprehensive range of physical and chemical quality control tests;
- implement and perform microbiological and other quality control tests for clean air facilities and staff;
- implement and supervise quality assurance and audit programmes;
- analyse and critically evaluate the results of quality control tests;
- perform internal and external quality audits;
- implement and review a radiopharmacy quality management system.
By the end of the end of this module the Clinical Scientist in HSST will be able to work effectively and make authoritative contributions to patient management within a multidisciplinary clinical team, by applying and critically reflecting on a range of clinical and communication skills related to radiopharmaceuticals and radiopharmacy. They will:
- Provide advice to colleagues about the choice of radiopharmaceutical for particular clinical applications.
- Advise colleagues about the administration of radiopharmaceuticals during pregnancy and counsel pregnant patients.
- Advise colleagues and patients of behavioural restrictions following the administration of radiopharmaceuticals in order to maintain radiation safety.
- Investigate and report adverse patient reactions to radiopharmaceuticals and associated medicinal products.
- Investigate unusual findings in nuclear medicine investigations to determine possible associations with the radiopharmaceutical and provide expert advice on interpretation of the images or results.
Attitudes and behaviours
By the end of this module the Clinical Scientist in HSST will be expected consistently to demonstrate the attitudes and behaviours necessary for the role of a Consultant Clinical Scientist and they will:
- Apply evidence-based professional practice.
- Display a professional commitment to ethical practice.
- Apply the principles of Good Scientific Practice and professional standards.
- Consistently operate in accordance with relevant current national legislation, policy and guidance.