Link to EAHP Statements
Section 3: Production and Compounding: Statements 3.2, 3.3, 3.4, 3.5
Section 4: Clinical Pharmacy Services: Statements 4.1, 4.2, 4.3, 4.8
Section 5: Patient Safety and Quality Assurance: Statements: 5.2, 5.4, 5.5, 5.6, 5.7, 5.8, 5,9, 5.10, 5.11
Radiopharmacy requires the expertise of pharmaceutical preparation and the skills to handle radioactive substances. Their clinical use, however, is associated with a risk deriving from radiation exposure and possible contamination during radiopharmaceutical formulation by chemical, biological and microbiological impurities. This is particularly important since the majority of radiopharmaceuticals are administered intra-venously. A thorough quality assurance (QA) programme should, therefore, be in place before administration to the patient.
The responsibilities of a Radiopharmacist or Radiopharmaceutical Scientist includes the preparation of radiopharmaceuticals paying particular attention to safety and efficacy considerations. A working knowledge of pharmaceutical sciences including microbiology, chemistry, physiology/pharmacology together with some radiation physics provides essential underpinning knowledge. In addition a knowledge of analytical techniques including chromatography, gel filtration and electrophoresis is useful in relation to quality control, would be useful. All radiopharmaceuticals are, by definition, radioactive, so that radiation protection forms an integral part of the job.
It goes without saying that radiopharmacy is highly regulated, and it is necessary to be aware of proper procedures, taking into account the dual nature of radiopharmaceuticals as both medicines and radioactive products.
Production of radiopharmaceuticals in hospitals is permitted in two ways. Firstly, materials are prepared under the terms of a Manufacturing Licence, issued by the Production Manager and a Quality Control Manager, one of whom is usually a pharmacist. In the second instance, materials are prepared under the so-called "section 10 exemption" and in this case supervision of the procedure has to be by a pharmacist.
This seminar will provide practical assistance to nuclear medicine centres in setting up and running a hospital 'hot laboratory' or radiopharmacy service. It also provides clear boundaries for different levels of radiopharmacy operations with a view to providing more information on staff qualifications, training, facilities, equipment, types of procedures, record keeping, QA and QC essential at that level.
After the seminar, participants should be able to:
• understanding the role and responsibility of radio-pharmacist in hospital;
• issues and implications of real life practice;
• issues with legislation and how to apply in hospital.
Educational need addressed
To learn and understand the role of a radio-pharmacist and the importance of complying with regulations and standards.
Keywords: Radiopharmacy, GMP, Guidelines, Aseptic manufacturing, Competencies.