Eur e opea icin n Association of Nuclear Med The Radiopharmacy A Technologist’s Guide Produced with the kind Support of Contributors James R Ballinger, PhD Helen Ryder Chief Radiopharmaceutical Scientist Clinical Specialist Radiographer Guy’s and St Thomas’ NHS Foundation Trust Dept. of Diagnostic Imaging London, United Kingdom St. James’s Hospital Dublin, Ireland Clemens Decristoforo, PhD (*) Chair of the EANM Radiopharmacy Committee Tanja Gmeiner Stopar, PhD Clinical Department of Nuclear Medicine Member of the Education Board, Medical University Innsbruck EANM Radiopharmacy Committee Innsbruck, Austria Radiopharmacy, Head University Medical Centre Ljubljana Brit Farstad Department for Nuclear Medicine Member of the EANM Radiopharamcy Committee Ljubljana, Slovenia M.Pharm/Radiopharmacist Department Head, Isotope Laboratories Wim van den Broek Institute for Energy Technology Chair of the EANM Technologist Committee Kjeller, Norway Chief Technologist Dept of Nuclear Medicine Brendan McCoubrey University Medicine Centre Radiation Safety Officer Nijmegen, The Netherlands Dept. of Diagnostic Imaging St. James’s Hospital Editors Dublin, Ireland Suzanne Dennan Geraldine O’Reilly, PhD Vice-Chair of the EANM Technologist Committee Acting Radiographic Services Manager Radiation Protection Advisor Dept. of Diagnostic Imaging Dept. of Medical Physics and BioEngineering St. James’s Hospital St. James’s Hospital Dublin, Ireland Dublin, Ireland Clemens Decristoforo, PhD * This booklet was sponsored by an educational grant from Lantheus Medical Imaging . The views expressed are those of the authors and not necessarily of Lantheus Medical Imaging. 2 Contents Foreword Wim van den Broek. 4 Introduction Clemens Decristoforo. 5 Chapter 1 - Radiopharmacy Technology Brit Farstad. 6 Chapter 2 - Radiopharmacy Design James Ballinger. .12 Chapter 3 - Radiopharmacy: Preparing & Dispensing Radiopharmaceuticals EANM Geraldine O’Reilly. .16 Chapter 4 - Radiopharmacy: Kits & Techniques Helen Ryder. 22 Chapter 5 – Radiopharmacy: Blood Labelling Tanja Gmeiner Stopar. .33 Chapter 6 - Radiopharmacy: Record Keeping & Administration Brendan McCoubrey. 41 References. .49 Imprint. .51 3 Foreword Wim van den Broek Since it was formed, the EANM Technologist should be provided for all staff working in ra- Committee has been devoted to the improve- diopharmacy departments in the aspects of ment of nuclear medicine technologists’ quality assurance in which they are involved. (NMTs’) professional skills. Publications that will This includes: preparation, release, quality con- assist in the setting of high standards for NMT’s trol and analytical techniques, cleaning, trans- work have been developed and since 2004 portation, calibration of equipment (especially a series of brochures, “Technologists Guides”, for the measurement of radioactivity), working have been published yearly. This booklet practices in the radiopharmacy, preparation of about radiopharmacy is already the fifth vol- the individual doses, documentation, hygiene, ume. The new and stricter regulations in the pharmaceutical microbiology, and microbio- field of preparation of radiopharmaceuticals logical monitoring. Often a Nuclear Medicine changed the daily practice in the radiophar- Technologist is the person who is involved macy in the last 5 years. in the preparation and quality control of the radiopharmaceuticals. Nuclear medicine is a multidisciplinary special- ty in which medicine, physics and pharmacy I am grateful for the effort and hard work of all are involved. The Radiopharmacy is an integral the contributors, who are the key to the con- part of a nuclear medicine department and its tents and educational value of this booklet. prime responsibility is the preparation of high The most essential and relevant aspects of ra- quality radiopharmaceuticals, the base for a diopharmacy in daily practice are emphasised high quality nuclear medicine examination. here. This booklet is prepared in cooperation The majority of these radiopharmaceuticals with the Radiopharmacy Committee of the is mainly used for diagnostic imaging, which EANM. This Committee is very active and criti- is the main activity of nuclear medicine. Ra- cal in the field of regulations and guidelines for diopharmaceuticals are medical products the production of radiopharmaceuticals and defined in the European directive 2004/27/ constantly proposes practical solutions. Many EC amending the directive 2001/83/EC. As in thanks to Suzanne Dennan who coordinated other disciplines the complex changes driven this project. by European legislation had their impact on everyday practice in the preparation of radio- With this new booklet, the EANM Technolo- pharmaceuticals. gist Committee offers to the NMT community again a useful and comprehensive tool that Only trained people should be responsible for may contribute to the advancement of their and participate in the preparation and qual- daily work. ity control of radiopharmaceuticals. Training 4 Introduction Clemens Decristoforo, PhD I want to congratulate the Technologists Com- The Technologists Committee of the EANM mittee of the EANM for this excellent Tech- has been very active in promoting profes- nologists Guide on the Radiopharmacy. Issues sional skills of technologists and to support of quality assurance especially in the field of high quality standards in daily practice. The pharmaceutical preparations are becoming series of “Technologists Guide” booklets by the increasingly important. The Radiopharmacy Eductional Sub-Committee has been a valu- Committee of the EANM therefore recently able part of these initiatives. The current issue has issued general guidelines for “Current of this series intends to provide guidance for Good Radiopharmacy Practice” describing a “good radiopharmacy practice,” to describe the quality standards in the preparation of quality standards and to bring radiopharmacy conventional and PET radiopharmaceuticals practice to equal standards throughout Eu- (http://www.eanm.org/scientific_info/guide- rope. EANM lines/gl_radioph_cgrpp.php). These serve as a general reference standard for radiophar- This booklet contains chapters of all relevant maceutical preparation as radiopharmacy topics of daily radiopharmacy practice of tech- practice still shows a great variability all over nologists such as radiopharmacy design, prep- Europe. aration and dispensing as well as documenta- tion written by European experts in the field, Technologists in many countries are the both radiopharmacists and technologists. backbone for radiopharmacy services within nuclear medicine departments. This is espe- I am very confident that this booklet will not cially true for the preparation and handling only provide valuable information and quick of conventional radiopharmaceuticals includ- reference for problems arising in daily prac- ing eluting radionuclide generators, prepara- tice, but also will help to continuously improve tion of 99mTc-radiopharmaceuticals from kits, quality standards of radiopharmacy practices dispensing and cell labelling. Therefore the in nuclear medicine. current issue of the Technologists Guides is dedicated to radiopharmacy practice. 5 Chapter 1 – Radiopharmacy Technology Brit Farstad Radiopharmacy A radiopharmaceutical can be as simple as a Radiopharmacy encompasses studies related radioactive element such as 133Xe, a simple salt to the pharmaceutical, chemical, physical, such as 131I-NaI, or a labelled compound such biochemical, and biological aspects of ra- as 131I-iodinated proteins and 99mTc-labeled diopharmaceuticals. Radiopharmacy com- compounds. prises a rational understanding of the design, preparation and quality control of radiophar- Usually, radiopharmaceuticals contain at least maceuticals, the relationship between the two major components: physiochemical and biological properties of radiopharmaceuticals and their clinical appli- • A radionuclide that provides the desired cation, as well as radiopharmaceuticals chem- radiation characteristics. istry and issues related to the management, selection, storage, dispensing, and proper use • A chemical compound with structural or of radiopharmaceuticals. chemical properties that determine the in vivo distribution and physiological behav- Characteristics of radiopharmaceuticals iour of the radiopharmaceutical. A radiopharmaceutical is a pharmaceutical that, when ready for use, incorporates one Radiopharmaceuticals should have several or more radionuclides (radioactive isotopes). specific characteristics that are a combination Radiopharmaceuticals are used for diagnosis of the properties of the radionuclide used as or therapeutic treatment of human diseases; the label and of the final radiopharmaceutical hence nearly 95% of radiopharmaceuticals are molecule itself. used for diagnostic purposes, while the rest is used for therapy. Decay of radionuclides Radionuclides are unstable nuclei that are sta- Radiopharmaceuticals usually have no phar- bilised upon radioactive decay. Approximately macologic effects, as they are used in tracer 3000 nuclides have been discovered so far; quantities. There is no dose-response relation- most of these are unstable, but only about 30 ship in this case, which thus differs significantly of these are routinely used in nuclear medicine. from conventional drugs. Most of these are artificial radionuclides, which may be produced by irradiation in nuclear re- Radiation is an inherent characteristic of all actors, cyclotrons, or large linear accelerators. radiopharmaceuticals, and