Safety Reports Series The pattern of practice throughout the world with regard to the release of patients from hospital after therapies using unsealed radionuclides is quite Safety Reports Series varied and has not been subject to harmonization. This report is focused on the decision to release the patient and its consequences. It will provide N o. 6 3 guidelines for national authorities on which to No.63 Release of Patients After Radionuclide Therapy base their regulations and guidance, and will help to resolve the diversity of international practices in this area. Particular attention is paid to the questions most frequently asked by patients. R e l e a s e o f P a t i e n t s A f t e r Radionuclide Therapy With contributions from the INTERNATIONAL ATOMIC ENERGY AGENCY VIENNA ISBN 978–92–0–108909–0 ISSN 1020–6450 09-25571_P1417_cover.indd 1 2009-10-20 10:48:01 RELATED PUBLICATIONS IAEA SAFETY RELATED PUBLICATIONS APPLYING RADIATION SAFETY STANDARDS IN NUCLEAR MEDICINE IAEA SAFETY STANDARDS Safety Reports Series No. 40 STI/PUB/1207 (137 pp.; 2005) Under the terms of Article III of its Statute, the IAEA is authorized to establish ISBN 92–0–111104–5 Price: €28.00 or adopt standards of safety for protection of health and minimization of danger to life FUNDAMENTAL SAFETY PRINCIPLES and property, and to provide for the application of these standards. IAEA Safety Standards Series No. SF-1 The publications by means of which the IAEA establishes standards are issued in STI/PUB/1273 (37 pp.; 2006) the IAEA Safety Standards Series. This series covers nuclear safety, radiation safety, ISBN 92–0–110706–4 Price: €25.00 transport safety and waste safety. The publication categories in the series are Safety Fundamentals, Safety Requirements and Safety Guides. RADIOLOGICAL PROTECTION FOR MEDICAL EXPOSURE Information on the IAEA’s safety standards programme is available at the IAEA TO IONIZING RADIATION Internet site IAEA Safety Standards Series No. RS-G-1.5 http://www-ns.iaea.org/standards/ STI/PUB/1117 (86 pp.; 2002) ISBN 92–0–111302–1 Price: €14.50 The site provides the texts in English of published and draft safety standards. The texts of safety standards issued in Arabic, Chinese, French, Russian and Spanish, the IAEA Safety Glossary and a status report for safety standards under development are also available. For further information, please contact the IAEA at P.O. Box 100, 1400 Vienna, Austria. All users of IAEA safety standards are invited to inform the IAEA of experience in their use (e.g. as a basis for national regulations, for safety reviews and for training courses) for the purpose of ensuring that they continue to meet users’ needs. Information may be provided via the IAEA Internet site or by post, as above, or by email to [email protected]. OTHER SAFETY RELATED PUBLICATIONS The IAEA provides for the application of the standards and, under the terms of Articles III and VIII.C of its Statute, makes available and fosters the exchange of information relating to peaceful nuclear activities and serves as an intermediary among its Member States for this purpose. Reports on safety and protection in nuclear activities are issued as Safety Reports, which provide practical examples and detailed methods that can be used in support of the safety standards. Other safety related IAEA publications are issued as Radiological Assessment Reports, the International Nuclear Safety Group’s INSAG Reports, Technical Reports and TECDOCs. The IAEA also issues reports on radiological accidents, training manuals and practical manuals, and other special safety related publications. Security related publications are issued in the IAEA Nuclear Security Series. www.iaea.org/books 09-25571_P1417_cover.indd 2 2009-10-20 10:48:01 RELEASE OF PATIENTS AFTER RADIONUCLIDE THERAPY SAFETY REPORTS SERIES No. 63 RELEASE OF PATIENTS AFTER RADIONUCLIDE THERAPY WITH CONTRIBUTIONS FROM THE INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION INTERNATIONAL ATOMIC ENERGY AGENCY VIENNA, 2009 COPYRIGHT NOTICE All IAEA scientific and technical publications are protected by the terms of the Universal Copyright Convention as adopted in 1952 (Berne) and as revised in 1972 (Paris). The copyright has since been extended by the World Intellectual Property Organization (Geneva) to include electronic and virtual intellectual property. Permission to use whole or parts of texts contained in IAEA publications in printed or electronic form must be obtained and is usually subject to royalty agreements. Proposals for non-commercial reproductions and translations are welcomed and considered on a case-by-case basis. Enquiries should be addressed to the IAEA Publishing Section at: Sales and Promotion, Publishing Section International Atomic Energy Agency Vienna International Centre PO Box 100 1400 Vienna, Austria fax: +43 1 2600 29302 tel.: +43 1 2600 22417 email: [email protected] http://www.iaea.org/books © IAEA, 2009 Printed by the IAEA in Austria October 2009 STI/PUB/1417 IAEA Library Cataloguing in Publication Data Release of patients after radionuclide therapy / with contributions from the International Commission on Radiological Protection. — Vienna : International Atomic Energy Agency, 2009. p. ; 24 cm. — (Safety reports series, ISSN 1020–6450 ; no. 63) STI/PUB/1417 ISBN 978–92–0–108909–0 Includes bibliographical references. 1. Radiotherapy — Safety measures. 2. Radiation — Dosage. 3. Patient discharge instructions. I. International Atomic Energy Agency. II. Series. IAEAL 09–00601 FOREWORD The use of unsealed radiopharmaceuticals for treatment of disease is common practice worldwide. This approach was widely employed some years ago and, following a decline, there has recently been a resurgence of interest in it. The combination of newly accessible radionuclides, improved labelling technology and developments in biotechnology has resulted in more enthusiasm and a wider range of applications for this form of therapy. Radionuclide treatments are performed with either the patient admitted to hospital or as an outpatient only. The criteria to determine which approach is best vary considerably, and are not always closely linked with the well established standards of radiation protection practice. Safety issues for the patient, their family, associated carers, staff and the general public arise with either approach. The potential risks are from both external irradiation and contamination. The International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (BSS) specify the dose constraints and limits for all of these groups, and their more general provisions with respect to the as low as reasonably achievable principle and justification also apply. One way of managing exposures of the various groups is to control when patients are released from hospital. While they are in hospital, it is relatively easy to control exposure. Once they have returned to their family in the community, they must be advised on how to restrict the exposure of those people that they will come into contact with. Until recently, the International Commission on Radiological Protection (ICRP) did not provide specific advice in this area, and relied on the application of dose limits and constraints. However, regulators in some countries took a prescriptive approach, often using estimates of retained activity as a release criterion. These only loosely relate to dose limits. This publication attempts to bring newly available advice from the ICRP to bear on providing a more consistent approach in this area. The approach to this issue is developed within the IAEA’s framework of statutory responsibility to establish standards for the protection of people against exposure to ionizing radiation and to provide for worldwide application of these standards. The Fundamental Safety Principles and the BSS, issued by the IAEA and co-sponsored by the Food and Agriculture Organization of the United Nations, the International Labour Office, the OECD Nuclear Energy Agency, the World Health Organization and the Pan American Health Organization, require the radiological protection of patients undergoing medical exposures through justification of the procedures involved and through optimization. This challenge is taken up here by expanding on an area dealt with relatively briefly in the recent IAEA publication, Applying Radiation Safety Standards in Nuclear Medicine (Safety Reports Series No. 40), and other initiatives in the areas of nuclear medicine and radiotherapy, to provide additional useful advice for Member States, particularly for practitioners of radionuclide therapy. This is timely given the wide divergences in practice throughout the world and the advice newly available from the ICRP. It endorses the ICRP’s view that infants and young children, as well as casual visitors, be limited to the public dose limit, and that patients should be released on the basis of an individual assessment of their specific family, medical and social circumstances while conforming to the dose limits and constraints. The IAEA is grateful to L. Collins (Australia) for his role in compiling the initial text and to J. Malone (Ireland) for bringing the final draft to fruition. The IAEA officer responsible for this publication was M.M. Rehani of the Division of Radiation, Transport and Waste Safety. EDITORIAL NOTE Although great care has been taken to maintain the accuracy of information contained in this publication, neither the IAEA nor its Member States assume any responsibility for consequences which may arise from its use. The use of particular designations of countries or territories does not imply any judgement by the publisher, the IAEA, as to the legal status of such countries or territories, of their authorities and institutions or of the delimitation of their boundaries. The mention of names of specific companies or products (whether or not indicated as registered) does not imply any intention to infringe proprietary rights, nor should it be construed as an endorsement or recommendation on the part of the IAEA. CONTENTS 1. INTRODUCTION . 1 1.1. Background . 1 1.2. Objectives and scope .