Title page
Contents
Preface 3
Acknowledgements 3
Introduction 7
Future Revision and Updates 7
Section 1. The Medicines Regulations, Order and Amendment Regulations (with respect to Radioactive Substances) 8
Introduction 8
The Medicines (Administration of Radioactive Substances) Regulations 1978 (MARS Regulations 1978) 9
The Medicines (Radioactive Substances) Order 1978 10
The Medicines (Administration of Radioactive Substances) Amendment Regulations 1995 11
The Medicines (Administration of Radioactive Substances) Amendment Regulations 2006 11
Section 2. Certificates 12
Who Should and Who Need Not Apply 12
Issuing Authority and Validity 13
Requirements for Initial Applications for Diagnosis or Treatment 13
Qualifications and Experience of the Practitioner 15
Qualifications and Experience of Supporting Staff 16
Supporting Services 16
Renewal, Extension and Variation of Certificates 17
Changes of Premises or Appointment 17
Urgent Applications - Particular Patient Requests 18
Representations 18
Section 3. Diagnosis 19
Routine Diagnostic Procedures 19
Activity Administered 19
General Techniques for Dose Reduction 20
Females and Males - Conception, Pregnancy and Breastfeeding 20
Children and Young Persons 20
Section 4. Treatment 21
Routine Therapeutic Procedures 21
Applying for a Therapy Certificate 21
Section 5. Research 23
Research Authorisations 23
Applying for a Research Certificate 23
Activity Administered 24
Selection of Subjects for Research Projects 24
Ethical Approval 26
Section 6. Investigations in Children and Young Persons 27
Children and Young Persons - Principles 27
Scheduling the Procedure 27
Scanning Children 27
Activity Administered 28
Environment, Specific Needs and Injection Process 29
Imaging Technique 29
Sedation 30
Radiation Protection 30
Section 7. Conception, Pregnancy and Breastfeeding 31
Advice to Females 31
Advice to Males 32
Advice to Females of Childbearing Potential after Administration of Long-lived Radionuclides 32
Diagnostic Administrations to Those Who Are Breastfeeding 33
Section 8. Thyroid Blocking 36
Use of Blocking Agents 36
Technetium-99m 36
Radioiodine 36
Blocking Agent Equivalents 36
Blocking Protocols 37
References 38
Appendix I. Routine Procedures, Activities and Doses 40
Introduction 40
Toxicological and Pharmaceutical Safety 40
Numbering System 41
Notes to Parts A and B 41
Part A: Diagnostic Procedures - Adult Patients 44
Part B: Diagnostic Procedures - Positron Emission Tomography 47
Part C: Therapeutic Procedures with Unsealed Sources 48
Part D: Therapeutic Procedures with Sealed Sources 49
Part E: Functional Groups 50
References 54
Appendix II. Calculating the Radiation Dose 55
S-factors 55
Cumulated Activity 55
Absorbed Dose 56
Equivalent Dose 56
Effective Dose 56
Dose to Children 57
References 57
Appendix III. Sample Size and Power Calculations 58
References 59
Appendix IV. Training and Experience 60
Introduction 60
Scope of the Service 60
Part A: Core Curriculum for Those Using Radioactive Substances 61
Part B: Additional Requirements for Those Using Positron Emission Tomography/Computed Tomography (PET/CT) 67
Part C: Requirements for Supporting Staff Working under the Written Directions of a Certificate Holder 69
References 70
Appendix V. Additional Acts and Regulations 71
The Radioactive Substances Act 1993 (RSA 1993) (as amended) and the Environmental Permitting Regulations 2010 (EPR 2010) (as amended) 71
The Medicines Act 1968 73
The Ionising Radiations Regulations 1999 (IRR 1999) (as amended) and the Ionising Radiations Regulations (Northern Ireland) 2000 (IRR(NI) 2000) (as amended) 74
The Ionising Radiation (Medical Exposure) Regulations 2000 (as amended) and the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2000 (IR(ME)R 2000) 75
References 76
Appendix VI. Certification Process under the MARS Regulations 1978 78
Appendix VII. Communicating Risk to Research Ethics Committees, Patients and Research Subjects 80
Communicating Risks in Research Applications 80
Communicating Risks to Patients and Research Subjects 81
References 83
Table 6.1. Scaling of adult administered activity for children or young persons by body weight 28
Table 6.2. Recommended minimum administered activity for children 29
Table 7.1. Period following therapy administration for which female patients should be advised to avoid pregnancy 32
Table 7.2. Breastfeeding interruption times by radiopharmaceutical administered 35
Table II.1. Tissue weighting factors 57
Table IV.1. Full nuclear medicine service curriculum 62
Table VII.1. General guidelines for assessing research proposals 80
Table VII.2. Examples of risks estimated to increase the annual chance of death by 1 in 1,000,000 (US statistics) 82
Table VII.3. Typical doses and risks from radionuclide studies 83
Table VII.4. Band classification of the typical effective doses of ionising radiation from common imaging procedures 83
Figure VI.1. Current certification procedure - new applications (diagnostic, therapy - including functional groups - and research) 79
Figure VII.1. Lifetime cancer risk for uniform whole body exposure as a function of age at exposure and sex (adapted from Wall et al) 81