CONTENTS

ABSTRACT ........................................................................................................ v

GUEST EDITORIAL ........................................................................................ 1

PREFACE........................................................................................................... 5

MAIN POINTS .................................................................................................... 7

1. INTRODUCTION....................................................................................... 9

2. PURPOSE OF THIS REPORT ................................................................ 11

3. TYPES AND FREQUENCY OF NUCLEAR MEDICINE

PROCEDURES ......................................................................................... 13
3.1. Hyperthyroidism therapy ................................................................ 14
3.2. Thyroid cancer therapy................................................................... 14
3.3. Bone metastases therapy ................................................................. 14
3.4. Intracavitary therapy ...................................................................... 15
3.5. Polycythaemia vera therapy ............................................................ 15
3.6. Intra-arterial therapy ...................................................................... 15
3.7. Radioimmunotherapy ..................................................................... 16

4. RADIATION PROTECTION AFTER USE OF THERAPEUTIC

RADIOPHARMACEUTICALS ............................................................. 17

5. CURRENT INTERNATIONAL RECOMMENDATIONS ON DOSE

LIMITS AND DOSE CONSTRAINTS .................................................. 19

6. CRITICAL PATHWAYS OF EXPOSURE FROM IODINE-131.......... 21

6.1. General.......................................................................................... 21
6.2. External dose rate from the patient ............................................... 23
6.3. Contamination of other people...................................................... 25

7. MAGNITUDE AND NATURE OF RISK FROM IODINE-131

EXPOSURE FOR RELATIVES, CAREGIVERS, AND
THE PUBLIC ......................................................................................... 29

8. ENVIRONMENTAL PATHWAYS OF RADIOIODINE ..................... 33

9. DISPOSAL OF RADIOACTIVE WASTE FROM THERAPY WITH

UNSEALED RADIONUCLIDES .......................................................... 35
9.1. General........................................................................................... 35
9.2. Retain to decay............................................................................... 36
9.3. Sewage, sludge, and incineration..................................................... 36
9.4. Landfills.......................................................................................... 39

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 ICRP Publication 94

10. DECISION TO HOSPITALISE OR RELEASE PATIENTS ................. 41

10.1. General ......................................................................................... 41
10.2. Occupational doses to hospital staff .............................................. 44
10.3. Psychological costs of hospitalisation............................................ 45
10.4. Cost–benefit analysis of hospitalisation......................................... 45
10.5. Doses to others during patient travel ............................................ 46
10.6. Radiation detectors at borders, airports, etc. ................................ 48
10.7. Exposure in the home environment............................................... 48

11. INTERNATIONAL AND NATIONAL GUIDANCE ON RELEASE

CRITERIA ........................................................................................ 53

12. ANTIBODY THERAPY .................................................................... 59

13. OTHER ISSUES ................................................................................ 61

13.1. Records......................................................................................... 61
13.2. Death, postmortem examinations, burial, and cremation .............. 61
13.3. Breastfeeding................................................................................. 64
13.4. Pregnant females........................................................................... 64
13.5. Subsequent pregnancy after radionuclide therapy ......................... 66

APPENDIX A. SAMPLE PATIENT INFORMATION SHEET FOR

HYPERTHYROIDISM .............................................................................. 69

APPENDIX B. SAMPLE INSTRUCTIONS FOR RADIATION

PROTECTION AFTER THERAPEUTIC ADMINISTRATION OF
RADIOIODINE......................................................................................... 71

APPENDIX C. SAMPLE CARD FOR PATIENTS GIVEN

RADIONUCLIDE THERAPY ................................................................... 73

REFERENCES .......................................................................................... 75

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 ICRP Publication 94

Release of patients after therapy with

unsealed radionuclides

ICRP Publication 94

Approved by the Commission in March 2004

Abstract–After some therapeutic nuclear medicine procedures with unsealed radionuclides,

precautions may be needed to limit doses to other people, but this is rarely the case after
diagnostic procedures. Iodine-131 results in the largest dose to medical staff, the public,
caregivers, and relatives. Other radionuclides used in therapy are usually simple beta emitters
(e.g. phosphorus-32, strontium-89, and yttrium-90) that pose much less risk. Dose limits apply
to exposure of the public and medical staff from patients. Previously, the ICRP has re-
commended that a source-related dose constraint for optimisation of a few mSv/episode ap-
plies to relatives, visitors, and caregivers at home, rather than a dose limit. The present report
recommends that young children and infants, as well as visitors not engaged in direct care or
comforting, should be treated as members of the public (i.e. be subject to the public dose
limit).
The modes of exposure to other people are: external exposure; internal exposure due to
contamination; and environmental pathways. Dose to adults from patients is mainly due to
external exposure. Contamination of infants and children with saliva from a patient could
result in significant doses to the child’s thyroid. It is important to avoid contamination of
children and pregnant women. After radioiodine therapy, mothers must cease breastfeeding
immediately. Many types of therapy with unsealed radionuclides are contraindicated in
pregnant females. Women should not become pregnant for some time after radioisotope
therapy. Technetium-99m dominates discharges to the environment from excreta of nuclear
medicine patients, but its short half-life limits its importance. The second largest discharges,
iodine-131, can be detected in the environment after medical uses but with no measurable
environmental impact. Storing patients’s urine after therapy appears to have minimal benefit.
Radionuclides released into modern sewage systems are likely to result in doses to sewer
workers and the public that are well below public dose limits.
The decision to hospitalise or release a patient should be determined on an individual basis.
In addition to residual activity in the patient, the decision should take many other factors into
account. Hospitalisation will reduce exposure to the public and relatives, but will increase
exposure to hospital staff. Hospitalisation often involves a significant psychological burden as
well as monetary and other costs that should be analysed and justified. Patients travelling after

v
 ICRP Publication 94

radioiodine therapy rarely present a hazard to other passengers if travel times are limited to a
few hours.
Environmental or other radiation-detection devices are able to detect patients who have had
radioiodine therapy for several weeks after treatment. Personnel operating such detectors
should be specifically trained to identify and deal with nuclear medicine patients. Records of
the specifics of therapy with unsealed radionuclides should be maintained at the hospital and
given to the patient along with written precautionary instructions. In the case of death of a
patient who has had radiotherapy with unsealed radionuclides in the last few months, special
precautions may be required.
Ó 2004 ICRP. Published by Elsevier Ltd. All rights reserved.
Keywords: Nuclear medicine; Radiation protection; Radioiodine; Dose constraint; Radio-
therapy

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 ICRP Publication 94

Guest Editorial

RADIOLOGICAL PROTECTION AFTER NUCLEAR MEDICINE

PROCEDURES

Radioactive substances have been used in medicine for over 100 years. Today,
medical use of radiation is the largest, and a growing, manmade source of radiation
exposure. Nuclear medicine has become an important diagnostic and therapeutic
specialty, and there are nearly 100 different procedures that provide information
about virtually every major organ system in the body.
The United Nations Scientific Committee on the Effects of Atomic Radiation
(UNSCEAR) estimated that, worldwide, more than 30 million diagnostic nuclear
medicine procedures and nearly 400,000 therapeutic procedures with radiopharma-
ceuticals are carried out each year (UNSCEAR, 2000). Radioactive iodine was intro-
duced in the 1940s, and although many other radiopharmaceuticals are used in
nuclear medicine, iodine-131 continues to be the most important radionuclide.
The use of unsealed radionuclides can result in exposure of other people as well as pa-
tients, and there is a need for guidance regarding the radiological protection of members
of the public, relatives, and caregivers from such exposures. The International Commis-
sion on Radiological Protection (ICRP) has not provided recommendations on the cri-
teria to follow regarding the release of patients from hospital after therapy with unsealed
radionuclides, or on activity levels that require hospitalisation of the patient. Instead, the
Commission has relied upon the dose limit of 1 mSv/year for the public, and the dose con-
straint of 5 mSv/episode for relatives, visitors, and caregivers (ICRP, 1991, 1996). These
recommendations have been interpreted differently in various countries, and the dose
constraint has often been inappropriately interpreted as a rigid annual dose limit.
The decision to hospitalise or release a patient should be determined on an indi-
vidual basis, and should consider factors such as the residual activity in the patient,
the patientÕs wishes, occupational and public exposures, family considerations, cost,
and environmental aspects. Committee 3 established a Task Group in 1999 to review
this topic. This report is one of a set of documents being developed by ICRP Com-
mittees to advise the Commission on the formulation of its next recommendations
for radiological protection.
This report covers both diagnostic and therapeutic procedures, but focuses on io-
dine-131, which is the major source of exposure to staff and relatives from therapy
with unsealed radionuclides. Precautions for the public are rarely required after diag-
nostic procedures, but doses to the public and relatives may need to be limited after
some therapeutic procedures.
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 ICRP Publication 94

The Commission adopted the Task GroupÕs report and its recommendations at its
meeting in Vienna in April 2004.
Thyroid cancer as a result of radiation exposure appears to be a significant risk for
fetuses, infants, and children. As such, particular efforts should be made to avoid
exposure in these groups.
Doses to other people from patients who have received radioiodine therapy are
predominantly the result of external exposure. Doses from other commonly used un-
sealed therapeutic radionuclides are well below public dose limits or dose constraints
applied to caregivers, regardless of the radionuclide or environmental pathway
considered.
This report by Committee 3 gives valuable guidance regarding whether to hospi-
talise or release patients. Hospitalisation will reduce exposure to the public and rel-
atives, but will increase exposure of hospital staff and can also result in significant
monetary costs that need to be analysed and justified. Patients travelling after radi-
oiodine therapy rarely present a hazard to other passengers if travel times are limited
to a few hours, and restrictions following release of patients should focus on infants
and children. The Commission now recommends that the public dose limit of 1 mSv/
year should apply to infants, children, and casual visitors, rather than the dose con-
straint of 5 mSv/episode.
Many radiopharmaceuticals can be transferred to a baby via breast milk. The
Commission recommends cessation of breastfeeding, for a short period at least, after
most nuclear medicine procedures, and breastfeeding should be stopped completely
after a therapeutic dose of radioiodine. Otherwise, the radioiodine may induce per-
manent hypothyroidism or increase the risk for thyroid cancer in the infant.
With the exception of contact with a patientÕs urine, several studies have shown
that the risk of contamination with radioiodine is generally low although not negli-
gible. This report shows that with appropriate regulations and even without storage
of urine, sewer disposal of excreta from radiotherapy patients is well within both
occupational and public radiation dose limits. Storing the urine of patients treated
with radioiodine appears to have minimal benefit. Radionuclides released into mod-
ern sewage systems are likely to result in doses to sewer workers or the public that
are well below public dose limits.
The Commission does not explicitly state that urine should be stored or that pa-
tients should be hospitalised after therapy with high activities of radiopharmaceuti-
cals. Instead, the Commission recommends that public dose limits and dose
constraints for others should be observed. This should be followed by optimisation.
With regard to release of patients following nuclear medicine therapy, optimisation
and its effect on necessary behavioural restrictions may differ between individuals.
Current detection instruments are highly sensitive and can detect radiation at lev-
els well below those that are of concern to health. Residual radioactivity may be
detectable for days or weeks, and detection devices will usually detect patients for
a period of weeks following radioiodine therapy. Personnel operating such detectors
should be specifically trained to identify and deal with nuclear medicine patients.
Many physicians give patients an information card of documentation that a medical
treatment has been performed, but this may not be acceptable to security personnel.
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 ICRP Publication 94

It may be best to suggest that patients do not travel in major public areas unless they
are willing to experience some inconvenience.
This report by Committee 3 clarifies the recommendations in relation to release of
patients following treatment with unsealed radiopharmaceuticals. It also gives the
principles for releasing patients after therapeutic administration of unsealed radio-
nuclides.

LARS -ERIK HOLM

3
 PREFACE

Over the years, the International Commission on Radiological Protection (ICRP),

referred to below as Ôthe CommissionÕ, has issued many reports providing advice on
radiological protection and safety in medicine. Publication 73 (ICRP, 1996) is a gen-
eral overview of this area. These reports summarise the general principles of radia-
tion protection, and provide advice on the application of these principles to the
various uses of ionising radiation in medicine and biomedical research.
Most of these reports are of a general nature, and the Commission wishes to ad-
dress some specific situations where difficulties have been observed. It is desirable
that reports on such problem areas be written in a style that is accessible to those
who may be directly concerned in their daily work, and that every effort is made
to ensure wide circulation of such reports.
A series of reports was initiated at the CommissionÕs meeting in Oxford, UK, in
September 1997. On the recommendation of ICRP Committee 3, the Commission
established a number of Task Groups to produce reports on topical issues in medical
radiation protection.
Some such reports have already appeared in print as Publications 84–87 and 93.
The present report continues this series of concise and focused documents, and sev-
eral more advisory reports are being prepared.
The Task Group drafting this report, on the release of patients after therapy with un-
sealed radionuclides, was launched at the CommissionÕs meeting in St Petersburg, Rus-
sian Federation, in September 1999. Its initial terms of reference were to: (i) examine
dose constraints for relatives and important circumstances; (ii) examine current appli-
cations and dose compared with dose rate considerations; (iii) analyse the importance
of the use of conflicting approaches and cost compared with dose; (iv) consider the use
of the public dose limit for dependent children with the patient as a radiation source;
(v) consider recommendations concerning death, postmortem examinations, crema-
tion, and burial; (vi) provide easily accessible recommendations for different types of
therapy in different countries, taking into account that different national approaches
may necessitate different practical solutions; and (vii) consider all relevant sources
including rhenium, samarium, phosphorus, and yttrium. At the CommissionÕs meeting
in Bethesda, MD, USA in October 2000, these terms of reference were amended to in-
clude an expanded treatment of underlying rationale, a discussion of environmental
pathways, a discussion of cost and benefit of alternative approaches, and a discussion
of the ethical issues concerned.
The membership of the Task Group was as follows:

L.K. Harding (Chairman) A. Aarkrog D. Ash

J.-M. Cosset S. Ebdon-Jackson Y. Sasaki
B. Westerholm

The corresponding members were:

K. Endo A. Martinez K. Parthasarathy

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 ICRP Publication 94

The membership of Committee 3 during the period of preparation of this report

was:

F.A. Mettler, Jr. (Chairman) J.-M. Cosset C. Cousins

M.J. Guiberteau I. Gusev L.K. Harding (Secretary)
M. Hiraoka J. Liniecki (Vice-Chairman) S. Mattsson
P. Ortiz-Lopez L.V. Pinillos-Ashton M.M. Rehani
H. Ringertz M. Rosenstein C. Sharp
W. Yin

This report aims to serve the purposes described above. In order to be as useful as
possible for these purposes, its style differs in a few respects from the usual style of
the CommissionÕs publications in the Annals of the ICRP.
The report was approved for publication by the Commission by postal ballot in
March 2004.

6
 MAIN POINTS

 After diagnostic nuclear medicine procedures, precautions for the public are rarely
required. However, after some therapeutic procedures, doses to the public, patientsÕs
relatives, and others may need to be limited.
 As iodine-131 is a frequently used high-energy gamma emitter and has an 8-day
physical half-life, it results in the largest dose to medical staff, the public, and rela-
tives after procedures involving therapeutic administration of unsealed radionuclides.
Other radionuclides used in therapy are primarily beta emitters (e.g. phosphorus-32,
strontium-89, and yttrium-90) that pose much less risk.
 The major aspect of radiation therapy that needs to be controlled when releasing
a patient treated with radioiodine is the external exposure of others; however, the
typical doses to adults from these patients have a very low risk of cancer
induction.
 Thyroid cancer as a result of radiation exposure appears to be a significant risk for
fetuses, infants, and those under the age of 20 years. As such, particular care should
be taken to avoid contamination of infants, children, and pregnant women. Internal
contamination of relatives is most likely to occur 17 days after treatment. The risks
from internal contamination of others are less significant than those from external
exposure. Incorporation of large activities of iodine-131 that might cause hypothy-
roidism in an adult caregiver or relative is extremely unlikely.
 Very low activities of iodine-131 are observed in the environment as a result of med-
ical uses. Even with direct release to sewage systems, the relatively short physical
half-life results in doses to the public and sewer workers that are well below public
dose limits and which are low compared with other sources. No environmental effects
have been linked to the levels of radionuclides released as a result of medical uses of
unsealed radionuclides.
 ICRP recommendations regarding dose limits and dose constraints related to release
of patients following unsealed radionuclide therapy have been interpreted differently
in various countries. These recommendations include the concept of a dose constraint
of a few mSv/episode for caregivers and relatives, who should not be subject to the
public dose limit. This dose constraint has often been inappropriately interpreted
as a rigid annual dose limit.
 The ICRP now recommends that a dose constraint of a few mSv/episode should not
apply to infants, young children, and casual visitors. Instead, they should be subject
to the public dose limit of 1 mSv/year.
 Some authorities require hospitalisation of patients based on retained activity alone.
Other important factors, including appropriate optimisation, are not taken into
account. ICRP recommendations do not explicitly state that urine should be stored
or that patients should be hospitalised after therapy with high activities of radiophar-
maceuticals. Instead, the ICRP recommends that public dose limits and dose con-
straints for others should be observed. This should be followed by optimisation.
 Recent publications have indicated that assumptions and models used by some
authorities to decide whether to hospitalise or release patients may overestimate
actual doses to the public and caregivers.
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 ICRP Publication 94

 The decision to hospitalise or release a patient should be determined on an individual

basis. In addition to residual activity in the patient, the decision should take many
other factors into account including the patientÕs wishes, occupational and public
exposures, family considerations, the presence of children, cost, and environmental
factors.
 Continuation of breastfeeding is absolutely contraindicated after radioiodine
therapy.

8
 1. INTRODUCTION

 Nuclear medicine radiotherapy involves the use of unsealed radionuclides that have
the potential to expose members of the public, relatives, and caregivers.
(1) Radioactive substances have been used in the diagnosis and treatment of
malignant and benign conditions for over 100 years. Unsealed radionuclides are
radiopharmaceuticals that are injected, ingested, or inhaled, and which move
through the body. These can localise in body tissues until they decay, or they can
be eliminated through various pathways (such as urine). The current report deals
with unsealed radionuclides, primarily those used for therapy.
(2) Nuclear medicine techniques are well established but the precautions necessary
for protection of relatives, caregivers, and the general public require further guid-
ance, particularly in light of the ICRP 1990 recommendations of a reduced annual
effective dose limit to the public of 1 mSv (ICRP, 1991, 1996).
(3) Disparate interpretations of the implementation of the ICRP 1990 recommen-
dations (ICRP, 1991) have been made, even between neighbouring countries. In
addition, a number of recent scientific studies have challenged the appropriateness
of assumptions that have been made in the past to estimate doses to people other
than the patient.
(4) Awareness of societal costs and patient and family social issues has increased,
as has awareness of environmental pathways of radionuclides and their potential ef-
fects. Regulations should be based on realistic models of radiation exposure as well
as other important factors.
(5) For the purposes of this report, there are several radiation doses of interest.
Organ-absorbed radiation dose is expressed in grays (Gy) or milligrays (mGy).
The gray is equal to 100 rads. Occupational and public dose limits as well as dose
constraints are expressed as effective dose, which is both radiation and tissue
weighted. Effective dose is expressed in sieverts (Sv). The sievert is equal to 100
rem. In most medical decision-making applications, 1 Gy is equal to 1 Sv.

9
 2. PURPOSE OF THIS REPORT

 Regulations concerning the release of patients after administration of unsealed radi-

onuclides vary widely around the world. Regulations should be based on assumptions
that reflect the current situation accurately, or appropriate interpretations of ICRP
recommendations.
(6) The purpose of this report is to clarify aspects of radiological protection related
to release of patients after administration of unsealed radiopharmaceuticals. This
document also aims to promote uniform understanding and practical implementa-
tion of ICRP recommendations (particularly flexible dose constraints). It is intended
for use by regulators, physicians, physicists, nurses, technologists, and appropriate
administrators. These principles apply to the use of unsealed radionuclides for both
diagnostic and therapeutic purposes. However, since the magnitude of exposure of
other people is much less following diagnostic uses, this report focuses on exposure
following therapeutic uses of unsealed radionuclides.
(7) The principles for releasing patients from hospital after therapeutic administra-
tion of unsealed radionuclides are reported here. As a basis, there is a review of
underlying scientific studies, particularly with regard to how actual measurements
have correlated with previous assumptions that have formed existing regulations
and legislation.
(8) This report does not detail every issue related to a prescribed inpatient hospital
stay, but focuses on issues related to release of the patient from a strictly controlled
environment. There is extensive examination of the major source of absorbed dose to
the public, relatives, and caregivers, namely external radiation. Issues regarding
routes and magnitude of contamination of other people are also included.
(9) This report concentrates on the exposure pathways and doses resulting from
the use of radioiodine, since this is the major source of exposure to medical staff, rel-
atives, and caregivers from therapy with unsealed radionuclides. This report also
examines radioiodine releases to the environment from medical sources, and evalu-
ates the magnitude of doses and the potential impact in terms of risk to medical staff,
relatives, and caregivers. Information on radioiodine doses to various organs and tis-
sues can be found in Publication 53 (ICRP, 1987).

11
 3. TYPES AND FREQUENCY OF NUCLEAR MEDICINE PROCEDURES

 Radioiodine treatment for hyperthyroidism and thyroid cancer is the main source of
exposure to the public and relatives from patients who have received unsealed
radionuclides.
(10) Nuclear medicine is a medical specialty that involves the use of radiopharma-
ceuticals in the diagnosis and treatment of patients. Diagnostic procedures use short-
lived gamma emitters that, when tagged to an appropriate pharmaceutical, localise
in specific tissues. The images obtained give both functional and anatomical
information.
(11) Common diagnostic procedures include bone scans to assess the presence
of metastases, and cardiac scans to examine the perfusion of heart muscle as well
as its functional capacity. UNSCEAR estimated that, worldwide, approximately
32 million diagnostic nuclear medicine procedures are performed each year
(UNSCEAR, 2000). Precautions for the general public and the patientÕs relatives
are not usually required following diagnostic procedures with radiopharmaceuti-
cals, since most radionuclides used for diagnosis have short physical or biological
half-lives. Two exceptions to this are if the patient is breastfeeding or if the pa-
tient has had an iodine-131 whole body scan to look for recurrent thyroid cancer.
(12) Compared with diagnostic applications, therapeutic treatments are much
fewer in number but often use greater activities and radionuclides with longer biolog-
ical and physical half-lives. Therapeutic radiopharmaceuticals are usually beta emit-
ters, but many also have gamma emissions. Thus, they have the potential to expose
other people to greater doses than diagnostic procedures.
(13) The use of radiopharmaceuticals has almost doubled over the last decade. In
developed countries, UNSCEAR estimated that the frequency of radiopharmaceuti-
cal treatments increased from 0.10 per 1000 in 1985–1990 to 0.17 per 1000 in
1991–1996. UNSCEAR also estimated that, worldwide, approximately 210,000 radi-
opharmaceutical treatments were performed in 1985–1990 and an estimated 380,000
therapeutic procedures with unsealed radionuclides were performed between 1991
and 1996. Actual frequencies of procedures in a particular country may vary signif-
icantly from global values, and would be more useful in assessing local or regional
radiation protection.
(14) The common types of therapy with unsealed radionuclides are oral or intra-
venous administration of liquids or capsules (systemic therapy), or instillation of col-
loidal suspensions into closed body cavities (intracavitary therapy). Examples of
systemic therapy include sodium iodide-131 for hyperthyroidism or thyroid cancer,
and strontium-89 for bone metastases. Examples of intracavitary therapy include
chromic phosphate-32 for malignancies of the pleural and peritoneal cavities, and in-
tra-articular administration for synoviectomy. Table 3.1 shows the annual estimated
numbers of common therapeutic procedures with unsealed radionuclides between
1991 and 1996.
(15) The various techniques of radiopharmaceutical therapy with unsealed radio-
nuclides are summarised briefly below.

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 ICRP Publication 94

Table 3.1. Nuclear medicine therapy: estimated annual procedures 1991–1996

Condition Radiopharmaceutical and route Procedures/million Procedures/million
population in population worldwide
developed countries
131
Thyroid malignancy I Na iodide (oral or i.v.a) 35 15
131
Hyperthyroidism I Na iodide (oral or i.v.a) 110 42
32
Polycythaemia vera P phosphate (oral or i.v.a) 3 1
89
Bone metastases Sr chloride (i.v.a) 5 2
153
Sm ethylene diamino-
methylene phosphoric
acid (i.v.)
90
Synovitis Y colloid 7 2
169
Er colloid (intra-articular)
131 b b
Malignant disease I m-iodo-benzylguanidine (i.v.)
90
(other than Y colloid (intracavitary)
thyroid cancer and
polycythaemia vera)
Source: United Nations Scientific Committee on the Effects of Atomic Radiation (2000).
a
Intravenous administration.
b
Unknown.

3.1. Hyperthyroidism therapy

(16) Hyperfunction of the thyroid gland is most commonly due to an autoimmune

disease (GravesÕs disease). Less commonly, it can be caused by a single toxic nodule
(autonomous adenoma) or multinodular goitre. All of these conditions can result in
overproduction of thyroid hormone with ensuing symptoms. Treatment may be with
antithyroid drugs, surgery, or radioiodine. In many countries, over two-thirds of
hyperthyroid patients ultimately receive radioiodine therapy. The radioiodine is con-
centrated by the thyroid gland, resulting in destruction of thyroid cells and a de-
crease in the production of thyroid hormone over a period of weeks or months.
This is the most common form of nuclear medicine therapy. Treatment should be
explained to the patients in a clearly written leaflet (see Appendix A).

3.2. Thyroid cancer therapy

(17) Thyroid cancer often spreads to local lymph nodes as well as the lungs and
bone. Many thyroid cancers will accumulate iodine, although to a lesser extent than
normal thyroid tissue. Typical therapy for many thyroid cancers is complete surgical
excision of the cancer and the thyroid gland. After this, radioiodine may be given in
order to destroy any residual iodine-accumulating cancer cells. Several courses of
radioiodine therapy are often necessary to achieve remission or cure. This is the sec-
ond most common form of therapy with unsealed radionuclides.

3.3. Bone metastases therapy

(18) Many cancers (e.g., prostate and breast) have a predilection for diffuse spread
throughout the skeleton. These metastases can be very painful and, due to their
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 ICRP Publication 94

widespread nature, they are not amenable to external beam radiotherapy. Their re-
sponse to chemotherapy is variable. A number of radiopharmaceuticals can be in-
jected intravenously and will localise in the metastatic lesions to provide palliation
but not cure. Common radiopharmaceuticals used are strontium-89 chloride,
rhenium-186 HEDP (hydroxyethylidene diphosphonate), samarium-153 EDTMP
(ethylenediaminetetramethylenephosphonate) and tin-117m DTPA (diethylenetri-
aminepentaacetic acid). These have to be used carefully as they may cause bone mar-
row depression. Due to their relatively long half-lives, they are not usually given to
terminally ill patients.

3.4. Intracavitary therapy

(19) Intracavitary therapy is generally used to treat diffusely spread tumours

in confined anatomical spaces, arthritis, and synovitis. Several radionuclides are
used for these types of therapy. For tumour therapy, direct injection of sodium
or chromic phosphate-32, gold-198 colloids or even iodine-131- or yttrium-
90-labelled antibodies into confined anatomical spaces (such as the pleural space
or the peritoneal cavity) is performed. For treatment of arthritis or synovitis,
direct instillation of yttrium-90 FHMA (ferric hydroxide macroaggregates),
dysprosium-165 FHMA, or erbidium-169 colloid into the joint space is
performed. As these are beta emitters, little is needed in the way of radiation pro-
tection precautions unless the patient dies or the radionuclide leaks from the
cavity.
(20) The following are much less common forms of therapy with
radiopharmaceuticals.

3.5. Polycythaemia vera therapy

(21) Polycythaemia vera is a relatively rare disease that is characterised by over-

production of red and white blood cells by the bone marrow. Phosphorus-32 is given
intravenously and localises in the bone. The beta emissions result in mild bone mar-
row suppression and reduced production of many blood elements. Since phospho-
rus-32 is a pure beta emitter, radiation precautions are minimal.

3.6. Intra-arterial therapy

(22) Some tumours, such as hepatomas, are highly vascularised and may not be
amenable to surgery or chemotherapy. In these circumstances, it is possible to place
a catheter in the arterial supply and inject insoluble radiolabelled particles that lodge
in the arterioles and capillaries of the tumour and provide a local radiation dose.
This is usually palliative and rarely curative. Iodine-131-labelled oil contrast and
yttrium-90 glass microspheres or resin are most commonly used.
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 ICRP Publication 94

3.7. Radioimmunotherapy

(23) Radioimmunotherapy involves the use of radiolabelled antibodies that are di-
rected against tumour-specific antigens. These agents are gaining in popularity and
are currently being used for the treatment of lymphomas. The antibodies are labelled
with iodine-131 or yttrium-90, and relatively large activities are injected
intravenously.

16
 4. RADIATION PROTECTION AFTER USE OF THERAPEUTIC
RADIOPHARMACEUTICALS

 Radiological protection issues following therapy with unsealed radionuclides include

recommendations regarding doses to medical staff, caregivers, and the general pub-
lic. After diagnostic nuclear medicine procedures, precautions for the public are
rarely required. However, doses to the public, patients’s relatives, and others may
need to be limited after some therapeutic procedures.
 As iodine-131 is a frequently used high-energy gamma emitter, it is the unsealed
radionuclide that results in the largest dose to medical staff, the public, caregivers,
and relatives. Other radionuclides used in therapy are usually simple beta emitters
(e.g., phosphorus-32, strontium-89, and yttrium-90) that pose much less risk.
(24) Radiopharmaceuticals used for therapeutic purposes vary widely in their need
for radiation protection precautions. Some radiopharmaceuticals remain relatively
fixed in the body with little excretion, and primarily or exclusively emit beta rays that
are essentially all absorbed within the patientÕs tissues. These present little risk to
other people or the environment. Examples of this type of radionuclide include
strontium-89, phosphorus-32, rhenium-186, yttrium-90, samarium-153, and gold-
198. Patients treated with up to 200 MBq of the beta emitters (phosphorus-32, stron-
tium-89, and yttrium-90) do not need to observe any special precautions in relation
to the exposure of other people. An exception is patients receiving phosphorus-32,
strontium-89, or samarium-153 lexidronam for the treatment of pain from osseous
metastases. Although approximately 60–70% of these compounds will localise in
the skeleton, some will be excreted in the urine (approximately 35% of the excretable
fraction in the first 6 h and 80–90% in the first 48 h) post injection, and there is a need
for careful hygiene to avoid contamination from urine (British Institute of Radiol-
ogy, 1999; Silberstein and Taylor, 1996).
(25) Some radionuclides have multiple routes of excretion from the body before
they decay, and emit gamma rays in addition to beta rays. Unless precautions are
taken, this type of radiopharmaceutical can expose other people and the environ-
ment to unwanted radiation and contamination. The most common radionuclide
of this type is iodine-131.
(26) The frequency of various types of nuclear medicine therapy with unsealed
radionuclides is shown in Table 3.1. It is clear that treatment of thyroid conditions
accounts for more than 90% of such procedures, and all of these are performed using
iodine-131. Thus, for practical purposes, most issues relating to radiation protection
of the public and relatives from patients who have received unsealed radionuclides
for therapeutic purposes are concentrated on iodine-131.
(27) Administered activity of iodine-131 for patients treated for hyperthyroidism
ranges from approximately 100 to 1000 MBq. For treatment of thyroid cancer,
the administered activity ranges from approximately 4000 to 8000 MBq. The major
source of radiation to members of the public and sewage treatment workers from
administrations of iodine-131 will be from external radiation. For medical personnel,
relatives, and caregivers, the major source of radiation is also from external

17
 ICRP Publication 94

exposure, but the potential also exists for them to be exposed by contamination from
the patient. Both exposure pathways should be considered when formulating recom-
mendations or requirements.

18
5. CURRENT INTERNATIONAL RECOMMENDATIONS ON DOSE LIMITS
AND DOSE CONSTRAINTS

 According to previous ICRP recommendations, dose limits apply to exposure of the

public and medical staff from patients. A dose constraint of a few mSv/episode (not a
dose limit) applies to relatives, visitors, and caregivers at home. Dose constraints
represent a source-related system of control of exposures to the individual, below
which optimisation is carried out.
 ICRP recommendations regarding dose limits and dose constraints have been
interpreted very differently in various countries. Some countries have interpreted
the dose constraint as a rigid annual dose limit. ICRP recommendations do
not explicitly state that patients should be hospitalised after nuclear medicine
therapy.
 This document recommends that young children and infants, as well as visitors who
are not engaged in direct care or comforting, should be treated as members of the
public (i.e., be subject to the public dose limit).
(28) In 1991, the ICRP issued recommendations concerning dose limits and dose
constraints. The dose limits are summarised in Table 5.1.
(29) The ICRP 1990 recommendations state that: ÔIt is not appropriate to in-
clude the doses incurred by patients in the course of diagnostic examinations
or therapy when considering compliance with dose limits applied to occupational
or public exposure.Õ It is also stated that ÔMedical exposure is confined to expo-
sures incurred by individuals as part of their own diagnosis and treatment and to
exposures (other than occupational) incurred knowingly and willingly by individ-
uals in the support and comfort of patients undergoing diagnosis or treatmentÕ
(ICRP, 1991).

Table 5.1. Dose limits recommended by the ICRPa

Application Occupational Public
Effective dose 20 mSv/year averaged over defined 5-year periodsb 1 mSv/yearc

Annual equivalent dose in:

Lens of the eye 150 mSv 15 mSv
Skind 500 mSv 50 mSv
Hands and feet 500 mSv
Source: International Commission on Radiological Protection (1991).
a
Dose limits apply to the sum of the relevant doses from external exposure in the specified period and
the 50-year committed dose (to 70 years of age for children) from intakes in the same period.
b
With the further provision that the effective dose should not exceed 50 mSv in any single year.
Additional restrictions apply to the occupational exposure of pregnant women.
c
In special circumstances, a higher effective dose value could be allowed in a single year, provided that
the average over 5 years does not exceed 1 mSv/year.
d
The limit on effective dose provides sufficient protection for the skin against stochastic effects. An
additional limit is needed for localised exposures in order to prevent deterministic effects.

19
 ICRP Publication 94

(30) Publication 73 (ICRP, 1996) addressed the issue of voluntary exposures in

medicine, as follows:
ÔFriends and relations helping in the support and comfort of patients are also
volunteers, but there is a direct benefit both to the patients and to those who care
for them. Their exposures are defined as medical exposure but dose constraints
should be established for use in defining the protection policy both for visitors
to patients and for families at home when nuclear medicine patients are dis-
charged from the hospital. Such groups may include children. The Commission
has not recommended values for such constraints but a value in the region of
a few millisieverts per episode is likely to be reasonable. This constraint is not
to be used rigidly. For example, higher doses may well be appropriate for the
parents of very sick children.Õ
(31) Prior recommendations on dose constraints include infants and young chil-
dren who live with the patient. Since infants and young children are unable to
give informed consent, are not usually involved in patient care or comforting,
and are susceptible to radiation-induced thyroid cancer (especially through inges-
tion, see Section 6.3), it is now felt that they should be treated as members of the
public, as should those visitors who are not essential to patient care or comfort-
ing. In other words, these groups should be subject to the public dose limit of
1 mSv/year.
(32) It should be emphasised that dose constraints represent a source-related sys-
tem of control of exposures to the individual, below which optimisation is carried
out. Optimisation is carried out after compliance with dose constraints. When a for-
mal cost-benefit analysis has been used, optimisation is essentially a procedure of
judgement that includes the magnitude of the dose, the number of people exposed,
and the likelihood of incurring exposures in abnormal conditions. With regard to
the release of patients who have received nuclear medicine therapy, optimisation
and its effect on necessary behavioural restrictions may differ between individuals.
(33) The International Atomic Energy Agency (IAEA, 2002a) recommended ac-
tual values for dose constraints and dose limits for comforters and visitors of pa-
tients in the Basic Safety Standards (para II-9), and indicated that Ôthe dose limits
set out in this part shall not apply to comforters of patients, i.e., to individuals know-
ingly exposed while voluntarily helping (other than in their employment or occupa-
tion) in the care, support, and comfort of patients undergoing medical diagnosis or
treatment or to visitors of such patients. However, the dose of any comforter or vis-
itor shall be constrained so that it is unlikely that his or her dose will exceed 5 mSv
during the period of a patientÕs diagnostic examination or treatment. The dose to
children visiting patients who have ingested radioactive materials should be similarly
contained to less than 1 mSv.Õ
(34) The IAEA requirement refers to ingested radioactive materials and, by anal-
ogy, this should also apply to patients who receive intravenous administration of
radioactive materials. Thus, the requirement is basically in line with the ICRPÕs rec-
ommendations, although it does not explicitly deal with avoidance of excessive dose
to an individual who comforts or cares for multiple radiotherapy patients in a non-
occupational setting.
20
 6. CRITICAL PATHWAYS OF EXPOSURE FROM IODINE-131

6.1. General

 In order of decreasing significance, the exposure to other people from patients who
have received radioiodine therapy is: external exposure; internal exposure as a result
of contamination; and general environmental pathways.
 Contamination of infants and young children with saliva from a treated patient during
the first few days after radioiodine therapy could result in significant doses to the child’s
thyroid, and potentially raise the risk of subsequent radiation-induced thyroid cancer.
 Doses from other unsealed therapeutic radionuclides that are commonly used are
well below public dose limits or dose constraints applied to caregivers, regardless
of the radionuclide or environmental pathway considered.
(35) Exposure of relatives, caregivers, and the public can occur in several ways:
(i) external irradiation of people close to the patient;
(ii) internal contamination of people close to the patient as a result of excreted or
exhaled radioiodine; and
(iii) exposure through environmental pathways including sewage, discharges to
water, incinerated sludge, or cremation of bodies.
(36) With the exception of iodine-131, other commonly used unsealed therapeutic
radionuclides result in doses to the public and caregivers that are well below recom-
mended dose limits and dose constraints, regardless of the radionuclide or environ-
mental pathway considered. As a result, this report will focus on radioiodine.
(37) Sodium iodide-131 may enter the body through inhalation, absorption
through the skin, or ingestion. It is usually administered orally in liquid or capsule
form for treatment of hyperthyroidism or thyroid cancer. The iodide is rapidly ab-
sorbed from the gastrointestinal tract into the blood stream, and trapped and organ-
ified by functional thyroid tissue. Radioiodine-labelled thyroid hormone circulates
on plasma-binding proteins that are metabolised by the liver and muscles. Some
radioiodine is conjugated in the liver and excreted in the bile to the intestinal lumen.
(38) The salivary glands, stomach, and lactating breast contain epithelia that can
maintain a concentration gradient of inorganic iodide that is approximately 1520
times the level in the plasma.
(39) Radioactive iodine is excreted primarily in the urine with smaller amounts in
saliva, sweat, and faeces. A small amount is exhaled.
(40) The retained activity in the patient is a function of a number of factors includ-
ing, but not limited to, the radiopharmaceutical, presence or absence of the thyroid
gland, hydration, and renal function. Typical retention curves for sodium iodide-131
therapy for thyroid cancer and hyperthyroid patients are shown in Fig. 6.1.
(41) The proportions of activity of various radionuclides that are released to the
sewage system are shown in Table 6.1. Driver and Packer (2001) reported on the dis-
charge of activity measured from 174 patients undergoing radioiodine therapy for
thyroid carcinoma. They found that approximately 55% of administered activity is

21
 ICRP Publication 94

% administered activity
100 (a)

80
60
40
20
0
0 20 40 60
days
% administered activity

100 (b)

80
60
40
20
0
0 20 40 60
days
% administered activity

100
(c)
80
60
40
20
0
0 20 40 60
days
Fig. 6.1. Typical effective retention curves and administered activity for iodine-131 in different types of
patient. (a) Cancer therapy, (b) cancer follow-up, and (c) thyrotoxicosis. Sources: Barrington et al. (1996a)
and Hilditch et al. (1991).

excreted in the first 24-h period following treatment, 22% in the second 24-h period,
and 6% in the third 24-h period. A total of 85% is discharged to the sewage system
over the first 5 days. Historically and for regulatory purposes, it was assumed that
100% of administered activity was discharged. Use of such values is somewhat
conservative and may overestimate potential environmental consequences by
approximately 15%.
22
 ICRP Publication 94

Table 6.1. Proportion of administered activity (until total decay) discharged to drains
Nuclide and form For treatment of: Discharged to sewage systems (%)
198
Au colloid Malignant disease 0
131
Iodine Hyperthyroidism 54
131
Iodine Thyroid carcinoma 84–90
131
I MIBG Phaeochromocytoma 89
32
P phosphate Polycythaemia vera, etc. 42
89
Sr chloride Bone metastases 92
90
Y colloid Arthritic joints 0
90
Y antibody Malignancy 12
169
Er colloid Arthritic joints 0
Source: Thompson et al. (1994).

6.2. External dose rate from the patient

 Doses to other people from patients who have received radioiodine therapy are pre-
dominantly due to external exposure.
(42) For many calculations of absorbed doses from radioactive patients to
other people, the activity distribution is assumed to be an unattenuated
point source. External dose estimates to nearby people are usually made using
the inverse square law. This is essentially true for hyperthyroid patients
or thyroid cancer patients with localised metastases where the iodine is
concentrated.
(43) However, if the activity is widely distributed in the patient, use of an unat-
tenuated point-source model will overestimate doses to nearby people. A line-
source attenuation correction model is more accurate and can be implemented
routinely. This model would be better for patients who have received palliative
treatment of osseous metastases or radioimmunotherapy (Lubin, 2002; Siegel
et al., 2002a).
(44) The cumulative external exposure from a patient who has received a given
activity of iodine-131 will vary by a factor of two or three depending on whether
the patient is euthyroid, thyrotoxic, or being treated for thyroid cancer. As a result,
a number of authors have measured dose rates from different types of patients and at
different times. Culver and Dworkin (1991) measured exposure rates at various dis-
tances at times up to 11 days after administration of sodium iodide-131 for the treat-
ment of hyperthyroidism (Table 6.2).
(45) OÕDoherty et al. (1993) performed a study of dose rates in patients who re-
ceived radioiodine for hyperthyroidism. The results are broadly similar and are
shown in Table 6.3.
(46) Barrington et al. (1996a) measured actual external dose rates from patients
who had received either ablation or follow-up iodine-131 treatment for thyroid
cancer. Results are shown in Tables 6.4 and 6.5.
(47) Tables 6.4 and 6.5 show that the external dose rate per unit of administered
activity decreases much more rapidly in the thyroid cancer patients. In the thyroid
23
 ICRP Publication 94

Table 6.2. Measured dose rates at various times post administration and at various distances from
patients treated for hyperthyroidism (lSv/h/MBq administered activity)
Distance (m) 0 days 24 days 57 days 811 days
0.6 0.059 0.034 0.024
1.0 0.046 0.022 0.014 –
Source: National Council on Radiation Protection and Measurements (1995).

Table 6.3. Mean dose rates from hyperthyroid patients at various times post administration and at
various distances from patients treated for hyperthyroidism (lSv/h/MBq administered activity)
Distance (m) Day 0 Day 1 Day 3 Day 6 Day 8 Day 10
0.1 1.3 0.4 0.3 0.2 0.2 0.1
0.5 0.2 0.1 0.1 0.07 0.05 0.04
1.0 0.06 0.05 0.04 0.03 0.02 0.02
Source: OÕDoherty et al. (1993).

Table 6.4. Dose rates from ablation patients at various times post administration and at various distances
from patients treated for hyperthyroidism (lSv/h/MBq administered activity)
Distance (m) Day 0 Day 1 Day 2 Day 3 Day 4 Day 7
0.1 0.665 0.187 0.088 0.069 0.053 0.016
0.5 0.114 0.049 0.025 0.019 0.014 0.007
1.0 0.046 0.019 0.009 0.007 0.007 0.004
Source: Barrington et al. (1996a).

Table 6.5. Dose rates from follow-up patients at various times post administration and at various
distances from patients treated for hyperthyroidism (lSv/h/MBq administered activity)
Distance (m) Day 0 Day 1 Day 2 Day 3 Day 4 Day 7
0.1 0.746 0.274 0.085 0.030 0.026 0.001
0.5 0.126 0.051 0.017 0.006 0.002 0.0003
1.0 0.046 0.019 0.007 0.003 0.002 0.004
Source: Barrington et al. (1996a).

cancer patients, the thyroid has been removed so it is not retaining the radioiodine.
As a result, the vast majority of administered radioiodine is eliminated in the urine in
the first 2 days following treatment. Some authors have suggested that external dose
measurements should be made 23 m from the patient to minimise geometric effects.
The situation is different if the patient has residual foci of tumours that have accu-
mulated a significant amount of the radiopharmaceutical.
24
 ICRP Publication 94

6.3. Contamination of other people

 Contamination of adults is much less important than controlling external exposure.

However, it is very important to avoid contamination of children and pregnant
women due to the sensitivity of fetal and child thyroid glands to induction of thyroid
cancer. Breastfeeding must be ceased immediately by a mother following radioiodine
therapy.
(48) A common rule of thumb is to assume that no more than one-millionth of the
activity being handled will become an intake to an individual working with the mate-
rial. This was developed for worker intakes during normal workplace operations,
accidental exposures, and public intakes from accidental airborne releases from a
facility. At least two studies have shown that the same order of magnitude applies
to intakes of individuals exposed to patients (Buchan and Brindle, 1970; Jacobson
et al., 1978). In some countries, much more conservative values are used. For exam-
ple, in the Netherlands, one-hundredth of the amount being handled is assumed for
internal intake. With the exception of contact with a patientÕs urine, a number of
studies have shown that the risk of contamination with radioiodine is generally
low but not negligible. For adult relatives, the internal dose due to contamination
is usually less than 10% of the external dose. Radioiodine excreted from the patient
as exhaled vapour, saliva, sweat, urine, or breast milk can potentially expose rela-
tives and caregivers. In a study where skin and thyroid doses were measured, external
exposures exceeded the internal thyroid dose equivalent by a factor of over 100
(Jacobson et al., 1978).
(49) Dose conversion coefficients from ingestion and inhalation of iodine-131 by
people of various ages are shown in Table 6.6. These are useful to calculate potential
doses prospectively. However, measurement of activity in body fluids and in people
other than the patient is more instructive.
(50) Activity in various body fluids has been measured in hyperthyroid patients
treated with 200,600 MBq ofsodium iodide-131 (OÕDoherty et al., 1993). Mean sal-
ivary activity collected in the first 24 h post treatment was 86.7 Bq/g/MBq adminis-
tered activity (range 0.6208 Bq/g/MBq administered activity). By 3 days post
treatment, this had decreased to approximately 27 Bq/g/MBq. Maximal salivary
activity occurs approximately 24 h post therapy. Some authors recommend no

Table 6.6. Dose conversion coefficients (Sv/Bq) for inhalation and ingestion of radioiodine
Age group (years) Inhalation Ingestion
<1 7.2 E 8 1.8 E 7
1–2 7.2 E 8 1.8 E 7
2–7 3.7 E 8 1.0 E 7
7–12 1.9 E 8 5.2 E 8
12–17 1.1 E 8 3.4 E 8
Adults 7.4 E 9 2.2 E 8
Source: International Commission on Radiological Protection (1996).

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 ICRP Publication 94

mouth-to-mouth contact between the patient and their relatives for the first 48 h post
therapy.
(51) The secretion of activity in palm sweat during the first 24 h post therapy was
170 Bq/cm2 (range 131,027 Bq/cm2 ), and the mean palmar secretion was 45 kBq in
24 h. There was poor correlation with administered activity or body size. Thus, the
risk from iodine-131 contamination in sweat is small.
(52) Nishizawa et al. (1980) monitored iodine excretions from a number of hyper-
thyroid patients, with some interesting findings. In patients who received 25 mCi,
activity per ml was highest in saliva (approximately 10 lCi/ml), with the exception
of the first few hours post administration. It was 20-fold lower in blood (approxi-
mately 0.5 lCi/ml) and 1000-fold lower in sweat (approximately 0.01 lCi/ml). In
addition, activity in saliva of these patients decreased very rapidly; at 3 days post
therapy, it was approximately 1% of the initial maximum.
(53) Lassmann et al. (1998) demonstrated that in the case of radioiodine therapy,
up to 0.1% of administered iodine-131 is released into the air of the therapy room.
Two-thirds of relatives of patients who have been hospitalised for 2 days after radi-
oiodine therapy will have activity in their thyroid glands that is detectable with a thy-
roid probe. Whether this activity is from exhalation of radioiodine or other
contamination is not clear. Activity has been measured at a maximum of 4 kBq in
the whole body and 0.2 kBq in the thyroid gland. This would have resulted in a thy-
roid dose of 2 mSv. The mean thyroid dose was 0.2 mGy. The effective dose from
internal contamination of the maximally exposed relative was below the annual
public dose limit of 1 mSv.
(54) Hanscheid et al. (2003) performed daily iodine-131 thyroid monitoring of per-
sonnel in a nuclear medicine therapy ward. Thyroid doses were determined and aver-
aged to 0.35 mGy/month, showing that the incorporation risk is low provided that
air exchange in the room is sufficient.
(55) Schomaecker et al. (2000) studied patients treated for hyperthyroidism and
thyroid cancer. They indicated lower values than those reported by Lassmann
et al. (1998), and found that the amount of radioiodine exhaled ranged from
0.008% to 0.03% of the administered activity. The percentage of radioiodine exhaled
was greater in hyperthyroid patients than in thyroid cancer patients. Most of the ex-
haled activity was present in an organic-bound form.
(56) Wellner et al. (1998) studied the exhalation of radioiodine by hyperthyroid
patients, and the resulting incorporation into their relatives. They concluded that
if patients were hospitalised for 3 days, none of their relatives had effective doses
exceeding 0.1 mSv. Based on their assumptions and model, if patients were treated
on an ambulatory basis, the predicted effective dose to relatives would be up to
6.5 mSv and would exceed the public dose limit of 1 mSv/year.
(57) Contamination from a thyroid cancer patient is greatest at approximately 24
h post radioiodine administration, and is higher than that from hyperthyroid pa-
tients. Ibis et al. (1992) studied the contamination patterns from these patients.
Removable activity from the skin was measured at 4, 24, and 48 h post administra-
tion. Activities ranged from 10 to more than 250 Bq/cm2. There was a correlation
between removable activity and administered activity. Patients who washed fre-
26
 ICRP Publication 94

quently had significantly lower amounts of removable contamination. Removable

contamination on surfaces that the patients touched was very variable and ranged
from less than 1 to 190 Bq/cm2. Removable activity on the rim of toilets during
the first 48 h post treatment was much greater for men (approximately 1500 Bq/
cm2) than for women (approximately 20 Bq/cm2). Salivary activity was found to
be proportional to administered activity and was highest at 24 h post therapy. For
patients receiving 11 GBq of activity, the 24-h activity was approximately 4 MBq/
ml of saliva.
(58) Exhaled activity and mean air concentration of iodine-131 were also meas-
ured during the first 2 days post treatment. The activities in exhaled breath ranged
from 20 to 190 Bq/l. The mean exhaled activity per hour during the first day post
treatment was 1.5 · 10 6 Bq/h/Bq administered activity. Total exhaled activity into
air for four thyroid cancer patients was 2.2–4.9 MBq. Mean room air concentrations
were 0.08–0.44 Bq/l. The air in the room where the measurements were made had 190
exchanges/day. In the USA, the maximum permissible concentration for a restricted
area is 0.33 Bq/l.

27
 ICRP Publication xxx

Chapters 7–10
J. Valentine *

ICRP, 17116 Stockholm, Sweden

*
Tel.: +46 8 729 7275; fax: +46 8 729 7298.
E-mail address: [email protected] (J. Valentine).

28
 7. MAGNITUDE AND NATURE OF RISK FROM IODINE-131 EXPOSURE
FOR RELATIVES, CAREGIVERS, AND THE PUBLIC

 The typical doses to adults from patients treated with radioiodine have a very low
risk of cancer induction. It is extremely unlikely that an adult would be contami-
nated with enough radioiodine to result in hypothyroidism.
 Thyroid cancer as a result of contamination (particularly with saliva) may be a sig-
nificant risk for those under 20 years of age.
 Since high absorbed thyroid doses may occur in infants and young children from con-
tamination (while remaining within a prior recommended dose constraint), and chil-
drenÕs thyroids are very radiosensitive for carcinogenesis, the ICRP now
recommends that this population should be restricted to the public dose limit of 1
mSv/year.
(59) Dose limits and dose constraints are risk based. As such, it is useful to eluci-
date the nature and magnitude of the risks that are associated with these values. As
mentioned earlier, the risks to others from patients who have received therapeutic
amounts of unsealed radionuclides are largely derived from external exposure and,
to a lesser extent, from internal contamination.
(60) Iodine-131 emits a 364-keV gamma photon and many of these emissions from
the patient will expose nearby people in a predominantly uniform whole body fash-
ion. Since the dose rates are relatively low, the risk is related to cancer induction. The
risk of fatal cancer for the general population is approximately 5%/Sv (ICRP, 1991).
(61) The ICRP public dose limit is 1 mSv/year, and the dose constraint is a few
mSv/episode and higher in some circumstances. Utilising a linear non-threshold ap-
proach, the risk of all fatal cancers at 1 mSv is approximately 0.005% for the general
population. It is clear that these are potential risks and that increases in cancer, if
present, at these dose levels are so small as to have eluded detection to date. This
potential risk can be compared with the lifetime spontaneous risk of fatal cancer
of 20–30%. Children are more sensitive to cancer induction than adults (by a factor
of 2–3) and therefore the risk from an effective dose of 1 mSv is 0.01–0.02% for
children.
(62) A Swedish study of 36,000 individuals who received diagnostic doses of radi-
oiodine only found an increase in thyroid cancer among patients who had reported
previous external radiation therapy to the neck. The thyroid dose from radioiodine
among the other patients was 0.94 Gy; however, most of the patients were over the
age of 20 years at exposure (Dickman et al., 2003).
(63) The hazard from internal contamination is very different in adults and
children.
(64) Adults appear to be fairly resistant to induction of thyroid cancer as a result
of external radiation or radioiodine (Ron et al., 1995). No dose-related increase in
thyroid cancer has been found in the Chernobyl recovery workers to date (UN-
SCEAR, 2000). The only measurable hazard to adults in other studies occurred after
high doses to the thyroid (in the range of 3 Gy), leading to subclinical hypothyroid-
ism (Larsen and Conard, 1978). These changes only occurred after incorporation of

29
 ICRP Publication 94

activities many orders of magnitude greater than those found in actual measure-
ments of contamination from relatives of radioiodine therapy patients.
(65) Contamination of children with radioiodine is a concern in light of the in-
crease in thyroid cancer seen after Chernobyl. Risk estimates in children after radi-
oiodine ingestion and the Chernobyl experience are an excess absolute risk (EAR) of
1.6–2.3 per 104 person-year Gray (PYGy) and an excess relative risk (ERR) of 23–38/
Gy (UNSCEAR, 2000). In a large study of children exposed to weapons fallout in
the western USA with estimated thyroid doses of 0.46 Gy, no significant increase
in thyroid cancer was found (Rallison et al., 1974). However, a later study revealed
an ERR of 0.7%/mGy for thyroid neoplasms in general, but the dose–response
slopes for both thyroid carcinomas and nodules were non-significant (Kerber
et al., 1993).
(66) The ICRP recommendations for the public are related to effective dose alone.
Except in special circumstances, children are treated as members of the public with
an effective dose limit of 1 mSv/year. These are general recommendations and do not
deal specifically with the issue of radioiodine and child sensitivity. It is conceivable
that an older child may help in the care or comfort of a patient in a home setting
if they are capable of giving consent. Given that exposure in the circumstances dis-
cussed in this report primarily concerns radioiodine and that childrenÕs thyroids ap-
pear to be sensitive to cancer induction, this issue may need further examination.
With a thyroid tissue weighting factor of 0.05, it is theoretically possible that a childÕs
thyroid could receive 20 mSv from radioiodine and still be in compliance with ICRP
recommendations. The induction of thyroid cancer in children from these doses has
not been shown. It is also unlikely that an older child would receive this much con-
tamination and no external exposure. As a result, if the effective dose to a child is
kept below 1 mSv/year, the thyroid dose should be substantially less than 20
mGy. This is also borne out by actual thyroid measurements made in relatives.
(67) If a nursing mother continues to breastfeed after radioiodine therapy and the
childÕs thyroid is not ablated, the risk of thyroid cancer can be very high.
(68) One can estimate doses to a childÕs thyroid as a result of a specific contami-
nation scenario in which a parent did not follow radiation protection instructions.
For example, for hyperthyroid patients, salivary activity in the first day after therapy
tends to average approximately 100 Bq/g saliva/MBq administered activity. If the
parent received 555 MBq, the activity would be approximately 55,500 Bq/g or ml
of saliva.
(69) The dose to the thyroid of an infant or young child after ingestion of iodine-
131 is approximately 4.3 E 07 Gy/Bq. As an example, if a parent did not follow
precautions and an infant received 1 ml of saliva by being kissed by such a parent,
the estimated thyroid dose would be approximately 2.4 E 02 Gy or 24 mGy (ICRP,
1999). Using the preliminary data in children from Chernobyl with an ERR/Gy from
radioiodine in the range of 20–30, the ERR for thyroid cancer induction would be
approximately 1.0 (i.e., the natural risk would be doubled). Actual measurements
from children when appropriate precautions were followed indicate lower thyroid
doses (and therefore lower cancer risks) than those indicated by this example. In
one study, iodine activity was detected in 25 of 89 children. In those children with
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 ICRP Publication 94

detectable activity, the thyroid dose ranged from 0.4 to 29.1 mGy (Barrington et al.,
2003). This study found that some parents did not receive, understand, or follow the
precautions.
(70) Doses to children from internal contamination can be compared with poten-
tial doses to a child from external exposure. If a parent who had 555 MBq of re-
tained radioiodine activity held a child at 0.1 m for 1 h, 1 day after radioiodine
administration, the external dose rate would be less (approximately 0.4 lSv/h/
MBq administered or if the parent had a retained activity of 555 MBq, the external
dose to the child would be 0.2 mSv). These calculations demonstrate the importance
of precautions to reduce or prevent internal contamination of children and infants.
(71) Since high absorbed thyroid doses may occur in infants and young children
from contamination while remaining within a prior recommended dose constraint
of a few mSv/episode, and childrenÕs thyroids are highly radiosensitive for carcino-
genesis, the ICRP now recommends that this population should be restricted to
the public dose limit of 1 mSv/year.

31
32
 8. ENVIRONMENTAL PATHWAYS OF RADIOIODINE

 The majority of radioactivity discharged to the environment from excreta of nuclear

medicine patients is from technetium-99m radiopharmaceuticals followed by iodine-
131. The half-life of technetium-99m (6 h) largely limits its importance as a source of
environmental exposure. Due to its half-life of 8 days, iodine-131 can be detected in
the general environment after medical use. Environmental impact from these prac-
tices has not been measurable.
(72) A number of recent publications have stressed the need for a radiation pro-
tection system that includes details of the potential impact on the environment (Cop-
plestone et al., 2000; ICRP, 2003; Nuclear Energy Agency, 1995; Pentreath, 2002) In
addition, the ICRP has a Task Group developing policy in this area at present. For
the purposes of this report, the impact of released iodine-131 on the environment
should be minimal. There are several reasons for this. The physical half-life of io-
dine-131 is relatively short (8 days), and the time it takes for the excreta of patients
to be processed and returned to the ecosystem is relatively long.
(73) Movement of radioiodine in the environment has been studied for decades
(Eisenbud, 1973; Ilyin et al., 1972). A vast amount of information is available as a
result of radioiodine releases from accidents, nuclear weaponsÕs tests, and intentional
releases. Under these circumstances, there have been vast releases of radioiodine into
the environment and food chain. Introduction into the environment has generally
been via direct release into the air, although other pathways can be involved, such
as sewage release into rivers and water courses that are subsequently used for
irrigation.
(74) Due to its relatively short half-life, iodine-131 is not a significant contaminant
in terms of soil uptake. The decay rate is rapid in relation to the growing time of
crops. Radioiodine deposited on foliage is a function of deposition velocity of trans-
fer from air to vegetation. Radioiodine is removed from foliage by weathering and
other mechanisms, and the effective half-life for removal is approximately 3.5 days.
Radioiodine deposited on the surfaces of plants can be ingested by cattle, and
approximately 5% of ingested radioiodine appears in their milk.
(75) Regarding the release of nuclear medicine patients from hospital, the situation
is very different as the radioiodine is in the body where it decays or is excreted pri-
marily in urine, and finds its way into the environment. In the sewage management
process, there is possible exposure of sewer maintenance workers and wastewater
treatment operators from effluent liquids discharged to water courses and sludge.
In general, the activities are very low and the dilution, dispersion, and length of time
it takes to return to the food chain make this pathway of very minor importance.
(76) Radioiodine can be deposited on soil in the form of sewage sludge. Sludge
may be characterised as untreated, treated, or advanced treated sludge. These terms
primarily relate to processes that reduce bacteria or other pathogens, and they have
little to do with removal of radioactivity other than the fact that the more processes
involved and the longer it takes, the lower the released activity will be.

33
 ICRP Publication 94

(77) Untreated sludge is not usually deposited on agricultural land for health rea-
sons related to bacteria. Treated sludge may be deposited directly on crops that are
serving as forage for cattle, but this is not common unless the sewage is held for up to
6 months prior to application. In some countries, there are restrictions that ban
application of untreated sewage sludge on all agricultural land, and treated sludge
can only be applied on grazing grassland when it is deep injected. In addition, when
some of the crops are eaten raw, the time from application to harvest must be 12–30
months depending on the crop.
(78) When radioiodine is released into bodies of water, it can accumulate in a num-
ber of marine organisms. The accumulation coefficient is 200–500 for algae, 10–70 in
molluscs and crustaceans, and 10–15 in the muscles of fish. In some Eastern Euro-
pean countries, sewage may be stored next to freshwater fish farms and put into
the water to increase fish flesh production. The time from sewage treatment to Ôfish
feedingÕ is not monitored.
(79) There is at least one publication concerning the effects of radioiodine in the
thyroid function of goldfish (Chavin and Cukrowski, 1968). It was found that direct
intraperitoneal injections of radioiodine with activities from 0.37 kBq affected the
cytological appearance of cells in the pituitary, intraperitoneal injection of 0.37
MBq (2.2 MBq/kg) achieved partial thyroidectomy, and 3.7 MBq (22 MBq/kg)
caused total thyroidectomy. Atlantic salmon (LaRoche and LeBlond, 1954) and
trout (LaRoche et al., 1965; Norris and Gorbman, 1965) have also been studied.
The activities used to cause radiothyroidectomy were 37–185 MBq/kg. It was also
noted that ablation of the thyroid gland occurs in juvenile rainbow trout placed in
water with activities of approximately 1 MBq/ml for 2–3 months. Similar studies
and results have also been reported in Chinook salmon, killifish, and eels (Harris,
1959; Olivereau, 1957; Olivereau and LaRoche, 1965). All reported effects occurred
at activities that were many orders of magnitude greater than those from medical
uses of unsealed radionuclides and discharges of patientsÕ urine to the sewage system
and subsequent effluent. However, with the use of sewage in freshwater fish farms,
there may be an effect on fish thyroid glands given the 8-day half-life of radioiodine,
but it is thought that this would have little impact on public health.
(80) With respect to the potential hazard, one must consider the concentration at
the point of discharge, high coefficients of dilution, mixing, and significant physical
decay of radioiodine along the water–algae–zooplankton–edible (by man) organism
chain. The aqueous pathway by which iodine-131 may enter the human body is
much less significant than the terrestrial pathway.

34
 9. DISPOSAL OF RADIOACTIVE WASTE FROM THERAPY WITH
UNSEALED RADIONUCLIDES

 With appropriate regulations, even without storage of urine, sewer disposal of

excreta from patients diagnosed or treated with unsealed radionuclides has been
shown to be well within both occupational and public radiation dose limits.
 ICRP recommendations do not require urine to be stored. Storing the urine of
patients following radioiodine therapy appears to have minimal benefit.
 Radionuclides released into modern sewage systems are likely to result in doses to
sewer workers and the public that are well below public dose limits.
 Radiation detectors used at landfills to detect orphan and illicit radiation sources
may detect contamination from radioiodine therapy patients or contamination in
sewage sludge.

9.1. General

(81) Public opinion regarding the disposal of radioactive waste has been studied by
many authors; however, a recent study has shed some insight into public opinion
regarding the source of the waste (Kelly and Finch, 2002). In general, radioactive
waste from the nuclear power industry or fuel reprocessing was met with scepticism,
while radioactive waste created by medical applications was acceptable given the nat-
ure of the benefits provided.
(82) A general framework for radiation protection and disposal of radioactive
waste was published in Publication 77 (ICRP, 1997). The strategies can be divided
into two types: dilute and disperse, or concentrate and retain. Waste management
can be a public health tool to limit public exposure from released radionuclides. It
should be remembered that the primary aim of radiological protection is to provide
an appropriate standard of protection for man without unduly limiting the beneficial
practices giving rise to radiation exposure. The ICRPÕs policies are based on limiting
the risk of stochastic effects by all reasonable means, but not eliminating the risk
entirely.
(83) Management options for most radioactive excreta from radioiodine therapy
patients can be divided into several categories similar to those above. Firstly, it
can be collected, stored for decay, and then released (usually into the sewage system)
at some point in the future. This is done in some countries when the patients are hos-
pitalised. Storage of urine has not been a practical solution following patient release.
A second option is to dispose of the radioactive excreta directly into the sewage sys-
tem without decay. In some countries, this is done by hospitals themselves without
storing urine for decay. Finally, a small amount of excreted radioactivity will be
in or on materials that cannot be disposed of in the sewer. These materials may
be landfilled or stored for decay (Evdokimoff et al., 1994). Each of these methods
is discussed below in more detail.
(84) Direct sewer disposal is probably best for contaminated milk from a nursing
mother following radioiodine treatment.

35
 ICRP Publication 94

(85) Other issues have arisen as hospitals have struggled to become water efficient.
This means that the facility may not be able to dilute the radioactivity to an accept-
able concentration. In Canada, this is in the range of a yearly average of 200 Bq/l. As
a result, at least one hospital uses multiple holding tanks (Leung and Nikolic, 1998).
Depending on tank geometry, the dose rate per unit activity ranges from 0.5 to 4.0
lSv/h/GBq. These tanks are often not automatic and require proper staffing and
maintenance. Such innovations may not always be necessary, and one must ensure
that realistic assumptions are made regarding the environmental pathways.

9.2. Retain to decay

(86) Retaining urine for decay is a controversial subject. It is done in some coun-
tries but not in others. Ultimately the question is, what are the benefits and costs of
this practice?
(87) One reason given for hospitalisation of patients is that urine can be stored and
released into the sewer after decay. In many countries, patients are hospitalised to
reduce the external exposure of relatives and other people, but many hospitals do
not store the patientsÕ urine. Instead, they release it directly under their authorised
limits and appropriate dilution.
(88) Storing urine for decay has raised several problems. The first is determination
of when the decay is sufficient (Meck, 1996). Having a requirement for ÔcompleteÕ de-
cay is unreasonable due to the nature of radioactivity. Even if one decays for 10 half-
lives with iodine-131, this means storing the urine for months. Erlandsson and
Mattsson (1978) recommended direct sewer disposal of all urine from radiotherapy
patients without any storage.
(89) Another point is that unless there are elaborate plumbing systems in the hos-
pital, potentially reduced public exposure will be offset by increased occupational
exposure and expense. Finally, even if one hospitalises patients for 1–2 days after
treatment, significant activity will be retained in the patient that will be excreted over
the next few days and that will go into the sewage system from their homes.
(90) In the UK, a multidecade strategy (UK Department of the Environment,
2002) found that reduced discharge as a result of holding tanks at hospitals was
not practical for most hospitals because of cost, the potential for exposing hospital
staff, and because a significant proportion of discharges occur after patient release.

9.3. Sewage, sludge, and incineration

(91) At the present time, in urban areas, the predominant method of disposal of
excreta from radioiodine therapy patients is via a municipal sewage system with
an associated wastewater treatment plant. Contemporary sewage treatment facilities
usually have primary and secondary treatment processes. The primary treatment re-
moves grit and large floating solids, and then uses sedimentation. The secondary
treatment removes unsettled solids and dissolved organic matter by flocculation or
oxidation followed by sedimentation. In most cases, the effluent is then discharged
36
 ICRP Publication 94

to rivers or coastal waters. The separated solids are termed ÔsludgeÕ and can be incin-
erated, applied to land as a fertiliser, or landfilled.
(92) In rural areas, excreta may be disposed into a local septic system or latrine.
Although there are few data on this topic, disposal by a reasonably designed latrine
or septic system is unlikely to result in measurable exposure of the public due to the
percolation rates of water and the 8-day half-life of radioiodine.
(93) The amount of radioactive iodine in sewer water from a patientÕs home can be
calculated from the daily urinary excretion of the patient and the volume of water
released into the sewer from all uses in the house. For a single person in the UK,
the latter value is approximately 1 m3/week and for a family of four it is approxi-
mately 3 m3/week. Approximately 55% of administered activity is excreted in urine
on Day 1 post treatment, 17% on Day 2, 5% on Days 3 and 4, and 2% on Day 5.
These values should not be considered alone as there will be significant dilution from
other homes using the same sewage system.
(94) Activity from medical radionuclides (particularly radioiodine) in treated efflu-
ents from wastewater plants has been studied for several decades (Erlandsson and
Mattsson, 1978; Prichard et al., 1981; Sodd et al., 1975). The amount of radioactivity
released from sewage plants depends largely on the input, plant design, and method
of ultimate disposal. The daily discharge of radioiodine from sewage plants near
medical centres has been estimated to be in the range of 150–370 MBq. For many
wastewater treatment plants, the effluent is sufficiently dilute that no iodine gamma
spike can be detected without the use of concentration methods.
(95) Some assessments have assumed an annual occupancy rate of 200 h for work-
ers in sewer pipes; however, in modern wastewater operations, this is more likely to
be approximately 2 h/year. The estimated occupational dose to workers in a waste-
water treatment facility depends not only on the episodic activity entering the plant
but on the actual processing. Workers at sewage plants receive higher doses than
sewer maintenance workers. The most important radionuclide contributing to the
occupational dose of sewer workers is technetium-99m, whereas iodine-131 is the
greatest contaminant of river water.
(96) Although releases to sewage systems are diluted by many orders of mag-
nitude, processing at a wastewater treatment plant can result in sludge that con-
tains easily measurable activity. The exact timing of radioiodine transit through
the sewer pipes and ultimately into the sludge can be quite different due to system
design and construction; however, in one Swedish study, maximal activity ap-
peared in the sludge 2–3 weeks after radioiodine release (Erlandsson and Matts-
son, 1978).
(97) The behaviour of both sodium iodide-131 and meta (131I) iodobenzylguani-
dine (MIBG) in a municipal sewage plant have been characterised (Fenner and Mar-
tin, 1997; Martin and Fenner, 1997). This was prompted by the fact that if
land application of sludge is not feasible, the sludge may be incinerated; this re-con-
centrates the radionuclides and the ash can trigger radioactivity detectors at landfills.
Seventeen percent of administered MIBG activity appeared in the primary sludge,
compared with 1.1% of administered sodium iodide-131 activity. Due to the rela-
tively short physical half-life of iodine-131, there are few radiological concerns if
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 ICRP Publication 94

the sludge is applied to land (provided that the sludge is ploughed in or held before
application to forage). Following incineration of sludge, the maximally exposed
worker (after a 2-h scrubber malfunction) would receive approximately 1.7 lSv.
For a typically exposed worker and the public (living 500 m from the incinerator),
the committed effective dose equivalents were 1.2 and 0.06 lSv, respectively, for a
22-week incineration period.
(98) In 1998, at a meeting of the Oslo and Paris Commission, contracting par-
ties to the 1992 Convention for the Protection of the Marine Environment of the
North East Atlantic agreed to a strategy with regard to radioactive substances.
The ultimate aim was to achieve concentrations in the environment close to zero
for artificial radioactive substances. In the UK, a multidecade strategy was devel-
oped to comply with this goal by 2020 by working with the non-medical nuclear
industry (UK Department of the Environment, 2002). It was clear that the major-
ity of medical releases are due to short-lived technetium-99m and iodine-131, both
of which decay to very low levels before entering the environment and which are
therefore unlikely to have a measurable effect on the environment. The two radio-
nuclides that originated in hospitals which were more of an issue were tritium and
carbon-14. It was concluded that if medical facilities discharged at their author-
ised limits, a sewage treatment worker would receive approximately 0.24 mSv/
year, and members of the public who ate large numbers of fish caught down-
stream from sewage outfalls might receive as much as 0.18 mSv/year. These are
obviously upper-bound estimates based upon pessimistic assumptions. The UK
Environment Agency uses a contractor to review the disposal of liquid radioactive
waste to the public sewer system due to changes in sewage treatment and disposal
practices, such as the increasing incineration of sewage sludge. Results from two
sewage works indicated that the dose to the public was below the dose limit of 1
mSv for maximum discharge quantities. The contractor also concluded that the
need for universal introduction of discharge reduction measures was not justified
on the basis of current practice (Environment Agency, 2000).
(99) Crockett (2000) reported actual measurements of radioactivity at two mu-
nicipal sewage plants in the UK, and used a computer model devised by the UK
National Radiological Protection Board to assess behaviour of radionuclides in
waste water and potential doses to sewer workers and the public. Crockett found
that the majority of activity in sewage plants was from technetium-99m radio-
pharmaceuticals followed by iodine-131. Doses to general sewer workers and
sludge press workers would be in the range of 40–80 and 150–240 lSv/year,
respectively, if all hospitals, etc. were discharging at their allowable limits. How-
ever, typically, they discharged at approximately 30% of the allowable maximum
limits. Public doses from release of the treated effluent would be 30–180 lSv/year
for maximal allowable hospital releases, and 1–19 lSv/year for typical releases.
Public doses from atmospheric releases from incinerated sludge were much less
(<2 lSv/year). Crockett (2000) also pointed out that when the capacity of the
sewage treatment plant was exceeded during storms, leading to untreated dis-
charge into water, the doses to the public were not significantly affected due to
the higher level of dilution by the storm water.
38
 ICRP Publication 94

9.4. Landfills

(100) Recent changes in the US Nuclear Regulatory Commission (USNRC)

regulations have enabled most patients requiring high-dose iodine-131 for thyroid
cancer to be treated as outpatients. Before the change in regulations, most patient-
contaminated articles were collected and decayed by the hospital. Now, however,
these materials are often sent to landfills, following collection of waste from outpa-
tientsÕs homes. Many landfills now have radiation detectors to find orphan sources
and illicit materials, and these detectors are quite sensitive and capable of detecting
radioiodine. They are usually triggered to alarm upon detection of extremely low
activity levels. This can result in an expensive search for the cause of the alarm,
and in some cases, the waste has been tracked back to the patients who were billed
for the expense. In some parts of the USA, the licensees are held responsible and this
is why some hospitals do not release patients even though they can legally do so. It
has been suggested that there is a need for reform of regulations regarding disposal
of low-level rapidly decaying materials, and possibly the need for spectrometry
capability.
(101) In modern landfills with leachate treatment, it is very unlikely that short-
lived radionuclides used in medicine will reach groundwater before complete decay.
Siegel and Sparks (2002) highlighted the paradox that released nuclear medicine pa-
tients are considered to be safe but their waste at a landfill site is considered to rep-
resent a hazard. Marcus and Aldrich (1997) made several suggestions to minimise
these problems until these issues can be resolved, including: using materials that
can be washed rather than paper plates or napkins; avoiding food items that cannot
be eaten in their entirety (e.g., apples, barbecued ribs, etc.) in the first week after
treatment because of contamination with saliva; and storing any materials that can-
not be washed or disposed of in the sewer.
(102) Radiation detectors at landfills have also resulted in changes in operational
policy at many hospitals. Although patients who were hospitalised for treatment
with radioiodine were controlled, radioactive waste in the form of blood samples
(usually contaminated with thallium-201, gallium-67 and iodine-131) and other items
(such as incontinence pads) had been disposed of with medical waste. These were
detected and the waste was returned to the hospitals. In one hospital, approximately
20% of surveys detected radioactivity in the waste (Evdokimoff et al., 1994). As a re-
sult, many hospitals have installed radiation detectors in the areas of the hospital
through which waste bins and medical waste are transported. If radiation is detected,
the source is located and is either held for further decay or disposed of with radio-
active waste.

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ICRP Publication 94

40
 10. DECISION TO HOSPITALISE OR RELEASE PATIENTS

 The decision to hospitalise or release a patient should be determined on an individual

basis. It should not be linked solely to residual activity in the patient but should take
many factors into account, including the patientÕs pattern of contact with other peo-
ple, the patientÕs wishes, occupational and public exposures, family considerations,
cost, and environmental factors.
 ICRP recommendations do not explicitly state that patients should be hospitalised
after therapy with high activities of radiopharmaceuticals, but recommend that pub-
lic dose limits and dose constraints for others should be observed. This should be fol-
lowed by optimisation.
 Recent publications have indicated that assumptions used by some authorities to hos-
pitalise patients may overestimate potential doses to the public and caregivers.
 Hospitalisation of patients for several days will reduce exposure to the public and
relatives, but will increase occupational exposure.
 Isolation and hospitalisation often involve a significant psychological burden for
patients and families.
 Hospitalisation of patients after radioiodine therapy can result in significant mone-
tary and other costs that should be analysed and justified.
 Patients travelling after radioiodine therapy rarely present a hazard to other passen-
gers if travel times are limited to a few hours.
 Environmental or other radiation-detection devices are usually sufficiently sensitive
to detect patients who have had radioiodine therapy for a period of weeks. Personnel
operating such detectors should be specifically trained to identify and deal with
nuclear medicine patients.
 Suggested restrictions on patient behaviour vary widely in the published literature
due to differences in modelling and assumptions.
 Actual measurements from relatives or caregivers who followed radiation protection
precautions show that doses rarely approach or exceed the ICRP recommended dose
constraint of a few mSv/episode.
 Restrictions following the release of patients should focus on the sensitive subgroup
(i.e., infants and children).

10.1. General

(103) Current recommendations regarding the release of patients after therapy

with unsealed radionuclides vary widely around the world. The following have been
used as criteria:
(i) ICRP dose limits and dose constraints;
(ii) dose constraints different from ICRP recommendations;
(iii) residual activity in the patient (assumed from external exposure
measurements);
(iv) dose rate at a specific distance from the patient;
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 ICRP Publication 94

(v) hospitalisation because of radioiodine therapy for a specific disease (either

hyperthyroidism or thyroid cancer); and
(vi) hospitalisation because of children at home.
(104) For practical purposes, it is convenient to relate activity remaining in the pa-
tient at the time of discharge to exposure to the public and relatives (Table 10.1). If
this is done, it should be based on recent publications and realistic models that can
be traced to dose measurements of the public. The question is whether many patients
may have been unnecessarily hospitalised. This view has been expressed by authors
from Russia, the UK, and the USA (Barrington et al., 1996a; deKlerk, 2000; NCRP,
1995; Shishkanov et al., 2001; Siegel, 1999). Also, Saenger and Kereiakes (1980) re-
ported that activity-based hospitalisations may cause physicians to administer less
activity than they would have liked, in order to avoid hospital stays. The use of re-
tained activity as the sole criterion for compliance has problems as this may have lit-
tle to do with subsequent patient behaviour and the ultimate dose to relatives and the
public.
(105) Considerations related to hospitalisation or release of patients are shown in
Table 10.2.
(106) Patients may be hospitalised after therapy with unsealed radionuclides for
one of the following reasons.

Table 10.1 Activities (MBq) for release of patients depending on external dose to other people (mSv
effective dose)
Radionuclide Half-life MBq for 5 mSv MBq for 1 mSv
111
Ag 8 days 19,000 3800
198
Au 65 h 3500 690
51
Cr 28 days 4800 960
64
Cu 13 h 8400 1700
67
Cu 61 h 14,000 2900
67
Ga 78 h 8700 1700
123
I 13 h 6000 1200
125
I 60 days 250 50
131
I 8 days 1200 240
111
In 67 h 2400 470
32 a a
P 14 days
186
Re 90 h 28,000 5700
188
Re 17 h 29,000 5800
47
Sc 80 h 11,000 2300
75
Se 120 days 89 18
153
Sm 47 h 26,000 5200
117
Snm 14 days 1100 210
89 a a
Sr 51 days
99
Tcm 6h 28,000 5600
201
Tl 74 h 16,000 3100
90 a a
Y 64 h
169
Yb 31 days 370 73
Source: US Nuclear Regulatory Commission (1997b).
a
No value given because of minimal exposures to the public.

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 ICRP Publication 94

Table 10.2 General issues used in deciding whether to release or hospitalise patients following treatment
with unsealed radionuclides
Issue Hospitalisation Released
Control of patient environment High Less
Occupational dose potential Present Minimal
Dose potential to relatives Minimal Present
Dose potential to the public Minimal Present
Method of disposal of waste Sewage or storage Sewage
Public exposure from waste Present unless stored Same
Monetary cost Potentially high Minimal
Psychological Significant due to isolation Minimal
Patient expiration/death Exposure of funeral staff Same
Possible limitation of cremation

(i) Confinement and isolation of the patient will reduce the dose to the public and
relatives, but will increase occupational doses to medical staff. This is an issue
related to iodine-131 alone. Patients treated with pure beta emitters need not be
hospitalised.
(ii) In hospital, urine can be collected and stored to reduce radioactive discharges
into the sewage system. As mentioned earlier, some hospitals confine and iso-
late patients but do not collect and store their urine as this practice is consid-
ered to be impractical, expensive, increases staff doses, and unnecessary in light
of actual measurements of discharges and their potential effect. Some authors
have also suggested collection and storage of faeces, although this is generally
not done as this is a minor route of excretion.
(iii) Patients with a serious illness who received therapy with unsealed radionuclides
(e.g., phosphorus-32 in the peritoneal cavity of a patient with widespread
metastases).
(iv) A mentally incompetent and/or incontinent patient who is incapable of follow-
ing radiation safety instructions and precautions.
(v) A home situation where children would be in close contact due to physical and
social constraints. If urine is not going to be collected and stored at the hospi-
tal, an alternative that is not usually discussed is for the patient to stay at a non-
hospital living facility, such as a hotel, for several days. This is less expensive
than staying in a hospital. This is apparently possible in some countries but
not in others.
(107) Another potential hazard of hospitalisation that is rarely mentioned but
which is a significant issue is the placement of a relatively well patient into an envi-
ronment that may harbour antibiotic-resistant infections. A few authors have sug-
gested that an advantage of hospitalisation is that one can calculate the iodine-131
biokinetics and evaluate absorbed doses accurately. This alone does not seem to jus-
tify hospitalisation as biokinetic studies could be performed as an outpatient
procedure.
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 ICRP Publication 94

(108) In the case of children or adults who lack the capacity to consent, the phy-
sician must decide who is the most appropriate person to be given radiation protec-
tion instructions and recommendations.
(109) The ICRP cannot provide criteria for all different patients and family cir-
cumstances. It is expected that the treating physician will assess the above factors
and determine what is most appropriate for each patient situation while taking radi-
ation protection issues into account.

10.2. Occupational doses to hospital staff

(110) The major source of occupational exposure when a patient is confined to

hospital is external radiation (Castronovo et al., 1986; Ho and Shearer, 1992). Bar-
rington et al. (1996a) calculated the occupational dose to nursing staff during 7 days
of care following iodine-131 administration for thyroid cancer ablation or follow-up.
The results are shown in Table 10.3. Actual measurements suggest that the calcula-
tions by Barrington et al. (1996a) are very conservative. For example, Denman and
Martin (2001) reported actual values in the carers of a terminally ill patient who re-
ceived 800 MBq of radioiodine, and found that the nurses received a maximum effec-
tive dose of 250 lSv.
(111) Some patients must not be released after therapy with unsealed radionuclides
because they are medically unstable, e.g., patients with metastatic thyroid carcinoma
or hyperthyroid patients with a cardiac problem. While such patients are usually
hospitalised in an isolation room, there can be emergencies that require surgery
and procedures up to and including resuscitation. Griffiths et al. (2000) reported
the occupational radiation doses and contamination in one such case. The patient
had received 3011 MBq of sodium iodide-131 and surgery was required 6 days later.
The patient ultimately died, had a postmortem examination, and was cremated. The
surgeon received a dose of 20 lSv, the intensive care nurses received 40 lSv, and the
mortuary assistant received 14 lSv. It was estimated that if the surgical crisis had
happened immediately after administration of the iodine-131, the staff doses could
have been as high as 0.8 mSv. There was a significant amount of contamination
(approximately 6 MBq) in the intensive care unit, in containers of body fluids,
and on laundry.

Table 10.3 Calculated cumulative dose (mSv) to nursing staff from patients for 7 days after thyroid cancer
ablation treatmenta with iodine-131
Activity (MBq) Helpless Partially Bedridden Semi-ambulant Ambulatory
patient helpless patient patient patient
1850 6.2 2.4 1.0–1.1 0.2 0.08
3700 12.6 4.8 2.1 0.4 0.16
5550 19.0 7.1 3.1 0.6 0.25
7400 25.3 9.5 4.2 0.8 0.33
Source: Barrington et al. (1996a).
a
Values for cancer follow-up patients are within 10% of these values.

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(112) Patients isolated in hospitals will contaminate surfaces that they touch, par-
ticularly the area around the toilet. These areas often need to be decontaminated be-
fore the room can be used by other patients. Iodine-131 is found in saliva, and nurses
should exercise caution when dealing with vomit, and coughing or sneezing patients.
Patients treated with iodine-131 will exhale some of this into room air. In at least one
report, a thyroid cancer patient exhaled enough to exceed the maximum permissible
concentration during the first day post treatment (Ibis et al., 1992). Occasionally, pa-
tients who have been treated with radioiodine require procedures concerning their
blood (particularly haemodialysis). Following haemodialysis of a patient treated
with iodine-131, no significant radioactive contamination of the dialysis equipment
was reported. This has been confirmed in patients receiving other radioisotopes such
as technetium-99m. After haemodialysis of a patient who was treated with iodine-
131, there was slight contamination of disposable lines, waste bags, and filters that
may require storage for approximately 8 weeks to allow for decay prior to disposal.
The average effective half-life of iodine-131 in hyperthyroid patients on haemodial-
ysis appears to be approximately 7 days, which is longer than that in hyperthyroid
patients who are not on haemodialysis (Homer and Smith, 2002).

10.3. Psychological costs of hospitalisation

(113) Isolation in hospitals is widely recognised as a unique and depressing situa-

tion for patients, although this has rarely been taken into account with respect to pa-
tient release. Patients have indicated on multiple occasions that isolation in a
hospital room suggests to them that the treatment must be much more dangerous
than it actually is. The more stringent the protective measures, the more apprehen-
sive the patients become. Patients do not realise that the major reason for isolation is
to limit the cumulative occupational dose of medical staff from multiple patients and
the ALARA (as low as reasonably achievable given social and economic factors)
principle. Patients who are given a long list of recommended restrictions after radio-
nuclide therapy feel that there must be a great radiation hazard. Unless the underly-
ing reasons for isolation are explained, psychological issues are heightened (Moreno
Garcia, 2001). Psychological issues should be a significant factor in the decision
whether to hospitalise or release patients.
(114) When there are infants or small children in the family of a patient treated
with radioiodine, there are risks from both external exposure and contamination
with the patientÕs saliva. However, parental support of a child is very important,
and considerations regarding separation of a child and parent should take the psys-
chological cost of such separation into account.

10.4. Cost–benefit analysis of hospitalisation

(115) As part of any radiation protection issue, cost should be considered in terms
of both justification and optimisation of the practice or procedure. Very few authors
or organisations have attempted to determine the costs associated with various meth-
odologies related to release of patients after therapy with unsealed radionuclides.
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 ICRP Publication 94

Table 10.4 Estimate of the annual costs in the USA of different alternatives regarding patient release after
administration of unsealed radionuclides
Alternative Collective Hospital Hospitalisation Value Record Psychological
dose retention cost of lost time keeping cost (relative)
(person Sv) (days) ($ millions) ($ millions) ($ millions)
1 184 427,000 427 256 0 High
2 298 16,000 16 10 0 Moderate
3 325 0 0 0 2.3 Low
Alternative 1 is associated with the lowest collective dose, highest cost, and highest psychological cost. If
one compares this with Alternative 3, the reduction in collective dose is at a cost of approximately $2
million/person/Sv.
Source: US Nuclear Regulatory Commission (1997a).

Ideally, ÔcostsÕ should include psychological and adverse health consequences, as well
as monetary costs. Cost–benefit analysis for a specific issue may vary substantially
from country to country, but it does provide a tool that may help the optimisation
process.
(116) The US Nuclear Regulatory Commission examined three alternatives, as
follows.
(i) Alternative 1: to amend regulations to achieve an annual effective dose limit of 1
mSv for everyone other than the patient.
(ii) Alternative 2: to require confinement until the residual activity in the patient
was less than 1100 MBq or the dose rate at 1 m from the patient was 0.05
mSv/h or less.
(iii) Alternative 3: to specify an effective dose limit of 5 mSv for people exposed to
the patient.
(117) With the exception of a few diagnostic procedures performed using iodine-131,
diagnostic procedures were unaffected by the choice of alternative, and only some ther-
apeutic procedures were affected by choice of alternative. The results of the analysis are
shown in Table 10.4. Due to the short physical half-life of iodine-131 and since the
majority of exposure to others is due to external exposure, collective dose is a function
of the number of people near the patient in the week or so after administration of radi-
oiodine. For this analysis, there was an assessment of average administered activity to
the patient and an estimate of the dose to the maximally exposed person other than the
patient. Based upon occupancy rates, the collective dose per procedure was assumed to
be approximately three times the dose to the most exposed individual. For thyroid
ablation and thyroid cancer treatment, the collective dose per procedure was estimated
to be 4.7 person mSv and 15 person mSv, respectively. While monetary costs differ by
country, and costs are related to frequency of the procedures, Table 10.4 shows the im-
pact of alternative choices in the USA.

10.5. Doses to others during patient travel

(118) In a recent UK study of hyperthyroid patients with less than 800 MBq of
activity, the travel dose rate during their journey home averaged 49 lSv/h (range
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 ICRP Publication 94

4–252 lSv/h). Based on this and other measurements, some authors have indicated
that time restrictions for private transport are not required, and restrictions will only
be required occasionally for public transport (Barrington et al., 1996b; Gunesekera
et al., 1996). OÕDoherty et al. (1993) suggested guidelines for travel of hyperthyroid
patients treated with radioiodine. These are shown in Table 10.5.
(119) Based on actual measured dose rates, Barrington et al. (1996a) calculated
travel guidelines for thyroid cancer patients treated with iodine-131 for ablation or
follow-up to restrict the public dose to 1 mSv/year. The results are shown in Table
10.6 and suggested restrictions are compared in Table 10.7.

Table 10.5 Suggested travel times (h) for adult hyperthyroid patients in order to restrict the public dose to
5 and 1 mSv/yeara
Activity Private Private Public Public
(MBq) travel/day week 1 travel/day week 2 travel/day week 1 travel/day week 2
200 24 (24) 24 (24) 24 (3.5) 24 (24)
400 24 (24) 24 (24) 12 (1.5) 24 (14)
600 24 (24) 24 (24) 7 (1.0) 24 (9)
800 24 (24) 24 (24) 4 (0.5) 24 (7)
It has been assumed that private travel involves contact at 1 m with a person other than the partner, and
public travel involves contact at 0.1 m with a person other than the partner.
Source: OÕDoherty et al. (1993).
a
Values in parentheses are the times suggested in order to restrict the public dose to 1 mSv/year.

Table 10.6 Travel times (h) for thyroid cancer patients in order to restrict the public dose to 1 mSv/year
Activity Private Private Private
(MBq) travel up to 24 h post dose travel 24 h post dose travel 48 h post dose
1850 8 20.5 24
3700 4 10 18.5, 24a
5550 2.5 6.5 12.5, 17a
7400 2 5 9, 13a
Source: Barrington et al. (1996a).
a
First value is for ablation patients and second value is for follow-up patients.

Table 10.7 Comparison of suggested travel restrictions developed by different models to limit exposure to
those who come in contact with iodine-131 patients to 1 mSv/year
Activity (MBq) Private travel/day (h) Public travel/day (h)
200 24 (24) 8.0 (3.5)
400 24 (24) 4.0 (1.5)
600 24 (24) 2.5 (1.0)
800 24 (24) 2.0 (0.5)
Values in parentheses are from OÕDoherty et al. (1993).
Sources: Leslie et al. (2002) and OÕDoherty et al. (1993).

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 ICRP Publication 94

10.6. Radiation detectors at borders, airports, etc.

(120) One consideration when releasing patients with internal radionuclides who
have measurable gamma emissions is the unanticipated detection of such people at
their place of employment, borders, airports, and other areas where there are radia-
tion-detection systems (IAEA, 2002b). There are also considerations in releasing
such patients when they return to work in areas that have radiation-detection sys-
tems (such as nuclear power plants and research laboratories). For people returning
to their place of employment, there is not usually much difficulty as they are often
well known and have some level of security clearance.
(121) When patients are detected at airports, etc., the situation is more difficult as
these instruments are in place to restrict transport of illicit radioactive materials and
detect inadvertent transport of orphan sources. Although many medical radionuc-
lides are short lived, residual radioactivity may be detectable by current detection
systems for days or weeks. Most alarms at borders are not due to illicit materials
but are ÔinnocentÕ alarms due to medical radionuclides or naturally occurring radio-
active materials. In the case of an alarm involving a person, the person is usually sent
through the detector a second time. If the alarm recurs, the person is separated from
items they are carrying and an assessment is made. Obviously it is best if the detec-
tion devices measure the gamma ray spectrum and identify the radionuclide.
(122) Many physicians give their patients an information card of documentation
that a medical treatment has been performed, but this may not be acceptable to
poorly trained security personnel. The IAEA have noted the possibility of illicit
material being transported with legal radionuclides, and as a result, many patients
will be stopped and questioned (Buettner and Surks, 2003). It may be best to suggest
that patients do not do much travelling in major public areas (airports, border cross-
ings, subways, boats, and public buildings) unless they are willing to experience some
inconvenience. If such advice is provided, it should be made clear to the patient that
the detection instruments are extremely sensitive and will detect radiation at levels
well below those of concern to health. With current technology, it is possible to de-
tect iodine-131 activity of approximately 0.01 MBq at 2–3 m.

10.7. Exposure in the home environment

(123) Suggested restrictions for relatives and caregivers of patients who have re-
ceived radioiodine therapy vary widely. There are a number of reasons for this. If
instantaneous measured dose rates at a certain distance are used as a surrogate for
effective dose, the suggested restrictions will be too stringent by a factor of 2 or more.
Some authors have made measurements in a phantom from either a point or a linear
source, and this makes a difference. There are also assumptions in many models
about the clearance kinetics of radioiodine from the patient. Finally, there are differ-
ences in assumptions regarding mode of travel, time of sleeping together, distance
from relatives, etc. Many of these factors differ significantly among countries and be-
tween families in the same country. When using models and making assumptions of
habits, it is probably prudent to use values that are not the mean, but which are be-
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 ICRP Publication 94

tween the 67th and the 95th percentiles. Finally, actual measured values of doses to
relatives and caregivers are likely to be more valuable than models.
(124) Hilditch et al. (1991) measured mean thyroid activity as a percentage at dif-
ferent times after administration of sodium iodide-131 in hyperthyroid patients, and
suggested that these values could be used to determine the duration of restricted con-
tact between the public/children and the patient. In the revision of the US Nuclear
Regulatory Commission regulations (1997b), release of patients after therapy was
no longer based on retained activity but was based on estimated doses to the public
and caregivers. The assumption was that contamination from patients was not likely
to result in a significant dose to others. Johnson et al. (2002) measured the thyroid
activity in relatives of thyroid cancer patients treated with radioiodine. The largest
thyroid uptake resulted in an effective dose of 0.08 mSv. For a newborn, the maximal
value would have resulted in an effective dose of 1.4 mSv.
(125) The hazard presented in the home by patients after radioiodine therapy has
been studied over many decades. Early studies of hyperthyroid patients who were
released after less than 740 MBq of sodium iodide-131 indicated that very low activ-
ities of iodine were detected in relatives, and the external radiation dose was felt to be
more important but still well within the recommended dose limits at the time (Bu-
chan and Brindle, 1970, 1971). Another early study also concluded that the external
dose to relatives substantially exceeded that from cross-contamination in the major-
ity of cases; however, detectable thyroid radioactivity was found in a number of rel-
atives (Jacobson et al., 1978).
(126) The suggested restrictions for a patient at home vary widely in the published
literature. A few examples are presented here (see Appendix B). Leslie et al. (2002)
indicated that most models overestimate dose rates from radioiodine at short dis-
tances. They used adult and infant phantoms. Doses received by the adult phantom
were measured at contact, 1 m, and 2 m from the patient, and doses received by the
infant phantom were measured at contact in two orientations (patient cradling infant
over shoulder and at waist). The doses measured in the phantoms were significantly
lower than doses predicted by other models; if correct, they suggest that patient con-
tact restrictions could be made less stringent than those currently in widespread use.
Table 10.8 compares the results of OÕDoherty et al. (1993) with those of Leslie et al.
(2002), and reveals major differences, particularly in sleeping with a partner and ab-
sence from work. Actual measurements of doses to relatives are most realistic. The
suggested guidelines of OÕDoherty et al. (1993) are shown in Table 10.9.
Table 10.8 Comparison of suggested restrictions at work and home developed by different models to limit
exposure to those who come in contact with iodine-131 patients to 1 mSv/year
Activity (MBq) Absence Sleep apart Time to restrict
from work (days) from partner (days) close contact with infant (days)
200 0 (0) 0 (15) 10 (15)
400 0 (4) 0 (20) 15 (21)
600 0 (6) 0 (24) 18 (25)
800 0 (8) 0 (26) 20 (27)
Values in parentheses are those from OÕDoherty et al. (1993).
Sources: Leslie et al. (2002) and OÕDoherty et al. (1993).

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(127) A Belgian study of patients released after 2 days of hospitalisation following

therapy for thyroid cancer found that the median dose equivalent over 2 weeks was
0.17 mSv (range 0.02–0.49 mSv) for partners with separate sleeping arrangements for
8 days, and 0.24 mSv (range 0.05–0.53 mSv) for those who slept together. For hyper-
thyroid patients, the corresponding figures were 1.07 mSv (range 0.22–1.27 mSv) and
1.01 mSv (range 0.05–5.23 mSv). This suggests that sleeping together may increase
partner dose by 0–40% (Mathieu et al., 1997).

Table 10.9 Guidelines after iodine-131 hyperthyroid therapy to restrict dose to 5 and 1 mSv in coworkers
and relativesb
Activity (MBq) Absence Time to Time to restrict Time to restrict Time to restrict
from sleep contact with child contact with child contact with
work aparta <2 years of age (days) 2–5 years of child 5–11 years
(days) (days) age (days) of age (days)
200 0 (0) 1 (15) 2 (15) 0 (11) 0 (5)
400 0 (3) 7 (20) 8 (21) 3 (16) 0 (11)
600 0 (6) 11 (24) 11 (24) 6 (20) 1 (14)
800 0 (8) 13 (26) 14 (27) 9 (22) 3 (16)
Source: OÕDoherty et al. (1993).
a
Assumes sleeping 1 m apart for 8 h.
b
Values in parentheses are the guidelines suggested in order to restrict the dose to 1 mSv.

Table 10.10 Estimates of cumulative dose (mSv) to coworkers and relatives from thyroid cancer patients if
no restrictions are observed
Activity (MBq) Coworker Partner Child <2 years Child 2–5 years Child 5–11 years
a
1850 1, 2 18, 26 25, 33 13, 17 7, 9
3700 3, 5 35, 52 50, 66 26, 35 13, 18
5550 4, 7 53, 78 75, 99 38, 52 19, 26
7400 5, 9 71, 104 100, 132 51, 69 26, 35
Source: Barrington et al. (1996a).
a
First values are for cancer follow-up patients, and second values are for ablation patients.

Table 10.11 Suggested guidelines for thyroid cancer patients to restrict dose to 1 mSv in coworkers and
relatives
Activity (MBq) Absence Time to sleep Time to restrict Time to restrict Time to restrict
from apart and restrict contact with contact with child contact with
work contact with child <2 years 2–5 years of child 5–11 years
(days) partner (days) of age (days) age (days) of age (days)
1850 1, 3a 3, 16 4, 16 3, 13 2, 10
3700 2, 7 4, 20 4, 20 4, 17 3, 13
5550 2, 10 4, 22 5, 22 4, 19 3, 16
7400 2, 12 5, 23 5, 24 4, 21 4, 17
Source: Barrington et al. (1996a).
a
First values are for cancer follow-up patients, and second values are for ablation patients.

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(128) A multicentre Belgian study reported data for relatives of 52 patients treated
for hyperthyroidism with a median activity of 759 MBq and a mean activity of 370
MBq (range 185–1665 MBq) (Monsieurs et al., 1998) The mean doses to relatives of
ambulatory patients and hospitalised patients were 0.6 mSv (range 0–2.0 mSv) and
0.8 mSv (range 0.4–1.7 mSv), respectively. The hospitalised patients were discharged
when the dose rate at 1 m from the patient was less than 20 lSv/h. Sleeping arrange-
ments were also studied when patients slept separately for 21 days, and all doses to
partners were less than 1 mSv.

Table 10.12 Recommended restrictions on behaviour after iodine-131 hyperthyroid therapy

Restriction 30–400 MBq 400–600 MBq 600–800 MBq
All close contact with 9 12 14
children or pregnant women (days)
Extended periods of contact 21 25 27
with children or pregnant
women (days)
Do not sleep with an – 4 8
adult in the same
bed (days)
Avoid prolonged contact – – 1
with other people (days)
Source: British Institute of Radiology (1999).

Table 10.13 Dose constraints for different categories of caregiver

Type of caregiver Reason for dose Dose constraint (mSv)
constraint (risks, habits)
Third person A fraction of the dose limit for the public 0.3
Relatives and close friends
Pregnant women Protection of the 1
unborn child
Children up Close physical contact 1
to 2 years old with parents
Children aged Same risk as unborn child 1
3–10 years
Adults up to 2–3 times lower risk than 3
60 years old for younger children
Certain recommendations for partners
Not to be applied when comforting
very ill, hospitalised patients
Adults over 60 3–10 times lower risk than for 15
years old average population.
Source: European Commission (1998).

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 ICRP Publication 94

(129) A study of hyperthyroid patients in five UK centres with a median activity of

388 MBq (range 200–608 MBq) reported that the external doses were less than 5.3
mSv in all adults in the family (Barrington et al., 1999). The authors also studied
the effect of sleeping arrangements. Two types of advice were given (A and B). With
Advice A, the period of separate sleeping was 1 day for 200 MBq, 5 days for 400
MBq, 9 days for 600 MBq, and 12 days for 800 MBq. Advice B was 15 days of sep-
arate sleeping for 200 MBq, 20 days for 400 MBq, 24 days for 600 MBq, and 26 days
for 800 MBq. The adult dose for those who followed Advice B was 32% of that for
those who followed Advice A (see Table 10.9).
(130) Barrington et al. (1996a) published estimates of potential doses that might be
received by coworkers and relatives if thyroid cancer patients disregarded the restric-
tions. These are shown in Table 10.10.
(131) In addition, Barrington et al. (1996a) published guidelines to restrict dose to
coworkers and relatives to 1 mSv. These are shown in Table 10.11.
(132) More recent recommendations from the British Institute of Radiology (1999)
indicate a somewhat shorter period of restriction, as shown in Table 10.12.
(133) In the case of a child who lacks the capacity to consent, radiation protection
advice should be given to the person with parental responsibility for the child. In
some countries, parents may consent on behalf of their child, but otherwise, dose
limits apply. Publication 60 (ICRP, 1991) indicated that a higher effective dose value
could be allowed in a single year, in special circumstances, provided that the average
over 5 years does not exceed 1 mSv/year. Prior ICRP recommendations did not men-
tion the issue of parental consent for radiation exposure of a child. Breastfeeding
should be ceased immediately following radioiodine therapy.
(134) A UK study of actual measured external doses in relatives of released hyper-
thyroid patients indicated that 89% of all children received <1 mSv. It is of interest,
however, that 35% of children aged 3 years or younger received more than 1 mSv,
indicating the need for special precautions in young children (Barrington et al.,
1999). Data from a Belgian study showed that if children stayed away from home
for 8 days after thyroid cancer patients were released from hospital, the dose to
the children was 0.08 mSv (range 0–0.35 mSv); from hyperthyroid patients, the dose
was 0.13 mSv (range 0.04–3.12 mSv) (Mathieu et al., 1999). Mathieu et al. (1999)
indicated that if a dose of 1 mSv to other adults is not to be exceeded, close contact
with a patient should not occur until thyroid activity is below 300 MBq. They also do
not recommend close contact with young children until thyroid activity is below 100
MBq, and 50 MBq for contact with infants and pregnant women. Some authors have
recommended that a short stay in hospital may be preferable for patients living with
children (Reiners and Lassmann, 1999). This would avoid the scenario of a small
child crawling into a sleeping motherÕs bed.
(135) The European Commission (1998) suggested dose constraints for different
categories of caregiver. These are more detailed than those recommended by the
ICRP and are shown in Table 10.13.

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LaRoche, G., LeBlond, C.P., 1954. Destruction of the thyroid gland of Atlantic salmon by means of
radioiodine. Proc. Soc. Exp. Biol. Med. 87, 273–276.
LaRoche, G., Johnson, C.L., Woodall, A.N., 1965. Thyroid function in the rainbow trout: biological and
histological evidence of radiothyroidectomy. Gen. Comp. Endocrinol. 5, 145–159.
Leslie, W.D., Havelock, J., Palser, R., Abrams, D.N., 2002. Large-body radiation doses following
radioiodine therapy. Nucl. Med. Communic. 23, 1091–1097.
Leung, P.M., Nikolic, M., 1998. Disposal of therapeutic iodine-131 waste using a multiple holding tank
system. Health Phys. 75, 315–321.
Martin, J.E., Fenner, F.D., 1997. Radioactivity in municipal sewerage and sludge. Public Health Rep.,
308–316.
Marcus, C.S., Aldrich, R., 1997. Avoiding solid waste contamination problems from iodine-131 patients.
J. Nucl. Med. 38, 26N.
Mathieu, I., Caussin, J., Smeesters, P., Wamberseie, A., Beckers, C., 1997. Doses in family members after
131
I treatment. Lancet 350, 1074–1075.
Mathieu, I., Caussin, J., Smeesters, P., et al., 1999. Recommended restrictions after iodine-131 therapy:
measured doses in family members. Health Phys. 76, 129–136.
Meck, R.A., 1996. Complete decay of radionuclides: implications for low-level waste disposal in municipal
landfills. Health Phys. 70, 706–7111.
Monsieurs, M., Thierens, H., Dierckx, R.A., et al., 1998. Real-life radiation burden to relatives of patients
treated with iodine-131: a study in 8 centers in Flanders (Belgium). Eur. J. Nucl. Med 25, 1368–1376.
Moreno Garcia, L., 2001. Expectations of PatientsÕ Advocates, Radiological Protection of Patients in
Diagnostic and Interventional Radiology, Nuclear Medicine and Radiotherapy. Proceedings of an
International Conference, Malaga, 26–30 March 2001. International Atomic Energy Agency, Vienna.
Norris, D.O., Gorbman, A., 1965. Radiothyroidectomy of larval steelhead trout. Proc. Soc. Exp. Biol.
Med. 119, 1205–1207.

54
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Nuclear Energy Agency, 1995. The Environmental and Ethical Basis of Geological Disposal of Long-lived
Radioactive Wastes. A Collective Opinion of the Radioactive Waste Management Committee of the
OECD Nuclear Energy Agency. NEA, Paris.
OÕDoherty, M.J., Kettle, A.G., Eustance, C.N.P., et al., 1993. Radiation dose rates from adult patients
receiving 131I therapy for hyperthyroidism. Nucl. Med. Communic. 14, 160–168.
Olivereau, M., LaRoche, G., 1965. Effects of low iodine intake or destructive doses of iodine-131 on
pituitary histochemistry of young Chinook salmon. Am. Zoologist 5, 234.
Olivereau, M., 1957. Radiothyroidectomie chez lÕAnguille. Arch. Anat. Microscop. Morphol. Exptl. 46,
39–59.
Pentreath, R.J., 2002. Radiation protection of people and the environment: developing a common
approach. J. Radiolog. Protect. 22, 45–46.
Prichard, H.M., Gesell, T.F., Davis, E., 1981. Iodine-131 levels in sludge and treated municipal
wastewaters near a large medical complex. Am. J. Public Health 71, 47–52.
Rallison, M.L., Dobyns, B.M., Keating, F.R., et al., 1974. Thyroid disease in children: a survey of
subjects potentially exposed to fallout radiation. Am. J. Med. 56, 457–463.
Reiners, C., Lassmann, M., 1999. Radioiodine (131I) treatment of hyperthyroidism: radiation protection
and quality assurance. Eur. J. Nucl. Med. 26, 683–685.
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pooled analysis of seven studies. Radiat. Res. 141, 259–277.
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Shishkanov, N.G., Bakun, Y.M., Roziev, R.A., et al., 2001. Radiation protection of members of the
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Siegel, J.A., 1999. Outpatient Radionuclide Therapy. Proceedings of the Thirty-Fifth Annual Meeting of
the National Council on Radiation Protection and Measurements, Proceedings No. 21, 7–8 April 1999,
Arlington VA. NCRP, Bethesda.
Siegel, J.A., Sparks, R.B., 2002. Radioactivity appearing at landfills in household trash of nuclear
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Sodd, V.J., Velten, R.J., Saenger, E.L., 1975. Concentrations of the medically useful radionuclides,
technetium-99m and iodine-131 at a large metropolitan waste water treatment plant. Health Phys. 28,
355–359.
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US Nuclear Regulatory Commission, 1997b. Release of Patients Administered Radioactive Materials.
Regulatory Guide 8.39. USNRC, Washington.

55
 11. INTERNATIONAL AND NATIONAL GUIDANCE ON
RELEASE CRITERIA

 The cornerstone of release criteria are dose limits for the public and dose constraints
for relatives and caregivers. In spite of this, there is wide variation in criteria used to
decide whether to release or hospitalise patients. At present, the two general forms of
release criteria are those based on individual situations and projected doses to other
people, and those based on retained activity (usually following conservative
assumptions).
 Since lifestyle habits differ between and even within countries, a single model for
release criteria would not be appropriate optimisation. It is recommended that
release of patients should be based on their family situation (rather than retained
activity and the worst-case scenario). It is also recommended that when there are
many contiguous countries, a uniform or similar approach to releasing patients
should be developed.

(136) The ICRP has not provided recommendations on the criteria to follow
regarding the release of patients after therapy with unsealed radionuclides. Instead,
the recommendations have been directed at dose limits for occupationally exposed
workers in hospitals, dose limits for the public, and dose constraints for caregivers.
Thus, the ICRP has not set any retained activity level to require hospitalisation. A
patient may be discharged regardless of the magnitude of retained activity provided
that the dose limit and dose constraint issues are met.
(137) The following text reviews the various release criteria that have been used in
different countries and regions. Several different approaches have been tried. The
most common approaches are release criteria based on activity or dose rate with cal-
culations and estimates of the doses that relatives, caregivers, and the public can ex-
pect to receive. Variations in the models and assumptions used have led to widely
differing release criteria for patients. As a result, some patients who live in countries
with very conservative release criteria will travel to another country for therapy (so-
called Ônuclear tourismÕ).
(138) A number of recent publications have reported actual measurements of
external dose rates as well as contamination potential. In light of these findings, it
has been suggested that the release criteria used in some countries are overly restric-
tive and are focused on radiation protection without appropriate justification and
optimisation. Beierwaltes and Widman (1992) indicated that while external dose
rates and contamination from patients treated with radioiodine are measurable,
the actual risks of detrimental effects have not been demonstrated as they are low.
(139) The International Basic Safety Standards (BSS) for radiation protection
(IAEA, 1996) include the maximum activity for patients to be discharged from a hos-
pital. The BSS indicates that Ô. . .a patient shall not be discharged from hospital be-
fore the activity of radioactive substances in the body falls below the level specified in
Schedule III, Table III–VIÕ. The guidance level only refers to iodine-131 and is 1100
MBq, although there is a footnote that a level of 400 MBq is used in some countries
as a measure of good practice.
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 ICRP Publication 94

(140) The IAEA indicated that, following radionuclide therapy, patients may not
be discharged until the remaining activity subsides to an acceptable level, and that
the regulatory authority should set the level according to international standards
(specifically BSS, Schedule III, Table III–VI), taking local conditions and the poten-
tial exposure of other members of the patientsÕs households into account. Addition-
ally, activity in the patient should be estimated or measured prior to discharge, and
the result should be recorded. The patients should be given written and verbal
instructions of necessary precautions for protection of relatives and others with
whom they may come in contact. Special precautions may be needed for the elderly
or children (IAEA, 2002a).
(141) The European countries have adopted or are in the process of adopting the
European BSS (European Union, 1996) and medical exposures standards (European
Union, 1997). The EURATOM (1997) guidelines on radiation protection following
iodine-131 therapy are quite restrictive, and can lead to 2–3 week restrictions for
those with young families after 400 MBq of activity. Within the European Union,
member states apply a derived residual activity constraint ranging from 95 MBq
to 800 MBq, but it is set between 400 and 600 MBq in most member states.
(142) Currently, the European Thyroid Association favours treatment with iodine-
131 on an outpatient basis for patients receiving up to 800 MBq of activity, provided
that they abide by certain restrictions (European Thyroid Association, 1996). The
EURATOM BSS 96/29 that limits the effective dose to 1 mSv/year does not apply
for Ôexposures of individuals, who are knowing and willingly helping other than as
part of their occupation, in the support and comfort of in-patients or outpatients
undergoing medical diagnosis and treatmentÕ (European Union, 1996).
(143) The European Commission (1998) stated that ÔAs a general rule, treatment
of thyroid cancer patients using radioactive iodine will only be performed in con-
junction with hospitalisation of the patient.Õ
(144) The following dose constraints were proposed in a number of European pub-
lications: children and fetuses, 1 mSv; adults up to 60 years of age, 3 mSv; adults over
60 years of age, 15 mSv; and third persons/general public, 0.3 mSv (European Com-
mission, 1998). These are identical to the regulations in Sweden. Hospitalisation is
not required in Sweden if activities in the patient are less than 600 MBq of iodine-
131, 1200 MBq of phosphorus-32, and 1200 MBq of yttrium-90 (Swedish Radiation
Protection Institute, 2000).
(145) In Germany, essentially all patients who receive radioiodine therapy must be
hospitalised for at least 48 h. The limit for discharge is 1 mSv to the public, corre-
sponding to 3.5 lSv/h measured at 2 m. Taking an effective 7-day half-life of io-
dine-131 into account, the limit of activity at patient discharge amounts to 250
MBq. The activity could be higher for patients with different biokinetics provided
that 1 mSv is not exceeded or for patients with a difficult psychological situation.
(146) In Japan, patients who have received iodine-131 may be released from hos-
pital if the activity in the body is less than 500 MBq or less than 30 lSv/h at 1 m from
the surface of the body. Patients who have received strontium-89 may be released if
the activity remaining in the body is less than 200 MBq. Current patient release cri-
teria in Russia are based upon not exceeding a dose of 1 mSv to the public.
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 ICRP Publication 94

(147) Several groups in Australia and New Zealand are studying radiation protec-
tion and safety issues related to patients treated with therapeutic amounts of un-
sealed radionuclides. These include the South Australian Hospital and University
Radiation Safety Officers Group, as well as the Australian and New Zealand Society
of Nuclear Medicine. The current draft discharge recommendations are essentially
based on a limit of 1 mSv/year to the public, children, and pregnant women, and
5 mSv/year to consenting friends and relatives who care for the patient. The ALARA
principle is used in addition to the dose limits. There is a provision that a patient
should not be discharged from a controlled to an uncontrolled area if the external
exposure rate exceeds 25 lGy/h at a distance of 3 m (ARPANSA, 2002). In addition,
there are suggestions related to release depending on the projected excretion of activ-
ity compared with the annual limit of intake for the particular radiopharmaceutical.
(148) In the UK, an advisory committee has recently provided guidance based on
national and international recommendations. This was essentially a guide to good
clinical practice but it did not include any guidance on release of patients (Adminis-
tration of Radioactive Substances Advisory Committee, 2000). This can be found in
the Medical and Dental Guidance Notes of the Institute of Physics and Engineering
in Medicine (NRPB, 2000). Patients may be discharged from hospital based on
potential doses to various groups. The recommended dose constraint and dose limit
per procedure for comforters and carers are 5 mSv and none, respectively. For other
members of the household, the values are 1 and 5 mSv in 5 years, and for members of
the general public, the values are 0.3 and 5 mSv in 5 years, respectively.
(149) In the USA, a dose-based approach to releasing patients was suggested over
30 years ago. In 1970, the National Council on Radiation Protection and Measure-
ments stated that since the exposure rates and half-lives of various radionuclides dif-
fer greatly, a more meaningful basis for release from hospital is the possible exposure
to other individuals with whom the patients are likely to associate (NCRP, 1970).
(150) In 1997, the USNRC amended its regulations for the release of patients
following treatment with radioactive materials from an activity-based limit to a
dose-based limit (USNRC, 1997b). The new regulations were based on the maxi-
mally exposed individual not being likely to exceed an effective dose equivalent of
5 mSv (Table 11.1). Compliance with the dose limit is demonstrated using a default
table for activity or dose rate, or performing a patient-specific dose calculation.
There is no specific guidance with regard to exposure of pregnant females, but it does
indicate that written instructions have to be provided if a nursing child is likely to
exceed an effective dose of 1 mSv.
(151) Specific instructions are required about maintaining distance from other
people, minimising time in public places, precautions to reduce the spread of radio-
active contamination, and the length of time that the precautions should be in effect.
Instructions are generally required at 0.2 of the release values shown in Table 11.1.
(152) The activities and dose rates in Table 11.1 are conservative as they are based
on physical half-life rather than effective half-life of each radionuclide. This overes-
timates the dose to the public as well as relatives and caregivers. With patient-specific
dose calculations, the dose estimate is more realistic and appropriate, and patients
can be discharged with higher activities. In fact, in the USA, competent and
55
 ICRP Publication 94

Table 11.1. Activities and dose rates below which patient release is authorised by the US Nuclear
Regulatory Commission

Radionuclide Activity (GBq) Dose rate at 1 m (mSv/h)

Au-198 3.5 0.21

Ga-67 8.7 0.18
I-123 6.0 0.26
I-131 1.2 0.07
In-111 2.4 0.2
a a
P-32
Re-186 28 0.15
Re-188 29 0.20
Sm-153 5.2 0.06
a
Sr-89
Tc-99m 28 0.58
Tl-201 16 0.19
a
Y-90
Yb-169 0.37 0.02
a
No value given because of minimal exposures to the public.

co-operative patients are now routinely discharged with activities as high as 8000
MBq of iodine-131.
(153) Coover et al. (2000) recently proposed a simplified method to conform to the
USNRC regulations. By using a mathematical model, dosing charts were developed
that took occupancy factors into account (Table 11.2). The results indicate that most
outpatients undergoing radioiodine therapy for thyroid cancer may be treated with
7400 MBq or more. The methodology requires the physician to determine the occu-
pancy factors (OFs) for three different periods. These are: a pre-equilibrium period
of 8 h after dosing (OFp); a constrained period of 2 days (OFc); and an uncon-
strained period (OFuc). The OF is determined by the percentage of time that the rel-
ative or caregiver is at a distance of 1 m from the patient. During the constrained
period, the patient would sleep in a separate bedroom. An example of use of this
method is shown below.
(154) A 29-year-old woman who lives with her 6-year-old daughter presents for
ablation of a thyroid remnant. Her daughter is at school for 8 h/day. The mother will

Table 11.2. Maximum administered activity (MBq)a based upon occupancy factors for three different
periods that will result in a dose of 5 mSv to relatives and caregivers from a patient being treated with
radioiodine for thyroid cancer

OFc = 0.125 OFc = 0.125 OFc = 0.25 OFc = 0.25

OFp OFuc = 0.25 OFuc = 0.50 OFuc = 0.25 OFuc = 0.50

0.0 20,600 12,700 15,000 10,300
0.25 13,200 9800 11,100 8300
0.75 8400 6700 7300 6000

Assumes 0.05 fractional uptake and 2-day period of constrained activity.

Source: Coover et al. (2000).
a
Values have been rounded.

56
 ICRP Publication 94

receive radioiodine on Monday morning, and she will travel home and be alone for
8 h. With counselling, the OFs for both the constrained period and the uncon-
strained period will be 0.25. Using the values in Table 11.2, the maximum activity
that should be administered is 15,022 MBq. Since she has a child and the dose limit
is 1 mSv, the value in Table 11.2 needs to be divided by 5 or 3000 MBq. Similar
methodology can be applied to treatment of patients with hyperthyroidism.
(155) A regulatory analysis published soon after the appearance of the new regu-
lations concluded that hospital stays were shorter or had been eliminated. This re-
duced costs significantly, and may have provided emotional benefits for the
patients and relatives, and reduced occupational exposure of hospital staff. At least
one author has suggested that the US approach should be adopted in other countries
because Ôit is of benefit for the patient while the risk to others is extremely low, not-
demonstrable at dose levels of 5 mSvÕ (Lubin, 2002).

57
 12. ANTIBODY THERAPY

 Antibody therapy with radioiodine is becoming more common. Radiation protection

issues are similar to those for other forms of radioiodine therapy.
(156) To date, the literature has predominantly dealt with sodium iodide-131 for
hyperthyroidism or thyroid cancer therapy. In recent years, there has been rapid
spread of immunotherapy for non-HodgkinÕs lymphomas. The radiotherapy works
by specific binding of the immunoglobulin G, kappa monoclonal antibody ibritum-
omab to the C20 antigen found on the surface of malignant and normal B lympho-
cytes. The antibodies can be labelled with iodine-131 or, more commonly, with
yttrium-90.
(157) In cases where iodine-131 labelling is used, the thyroid is usually blocked
with saturated potassium iodine. Any iodine-131 that dissociates is excreted rapidly
in the urine. Urinary excretion is approximately 7% during the first week. From the
start of therapy for a period of 1 week, it is recommended that a condom should be
used during intercourse, and deep kissing should be avoided, as should other forms
of transfer of body fluids. Patients are advised to wash their hands thoroughly after
using the toilet. When the antibody is labelled with yttrium-90, radiation protection
issues are minor as yttrium-90 is a pure beta emitter with a beta path length of 5 mm
(100–200 cell diameters).
(158) Recent research on dose rates in antibody therapy patients has indicated that
for mean administered activities of 3100 MBq, the mean measured dose rate at 1 m
immediately after administration is approximately 0.11 mSv/h. This is approximately
60% of the calculated dose rate using a point-source model. The mean calculated
dose to a maximally exposed person nearby (0.25 occupancy rate at 1 m) is approx-
imately 3 mSv (Siegel et al., 2002b). Actual measurement of the doses to relatives of
patients who had received anti B1 immunotherapy with activities ranging from 0.94
to 4.77 GBq yielded values ranging from 0.17 to 4.09 mSv (Rutar et al., 2001). It is of
interest to note that the measured doses were approximately one-third of the doses
calculated using US Nuclear Regulatory Commission methodology.

59
 13. OTHER ISSUES

 Records of the specifics of therapy with unsealed radionuclides should be main-

tained at the hospital and given to the patient along with written precautionary
instructions.
 In the case of death of a patient who had received radiotherapy with unsealed radi-
onuclides in the last few months, it is advisable to contact a radiation protection spe-
cialist or the hospital that treated the patient to determine what precautions are
necessary in accordance with national regulations.
 Many types of therapy with unsealed radionuclides are contraindicated in pregnant
females.
 Women should not become pregnant for a variable period of time after radioiso-
tope therapy. The time depends on the type of therapy, and is a function of clear-
ing the radionuclide from the body and ensuring that the underlying disease is
controlled.

13.1. Records

(159) On release from hospital after therapy with unsealed radionuclides, all pa-
tients should be given written details (such as a wallet-sized card) of the radionuclide,
the physical or chemical form, the administered activity, and the name and telephone
number of the treating physician. In addition, patients should be given written radi-
ation safety precautions and information about when these precautions can be ter-
minated. An example of such a card is shown in Appendix C.

13.2. Death, postmortem examinations, burial, and cremation

(160) While it is common practice to issue written information indicating that a

patient has received radionuclide therapy, one cannot always assume that the patient
will have it with them in case of an emergency or death.
(161) Actual measurements from a postmortem examination of a patient who had
received 800 MBq of radioiodine were reported by Denman and Martin (2001). The
patient, who was terminally ill, died 3 days after administration of the radioiodine,
and the postmortem examination was delayed for 2 weeks. The pathologist was esti-
mated to have received a maximum whole body dose of 400 lSv. Contamination
measurements were: pathologistÕs hands, 5 Bq/cm2; towels, 1.8 Bq/cm2; saw, 5 Bq/
cm2; instruments, 0.5 Bq/cm2; plastic sheet, 0.8 Bq/cm2; scales, 0.4 Bq/cm2; and floors
and walls, 1.1 Bq/cm2.
(162) There are at least two reports of postmortem examinations of patients who
had received radioiodine therapy for thyroid cancer. One patient had received 1850
MBq of radioiodine for metastatic thyroid cancer (Parthasarathy et al., 1982). The
patient died 7 days later having excreted very little radioiodine in the urine. The radi-
ation dose level after death ranged from 0.1 to 0.5 mGy/h at 10 cm from the body
surface. Several pathologists performed the postmortem examination in order to
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 ICRP Publication 94

keep individual doses low. The most-exposed pathologist received a whole body dose
of 220 lSv and a hand dose of 5.5 mSv.
(163) The second report concerned the postmortem examination of a patient who
had received 7.4 GBq of iodine-131. The patient died 10 days after treatment, with
1.85 GBq remaining in the cadaver (Johnston et al., 1979). Most excretion curves for
such patients would have predicted less remaining activity. Poor hydration or renal
function may have precluded normal excretion rates. The measured dose rate at the
surface of the chest was approximately 0.6 mSv/h. With appropriate radiation pro-
tection precautions and a maximum time limit of 90 min, the pathologist had a meas-
ured dose of approximately 0.2 mGy in his pocket ionisation chamber and about
three times this on his hands.
(164) There is little guidance regarding the safe handling of corpses. In Aus-
tralia, the Code of Practice (National Health and Medical Research Council,
1987) includes the following information: ÔRadioactive material administered by
oral, intravenous, or intracavitary routes may become distributed throughout the
body or may be selectively held in specific organs. The degree of possible hazard
presented by the patient reduces with the lapse of time from the time of adminis-
tration of the radioactive material. This reduction arises partly from the normal
decay of the radioactivity of the material used and partly from the excretion of
the material from the body. A patient who had received very small amounts of
radioactive materials used for diagnostic or tracer tests presents no hazard to any-
one called upon to attend the corpse and is not considered further.Õ With regard to
autopsies, the Code states that Ôif a corpse contains less than any of the following
activities:
150 MBq radon-222, colloidal yttrium-90, or gold-198;
300 MBq phosphorus-32;
450 MBq iodine-131, sealed yttrium-90, or gold-198;
the procedures normally observed during autopsy are adequate for the examination
unless such examinations are carried out frequently in the same institution. If activ-
ities are greater than that quoted above or if autopsies of the above activities are car-
ried out frequently in the same institution, the pathologist is advised to consult with
the radiation safety officerÕ. In addition, the Australian Code of Practice (National
Health and Medical Research Council, 1987) indicates that if the radioactive mate-
rial used for treatment has been selectively absorbed in a particular organ (e.g., io-
dine-131 in the thyroid), the organ should be excised before the examination
proceeds and removed from the work area. It may later be disposed of with the body.
If the radioactive material is distributed within certain body fluids, the fluids should
be drained off, using suitable equipment, before the examination proceeds and the
fluids may be disposed of safely via the sewage system with regard to legislation
requirements.
(165) For burial of the corpse, the Australian Code of Practice (National Health
and Medical Research Council, 1987) states that: ÔNo special precautions are nor-
mally required in direct burial, without embalming. No special precautions are re-
quired for embalming if activities do not exceed those levels mentioned above. If
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 ICRP Publication 94

the activities are greater then the corpses should not normally be embalmed but if
embalming is required, a radiation safety officer should be consulted.Õ
(166) For cremation, the Australian Code of Practice (National Health and Med-
ical Research Council, 1987) states that no special precautions are required if the
corpse does not contain more than 1000 MBq of yttrium-90, iodine-131, gold-198,
iodine-125, or radon-222, or 400 MBq of phosphorus-32. Corpses containing in ex-
cess of these levels should be stored until these limits are reached.
(167) The UK regulations for cremation and/or burial after iodine-131 therapy
state that activity should not be more than 400 MBq (NRPB, 1988). More recent
guidance has confirmed the 400 MBq value but states that if the activity is greater
than 400 MBq, it may still be possible to bury or cremate the body but advice should
be sought from the radiation protection advisor (NRPB, 2000).
(168) Swedish regulations are very similar to those in Australia. The Swedish reg-
ulations indicate that the highest activities at which a postmortem examination can
be performed without radiation protection measurements are 600 MBq of iodine-
131, 400 MBq of phosphorus-32, and 200 MBq of yttrium-90. For cremation
without radiation protection measures, the values must not exceed 1200 MBq of
iodine-131, 400 MBq of phosphorus-32, and 1200 MBq of yttrium-90 (Swedish
Radiation Protection Institute, 2000).
(169) In some countries, such as Japan, cremation is much more common than
burial. As a result, there is greater concern about the potential release of radionuc-
lides to the environment. UNSCEAR (2000) reported that there were 0.0073 io-
dine-131 thyroid cancer treatments per 1000 population and 0.023 iodine-131
hyperthyroidism treatments per 1000 population between 1991 and 1996. Assuming
that the population at that time was approximately 110 million, approximately 2300
hyperthyroid and 730 cancer patients would be treated annually. It seems unlikely
that more than 1% of these patients (approximately 30 patients) would die within
a few weeks of treatment, so the amount of radioiodine potentially released to the
public would be very small.
(170) Cremation of corpses containing bone-seeking radionuclides used for palli-
ation of osseous metastases is more of a problem since the radionuclides have a rel-
atively long half-life (Aerts, 2000). Typically, this therapy is not used if life
expectancy is less than 3 months; however, if the patient dies before this time, it
can take up to 1 year for the activity of strontium-89 to decay to 1 MBq. Storage
of the corpse is impractical given the physical half-life of 50.5 days. A study of sev-
eral cremations in Australia indicated that most, if not all, of the activity remains
with the bone dust. Depending on the familyÕs intention for the ashes, storage
may be needed in order to comply with local regulations. In the USA, there is no
problem with cremation if bodies contain less than 74 MBq for all radionuclides, ex-
cept iodine-131 which has a limit of 7400 MBq/year for a particular crematorium
(Silberstein et al., 2003).
(171) There was an interesting anecdotal discussion recently concerning the de-
mand of an undertaker. It was pointed out that a coffin lined with 2.6 mm of lead
would weigh over 1000 kg and this would be impractical from a number of respects
(Osborn et al., 2002). There is at least one report in which a patient who had received
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 ICRP Publication 94

radioiodine therapy for thyroid cancer died and was placed in a casket lined with 1.6
mm of sheet steel. The dose rate measured at the chest surface of the cadaver was 0.6
mSv/h, and after placement in the casket, the dose rate was 0.5 mSv/h at the surface
of the casket, indicating little shielding effect.

13.3. Breastfeeding

(172) Many laboratories ask all females to indicate if they are breastfeeding, as
many radiopharmaceuticals can be transferred to a baby via breast milk. Cessation
of breastfeeding, for a short period at least, is recommended for most nuclear med-
icine studies. Breastfeeding should be ceased completely after a therapeutic dose of
radioiodine. If this is not done, the infant may become permanently hypothyroid
or be at high risk for subsequent thyroid cancer. Doses to infants as a result of
breastfeeding are shown in Table 13.1.
(173) It may be beneficial for women to cease breastfeeding 2–3 weeks before
receiving radioiodine therapy. The advantages are that the breasts will stop produc-
ing milk, dose to the breast tissue will be reduced, there is no danger of non-compli-
ance, and contaminated brassieres and breast binders will not be an issue.

13.4. Pregnant females

(174) In 2000, the ICRP published a document on issues related to pregnancy and
occupational radiation, and indicated that Ôdose limits for the fetus are broadly com-
parable with those for the general publicÕ (ICRP, 2000). It was also stated that after
pregnancy was declared, the dose to the conceptus should not exceed approximately
1 mGy for the rest of the pregnancy.
(175) As certain radiopharmaceuticals, including iodine-131 and phosphorus-32,
can cross the placenta rapidly, the possibility of pregnancy should be very carefully
considered before such radionuclides are given for therapy or for a whole body io-
dine-131 scan for thyroid carcinoma. As a rule, a pregnant woman should not be

Table 13.1. Dose (Sv/Bq) to an infant as a result of breastfeeding from a mother after a single ingestion of
iodine-131

Time of ingestion Effective dose

26 weeks before pregnancy 0

5 weeks of pregnancy 0
15 weeks of pregnancy 3.4E 16
35 weeks of pregnancy 1.3E 10
Birth + 1 day 5.4E 08
Birth + 10 days 5.4E 08
Birth + 20 days 5.4E 08

Source: Draft report of ICRP Committee 2 Task Group on doses to the infant from ingested radionuclides
in mothersÕ milk.

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 ICRP Publication 94

treated with a radioactive substance unless the radionuclide therapy is required to

save her life. In that extremely rare event, the potential absorbed dose and risk to
the fetus should be estimated and conveyed to the patient and the referring physi-
cian. Considerations may include terminating the pregnancy.
(176) In women, thyroid carcinoma comprises over 80% of cancers of the head
and neck between the ages of 15 and 45 years. Thyroid cancers are relatively
non-aggressive compared with most other cancers. As a result, both surgery and
radioiodine treatment are often delayed until after pregnancy. In general, if any
therapy is necessary during pregnancy, it will be performed during the second or
third trimesters.
(177) Radioiodine can cross the placenta easily and the fetal thyroid begins to
accumulate iodine at approximately 10 weeksÕ gestational age. Radioiodine therapy
is essentially contraindicated in patients who are known to be pregnant. If radioio-
dine treatment of thyroid carcinoma is necessary, it should be delayed until after
delivery. If this is done, the physician should be aware that radioiodine is excreted
in breast milk, and breastfeeding should be ceased completely after a therapeutic
dose.
(178) A major problem occurs when a female, who is not thought to be pregnant,
is treated for thyroid carcinoma and is found out to be pregnant after administration
of the radioiodine. Menstrual history is often not adequate to ensure that a patient is
not pregnant. In most developed countries, it is common practice to obtain a preg-
nancy test prior to high-dose iodine-131 scanning or therapy for women of child-
bearing age unless there is a clear history of prior tubal ligation or hysterectomy.
Despite the above, pregnant women do still receive treatment, either because of false
histories or because the pregnancy is at such an early stage that the pregnancy test is
not yet positive.
(179) Most commonly, the pregnancy is early and the major problem is fetal whole
body dose due to gamma emissions from radioiodine in the maternal bladder. Dur-
ing pregnancy, the whole body dose to the conceptus is in the range of 50–100 lGy/
MBq of administered activity. Dose to the embryo and fetus from maternal ingestion
of radioiodine-131 is shown in Table 13.2.
(180) The dose can be reduced by oral hydration of the patient and by encouraging
frequent voiding. This is a common recommendation for all patients, whether preg-
nant or not.
(181) If the conceptus is more than 8 weeksÕ gestational age (and the fetal thyroid
can accumulate iodine) and the pregnancy is discovered within 12 h of iodine admin-
istration, a maternal dose of 60–130 mg stable potassium iodide will partially block
the fetal thyroid and reduce the thyroid dose. More than 12 h after radioiodine
administration, this intervention is not very effective.
(182) Maternal hyperthyroidism can occur during pregnancy. The diagnosis can
be made on the basis of serum hormone determinations rather than radioiodine up-
take studies or thyroid scintigraphy. Treatment can often be delayed until after preg-
nancy, and the patient can be treated with drugs in the interim. Again, the major
problem is discovering that a patient is pregnant after they have received a therapeu-
tic dose of radioiodine.
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 ICRP Publication 94

Table 13.2. Dose coefficients (Sv/Bq) for the offspring from acute maternal ingestion of iodine-131 during
and after pregnancy

Time (weeks)a Most Highest Effective Effective Total effective

exposed organ organ dose in-utero dose postnatal dose dose to offspring

130 – <1E 15 <1E 15 <1E 15 <1E 15

26 – <1E 15 <1E 15 <1E 15 <1E 15
At conception All 7.8E 11 7.8E 11 <1E 15 7.8E 11
5 Thyroid 2.4E 11 8.1E 11 <1E 15 8.1E 11
10 Thyroid 3.2E 09 2.1E 10 <1E 15 2.1E 10
15 Thyroid 2.4E 07 1.2E 08 4.3E 15 1.2E 08
25 Thyroid 6.8E 07 3.4E 08 3.3E 12 3.4E 08
35 Thyroid 1.1E 06 5.5E 08 5.3E 09 6.0E 08

Source: International Commission on Radiological Protection (2002).

a
Intake at the indicated time (weeks); negative times are prior to pregnancy.

Table 13.3. Periods for avoiding pregnancy after radioisotope therapy to ensure that the dose to the fetus
will not exceed 1 mGy

Nuclide and form For treatment of: All activities up to: Avoid pregnancy
(MBq) (months)
98
Au colloid Malignant disease 10,000 2
131
I Na iodide Hyperthyroidism 800 4
131
I Na iodide Thyroid cancer 6000 4
131
I-MIBG Phaeochromocytoma 7500 3
32
P phosphate Polycythaemia vera etc. 200 3
89
Sr chloride Bone metastases 150 24
90
Y colloid Arthritic joints 400 0
90
Y colloid Malignancy 4000 1
169
Er colloid Arthritic joints 400 0

Source: Administration of Radioactive Substances Advisory Committee (2000).

(183) Patients treated with radioiodine can be an external radiation source to preg-
nant relatives. Perhaps more importantly, these patients must be careful not to trans-
fer radioiodine contamination to pregnant relatives by direct contact or through
indirect means.

13.5. Subsequent pregnancy after radionuclide therapy

(184) Occasionally, the question arises about the advisability of becoming preg-
nant after a nuclear medicine examination or treatment. Most female patients are ad-
vised not to become pregnant for at least 6 months after therapy with radioiodine.
This is not primarily based upon potential heritable radiation effects or radiation
protection considerations per se, but is based upon the need to be sure that:
(1) the hyperthyroidism or cancer is controlled; and (2) another treatment with
radioiodine will not be needed when the patient is pregnant.
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 ICRP Publication 94

(185) Phosphorus-32, strontium-89, and MIBG are occasionally used for therapy.
In order to keep the dose to the fetus below 1 mGy, pregnancy should be avoided for
3, 24, and 3 months, respectively. The ICRP has recommended that a woman should
not become pregnant until the potential fetal dose from remaining radionuclide does
not exceed 1 mGy. This is not usually a consideration except for radioiodine therapy
or radiopharmaceuticals labelled with iron-59 (for metabolism studies) or selenium-
75 (for adrenal imaging). As a result of the long physical half-lives of these radionuc-
lides and their long residence times in the body, it is recommended that pregnancy
should be avoided for 6 and 12 months, respectively. Advice in the UK is presented
in Table 13.3 (Administration of Radioactive Substances Advisory Committee,
2000).

67
 APPENDIX A. SAMPLE PATIENT INFORMATION SHEET FOR
HYPERTHYROIDISM

Radioiodine treatment for hyperthyroidism

Your questions answered
Why do I need treatment?
You have a condition called hyperthyroidism. This means that your thyroid gland
is overactive. If it is not properly treated, your health may be affected in the future.
What is radioiodine treatment?
Radioiodine treatment uses a form of iodine that is radioactive. Iodine is taken up
by the thyroid gland, so only a small amount of radioactivity is needed. Your doctor
considers that this is the best form of treatment for you.
Where does the radioactivity go?
Most of the iodine is taken up by the thyroid. The rest of the iodine mainly passes
out of your body in urine.
How is the iodine given?
Radioiodine is colourless and tasteless. You will be asked to swallow a liquid or a
capsule containing the radioiodine.
Will I have any side-effects?
Minor side-effects (such as a sore throat) may be associated with treatment.
What about my medication?
Your hospital doctor may have given you instructions about the medication you
are taking.
Is radioiodine treatment safe?
Radioiodine has been used for over 40 years to treat hyperthyroidism. Patients
treated this way have been studied carefully. This form of treatment is considered
to be safe and effective.
Are there any extra risks in having children afterwards?
There has been no effect on the health of children of patients who have had radioio-
dine. However, we do ask you to avoid pregnancy and breastfeeding for several months
after radioiodine treatment, just in case you need another radioiodine treatment.
Is there a risk to others?
No, not if you follow the radiation precautions given to you by your physician.
You will be given some simple precautions to follow when you attend for your treat-
ment. These are merely to avoid any unnecessary radiation to others. Others may
need to be made aware of the risk of exposure.

Will I need to see a doctor after the radioiodine treatment?

You should be seen by your doctor after the treatment and have blood tests taken.
These are to check how your thyroid gland has responded. It takes 2–3 months for
radioiodine to take effect.
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 ICRP Publication 94

How many radioiodine treatments will I need?

Occasionally, a second or even a third treatment is necessary. The blood tests after
your first treatment will show whether further treatment is needed.
Are there any long-term effects?
Radioiodine is a very safe treatment. However, your thyroid gland will probably
be underactive after your treatment. This could happen within a few months or may
take many years. That is why the blood tests to check the function of your thyroid
are important and should be performed regularly for the rest of your life. If your thy-
roid becomes underactive, you will be started on thyroxine treatment. This has no
side-effects and only needs to be taken once a day.
We want you to understand what the treatment involves. If you have any other
questions, please ask when you come to the hospital for treatment when you will
have the opportunity to discuss your concerns with us.

70
APPENDIX B. SAMPLE INSTRUCTIONS FOR RADIATION PROTECTION
AFTER THERAPEUTIC ADMINISTRATION OF RADIOIODINE

To be followed for approximately 1 week

Source: European Commission (1998).
Immediately
Do not eat for 1 h after oral administration of radioiodine. If you vomit within 4
h, try to do so in a waste bin and inform the nuclear medicine department
immediately.
Travel
Avoid public transport if possible. If necessary, travel by public transport should
be restricted to about 2 h. Do not take a long trip (6 h or more) with relatives or
caregivers. Try to sit at least 1 m from others.
At home
Avoid prolonged physical contact. Stay as far away as possible from
everyone at home, more than 1 m at all times and more than 2 m for extended
periods of time. Do not remain within 1 m of any individual for more than 6 h/
day.
Sleep in a separate bed and in a separate bedroom if possible.
Drink plenty of liquids.
Do not share food or drinks with others. Some recommend using disposable
dishes and utensils but this is not necessary and may cause difficulties at landfills.
It is acceptable to simply wash the dishes well and re-use them.
Avoid kissing or sexual intercourse.
Shower daily if possible but especially for the first 2 days. Rinse the shower or bath
well after use.
Wash your clothing and bedclothes separately from other laundry.
If possible, have sole use of a bathroom. Patients (including men) should sit down
while urinating. Toilet paper should be used to dry the genitals and should then be
flushed down the toilet. Hands should be washed (within the toilet room if possible).
Use a separate towel, face cloth, and toothbrush from the rest of the family.
Babies, children, and pregnant women
If you have a baby, it is best for someone else to care for it. If this is not possible,
do not have the baby too close to you (i.e., sleeping, sitting on your lap for more than
a very short time).
Visits by children and pregnant women should be discouraged. If necessary, try to
minimise contact and maximise distance from children and pregnant women.
It is very important to avoid kissing your infant or child for a period of a few
weeks as this can transfer radioiodine and result in an unnecessary risk to your child.

Breastfeeding
If you have been breastfeeding your baby, you must stop before radioiodine
therapy.
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 ICRP Publication 94

Elderly partners
For people aged 60 years or more, the risk of radiation detriment is small; there-
fore, only those measures that are easy to take should be encouraged.
Social events
Visits to the cinema and other social events where the patient is in close contact
with other individuals for several hours should be avoided.
Returning to work
Patients should not return to work for at least 2 days after treatment. You may
return after that if you do not have close contact with other people. If you do have
close contact with other people, 1 week may be sufficient, but if you work preparing
food for others or work with children or pregnant women, it may be necessary to
take several weeks off work. Ask your physician how long you will need to be absent
from work.
Emergencies
If you are involved in a traffic accident or another medical emergency, the medical
caregivers should be informed of the date, type, and amount of radionuclide therapy
you received.
Pregnancy
If you think that you are pregnant and did not know it at the time you received
radioiodine, inform your physician immediately. Discuss with your physician how
long you should wait before becoming pregnant after radioiodine treatment for
hyperthyroidism or thyroid cancer treatment. Typically, pregnancy should be
avoided for 4–6 months.

72
 APPENDIX C. SAMPLE CARD FOR PATIENTS GIVEN
RADIONUCLIDE THERAPY

Radionuclide
Instruction Card

Radionuclide: Iodine-131 Name:

Activity Address:
MBq

Administered on ...../...…./.......

Hospital No.:

Hospital:

Consultant:

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 ICRP Publication 94

1) Refrain from all close contact with

children or pregnant women until: This card should be carried at all
....................................................................... times until latest date shown on page
2) Refrain from extended periods of close 2
contact with children or pregnant women
until:
In case of difficulty, please contact
.......................................................................
3) Avoid prolonged personal contact at home
until:
.......................................................................
4) Avoid prolonged close contact with other
people away from home until.........................
5) You may return to work on
.......................................................................
Telephone
6) Do not sleep with an adult in the same bed
Or the consultant mentioned on page 1
until................................................................
Please contact the hospital if vomiting or
Signed: incontinence of urine occurs within 24 h of
(Doctor) treatment.

74
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