Misadministration of Radioactive Material in Medicine-Scientific Background

55 Pages·1991·2.158 MB·English

by  A. Bertrand Brill

NCRP COMMENTARY No. 7
MISADMINISTRATION OF
RADIOACTIVE MATERIAL
-
IN MEDICINE
SCIENTIFIC BACKGROUND
Issued October 1, 1991
National Council on Radiation Protection and Measurements
7910 WOODMONT AVENUE / BETHESDA, MARYLAND 20814
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Library of Congress Cataloging-in-Publication Data
Misadministration of radioactive material in medicine:
scientific background.
p. cm. -- (NCRP commentary : no. 7)
."
"Issued October 1, 1991
Includes bibliographical reference.
ISBN 0-929600-22-3: $15.00 (est.)
1. Radioisotopes--Toxicology. 2. Nuclear medicine. I. National
Council on Radiation Protection and Measurements. 11. Series.
[DNLM: 1. Nuclear Medicine. 2.'Radiation Effects.
3. Radiobiology. 4. Radiotherapy Dosage. WN 610 M6781
RM858.M57 1991
616.9'897--dc2O
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for Library of Congress 91-35005
CIP
Copyright O National Council on Radiation
Protection and Measurements 1991
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Preface
Recently, the Society of Nuclear Medicine (SNM) and the American
College of Nuclear Physicians (ACNP) requested that the NCRP
prepare a commentary on the radiobiological significance of nuclear
medicine misadministrations. An examination of this problem was
undertaken in October 1990 by an Ad Hoc Committee of the NCRP (J.S .
Robertson, Chairman, H.L. Atkins, A.B. Brill and J.G. Kereiakes,
members). This Committee recommended that the NCRP undertake a
study of the scientific background of reporting requirements for
misadministrations which were being proposed by the Nuclear
Regulatory Commission. At about the same time, the Nuclear
Regulatory Commission requested the NCRP to study the scientific
bases for reporting misadministration of radioactive by-product
material in medicine. As a result of these combined requests, the
NCRP Board of Directors established a second ad hoc committee (Ad
Hoc Committee on the Misadministration of Radioactive Material) to
draft this commentary.
Serving on this Committee during the preparation of the
commentary were:
Warren K. Sinclair, Chairman
National Council on Radiation Protection and Measurements
Bethesda, Maryland
Members
A. Bertrand Brill James G. Kereiakes
University of Massachusetts University of Cincinnati
Medical Center Cincinnati, Ohio
Worcester, Massachusetts
Clarence C. Lushbaugh James S. Robertson
Clinton, Tennessee U.S. Department of Energy
Washington, District of Columbia
iv / PREFACE
Advisory Member
Fun Fong, Jr.
Oak Ridge Associated Universities
Oak Ridge, Tennessee
Consultants
Harold L. Atkins R.J. Michael Fry
State University of New York Oak Ridge National Laboratory
Stoney Brook, New York Oak Ridge, Tennessee
Fred A. Mettler, Jr. Arthur C. Upton
University of New Mexico New York University
Albuquerque, New Mexico Medical Center
Tuxedo, New York
NCRP Secretariat - William M. Beckner
This commentary was also reviewed by the following members and
honorary members of the Council in addition to the Board of
Directors, J.I. Fabrikant, H.R. Maxon, L.N. Rothenberg, E.L.
Saenger and E.W. Webster.
The Council wishes to express its appreciation to the
committee members, advisor and consultants, and reviewers for the
time and effort devoted to the preparation of this commentary.
October 1, 1991 Charles B. Meinhold
Bethesda, Maryland President
Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . iii
The Administration of Radioactive Materials
in Nuclear Medicine . . . . . . . . . . . . . . . . . . 2
. . . . . . . . . . . . . . . . . .
2.1 Introduction 2
2.2 Number and Variety of Nuclear Medicine Procedures 2
2.3 Distribution with Age . . . . . . . . . . 4
. . . . . . . . . . . . . . . . .
2.4 Thyroidstudies 5
.
2.5 Effective Dose (E)a nd Collective Effective Dose 6
. . . . .
2.6 Absorbed Doses to Organs and Whole Body 7
3 . Misadministrations in Nuclear Medicine . 10
3.1 Introduction . . . . . . . . . . . . . . . . . . 10
3.2 Definition of Misadministration . . . . . . . . 10
3.3 Frequency of Misadministrations . . . . . . . . 11
3.4 Dose Implications . . . . . . . . . . . . . . . 13
.
3.5 Total Number of Misadministrations 13
3.6 Therapeutic Misadministrations . . . . . . . . . 13
3.7 Diagnostic Misadministrations . . . . . . . . . 14
4 . Radiobiological Effects Deterministic . 16
.
4.1 Introduction . . . . . . . . . . . . . 16
4.2 CellularEffects . . . . . . . . . . . . . . . 16
4.3 TissueEffects . . . . . . . . . . . . . . . . . 17
4.4 Specific Organ Effects . . . . . . . 1 8
. . . . . . . . . .
4.4.1 Hematopoietic System 18
. . . . . . . . .
4.4.2 Gastrointestinal System 19
4.4.3 Respira-tory System . . . . . . . . 20
. . . . . . . .
4.4.4 Central Nervous System 21
4.4.5 Testis . . . . . . . . . . . . . . . . . . 21
4.4.6 Ovary . . . . . . . . . . . . . . . . . . . 22
. . . . . . . . . . . . . .
4.4.7 Urinary Bladder 22
4.4.8 Thyroid . . . . . . . . . . . . . . . . . . 23
4.4.9 Skin . . . . . . . . . . . . . . . . . 24
4.5 Thresholds and Other Levels for Deterministic
Effects . . . . . . . . . . . . . . . . . . . . 25
vi / CONTENTS
. . . . .
5 Radiobiological Effects . Stochastic 29
. . . . . . . . . . . . . . . .
5.1 Introduction 29
. .
5.2 Risk of Induced Cancer (Whole Body) 29
5.3 Risk of Induced Cancer in Individual Organs.
. . . . . . . . . . . . .
TotalDetriment 30
. . . . . . . . . . . . .
5.4 EffectiveDose (E) 31
5.5 Application of Stochastic Detriments
. . . . . . . . . . . .
inNuclearMedicine 33
6 . Consideration of Radiobiological Effects . 36
. . . . . . . . . . . . . . . .
6.1 Introduction 36
. . . . . . . . . . . .
6.2 Deterministic Effects 36
. . . . . . . . . . . . .
6.3 StochasticEffects 37
7 . Summary . . . . . . . . . . . . . . . . . 39
. . . . . . . . . . . . . . . . . .
Appendix A 40
. . . . . . . . . . . . . . . . . .
References 45
The NCRP . . . . . . . . . . . . . . . . . . . . . . . . 48
1. Introduction
Misadministration of radioactive material is of concern t o the
health professions and t o the Nuclear Regulatory Commission (NRC)
alike. One concern arises from the professional desire t o maintain
the highest possible standards i n the protection of patients while
the other arises from the statutory obligation of the NRC with
respect t o the use of radioactive by-product material.
While the main focus of t h i s report w i l l be diagnostic nuclear
medicine and the misadministrations that might occur i n medical
practice, it is also desired that it be applicable t o situations i n
therapy (radionuclide, external beam and brachytherapy) , as w e l l .
For t h i s reason, the sections on biological effects include
discussions of deterministic effects i e ef fects which have a
threshold dose and whose severity increases with dose above the
threshold), including severe effects which only rarely apply t o
diagnostic circumstances, but could be relevant i n therapy.
Similarly, the section on stochastic effects (i.e ., effects which
are assumed t o have no threshold and with the probability, not the
severity, dependent on the dose) w i l l deal with these effects i n a
general way and over a broad range of expected risks, even though
the risks t o be anticipated from the diagnostic use of radioactive
material are small compared with the benefits the exposed patients
are expected t o receive from the medical procedures used.
In t h i s report, the present situation with respect t o the use
of radionuclides i n nuclear medicine, the number and variety of the
procedures used, the administered activity, and the radiation doses
resulting from them is reviewed. Then, for orientation purposes,
what is presently known about the frequency and nature of
misadministrations i n nuclear medicine is summarized, before going
on t o consider the possible deterministic and stochastic effects
that may occur as a result of the medical use of radioactive
material including by-product material. The deterministic and
stochastic effects that might arise are dependent on the dose
delivered and not on the mode by which it is delivered although in
some circumstances dose rate may also be relevant. Therefore, the
discussion of these effects applies t o nuclear medicine,
teletherapy and brachytherapy.
2. The Administration of ~adioactive Materials in
Nuclear Medicine
2.1 Introduction
A wide range of different radionuclides, often in different
chemical forms, are used in the practice of diagnostic and
therapeutic nuclear medicine. These materials and the resulting
radiation doses to individual organs of the body per unit
administered activity are listed in various compilations including
NCRP Report 70, Nuclear Medicine Factors Influencing the Choice
-
and Use of Radionuclides in Diagnosis and Therapy (NCRP, 1982),
ICRP Publication 53, Radiation Dose to Patients from
Radiopharmaceuticals ( ICRP, 1987) and a variety of individual
publications such as Freeman (1984). Furthermore, NCRP Report No.
100 (NCRP, 1989) surveyed the exposure of the U.S. population from
diagnostic medical radiation including nuclear medicine. NCRP
(1989) dealt with the frequency of given examinations and their
growth in recent years, the distribution of examinations among
patients as a function of age, the effective dose1 (E)f or the most
common techniques, and the total collective effective dose to those
exposed, and to the U.S. population as a result. It should be
noted that NCRP (1989) does not consider data beyond 1982 and there
have been changes in the numbers and variety of nuclear medicine
examinations since then. Additional data have been added in this
commentary where possible.
2.2 Number and Variety of Nuclear Medicine Procedures
The number of nuclear medicine procedures carried out in the
United States doubled from 1972 to 1980. During this interval,
bone scans and cardiac studies experienced the most rapid rate of
growth. The frequency distribution by type of procedure through
1982 is given in Table 4.1 of NCRP Report No. 100 (NCRP, 1989).
More recent data are given for the time period of 1984 to 1989 in
Table 2.1 of this document. A further detailed breakdown,
including the radiopharmaceutical involved, is given in Appendix A.
Effective dose (E)a nd collective effective dose are used in
this commentary in place of effective dose equivalent and
collective effective dose equivalent (ICRP, 1991).
Table 2.1 - Estimated number o f diagnostic radionuclide i n vivo examinations i n
the United Statesa
Number of procedures (in thousands)"
Summary 1984 1985 1986 1987 1988 1989
Brain scans 295
Lung perfusion scans 670
Lung ventilation scans 434
Thyroid uptakes 160
Thyroid scans 399
Bone scans 1,698
Liver and/or spleen scans 930
Biliary tree studies 209
Kidney scans 223
Soft tissue tumor localization 82
Cisternography 11
Blood pool left ventricle/
wall motion 5 63
Infarction 96
Ischemia/perfusion 369
AV shunt 5
Venography 37
Abscess localization 81
Total 6,263
" Data from Market Measures Incorporated, West Grange, New Jersey. See also SNM
(1988). More detailed information is provided in Appendix A.
4 / 2. RADIOACTIVE MATERIALS IN NUCLEAR MEDICINE
The number of cardiovascular studies, and to a lesser extent bone
studies, continues to grow at a rapid rate but, other procedures
seem to have leveled off and still others, such as brain and liver
studies, appear to have declined in the period of 1984 to 1989. In
addition. there has been a reduction in radiation dose per
procedure and a correspo~ n~ ding reduction in total dose.
2.3 Distribution with Age
The distribution of diagnostic studies in nuclear medicine is
heavily weighted toward patients in the older age groups. Overall,
2.8 percent of the U.S. population in 1980 received nuclear
medicine examinations. Of the examinations performed, 76.8 percent
were performed in persons age 45 and over, 39 percent in persons
age 65 and over, and 1.7 percent were conducted in persons under
age 15. Female patients were more frequently examined than males,
in all age groups, except under age 15, see Table 2.2.
Table 2.2 - Age and sex of those in the U.S. population having
nuclear medicine examinations in 1980 (percent of those examined)"
Total 44.9 (2.6) 55.3 (3.0) 100.0 (2.8)
" From FDA (1985) and NCRP (1989).
b Numbers in parentheses refer to rate of examinations per 100
persons in the U.S. population.