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Society of Nuclear Medicine Procedure Guideline for

the Use of Radiopharmaceuticals
version 3.0, approved June 23, 2001

Authors: Ronald J. Callahan, PhD (Massachusetts General Hospital, Boston, MA); Henry M. Chilton, PharmD (Bowman
Gray School of Medicine, Winston-Salem, NC); David A. Goodwin, MD (VA Medical Center, Palo Alto, CA); Donald J.
Hnatowich, PhD (University of Massachusetts Medical Center, Worcester, MA); James A. Ponto, MS (University of Iowa
Hospitals and Clinics, Iowa City, IA); Dennis P. Swanson, RPh, MS (University of Pittsburgh, Pittsburgh, PA); and Henry
D. Royal, MD) (Mallinckrodt Institute of Radiology, St. Louis, MO).

I. Purpose dure by affecting the distribution and pharma-
cokinetics of the administered agents through
This guideline was developed by the Society of
an alteration in organ physiology.
Nuclear Medicine to describe important factors
common to most nuclear medicine procedures. It
is intended to guide nuclear medicine practition- III. Common Indications
ers in establishing policies and procedures for the
Any procedure which uses a radiopharmaceutical
use of radiopharmaceuticals in clinical practice.
(see specific procedure guideline).
This guideline is intended to be concordant with
the regulations of the Nuclear Regulatory Com-
mission (NRC) and other state and federal gov- IV. Procedures
ernment agencies.
A. Clinical Use of Radiopharmaceuticals
1. A physician-derived order (e.g., prescription,
II. Background Information and Definitions requisition) is required for the conduct of all
procedures. The order should specify the pro-
A. Radiopharmaceuticals (also known as radioac-
tive drugs) are drugs that contain radionu- cedure desired, the drug(s) to be used, the
clides that emit radiation(s). The distribution of amount(s) to be administered, the route of ad-
the radiopharmaceutical within the body is de- ministration, and, if applicable, the rate of in-
termined by the physiochemical properties of fusion. Alternately, the order may specify a
the drug, the stability of the radiolabel, the pu- standard procedure with the other required
rity of the radiopharmaceutical preparation, information, i.e., standing orders, specified in
the pathophysiological state of the patient and a routinely updated and physician-approved
the presence or absence of interfering drugs. procedure manual located within the nuclear
Dynamic and static images of the distribution medicine laboratory.
of the radiopharmaceutical within the body can 2. The prescribing physician is ultimately re-
be obtained using a gamma camera, or other sponsible for the safety, quality, and correct-
suitable instrument appropriate for the radio- ness of all radiopharmaceuticals prepared
pharmaceutical being imaged, e.g., positron and dispensed for administration under his
emitting radiopharmaceuticals. Measurement (her) direction.
of radioactivity in specified sites of accumula- 3. The nuclear pharmacist is ultimately respon-
tion or in biological samples following admin- sible for the safety, quality and correctness of
istration of the radiopharmaceutical can be per- radiopharmaceuticals prepared and dis-
formed for non-imaging procedures. High pensed under his (her) supervision.
dose, nonpenetrating radiation in localized 4. The preparation, quality control, dispensing
sites of accumulation of the radiopharmaceuti- and patient administration of radiopharma-
cal can be useful for therapeutic procedures. ceuticals and adjunctive drugs may be dele-
B. Physiologic and pharmacologic interventions gated to qualified personnel, in accordance
are procedures, which increase the sensitivity with applicable state and local laws.
and/or specificity of a nuclear medicine proce- 5. There must be a signed and dated written di-
82 • USE OF RADIOPHARMACEUTICALS

rective for each patient for I-125 or 1-131 nuclear pharmacist; in such instances, the
sodium iodide in quantities ≥ l.1 MBq (30 µCi) physician or pharmacist responsible for
and for all therapeutic radiopharmaceuticals, preparing the radiopharmaceutical is respon-
such as strontium-89. sible for assuring that it meets applicable USP
6. The identity of the radiopharmaceutical, pa- specifications.
tient and route of administration shall be ver- 3. Aseptic procedures must be followed when-
ified prior to administration. Female patients ever handling parenteral or ophthalmic ra-
who are post-menarche and pre-menopause diopharmaceutical preparations or their
should be asked about pregnancy, lactation components.
and breast-feeding prior to administration. 4. A comprehensive radiopharmaceutical qual-
Pregnancy testing in females of childbearing ity control program should be developed and
capability should be performed prior to ad- implemented. The scope of the program
ministration of any radiopharmaceutical that should be compatible with the type of practice
could potentially result in a dose to an em- and the availability of equipment and person-
bryo or fetus of 50 mSv (5 rems) or more (e.g., nel. The parameters to monitor in a radio-
I-131 therapy). pharmaceutical quality control program in-
7. The quantity of each radiopharmaceutical clude: (a) chemical purity; (b) radiochemical
dosage must be determined prior to patient purity; (c) radionuclide purity; (d) biological
administration and must be consistent with purity (sterility and apyrogenicity); and (e)
that ordered by the physician or addressed in pharmaceutical purity (e.g., pH, particle size,
the procedure manual of the nuclear medicine absence of foreign particulate matter).
laboratory. The quantity of radioactivity dis- C. Positron Emitting Radiopharmaceuticals
pensed should be within 10% of the pre- Radiopharmaceuticals used in positron emission
scribed dose or dosage range and the actual tomography require specialized personnel; facil-
quantity administered must be recorded in ities and equipment due primarily to the rela-
the patient’s medical record. tively short physical half-lives of the radionu-
8. Radiopharmaceuticals should not be used be- clides used (2 min to 1.8 hr), their energetic
yond the manufacturer’s recommended expi- photon emissions and the chemical syntheses
ration date/time unless specific quality con- necessary for their preparation. Preparation of
trol testing demonstrates that the product still PET radiopharmaceuticals must comply with
meets applicable USP specifications at the USP compounding standards or FDA manufac-
time of use. turing requirements. Nuclear medicine practi-
9. Any discrepancies shall be resolved prior to tioners involved in positron emission tomogra-
administration. phy should consult with qualified chemists,
B. Elution of Generators and On-Site Preparation pharmacists, physicists and technologists in es-
of Kits tablishing and operating a PET program.
1. Each time a generator is to be eluted, the gen- D. Record Keeping
erator to be eluted and the volume of eluent to 1. Records of receipt, usage, administration and
be used should be selected based on the cali- disposal of all radiopharmaceuticals shall be
bration and elution history of the generator. kept in compliance with license conditions
The quantity of radioactivity eluted and the and applicable medical records and radiation
concentration of parent nuclide breakthrough control regulations.
must be measured and recorded for each elu- 2. Records concerning the receipt of packages
tion performed. The extent of breakthrough containing radioactive material should in-
must be verified to be below the appropriate clude proper identification of contents, in-
regulatory limit. The final volume of the elu- spection for physical damage and testing for
ate, the identity of the person performing the external contamination, as required by the ap-
elution and the date and time of elution shall propriate regulatory agency. Appropriate
be recorded. Proper radiation safety proce- records of the receipt of radioactive material
dures must be employed throughout the elu- shall be maintained and stored in accordance
tion process. with applicable local state and federal regula-
2. Radiopharmaceuticals should be prepared ac- tions. Such records shall address the identity
cording to manufacturer’s instructions. Devi- of the radiopharmaceutical, its source, the
ations from the package insert instructions amount of activity received and the results of
may be made by the prescribing physician or radiation surveys and contamination testing.
SOCIETY OF NUCLEAR MEDICINE PROCEDURE GUIDELINES MANUAL JUNE 2002 • 83

Any discrepancies must be reported to the ministration to the wrong patient. The handling
manufacturer and/or proper regulatory and administration of blood products must be
agency. subject to special safeguards and procedures, the
3. For all radiopharmaceuticals prepared on- goal of which is to eliminate any possibility of
site, records should include the date and time administration to the wrong patient, contamina-
of preparation, quantity, volume and concen- tion of the blood by environmental substances,
tration of radioactivity used, reagent lot num- and contamination of workers during radiolabel-
bers, quality control data, expiration time, ing procedures.
waste disposal information, and name or ini- H. Drug Interactions and Altered Distribution
tials of the individual responsible for the Patterns
preparation. 1. The in vivo distribution of radiopharmaceuti-
4. For all radiopharmaceuticals, the identity of cals can be altered by
the radiopharmaceutical, the amount of ra- Concurrent medications and prior diag-
dioactivity administered, patient identity, nostic tests (including contrast dye and previ-
identity of individual performing the admin- ous radiopharmaceuticals). The nuclear
istration, route of administration, and date medicine practitioner should be familiar with
and time of use must be recorded. documented drug interactions and consider
5. Appropriate records of radionuclide dose cali- this information when planning the nuclear
brator testing for constancy, accuracy, linearity medicine procedure to be performed and
and geometric variation shall be maintained. when altered distribution patterns are identi-
6. Disposal of all radioactive material must be fied on patient studies.
accomplished in accordance with institu- 2. Problems in the formulation of radiopharma-
tional, state and federal regulations. Policy ceuticals can result in altered distribution pat-
and procedures should be developed to as- terns. Appropriate quality control programs
sure that radioactive material does not enter should identify such problems prior to patient
the normal waste stream of the institution ex- administration. The possibility of a formula-
cept in exempt quantities or in exempt forms tion-related cause of an altered distribution
(e.g., patient excreta). pattern should be considered in evaluation of
E. Adverse Reactions/Product Problems any unexplained image findings.
Adverse reactions associated with administra-
tion of radiopharmaceuticals should be investi-
V. Issues Requiring Further Clarification
gated and documented. Reports of serious ad-
verse reactions and product problems should be None
made to the manufacturer and to MedWatch.
F. Misadministration of Radiopharmaceuticals
VI. Concise Bibliography
Policies and procedures should be developed
which assure that the correct patient receives the Chilton HM, Witcofski RL. Nuclear Pharmacy. An Intro-
correct drug, at the correct time, at the correct duction to the Clinical Applications of Radiopharmaceu-
dose and by the correct route of administration. ticals. Philadelphia, PA; Lea and Fiebiger: 1986.
Misadministrations, also known as medical Henkin RE, Boles MA, Dillehay GL, et al. The Scientific
events, have been defined by federal and state Basis of Nuclear Medicine; Part IIB: Radiopharmacy.
regulatory agencies and include a timely report- In: Nuclear Medicine. Mosby; New York, NY. 1996.
ing requirement. When required, such events Hladik WB, Ponto JA, Lentle BC, et al. Iatrogenic Alter-
should be reported to the appropriate agency ations In Biodistribution of Radiotracers As A Re-
within the time frame specified. sult of Drug Therapy: Reported Instances. In:
G Special Considerations for Labeled Blood Hladik WB, Saha GB, Study KT (eds): Essentials of
Products Nuclear Medicine Science. Baltimore, MD; Williams
While the misadministration of any radiophar- and Wilkins: 1987.
maceutical is serious, special precautions must Hung JC, Ponto JA, Hammes RI. Radiopharmaceutical-
be implemented to prevent the misadministra- related Pitfalls and Artifacts. Semin Nucl Med l996;
tion of radiopharmaceuticals containing blood 26:208–255.
products, i.e., Tc-99m red blood cells and In-111 Kowalsky RJ, Perry JR. Radiopharmaceuticals in Nu-
and Tc-99m leukocytes. Procedures which in- clear Medicine Practice. Norwalk, CT: Appleton &
volve the removal of blood for radiolabeling and Lange: 1987.
subsequent reinjection have potential for misad- Laven DL, Shaw SM. Detection of Drug Interactions In-
84 • USE OF RADIOPHARMACEUTICALS

volving Radiopharmaceuticals: A Professional Re- proved guidelines to promote the cost-effective use of
sponsibility of the Clinical Pharmacist. J Pharm high quality nuclear medicine procedures. These
Practice l989; 2:287–298. generic recommendations cannot be applied to all pa-
Nuclear Pharmacy Practice Guidelines. Washington, tients in all practice settings. The guidelines should
DC; American Pharmaceutical Association: 1995. not be deemed inclusive of all proper procedures or
Radiopharmaceuticals for Positron Emission Tomogra- exclusive of other procedures reasonably directed to
phy-Compounding. In: USP 24 and NF 19. obtaining the same results. The spectrum of patients
Rockville, MD: The United States Pharmacopeial seen in a specialized practice setting may be quite dif-
Convention, Inc: 1999:1988–1990. ferent than the spectrum of patients seen in a more
Saha GB. Fundamentals of Nuclear Pharmacy, Fourth general practice setting. The appropriateness of a
Edition. New York, NY; Springer-Verlag:1992. procedure will depend in part on the prevalence of
Sampson CB. Textbook of Radiopharmacy: Theory and disease in the patient population. In addition, the re-
Practice, Third Edition. Amsterdam; Gordon and sources available to care for patients may vary greatly
Breach Science Publishers. 1999. from one medical facility to another. For these rea-
sons, guidelines cannot be rigidly applied.
Advances in medicine occur at a rapid rate. The
VIII. Disclaimer
date of a guideline should always be considered in
The Society of Nuclear Medicine has written and ap- determining its current applicability.