Transcript Written Directives - University of Virginia

Written Directives
Medical Use of Radioactive Material
Prepared by Deborah Steva
Office of Environmental Health & Safety
August 2007
Medical Use of Radioactive Material
The Nuclear Regulatory Commission (NRC)
defines Medical Use as “the intentional internal or
external administration of byproduct material, or
the radiation from byproduct material, to patients
or human research subjects under the supervision
of an authorized user.
An Authorized User is defined as…..
a physician, dentist, or podiatrist who meets the
training and experience qualifications specified in
10 CFR Part 35.”
Byproduct Material: Radioactive material regulated by the NRC
Medical Use of Radioactive Material
The Code of Federal Regulations (CFR) is
the set of rules and regulations used by the
federal government to control (among other
things) the use of radioactive materials in
the United States.
The section of the CFR that regulates
medical use of radioactive materials is
Title 10 CFR Part 35.
10 CFR Part 35
• This section of the regulations specifies
the training and experience requirements
for individuals using byproduct materials
and the specific technical requirements
that must be followed during use
• All licensees must comply with these
regulations when engaging in the use of
NRC regulated materials.
Administration of radioactive material
(radiopharmaceutical and/or sealed source
administration of radiation) can be divided
into two categories
• Those requiring a “written directive” and
• Those not requiring a “written directive”.
What is a Written Directive?
A written directive is a prescription for a
specific nuclide and administration route.
A written directive is not the prescription
prepared by the referring physician
but is the directive that must be prepared by
a physician who is an authorized user, i.e.
authorized user approved by the NRC or
UVa’s Radiation Safety Committee (RSC) to
administer the type of materials or
treatments ordered.
Administrations Requiring a
Written Directive
A written directive must be prepared, dated and
signed by an authorized user
before the administration of:
 I-131 sodium iodide greater than 1.11
Megabecquerels (MBq) (30 microcuries (μCi))
 Any therapeutic dosage of unsealed radioactive
material (examples: I-131, Y-90) or
 Any therapeutic dose of radiation from radioactive
material (examples: HDR, brachytherapy).
All other administrations of radioactive
materials can be administered without a
specific “written directive”.
The non-written directive administrations
(standard diagnostic nuclear medicine
studies) can be ordered in the traditional
way and the specific dosage for an
administration can be referenced from an
authorized user approved dose chart.
(Examples: Tc-99m, Tl-201, F-18)
If a written directive is required,
very specific rules must be followed.
The written directive must contain:
the patient or human research subject's
name and the following information-For any administration of quantities
greater than 1.11 MBq (30 μCi) of sodium
iodide I-131: the dosage
Content of Written Directive continued….
For an administration of a therapeutic
dosage of unsealed byproduct material
other than sodium iodide I-131:
 the radioactive drug,
 dosage, and
 route of administration
Content of Written Directive continued…..
For gamma stereotactic radiosurgery: the total
dose, treatment site, and values for the target
coordinate settings per treatment for each
anatomically distinct treatment site
For teletherapy: the total dose, dose per fraction,
number of fractions and treatment site;
For high dose-rate remote afterloading
brachytherapy: the radionuclide, treatment site,
dose per fraction, number of fractions, and total
dose; or
Content of Written Directive continued…..
For all other brachytherapy, including low, medium,
and pulsed dose rate remote afterloaders:
 Before implantation: treatment site, the
radionuclide, and dose; and
 After implantation, but before completion of the
procedure: the radionuclide, treatment
site, number of sources, and total source strength
and exposure time (or the total dose).
Procedures for Written Directives
Written procedures must be developed, implemented and
maintained to provide high confidence that the written directive is
rigorously followed. The procedure must provide assurance
that…..
 the patient’s identity is verified before any administration of a
noted nuclide and
 each administration is in accordance with the written directive.
 Verifying that the administration is in accordance with the
treatment plan, if applicable, and the written directive
 Both manual and computer-generated dose calculations are
checked
 Verifying that any computer –generated dose calculations are
correctly transferred into the consoles of therapeutic medical
units (e.g. for teletherapy, HDR, gamma knife)
Written Directive Rules
If, because of the emergent nature of the patient's
condition, a delay in order to provide a written
directive would jeopardize the patient's health,
an oral directive from the authorized user is
acceptable. The information contained in the oral
directive must be documented as soon as
possible in writing in the patient's record.
A written directive must be prepared within 48
hours of the oral directive.
Rules for Revision of a Written Directive
A written revision to an existing written
directive may be made if
the revision is dated and signed by an
authorized user before the administration of
the dosage of unsealed byproduct material,
the brachytherapy dose, the gamma
stereotactic radiosurgery dose, the
teletherapy dose, or the next fractional dose.
Revision of Existing Written Directive….
If, because of the patient's condition, a delay
in order to provide a written revision to an
existing written directive would jeopardize
the patient's health, an oral revision to an
existing written directive is acceptable.
The oral revision must be documented as
soon as possible in the patient's record.
A revised written directive must be signed by
the authorized user within 48 hours of the
oral revision. “
All Medical Use of Radioactive
Materials requires
an “Authorized User”
or
someone who is working under the
supervision of an authorized user
(as defined by 10CFR35)
No one may administer
radioactive material to humans
without approval.
Medical Use must be under
supervision of Authorized User
10 CFR Part 35 and UVa’s license require that
management (RSC) shall approve in writing …
Any individual before allowing that individual
to work as an authorized user, authorized
nuclear pharmacist, or authorized medical
physicist….
To become an authorized user at UVa….
you must submit an application to EHS and
receive approval from the Radiation Safety
Committee (RSC)
Approved Authorized User
Must be identified as an authorized
user on a NRC or Agreement State
license that authorizes the medical use
of byproduct material or is designated
in writing as an authorized user by the
Radiation Safety Committee of a
broadscope license
What is an Authorized User?
A physician, dentist, or podiatrist who:
Authorized User ….
• Is certified by a medical specialty board
whose certification process includes all of the
requirements identified in Part 35 for each
specialty requested and whose certification has
been recognized by the NRC or Agreement
State or
• Has completed the required training,
experience and work experience specified in
Part 35 for the specialty they wish to be
authorized for
Training Requirements
There are specific classroom and laboratory
training requirements specified in Part 35 for
each application, e.g. HDR, iodine therapy,
gamma knife, etc. and
Required number of hours/years work experience
under supervision of an authorized user
Part 35 on NRC website:
http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/
How to become an Authorized User
For guidance on required training and
documentation to become an
authorized user at UVa
Contact the Environmental Health &
Safety Office at 2-4911
www.ehs.virginia.edu
Medical Event
(formerly known as Misadministration)
If an administration of byproduct material, or
the radiation from byproduct material, to
patients or human research subjects does
not go as planned, you must notify the
Radiation Safety Officer in the Office of
Environmental Health & Safety. A
determination must be made as to whether a
“medical event” has occurred.
Medical Event
You must report to the Radiation Safety
Officer (2-4911) immediately…
Any event, in which the administration
of byproduct material or radiation from
byproduct material results in ……
Medical Event……
A dose that differs from the prescribed dose
or dose that would have resulted from the
prescribed dosage
• By more than 0.05 Sv (5 rem) effective
dose equivalent
• 0.5 Sv (50 rem) to an organ or tissue or
• 0.5 Sv (50 rem) shallow dose equivalent
to the skin AND
Medical Event …..
• The total dose delivered differs from the
prescribed dose by 20% or more;
• The total dosage delivered differs from the
prescribed dosage by 20% or more or falls
outside the prescribed dosage range or
• The fractionated dose delivered differs
from the prescribed dose, for a single
fraction, by 50 percent or more.
Medical Event …..
A dose that exceeds 0.05Sv (5 rem) effective dose
equivalent, 0.5 Sv ( 50 rem) to an organ or tissue, or 0.5 Sv
(50 rem) shallow dose equivalent to the skin from any of the
following:
• Administration of a wrong radioactive drug
• Administration of radioactive drug by the wrong route of
administration
• An administration of a dose or dosage to the wrong
individual or human research subject
• An administration of a dose or dosage delivered by the
wrong mode of treatment or
• A leaking sealed source
Medical Event …..
• A dose to the skin or an organ or tissue
other than the treatment site that
exceeds by 0.5 Sv (50 rem) to an organ or
tissue and 50 percent or more of the dose
expected from the administration defined
in the written directive (exclusion: for permanent
implants, seeds that were implanted in the correct site
but migrated outside the treatment site).
Report and notification of a dose to
an embryo/fetus or a nursing child
The RSO must report to the NRC
Any dose to an embryo/fetus or nursing
child that is greater than 50 mSv (5 rem)
dose equivalent
that is a result of an administration of
byproduct material or radiation from
byproduct material to a pregnant or
breastfeeding individual
Questions??
Contact
Environmental Health & Safety Office
2 - 4911
Test
1. The section of the Code of Federal Regulations that regulates medical use of
radioactive material is a. 10CFR Part 50, b.10 CFR Part 35, c. 10 CFR Part 19
2. Any referring physician can prescribe the administration of radioactive material to a
patient her at UVa.
T or F
3. In accordance with the regulations, a written directive for a dose of radioactive material
must be dated and signed by a. the technologist administering the dose b. the
pharmacist c. an authorized user
4. A written directive for administration of a therapeutic dosage of unsealed byproduct
material (other than sodium iodide I-131) must specify:
a. radioactive drug to be administered b. dosage and route of administration
c. both a. and b.
5. A revision to a written directive for administration of a dose of sodium iodine I-131(100
mCi) may be made a. if approved by the authorized user before the administration
b. if approved by the authorized user after the administration c. either a. or b.
6. When can an individual work as an authorized user at UVa?
a. after they are board certified b. after they have completed their required training
and work experience c. only after they have been approved in writing and
designated an authorized user by the Radiation Safety Committee
7. Mrs. Smith received a therapeutic dose of sodium iodide (I-131). A day after
administration it is discovered that the wrong Mrs. Smith received the dose and her
thyroid received 100 rem. Has a medical event occurred? a. yes b. no
Answers
1.
b. 10 CFR Part35
2.
F. Only a physician who is an authorized user approved by UVa’s
Radiation Safety Committee may administer radioactive material at
UVa
3.
c. The written directive must be signed by the authorized user
4.
c. Both a. and b. Must include radioactive drug, dosage and route of
administration
5.
a. If approved by the authorized user before the administration
6.
c. Only after they have been approved in writing and designated an
authorized user by the Radiation Safety Committee
7.
a. Yes. A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent,
0.5 Sv ( 50 rem) to an organ or tissue resulting from an
administration of a dosage to the wrong individual