Written Directives Medical Use of Radioactive Material Prepared by Deborah Steva Office of Environmental Health & Safety August 2007.

Written DirectivesMedical Use of Radioactive Material

Prepared by Deborah StevaOffice of Environmental Health & SafetyAugust 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

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).

Content of Written Directive continued…..

Procedures for Written DirectivesWritten 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

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 (formerly known as Misadministration)

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 …..

• 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

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:

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

Test1. 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

Answers1. 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