Written Directives

1
Written Directives
Medical Use of Radioactive Material
Prepared by Deborah Steva Office of Environmental
Health Safety August 2007
2
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

3
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.

4
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.

5
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.

6
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 UVas
  Radiation Safety Committee (RSC) to administer
  the type of materials or treatments ordered.

7
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).

8

• 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)

9
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

10
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

11
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

12
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).

13
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 patients 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)

14
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.

15
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.

16
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.

17

• 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)

18
No one may administer radioactive material to
humans without approval. Medical Use must be
under supervision of Authorized User
19
10 CFR Part 35 and UVas 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)

20
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

21
What is an Authorized User?

• A physician, dentist, or podiatrist who

22
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

23
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/

24
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
25
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.

26
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

27
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

28
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.

29
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

30
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).

31
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

32

• Questions??
• Contact
• Environmental Health Safety Office
• 2 - 4911

33
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

34
Answers

• 1. b. 10 CFR Part35
• 2. F. Only a physician who is an authorized
  user approved by UVas 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