Presentation on theme: "Written Directives Medical Use of Radioactive Material"— Presentation transcript:
1Written Directives Medical Use of Radioactive Material Prepared by Deborah StevaOffice of Environmental Health & SafetyAugust 2007
2Medical 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
3Medical 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 isTitle 10 CFR Part 35.
410 CFR Part 35This 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 useAll licensees must comply with these regulations when engaging in the use of NRC regulated materials.
5Administration of radioactive material (radiopharmaceutical and/or sealed source administration of radiation) can be divided into two categoriesThose requiring a “written directive” andThose not requiring a “written directive”.
6What 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 physicianbut 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.
7Administrations 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 Megabecquerels (MBq) (30 microcuries (μCi))Any therapeutic dosage of unsealed radioactive material (examples: I-131, Y-90) orAny therapeutic dose of radiation from radioactive material (examples: HDR, brachytherapy).
8All 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)
9If 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
10Content 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, androute of administration
11Content 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 siteFor 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
12Content 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; andAfter 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).
13Procedures 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 andeach administration is in accordance with the written directive.Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directiveBoth manual and computer-generated dose calculations are checkedVerifying that any computer –generated dose calculations are correctly transferred into the consoles of therapeutic medical units (e.g. for teletherapy, HDR, gamma knife)
14Written 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.
15Rules for Revision of a Written Directive A written revision to an existing written directive may be made ifthe 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.
16Revision 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. “
17All Medical Use of Radioactive Materials requires an “Authorized User” someone who is working under the supervision of an authorized user(as defined by 10CFR35)
18No one may administer radioactive material to humans without approval. Medical Use must be under supervision of Authorized User
1910 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)
20Approved 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
21What is an Authorized User? A physician, dentist, or podiatrist who:
22Authorized 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 orHas completed the required training, experience and work experience specified in Part 35 for the specialty they wish to be authorized for
23Training Requirements There are specific classroom and laboratory training requirements specified in Part 35 for each application, e.g. HDR, iodine therapy, gamma knife, etc. andRequired number of hours/years work experience under supervision of an authorized userPart 35 on NRC website:
24How to become an Authorized User For guidance on required training and documentation to become an authorized user at UVaContact the Environmental Health & Safety Office at
25(formerly known as Misadministration) 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.
26You must report to the Radiation Safety Officer (2-4911) immediately… Medical EventYou 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 ……
27By more than 0.05 Sv (5 rem) effective dose equivalent Medical Event……A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosageBy more than 0.05 Sv (5 rem) effective dose equivalent0.5 Sv (50 rem) to an organ or tissue or0.5 Sv (50 rem) shallow dose equivalent to the skin AND
28Medical 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 orThe fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more.
29Medical 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 drugAdministration of radioactive drug by the wrong route of administrationAn administration of a dose or dosage to the wrong individual or human research subjectAn administration of a dose or dosage delivered by the wrong mode of treatment orA leaking sealed source
30Medical 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).
31The RSO must report to the NRC Report and notification of a dose to an embryo/fetus or a nursing childThe RSO must report to the NRCAny dose to an embryo/fetus or nursing child that is greater than 50 mSv (5 rem) dose equivalentthat is a result of an administration of byproduct material or radiation from byproduct material to a pregnant or breastfeeding individual
32Environmental Health & Safety Office Questions??ContactEnvironmental Health & Safety Office
33Test1. 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 192. Any referring physician can prescribe the administration of radioactive material to a patient her at UVa. T or F3. 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 user4. 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 Committee7. 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
34Answers1. b CFR Part352. F. Only a physician who is an authorized user approved by UVa’s Radiation Safety Committee may administer radioactive material at UVa3. c. The written directive must be signed by the authorized user4. c. Both a. and b. Must include radioactive drug, dosage and route of administration5. a. If approved by the authorized user before the administration6. c. Only after they have been approved in writing and designated an authorized user by the Radiation Safety Committee7. 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