Reading...
Play button
Play button
Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
54 Cards in this Set
- Front
- Back
|
Define: Radiopharmaceuticals
|
prescription drug products that are internally administered,
intended for use in the diagnosis, treatment, and mitigation of disease, used in Nuclear Medicine and Molecular Imaging |
|
|
What type of energy is used in diagnostic energy and why?
|
gamma
gamma's higher energy is able to reach the camera head with minimal distortion |
|
|
What is the target drug half life relative to imaging time?
|
target half life = 1-1.5 times the imaging time
|
|
|
What are the five important biological considerations for a radiopharmaceutical?
|
1) Localize in organ of interest rapidly & exclusively
2) Localize more in pathologic tissue than in normal tissue (or vice versa) 3) Metabolically inert unless metabolism determines targeting 4) Clear rapidly from background tissue 5) Rapid excretion after study completion |
|
|
What are the mechanisms of localization? (9)
|
- passive diffusion
- active transport - capillary blockage - phagocytosis - sequestration - metabolic trapping - compartmental localization - receptor binding - antibody binding - abnormal extravasation (leakage of fluid) |
|
|
BOP
|
Board of Pharmacy
|
|
|
FDA
|
Food and Drug Administration
|
|
|
NRC
|
Nuclear Regulatory Commission
|
|
|
RPP
|
Radiation Protection Program
|
|
|
RDRC
|
Radioactive Drug Research Committee
|
|
|
TJC
|
The Joint Commission
|
|
|
DOT
|
Department of Transportation
|
|
|
What agency is in charged with ensuring the safe use of radioactivity?
What is the code and the 6 responsibilities? |
NRC - Nuclear Regulatory Commission
10 CFR Part 35 (Code of Federal Regulations) 1) Issuance of license authorizations 2) Protect patients from unnecessary exposure 3) Protect personnel from the material they handle 4) Protect general public from unnecessary exposure 5) Licensing 6) Exposure limits |
|
|
What is the former name of the NRC?
|
Atomic Energy Organization
|
|
|
Define: Radiation Protection Program
|
The documented program, including, but not limited to, the plans, schedules, and other measures developed and implemented to achieve and ensure continuing compliance with 10 CFR 835 and to apply the as low as reasonably achievable process to occupation dose.
|
|
|
ALARA
|
as low as reasonably achievable
|
|
|
Who is charged with administration of the Radiation Protection Program?
Who does he report to? |
Radiation Safety Officer
reports to Radiation Safety Commitee |
|
|
What are the three variable factors used to reduce exposure?
|
- time
- distance - shielding |
|
|
How is dose related to time?
|
dose is directly proportional to time exposed to the source
|
|
|
Compare "deterministic" effects to "stochastic" effects
|
deterministic: no effect until a certain threshold is met, but then effects become more severe as dose increases
stochastic: linear relationship, probability of effects is directly dependent on amount of exposure |
|
|
How is exposure related to distance from the source?
What is the formula? |
exposure decrease proportionally with the square of the distance from the source
AΓ E = --------- d^2 - remember to calculate using distance from the SOURCE!! |
|
|
Define: HVL
|
Half value layer - the thickness of a material required to reduce intensity of a radiation field to half of its original value
|
|
|
What materials will reduce the intensity of
- alpha particles? - beta particles? - gamma particles? |
α - paper, 1" wood, or 1/4" plastic
ß - aluminum or lucite Γ - lead or tungsten |
|
|
NCRP
|
National Council on Radiation Protection and Measurements
|
|
|
What are the NCRP regulations for exposure to the general public?
|
2% of occupational exposure
- g.p. shall not be exposed to more than 100 mRem/yr - dose rate to an unrestricted area not to exceed 2 mRem in any 1 hr |
|
|
What are the annual Occupation Dose Limits?
|
5000 mRem TEDE (Deep Dose Equiv. + Commited Effective Dose Equiv) - ex: body badges
15,000 mRem LDE (Lens Dose Equivalent) 50,000 mRem SDE (Shallow Dose Equivalent (Extremities) |
|
|
What organizations regulate the use of volunteers in radiopharmaceutical trials?
What do they do? |
IRB - Institutional Review Board
RDRC - Radioactive Drug Research Committee - review/approve radioactive drug research - qualifications of personel - typ. <30 test subjects - subjects > 18 yoa - sub-pharmacologic doses (just looking at basic PK) - dose limits |
|
|
What is meant by a "Radioactive Materials" sign?
|
The facility is licensed to have radioactive materials. There may or may not be any radioactive materials on the site
|
|
|
What is meant by a "Radiation Area" sign?
|
an area in which an individual could receive a dose equivalent in excess of 5 mRem/hr at 30 cm
- will be a restricted area (locked door, entry badges) |
|
|
What is meant by a "High Radiation Area" sign?
|
area in which an individual could receive a dose equivalent in excess of 100 mRem/hr at 30 cm
- i.e. oncology, cyclotron, radiation pt room |
|
|
Compare a survey meter versus a scintillation counter
|
survey meter: monitors exposures, not contamination
scintillation counter: measures contamination of a surface in counts per minute (counting atoms disintegrating) - a surface is swabbed by a wipe, then the wipe read by the counter |
|
|
What are the limits of white and yellow transportation labels?
|
|
|
|
What is "TI"?
- how are the values rounded? - what is the total limit? |
TI - Transportation Index
= highest dose rate at 1 meter from the exterior of the package - values are rounded UP to the nearest tenth - total of all packages in a shipment may not exceed 50 |
|
|
What extra regulations must be followed to ship Yellow III packages? (4)
|
1) Placards
2) CDL license 3) Registration 4) Regulations |
|
|
AU
|
Authorized User
- has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training in basic radionucleotide handling techniques - has at least thrice administered dosages of radioactive drugs to patients or human research subjects in each category for which AU status is requested |
|
|
ANP
|
Authorized Nuclear Pharmacist
- Pharmacy license - 200 hours didactic training - 500 hours experiential supervised practice - written attestation signed by an ANP preceptor - approval by Radiation Safety Committee and added to AU list |
|
|
AMP
|
Authorized Medical Physicist
- masters/doctorate in physics or other physical science - 2 years of full time practical training and/or supervised experience in medical physics - written attestation from AMP |
|
|
What was accomplished by the Atomic Energy Act of 1946?
|
- Transferred authority to AEC for distribution of radionucleotides for peaceful research purposes
- Subcommittee on Human Applications to review and approve each application for human medical use |
|
|
What year were radiopharmaceuticals placed under FDA regulatory authority?
|
1975
- radiopharmaceuticals have same NDA requirements as non-radioactive drugs |
|
|
What was the result of the Atomic Energy Commission split of 1975?
|
Department of Energy
- energy research and development Nuclear Regulatory Commission - responsible for all licensing and regulatory functions |
|
|
What are the roles of the FDA vs. roles of the NRC?
|
|
|
|
NOPR
|
National Oncologic PET Registry
|
|
|
When did PET change from being considered compounding to being considered manufacturing?
|
2011 when the FDA required NDA (or aNDA) for any PET drug product in clinical use
|
|
|
cGMP
|
Current Good Manufacuring Practices
minimum requirements for the methods to be used in, and the facilities and controls used for, the production, quality control, holding, or distribution of a safe and effective PET drug product intended for human use. |
|
|
What is required in order to be allowed to compound PET drugs?
|
an NDA, IND, or through the RDRC
|
|
|
What parameters are established in Pre-clinical studies of radiopharmaceuticals?
|
1) Conducted with relevant animal studies to clearly establish that the radioactive drug is reasonably safe for humans
2) Procedures and Methodology for obtaining the information described in detail 3) Radiochemical and radionuclidic purity, biodistribution, acute toxicity |
|
|
RDRC
|
Radioactive Drug Research Committee
an FDA mandated committee |
|
|
What are the conditions for the RDRC to allow limited use of radiopharmaceuticals in human research before an IND application?
|
- recognized as safe and effective in humans
- intended to characterize basic PK & PD properties of the drug - can have NO intention to provide immediate therapeutic or diagnostic effect, or provide safety or efficacy data |
|
|
What are the responsibilities of the RDRC?
|
- review/approve all non-IND drug research
|
|
|
IND
|
Investigational New Drug
- an application to the FDA outlining well-controlled, scientifically designed safety and efficacy studies |
|
|
IRB
|
Institutional Review Board
FDA mandated committee that reviews and monitors biomedical research involving human subjects - protection of rights and welfare of human research subjects - approve, modify, or disapprove research |
|
|
eIND
|
Exploratory IND Study
quicker and less costly than IND study, - conducted early in phase 1 - limited human exposure - no therapeutic or diagnostic intent - usually a "proof of mechanism" study |
|
|
NDA
What is information is provided in one? (4) |
New Drug Application
Provides: - product is safe and effective - product labeling is suitable - manufacturing methods ensure drug's identity, strength, quality, and purity - entire developmental history |
|
|
TJC
|
The Joint Commission
accreditation agency used by more the 82% of US hospital (TJC accreditation is required to recieve Medicaid payments) |
