Lecture 1 Flashcards
Nucelar Pharmacy and Radiopharmaceutical Manufacturing at Purdue
Nuclear Pharmacy
speciality area of pharmacy practice dedicated to the compounding and dispensing of radioactive materials for use in nuclear medicine procedures
two main aspects of nuclear pharmacy
pharmacy
handling radioactive materials
learning requirements of an ANP
meet the Nuclear Regulatory Commission (NRC) and/or state specific training requirements for handling radioactive material
200 hours of didactic training
500 hours of hands on practical experience in a nuclear pharmacy setting
didactic training
200 hours
radiation physics and instrumentation
radiation protection
mathematics pertaining to the use and measurement of radioactivity
chemical of byproduct material for medical use
radiation biology
good for 7 years
supervised practice experience
shipping, receiving RAM and related radiation surveys
using and performing checks for proper use of instrumentation
calculating, assaying, and preparing human doses
using administrative controls to avoid misuse of byproduct material
using procedures to prevent contamination and/or decontaminate if necessary
completion
must be signed off by an authorized educator
submitted to NRC/state regulator along with pharmacy license
Hands on Experience types
summer internships
clerkship rotations
submissions
signed educator statement
transcript showing successful completion of courses
affidavit of any practical experiences hours signed by preceptor ANP
Agreement state
assume regulatory authority to license and regulate certain nuclear materials
indiana is trying to become one
radiopharmaceuticals
radioactive compounds used to identify, diagnose, and treat a variety of diseases and conditions (especially cancer) in people and animals
types of Radiopharmaceutical manufacturing
PET (positron emission tomography)
large scale radiopharmaceutical production
positron emission tomography (PET)
short lived isotopes
cGMP compliant facilities - specific FDA manufacturing guidelines
typical job duties - cyclotron operation/maintenance, chemical synthesis, and radiopharmaceutical quality control testing and batch release
large scale radiopharmaceutical production
follows all FDA manufacturing regulations and handling radioactive materials through the process
AU
authorized user status
not needed for most operators at a manufacturing facility
if needed, same training as for ANP