Lecture 2 Flashcards
Materials used to prepare radiopharmaceutical sources
Kit formulations
radiopharmaceutical repackaging
kit formulations
requires generators, radiopharmaceutical kits, and in-house prep
radiopharmaceutical repackaging
some are simply repackaged from a vial shipped from the manufacturer into a syringe for ease of administration
job opportunities in RM
production
research and development
regulatory
transportation and shipping
medical science liaisons
job opportunities in NP
most in centralized with freestanding lab setting
select in large teaching hospitals with in-house nuclear pharmacies
locations within facilities
restricted areas
non-restricted areas
restricted areas - compounding/dispensing
where sterile products are prepped and dispensed into unit dose containers
must meet sterile product preparation requirements
compounding personnel only (pharmacists and technicians)
everything done in an ISO 5 laminar flow hood
USP <797>
requirement for NON-radioactive preparation and compounding
USP <825>
requirement for radioactive preparation and compounding
restricted area - non dispensing
generally the most people heavy
all non-sterile activities are carried out here
Long Lived RM
full scale cGMP production facilities
cGMP production suites
research and development space
sterility and quality control
waste handling
RM restricted area
area in which radioactive material is stored with only authorized personnel
divided into several subsections: chemistry R/D, manufacturing/production, and quality control/sterility validation
must maintain cGMP standards
non restricted areas of all facilities
kitchen
office areas
restrooms
entry
ANP duties
oversee/carry out the pharmaceutical compounding and dispensing process
assure quality of products
assist in the maintenance of regulatory compliance in all areas
minimize cost and maximize profit
coordinate logisitcs
educate pharmacy staff, customers, and members of the general public
document
opening shift
11pm to 1am start
5am or 6am end
busiest time with 80% of RXs to be ready when hospitals open
very few phone calls
day shift
starts between 5am and 9am
close at 5pm
On call
anytime pharmacy is closed
usually nothing but sometimes it can be critical to the patient
weekends
Saturday - usually short hours early AM to noon
Sunday - supply backup doses; 1 or 2 hours in the AM
someone is usually on-call
first run duties
first thing - check orders placed during late evening hours (sometimes phone in)
must assure that all instruments are working correctly - SCA/MCA, Dose callibratory, and survey meter checks
Non-pharmacist duties
returns of used radioactive materials for decay in storage before disposing as medical waste; waste must be opened, segregated into dedicated storage areas, and stored until radioactivity decays
Third/Fourth run
back up doses used for on call situations
delivery must be done before staff at hospital leaves for the day
afternoon duties
spent receiving and processing orders for the next day
pet facilities
close even earlier in the day due to no study requiring 24 hour service
production goal of RM
must meet shipping/transportation needs
longer half-life of isotopes may give more flexibility than nuclear pharmacy
