Lecture 2

Question 1

Materials used to prepare radiopharmaceutical sources

Answer 1

Kit formulations
radiopharmaceutical repackaging

Question 2

kit formulations

Answer 2

requires generators, radiopharmaceutical kits, and in-house prep

Question 3

radiopharmaceutical repackaging

Answer 3

some are simply repackaged from a vial shipped from the manufacturer into a syringe for ease of administration

Question 4

job opportunities in RM

Answer 4

production
research and development
regulatory
transportation and shipping
medical science liaisons

Question 5

job opportunities in NP

Answer 5

most in centralized with freestanding lab setting
select in large teaching hospitals with in-house nuclear pharmacies

Question 6

locations within facilities

Answer 6

restricted areas
non-restricted areas

Question 7

restricted areas - compounding/dispensing

Answer 7

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

Question 8

USP <797>

Answer 8

requirement for NON-radioactive preparation and compounding

Question 9

USP <825>

Answer 9

requirement for radioactive preparation and compounding

Question 10

restricted area - non dispensing

Answer 10

generally the most people heavy
all non-sterile activities are carried out here

Question 11

Long Lived RM

Answer 11

full scale cGMP production facilities
cGMP production suites
research and development space
sterility and quality control
waste handling

Question 12

RM restricted area

Answer 12

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

Question 13

non restricted areas of all facilities

Answer 13

kitchen
office areas
restrooms
entry

Question 14

ANP duties

Answer 14

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

Question 15

opening shift

Answer 15

11pm to 1am start
5am or 6am end
busiest time with 80% of RXs to be ready when hospitals open
very few phone calls

Question 16

day shift

Answer 16

starts between 5am and 9am
close at 5pm

Question 17

On call

Answer 17

anytime pharmacy is closed
usually nothing but sometimes it can be critical to the patient

Question 18

weekends

Answer 18

Saturday - usually short hours early AM to noon
Sunday - supply backup doses; 1 or 2 hours in the AM
someone is usually on-call

Question 19

first run duties

Answer 19

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

Question 20

Non-pharmacist duties

Answer 20

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

Question 21

Third/Fourth run

Answer 21

back up doses used for on call situations
delivery must be done before staff at hospital leaves for the day

Question 22

afternoon duties

Answer 22

spent receiving and processing orders for the next day

Question 23

pet facilities

Answer 23

close even earlier in the day due to no study requiring 24 hour service

Question 24

production goal of RM

Answer 24

must meet shipping/transportation needs
longer half-life of isotopes may give more flexibility than nuclear pharmacy