par Sean Ruck
, Contributing Editor | June 13, 2016
From the June 2016 issue of HealthCare Business News magazine
The VA was providing scholarships for people to attend the USC Nuclear Pharmacy program. It was an intense 12-month program with the last three months being internships. The didactic and laboratory program went from 8 a.m. to 5 p.m., five days a week. Four VA hospitals in southern California hosted the summer student internships. You were able to observe nuclear pharmacy at each hospital. All were a bit different. The San Diego VA was the newest and most exciting location, and was also involved in nuclear medicine research.
When I graduated from the program, I was hired by Michael J. Welch, Ph.D., and Barry A. Siegel, M.D. to come to Washington University in St. Louis, to work in both traditional nuclear medicine and in radiopharmaceutical research. I am still there today. I think nuclear pharmacy has progressed tremendously. In traditional nuclear pharmacy Tc-99 was the primary radionuclide utilized for clinical studies. Nuclear pharmacists were often involved in preparing the non-radioactive kit formulations (kits). These were used for preparing Tc-99m-labeled radiopharmaceuticals.
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Kits could be purchased from manufacturers, but in-house production by the nuclear pharmacist helped reduce the cost of the final products. Today, everything is produced by commercial manufacturers. In 1995, I moved from traditional nuclear medicine to oversee the production of F-18 labeled fluorodeoxyglucose for use in PET. Managing FDG and other PET radiopharmaceuticals gave me the opportunity to be more involved in chemistry, which was very exciting to me. During the interval from 1995 to 2014, FDG production went from having no direct FDA oversight to requiring that it be produced under FDA regulation in 2012. Since 2012, we have had to become an FDA manufacturer and submit an application to the FDA to be able to continue to produce FDG. It’s been a very interesting journey.
HCB News: What’s the major initiative or initiatives you plan to push during your time as president?
The current president has opened a Therapy Center of Excellence, and in my opinion therapy is an important direction for nuclear medicine. I plan to launch a Qualified Person Training Program to train individuals — chemists and pharmacists — in the release of radiopharmaceuticals, including PET, SPECT and therapeutic radiopharmaceuticals. I want to develop a curriculum that takes into consideration all the aspects needed for releasing a drug. It would deal with media fill testing, aseptic process, radiopharmaceutical formulation, release specifications and all the regulatory requirements — including FDA 21 CFR Part 213, USP chapters 823 and 797. There is a need for pharmacists and chemists to be cross-trained in all of these areas.