UT Cyclotron Gets Houston's First Nuclear Pharmacy License

Dr. Carlos Gonzalez Lepera

The strategic planning and hard work of Dr. Carlos Gonzalez Lepera, and the cyclotron staff, has resulted in The University of Texas-Houston Health Science Center's nuclear medicine facility having the first nuclear pharmacy license in Houston. This new license allows the UT cyclotron to distribute its isotopes to other facilities.

In order to keep up with other nuclear medicine sites and the changes taking place in the field, obtaining this license was one of Dr. Gonzalez's first goals when he became the facility's executive director in October 1998. "Once the new Federal Drug Administration regulations for cyclotron facilities are introduced we will be considered a drug-manufacturing facility," states Dr. Gonzalez, an associate professor in the UT-Houston Medical School department of radiology.

The cyclotron, located next to the UT-Houston Medical School, is a service center that produces short half-life radiotracers used in research and clinical activities within the Medical School and throughout the Texas Medical Center. The radioisotopes are produced in a cyclotron located in a specially designed building with the purpose of providing a reliable source of radioactive materials to researchers and physicians for nuclear medicine imaging. This technique is unique in that it documents organ function and structure, in contrast to diagnostic radiology, which is based on anatomy. The staff consists of Dr. Gonzalez, two cyclotron operators, two radiopharmacists, one chemical technician and one administrative coordinator.

"The progress of the cyclotron facility in recent years has been remarkable," observes Dr. Thomas F. Burks, UT-Houston executive vice president for research and academic affairs. "Dr. Gonzalez and his staff have engaged very successfully in improving reliability of radionuclide production enhancing efficiency and expanding operations to meet patient care and research needs. UT-Houston is fortunate to have a high quality and well-operated support facility for specialized imaging available for use by our faculty. Short half-life cyclotron products continue to be important for our clinical and research needs. Having a nuclear pharmacy license presents new opportunities to offer the advantages of cyclotron-generated radionuclides to other institutions and their clinical and research communities."

Nuclear medicine is a specialty that uses safe, painless and cost-effective techniques both to image the body and to treat disease. It is used in diagnosis, management, treatment and prevention in many specialties including cardiology, oncology and neurology. Nuclear medicine is also used to evaluate bone pain, injuries, infection, or kidney and bladder function. Common uses are diagnosis of hyperthyroidism (Graves's Disease), cardiac stress tests, bone scans for orthopaedic injuries, lung scans for blood clots, and liver and gall bladder procedures to diagnose abnormal function or blockages.

Before applying to the Texas State Board of Pharmacy for the nuclear pharmacy license, Dr. Gonzalez and his staff reviewed the current standard operating procedures. "We made many improvements in the way we produce the isotopes and the radiopharmaceuticals. We developed new techniques for production and purchased commercial equipment," he explains. Then he applied for an amendment to the existing radioactive materials license from the Texas Bureau of Radiation Control, showing that the facility had the proper equipment, personnel and appropriate safety measures to operate a nuclear pharmacy.

"Before, the state license allowed us to produce the radioisotopes, but the pharmaceuticals were considered experimental by the FDA, and had to be produced as part of a research study with a faculty. Dr. K. Lance Gould, a professor of cardiology who established the Weatherhead P.E.T. (Positron Emission Tomography) Center for Preventing and Reversing Atherosclerosis, has been the primary customer for the pharmaceuticals," says Dr. Gonzalez, who received his Ph.D. in physics in 1983 from the Instituto Balseiro and Centro Atomico Bariloche in Argentina. Before coming to UT-Houston, he was a postdoctoral research associate at the University of Tennessee and Oak Ridge National Laboratory and was the cyclotron facility manager at the University of Pennsylvania School of Medicine.

In March, the FDA approved the P.E.T. technique, stating it is valuable and safe to be used in a clinical environment, and announced that two of the isotopes, fluorine 18 glucose and nitrogen 13 ammonia, are safe and effective in several procedures in oncology and cardiology. The Health Care Financing Administration recognized codes for reimbursement of tests, which was a major component of this action. These events resulted from the FDA Modernization Act of 1997, which dictated that the P.E.T. technique be analyzed and a set of regulations for PET facilities be established within two years.

"Most imaging procedures provide information about anatomy, but PET provides pictures of how organs and tissues are functioning," explains Dr. Gonzalez. His goals for the facility include expanding the use of current tracers, establishing first-class research in the development of new tracers, and creating a strong research program that encourages collaboration among researchers.

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©2006 Texas Medical Center

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