Abstract
4080
Introduction: Many nuclear medicine departments worldwide have been recently strained due to current supply shortages; they have worked through these limitations by adjusting patient schedules and reducing volumes. This project looks at another way to work through supply shortages in the radiopharmacy while still meeting the needs of both facilities and the patients they serve. The specific purpose of this study was to look at effectively fractionating three radiopharmaceuticals: sulfur colloid (SC), mebrofenin, and macro aggregated albumin (MAA). Effective kit manipulation extends the available supply to still adequately and sufficiently meet the demands of the facilities that rely on the pharmacy for their doses.
Methods: Fractionated kits were prepared from manufacturer vials of SC, mebrofenin, and MAA. These fractionated kits were then reconstituted by adding an adjusted amount of sodium pertechnetate, 159 mCi to SC, 36.15 mCi to MAA, and 50 mCi to mebrofenin, while following all other manufacturer instructions. After the kits were reconstituted, quality control (QC) with thin layer chromatography (TLC) strips was performed. For both SC and MAA, two Whatman 31ET TLC strips were completed in 2 separate vials of acetone for each product. For mebrofenin, two SA TLC strips were placed in two separate vials of 20% NaCl solution. After the TLC strip was complete, it was cut at the designated cut line determined by Rf value, with each section then being placed on the AtomLab 500 wipe counter where results were collected. These counts were then recorded. QC was measured every two hours within a continuous 12-hour period for all 3 kits. Upon completion of data collection, product purity was determined for each prepared fractionated kit. For the radiopharmaceutical to pass QC, the percentage of labeled Tc99m vs impurity must be in a specific pre-determined range. Specifically, we are looking to achieve a purity above 90% for MAA and Mebrofenin and above 92% for SC.
Results: All of the radiopharmaceutical kits passed quality control with a value of over 95% product purity for mebrofenin and a value of over 90% for SC and MAA within a continuous 12-hour time frame. The average value recorded for sulfur colloid was 97.31% and the standard deviation was 0.53%. The average value recorded for mebrofenin was 98.23% and the standard deviation was 1.04%. The average value recorded for MAA was 96.63% and the standard deviation was 2.00%. This lower value of 92% was most likely due to previous contamination of the wipe that was used for the past TLC strips during testing. See Figure 1 "Percent Purity of SC, mebrofenin, and MAA" for complete review of results.
Conclusions: Overall, fractionating radiopharmaceutical kits showed to be an effective manipulation in order to maneuver through supply shortages. Due to the practice of fractionating kits, there was no impact to any patient care for any site supplied by our radiopharmacy. Knowing that these products are safe for patients throughout a 12-hour period guarantees that a pharmacy will be able to navigate through shortages and provide sufficient care to properly diagnose patients in the field of nuclear medicine.