Technetium-99m labeled radiopharmaceuticals are currently the main diagnostic agents used in nuclear medicine. Radiopharmaceuticals are prepared locally through a reaction between a complexant agent (pharmaceutical) and technetium-99m. These reactions may generate impurities resulting into the production of radiopharmaceuticals with substandard quality or with different characteristics from those considered ideal. In this article we discuss some of the factors that may interfere with the preparation of radiopharmaceuticals and the quality control tests that can be used to ensure the quality of the agents.

Keywords: Radiopharmaceuticals. Generators. Technetium-99m. Quality controls.

Objective: To establish the costs for quality control of [^99mTc]technetium radiopharmaceuticals in Brazilian nuclear medicine centers, in compliance with Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency) resolutions RDC No. 38/2008 and No. 63/2009. Materials and Methods: Prices for consumables, equipment and labor involved in quality control procedures were calculated and the values were converted into units of volume, time or other appropriate units for use in mathematical formulas for determining unit prices. Results: Estimated investment for acquisition of consumables and equipment was R$ 35,500.00. The final unit cost for quality control of a [^99mTc]technetium radiopharmaceutical kit ranged from R$ 6.44 to R$ 7.80 per kit, depending on the product under analysis, on the methodology applied and on the qualification of the professional involved in the process. Such values may correspond to 0.5% to 10% of the amount received by the institution per diagnostic procedure. In practice the effective cost might be lower, considering that a single labeled kit can be fractionated into several doses. Conclusion: Considering the gains in quality and patients’ safety, the authors conclude that costs for implementing a quality control program for radiopharmaceuticals can be absorbed in the financial planning of nuclear medicine centers.

Keywords: Technetium; Radiopharmaceuticals; Quality control; Cost analysis; Nuclear medicine; National Health Surveillance Agency; Anvisa.