Avaliação dos custos para realização de controles de qualidade de radiofarmacos marcados com [99m Tc]tecnécio em serviços de medicina nuclear no Brasil.

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 methodolo~' 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. [ABSTRACT FROM AUTHOR]