Microbial evaluation of the handling of antineoplastic agents at a reference cancer treatment hospital in Pará State, Brazil

Abstract

ABSTRACT

The Agência Nacional de Vigilância Sanitária RDC 220/04 sets minimum requirements for operating an antineoplastic therapy service, which emphasizes the importance of a quality assurance system that incorporates the best practices for the preparation of antineoplastic therapy. According to pharmacy protocols, pharmaceutical products must be of a quality that complies with specifications determined by official codes. The microbiological quality of the environment for the preparation of these medicines is a critical factor in achieving efficiency and safety. Patient safety depends on the sterility of the product because these patients are usually immunocompromised. The aim of this study was to assess the microbiological quality of the process of handling anti-cancer drugs at a reference cancer treatment hospital in Pará State, Brazil. Material was collected by surface swab and spontaneous sedimentation from the biological safety cabinet (BSC), the handlers' gloves and the air conditioning system. The bacteria and fungi were identified using standard biochemical procedures and microculture. We isolated 31 colony forming units: 22 were from samples from the BSC, six from the air conditioning system and three from the handler's glove. The majority of the microorganisms identified in the BSC samples were Staphylococcus and Bacillus sp. Staphylococcus and Klebsiella sp were found on the handlers' gloves and in the air conditioning system. These results showed microbiological contamination of processes involved in antineoplastic preparations. A continuous monitoring of microbiological quality of the processes, equipment and the environment is necessary as well as a validation of asepsis and restructuring of the physical space to conform to the RDC 50/02 and 220/04.