| Abstrakt: |
BACKGROUND: Pharmaceuticals are a large component of the healthcare system. The cost of drugs continues to rise every year, especially intravenous antineoplastic agents and monoclonal antibodies. Extending the beyond-use date of nonpreserved vials of antineoplastic agents allows them to be used in multiple preparations, which has been shown to save costs. Studies of closed-system transfer devices (CSTD) usually focus on reducing exposure to hazardous materials. Data on maintaining the sterility of single-use vials beyond-use date with the use of a CSTD are limited. OBJECTIVES: To validate in actual practice in a hematology-oncology pharmacy the internal 7-day beyond-use date for unpreserved vials of antineoplastic agents that are known to be chemically stable for at least 7 days, and to assess if they could remain stable for up to 15 days. METHODS: We performed a real-time collection and validation of the sterility of single-use vials of antineoplastic agents between March 2015 and June 2015. Drugs in nonpreserved, single-use vials that had at least 1 mL of liquid and had a CSTD (ie, the PhaSeal system) adaptor attached, were collected at day 8. All vials had been used at least once for regular preparation of antineoplastic doses dispensed to patients to verify sterility after actual practice manipulation of the CSTD and the vials. Two 0.5-mL samples were tested in a thioglycollate broth and in a tryptic soy broth separately. Each sample was then incubated for 15 days. On day 15, 2 additional 0.5-mL samples were removed from the vials and were sampled in a thioglycollate broth and in a tryptic soy broth. RESULTS: A total of 50 vials with a CSTD were collected during the 4-month study period. This included 18 different cytotoxic agents and 4 monoclonal antibodies. Two samples of 1 drug, carfilzomib, tested positive for microbial growth on day 8. Further testing suggested that these were false-positive findings, which were caused by a reaction of the drug to the growth media. CONCLUSION: Our findings show that when compounding hazardous medicines, the use of a CSTD, such as the PhaSeal system, can maintain sterility in nonpreserved single-use vials for 7 days, and extend their beyond-use date for a minimum of 15 days. [ABSTRACT FROM AUTHOR] |
