HPE HPE 85 – Spring 2017 - Page 14

Symposium report “This experimental design follows a method described in a published protocol”, commented Dr Wilkinson. The effect of the nitrogen flow is to present constantly saturated cyclophosphamide vapour to the ToxiGuard filtration system of the Tevadaptor CSTD. If the CSTD system remains effective then nitrogen gas will flow through the 0.2 micron filter and the ToxiGuard activated carbon membrane, providing pressure equalisation at all times, but the drug will be retained. The exit tube from the apparatus (carrying the exhaust nitrogen) goes to a cold trap (at -90°C) so that all of the vapour that is released by the system is captured. In addition, the rinsate from the trap plus washings from the internal surfaces of the apparatus was analysed using liquid chromatography with tandem mass spectrometry (LC-MS/MS) equipment capable of detecting as little as 10 picograms of cyclophosphamide. The activated charcoal membrane was being challenged with cyclophosphamide vapour – one of the most volatile hazardous drugs in existence – at 50°C at a flow rate of 300ml/minute for 24 hours, and even under these stringent test conditions, the results consistently showed that the amounts of cyclophosphamide that escaped was below the limit of quantitation, suggesting that the ToxiGuard filter was capturing all of the drug, said Dr Wilkinson. The ToxiGuard filters were later removed and extracted to determine the amounts of cyclophosphamide trapped. The results showed that in two (out of five replicates) the amount of cyclophosphamide detected exceeded 10,000 nanograms. “This study provided two robust pieces of evidence – first, there was no cyclophosphamide outside the Tevadaptor CSTD/drug vial assembly and, second, the ToxiGuard filter captured and retained 100% of the cyclophosphamide vapour. A flow rate of 300 ml/hour for 24 hours means that the CSTD was challenged with 432 litres of cyclophosphamide-containing vapour, whereas in normal use a volume of 100ml might be pushed through a CSTD – so we conclude that OnGuard/Tevadaptor is 100% effective”, said Dr Wilkinson. Dr Ian Pengelly anaphylactic shock. In addition, health care staff can harbour resistant organisms as a result of frequent exposure. Nurses have reported seeing splashes and leakages during preparation of injections and experiencing a bitter taste. The Swedish Work Environment Authority has recently established a maximum limit for penicillin of 0.1mg/m 3 as inhalable dust. Pilot studies in Sweden and Hungary assessed the effectiveness of the Tevadaptor CSTD to reduce environmental contamination with antibiotics (vancomycin, Augmentin, ceftriaxone and meropenem in Hungary, and cefotaxime, piperacillin, benzylpenicillin, vancomycin, ceftriaxone and meropenem in Sweden). Baseline studies showed that the needle and syringe method of preparation was associated with widespread contamination. The introduction of the CSTD resulted in substantial, statistically significant reductions in the levels of contamination with all antibiotics in Hungary, and with four out of six in Sweden. There were no reduction in the levels of ceftriaxone and meropenem in some positions and the reasons for this are not clear, said Dr Sessink. References 1 Preventing occupational exposure to cytotoxic drugs. Sessink PJM, Sewell G, Vandenbroucke J (eds). www.europeanbiosafetynetwork.eu/preventing -occupational-exposure-to-cytotoxic-drugs/ (accessed April 2017). 2 Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration 2011. Am J Health Syst Pharm 2012;69:768–85. 3 US Department of Health and Human Services. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/ classification.cfm?ID=ONB. 4 Nygren O et al. NIOSH Definition of closed-system drug-transfer devices. Ann Occup Hyg 2009;53:549. The satellite symposium, Containing hazardous drugs with CSTDs: Understand the evidence and requirements from USP 800 to the NIOSH Universal Testing Protocol was held during the ASHP Midyear Clinical Meeting, Las Vegas USA in December 2016. The symposium was sponsored by B Braun USA, which markets OnGuard / Tevadaptor in the US. Key points • Closed system transfer devices (CSTDs) should be tested for vapour containment using suitable surrogate agents and with actual hazardous drugs. • 2-Phenoxyethanol 2.5% is a safe and suitable surrogate agent for vapour- containment testing. 12 Exposure to antibiotics Occupational exposure to antibiotics can be a serious hazard, according to Dr Sessink, with effects ranging from hypersensitivity and allergies to hospitalpharmacyeurope.com • Both Tevadaptor (filtration-type) and BD-PhaSeal (barrier-type) CSTDs contain vapour effectively when tested using the NIOSH protocol. • Rigorous testing of the Tevadaptor shows that it is 100% effective at containing cyclophosphamide vapour