Use and handling safety of Mini-Spike 2® chemo and puresite for safe chemotherapy compounding in a hospital pharmacy

Regul Toxicol Pharmacol. 2018 Dec:100:1-6. doi: 10.1016/j.yrtph.2018.10.002. Epub 2018 Oct 6.

Abstract

We wanted to evaluate the impact of Mini-Spike 2® Chemo + Puresite (MSCP) use on contamination surface levels, professionals' satisfaction and compounding time at pharmacy compared with Phaseal™. Presence of cyclophosphamide (CYP) and 5-fluorouracil (5FU) was evaluated at three sampling times: baseline; after a decontamination procedure and six months after MSCP use for CYP and 5FU compounding. Testing was carried out using an independent laboratory and wipe testing kit. To test compounding time, four different nurses followed the same compounding protocol with each device. We also developed a questionnaire to obtain feedback from the nurses. We did not find statistically significant differences in the median contamination surface levels between basal and final sampling time, CYP (0.140; 95% CI -1.135, 1.601), 5FU (-0.506; 95% CI -1.756, 0.287). We observed a difference of 10 s on compounding times between the two devices tested (p < 0.001) favoring MSCP. Finally, eight nurses answered the survey, with the best valued aspect as the aspiration/injection flow and resistance, and the worst value the comfort using Puresite and valve connection. MSCP maintains low surface contamination levels in our setting assuring compounding time standards. Satisfaction survey let us know which were the major advantages and disadvantages of the device.

Keywords: Chemotherapy; Compounding; Drug transfer device; Occupational health; Pharmacy.

MeSH terms

  • Antineoplastic Agents / analysis*
  • Cyclophosphamide / analysis*
  • Environmental Monitoring
  • Equipment Contamination
  • Filtration / instrumentation*
  • Fluorouracil / analysis*
  • Nursing Staff, Hospital
  • Occupational Exposure / prevention & control*
  • Pharmacy Service, Hospital
  • Surveys and Questionnaires

Substances

  • Antineoplastic Agents
  • Cyclophosphamide
  • Fluorouracil