HPE HPE 85 – Spring 2017 - Page 9

Symposium report Issue 85 | Spring 2017 administration on the ward. Once a week, a two-step cleaning procedure was recommended. The first step involved cleaning using a cloth or tissue moistened with 0.05 M sodium hydroxide and the second step, 70% isopropyl alcohol or ethanol. A reference value of 0.1ng/cm 2 was taken for all drugs (any value above this was recorded as being positive). The results showed that the proportion of positive samples (of 814) was 19% in part I, 15% in part II and 14% in part III. A more detailed examination of the results showed that the overall levels of contamination also decreased. As expected, the most highly-contaminated areas were the work surfaces inside the BSC/isolator and the floor beneath the BSC/isolator. An observational study was carried out in Heidekreis-Klinikum (Soltau, Lower Saxony, Germany) hospital pharmacy over 180 preparation days (from February to October 2016) when a closed system medical device portfolio (supplied by B Braun Melsungen) was used routinely. This pharmacy normally prepares 1500–1600 cytotoxic drug doses per year. The results showed that contamination with 5-fluorouracil (5FU) (the most frequently used product) and cyclophosphamide (the product that is most difficult to clean) was sharply reduced when using the closed system portfolio. Mr Meier concluded that the closed system reduced the risk of contamination and the safety that it provided was affordable. However, there was one factor that was beyond the phamacy's control and that was the contamination on the exterior surfaces of the drug vials, which can affect the processes and has to be considered as well. Safe handling procedures for hazardous drugs can dramatically reduce the The closed system was composed of the following main products: • Mini-Spike ® 2 Chemo: a closed- system device that enables reconstitution of hazardous medications. Its integrated 0.2µm air filter retains all aerosol generated during drug reconstitution. The device prevents entry of bacteria in the medication vial and maintains sterility of the solution for up to 14 days when working in an aseptic environment and if the medication is stable up to this period • PureSite: enables use of a syringe in a closed-system and offers the comfort of reducing contamination from a filled syringe. The PureSite is designed with a dedicated cap that provides all necessary risk reduction during transportation of bolus syringes • Cyto-Set ® Mix: a secondary line that allows the needle-free admixture of cytotoxic drugs. The needle-free connector made of tritan is tested for resistance with cytostatic drugs • Cyto-Set ® Main Line: a special IV set that helps to reduce the risks of chemical contamination and air embolism thanks to the creation of a closed system. The risk of drug incompatibility is reduced through the flushing of the line. The needle-free connectors made of tritan are tested with different kinds of cytotoxic drugs and have integrated back-check valves potential exposure of health care workers to these drugs; they should be implemented at all points where there is the potential for exposure of staff or patients. These include receipt and storage of drugs, drug preparation, administration, transportation, and waste Research about Environmental Contamination by Cytotoxics and Management of Safe Handling Procedures (MASHA) The goal of the project was to obtain an overview of the current situation in Europe concerning cytotoxic drug contamination in the workplace. The project involved assessment of surface contamination in preparation and administration areas at baseline (part I) and after the implementation of cleaning recommendations (part II). Part III includes further measures (for example, closed system) to protect health care staff who handle cytotoxic drugs. Nineteen European hospitals took part in the study. Variable amounts of surface contamination were detected including measurable amounts of at least one agent in each hospital. There was no correlation between the levels of contamination and the amounts of drugs pre pared. www.esop.li/masha.php handling, including patient waste, drug waste, and laundry. In summary, Mr Meier said that the MASHA project has provided an overview of the cytotoxic contamination and the local procedures for safe handling of cytotoxic drugs in European hospitals. Evidence of contamination is still being found but the levels differ between hospitals. The study conducted in Heidekreis Klinikum has demonstrated that in order to reduce contamination, it is necessary to implement safe products which, when used together, provide closed system during reconstitution, transportation, administration and disposal. In conclusion, the two key steps to decrease contamination of hazardous substances are appropriate implementation of cleaning procedures and appropriate choice of devices. The next steps will be to formulate safe handling procedures based on the European Society for Oncology Pharmacy (ESOP) Quality Standards for the Oncology Pharmacy Service (QuapoS). These will deal with the whole process from drug delivery to pharmacies through to their use in wards. A collaborative research programme with the European Society of Medical Oncologists (ESMO) and the European Society of Paediatric Oncology (SIOPE) is also planned. This will include 50 hospitals and be concerned exclusively with the handling of cytotoxic drugs on wards. At present there is no quality management in this area and practices for preparation and administration of drugs are inconsistent, he explained. “We need to look for devices that can make this a safe procedure because it is important to protect health care staff from the risks of occupational exposure to cytotoxic drugs”, he concluded. Parenteral nutrition Parenteral nutrition (PN) solutions are high-risk products because of their complexity and the dangers posed if prepared or administered in error, Simbarashe Mavhunga (Advanced pharmacist, aseptic dispensing, NHS Tayside, UK) explained. Products containing visible precipitates can easily be identified and withdrawn but micro- crystallisation can also be hazardous and is difficult to detect, he continued. PN is prescribed for patients of all ages with underlying health problems or who are unable to tolerate nutrient by the hospitalpharmacyeurope.com 7