Risk management is necessary for preparation of anticancer agents in terms of ‘safe handling’ based on recognition of hazards by occupational exposure to the drugs during preparation. However, penetration of the concept of safe handling and discussion on protective measures for the issue by hospital management and pharmacists has been behind for years in Japan compared with other foreign countries
Cancer Institute Hospital of JFCR is one of major hospitals with more than 150 patients per day in average in treatment with chemotherapy. Sterile compounding environment in our hospital is controlled with high level of engineering by four biological safety cabinets which are equipped in an isolated negative pressure room to exhaust 100% to outside (Class II type B2). Also it is standard procedure in our department to follow the sterile compounding guideline and pharmacists have donned PPE such as mask, gloves, gown and so on during preparation of chemo drugs.
In 2006 wipe and urine tests were carried out in our department which has been considered to comply with the guideline. Cyclophosphamide (CPA) was used as indicator for environmental contamination and human uptake. The test detected 293–22 363 ng/cm2 in the environment and 12.5–45.8 ng/24 h in urine samples of four out of six pharmacists who were engaged in the drug preparation.
Consequently improvements were made upon review and revision of cleaning procedure and PPE selection. In addition, pharmacists were educated in regard to occupational exposure during preparation of anticancer agents and also preparation manual and the technique were assessed for improvement. Closed-system drug transfer device (PhaSeal® System) was implemented in 2010 for CPA preparation only. Having these interventions enforced, CPA was measured in the same environment again in 2008, 2009 and 2011. Contamination was reduced evidently after implementation of the CSTD (PhaSeal® System).
Further discussion remains to determine whether the CSTD (PhaSeal® System) is necessary for all anticancer drug preparations. Other challenges outside pharmacy include how to protect healthcare workers during transfer, priming in wards and disposing IV bags after administration of anticancer agents.