Many drugs used in the treatment of cancer are considered to be hazardous to healthcare workers. Over the last 20 years, several studies have reported environmental contamination with hazardous drugs in hospital pharmacies (Castiglia et al. 2008;Ensslin et al. 1994;Hedmer et al. 2008;McDevitt et al. 1993;Sessink et al. 1992;Sessink et al. 1995;Sugiura et al. 2011;Vandenbroucke and Robays 2001;Yoshida et al. 2011). In addition, hazardous drugs were inadvertently absorbed, as determined by the presence of parent compounds and/or their metabolites in the urine of health care workers (Ensslin et al. 1997;Schreiber et al. 2003;Sessink et al. 1992;Sessink et al. 1994;Sessink et al. 1997). Due to the potential health risks of hazardous drugs, the increasing use of these drugs, and continuing environmental contamination, the National Institute for Occupational Safety and Health (NIOSH) published an alert for antineoplastic and other hazardous drugs used in healthcare settings (National Institute for Occupational Safety and Health NIOSH 2004). Based upon recommendations, the American Society of Health-System Pharmacists (ASHP) and the International Society of Oncology Pharmacy Practitioners (ISOPP) have published updated guidelines on the safe-handling of cytotoxic and hazardous drugs (American Society of Health-System Pharmacists guidelines on handling hazardous drugs 2006;International Society of Oncology Pharmacy Practitioners Standards Committee. ISOPP standards of practice 2007).
;In Japan, guidelines for handling antineoplastic drugs in hospitals were issued by the Japan Pharmaceutical Association in 1991, which was updated in 1994. Furthermore, these guidelines were revised and published as “Compounding Manuals for Antineoplastic Agents” in 2005 and In Japan, guidelines for handling antineoplastic drugs in hospitals were issued by the Japan Pharmaceutical Association in 1991, which was updated in 1994. Furthermore, these guidelines were revised and published as “Compounding Manuals for Antineoplastic Agents” in 2005 and In Japan, guidelines for handling antineoplastic drugs in hospitals were issued by the Japan Pharmaceutical Association in 1991, which was updated in 1994. Furthermore, these guidelines were revised and published as “Compounding Manuals for Antineoplastic Agents” in 2005 and 2009(Kitada et al.). The Japanese Society of Hospital Pharmacists (JSHP) academic committee then updated and published the “Guidelines for Compounding Antineoplastic Agents,” referring to the “ALERT” in “Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings” announced by the NIOSH and guidelines from the ASHP.
Introduction of the biological safety cabinet (BSC) for the preparation of anticancer drugs is limited, with only 35.2% of hospitals using the BSC in Japan, even though guidelines on the preparation of anticancer drugs exist(JSHP. 2012). Recently, the advantage of closed-system drug transfer device (CSTD) is recognized to prevent or reduce exposure of healthcare providers from hazardous drugs. The CSTD is a device that mechanically prevents contamination of the environmental substances into a drug solution and the escape of hazardous drug or vapor concentrations outside the system. In addition, only 10.7% of hospitals in Japan currently use the CSTD (JSHP. 2012), although pharmacists in 90% or more of hospitals recognize the usefulness of the CSTD. Reimbursement of technical fees for the use of CSTD to the medical institutions under the medical insurance system were introduced in 2010, and the value was raised in2012for the preparation of volatile anticancer drugs, i.e. cyclophosphamide, ifosfamide and bendamustine; therefore, the use of the CSTD in a hospital setting has been increasing in Japanese hospitals. Interestingly, there is no authorized pharmacy technician system in Japan, and, as such, pharmacists are regarded as being primarily in charge of compounding hazardous drugs.
At Yamada Red Cross Hospital (current name: Ise Red Cross Hospital), we developed institutional manuals for compounding anticancer drugs in reference to the above guidelines and began to use BSC Class IIB2 and personal protective equipment (PPE) in the compounding room of the pharmacy department. Each pharmacist in charge of compounding anticancer drugs wear two layers of gloves, a disposable polypropylene gown with long sleeves and closed fronts, a disposable cap and a disposable surgical mask. In addition, the BSC and floor of the compounding room are wiped after compounding according to the Japanese guidelines. However, we revealed that cyclophosphamide (CP) was still detected at the sites of the wipe tests as well as in urine samples from all pharmacists in charge of CP compounding (Tanimura et al. 2009). Several studies have shown nearly complete containment or reduction in surface contamination accompanying preparation and/or administration of hazardous drug (Connor et al. 2002;Vandenbroucke and Robays 2001;Wick et al. 2003).
We conducted this study to evaluate the effects of the CSTD on surface contamination and exposure of pharmacists in charge of compounding CP in a Japanese hospital setting.