Exposure to hazardous drugs in Healthcare: An issue that will not go away

Abstract

The Journal of Oncology Pharmacy Practice (JOPP) was first published in June 1995 as the official journal of the International Society of Oncology Pharmacy Practitioners (ISOPP). In a supplement to that issue, as part of a review of the ISOPP IV symposium presentations, an article by Professor Graham Sewell was included titled ‘Pharmaceutical issues: preparation and handling’. This article raised concerns about various aspects of quality and safety associated with cytotoxic drug reconstitution. It discussed the use of cytotoxic safety cabinets versus isolators, the use of early ‘closed systems’ and even the possible future use of robotics. In the 15 years since that first publication, interest in the handling of hazardous drugs used to treat cancer patients has not waned. At the recent ISOPP XII symposium held in Prague in May 2010, ten presentations and seven submitted abstracts on the topic of safe handling were included. From the highly technical use of robotics and the use of specialized closed systems to the basic use of personal protective equipment (PPE) in under-resourced countries, this subject remains highly topical. One reason for the interest in this topic is the inability to quantify the occupational risk of handling anticancer drugs. It is well recognized that patients treated with therapeutic doses of these drugs may develop second cancers years later. However, the risk associated with long-term very low level exposure to these agents is not currently measurable. A basic tenet of employment is the provision of a safe workplace. It may be impossible to remove all risk but it is imperative that risk is minimized. Large pharmaceutical companies manufacturing anti-cancer drugs do so in totally enclosed environments with workers wearing full respirator suits reminiscent of movies of outbreaks of a deadly virus. But it is financially completely beyond individual hospitals, institutions and clinics to supply such protective equipment. The smaller the preparation facility, the less viable it is to introduce expensive protective measures. Many pharmaceutical companies have improved the presentation of their anti-cancer drug products in several ways. The drugs are generally presented, when stability allows, in liquid form – this means less manipulation is required to prepare a dose. The drugs are generally packaged in plastic containers – this means less chance of vial breakage. When compatibility problems arise and do not permit plastic packaging, and glass containers are required, these are generally protected in some way to avoid breakage and leakage e.g., an ‘overcoat’ of plastic is placed over the vial. These improvements in packaging are applauded. However, it is known that external chemical contamination of drug vials arriving from the manufacturer is a problem. Manufacturers must accept responsibility for ensuring that only clean product leaves their facilities. It is discouraging when every safeguard is taken to protect staff preparing anti-cancer drugs, to find that a major source of contamination is the outside of the drug vials themselves. Before we place all the responsibility onto the manufacturers, we must first ensure that we are doing everything possible ourselves to reduce the contamination of the environment and ourselves and we still have quite a long way to go. The paper by Shin-ichi Sugiura et al. ‘Risks to health professionals from hazardous drugs in Japan: a pilot study of environmental and biological monitoring of occupational exposure to cyclophosphamide’ in this issue of The Journal describes a pilot study performed in 2006 looking at cytotoxic drug environmental contamination in two similar hospital departments.