Packaging
Safe packaging and labelling of cytotoxics/hazardous drugs
Exterior contamination of cytotoxic vials can be hazardous for those involved in the transport, receipt and storage of drugs. Improved packaging, labelling and training could protect this group of workers from occupational exposure
Helene Labrosse PharmD Laurence Gilles-Afchain PharmD Bertrand Favier PharmD PhD
Antineoplastic drugs are used in the treatment of cancer and other diseases such as rheumatoid arthritis or multiple sclerosis. Most of these agents are cytotoxics and act on the process of DNA synthesis within the cancer cell. Nevertheless, because of their non- selective mechanism of action, they affect non-cancerous as well as cancerous cells, resulting in well-documented side effects. Furthermore, they have teratogenic, genotoxic and carcinogenic characteristics. These hazardous drugs can be dangerous for healthcare handlers if suitable protective measures are not in place.
Workers’ exposure can occur by inhalation, absorption through the skin or ingestion. The main route of
contamination is direct skin contact with the drugs.
Many studies have now demonstrated that the working surfaces within hospitals are contaminated with cytotoxic drugs. In recent years, several international guidelines have been published for the safe handling of anticancer agents.1 Pharmacy technicians are asked to prepare the treatments using biological safety cabinets (BSCs) or isolators. Nurses must wear gloves when administering the drugs to the patients. We also know that occupational exposure can arise from the outside of cytotoxic vials, which have been found contaminated in several instances.2–4
This article reviews the ways 6
to reduce contamination of workers who are directly in contact with the packages
www.hospitalpharmacyeurope.com
Pharmacy department, Centre Régional de Lutte, Contre le Cancer Léon, Bérard, Lyon, France
and the vials supplied by pharmaceutical manufacturers.
Several authors report a significant contamination of the outside of cytotoxic vials and of the delivery packaging.2–4 This situation can result in the contamination of the hands of the employees who are carrying or handling these packages or vials.2
Packaging
Information is not always available for those people in charge of transport, at reception, in the inventory control and in storage of antineoplastic vials. All cytotoxics supplied must be clearly identified on the external packaging. Most European countries ask manufacturers to
primary containers: they supply their cytotoxic agents encased in specially- designed moulded plastic containers to confine any possible contamination in case of spillage and also to provide protection against shocks during transport.
Vials
In our cancer treatment centre in Lyon, the preparation of cytotoxic drugs is centralised under the control of pharmacists using BSCs. In this unit, where more than 50,000 preparations a year are made, 400–500 vials are removed from their packages every day. If we consider that the outside contamination is around 100ng per vial,
“Many studies have now demonstrated that the working surfaces within hospitals are contaminated with cytotoxic drugs”
attach a pictogram in order to help recognise anticancer agents. A warning sign identifying hazardous drugs can also appear on the outer packaging. All these measures are necessary for people handling cytotoxic agents to make identification of these drugs easier. The packaging is also important to prevent material breakage during the carriage from manufacturer to hospitals and thus limit the potential exposure of pharmacy storekeepers. Some manufacturers have finalised new
the operator who opens cytotoxic drugs packaging before preparation in the unit can be exposed to more than 40 micrograms everyday.
It is recommended, from now on, to wear personal protective equipment such as gloves and gowns in order to create a temporary barrier between the healthcare worker and the vials.
Pharmaceutical suppliers can help decrease the exposure of healthcare workers by extra washing and/or wrapping vials in plastic during
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