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Published on 4 November 2009

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Safe packaging and labelling of cytotoxics/hazardous drugs

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The use of informative labels and new safeguards for cytotoxic vials should be employed by hospital pharmacists, in order to reduce occupational exposure of healthcare workers

H Labrosse

L Gilles-Afchain


B Favier

Pharmacy department
Centre Régional de Lutte
Contre le Cancer Léon
Bérard, Lyon, France

Antineoplastic drugs are used in the treatment of cancer and other diseases such as rheumatoid arthritis or multiple sclerosis. Most of these agents, called cytotoxics, are chemicals that 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.2,3,4 This paper reviews the ways to reduce contamination of workers who are directly in contact with the packages and the vials supplied by pharmaceutical manufacturers.

Several authors report a significant contamination of the outside of cytotoxic vials and of the delivery packaging.2,3,4 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 stick on 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 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 to 500 vials are removed from their packages every day. If we consider that the outside contamination is around 100 ng per vial, the operator who opens cytotoxic drugs packaging before preparation in the unit can be exposed to more than 40 μg 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 production. Some manufacturers (including Teva, Mayne and Lilly) have added a plastic base and/or a sleeve on the bottom and/ or around the glass chemo vials. Others have decided to deliver glass vials provided in specially designed outer plastic containers (such as Onko-Safe from Ebewe). All these changes are implemented to minimise the risk of vial breakage. When possible, drugs packaged in plastic unbreakable vials (such as Pfizer’s irinotecan) must be preferred to other cytotoxics packaged in glass vials.

As these new marketed vials can be used easily inside BSCs and isolators, hospital pharmacists should preferentially buy from pharmaceutical companies that have introduced some measures to reduce the contamination of their packaging and the risk of breakage during transport.

However, in hospital pharmacies, precautionary measures must be taken. The operators involved in the storage of cytotoxic drugs are often forgotten when recommendations are made. They also need to be aware of the potential risks and should receive appropriate training for safe handling. Procedures dealing with breakages and spillage should be implemented. For example, employees in charge of the reception of the drugs should systematically control the packaging in order to detect possible damage. They must wear gloves when they are handling chemotherapy vials and must wash their hands after these operations. Discarded equipment, packaging materials, gloves and decontamination run-off must be treated as hazardous waste.

In our opinion, education and training are not enough; performance also needs to be reviewed periodically.[5]

Improving future practice
Most studies have evaluated the risk of exposure of nurses and pharmacy technicians, but operators involved in the transport, the reception and the storage of cytotoxic drugs should not be forgotten.

These workers should be aware of the potential contamination of the outside of vials and informed of the need to use personal protective equipment when appropriate. Suitable procedures regarding this problem should be introduced in hospitals.

The use of well-labelled packaging and new safeguards for cytotoxic vials should be preferred by hospital pharmacists. In fact, pharmacists should favour manufacturers who take this problem into account and are determined to improve their practices so as to ensure the production of contamination-free vials.

References
1. ISOPP. Standards of practice. Safe handling of cytotoxics. J Oncol Pharm Practice 2007;13:1-81.
2. Favier B, Gilles L, Ardiet C, Latour JF. External contamination of vials containing cytotoxic agents supplied by pharmaceutical manufacturers. J Oncol Pharm Practice 2003;9:15-20.
3. Connor T, Sessink P, Harrison B, Pretty J, Peters B and al. Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: results of
three studies. Am J Health Syst Pharm 2005;62:475-484.
4. Delporte JP, Chenoix P, Hubert Ph. Chemical contamination of the primary packaging of 5-Fluorouracil RTU solutions commercially available on the Belgian market. Eur J Hosp Pharm 1999;5:119-121.
5. Massoomi F, Neff B, Pick A, Danekas P. Implementation of a safety program for handling hazardous drugs in a community hospital. Am J Health Syst Pharm 2008;65(9):861-865.



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