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Expert panel report

Case study Safety improvements in the preparation of intravenous cytotoxic drugs

The first evidence of occupational exposure of health care workers to cytotoxic agents was published by Falck in 1979, and since then there have been numerous publications dealing with this topic, said Bertrand Favier (Production Pharmacist, Cancer Hospital Lyon, France), describing how practices have been developed to improve the safety of intravenous drugs for use in oncology. The first step was to determine where and how environmental contamination arose and this was done using fluorescein to detect leakage or spillage during compounding. The results showed that the most commonly contaminated areas were the work surface cover and the gloves. There were also splashes on the walls of the cabinet. Procedures were altered such that the work surface cover and gloves were changed more frequently and vented needles were introduced to avoid overpressure.

A further study to examine the contamination of gloves during preparation showed that there was considerable variability between operators – some staff contaminated their gloves on relatively few occasions but one contaminated the gloves on 100% of occasions. Procedures were changed to ensure that air was only expelled from

syringes with a cap over the needle and staff training was reviewed. The training and education of staff in good techniques was critical, noted Dr Favier.

The most dramatic results were seen when the impact of priming the administration sets in the pharmacy was investigated. A study compared the levels of 5-fluorouracil (5-FU) on nurses’ gloves when pharmacy-primed administration sets were used and when the administration sets were attached and primed on the ward. The results showed that the risk of contamination was doubled and the amount of 5-FU on the gloves was increased eight-fold when the administration sets were attached and primed on the ward. Consequently, administration sets are now attached and primed in the pharmacy. This study also underlined the need for a proper quality assurance procedure for administration of cytotoxic agents, commented Dr Favier.

A comparison between laminar flow cabinets and isolators had shown that levels of contamination were higher in isolators than in laminar flow cabinets. These results had prompted Dr Favier to keep laminar flow cabinets in his department.

device is one that is both airtight and leakproof. NIOSH defines a closed system drug transfer device as “a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system”.

Torsten Hoppe-Tichy

cytotoxic drugs. There was uncertainty about the precise definitions of open and closed systems. Some pharmacists referred to the definitions given in official guidelines whilst others felt that vials are, in their very nature, closed systems. The panel agreed that chemical and microbiological closed systems need to be defined clearly.

The National Institute for 6

Occupational Safety and Health (NIOSH) defines a closed system as “a device that does not exchange unfiltered air or contaminants with the adjacent environment”. This closed system definition originally referred to a biological safety cabinet and not to drug containment devices. A drug containment

Some centres use CSTDs routinely in the preparation of cytotoxic injections but others do not. In one hospital in France, in order to protect healthcare workers from occupational exposure to methotrexate a CSTD (BD-PhaSeal) is provided for nurses to make up methotrexate injection on the ward (for urgent treatment of ectopic pregnancy). One hospital has found that one CSTD (BD-PhaSeal) requires approximately seven times extra force to be applied (compared with a simple needle) and therefore increases the risk of repetitive strain injury (RSI).

Robotic preparation

Another approach to containment of cytotoxic drugs has been the use of compounding robots to prepare doses. This is most widespread in Turkey, where 35 hospitals are using robotic systems, including 12 hospitals that use a total of 14 Cytocare robots. Cytocare robots can prepare cytotoxic injections in sterile conditions once the ingredients have been placed in the robot cabinet and the details entered into the robot’s computer. Smaller numbers of Cytocare robots are

Severine Foucher

also in use in the Czech Republic, Denmark, Italy and Spain.

One key advantage of the Cytocare robot is that, when correctly adjusted, it can prepare cytotoxic doses with no spillage at all. In addition, it is possible to organise the pharmacy workload so that a compounding robot is used for the jobs that it handles best, leaving pharmacy staff free to prepare other products. At present there are a number of disadvantages to the use of compounding robots. Current robotic compounding systems are expensive and slow – one is able to make only 35 injections in eight hours. The speed of operation is also dependent on the altitude at which the robot is situated. Compounding robots

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