Use of a risk analysis methodology to evaluate and follow the risk of exposure of healthcare workers to cytotoxic drugs

3 October 2014

Laetitia Lê1,2, Yann Orven2, Patrice Prognon1,2, Eric Caudron1,2 1 Université Paris Sud, EA 4041, 5 rue Jean Baptiste Clément, 92290 Chatenay Malabry
2 Hôpital Européen Georges Pompidou (AP-HP), Service de Pharmacie, 20 rue Leblanc, 75015 Paris


Antineoplastic drugs are potentially cancerogenic, mutagenic and teratogenic and thus, present a risk for exposed healthcare workers. The aim of this study was to illustrate the interest of a risk-analysis-methodology based on numerous criteria to evaluate and follow the risk of exposure of healthcare workers in a compounding unit of a pharmacy. According to this specific tool, the risk can be quantified and classified allowing adaptation of new corrective measures in order to reduce the risk of exposure.

Material and methods

Chemical contamination surface and working conditions (time of exposure, level of protection and level of training have been taken into account in the risk of exposure. The risk was quantified by a critical index (CI) allowing to focus on corrective measures; a score lower than 74 is considered acceptable whereas a value superior to 194 reflects an unacceptable situation. 5 homogeneous groups of actors were followed from 2011 to 2014.

Results and Discussion

In 2011, the average CI was 92 corresponding to a tolerable situation. The implementation of targeted corrective measures enabled to decrease the CI to 66 in 2014 (-29 %). Over these 4 years, the pharmacist always presented acceptable exposure (CI≤74) thus no particular measure was required. Besides, the pharmacy technician, the pharmacy technician aid, the cleaners and the laboratory technician presented tolerable exposure (74<CI≤194) from 2011 to 2013.

The implementation of successive corrective measures (increase of the level of protection, modification of cleaning protocols) has induced a reduction of the exposure of the laboratory technician since 2013 and the pharmacy technician in 2014 to an acceptable level.


Through this indirect approach, the risk of exposure can be objectivized and reduced by the implementation of targeted corrective measures. An annual monitoring allows appreciation of the efficiency of the corrective measures and the drift of practices.

Key words: Risk analysis, exposure assessment, cytotoxic drugs

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