Non-sterile preparations: how to assess occupational risk for pharmacy technicians ?

Objective
When producing non-sterile preparations (NSPs), pharmacy technicians are required to handle hazardous substances - including those classified as carcinogenic, mutagenic, or toxic to reproduction (CMR). The objective of the present study is to establish a method for assessing chemical and CMR-related risks to personnel exposed to hazardous substances, in order to adapt the personal protective equipment (PPE) and collective protective equipment (CPE) required.

Methods
The list of NSPs prepared over the past five years was analyzed. Various risk scores (including a potential risk hierarchization (PRH) score) were calculated using the simplified chemical risk assessment methodology developed by the French National Research and Safety Institute (Institut national de recherche et de sécurité, INRS, Paris, France). The PRH score was weighted with regard to the frequency, the hazard class, the quantity and the preparation process. Intrinsic hazard classes were determined from each compound’s summary of product characteristics (SPC), safety data sheet (SDS), and information on the European Chemicals Agency (ECHA) website.

Results
Of the 36 NSPs analyzed, 4 did not include any health hazard statements. A high priority (HP) was defined as a PRH score of >10,000 regarding ocular, dermal, and respiratory toxicity, or a PRH score >3,000 regarding CMR risks. Of the 32 NSPs presenting a risk, 19 included an ocular hazard statement, and 2 of the latter required the use of safety goggles. Twenty-seven NSPs (including 4 with an HP) presented a respiratory hazard, and 14 NSPs (including 8 with an HP) had a CMR hazard statement (H350 "May cause cancer", H360 "May damage fertility or the unborn child") and therefore required handling in a biological safety cabinet. Furthermore, 25 NSPs (including 4 with an HP) required handling with gloves (in compliance with European standard EN 374).

Discussion/Conclusion
The results of the present study helped us to identify the NSPs that posed the highest risk to technicians. Based on the identified risks, PPE and CPE requirements were updated for each NSP. Although the INRS methodology does not factor in PPE, the dermal risk is mitigated by the systematic use of gloves: more frequent glove changes or the use of more pairs could be considered for high-risk NSPs. The INRS methodology had to be adapted for the evaluation of (i) intrinsic toxicity (due to limited data in SPCs, differing SDS hazard statements for the same compound, and a lack of consensus in ECHA data) and (ii) the actual exposure levels (bulk volatile powders, grinding operations, etc.). A standardized risk analysis form was developed

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