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HANDLING OF HAZARDOUS DRUGS IN HEALTHCARE SETTINGS – HAZARD EVALUATION AND PROTECTIVE MEASURES RELATED TO EXPOSURE LEVELS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Falko Schüllner, Martina Jeske, Martin Munz, Sabine Bischinger, Anna Reich

Why was it done?

The right handling of hazardous drugs in healthcare settings is essential to ensure occupational safety and health as the use and number of these potent drugs increase. In the last decades, protection at the workplace has become more important and several organizations analyze substances for this very reason. Although the antineoplastic drugs remain the principal focus, other drugs may also be considered hazardous because they are potent or cause irreversible effects.

What was done?

In this study drugs used in the University Hospital considered hazardous and to describe potential exposure values were evaluated in connection with exposure limits. A health risk assessment was conducted regarding protective measures related to exposure levels.

How was it done?

The National Institute for Occupational Safety and Health (NIOSH) assumes five categorizations with hazardous potential. According to their ATC-Code, substances from this categorization were listed. Findings of the European Chemicals Agency (C&L inventory), European Directorate for the Quality of Medicines & HealthCare, manufacturer’s guidance, European public assessment report, and safety data sheets were compared with categorization from the International Agency for Research on Cancer, NIOSH, Food and Drug Administration pregnancy categories, and publications from the German Berufsgenossenschaft für Gesundheit und Wohlfahrtspflege. The topic of exposure was divided into a determination of exposure limits in safety data sheets or in the “Grenzwerteverordnung” and into published information regarding exposure in healthcare settings. Monoclonal antibodies were examined separately. For risk assessment purposes, Stoffenmanager and other relevant tools were used.

What has been achieved?

717 substances were analyzed. 461 of them showed at least one probable hazardous or hazardous characteristic. It was possible to establish 177 threshold values, 124 for hazardous substances. The range of threshold values for the criterion “hazardous” was 0,015 μg/m3 – 10 mg/m3. Further research yielded a few public health publications referring to exposure values.It is hardly possible to quickly obtain information on the hazard potential of drugs, but C&L inventory has shown good results . Beside, there is a lack of data on exposure limit values, which is due to the difficulty in providing safety data sheets from manufacturers. As a result, exposure tools are not readily available for use by healthcare workers.

What next?

In an ongoing process every new drug will be evaluated towards the hazardous properties respectively associated exposure limits and communicated to the health care workers in the institution.

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