GM-026 Quality management system in cytotoxic drugs laboratory: monitoring activity and improvement actions

    loading  Checking for direct PDF access through Ovid



The Quality Management System (QMS), present in hospital pharmacy certified according to UNI EN ISO 9001:2008, has been implemented in the antineoplastic drugs laboratory.


The purpose of this study was to present tools and evaluation methods for work activity to improve both quality and safety of therapies.

Material and methods

Several specific performance indicators, with related reference values, were identified for critical activities: number of non-compliant preparations/number of controls executed (3%); number of sterility checks with negative results/number of checks executed; number of environmental negative controls/number of environmental controls (both 100%). In addition, a questionnaire was submitted to internal users concerning the main aspects of our service: quality, packaging of the preparations, clarity of the labels and administration form, and delivery time. Finally, we analysed the non-conformities recorded and then we implemented corrective/preventive actions.


The indicators were verified and provided values in line with the reference values: non-compliant preparations 1–2%; product and surfaces sterility 100% negative reports. The questionnaire of internal user satisfaction confirmed that the overall quality of the service was good and packaging was in line with the indications in the data sheet. Delivery time was judged as not always on time and the labels, included in photo-shielding envelopes, as not clear. Given that the validation phase has been optimised, giving priority in parallel to monotherapy set ups and to first therapies for multiple patients, the delivery frequency to the department was increased; a packaging update improved the visibility of the labels. The registered non-conformities were 5 and led to the opening of four corrective and two preventive actions: it was decided to optimise staff training regarding the risk of cytotoxic drugs and the need for double controls during work in the hood was reiterated.


QMS support has helped us to create condition for effective management of the laboratory since its activation, to provide appropriate instruments for activity evaluation and to identify critical issues that can be resolved through concerted and shared measures.

References and/or acknowledgements

Thanks to the pharmacy service.

References and/or acknowledgements

No conflict of interest

Related Topics

    loading  Loading Related Articles