Harmonisation of pharmaceutical release practices for injectable chemotherapy preparations after analytical control

M. Beaurain1, A. Teixeira1, A. Baudouin1, F. Ranchon1, C. Rioufol1, N. Vantard1
1 : Oncology Clinical Pharmacy Unit, Pharmacy, Lyon South Hospital Group, Hospices Civils de Lyon

Context and objective
More than 70,000 preparations of injectable chemotherapies are produced per year, in a non-robotic way, in our unit. Analytical control is performed for about 60% of the production with the QcPrep+® (UV/visible and Raman) and MultiSpec® (UV/visible and IR) automated systems. The pharmaceutical release of the preparations includes the validation of the results of the analytical control and the management of possible non-conformities. The aim of this study was to compare the management practices of the analytical control results by the pharmaceutical team before/after optimization of the procedure for this step.

Material and methods
An optimised procedure for managing non-conformities following analytical controls was implemented and the team of pharmacists involved in the pharmaceutical release of preparations (n= 9) was trained in this new procedure. To assess the impact, a retrospective study over 10 months (5 months before, representing 16,441 doses and 5 months after, i.e. 16,038 doses) was carried out to analyse the behaviour of pharmacists with regard to the results of analytical controls (validation, new sample, destruction and remanufacture). The compliance criteria are quantitative (measured concentration of active ingredient between +10% and -15% of the theoretical value) and qualitative (active ingredient and solvent). In case of non-compliance, a second assay must be performed. For the preparations released despite a non-conformity on the concentration of the finished preparation, an assessment of the potential clinical impact has been performed. For the non-toxic preparations, the potential clinical impact was considered low, in contrast to the cytotoxic preparations for which it was considered high. A test for comparison of mean proportions (Student’s t test) was used.

Results
The implementation of the new procedure significantly (p=0.008) reduced the proportion of preparations released despite non-compliance (4.40% before vs. 1.54% after), but the number of preparations remanufactured increased (2.3 bags remanufactured per 1000 before the procedure vs. 4.0 after, p=0.003). Some non-compliant preparations were released because they were visually double-checked during the manufacturing process. Preparations released with a low or high potential clinical impact were less frequent after the implementation of the procedure (29.5 preparations with low clinical impact per 1000 before vs. 11.4 after; p=0.002 and 1.8 preparations with high clinical impact per 1000 before vs. 0.7 after; p =0.22).

Discussion – Conclusion
This study highlighted the relevance of this optimised procedure for validating dosages of chemotherapy preparations. It allowed a standardisation of release practices and a better guarantee of patient safety. Regular training will be necessary to ensure its correct application. The secondary benefit of this new procedure was to reduce the number of samples and dosages wrongly taken, and thus improve the unit’s productivity.

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