Feasibility study of a blood derived eye drops preparation
23 November 2020Grassi Enzo , Hugerot Hélène, Loeuillet Caroline, Cogulet Virginie Pharmacy, UHC of Brest, France
Blood derived eye drops can be used as second-line therapy in various ocular pathologies. In this context, hospital pharmacies might have to develop the corresponding preparation. Regarding the recent requests from the clinicians, a feasibility study of this compounding has been realised.
II. Material & Methods
First, a review of the literature has been conducted, allowing to replace these preparations in the therapeutic arsenal, but also to compare the different blood derived preparations to each other: in particular, the Autologous Serum (AS) eye drops and the Plasma Rich in Growth Factors (PRGF). An investigation of the practices has been conducted and circulated to french hospital pharmacies. Various suppliers of medical devices (MD), aiming to standardize the preparation of these eye drops, have been consulted. To this process thus established, the fishbone diagram (or Ishikawa diagram) has been applied
From the review of the literature, a process of AS eye drops preparation has thus shaped. That has highlighted the importance of specifying the relationships with some of the subcontractors, especially the one charged with the blood sampling and the one performing the sterility tests of the preparation. In terms of the investigation, 100% of the hospital pharmacies are using AS as raw material and a 20% dilution. Furthermore, disparities in the process have come out, some of them directly related to the availability of the subcontractors: concerning the blood sampling for example, 38% are collaborating with the collection centre, 24% with the french blood establishment (EFS), and 38% with the ophthalmology unit.
Finally, the MD suppliers consulted have not been selected.
Our feasibility study has led to a precise process, the fishbone diagram having helped greatly. The implementation of this process is in progress, also via a Media Fill Test which will participate in the validation of it.