Pharmaceutical aseptic preparation on-call duty period: setting up a training and accreditation program for pharmacists

Introduction
The performance of aseptic preparations during on-call duty meets the pharmaceutical permanence obligations of public health establishments. In the context of the re-authorisation of activities by the competent authorities and the enforceability of French Good Preparation Practices 2023, it is necessary to ensure that pharmacists participating in on-call pools have the necessary skills. This work will present the training and accreditation program implemented in our establishment.

Material and Methods
A 3-phase accreditation program has been decided following consultation between training pharmacists
• Phase 1 : making of 5 placebo preparations inside an isolator, under the supervision of a pharmacist. Objective : to determine the learner’s skills based on his experience, review of basic aseptic handling techniques.
• Phase 2 : training in the production of preparations, under the supervision of qualified preparers, with a set objective as to the nature of the preparations to be made.
• Phase 3 : accreditation with 5 placebo preparations inside an isolator and aseptic filling test (AFT) under laminar flow hood with worst case (minimum 3 criteria).

A review of the protocols carried out on-call duty selected the nature of the 10 simulated preparations (phases 1 and 3). For these, the following variation criteria were established: final container (bag, syringe), withdrawals/dilutions, drug presentation (lyophilisate, ready-to-use product, glass ampoule), use of specific medical devices (Spiros^®, 0.22µm filters).

An accreditation grid (58 points divided into 13 categories) was drawn up. Pharmacist accreditation was based on validation of at least 50 points and compliance of the AFT after incubation.

Results and discussion
Since January 2024, 9 pharmacists (out of 20) have been re-certified by this program (average score : 55,1 [53 ; 58], compliance of all AFT). Training and accreditation require a considerable amount of time (average of 6 hours for phases 1 and 3, not including the preparation of equipment kits). This is why, initially, accreditation will be validated for 3 years. Using placebo preparations was based in particular on the simulation of costly or exceptional preparations (antidotes). In the long term, this protocol could be improved to also vary the excipient composition of the placebos (foaming, viscous). From a subjective point of view, the re-accreditation helped to boost the confidence of pharmacists, particularly those who do not carry out their day-to-day work in a sterile preparation unit.

Conclusion
The proposed programme meets a need to formalise training and accreditation in aseptic handling and has been fully integrated, in our hospital centre, into the wider training programme for pharmacists’ on-call duties.

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