Training and qualification in the visual inspection and labelling of hospital-compounded eye drops

Context and objectives
In accordance with Ophthalmic Preparations monograph of the European Pharmacopoeia, hospital-compounded eye drops must undergo visual inspection before vial labelling. Our unit produces these preparations and has inspection tables and an automated labelling system to perform these final steps. To comply with Good Preparation Practices (GPP), the objective of this work was to formalize staff training for these processes and to implement evaluation tools to authorize staff.

Materials and methods
A training booklet was developed, including a description of the workflow and equipments, instructions for using inspection tables (visual control) and automated labelling machines. A defect library consisting of 10 non-compliant (NC) vials was also created for training purpose.
Evaluation tools included a written knowledge test ; a test batch of 60 eye drops vials, similar to those produced in routine practice, including 11 NC (improperly sealed caps, non-compliant fill volumes, presence of various types of particles) and a skills evaluation grid completed by the assessor during a practical session. In the case of successful completion of these assessments and following an interview with a pharmacist, staff members were authorized to perform the inspection and labelling eye drop vials.

Results
Five participants (4 pharmacy technicians and 1 pharmacy resident) completed the training and were evaluated. The training lasted 3 days, with evaluation conducted 7 days later. The knowledge test was the least sucessfully component, with an average score of 15.5/20.
Regarding the test batch of 60 vials, 4 of the 5 participants identified 100% of the NC. One participant failed to detect an underfilled volume. Finally, 2 of the 5 participants incorrectly rejected some compliant vials due to false false detection of particles in oily eye drops. As this was not considered a critical error, these participant were still authorized (second opinion can be requested in case of doubt during routine work). The final interview also provided an opportunity to review theoritical concepts. All participants reported satisfaction with the training.

Discussion and conclusion
The results showed that the training effectively enables staff to acquire the necessary skills for inspection and labelling of eye drop vials. Feedback from learners helped to clarify ambiguous items in the knowledge test. These tools will continue to be used to train new staff and for the periodic reassessment of current personnel.

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