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Standardization of Autologous Serum Eye Drops Preparation Practices in France: Delphi Method
Lucille Champmartin1, Damien Lannoy2,3, Marine Coulomb1
1Unité des préparations galéniques, PUI, CHU de Limoges, France.
Summary
A Delphi method developed a consensus protocol for preparing autologous serum eye drops (ASEDs). This standardization aims to improve the quality, safety, and availability of ASEDs for dry eye disease patients.
Area of Science:
- Ophthalmology
- Pharmacology
- Health Services Research
Background:
- Dry eye disease significantly impacts quality of life and incurs healthcare costs.
- Severe, treatment-resistant dry eye can lead to visual impairment.
- Autologous serum eye drops (ASEDs) offer a therapeutic alternative for refractory cases.
Purpose of the Study:
- To establish a national consensus-based protocol for ASED preparation in French university hospitals.
- To enhance the quality, safety, and supply of ASEDs.
- To address preparation heterogeneity and limited availability of ASEDs.
Main Methods:
- A Delphi method was employed for consensus building among hospital pharmacists.
- The protocol development covered blood sampling, preparation, postproduction controls, and storage.
- Four rounds of anonymous expert consultation via Google Forms® were conducted.
Main Results:
- A 26-item standardized protocol for ASED preparation was validated.
- The consensus process involved 12 experts over 86 days.
- Specific items were validated across sampling, preparation, control, and storage phases.
Conclusions:
- A standardized ASED preparation protocol was successfully developed.
- Implementation of this protocol is expected to improve ASED availability nationwide.
- The Delphi method ensured expert consensus and avoided opinion leader bias.
