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CIRCUIT FOR THE PREPARATION, CONTROL, AND DISPENSATION OF AUTOLOGOUS SERUM EYE DROPS IN A PHARMACY SERVICE

European Statement

Production and Compounding

Author(s)

Eva Gómez-Costa; María Begoña Feal-Cortizas; María Mateos-Salvador; Sandra Rotea-Salvo; Andrea Luaces-Rodríguez; Laura Caeiro-Martínez; Clara Fernández-Diz; Andrés Torres-Pérez; Luis Margusino-Framiñán; María Isabel Martín-Herranz

Why was it done?

Implement a circuit for the preparation, microbiological control, analytical control of patients, and dispensation of autologous serum eye drops in the Pharmacy Service (PS) of a tertiary-level hospital.

What was done?

Autologous serum eye drops are classified as a special medication that must be prepared in authorized centers with an up-to-date patient registry. This initiative aims to ensure the safe use of autologous serum eye drops, guaranteeing quality and safety in their preparation and administration.

How was it done?

The circuit was established in the PS in 2015. After prescription by the Ophthalmology Service, pharmaceutical validation confirms that the treatment is optimal and complies with regulatory requirements. Blood samples are collected from patients under controlled conditions, and the serum is prepared in a vertical laminar flow hood. Once prepared, the eye drops are stored frozen in the PS until dispensation to the patient. The pharmacist reviews the microbiological control of each batch and the patient’s serological results. When collecting the eye drops, the pharmacist records batch traceability and provides the patient with necessary information on storage and administration.

What has been achieved?

Between January and August 2024, 294 patients were treated, with 477 blood extractions performed and a 11,925 eye drops prepared. Autologous serum concentration: 20%(76.9%), 30%(11.5%), 50%(11.2%), and 100%(0.4%). Microbiological control of the eye drops: 98.1% negative and 1.9% false positives, confirmed by a second negative control. Infectious diseases were detected in the serology of 3 patients: hepatitis C(1), hepatitis B(1) and syphilis(1). These data reflect a high success rate in the preparation and quality control, as well as the effectiveness of the implemented circuit. Additionally, the system has allowed for the early detection of viral infections, reinforcing treatment safety.

What next?

The implementation of this circuit has proven effective in ensuring the safety and efficacy of autologous serum eye drops, providing rigorous control over treatments and the quality of dispensed products. Future steps will involve pharmacists requesting serological tests and developing protocols for managing patients with identified infections. Furthermore, patient surveys will evaluate treatment effectiveness and overall patient experience.

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