Consensus SEO-SEFH of recommendations for use and compounding of ophthalmic preparations.

There are many medicinal products that, although having shown efficacy and  safety in different ophthalmological indications, they are not authorized or  commercially available for ophthalmic administration. This implies, on one hand,  that they must be used according to legislation that regulates the availability of  medicines in special situations and, on the other hand, that they must be  prepared in the pharmacy services for ophthalmic administration, according to  quality criteria to ensure its effectiveness, stability and sterility. This document  gathers the consensus between the Spanish Society of Ophthalmology and the  Spanish Society of Hospital Pharmacy about these selected preparations which  have shown enough evidence in their efficacy and safety for their ophthalmic use (off label) and ophthalmic administration. This document includes  recommendations about its use according to the current legislation. In addition,  with the aim of harmonizing the preparation of intraocular injections in the  hospital pharmacy services, general recommendations are set in this document  to ensure the compliance with standards established in the Spanish Guideline for Good Preparation Practices of Medicinal Products in Hospital Pharmacies. These  recommendations include sections such as the area of preparation, material,  technique, packaging, stability, quality control, prescription and traceability of  intraocular preparations.

Son muchos los medicamentos que, aun habiendo demostrado eficacia y seguridad en diferentes indicaciones oftalmológicas, no están autorizados ni disponibles comercialmente en una forma adecuada para esta vía de  administración.Esto implica, por un lado, que se deban utilizar según la legislación que regula la disponibilidad de medicamentos en situaciones especiales y, por otro, que se  deban preparar en los Servicios de Farmacia para su administración por vía  oftálmica, conforme a unos criterios de calidad que aseguren su efectividad,  estabilidad y esterilidad. Este documento recoge un consenso entre la Sociedad  Española de Oftalmología y la Sociedad Española de Farmacia Hospitalaria sobre  aquellas preparaciones con suficiente evidencia respecto a su eficacia y  seguridad para su uso no autorizado en indicaciones y vía de administración  oftálmicas. Se incluyen recomendaciones para su utilización de acuerdo con la  legislación vigente. Además, con el ánimo de armonizar la preparación de  inyecciones intraoculares en los Servicios de Farmacia Hospitalaria, se  establecen unas recomendaciones generales para su elaboración siguiendo los  estándares establecidos en la Guía de Buenas Prácticas de Preparación de  Medicamentos en los Servicios de Farmacia Hospitalaria. En estas  recomendaciones se incluyen apartados como el lugar de preparación, el  material, la técnica, el envasado, el periodo de validez, el control de calidad, la  prescripción y la trazabilidad de las preparaciones intraoculares.

Assessment of lower tear meniscus measurements obtained with Keratograph and agreement with Fourier-domain optical-coherence tomography.

AIMS: To compare intraobserver repeatability and interobserver and intersession reproducibility of lower tear meniscus height measurements (LTMH) obtained with the new Keratograph 5M and a Fourier-domain optical-coherence tomography (OCT; Spectralis OCT) and to assess the agreement between the two devices. METHODS: This is a observational cross-sectional study. Thirty eyes of 30 normal subjects were randomly imaged twice with both devices in our setting. Two examiners randomly made LTMH measurements using the devices. To assess intraobserver repeatability and interobserver and intersession reproducibility within-subject SD (Sw), test-retest repeatability, coefficient of variation (CoV) and intraclass correlation coefficients (ICCs) were calculated. Agreement between both devices was also determined. RESULTS: Average LMTH for Keratograph was 235.46±57.61 µm, whereas the mean LTMH measured by OCT was 245.84±67.18 µm. Intraobserver repeatability and interobserver and intersession reproducibility were moderate with Keratograph (CoV ≥0.16%, ≥0.19%, ≥0.17% and ICC ≤0.83, ≤0.76, ≤0.83, respectively) and high for the Spectralis OCT (CoV ≤0.13%, ≤0.12%, ≤0.11% and ICC ≥0.9, ≥0.92, ≥0.92, respectively). No statistically significant difference was detected in mean LMTH measurements made with both devices, although correlation was low (CoV 0.25%, ICC 0.55). CONCLUSIONS: Spectralis OCT LTMH measurements were more reliable than the new Keratograph data. Agreement between the devices was poor.