[Translated article] Syringes for intraocular administration: A systematic review.

OBJECTIVE: The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs. METHOD: A systematic review was performed following the PRISMA 2020 guidelines by searching PubMed with the descriptors: (silicone) AND (syringes) AND ((intraocular) OR (intravitreal)) and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences. RESULTS: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone; the administration technique; the physicochemical aspects of silicone release; and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialised syringes, the existing syringes for this use have been collected, finding 2 that will probably be commercialised in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic. CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.

Syringes for intraocular administration: Systematic review. / Jeringas para administración intraocular: revisión sistemática.

OBJECTIVE: The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs. METHOD: A systematic review was performed following the PRISMA 2020 Guidelines by searching PubMed with the descriptors: "silicone" AND "syringes" AND ("intraocular" OR "intravitreal") and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences. RESULTS: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone, the administration technique, the physicochemical aspects of silicone release, and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialized syringes, the existing syringes for this use have been collected, finding two that will probably be commercialized in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic. CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.

Topical 15% Resorcinol Is Associated with High Treatment Satisfaction in Patients with Mild to Moderate Hidradenitis Suppurativa.

BACKGROUND: Topical 15% resorcinol is commonly used in clinical practice for the treatment of nodules and abscesses in patients with hidradenitis suppurativa (HS). It has been shown to be clinically effective in some small studies, but data on satisfaction perceived by patients are lacking. The Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 is a validated measure of patient satisfaction, evaluating four domains: effectiveness, side effects, convenience, and global satisfaction. Our objective was to obtain data from HS patients regarding resorcinol treatment satisfaction and its relationship with clinical and epidemiological variables. METHODS: We performed a cross-sectional study providing TSQM version 1.4 questionnaires to HS patients who had been prescribed topical resorcinol during the previous 24 months. RESULTS: Ninety-two patients answered the questionnaire. Eighty-five out of 92 (92.4%) were Hurley II and 7 Hurley I. The mean total score was 317.5 out of 400 (71.0 points in effectiveness, 93.6 in side effects, 79.3 in convenience, and 73.2 in global satisfaction). Total score was higher in men than in women (329.7 vs. 311.6, p = 0.026) and higher scores on convenience were seen in patients who were not overweight or obese (86.9 vs. 77.1, p = 0.016). Most patients (65, 70.6%) denied having any side effect. 78 (84.8%) of the patients would recommend the treatment. CONCLUSION: The results of this study suggest that HS patients treated with resorcinol 15% are very satisfied with this treatment.

Hospital Pharmacy: Comprehensive management of medical devices during SARS-CoV-2.

Medical devices have become essential to the prevention and control of the  COVID-19 pandemic, being crucial for health professionals and patients in  particular, and the population in general. It is important to be aware of the laws  that regulate the management, distribution, and control of medical devices.  Article 82 of the Spanish Law 29/2006 on Guarantees and Rational Use of  Medicines and Medical Devices establishes that it is the responsibility of Hospital  Pharmacy Services "to participate in and coordinate the purchase of medicines and medical devices in the hospital to ensure an efficient acquisition  and rational use of medical devices". For this reason, working groups of the Spanish Society of Hospital Pharmacy and other scientific societies have issued technical guidelines and consensus statements to provide technical support and updated information on the use of masks, individual  protection equipments and other medical devices. In addition, the shortage of  medical devices caused by the high demand has resulted in the uncontrolled  production and distribution of medical devices. This phenomenon, added to the  fraudulent selling of medical devices, highlights the need for a closer surveillance of the market to guarantee the efficacy and safety of available medical devices. A rational use of medical devices is necessary to ensure the availability and safety of these products, which requires the involvement of  different stakeholders, including hospital pharmacists. Thus, it is essential that  hospital pharmacists receive specific training in technical aspects concerning the possession and use of medical devices. This will help guarantee an effective and safe use of medical products. The acquisition and use of medical  devices requires a keen understanding of the technical and legal aspects  concerning these products, which makes hospital pharmacists essential for the  integral management of medical devices.

Los productos sanitarios se han convertido en imprescindibles en la prevención y control de la pandemia actual generada por COVID-19, tanto para el personal  sanitario y pacientes, como para la ciudadanía en su totalidad. Los productos  sanitarios cuentan con una legislación propia que es preciso conocer para su  correcta gestión, distribución y control. El artículo 82 de la Ley 29/2006 de  garantías y uso racional de los medicamentos y productos sanitarios establece  que es responsabilidad de los servicios de farmacia hospitalaria "participar y  coordinar la gestión de las compras de los productos sanitarios del hospital a  efectos de asegurar la eficiencia de la misma y así contribuir al uso racional de  los mismos". Por este motivo, grupos de trabajo de expertos de la Sociedad Española de Farmacia Hospitalaria, junto a otras sociedades científicas, han desarrollado durante esta pandemia documentos técnicos y consensos para dar soporte técnico e informativo de forma actualizada en  relación con las mascarillas, los equipos de protección individual y otros  productos sanitarios. Por otro lado, los problemas de desabastecimiento  secundarios a la elevada demanda han llevado a una producción y  comercialización descontrolada de productos sanitarios. Este hecho, asociado a  la comercialización fraudulenta de productos sanitarios en el mercado, ha  generado la necesidad de una vigilancia exhaustiva, capaz de garantizar la  eficacia y seguridad de los productos sanitarios en circulación. El uso racional,  para asegurar la disponibilidad y seguridad de los productos sanitarios, es una  responsabilidad multidisciplinar compleja. Para ello, es fundamental una  formación específica como la del farmacéutico de hospital en aspectos técnicos  de tenencia y uso que permite salvaguardar las garantías de eficacia, seguridad  y calidad de los productos sanitarios. El conocimiento técnico y legal que  requieren los productos sanitarios hace imprescindible la implicación del  farmacéutico de hospital como uno de los profesionales sanitarios capacitado  para la gestión integral de estos productos.

El servicio de farmacia: Gestión integral de productos sanitarios en SARS-CoV-2 / Hospital Pharmacy: Comprehensive management of medical devices during SARS-CoV-2

Los productos sanitarios se han convertido en imprescindibles en la prevención y control de la pandemia actual generada por COVID-19, tanto para el personal sanitario y pacientes, como para la ciudadanía en su totalidad. Los productos sanitarios cuentan con una legislación propia que es preciso conocer para su correcta gestión, distribución y control. El artículo 82 de la Ley 29/2006 de garantías y uso racional de los medicamentos y productos sanitarios establece que es responsabilidad de los servicios de farmacia hospitalaria “participar y coordinar la gestión de las compras de los productos sanitarios del hospital a efectos de asegurar la eficiencia de la misma y así contribuir al uso racional de los mismos”. Por este motivo, grupos de trabajo de expertos de la Sociedad Española de Farmacia Hospitalaria, junto a otras sociedades científicas, han desarrollado durante esta pandemia documentos técnicos y consensos para dar soporte técnico e informativo de forma actualizada en relación con las mascarillas, los equipos de protección individual y otros productos sanitarios. Por otro lado, los problemas de desabastecimiento secundarios a la elevada demanda han llevado a una producción y comercialización descontrolada de productos sanitarios. Este hecho, asociado a la comercialización fraudulenta de productos sanitarios en el mercado, ha generado la necesidad de una vigilancia exhaustiva, capaz de garantizar la eficacia y seguridad de los productos sanitarios en circulación. El uso racional, para asegurar la disponibilidad y seguridad de los productos sanitarios, es una responsabilidad multidisciplinar compleja. Para ello, es fundamental una formación específica como la del farmacéutico de hospital en aspectos técnicos de tenencia y uso que permite salva-guardar las garantías de eficacia, seguridad y calidad de los productos sanitarios. El conocimiento técnico y legal que requieren los productos sanitarios hace imprescindible la implicación del farmacéutico de hospital como uno de los profesionales sanitarios capacitado para la gestión integral de estos productos

Medical devices have become essential to the prevention and control of the COVID-19 pandemic, being crucial for health professionals and patients in particular, and the population in general. It is important to be aware of the laws that regulate the management, distribution, and control of medical devices. Article 82 of the Spanish Law 29/2006 on Guarantees and Rational Use of Medicines and Medical Devices establishes that it is the responsibility of Hospital Pharmacy Services “to participate in and coordinate the purchase of medicines and medical devices in the hospital to ensure an efficient acquisition and rational use of medical devices”. For this reason, working groups of the Spanish Society of Hospital Pharmacy and other scientific societies have issued technical guidelines and consensus statements to provide technical support and updated information on the use of masks, individual protection equipments and other medical devices. In addition, the shortage of medical devices caused by the high demand has resulted in the uncontrolled production and distribution of medical devices. This phenomenon, added to the fraudulent selling of medical devices, highlights the need for a closer surveillance of the market to guarantee the efficacy and safety of available medical devices. A rational use of medical devices is necessary to ensure the availability and safety of these products, which requires the involvement of different stakeholders, including hospital pharmacists. Thus, it is essential that hospital pharmacists receive specific training in technical aspects concerning the possession and use of medical devices. This will help guarantee an effective and safe use of medical products The acquisition and use of medical devices requires a keen understanding of the technical and legal aspects concerning these products, which makes hospital pharmacists essential for the integral management of medical devices

Diseño de un aplicativo para el registro de implantes, gestión de alertas e incidentes relacionados con productos sanitarios como herramienta para el responsable de vigilancia de productos sanitarios / Design of a computer program for the registration of implantable medical device, field safety corrective action and advers events, as a tool for medical device surveillance

Objetivo: Describir las funcionalidades de un programa informático de soporte a la actividad del responsable de vigilancia de productos sanitarios (PS). Analizar su utilidad tras un año de implantación. Método: Las etapas del proceso fueron: descripción de actividades básicas del responsable de vigilancia, definir las funcionalidades y datos a procesar, crear los formularios de registro y opciones de la herramienta SIVIPS, implantación en un hospital privado que gestiona PS, validación del programa y análisis de su utilidad al año. Resultados: Se desarrolló la herramienta SIVIPS en Acces® por farmacéuticos. Se describieron las variables básicas para todas las actividades del responsable de vigilancia de PS (registro implantes, registro de alertas, registro de incidentes con PS, incluidos los de diagnóstico in vitro) y las funcionalidades del programa. Al año de su implantación se encontraron registros de 564 implantes con la posibilidad de desglose por tipo de implante, 31 alertas con PS y 6 incidentes con PS, permitiendo el seguimiento de las actuaciones realizadas en estos casos. Conclusiones: SIVIPS® es la primera herramienta de soporte a la actividad del responsable de vigilancia de PS. Es una herramienta sencilla que permite de forma ágil el registro de alertas e incidentes con PS, así como el registro de los implantes realizados en el centro, consiguiendo mejorar la trazabilidad del PS (AU)

Objective: To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. Method: The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. Results: SIVIPS was developed using Acces®. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics) and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. Conclusions: SIVIPS® is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS (AU)

[Design of a computer program for the registration of implantable medical device, field safety corrective action and advers events, as a tool for medical device surveillance]. / Diseño de un aplicativo para el registro de implantes, gestión de alertas e incidentes relacionados con productos sanitarios como herramienta para el responsable de vigilancia de productos sanitarios.

OBJECTIVE: To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. METHOD: The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. RESULTS: SIVIPS was developed using Acces. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics) and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. CONCLUSIONS: SIVIPS is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS.

Objetivo: Describir las funcionalidades de un programa informático de soporte a la actividad del responsable de vigilancia de productos sanitarios (PS). Analizar su utilidad tras un año de implantación. Método: Las etapas del proceso fueron: descripción de actividades básicas del responsable de vigilancia, definir las funcionalidades y datos a procesar, crear los formularios de registro y opciones de la herramienta SIVIPS, implantación en un hospital privado que gestiona PS, validación del programa y análisis de su utilidad al año. Resultados: Se desarrolló la herramienta SIVIPS en Acces® por farmacéuticos. Se describieron las variables básicas para todas las actividades del responsable de vigilancia de PS (registro implantes, registro de alertas, registro de incidentes con PS, incluidos los de diagnóstico in vitro) y las funcionalidades del programa. Al año de su implantación se encontraron registros de 564 implantes con la posibilidad de desglose por tipo de implante, 31 alertas con PS y 6 incidentes con PS, permitiendo el seguimiento de las actuaciones realizadas en estos casos. Conclusiones: SIVIPS® es la primera herramienta de soporte a la actividad del responsable de vigilancia de PS. Es una herramienta sencilla que permite de forma ágil el registro de alertas e incidentes con PS, así como el registro de los implantes realizados en el centro, consiguiendo mejorar la trazabilidad del PS.

Seguridad de un catéter multiperforado implantado en la herida quirúrgica para la infusión continua de anestésicos locales en la analgesia post-operatoria / Safety of a multiperforated catheter implanted in the surgical wound for the continuous infusion of local anaesthetics in post-operative analgesia

Objetivo Evaluar la incidencia de infección del sitio quirúrgico en pacientes en los que se implanta un catéter multiperforado para infusión continua de un anestésico local a este nivel con intención analgésica. Pacientes y método Estudio observacional, descriptivo, y prospectivo, de un mes de duración. Se incluyeron 50 pacientes sometidos a laparotomía programada en los que se implantó el catéter pre-peritoneal multiperforado con intención analgésica (Painfusor®. Baxter). Se excluyeron del estudio los pacientes con una incisión quirúrgica inferior a 15cm y/o ASA>III. Resultados El catéter se retiró en todos los pacientes a las 48 horas. El 6% de los pacientes a los que se les implantó el catéter presentó una infección del sitio quirúrgico, con una incidencia similar a la del centro para cirugías limpias-contaminadas (5,5%; IC95%: 3,4-8,7%). En dos pacientes se observó colonización del catéter, presentando solo uno infección del sitio quirúrgico. Conclusiones La utilización del catéter en posición pre-peritoneal para analgesia post-quirúrgica no incrementa el riesgo de infección del sitio quirúrgico (AU)

Objective To evaluate the incidence of infection at the surgical site in patients who have a multiperforated catheter implant for continuous infusion of a local anaesthetic as a local analgesic. Patients and method An observational, descriptive and prospective study, of one month duration. It included 50 patients subjected to selective laparotomy in whom a multiperforated pre-peritoneal catheter was implanted for analgesia purposes (Painfusor®. Baxter). Patients with a surgical incision of less than 15cm and/or ASA>III, were excluded from the study. Results The catheter was removed from all patients at 48hours. An infection at the surgical site was present in 6% of the patients who had the catheter implanted, which was similar to the incidence in clean-contaminated surgery (5.5%; 95% CI: 3.4-8.7%). Colonisation of the catheter was observed in two patients, causing only one infection of the surgical site. Conclusions The use of an in-situ pre-peritoneal catheter for post-surgical anaesthesia does not increase the risk of surgical site infection (AU)

[Safety of a multiperforated catheter implanted in the surgical wound for the continuous infusion of local anaesthetics in post-operative analgesia]. / Seguridad de un catéter multiperforado implantado en la herida quirúrgica para la infusión continua de anestésicos locales en la analgesia post-operatoria.

OBJECTIVE: To evaluate the incidence of infection at the surgical site in patients who have a multiperforated catheter implant for continuous infusion of a local anaesthetic as a local analgesic. PATIENTS AND METHOD: An observational, descriptive and prospective study, of one month duration. It included 50 patients subjected to selective laparotomy in whom a multiperforated pre-peritoneal catheter was implanted for analgesia purposes (Painfusor®. Baxter). Patients with a surgical incision of less than 15 cm and/or ASA>III, were excluded from the study. RESULTS: The catheter was removed from all patients at 48 hours. An infection at the surgical site was present in 6% of the patients who had the catheter implanted, which was similar to the incidence in clean-contaminated surgery (5.5%; 95% CI: 3.4-8.7%). Colonisation of the catheter was observed in two patients, causing only one infection of the surgical site. CONCLUSIONS: The use of an in-situ pre-peritoneal catheter for post-surgical anaesthesia does not increase the risk of surgical site infection.

Voriconazole in fungal keratitis caused by Scedosporium apiospermum.

OBJECTIVE: To describe the first case, to the best of our knowledge, of posttraumatic Scedosporium apiospermum (ScA) keratitis successfully treated with systemic and topical voriconazole. CASE SUMMARY: A 19-year-old man was admitted to the hospital with an incisive wound of his left eye and the cornea totally sectioned after trauma with a cutter used in gardening. Initial empirical treatment was followed by systemic and topical voriconazole, and the eye did not have to be enucleated. Five months after the trauma, a penetrating keratoplasty and chamber intraocular lens implantation was performed with a favorable visual outcome. DISCUSSION: ScA keratitis is rare, but it must be suspected if a history of ocular injury with contaminated objects exists. Among the antifungals available to treat ScA keratitis, voriconazole has shown advantages such as the lowest minimum inhibitory concentration and the availability of an oral formulation. CONCLUSIONS: Voriconazole shows promise as an effective alternative to conventional antifungals in the treatment of ScA keratitis. It is available both as oral and intravenous preparations, which is a great advantage in these lengthy infections.