Implementation of a traceability system and safe manufacturing medications in a clean room. / Implantación de un sistema de trazabilidad y elaboración segura de medicamentos en la sala blanca.

OBJECTIVE: To describe the process of implementing a traceability and safe drug manufacturing system in the clean room of a Pharmacy Service to increase patient safety, in accordance with current legislation. METHODS: The process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the "Good Practices Guide for Medication Preparation in Pharmacy Services" (GBPP). The following sections were parameterized in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardized work procedures, and quality controls. RESULTS: A total of 50 users, 4 elaboration areas and 113 equipments were included. 435 components were parameterized (195 raw materials and 240 pharmaceutical specialties), 54 packaging materials, 376 standardized work procedures (123 of them corresponding to sterile medicines and 253 to non-sterile medicines, of which 52 non-sterile were dangerous), in addition 17 were high risk, 327 medium risk, 32 low risk, and 13 quality controls. CONCLUSIONS: The computerization of the production process has allowed the implementation of a traceability and secure drug manufacturing system in a controlled environment in accordance with current legislation.

Physicochemical and microbiological stability study of two new preservative-free methylprednisolone eye drops. / Estudio de estabilidad fisicoquímica y microbiológica de 2 nuevos colirios de metilprednisolona sin conservantes.

OBJECTIVE: To study the physicochemical and microbiological stability over 90 days of two preservative-free methylprednisolone sodium succinate (MTPSS) 1 mg/ml and 10 mg/ml eye drops for use in ocular pathologies such as Sjögren's syndrome and dry eye syndrome. METHOD: The two eye drops were prepared from injectable MTPSS (Solu-moderin® and Urbason®), water for injection and normal saline solution. In accordance with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, they were then stored in triplicate under refrigerated conditions (5 ±3 °C), at room temperature (25 ± 2 °C), and at 40 °C (±2 °C). In accordance with the USP (United States Pharmacopeia), physicochemical controls of the active ingredient content were carried out by HPLC-UV (High Performance Liquid Chromatography with Ultraviolet detection), together with controls of pH, osmolality, and visual examination. Microbiological sterility was also tested under refrigerated conditions up to 30 days in open containers and up to 90 days in closed ones. RESULTS: The eye drops stored at 5 °C were the most stable; in the 1 mg/ml eye drops, degradation of the drug fell below 90% from day 21, and in the 10 mg/ml eye drops, from day 42. pH change did not vary by ≥1 unit in formulations stored at 5 °C, unlike the other formulations. Changes in osmolality did not exceed 5% on day 90 in any storage conditions. Samples of non refrigerate eye drops at 10 mg/ml, presented a white precipitate from day 14 and 28 respectively. Non-refrigerated 1 mg/ml eye drops presented suspended particles on day 90. There were no color changes. Microbiological analysis showed that sterility was maintained for over 90 days in the closed containers, although microbial contamination was detected from day 21 in the open containers. CONCLUSIONS: 1 mg/ml MTPSS eye drops show physicochemical and microbiological stability for 21 days under refrigeration, compared to 42 days for 10 mg/ml eye drops stored under the same conditions. However, since they do not include preservatives in their composition, they should not be used for more than 7 days after opening.

[Translated article] Current situation and evolution of the availability of drugs in the pediatric population in Spain.

OBJECTIVE: To analyze the characteristics of the new medicines approved in the pediatric population in the last 3 years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. METHODS: Descriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorized or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. RESULTS: During the study period, 129 drugs included their indication in the pediatric population. 13.9% of them are not marketed, 46.5% are in a situation of non-financing, under study or without a request for financing, and 4.6% are financed for a specific pediatric subpopulation. 52.7% are original drugs, 4.7% are generic, 38.8% are biological, 3.8% are biosimilar, and 17.8% are orphan drugs. 57.36% of these medicines obtain the pediatric indication due to extension of the indication and 42.64% obtain it because they are new medicines that already include their studies in the pediatric population. CONCLUSIONS: Drugs with authorized indications are increasingly available in the pediatric population and the trend is to extend the indication of authorized drugs to the adult population. However, barriers in terms of financing and marketing need to be expedite and overcome to facilitate access to them.

[Concordance of medication prescription records in the hospitalised surgical patient]. / Concordancia de los registros de prescripción de medicamentos en el paciente quirúrgico hospitalizado.

INTRODUCTION: Electronic prescription is the prescription system that allows healthcare professionals to send medication prescriptions directly to community pharmacies and the outpatient unit of Hospital Pharmacy Services for dispensing. However, there is difficulty in obtaining a reliable pharmacotherapeutic history in chronic patients through electronic prescription upon hospital admission as a critical point for adequate treatment adaptation. Therefore, the pharmacist as a member of the multidisciplinary team must ensure, through medication conciliation, an adequate transition of care through the correct management of the treatment that the chronic patient requires during their hospitalization. OBJECTIVES: To evaluate the quality of electronic prescription records for routine chronic treatment by analyzing the concordance of the electronic prescription. MATERIAL AND METHODS: Observational, cross-sectional and retrospective study at the General University Hospital of Elche. Hospitalized patients in charge of the Orthopedic Surgery and Traumatology, Urology and Neurosurgery Services in which the responsible doctor requested medication reconciliation by the Pharmacy Service between January 2022 - December 2022 were included. RESULTS: 378 patients, 209 (55.3%) women and 169 (44.7%) men, with a mean age±standard deviation of 71.0±11.6 years and 69.0±11.8 years, respectively. The total percentage of patients with discrepancies in the electronic prescription with respect to the usual chronic treatment was 60.6%, reflecting that only 39.4% of the patients had non-discordant electronic prescriptions. CONCLUSIONS: More than half of hospitalized surgical patients present discrepancies in the medications prescribed in the home electronic prescription, which justifies the importance of treatment reconciliation upon admission carried out by hospital pharmacists.

Psychotropic medicine use without current or prior medical advice, storage at home and association with perceived stress in a primary health care setting in Greece / Uso de medicamentos psicotrópicos sin consejo médico actual o previo, almacenamiento en el hogar y asociación con estrés percibido en un entorno de atención primaria en Grecia

Objective: Psychotropic medicines use alters according to socio-economic factors and perceived stress. The study aimed to assess the prevalence of use of psychotropic medicines and supplements (PMS) without medical advice, including storage at home, and its relationship with socio-demographic characteristics and perceived stress in primary care patients. Materials and methods: A cross-sectional sample of adult attendees in an urban primary care unit in Crete, Greece, were surveyed during regularly scheduled appointments during a three-week period in October 2020. A questionnaire was distributed to investigate PMS use during the last 12 months. The validated Greek version of Perceived Stress Scale (PSS-14) was adopted to measure perceived stress. Results: Of 263 respondents (mean age 46.3±14.5 years; 66.5% females), 101 (38.4%; 95%CI 33.1–43.7%) recalled having psychotropic medicines stored at home cabinets and 72 (27.4%; 95%CI 22.4–32.3%) reported using PMS without medical advice in the last 12 months. Conclusions: This study revealed a high prevalence of PMS use without medical advice, including storage at home. People>59 years of age, experiencing irregular sleep and scoring high in PSS, displayed increased prevalence of storing PMS at home or using them without medical advice. The findings could potentially inform primary care providers to focus on patients most likely to be users of PMS without medical advice.(AU)

Objetivo: El uso de medicamentos psicotrópicos cambia según los factores socioeconómicos y el estrés percibido. El estudio tuvo como objetivo evaluar la prevalencia de uso de medicamentos y suplementos psicotrópicos (MSP) sin consejo médico, incluido el almacenamiento en el hogar y su relación con las características sociodemográficas y el estrés inferido en pacientes de atención primaria. Materiales y métodos: Se encuestó a una muestra transversal de asistentes adultos en una Unidad de Atención Primaria Urbana en Crete, Grecia, durante citas programadas regularmente durante un periodo de tres semanas en Octubre de 2020. Se distribuyó un cuestionario para investigar el uso de MSP durante los últimos 12 meses. Se adoptó la versión griega validada de la Escala de Estrés Percibido (Perceived Stress Scale 14, PSS-14) para medir el estrés percibido. Resultado: De 263 encuestados (edad media 46,3 ± 14,5 años; 66,5% mujeres), 101 (38,4%; IC 95%; 33,1-43,7%) recordaban tener medicamentos psicotrópicos almacenados en los armarios de sus casas y 72 (27,4%; IC 95%; 22,4-32,3%) informó haber usado MSP sin consejo médico en los últimos 12 meses. Conclusiones: Este estudio reveló una alta prevalencia de uso de MSP sin consejo médico, incluido el almacenamiento en el hogar. Las personas mayores de 59 años, que experimentaron sueño irregular y puntuaron alto en PSS, mostraron una mayor prevalencia de almacenar MSP en casa o usarlos sin consejo médico. Los hallazgos podrían informar potencialmente a los proveedores de atención primaria para que se centren en los pacientes con mayor probabilidad de usar MSP sin consejo médico.(AU)

Estudio sobre las características de la información sanitaria en las conducciones entre centros penitenciario / Study of the characteristics of medical information in transfers between prisons

Introducción: La movilidad de la población penitenciaria precisa que la información transmitida en los traslados entre centros garantice una óptima continuidad asistencial. Objetivo: Valorar la calidad de la transmisión de información sanitaria cuando los internos son trasladados en conducción entre centros penitenciarios de todo el territorio español. Material y método: Estudio observacional, descriptivo y transversal, consistente en la revisión de historias clínicas de los internos que transitaron por el Centro Penitenciario (CP) Madrid III en un periodo de tres meses. Todas las variables medidas fueron cualitativas, expresadas en frecuencias absolutas y relativas. Resultados: Durante ese tiempo, 1.168 internos transitaron por el CP Madrid III. Solo 21 procedían de centros penitenciarios de Cataluña, País Vasco o Navarra, cuya historia clínica es diferente a la del resto del Estado, y solo el 57,14% aportaban algún tipo de información sanitaria. Del resto de internos, el 70,79% aportaba algún tipo de información: el 63,90% del total tenía medicación prescrita y el 5% metadona. De aquellos que tenían medicación, el 89,10% la tenían prescrita en la prescripción electrónica, siendo correcta en el 98% de los casos. Respecto a la metadona, solo el 75,44% lo tenía prescrito electrónicamente, siendo correcta en todos los casos. La fecha de la última dosis administrada solo se indicó en el 72,40% de los tratamientos. Discusión: Solo el 34,70% de las historias presentaban una calidad óptima en cuanto a la información transmitida, siendo en el 2,50% de los casos la información recibida deficiente. El uso de herramientas informáticas facilita la transmisión de la información, reduce la carga de trabajo y mejora la seguridad del paciente.(AU)

Introduction: The mobility of the prison population creates a need for information transmitted in transfers between centers that can guarantee optimal care continuity. Objective: To assess the quality of transmission of health information when inmates are transferred between prisons in Spain. Material and method: Observational, descriptive and cross-sectional study, consisting of a review of medical records of inmates who passed through Madrid III Prison in a three-month period. All measured variables were qualitative, and were expressed in absolute and relative frequencies. Results: 1,168 inmates passed through Madrid III Prison in this period. Only 21 came from prisons in Catalonia, the Basque Country or Navarre, where their medical records are different from those in the rest of Spain, and only 57.14% provided some type of health information. Of the remaining inmates, 70.79% provided some type of information: 63.90% of the total had prescriptions for medication and 5% were prescribed with methadone. Of those taking medication, 89.10% were prescribed it in electronic prescriptions, which were correct in 98% of the cases. For methadone, only 75.44% had electronic prescriptions,which were correct in all cases. The date of the last dose administered was only indicated in 72.40% of the treatments. Discussion: Only 34.70% of the records presented optimal quality in terms of the information transmitted, and in 2.50% of the cases the information received was deficient. The use of computerized tools facilitates the transmission of information, reduces the workload and improves patient safety.(AU)

Accesibilidad, disponibilidad y asequibilidad de medicamentos para Niños con Enfermedad Renal Crónica en Guatemala / Access, availability and affordability of medications for children with Advanced Chronic Kidney Disease in Guatemala

El artículo tiene como objetivo analizar la disponibilidad, acceso y asequibilidad de los medicamentos para niños con Enfermedad Renal Crónica (ERC) en tratamiento con hemodiálisis (HD) en un país de bajos a medianos ingresos. Se llevó a cabo un estudio transversal para determinar los medicamentos más utilizados en una unidad de hemodiálisis pediátrica, incluyendo el nombre del medicamento, dosis, frecuencia, forma farmacéutica y vía de administración. Dos farmacias dentro del perímetro del hospital, una pública y una privada, fueron consultadas para determinar el costoy disponibilidad de medicamentos genéricos y de marca. De un total de 30 pacientes de la unidad de hemodiálisis, 22 expedientes fueron revisados. En general 94% de marca se encontraban disponibles en las farmacias consultadas en comparación a un 52% de los medicamentos genéricos. En farmacias públicas, 41% de medicamentos de marca y 29% de medicamentos genéricos se encontraban disponibles. El costo promedio para un mes de tratamiento con medicamentos de marca adquiridos en una farmacia privada era de $495.00 vs $299.00 en una farmacia pública. Para medicamentos genéricos, el costo promedio correspondía a $414.00 y $239.00 en farmacias privadas y públicas respectivamente. En promedio, los medicamentos de marca adquiridos en una farmacia privada requieren 41 días de trabajo en un mes a comparación de 25 días si se adquieren en una farmacia pública. Los medicamentos genéricos adquiridos en farmacias privadas corresponden a 34 días de trabajo vs 20 días en farmacias públicas. En general existió un acceso limitado a medicamentos genéricos y los medicamentos poseen un costo general más elevado a comparación de otros países lo que implica un posible impacto en la adherencia terapéutica y los padecimientos secundarios de la ERC en los pacientes pediátricos en Guatemala. Esta realidad se puede aplicar a otros países de bajos a medianos ingresos.

This article aims to analyze the availability, access, and affordability of medications for children with advanced Chronic Kidney Disease (CKD) treated with hemodialysis (HD) in a low to middle income country (LMIC). A cross- sectional chart review was carried out to determine the most common medications used in an HD pediatric unit, including medication name, dose, frequency, dosage form, and route of administration. Two pharmacies within the hospital perimeter, one public and one private, were consulted to determine medication cost and availability for generic and brand-name equivalents. From 30 patients attending the HD unit, 22 records were reviewed. Overall, 94 % of brand name medications were available at pharmacies consulted, versus and 52% of generic medications. In public pharmacies, 41% of brand name, and 29% of generic medications were available. The average cost for a full month´s treatment for brand name drugs in the private pharmacy was 495.00 USD versus 299.00 USD in the public pharmacy. For generic drugs, the average cost was 414.00 USD, and 239.00 USD in private and public pharmacies respectively. On average, brand-name drugs in the private pharmacy cost 41 days' wages versus 25 in the public pharmacy. Generic drugs in the private pharmacy cost 34 days' wages versus 20 in the public pharmacy. Overall, there was limited access to generic medications, medications had an overall high cost compared to other countries both of which have the potential to impact treatment adherence and overall outcomes of CKD5 pediatric patients in Guatemala. This reality can be translated to other LMIC.

Pharmaceutical recommendations for therapeutic appropriateness in multiple sclerosis patients. / Recomendaciones farmacéuticas de adecuación terapéutica en pacientes con esclerosis múltiple.

OBJECTIVE: To determine the prevalence of PIMDINAC criteria and to implement pharmacological interventions in a population with multiple sclerosis over 55 years of age. METHODS: Retrospective observational open-label study including patients with multiple sclerosis aged 55 years and older between December 2022 and February 2023. The main variable determined was the percentage of compliance with the PIMDINAC criteria. RESULTS: Ninety-five patients were included, with the presence of PIMDINAC criteria detected in 67.4%. The most frequently detected criterion was non-adherence to concomitant treatment (84,4%), followed by drug-drug interactions (56.2%) and potentially inappropriate medication (25%). A total of 20 pharmaceutical interventions were performed in 17 patients (17.9%). Potentially inappropriate medication was responsible for 11 interventions, non-adherence for 7 and drug-drug interactions for 2. The 81.8% of interventions were accepted, resulting in the discontinuation of 15 inappropriately prescribed drugs. The prevalence of PIMDINAC criteria in this group of patients is high. The study revealed that PIMDINAC criteria were prevalent in 67.4% of the study population, with polypharmacy playing an important role, suggesting the potential for a multidisciplinary approach, through pharmaceutical interventions to address unnecessary or duplicate treatments.

Detection and reduction of errors in parenteral nutrition compounding through gravimetric and product control. / [Artículo traducido] Detección y reducción de errores en la elaboración de la nutrición parenteral mediante control gravimétrico y de producto.

OBJECTIVE: To analyze the errors in the preparation of parenteral nutrition in a Pharmacy Service, detected through an already consolidated gravimetric and product quality control, and compare them with those detected during the initial years of implementing this quality control. METHODS: All errors detected through quality control in the compounding of pediatric and adult parenteral nutrition between 2019 and 2021 were prospectively analyzed. This quality control consisted of 3 sequential processes: a visual check, a gravimetric control, and a product control. Errors were classified as gravimetric, when the nutrition had a deviation of more than 5% from the theoretical weight, or as product errors when a qualitative or quantitative error was detected upon reviewing the remainder of the components used. These errors were analyzed in terms of type and the component involved. A comparison was made with the errors detected during the implementation phase of this quality control from 2016 to 2018. RESULTS: A total of 41,809 parenteral nutritions were reviewed, and 345 errors were detected (0.83% of the preparations); of these, 59 errors were found in pediatric nutritions (0.68% of them), and 286 in adult nutritions (0.86% of them). Among these errors, 193 were of gravimetric nature, while 152 were detected through product control. The main components involved in product errors were electrolytes, primarily due to the addition of excessive volumes and the use of incorrect components. A significant absolute reduction of 0.71% (p < 0.05) in the total number of errors was observed when compared to the implementation phase. This reduction was consistent in both gravimetric errors (-0.59%) and product-related errors (-0.12%) (p < 0.05). CONCLUSIONS: Comprehensive quality control of parenteral nutrition preparation is an easily implementable tool that effectively detected and prevented significant errors. Furthermore, its widespread adoption contributed to a reduction in the overall error count.

Presence of metallic components in transdermal drug delivery systems and risk of skin burns. / [Artículo traducido] Presencia de partículas metálicas en parches transdérmicos de medicamentos y riesgo de quemaduras.

OBJECTIVE: Skin burns are associated with the presence of metallic components in transdermal drug delivery systems during Magnetic Resonance Imaging, cardioversion or defibrillation procedures. The aim of the study was to review the presence of metallic components in marketed products of transdermal drug delivery systems in Spain. METHOD: For each presentation, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted. RESULTS: We identified 59 marketed products of transdermal drug delivery systems of 12 different active substances. 59.3% of patches contained metallic components or their presence could not be ruled out. Information regarding the need to remove the patch was only included in 8 summaries of product characteristics (13.6%). A table was elaborated and included the following aspects: product, active substance, manufacturer, need to remove the patch before the exposure to magnetic or electric fields and references. CONCLUSION: More than a half of the patches at the time of the study contained metals or their absence could not be confirmed by the manufacturer. However, this information was only included in 13.6% of summaries of product characteristics.

Acute pancreatitis due to different semaglutide regimens: An updated meta-analysis.

OBJECTIVES: Some concerns persist regarding the safety of semaglutide. The objective of this updated meta-analysis is to assess the risk of acute pancreatitis with the use of semaglutide, assessing the results according to the different administration regimens. METHODS: We performed an updated meta-analysis of randomised, placebo-controlled studies of semaglutide therapy that report acute pancreatitis. This meta-analysis was performed in line with PRISMA guidelines. A global and stratified analysis according to the therapeutic scheme used was performed using the fixed-effects model. RESULTS: Twenty-one eligible trials of semaglutide, including 34,721 patients, were identified and considered eligible for the analyses. Globally, semaglutide therapy was not associated with an increased risk of acute pancreatitis (OR 0.7; 95% CI 0.5-1.2, I2 0%). When we analysed the studies according to the different schemes used, the results were similar (group with oral semaglutide: OR 0.40; 95% CI 0.10-1.60, I2 0%; group with low subcutaneous doses of semaglutide: OR 0.80; 95% CI 0.40-1.90, I2 0%; group with high subcutaneous doses of semaglutide: OR 0.70; 95% CI 0.50-1.20, I2 0%; interaction p-value=0.689). CONCLUSION: This updated meta-analysis demonstrates that the use of semaglutide is not associated with an increased risk of acute pancreatitis compared to placebo. In the stratified analysis, the results were similar with the different semaglutide regimens analysed.

Variaciones en el consumo de medicamentos para la salud mental en una unidad de atención primaria brasileña: ¿hay influencia de la pandemia? / Variations in the consumption of mental health medications in a brazilian primary care unit: is there influence of the pandemic?

Introducción: La pandemia de COVID-19 ha generado la necesidad de ajustes y adaptaciones en diversas áreas, desde el comportamiento hasta la normativa, con grandes repercusiones en términos de salud pública. Objetivo: Comparar los consumos promedio mensuales (CPM) de medicamentos de control especial utilizados para la salud mental antes y durante la pandemia en una Unidad Básica de Salud (UBS) en el Distrito Federal, Brasil. Métodos: Los consumos se obtuvieron a través del sistema de gestión de inventarios local y el CPM (±desviación estándar) se calculó sin tener en cuenta los meses de desabastecimiento, considerando el período de 2020 a 2022. Como parámetro comparativo, se utilizó el CPM±DE de 2019. Resultados: Se analizaron los consumos de 32 medicamentos, siendo la mayoría antiepilépticos (N=10; 31,2 %), antidepresivos (N=10; 31,2 %) y antipsicóticos (N=8; 25,0 %). Se observó que más de la mitad de los medicamentos analizados (n=18; 56,3 %) mantuvieron un aumento en el consumo a lo largo de los años de la pandemia. Conclusión: Hubo una variación significativa en el consumo de medicamentos sujetos a control especial en la UBS durante la pandemia. Estos resultados pueden estar asociados a diversos factores, como el aumento de los cuadros clínicos que justifican su prescripción, en línea con la literatura actual sobre el impacto potencial del aislamiento social y las medidas tomadas por las autoridades competentes para contener la propagación del virus SARS-COV-2. (AU)

Introduction: The COVID-19 pandemic has generated the need for adjustments and adaptations in various areas, from behaviour to regulations, with significant repercussions in terms of public health. Objective: To compare the monthly average consumption (MAC) of special control medications used for mental health before and during the pandemic in a Basic Health Unit (UBS) in the Federal District, Brazil. Methods: Consumption data were obtained through the local inventory management system, and the MAC (±stan-dard deviation) was calculated excluding months of stockouts, considering the period from 2020 to 2022. The MAC±SD of 2019 was used as a comparative parameter. Results: Consumption of 32 medications was analyzed, with the majority being antiepileptics (N=10; 31.2 %), anti-depressants (N=10; 31.2 %), and antipsychotics (N=8; 25.0 %). It was observed that more than half of the analyzed medications (n=18; 56.3 %) maintained an increase in consumption throughout the pandemic years. Conclusion: There was a significant variation in the consumption of special control medications at the UBS during the pandemic. These results may be associated with various factors, such as the increase in clinical conditions justi-fying their prescription, in line with current literature on the potential impact of social isolation and measures taken by competent authorities to contain the spread of the SARS-CoV-2 virus. (AU)

Análisis de las notificaciones de úlceras cutáneas inducidas por medicamentos en España / Analysis of notifications of drug-induced skin ulcers in Spain

Las úlceras cutáneas son un serio problema de salud, el cual tiene repercusiones socioeconómicas y laborales muy importantes con una elevada tendencia a la cronicidad y recidiva, estimándose que hasta el 50% de ellas permanecerán activas entre 6 meses y un año. Objetivo: Estudio del papel de los medicamentos en la etiología de las úlceras cutáneas. Material y método: Estudio de todas las notificaciones espontáneas relativas a úlceras cutáneas que constan en la base de datos del Sistema Español de Farmacovigilancia de medicamentos de uso humano.Resultados: Se identificaron 292 notificaciones en las que constaban sospechas de reacción adversa a medicamentos (RAM) del tipo lesión ulcerosa relacionadas con el consumo de medicamentos. Estaban implicados 369 medicamentos que suponen 427 principios activos. Las úlceras fundamentalmente aparecían en mujeres con una media de edad de 56,6 años. Los medicamentos sospechosos más frecuentemente notificados fueron los iSGLT-2, vacunas frente al COVID-19, metotrexato, hidroxicarbamida, trimetropim-sulfametoxazol, foscarnet trisódico hexahidrato, ribavirina, docetaxel, acenocumarol e imiquimod y asociación de lidocaína Hcl-pentosano polisulfato sodio-triamcinolona acetónido. Discusión: Numerosos medicamentos tienen como reacción adversa la aparición de úlceras. No debería descartarse esta posibilidad ante la aparición de una lesión cutánea nueva tras la administración de un nuevo medicamento dado que el 25% de las RAM eran desconocidas en el momento de su notificación, como eran los casos de úlceras asociadas a los i-SGLT2 y a las vacunas contra el COVID al inicio de su comercialización; sin embargo, gracias al hecho de seguir notificando las sospechas de RAM, se crearon alertas sanitarias advirtiendo de este hecho y es por ello que aconsejamos seguir notificando cualquier sospecha de RAM a los sistemas regionales de farmacovigilancia.(AU)

Skin ulcers are a serious health problem with significant socioeconomic and labour repercussions and a high tendency to chronicity and recurrence; approximately, up to 50% remain active between six months to one year. Aim: To study the role of drugs in the aetiology of skin ulcers. Material and method: A comprehensive study of all spontaneous reports related to skin ulcers that appear in the Spanish Pharmacovigilance System of Medicines for Human Use database. Results: A total of 292 reports were identified containing suspected adverse drug reactions (ADRs) of ulcer lesion type. Three hundred sixty-nine medications with 427 active ingredients were identified. The ulcers appeared mainly in women with a mean age of 56.6 years. The most frequently reported suspected drugs were SGLT-2, vaccines against COVID-19, methotrexate, hydroxycarbamide, trimethoprim-sulfamethoxazole, foscarnet trisodium hexahydrate, ribavirin, docetaxel, acenocumarol and imiquimod, and the combination of lidocaine Hcl-pentosan polysulfate sodium-triamcinolone acetonide. Discussion: Numerous medications may cause ulcers as an adverse reaction. This possibility should not be ruled out when a new skin lesion appears after the administration of new drugs since 25% of the ADRs were unknown at the time of their notification, as were the cases of ulcers associated with i-SGLT2 and vaccines against COVID at the beginning of their commercialization. However, informative health alerts can be generated by continuously notifying suspected ADRs, so we strongly advise reporting any suspected ADRs to the regional pharmacovigilance system.(AU)

Erupción fija por luz solar, una serie de 13 casos en Bogotá, Colombia / Fixed Sunlight Eruption: A Series of 13 Cases in Bogotá, Columbia

Desde 1975 se han publicado algunos casos que asocian la radiación ultravioleta como un desencadenante de erupciones cutáneas fijas (erupción o exantema fijo por luz solar o síndrome de fotosensibilidad localizada de amplio espectro). Describimos los casos de 13 pacientes con esta dermatosis, 4 varones (30,8%) y 9 mujeres (69,2%), con edades comprendidas entre los 28 y los 56 años, atendidos en un centro de referencia en dermatología en Bogotá, Colombia. Las lesiones se localizaron en la cara interna de los muslos, los glúteos, la región poplítea, la axilar anterior y posterior y el dorso de los pies. La prueba de fotoprovocación logró la reproducción de las lesiones en todos los casos en las áreas afectadas y la histopatología reveló cambios similares a los descritos en los eritemas fijos por medicamentos. Esta enfermedad podría corresponder a un subtipo de erupción fija, aunque no se descarta que sea una dermatosis diferente con una patogenia común.(AU)

Few reports describing an association between UV radiation and fixed skin eruptions have been published since 1975. These reactions have received various names, including fixed sunlight eruption, fixed exanthema due to UV radiation, and broad-spectrum abnormal localized photosensitivity syndrome. We present a series of 13 patients (4 men [30.8%] and 9 women [69.2%]) aged between 28 and 56 years who were evaluated for fixed eruptions induced by UV radiation at a dermatology referral hospital in Bogotá, Colombia. The lesions were located on the inner thighs, buttocks, popliteal region, anterior and posterior axilla, and dorsum of the feet. Photoprovocation reproduced lesions in all the affected areas, and histopathology showed changes similar to those seen in fixed drug eruptions. While these UV-provoked reactions may be a type of fixed skin eruption, we cannot rule out that they may also be a distinct condition that simply shares a pathogenic mechanism with fixed eruptions.(AU)

[Translated article] Fixed Sunlight Eruption: A Series of 13 Cases in Bogotá, Colombia / Erupción fija por luz solar, una serie de 13 casos en Bogotá, Colombia

Desde 1975 se han publicado algunos casos que asocian la radiación ultravioleta como un desencadenante de erupciones cutáneas fijas (erupción o exantema fijo por luz solar o síndrome de fotosensibilidad localizada de amplio espectro). Describimos los casos de 13 pacientes con esta dermatosis, 4 varones (30,8%) y 9 mujeres (69,2%), con edades comprendidas entre los 28 y los 56 años, atendidos en un centro de referencia en dermatología en Bogotá, Colombia. Las lesiones se localizaron en la cara interna de los muslos, los glúteos, la región poplítea, la axilar anterior y posterior y el dorso de los pies. La prueba de fotoprovocación logró la reproducción de las lesiones en todos los casos en las áreas afectadas y la histopatología reveló cambios similares a los descritos en los eritemas fijos por medicamentos. Esta enfermedad podría corresponder a un subtipo de erupción fija, aunque no se descarta que sea una dermatosis diferente con una patogenia común.(AU)

Few reports describing an association between UV radiation and fixed skin eruptions have been published since 1975. These reactions have received various names, including fixed sunlight eruption, fixed exanthema due to UV radiation, and broad-spectrum abnormal localized photosensitivity syndrome. We present a series of 13 patients (4 men [30.8%] and 9 women [69.2%]) aged between 28 and 56 years who were evaluated for fixed eruptions induced by UV radiation at a dermatology referral hospital in Bogotá, Colombia. The lesions were located on the inner thighs, buttocks, popliteal region, anterior and posterior axilla, and dorsum of the feet. Photoprovocation reproduced lesions in all the affected areas, and histopathology showed changes similar to those seen in fixed drug eruptions. While these UV-provoked reactions may be a type of fixed skin eruption, we cannot rule out that they may also be a distinct condition that simply shares a pathogenic mechanism with fixed eruptions.(AU)

Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis. / Monitorización terapéutica de los fármacos biológicos en la enfermedad inflamatoria intestinal. Documento de Posicionamiento del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU).

The treatment of inflammatory bowel disease has undergone a significant transformation following the introduction of biologic drugs. Thanks to these drugs, treatment goals have evolved from clinical response and remission to more ambitious objectives, such as endoscopic or radiologic remission. However, even though biologics are highly effective, a significant percentage of patients will not achieve an initial response or may lose it over time. We know that there is a direct relationship between the trough concentrations of the biologic and its therapeutic efficacy, with more demanding therapeutic goals requiring higher drug levels, and inadequate exposure being common. Therapeutic drug monitoring of biologic medications, along with pharmacokinetic models, provides us with the possibility of offering a personalized approach to treatment for patients with IBD. Over the past few years, relevant information has accumulated regarding its utility during or after induction, as well as in the maintenance of biologic treatment, in reactive or proactive strategies, and prior to withdrawal or treatment de-escalation. The aim of this document is to establish recommendations regarding the utility of therapeutic drug monitoring of biologics in patients with inflammatory bowel disease, in different clinical practice scenarios, and to identify areas where its utility is evident, promising, or controversial.

Proyecto Trazam: aplicación móvil para la trazabilidad de preparaciones elaboradas en un servicio de farmacia / Trazam project: A mobile application for the tracking of compounded preparations in a Pharmacy Department

Introducción el objetivo principal es describir el diseño e implementación de una aplicación para dispositivos móviles para facilitar el seguimiento de las preparaciones elaboradas en el servicio de farmacia hospitalaria. Los objetivos secundarios fueron evaluar el tiempo dedicado a la resolución de incidencias relacionadas con la dispensación/distribución de las preparaciones pre y postimplantación de la aplicación, conocer el grado de satisfacción de los usuarios y disponer de información cualitativa y cuantitativa del proceso que permita establecer indicadores de seguimiento. Métodos se definieron los requisitos a cumplir por el aplicativo informático, los fármacos susceptibles de entrar en el sistema y los circuitos de entrega. Se procedió al desarrollo de la aplicación por parte del proveedor e integración con los programas informáticos de prescripción/validación. Se crearon y añadieron los códigos QR de identificación en los puntos de entrega de medicamentos en las unidades de destino. Se adquirieron los dispositivos móviles necesarios. Primera etapa de formación de usuarios en la aplicación y prueba piloto en una planta de hospitalización. Posteriormente se inició la fase de expansión y consolidación. Resultados el 86,9% de las preparaciones estériles elaboradas en el servicio de farmacia hospitalaria se han incorporado al sistema, incluyendo quimioterapia, nutriciones parenterales de adultos y otras preparaciones estériles no peligrosas. Se han incluido en la aplicación las salas de hospitalización, los hospitales de día y 2 sedes externas. La media de preparaciones trazadas mensualmente es de 5.403 (DE = 297,3) (AU)

Introduction The primary objective of this study is to describe the design and implementation of a mobile application (App) for tracking preparations compounded in the Pharmacy Department. Secondary objectives include evaluating the time spent on resolving incidents related to the distribution of preparations before and after implementation, assessing users satisfaction with the application, and establishing a panel of quality indicators based on the data extracted from the App. Methods Defining application requirements, identifying drugs to be included in the software and outlining different workflows. Developing the App in collaboration with the supplier and integrating it with the computer programs involved in prescription and validation. Additionally, QR codes were created to identify delivery points at destination units, and suitable mobile devices were acquired. The initial phase involved user training in the application and a pilot test conducted in a hospital ward. The subsequent phase focused on expansion and consolidation. Results The system includes 86.9% of all sterile preparations prepared in the Hospital Pharmacy, encompassing chemotherapy, adult parenteral nutrition, and other non-hazardous sterile preparations. Furthermore, the application has been implemented in all hospitalization wards, day care units and two external sites. On average, 5,403 preparations were tracked per month (SD = 297.3). The time required to address incidents related to the distribution of preparations has decreased by 83% (from 38.9 to 6.6 minutes per day). The App regularly provides valuable management data for optimizing workflow in the compounding area. Additionally, users have expressed satisfaction with the application (AU)

Exploring the impact of pharmacogenetics on personalized medicine: A systematic review.

INTRODUCTION: Pharmacogenetics evaluates how genetic variations influence drug responses. Nowadays, genetic tests have advanced, becoming more affordable, and its integration is supported by stronger clinical evidence. Guidelines such as those from CPIC (Clinical Pharmacogenetics Implementation Consortium) and resources like PharmGKB facilitate genotype-based prescribing; and organizations like the FDA promote genetic testing before initiating certain medications. Preventive pharmacogenetic panels seem promising, but further research on biomarkers and diverse populations is needed. The aim of this review is to analyze recent evidence on the genotype-drug response relationship to examine how the genetic profile of patients influences the clinical response to treatments, and analyze the areas of research that need further study to advance towards a genetic-based precision medicine. MATERIALS AND METHODS: A systematic search was conducted on PubMed to identify articles investigating the genotype-drug response relationship. The search strategy included terms such as "pharmacogenetics", "personalized treatment", "precision medicine", "dose adjustment", "individualizing dosing", "clinical routine", and "clinical practice." Clinical trials, observational studies, and meta-analyses published in English or Spanish between 2013 and 2023 were included. The initial search resulted in a total of 136 articles for analysis. RESULTS: 49 articles were included for the final analysis following review by 2 investigators. A relationship between genetic polymorphisms and drug response or toxicity was found for drugs such as opioids, GLP-1 agonists, tacrolimus, oral anticoagulants, antineoplastics, atypical antipsychotics, efavirenz, clopidogrel, lamotrigine, anti-TNFα agents, voriconazole, antidepressants, or statins. However, for drugs like metformin, quetiapine, irinotecan, bisoprolol, and anti-VEGF agents, no statistically significant association between genotype and response was found. CONCLUSION: The studies analyzed in this review suggest a strong correlation between genetic variability and individual drug responses, supporting the use of pharmacogenetics for treatment optimization. However, for certain drugs like metformin or quetiapine, the influence of genotype on their response remains unclear. More studies with larger sample sizes, greater ethnic diversity, and consideration of non-genetic factors are needed. The lack of standardization in analysis methods and accessibility to genetic testing are significant challenges in this field. As a conclusion, pharmacogenetics shows immense potential in personalized medicine, but further research is required.

Percepção dos profissionais de enfermagem sobre manejo de reação infusional a antineoplásicos: estudo qualitativo / Perception of nursing professionals on the management of infusion reactions to antineoplastics: qualitative study

Identificar a percepção dos profissionais de enfermagem sobre o manejo de reação infusional imediata a antineoplásicos. Método: Trata-se de um estudo descritivo de caráter exploratório com abordagem qualitativa realizado em um hospital no Rio Grande do Sul. Resultados: Todos os participantes afirmaram saber identificar uma reação infusional. Após a identificação da reação, nota-se que a maioria obedeceu a uma ordem de condutas a serem realizadas. Quanto aos cuidados para prevenção das reações infusionais, a maioria dos participantes mencionou a administração de medicamentos pré-quimioterápicos, como antialérgicos e antieméticos. Conclusão: Os achados demonstram que a maioria dos profissionais sabe reconhecer e manejar, porém há a necessidade de treinamentos e padronização das ações.(AU)

To identify the perception of nursing professionals about the management of immediate infusion reactions to antineoplastic drugs. Method: This is a descriptive, exploratory study with a qualitative approach carried out in a hospital in Rio Grande do Sul. Results: All the participants said they knew how to identify an infusion reaction. After identifying the reaction, it was noted that the majority followed an order of conduct to be carried out. As for precautions to prevent infusion reactions, most of the participants mentioned the administration of pre-chemotherapy drugs, such as anti-allergic and anti-emetic drugs. Conclusion: The findings show that most professionals know how to recognize and manage them, but there is a need for training and standardization of actions.(AU)

Identificar la percepción de los profesionales de enfermería sobre el manejo de las reacciones infusionales inmediatas a medicamentos antineoplásicos. Método: Se trata de un estudio descriptivo, exploratorio, con abordaje cualitativo, realizado en un hospital de Rio Grande do Sul. Resultados: Todos los participantes afirmaron saber identificar una reacción a la infusión. Después de identificar la reacción, la mayoría siguió un orden de conducta. En cuanto a las precauciones para prevenir las reacciones a la infusión, la mayoría de los participantes mencionó la administración de fármacos prequimioterápicos, como antialérgicos y antieméticos. Conclusión: Los hallazgos muestran que la mayoría de los profesionales saben reconocerlas y manejarlas, pero es necesaria la formación y la estandarización de actuaciones.(AU)

Adherencia al tratamiento en paciente polimedicado con sistemas personalizados de dosificación (SPD) y su impacto en salud / Adherence to treatment in polymedicated patients using Monitored Dosage Systems (MDS) and their impact on health

Los Sistemas Personalizados de Dosificación (SPD) son una herramienta eficaz, segura y homologada para el reacondicionamiento de fármacos en farmacia comunitaria. Estos implican la revisión del uso del medicamento (RUM) y la colaboración con el médico de atención primaria (MAP). En el presente artículo se describe el caso de una paciente de 57 años intervenida de lumbociatalgia en 2021 y 2022, con dolor crónico mal controlado y aturdimiento derivado del olvido y/o duplicidad de las tomas. Durante la dispensación habitual se detectan estos problemas relacionados con el medicamento (PRM) y se deriva a la paciente al servicio SPD. Tras la implantación del mismo, la paciente mejora a nivel cognitivo, eliminando el aturdimiento y controlando el dolor, lo que supuso un aumento en su calidad de vida. En conclusión, se destaca la importancia de los diferentes servicios disponibles en la farmacia para mejorar la calidad de vida del paciente, la adherencia al tratamiento y la detección de PRM. (AU)

Monitored Dosage Systems (MDS) are an efficient, reliable and approved device for drug reconditioning in pharmacy. These systems imply a review on proper drug use and the collaboration between primary health care and pharmacists. The case study describes a female patient with a surgical intervention due to lumbosciatica in 2021 and 2022. Patient describes uncontrolled chronic pain and confusion related to improper drug use. During regular dispensing of her medication, these medicine-related problems (MRP) were detected and the patient was referred to the MDS service. After its implementation, the patient’s confusion was eliminated and pain management was achieved, increasing her quality of life. As a conclusion, the different health services provided by the pharmacy can improve a patient’s quality of life, treatment adherence and MRP detection. (AU)