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      Uso y optimización de una metodología para la priorización de la validación de métodos analíticos basada en la evaluación de riesgos en Servicios de Farmacia Hospitalaria Translated title: Implementation and optimisation of a tool for the prioritisation of analytical method validation based in risk management in Hospital Pharmacies

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          Abstract

          Resumen Objetivo: Poner en práctica y optimizar una metodología para evaluar los riesgos implicados en la elaboración de medicamentos en Servicios de Farmacia Hospitalaria con el fin de priorizar la validación de métodos analíticos de control de calidad. Método: Se han diseñado dos métodos para el cálculo del Número de Prioridad de Riesgo. Para el análisis y comparación entre ambos, se seleccionaron 3 parámetros a evaluar en cada medicamento: vía de administración, frecuencia de dispensación y complejidad del proceso de elaboración. A cada uno se asignó 4 niveles de gravedad, siendo 1 el más bajo y 4 el más alto. Se modificaron los criterios para la asignación de la gravedad en cada parámetro evaluado en el Método 2 con respecto al Método 1. Ambos métodos se han ensayado sobre 65 fórmulas. Resultados: El Método 1 segrega las formulaciones en 8 grupos según su Número de Prioridad de Riesgo. El Método 2 las separa en 14 grupos de 16 posibles. La frecuencia, en el Método 1 agrupa el 92,31% de las fórmulas en el primer nivel; la complejidad acumula el 86,15% en los niveles 2 y 4. Mientras el Método 2 separa el 25% de fórmulas en cada nivel según frecuencia, al segregar por cuartiles. La complejidad, al diferenciar las fórmulas asépticas con esterilización final de las elaboradas mediante llenado aséptico, separa las formulaciones en grupos más homogéneos. Conclusiones: El Método 2 es capaz de priorizar de forma más eficaz la validación de los métodos analíticos de las fórmulas analizadas, mejorando la consecución del objetivo propuesto.

          Translated abstract

          Summary Aim: To implement an optimise a methodology to evaluate the risks involved in the compounding of drug products in Hospital Pharmacy Services with the objective of prioritise the validation of analytical methods for quality control. Method: Two different methods were designed to assess the Risk Priority Number. For their analysis and comparison, 3 parameters were evaluated in each drug product: administration route, dispensing rate and compounding process complexity. To each parameter 4 levels of severity were allotted, being 1 the lowest and 4 the highest. The criteria to assign the level of severity for each parameter differ in both methods used. 65 drug products were evaluated with each method. Results: The use of Método 1 segregates drug products in 8 groups as per the Risk Priority Number, whilst Método 2 separates them in 14 groups out of the 16 feasible ones. Dispensing rate in Método 1 lumps together in the first level 92,31% of the drug products; complexity, by its side, clusters 86,15% in levels 2 and 4. On the other hand, Método 2 divides drug products in groups of 25% per severity level according to dispensing rate, since they are distributed in quartiles. Complexity, since it separates aseptic drug products exposed to final sterilisation from the ones compounded by aseptic processing, sets products apart in a more homogeneous groups. Conclusions: Método 2 is capable to prioritise in a more effective way the validation of analytical methods for quality control of analysed drug products; with a slightly higher convolution, it accomplishes the aim of these methods to a larger extent.

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          Supply chain disruption during the COVID-19 pandemic: Recognizing potential disruption management strategies

          The COVID-19 pandemic has made a significant impact on various supply chains (SCs). All around the world, the COVID-19 pandemic affects different dimensions of SCs, including but not limited to finance, lead time, demand changes, and production performance. There is an urgent need to respond to this grand challenge. The catastrophic impact of the COVID-19 pandemic prompted scholars to develop innovative SC disruption management strategies and disseminate them via numerous scientific articles. However, there is still a lack of systematic literature survey studies that aim to identify promising SC disruption management strategies through the bibliometric, network, and thematic analyses. In order to address this drawback, this study presents a set of up-to-date bibliometric, network, and thematic analyses to identify the influential contributors, main research streams, and disruption management strategies related to the SC performance under the COVID-19 settings. The conducted analyses reveal that resilience and sustainability are the primary SC topics. Furthermore, the major research themes are found to be food, health-related SCs, and technology-aided tools (e.g., artificial intelligence (AI), internet of things (IoT), and blockchains). Various disruption management strategies focusing on resilience and sustainability themes are extracted from the most influential studies that were identified as a part of this work. In addition, we draw some managerial insights to ensure a resilient and sustainable supply of critical products in the event of a pandemic, such as personal protective equipment (PPE) and vaccines.
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            The Quality Toolbox

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              Optimization of Inventory Management to Prevent Drug Shortages in the Hospital Supply Chain

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                Author and article information

                Journal
                ofil
                Revista de la OFIL
                Rev. OFIL·ILAPHAR
                Organización de Farmacéuticos Ibero-Latinoamericanos (Madrid, Madrid, Spain )
                1131-9429
                1699-714X
                September 2023
                : 33
                : 3
                : 244-248
                Affiliations
                [1] Navarra orgnameUniversidad de Navarra orgdiv1Facultad de Farmacia y Nutrición orgdiv2Departamento de Tecnología y Química Farmacéuticas Spain
                Article
                S1699-714X2023000300004 S1699-714X(23)03300300004
                10.4321/s1699-714x2023000300004
                594393a6-4f99-4c2c-a664-0e4014ba4ef3

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 25 April 2023
                : 29 March 2023
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 15, Pages: 5
                Product

                SciELO Spain

                Categories
                Originales

                Elaboración,Garantía de calidad,Risk assessment,Hospital Pharmacy Service,Drug compounding,Quality control,Quality assurance,Evaluación de riesgos,Farmacia Hospitalaria,Control de calidad

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