Computer programs used in the field of hospital pharmacy for the management of dangerous drugs: systematic review of literature.

Background: This review wants to highlight the importance of computer programs used to control the steps in the management of dangerous drugs. It must be taken into account that there are phases in the process of handling dangerous medicines in pharmacy services that pose a risk to the healthcare personnel who handle them. Objective: To review the scientific literature to determine what computer programs have been used in the field of hospital pharmacy for the management of dangerous drugs (HDs). Methods: The following electronic databases were searched from inception to July 30, 2021: MEDLINE (via PubMed), Embase, Cochrane Library, Scopus, Web of Science, Latin American and Caribbean Literature in Health Sciences (LILACS) and Medicine in Spanish (MEDES). The following terms were used in the search strategy: "Antineoplastic Agents," "Cytostatic Agents," "Hazardous Substances," "Medical Informatics Applications," "Mobile Applications," "Software," "Software Design," and "Pharmacy Service, Hospital." Results: A total of 104 studies were retrieved form the databases, and 18 additional studies were obtained by manually searching the reference lists of the included studies and by consulting experts. Once the inclusion and exclusion criteria were applied, 26 studies were ultimately included in this review. Most of the applications described in the included studies were used for the management of antineoplastic drugs. The most commonly controlled stage was electronic prescription; 18 studies and 7 interventions carried out in the preparation stage focused on evaluating the accuracy of chemotherapy preparations. Conclusion: Antineoplastic electronic prescription software was the most widely implemented software at the hospital level. No software was found to control the entire HD process. Only one of the selected studies measured safety events in workers who handle HDs. Moreover, health personnel were found to be satisfied with the implementation of this type of technology for daily work with these medications. All studies reviewed herein considered patient safety as their final objective. However, none of the studies evaluated the risk of HD exposure among workers.

Design and biopharmaceutical preclinical characterisation of a new thermosensitive hydrogel for the removal of gastric polyps.

BACKGROUND AND AIMS: Submucosal injection agents are widely used solutions in gastric polyp resection techniques. Currently, many different solutions are used in clinical practice, but most are not authorised for this use or are not biopharmaceutical characterised. The objective of this multidisciplinary work is to test the efficacy of a novel thermosensitive hydrogel designed specifically for this indication. METHODS: A mixture design of various components (Pluronic®, hyaluronic acid and sodium alginate) was carried out to select the combination with optimal properties for this use. Three final thermosensitive hydrogels were selected on which biopharmaceutical characterisation was performed and stability and biocompatibility were analysed. Efficacy in maintaining elevation was tested ex vivo on pig mucosa and in vivo in pigs RESULTS: The mixture design allowed selection of the ideal combinations of agents for the characteristics sought. The thermosensitive hydrogels studied showed high values of hardness and viscosity at 37 °C, maintaining good syringeability. One of them demonstrated superiority in maintaining polyp elevation in the ex vivo assay and non-inferiority in the in vivo assay. CONCLUSION: The thermosensitive hydrogel specifically designed for this use is promising both for its biopharmaceutical characteristics and for its demonstrated efficacy. This study lays the foundation for evaluating the hydrogel in humans.

Assessing the risk of using hazardous drugs in Hospital-at-Home Units: a big data study protocol.

OBJECTIVE: This article describes a study protocol for the implementation of quality and traceability control in the hazardous  medication circuit through an analysis of risks and the development and  introduction of a Big Data-based software application aimed at performing  a continuous and dynamic audit of the whole system. Method: A standardized graphical modeling tool called Business Process Model Notation will be used to generate a detailed description of each of the stages in the hazardous medication circuit with a view to  ensuring full traceability of the system. The information on each stage will  be collected in a flowchart, which will be used -together with each event's likelihood of occurrence and severity- as a basis to calculate the  criticality index of the different control points established and to determine  any control measures that may be required. The flowcharts will  also be used to develop the technological support needed to capture  all such data as may be relevant to the model. Proper quality control of the process will be ensured by client software agents intended to allow  automatic applica tion of efficient data processing tools at the different  phases. In addition, Big Data methodologies, in particular machine  learning, will be used to develop algorithms based on the repository of  generated data to come up with patterns capable of improving the  protocols to be applied. Lastly, proper operation of the process will be  ensured by means of clinicalpharmaceutical verification and a full  technical-documentary review of control and registration systems. CONCLUSIONS: The development of a risk management system based on  mobile technology will allow integration of hazardous drugs into a standardized system, ensuring the safety, quality, and traceability of the hazardous medication handling process.

Objetivo: Describir el protocolo del estudio para la instauración del control del proceso de los medicamentos peligrosos que asegure la calidad y su trazabilidad, mediante el análisis de riesgos, desarrollando e  Implantando una herramienta informatizada que, gracias a la utilización de técnicas de big data, permita conocer y auditar el conjunto del sistema de  forma continua y dinámica.Método: Mediante los procesos de notación gráfica normalizada Business Process Model Notation se desarrollarán los flujogramas  Específicos que permitan conocer las etapas del proceso de los  Medicamentos peligrosos que determinen la trazabilidad total del sistema.  Cada una de las etapas será recogida en los cuadros de gestión, donde a  través de la probabilidad del suceso y su gravedad se calculará el índice de criticidad de cada punto de control que se determine, y se establecerán las medidas de control. A partir de los cuadros de gestión se desarrollará el  soporte tecnológico para la captura de todos los datos que sean  pertinentes al modelo. Para asegurar el control de la calidad del proceso se optará por agentes software cliente, que permitan en fases posteriores  aplicar herramientas eficientes en el procesamiento de datos de modo  automático. A partir de aproximaciones metodológicas del big data, y en  particular del ámbito de machine learning, se desarrollarán algoritmos  sobre el repositorio de datos generado para poder obtener patrones que  permitan mejorar los protocolos de aplicación. Por último, para asegurar el funcionamiento del proceso se realizará la verificación clínico-farmacéutica  y la revisión completa, técnico-documental, de los sistemas de control y  registro.Conclusiones: La generación del sistema de gestión de riesgos mediante  tecnología móvil permitirá integrar los medicamentos peligrosos en un sistema normalizado, con el fin de mejorar la seguridad, calidad y  trazabilidad del proceso de manipulación de los medicamentos peligrosos.

Análisis de riesgos mediante modelos big data del uso de medicamentos peligrosos en Unidades de Hospitalización a Domicilio: protocolo de estudio / Assessing the risk of using hazardous drugs in Hospital-at-Home Units: a big data study protoco

Objetivo: Describir el protocolo del estudio para la instauración del control del proceso de los medicamentos peligrosos que asegure la calidady su trazabilidad, mediante el análisis de riesgos, desarrollando e implantando una herramienta informatizada que, gracias a la utilización de técnicas de big data, permita conocer y auditar el conjunto del sistema de formacontinua y dinámica.Método: Mediante los procesos de notación gráfica normalizada Business Process Model Notation se desarrollarán los flujogramas específicosque permitan conocer las etapas del proceso de los medicamentos peligrosos que determinen la trazabilidad total del sistema. Cada una de lasetapas será recogida en los cuadros de gestión, donde a través de laprobabilidad del suceso y su gravedad se calculará el índice de criticidadde cada punto de control que se determine, y se establecerán las medidasde control. A partir de los cuadros de gestión se desarrollará el soportetecnológico para la captura de todos los datos que sean pertinentes al modelo. Para asegurar el control de la calidad del proceso se optará poragentes software cliente, que permitan en fases posteriores aplicar herramientas eficientes en el procesamiento de datos de modo automático. Apartir de aproximaciones metodológicas del big data, y en particular delámbito de machine learning, se desarrollarán algoritmos sobre el repositorio de datos generado para poder obtener patrones que permitan mejorarlos protocolos de aplicación. Por último, para asegurar el funcionamientodel proceso se realizará la verificación clínico-farmacéutica y la revisióncompleta, técnico-documental, de los sistemas de control y registro. (AU)

Objective: This article describes a study protocol for the implementation of quality and traceability control in the hazardous medication circuitthrough an analysis of risks and the development and introduction of a BigData-based software application aimed at performing a continuous anddynamic audit of the whole system.Method: A standardized graphical modeling tool called Business Process Model Notation will be used to generate a detailed description ofeach of the stages in the hazardous medication circuit with a view to ensuring full traceability of the system. The information on each stage will becollected in a flowchart, which will be used —together with each event’slikelihood of occurrence and severity— as a basis to calculate the criticality index of the different control points established and to determine anycontrol measures that may be required. The flowcharts will also be usedto develop the technological support needed to capture all such data asmay be relevant to the model. Proper quality control of the process will be ensured by client software agents intended to allow automatic application of efficient data processing tools at the different phases. In addition,Big Data methodologies, in particular machine learning, will be used todevelop algorithms based on the repository of generated data to comeup with patterns capable of improving the protocols to be applied. Lastly,proper operation of the process will be ensured by means of clinicalpharmaceutical verification and a full technical-documentary review ofcontrol and registration systems. (AU)

Perception of risk of exposure in the management of hazardous drugs in home hospitalization and hospital units.

OBJECTIVE: To assess the perception of risk of exposure in the management of hazardous drugs (HDs) through home hospitalization and hospital units. MATERIAL AND METHODS: A questionnaire was released, at the national level, to health professionals with HD management expertise. Questionnaire included 21 questions that were scored using a Likert scale: 0 (null probability) to 4 (very high probability). The internal consistency and reliability of the questionnaire were calculated using Cronbach's alpha and the intraclass correlation coefficient, respectively. RESULTS: 144 questionnaires (response rate 70.2%) were obtained: 65 (45.1%) were nurses, 42 (28.9%) occupational physicians, and 37 (26.1%) were pharmacists. Cronbach's alpha was 0.93, and intraclass correlation coefficient was 0.94 (95% CI 0.91-0.97; p-value < 0.001). The mean probability was 1.95 ± 1.02 (median 1.9; minimum: 0.05; 1st quartile 1.1; 3rd quartile 2.6; and maximum 4). Differences were observed in scoring among professional groups (occupational physicians versus nurses (1.6/2.1, p = 0.044); pharmacists versus nurses (1.7/2.1, p = 0.05); and occupational physicians versus pharmacists (1.6/1.7, p = 0.785), due mainly to the administration stage (p = 0.015). CONCLUSIONS: The perception of risk of exposure was moderate, being higher for nurses. It would be advisable to integrate HDs into a standardized management system (risk management model applicable to any healthcare center) to improve the safety of health professionals.

Consensus to identify the dangerous drugs risks in hospital pharmacy services.

OBJECTIVE: To identify the hazards and define the theoretical  occupational risks arising from the process of handling hazard drugs in  hospital pharmacy services on the basis of expert consensus. METHOD: An expert consensus was conducted (nominal group and documentary techniques) using a mixed method of two face-to-face rounds (meeting of participants and approval of proposals) and  three masked rounds (individualized review). The analysis was applied  to the field of hospital pharmacy. The stages of the process were  designed using the standardized graphical Business Process Model and Notation. RESULTS: A specific flowchart was obtained for the management and  traceability of hazardous drugs. All general process phases were  characterized. A management chart included operations addressing the  reception and storage, compounding, conservation, and dispensation of  hazardous drugs in hospital pharmacy services. This chart provides a  description of the chemical hazards and exposure routes. CONCLUSIONS: The hazardous drug process should be integrated in a standard management system to improve the safety of patients and  healthcare professionals. Efficiency can maximized and procedural  incidents minimized, thereby ensuring the quality and the safety of  hazardous drugs handling in hospital pharmacy services. Once hazards  are identified, risk assessment should be implemented using a  systematic and preventative methodology to minimize the risk and  severity of any adverse event.

Objetivo: Identificar los peligros y definir los riesgos laborales teóricos derivados del proceso de manipulación de los medicamentos  peligrosos en los servicios de farmacia hospitalaria mediante un  consenso de expertos.Método: Se realizó un consenso de expertos (grupo nominal y técnicas documentales) utilizando un método mixto mediante dos  rondas presenciales (reunión de los participantes y aprobación de  propuestas) y tres rondas enmascaradas (revisión del material de forma individual). El análisis se aplicó al ámbito de la farmacia hospitalaria y  las etapas del proceso se diseñaron mediante notación gráfica  normalizada Business Process Modeling Notation.Resultados: Se obtuvo el diagrama de flujo específico para la gestión y trazabilidad de los medicamentos peligrosos, caracterizándose cada  una de las fases del proceso general, recopiladas en un cuadro de  gestión de etapas y operaciones de recepción y almacenamiento,  elaboración, conservación y dispensación de medicamentos peligrosos  en los servicios de farmacia hospitalaria, que sirvió para la posterior  descripción de riesgos químicos y vías de exposición.Conclusiones: Los medicamentos peligrosos deben integrarse en un sistema normalizado de gestión con el fin de mejorar la seguridad del paciente y de los profesionales sanitarios, a la vez que se maximizan la eficiencia de los recursos y minimizan los incidentes procesales,  garantizando la calidad y la seguridad del proceso de manipulación de  medicamentos peligrosos en los servicios de farmacia. Sería deseable,  una vez se han identificado los peligros, llevar a cabo una evaluación de  los riesgos siguiendo una metodología sistemática y de abordaje  preventivo que permita calibrar la probabilidad de ocurrencia y la  gravedad de cualquier suceso adverso.

Consenso para identificar los riesgos de los medicamentos peligrosos en los servicios de farmacia hospitalaria / Consensus to identify the dangerous drugs risks in hospital pharmacy services

OBJETIVO: Identificar los peligros y definir los riesgos laborales teóricos derivados del proceso de manipulación de los medicamentos peligrosos en los servicios de farmacia hospitalaria mediante un consenso de expertos. MÉTODO: Se realizó un consenso de expertos (grupo nominal y técnicas documentales) utilizando un método mixto mediante dos rondas presenciales (reunión de los participantes y aprobación de propuestas) y tres rondas en-mascaradas (revisión del material de forma individual). El análisis se aplicó al ámbito de la farmacia hospitalaria y las etapas del proceso se diseñaron mediante notación gráfica normalizada Business Process Modeling Notation. RESULTADOS: Se obtuvo el diagrama de flujo específico para la gestión y trazabilidad de los medicamentos peligrosos, caracterizándose cada una de las fases del proceso general, recopiladas en un cuadro de gestión de etapas y operaciones de recepción y almacenamiento, elaboración, conservación y dispensación de medicamentos peligrosos en los servicios de farmacia hospitalaria, que sirvió para la posterior descripción de riesgos químicos y vías de exposición. CONCLUSIONES: Los medicamentos peligrosos deben integrarse en un sistema normalizado de gestión con el fin de mejorar la seguridad del paciente y de los profesionales sanitarios, a la vez que se maximizan la eficiencia de los recursos y minimizan los incidentes procesales, garantizando la calidad y la seguridad del proceso de manipulación de medicamentos peligrosos en los servicios de farmacia. Sería deseable, una vez se han identificado los peligros, llevar a cabo una evaluación de los riesgos siguiendo una metodología sistemática y de abordaje preventivo que permita calibrar la probabilidad de ocurrencia y la gravedad de cualquier suceso adverso

OBJECTIVE: To identify the hazards and define the theoretical occupational risks arising from the process of handling hazard drugs in hospital pharmacy services on the basis of expert consensus. METHOD: An expert consensus was conducted (nominal group and documentary techniques) using a mixed method of two face-to-face rounds (meeting of participants and approval of proposals) and three masked rounds (individualized review). The analysis was applied to the field of hospital pharmacy. The stages of the process were desig-ned using the standardized graphical Business Process Model and Notation. RESULTS: A specific flowchart was obtained for the management and traceability of hazardous drugs. All general process phases were characterized. A management chart included operations addressing the reception and storage, compounding, conservation, and dispensation of hazardous drugs in hospital pharmacy services. This chart provides a description of the chemical hazards and exposure routes. CONCLUSIONS: The hazardous drug process should be integrated in a standard management system to improve the safety of patients and health-care professionals. Efficiency can maximized and procedural incidents minimized, thereby ensuring the quality and the safety of hazardous drugs handling in hospital pharmacy services. Once hazards are identified, risk assessment should be implemented using a systematic and preventative methodology to minimize the risk and severity of any adverse evento

La enseñanza de Farmacogenética/Farmacogenómica y Genética en las facultades de Farmacia de España, las causas del atraso / Teaching of Pharmacogenetics, Pharmacogenomics and Genetics in Spanish Pharmacy Faculties; causes of delay

La asignatura de Farmacogenética/Farmacogenómica (FG) se imparte en el 26,1% de las facultades de Farmacia (FF), siendo su porcentaje en las privadas del 40% y en las públicas 15,3%, y la de Genética en un 30,4%, homogéneo en ambas. Hace 6 años, en el 2010, y referido a la FG, este porcentaje era más de 3 veces superior (89,3%) en las FF de Estados Unidos. El mayor porcentaje de aquellas en las que no se imparte ninguna de las 2 asignaturas se da en las facultades que concentran la mayor oferta de plazas. En aquellas que las imparten, el carácter es mayoritariamente obligatorio. A la asignatura de Genética se le dedican 6 ECTS y a la de FG 3 ECTS. Ambas tienen un marcado carácter teórico, con una escasa o nula formación en el ámbito experimental, analítico, clínico o sanitario. Las desigualdades formativas de estas materias en nuestro país, cuando los conocimientos son universales, sientan las bases para una desigual aplicación de los avances científicos y condicionan el principio de universalidad de nuestra sanidad. Esta falta de conocimientos impide hoy una dispensación segura y eficaz en un buen número de fármacos siguiendo las recomendaciones de agencias reguladoras, como la Agencia Europea de Medicamentos o la Food and Drug Administration

The subject of Pharmacogenetics/Pharmacogenomics (PG) is provided in the 26.1% of the Spanish Pharmacy faculties, with the percentage being higher in private faculties (40%) than in the public ones (15.3%), and similar in Genetics (30.4%, in both). Six years ago in 2010, the teaching of PG was three times higher (89.3%) in American faculties. The higher percentage of those who do not provide/teach either of these two subjects relates to faculties that offer a higher number of places. In those where it is provided, it is mainly a mandatory subject. The subject of Genetics subject consists of 6 ECTS (European credit transfer and accumulation system), and the PG course 3 ECTS. Both have a high theoretical content, with a partial or total absence of practical, analytical, or health-related training. As knowledge is universal, these inequalities in the area of education of those subjects in our country lays the foundation for an unequal application of scientific advances and influences the principal of universality in our health. This lack of knowledge prevents having a safe and effective dispensation of drugs, following the recommendations of Regulatory Agencies like European Medicines Agency and Food and Drug Administration

[Recommendations for the safety preparation of sterile medicines in medical wards]. / Recomendaciones para la preparación de medicamentos estériles en las unidades de enfermería.

OBJECTIVE: To develop a recommendations guide about the preparation of sterile medicines in medical wards, and to figure out the current situation of different Spanish hospitals, regarding the preparation of sterile medicines outside the pharmacy. METHODS: The authors reviewed the available international guidelines in order to summarize the main quality recommendations. To know about the current situation in Spanish hospitals, a 30 questions survey was designed and spread to 500 different hospitals. Answers were analysed with SurveyMonkey® platform in the period February-July 2012. RESULTS: Based on the literature review, the authors agreed a recommendations list for the safe preparation of sterile medicines in medical wards, which was structured in 8 sections. Regarding the survey results, 8.4% of the hospitals answered, showing a great variability among centres in the quality requirements for sterile compounding outside the pharmacy. It should be pointed out the lack of assigned areas for drug preparation in wards, the lack of protocols to discern which kind of medicines can be compounded in wards as well as the poor recommendations about garment and aseptic technique. CONCLUSIONS: The authors confirm the absence of qualified practice standards to be applied in the preparation of sterile medicines in medical wards, as well as the great variability of diary practice. The implementation of quality and safety recommendations in the preparation of sterile medicines in medical wards may contribute to improve patient safety.

Recomendaciones para la preparación de medicamentos estériles en las unidades de enfermería / Recommendations for the safety preparation of sterile medicines in medical wards

Objetivo: Elaborar una guía de recomendaciones de preparación de medicamentos estériles en las unidades de enfermería, así como averiguar la situación actual de las condiciones de preparación en distintos hospitales españoles mediante una encuesta. Material y métodos: Se llevó a cabo una revisión bibliográfica de las recomendaciones internacionales publicadas y se elaboró un check-list de criterios de calidad. Para conocer la situación actual en los hospitales españoles, se diseñó una encuesta on-line de 30 preguntas dirigida al personal de enfermería que se ha difundido a 500 centros hospitalarios. Las respuestas auto cumplimentadas en el periodo de estudio (Febrero-Junio 2012), se analizaron con la aplicación Survey monkey®. Resultados: En base a la revisión, los autores consensuaron un listado de recomendaciones para la preparación segura de medicamentos estériles en unidades de enfermería, estructurado en 8 apartados. En cuanto a los resultados dela encuesta, respondieron un 8,4% de los centros, mostrando gran variabilidad en los requerimientos de calidad para la preparación de estériles en las plantas. Es destacable la ausencia de zonas designadas para la preparación en las unidades, la falta de protocolos sobre cuáles son los preparados estériles que pueden o no prepararse en planta y la escasez de normas en indumentaria y comportamiento para asegurar la asepsia. Conclusiones: Se constata la ausencia de estándares de práctica reconocidos que se apliquen de forma general en la preparación de medicamentos estériles en planta, así como una gran variabilidad en la práctica diaria. La aplicación de recomendaciones contrastadas de calidad y seguridad para la preparación de medicamentos estériles en las unidades de enfermería, puede contribuir a asegurar la asepsia de las preparaciones y disminuir los errores de medicación en planta

Objective: To develop a recommendations guide about the preparation of sterile medicines in medical wards, and to figure out the current situation of different Spanish hospitals, regarding the preparation of sterile medicines outside the pharmacy. Methods: The autors reviewed the available international guidelines in order to summarize the main quality recommendations. To know about the current situation in Spanish hospitals, a 30 questions survey was designed and spread to 500 different hospitals. Answers were analysed with Survey monkey® platform in the period February-July 2012. Results: Based on the literature review, the authors agreed a recommendations list for the safe preparation of sterile medicines in medical wards, which was structured in 8 sections. Regarding the survey results, 8.4% of the hospitals answered, showing a great variability among centres in the quality requirements for sterile compounding outside the pharmacy. It should be pointed out the lack of assigned areas for drug preparation in wards, the lack of protocols to discern which kind of medicines can be compounded inwards as well as the poor recommendations about garment and aseptic technique. Conclusions: The authors confirm the absence of qualified practice standards to be applied in the preparation of sterile medicines in medical wards, as well as the great variability of diary practice. The implementation of quality andsafety recommendations in the preparation of sterile medicines in medical wards may contribute to improve patient safety