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.

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.

[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.