Medication safety in intravenous drug administration : error causes and systemic defenses in hospital setting

Intravenous administration of drugs is associated with the highest medication error frequencies and more serious consequences to the patient than any other administration route. The bioavailability of intravenously administered medication is high, the therapeutic dose range is often narrow, and effects are hard to undo. Many intravenously administered drugs are high-alert medications, bearing a heightened risk of causing significant patient harm if used in error. Smart infusion pumps with dose error-reduction software can be used to prevent harmful medication errors in high-risk clinical settings, such as neonatal intensive care units. This study investigated intravenous medication safety in hospital settings by identifying recent research evidence related to systemic causes of medication errors (Study I) and systemic defenses to prevent these errors (Study II). The study also explored the development of dose-error reduction software in a neonatal intensive care unit (Study III). A systems approach to medication risk management based on the Theory of Human Error was applied as a theoretical framework. The study was conducted in two phases. In the first phase, a systematic review of recent research evidence on systemic causes of intravenous medication errors (Study I) and systemic defenses aiming to prevent these errors (Study II) was carried out. In Study I, 11 studies from six countries were included in the analysis. Systemic causes related to prescribing (n=6 studies), preparation (n=6), administration (n=6), dispensing and storage (n=5) and treatment monitoring (n=2) were identified. Insufficient actions to secure safe use of high-alert medications, lack of knowledge of the drug, failures in calculation tasks and in double-checking procedures, and confusion between look-alike, sound-alike medications were the leading causes of intravenous medication errors. The number of the included studies was limited, all of them being observational studies and graded as low quality. In Study II, 46 studies from 11 countries were included in the analysis. Systemic defenses related to administration (n=24 studies), prescribing (n=8), preparation (n=6), treatment monitoring (n=2), and dispensing (n=1) were identified. In addition, five studies explored defenses related to multiple stages of the medication use process. Defenses including features of closed-loop medication management systems appeared in 61% of the studies, smart pumps being the defense most widely studied (24%). The evidence quality of the included articles was limited, as 83% were graded as low quality, 13% moderate quality, and only 4% high quality. A mixed-methods study was conducted in the second phase, applying qualitative and quantitative methods (Study III). Medication error reports were used to develop simulation-type test cases to assess the suitability of dosing limits in a neonatal intensive care unit’s smart infusion pump drug library. Of all medication errors reported in the neonatal intensive care unit, 3.5% (n=21/601) involved an error or near-miss related to wrong infusion rate. Based on the identified error mechanisms, 2-, 5-, and 10-fold infusion rates and mix-ups between infusion rates of different drugs were established as test cases. When conducting the pump programming for the test cases (n=226), no alerts were triggered with infusion rates responding to the usual dosages (n=32). Of the erroneous 2-, 5-, and 10-fold infusion rates, 73% (n = 70/96) caused an alert. Mix-ups between infusion rates triggered an alert only in 24% (n=24/98) of the test cases. This study provided an overview of recent research evidence related to intravenous medication safety in hospital settings. Current intravenous medication systems remain vulnerable, which can result in patient harm. While in-hospital intravenous medication use processes are developing towards closed-loop medication management systems, combinations of different defenses and their effectiveness in error prevention should be explored. In addition to improved medication safety, implementing new systemic defenses leads to new error types, emphasizing the importance of continuous proactive risk management as an essential part of clinical practice.Laskimonsisäiseen lääkkeen annosteluun liittyy merkittävä lääkityspoikkeamien ja vakavien haittatapahtumien riski. Sairaaloissa käytetään useita laskimoon annosteltavia suuren riskin lääkkeitä, joiden virheellinen käyttö johtaa muita lääkkeitä todennäköisemmin vakaviin haittoihin. Tässä tutkimuksessa tunnistettiin järjestelmällisen kirjallisuuskatsauksen perusteella lääkityspoikkeamien järjestelmälähtöisiä syitä (osatyö I) sekä lääkehoitoprosessin suojauksia (osatyö II). Lisäksi tutkittiin älyinfuusiopumppujen käyttöönottoa vastasyntyneiden teho-osastolla. Teoreettisena viitekehyksenä käytettiin inhimillisen erehdyksen teoriaa ja järjestelmänäkökulmaa lääkehoitoprosessin riskien hallinnassa. Osatyön I aineistosta (n=11 tutkimusta) tunnistettiin lääkityspoikkeamien syntyyn vaikuttavia järjestelmälähtöisiä syitä, jotka liittyivät lääkehoidon määräämiseen (n=6), käyttökuntoon saattoon (n=6), antoon (n=6), jakeluun ja varastointiin (n=5) sekä seurantaan (n=2). Yleisimpiä syitä olivat riittämättömät toimenpiteet suuren riskin lääkkeiden turvallisen käytön varmistamisessa, ammattilaisten heikot tiedot lääkkeistä, virheet laskutoimituksissa ja kaksoistarkistuksissa sekä toisiltaan näyttävien ja kuulostavien lääkkeiden sekaantuminen keskenään. Osatyön II aineistossa (n=46 tutkimusta) kuvattiin lääkehoitoprosessin suojauksia, jotka liittyivät lääkkeiden annosteluun (n=24), määräämiseen (n=8), käyttökuntoon saattoon (n=6), hoidon seurantaan (n=2) ja jakeluun (n=1). Lisäksi viidessä tutkimuksessa kuvattiin useaan lääkehoitoprosessin vaiheeseen liittyviä suojauksia. Katkeamattoman lääkehoitoprosessin piirteitä tunnistettiin 61 prosentissa tutkimuksista ja älyinfuusiopumput olivat eniten tutkittu suojaus (24 %). Osatyö III toteutettiin monimenetelmätutkimuksena. Vastasyntyneiden teho-osastolla raportoitujen lääkityspoikkeamien pohjalta kehitettiin simulaatiotyyppisiä testitapauksia, joilla arvioitiin annosrajojen sopivuutta älyinfuusiopumppujen lääkekirjastoon. Lääkityspoikkeamista 3,5 % (n=21/601) liittyi väärään infuusionopeuteen ja niiden perusteella testitapauksiksi määritettiin 2-, 5- ja 10-kertaiset infuusionopeudet sekä eri lääkkeiden antonopeuksien sekaantuminen keskenään. Testitapauksissa (n=226) infuusiopumput eivät hälyttäneet tavanomaisia nopeuksia ohjelmoitaessa (n=32), mutta virheellisistä infuusionopeuksista 73 % (n=70/96) aiheutti hälytyksen. Nopeuksien sekaantuminen keskenään laukaisi hälytyksen vain 24 %:ssa (n=24/98) testitapauksista. Sairaaloiden laskimonsisäinen lääkehoitoprosessi kehittyy kohti katkeamatonta lääkehoitoprosessia, mutta se on edelleen altis lääkityspoikkeamille. Kirjallisuuskatsauksiin sisällytettyjen tutkimusten laatu oli pääosin heikko, joten lääkityspoikkeamien riskitekijöitä ja suojauksia tulee edelleen tutkia yhä laadukkaammissa tutkimusasetelmissa. Uusien suojausten käyttöönotto muuttaa myös riskikohtia, mikä korostaa ennakoivan riskienhallinnan merkitystä osana sairaaloiden toimintaa

Standardization of intravenous medication beyond use dating at a large health-system

Within a large, nine-hospital health-system, there are a number of hospitals that have historically reviewed the current literature individually to establish hospital-specific non-hazardous compounded sterile product (CSP) beyond-use date (BUD) lists. Creating and standardizing the list on a system level is a potential model that could reduce work at the individual site level, increase network patient safety, and facilitate the implementation of network technology. Researchers reviewed the most up-to-date literature and current non-hazardous CSP BUD lists at each site for inconsistencies to highlight the value and increased safety associated with standardizing this resource across the network

The Development and Evaluation of E-Management Platform for Patient-reported Outcomes Research Based on Business Process Improvement Theory

Background Patient-reported outcomes (PROs) refer to the health-related information coming directly from patients without any explanation by the doctors or others. It is of great significance for patients to participate in medical decision-making, have a higher quality of care，and have a better medical outcome. Therefore, patient-reported outcomes measurements (PROMs) have important clinical value. Patient-reported Outcomes Measurement Information System (PROMIS) is one of the most accurate PROMs led by NIH and focuses on health-related big data's scientific characteristics. PROMIS advocates cross-population, cross-region, and cross-disease studies and is widely recognized among the research community. PROMIS Health Organization (PHO) now promotes the global implementation of PROMIS by setting up PROMIS National Center (PNC) in various countries, and PNCs organize the research cooperation with many research groups to promote PROMIS. PROMIS China Center is one of the PNCs that takes charge of the PROs cooperative research with many research teams to promote PROMIS in China. Due to the diverse tasks, complex procedures, and low efficiency of the current cooperative management mode of PROMIS China Center, it cannot meet the efficient research management requirements. Therefore, it is necessary to analyze the needs, improve the process, and build an E-management platform under the guidance of business improvement theory to improve the management efficiency of the patient-reported outcome research and eventually promote PROMIS in China. Objectives The general purpose of this research is to improve the management process of patient-reported outcomes research based on the business process improvement theory and develop an E-Management platform as well as evaluate the usability of the E-management platform. Purpose one: The need analysis of the E-management platform for the patient-reported outcomes research; Purpose two: The framework construction of the E-management platform for patient-reported outcomes research; Purpose three: The development of the E-management platform for patient-reported outcomes research; Purpose four: The usability evaluation of the E-Management Platform for Patient-reported outcomes research. Methods The study was comprised of 4 parts： Part1: The need analysis of the E-management platform for the patient-reported outcomes research Based on business improvement theory (ESIA theory), the researcher conducted the semi-structured qualitative interviews, including five rounds of focus group interviews with 5 management staffs of the PROMIS China Center and one-on-one interviews with 11 cooperative team members to know the current management process of patient-reported outcomes research, the problems of current management process, and the need for the E-management platform. Part2: The framework construction of the E-management platform for patient-reported outcomes research The researcher held a brainstorming discussion with 13 management staffs to improve the current management process based on business improvement theory; Meanwhile, the researcher accomplished the literature study about the patient-reported outcomes research E-management platforms of other countries and analyzed the framework; Then, the researcher combined the results of need analysis, brainstorming, and literature study to draw the preliminary framework of the patient-reported outcomes research E-management platform; Finally, the researcher held an expert group meeting with 7 experts from the field of both nursing research and software engineering to revise the preliminary framework and make a final framework. Part3: The development of the E-management platform for patient-reported outcomes research The researchers organized and coordinated close cooperation among experts in different fields. Based on the final framework of the E-management platform formed in the early stage, the researchers adopted the human-centered concept and the agile development method to develop the E-management platform with 3 software engineers. Part4: The usability evaluation of the E-Management Platform for Patient-reported outcomes research The researcher implemented the formative usability evaluation during the process of development to find the problems about the interface, like font and module; Then the researcher implemented the summarized usability evaluation by task analysis and semi-structured interviews with 15 users，including 5 management staffs of the PROMIS China Center and 10 cooperative team members. The evaluation outcomes were reported after data analysis. Results Part1: The need analysis of the E-management platform for the patient-reported outcomes research The qualitative research results show the: ① PROMIS translation, validation, clinical application management processes, and the researcher presented them in text and flow chart. ② The current process's problems, like the current management process is tedious; the current management process involves too much paper materials; it is difficult for management staffs to supervise the process. ③ the need for the E-management: all the participants said they need the E-management platform and expressed their specific needs. Part2: The framework construction of the E-management platform for patient-reported outcomes research The brainstorming efficiently improved the management process, and the improved process was shown with text and flowchart; The literature study presented the framework of the Netherlands PROMIS E-management platform; the researcher drew a preliminary framework of the E-management platform under the guidance of need analysis, improved management process, and Netherlands PROMIS E-management platform, which contains 7 first-level modules, and 5 second-level modules. After the expert group meeting, the final framework was constructed, which includes 6 first-level modules: "Home", " Introduction ", "PROMIS Measurement", "News Center", "Resources", and " Research Cooperation", 16 second-level modules, and the content covered by the second-level modules. Part3: The development of the E-management platform for patient-reported outcomes research The researchers demonstrated the preliminary framework of the E-management platform to the software engineers, and we worked jointly to complete the development of the E-management platform after the steps of requirement clarification, design, development, testing, and release. Part4: The usability evaluation of the E-Management Platform for Patient-reported outcomes research During the formative usability evaluation, the researcher found many problems, and they were all solved by software engineers; During the summarized usability evaluation, we demonstrated the platform in terms of effectiveness, efficiency, and satisfaction. Based on the scores of the usability evaluation questionnaire after the test: system usefulness is 5.2 (from management staffs) and 5.8 (from cooperative team members), information quality is 6.8 (from management staffs) and 6.0 (from cooperative team members), interface quality is 5.4 (from management staffs) and 5.9 (from cooperative team members), and overall evaluation is 6.0 (from management staffs) and 6.2 (from cooperative team members). Through qualitative interviews, we understand the user experience of the platform. The interview data shows two topics related to usability. By combining quantitative and qualitative outcomes, the researcher thinks that the E-management platform's usability is generally good, but there are still some shortcomings. Conclusions Both the management staffs and cooperative team members of the PROMIS China Center have a high level of need for the E-management platform. The final framework based on need analysis and process improvement is good guidance for developing the E-management platform. The usability evaluation shows that the E-management platform has a good usability and can help manage the patient-reported outcomes cooperative research. It will be able to enhance the management efficiency of patients-reported outcomes research extensively and accelerate the rapid promotion of PROMIS in China

Calidad de la preparación de quimioterapia asistida electrónicamente

Los sistemas tecnológicos de soporte a la preparación manual de quimioterapia (QT) parenteral constituyen una de las principales herramientas para la prevención de errores de preparación (EP) en estos tratamientos. No obstante, la evidencia científica que respalda su beneficio potencial en la práctica asistencial es aún limitada. OBJETIVOS La Tesis Doctoral que se presenta se ha desarrollado con el fin de mejorar el conocimiento del valor añadido que aportan estos sistemas tecnológicos en la preparación de QT parenteral, en concreto, el Sistema ePASE® (IMF, SL), que integra un control de calidad cualitativo, mediante verificación del código data-matrix (DM) de las presentaciones, y cuantitativo mediante gravimetría. Para ello se evaluó su impacto en las diferentes dimensiones de la calidad asistencial (efectividad, seguridad, eficiencia comparada con el proceso de preparación no asistido y satisfacción del usuario). El objetivo principal fue cuantificar el impacto del control tecnológico en términos de efectividad-seguridad del paciente en comparación con el control de calidad estándar (basado en los métodos visual y semi-cuantitativo). MATERIAL Y MÉTODOS El proyecto de investigación se desarrolló en tres fases. En la Fase I (01/01/2013 - 31/03/2013) se validó el control tecnológico, obteniéndose los valores de Sensibilidad, Especificidad y Valores Predictivos para interceptar EP y se analizaron los riesgos introducidos por la tecnología mediante el Análisis de Modos de Fallo y Efectos (AMFE). En la Fase II (1/04/2013 - 21/11/2013) se analizó la calidad de la preparación de QT asistida por ePASE® en términos de seguridad del paciente y del preparador. Se cuantificó la variabilidad en la dosis de fármaco preparada mediante el Error Gravimétrico Porcentual (EGP), se determinaron la prevalencia y tipología de los EP interceptados, se analizaron los factores de riesgo a través de modelos de regresión logística, y se midió el tiempo acumulado de exposición a fármacos peligrosos por trabajador. En la Fase III (22/11/2013 -30/04/2014) se desarrolló un estudio cuasi-experimental aleatorizado no enmascarado, para demostrar superioridad en la interceptación de EP del control tecnológico respecto al estándar. Además, se evaluó la eficiencia de la preparación asistida vs no asistida mediante el cálculo del ratio coste-efectividad incremental (CEI) desde la perspectiva del SNS, teniendo en cuenta los costes sanitarios directos, a 5 meses y 15 años (vida útil estimada de la tecnología). Finalmente se investigó la satisfacción de los profesionales con el control tecnológico mediante un cuestionario validado. RESULTADOS En términos de efectividad-seguridad del paciente, el control de calidad tecnológico ha duplicado la capacidad de interceptar EP respecto al control de calidad estándar, con un RR global de 2,60 (IC 95% 1,84-3,65), siendo especialmente relevante el impacto en la detección y prevención de errores relacionados con la dosis de fármaco. A su vez, este control de calidad tecnológico ha demostrado una elevada validez diagnóstica para interceptar EP (Sensibilidad del 100% y Especificidad del 96%), clasificando correctamente las preparaciones como correctas o erróneas en el 98,1% de los casos. Además, ha evidenciado la gran variabilidad que existe en la dosificación de la mayoría de los fármacos cuando se utiliza el método volumétrico de preparación, que incorpora errores sistemáticos en el proceso. Gracias al análisis retrospectivo de los registros del control de calidad de la preparación que permite el control tecnológico del Sistema ePASE®, se ha cuantificado la prevalencia de EP en nuestra institución, con 43,6 EPx1000 preparaciones (el 80% EP cuantitativos, principalmente en la dosis de fármaco) y se han identificado los factores de riesgo para cada subtipo de EP; resultados de gran utilidad para poder desarrollar estrategias preventivas en el futuro. El AMFE realizado ha permitido identificar los riesgos asociados al uso de esta nueva tecnología, cuya incorporación al proceso de preparación de QT parenteral llevó asociados 24 nuevos modos de fallo que fueron priorizados, en función del riesgo asociado, con el fin de implantar estrategias, como la estandarización de procesos y la formación de los profesionales, para prevenir problemas futuros de calidad y seguridad. En cuanto a seguridad del preparador, el Sistema ePASE® ha permitido cuantificar el tiempo acumulado de exposición a fármacos peligrosos, mostrando una gran variabilidad entre profesionales. En términos de eficiencia, la preparación de QT parenteral asistida tecnológicamente ha presentado un CEI global respecto a la preparación no asistida de 25,92–33,64 €/EP para un horizonte temporal de 15 años. El escenario de mayor eficiencia ha correspondido al control gravimétrico completo (de la dosis de fármaco y volumen de vehículo preparados) y, el de menor eficiencia, al control cualitativo de fármaco mediante la verificación del código DM. Finalmente, el grado de satisfacción global de los usuarios ha sido elevado y la valoración global positiva o muy positiva por parte de todos ellos. CONCLUSIONES Los resultados obtenidos en esta Tesis Doctoral ponen de relieve el valor añadido de los sistemas tecnológicos de soporte a la preparación de QT parenteral. En este sentido, la integración del Sistema ePASE® en el proceso de preparación mejora la calidad asistencial, ya que incrementa la seguridad del paciente y del trabajador, presenta un CEI razonable y tiene una buena aceptación por los profesionales.IV workflow management systems, applied to parenteral chemotherapy (QT) compounding process are one of the main tools to prevent compounding errors (CE). However, due to its recent development, the scientific evidence supporting its potential benefit in healthcare practice is still limited. OBJECTIVES This Doctoral Thesis has been developed in order to improve the knowledge of the added value that these technological systems provide in the parenteral QT compounding process, specifically, the ePASE® System (IMF, SL), that integrates a qualitative control, based on verifying the data-matrix code (DM) of diluents and drugs and a quantitative control based on gravimetry. With this aim, we evaluated its impact in the different dimensions of healthcare quality (effectiveness, safety, efficiency -compared to the compounding process non-assisted by technology- and user satisfaction). The main objective was to quantify the impact of technological control in terms of effectiveness-patient safety compared to standard quality control (based on visual and semi-quantitative methods). MATERIAL AND METHODS The research project was developed in three phases. In Phase I (01/01/2013-03/31/2013), technological control was validated, getting the Sensitivity, Specificity and Predictive Values to intercept CE, and the risks introduced by the technology were analyzed using the Failure Modes and Effects Analysis (FMEA). In Phase II (04/01/2013-11/21/2013) we analyzed the quality of the QT compounding process assisted by ePASE®, in terms of patient and compounder safety. Variability in the dosage of drugs was quantified using the Percentage Gravimetric Error (PGE); the prevalence and typology of the intercepted CEs were analyzed, and risk factors for this CE were identified through logistic regression models. Finally we measured the accumulated time exposure to hazardous drugs per compounder. In Phase III (11/22/2013-30/04/2014) we developed a non-masked randomized quasi-experimental study to demonstrate the superiority of technological control in the interception of CE over the standard control. In addition, the efficiency of technological assisted compounding process vs. non-assisted was evaluated by the incremental cost-effectiveness ratio (ICER) from the National Healthcare Service perspective, taking into account only direct healthcare costs, and for a time horizon of 5 months and 15 years (expected useful life of technology). Finally, the satisfaction of the professionals was investigated through a validated questionnaire. RESULTS In terms of effectiveness-patient safety, technological quality control has doubled the ability to intercept CE compared to standard quality control, with an overall RR of 2.60 (95% CI 1.84-3.65), highlighting the impact on the interception and prevention of errors related to the drug dose. This technological quality control has shown a high diagnostic validity to intercept CE (Sensitivity of 100% and Specificity of 96%), and classifies correctly the preparations as correct or erroneous in 98.1% of cases. Furthermore, it has evidenced the great variability that exists in the dosage of most drugs when using the volumetric method during compounding, which incorporates systematic errors in the process. Thanks to the retrospective analysis of the quality control records of the compounding process allowed by the technological control of the ePASE® System, the prevalence of CE in our institution has been quantified, with 43.6 CE x 1000 preparations (80% quantitative CE, mainly in drug dose) and risk factors for each CE subtype have been identified. This results are relevant to develop preventive strategies in the future. The FMEA carried out has made it possible to identify the risks associated with the use of this new technology, whose incorporation into the parenteral QT compounding process involved 24 new failure modes that were prioritized, based on the associated risk, in order to implement strategies, such as the standardization of processes and the training of professionals, to prevent future quality and safety problems. Regarding the safety of the compounder, the ePASE® System has made it possible to quantify the accumulated time of exposure to dangerous drugs, showing great variability among professionals. In terms of efficiency, the compounding of parenteral QT technologically assisted, has presented a global ICER (compared to non-assisted process) of € 25.92–33.64 / CE for a time horizon of 15 years. The most efficient scenario corresponded to complete gravimetric control (of the drug dose and vehicle volume prepared) and, the least efficient scenario, to the qualitative control of the drug by verifying the DM code. Finally, the global satisfaction of the users has been high and the overall assessment was positive or very positive by all of them. CONCLUSIONS The results obtained in this Doctoral Thesis highlight the added value of IV workflow management systems applied to the compounding process of parenteral QT. In this sense, the integration of the ePASE® System in the compounding process improves the quality of care, since it increases the safety of the patient and the compounder, presents a reasonable ICER and is well accepted by professionals