Actionable Patient Safety Solution (APSS) #3D: Pediatric Adverse Drug Events

This report presents a plan of action for introducing a program to reduce the incidence of pediatric adverse drug events (pADEs) and harm ... [that] combine[s] leadership strategies, software (healthcare IT), hardware (drug compounding systems, drug delivery technology, and physiological monitoring systems), and most importantly people (changes in clinical practice, protocols and education) to protect pediatric patients

Incorporating new technology into healthcare: an analysis of performance, acceptance, and safety

Each year, advances in the healthcare industry allows for better patient care and increased ability to save lives. Looking at standardized and common healthcare devices for both inside and outside the hospital environment, this research studied the tradeoffs and human factors that affect operator performance and patient survival. This research studied the impact of human factors and technology in the development and implementation of the automated external defibrillator for out-of-hospital use and the incremental advantages of SMArT infusion pump technology over traditional intravenous infusion pumps for in-hospital care. The study highlights the complex human factors of both products and establishes a need for more extensive user modeling and operator studies in order to better integrate the devices into the patient care system. Based on current results, minor changes to the design should provide significant positive impact to the overall effectiveness and performance of these devices --Abstract, page iv

Alarm fatigue in infusion pumps in the pediatric context: integrative review / Fadiga de alarmes em bombas de infusão no contexto pediátrico: revisão integrativa

Objetivo: identificar as causas da fadiga de alarmes em estudos de usabilidade de bomba de infusão em terapia intensiva pediátrica. Métodos: Realizou-se uma revisão integrativa nas bases de dados LILACS, SciELO, IBECS, SCOPUS e MEDLINE. Resultados: Foram identificadas 1.164 publicações e selecionados seis estudos primários que emergiram em duas temáticas: compreender as causas dos alarmes da bomba de infusão que constou: biblioteca de fármacos incompleta, limites absolutos e relativos rígidos, falta de protocolo de preparo e administração de medicação, período de férias dos funcionários; e as medidas que podem evitar a fadiga de seus alarmes.Conclusão:falhas na usabilidade de bombas de infusão aumentam os alarmes desnecessários que podem promovem sua fadiga. A utilização segura de bombas de infusão demanda uma equipe que monitore suas práticas e atue promovendo mudanças no contexto de trabalho.

Provider issues related to patient controlled analgesia and nurse controlled analgesia errors in a pediatric hospital

Background: Medical errors are a danger to patient safety and a significant cause of morbidity and mortality. Additionally, they increase expenditures in an already significantly indebted U.S. health care system. Much confusion exists about definitions of medical errors, which include medication errors and adverse drug events (ADEs). Several federal and international organizations have attempted to standardize definitions in order to streamline data collection, but until these standards are universally adopted, error reports and trends are still subject to questions of validity. Reporting errors, in general, has become a more socially acceptable practice in health care with the advent of several anonymous reporting databases. There have also been several initiatives aimed at reducing the incidence of errors, which range from national programs to intrafacility guidelines. Several pieces of health information technology (HIT) have made an impact on error incidence and data collection, although there is much room for improvement. Patient controlled analgesia (PCA) pumps for pain management have been in existence for decades, and "smart pump" software has improved their safety and ease of programming. PCA use in children presents challenges to clinicians, and the characteristics of providers who write PCA orders and those who program PCA pumps may play a role in the incidence of events related to PCA. This study seeks to elucidate trends in errors as they related to these different PCA providers in a pediatric hospital in the northeastern U.S. and provide recommendations for how PCA practice can be improved in this facility. Methods: Safety Event Reporting System (SERS) reports of PCA events (n = 117) during the period of 2004 - 2012 were analyzed retrospectively to determine several key variables for data analysis. The main focus of this analysis was those variable trends related to providers, including: proportion of events caused by human error, proportion of events related to subcategories of human error, proportion of types of prescribers involved in PCA events, proportion of errors in medical and surgical patients, proportion of errors occurring on day and night shifts for the nursing staff, and proportion of events that were dosing mistakes. Statistical analysis was performed for these results when possible to determine significance. Results: Human errors were implicated in 84.1% of events, whereas PCA pump mechanical errors and software errors were implicated in 7.1% and 7.9% of events, respectively. Statistically significant differences were found in all variables tested, including the proportion of nursing errors (60.9%) versus prescriber errors (28.7%) (p < 0.0002). For types of prescribers, the proportion of PCA events occurring when a M.D. wrote the PCA order (56.41%) was statistically different than when a N.P. wrote the PCA order (39.32%) (p = 0.0129). More surgical patients (61.5%) were affected by PCA events than medical patients (36.8%) (p < 0.0002). There were more events occurring on the nursing staff day shift (59.8%) than the night shift (36.8%) (p = 0.0004). Finally, dosing mistakes (66.7%) were implicated in significantly more PCA events than any other error type (33.3%) (p < 0.0002). Conclusion: Several recommendations for improving the safety of PCA in pediatric pain management are justified by the results of this data analysis. First, further education and simulation for entering PCA orders into the CPOE system is needed for all prescribers. Secondly, further education and simulation in PCA pump programming and system set-up is needed for all nursing staff members. In regard to prescriber credentials, it is recommended that Pain Treatment Service (PTS) staff members train M.D. residents in writing PCA orders and entering them into the CPOE system. Finally, it is recommended that the SERS management team publish standardized error report content and entry format in order to streamline data analysis for quality improvement (QI) purposes

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

A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations

Parenteral nutrition (PN) serves as an important therapeutic modality that is used in adults, children, and infants for a variety of indications. The appropriate use of this complex therapy aims to maximize clinical benefit while minimizing the potential risks for adverse events. Complications can occur as a result of the therapy and as the result of the PN process. These consensus recommendations are based on practices that are generally accepted to minimize errors with PN therapy, categorized in the areas of PN prescribing, order review and verification, compounding, and administration. These recommendations should be used in conjunction with other A.S.P.E.N. publications, and researchers should consider studying the questions brought forth in this document

Barriers to the Use of Guardrails On IV Smart Pumps

Medication errors involving hospitalized patients have been an evolving challenge for decades. Moreover, errors related to intravenous (IV) medication administration continue to rise in hospitals despite implemented policies governing the use of Guardrails™ for safe IV medication infusion via smart pump technology. An organizational investigation was performed to identify barriers to the use of Guardrails™ among nursing staff. From 2015 through 2017, multiple interventions that aimed to identify barriers and increase nurses’ use of the safety features on IV smart pumps were implemented in the hopes of reaching a compliance goal of 90-100%. This quality improvement project assesses Guardrails™ compliance with smart pumps since its initial integration in 2010 and through 2017. A systematic organizational assessment was conducted at a Magnet®-recognized facility in South Carolina to identify the factors that influence the use of Guardrails™ by nurses, implement changes based on the assessment, measure outcomes, and make recommendations for future change to foster continued progress towards the 90-100% benchmark. Participants included all nurses who utilized the smart pumps with Guardrails™ (N=2,500). The results provided insights into the factors that either succeeded or not through collaboration with numerous stakeholders, metrics on Guardrails™ utilization, self-reported IV medication errors per year, and a pre- and post-project survey. The project offered valuable information that was used to implement changes that eventually resulted in an increase in nurses\u27 compliance with Guardrails™ use, provided recommendations for sustaining compliance, and proposed updates to the facility\u27s IV medication administration policy. The data results from the Guardrails™ compliance report and IV medication error rate between 2015 and 2017 provided enough evidence to suggest that a structured continuous education plan is essential to increase nurses’ awareness and adherence to policies and procedures governing the use of Guardrails™ on IV smart pumps

Safety Measures to Reduce Medication Administration Errors in Paediatric Intensive Care Unit

Objective: Medicine administration is the last process of the medication cycle. However, errors can happen during this process. Children are at an increased risk from these errors. This has been extensively investigated but evidence is lacking on effective interventions. Therefore, the aim of this research is to propose safety measures to reduce medication administration errors (MAE) in the Paediatric Intensive Care Unit (PICU). Method: The research was carried out over five studies; 1) systematic literature review, 2) national survey of PICU medication error interventions, 3) retrospective analysis of medication error incidents, 4) prospective observation of the administration practice, and 5) survey of PICU healthcare professionals’ opinions on MAE contributory factors and safety measures. Results: Hospital MAE in children found in literature accounted for a mean of 50% of all reported medication error reports (n= 12552). It was also identified in a mean of 29% of doses observed (n= 8894). This study found MAE retrospectively in 43% of all medication incidents (n= 412). Additionally, a total of 269 MAEs were observed (32% per dose observation). The characteristics of the interventions used to reduce MAE are diverse but it illustrated that a single approach is not enough. Also for an intervention to be a success it is fundamental to build a safety culture. This is achieved by developing a culture of collaborative learning from errors without assigning blame. Furthermore, MAE contributing factors were found to include; interruptions, inadequate resources, working conditions and no pre-prepared infusions. The following safety measures were proposed to reduce MAE; 1) dose banding, 2) improved lighting conditions, 3) decision support tool with calculation aid, 4) use of pre-prepared infusions, 5) enhance the double-checking process, 6) medicine administration checklist, and 7) an intolerant culture to interruption. Conclusion: This is one of the first comprehensive study of to explore MAE in PICU from different perspectives. The aim and objectives of the research were fulfilled. Future research includes the need to implement the proposed safety measures and evaluate them in practice

Accuracy of Intravenous and Enteral Preparations Involving Small Volumes for Paediatric Use: A Review

Background: Children often need to be administered very small volumes of medicines that are authorised for use in adults. Neonatal drug delivery is particularly challenging and doses are often immeasurable with the equipment currently available. Aim: To summarise research to date on the accuracy of intravenous and enteral medicine preparation requiring small volumes (<0.1mL), with a focus on paediatric use and to identify areas for further work. Method: Twenty-three publications were identified for the narrative review via: Web of Science (1950-2016), Cumulative Index to Nursing and Allied Health Literature (1976-2016), Excerpta Medica Database (1974-2016) and International Pharmaceutical Abstracts (1970-2016) searches. Nine additional papers were identified through backward citation tracking and a further 17 were included from the personal knowledge of the review team. Results: Measurement of volumes (<0.1mL), for enteral and intravenous dosing, account for 25% of medicine manipulations within paediatric hospitals. Inaccuracies are described throughout the literature with dose administration errors attributed to technique, calculation, dilution and problems associated with equipment. Whilst standardised concentrations for intravenous infusion and drug concentrations which avoid measurement of small volumes would ameliorate problems, further work is needed to establish accurate methods for handling small volumes during the administration of medicines to children and risk minimisation strategies to support staff involved are also necessary. Conclusion: This review has revealed a paucity of information on the clinical outcomes from problems in measuring small volumes for children and highlighted the need for further work to eliminate this source of inaccurate dosing and potential for medication error