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

Electronic Prescribing In Children (EPIC): an evaluation of implementation at a children’s hospital.

Medication errors are common and can cause significant mortality and morbidity. Electronic prescribing (EP), with or without clinical decision support systems (CDSS), is a complex intervention that has been proposed as a solution. US studies indicate that there may be a reduction in medication errors as well as adverse events, but equally new errors may be introduced. There is a paucity of studies assessing the use and impact of EP in the UK hospital setting, especially those involving paediatric patients. The aim of this thesis was to investigate and evaluate the implementation of an EP system at a children's hospital in the UK. The objectives were to assess the effect on prescribing errors, to explore the level of CDSS available and in use within the system, to identify any changes in practice and workflow patterns of healthcare professionals, and to determine the views of patients and users. Mixed qualitative and quantitative methods were used within an evaluation framework (the Cornford framework). The results show an overall reduction in prescribing errors directly as a result of more complete and legible prescriptions after EP. Outpatient errors decreased from 1219/1574 (77.4%) to 33/648 (5.1%), a 72.3% reduction [95% confidence interval (CI) -74.6% to -69.3%]. The number of outpatient visits that were error free increased from 185/883 (21%) to 225/250 (90%), 95% Cl of difference in proportions, 64% to 73.4%. Inpatient errors decreased from 85/1267 (6.7%) to 96/ 2079 (4.6%), 95% CI of difference in proportions, -3.4% to -0.5% There was an increase in discharge prescription errors from 839/1098 (76.4%>) to 1777/2057 (86.4%), 95% CI of difference in proportions, 7.88% to 12.94%. The dosing error rate in all types of prescriptions was lower after EP: 88/3939 (2.2%) vs. 57/4784 (1.2%), 95% CI of difference in proportions, -1.6% to -0.5%, but there was no statistically significant change in severity ratings of dosing errors. New types of errors, such as selection errors, were seen due to EP. Although principles of the medicines use process remained the same, the practical approach to tasks was altered. The system was accepted by users and patients, but there was a desire for further improvements, especially in the level of clinical decision support available to the end user. In conclusion, the EP system was implemented successfully. The benefits in medication safety appear to be the results of effective interaction between system functionality and usability, user acceptance and organisational infrastructure

Master of Science

thesisCampylobacteriosis is a foodborne and waterborne zoonotic gastrointestinal illness and the most common cause of acute gastroenteritis worldwide. In the United States Campylobacter infections are second only to Salmonella as the most common cause of gastroenteritis, accounting for an estimated 2.4 million symptomatic infections annually. It is estimated that the total cost of foodborne illness in the United States is $152 billion of which$18.8 billion is attributed to Campylobacter. Diagnosis can be challenging because the organism is difficult to isolate, grow, and identify. Clinical manifestation of Campylobacter is indistinguishable from other enteric pathogens; (Salmonella, Shigella, Yersinia, Clostridium difficile, and E. coli 0157:H7 and other enterohemorrhagic E. coli) therefore, a presumptive diagnosis cannot be made putting them at risk for untreated infection. There are a growing number of diagnostic methods available for detection and/or isolation of Campylobacter species from stool, but there is currently no national or state public health testing guidelines. Eight assays were evaluated for performance in the detection of Campylobacter species in stool. The assays are comprised of four culture medias (CVA, CSM, Cefex, and mCCDA); three EIA/ELISA kits (ImmunoCard STAT! Campy, Premier Campy and ProSpecT Campy); and one molecular method (FilmArray GI panel). The FilmArray GI panel due to its ability to detect viable and nonviable organism was used as the gold standard. To verify the gold standard was accurate all positive FilmArray samples were analyzed by DNA sequencing. The sensitivity and specificity, respectively, of each assay are as follows: CVA 87.8%, 100%; CSM 87.8%, 100%; Cefex 87.8%, 100%; mCCDA 78.0%, 100%; ImmunoCard STAT! Campy 31.7%, 65.2%; Premier Campy 80.5%, 26.1%; and the ProSpecT Campy 75.6%, 82.6%. In contrast the FilmArray produces a sensitivity and specificity of 100% when compared to culture. Furthermore the FilmArray GI panel takes the least amount of time to produce a result, 1 hour compared to 48-72 hours for culture. In conclusion, the FilmArray GI panel is the most sensitive, specific, rapid, cost effective, and objective method for the detection of Campylobacter species in stool. Molecular assays such as the FilmArray GI panel should replace traditional culture techniques in the microbiology lab

An investigation of healthcare professionals’ experiences of training and using electronic prescribing systems: four literature reviews and two qualitative studies undertaken in the UK hospital context

Electronic prescribing (ePrescribing) is the process of ordering medicines electronically for a patient and has been associated with reduced medication errors and improved patient safety. However, these systems have also been associated with unintended adverse consequences. There is a lack of published research about users’ experiences of these systems in UK hospitals. The aim of this research was therefore to firstly describe the literature pertaining to the recent developments and persisting issues with ePrescribing and clinical decision support systems (CDS) (chapter 2). Two further systematic literature reviews (chapters 3 and 4) were then conducted to understand the unintended consequences of ePrescribing and clinical decision support (CDS) systems across both adult and paediatric patients. These revealed a taxonomy of factors, which have contributed to errors during use of these systems e.g., the screen layout, default settings and inappropriate drug-dosage support. The researcher then conducted a qualitative study (chapters 7-10) to explore users’ experiences of using and being trained to use ePrescribing systems. This study involved conducting semi-structured interviews and observations, which revealed key challenges facing users, including issues with using the ‘Medication List’ and how information was presented. Users experienced benefits and challenges when customising the system, including the screen display; however, the process was sometimes overly complex. Users also described the benefits and challenges associated with different forms of interruptive and passive CDS. Order sets, for instance, encouraged more efficient prescribing, yet users often found them difficult to find within the system. A lack of training resulted in users failing to use all features of the ePrescribing system and left some healthcare staff feeling underprepared for using the system in their role. A further literature review (chapter 5) was then performed to complement emerging themes relating to how users were trained to use ePrescribing systems, which were generated as part of a qualitative study. This review revealed the range of approaches used to train users and the need for further research in this area. The literature review and qualitative study-based findings led to a follow-on study (chapter 10), whereby the researcher conducted semi-structured interviews to examine how users were trained to use ePrescribing systems across four NHS Hospital Trusts. A range of approaches were used to train users; tailored training, using clinically specific scenarios or matching the user’s profession to that of the trainer were preferred over lectures and e-learning may offer an efficient way of training large numbers of staff. However, further research is needed to investigate this and whether alternative approaches such as the use of students as trainers could be useful. This programme of work revealed the importance of human factors and user involvement in the design and ongoing development of ePrescribing systems. Training also played a role in users’ experiences of using the system and hospitals should carefully consider the training approaches used. This thesis provides recommendations gathered from the literature and primary data collection that can help inform organisations, system developers and further research in this area

Antimicrobial stewardship programs in a hospital setting : development of quality indicators and implementation of interventions

Health care is challenged by the emergence of antibiotic resistance and the slow pipeline of new antibiotics, especially against Gram negative multi-resistant bacteria. The most important cause of emergence and spread of antimicrobial resistance has been a massive overuse of antibiotics worldwide across all ecosystems over the past decades, including humans, animals, aquaculture, and agriculture. Antimicrobial resistance may lead to more difficult to treat infections and may hence be associated with increased patient mortality, longer hospital stays, and increased healthcare costs. Up to 30% of antimicrobial regimens in hospitals are considered inappropriate. An effective approach to improving antimicrobial use in hospitals is an organised antimicrobial stewardship program. In this thesis we tried to develop and validate quality indicators in order to monitor antimicrobial stewardship programs in a hospital setting. Furthermore we evaluated key components of an antimicrobial stewardship program to optimize antimicrobial prescribing. With a multidisciplinary panel from four European countries we developed 57 structure indicators from which ten indicators were identified as a minimal set of key indicators. A validation survey in eleven European hospitals showed a significant heterogeneity with regard to their scoring for structural components of effective antibiotic stewardship. We concluded that potential structure indicators examined in this study, with focus on the top-ten indicators, could be used for regular assessment of the extent and strength of hospital antimicrobial stewardship programs. The feasibility and clinical relevance of measuring a process indicator for appropriate iv use of highly bioavailable antimicrobial drugs, allowing early IV to oral switch, was evaluated revealing a substantial heterogeneity of the performance gap. Absence of an iv-to-po switch programme was associated with more inappropriate prescribing. The results of this study indicated that the iv-to-po quality indicator is widely applicable and could be a tool to evaluate compliance with iv-to-po switch guidelines. Optimizing antibiotic dosing regimens is a core activity within an antimicrobial stewardship program. Extended and continuous infusions with betalactam antibiotics have been suggested as a means of pharmacokinetic and pharmacodynamic optimisation of antimicrobial therapy. A survey was undertaken to investigate the recommendations on extended and continuous infusions of ceftazidime, cefepime, piperacillin–tazobactam, meropenem and vancomycin by the local antibiotic management teams (AMTs) in Belgian acute hospitals. This survey showed that extended and continuous infusions are widely implemented in Belgian hospitals but revealed significant variation in the recommended dosing regimens. Two interventional studies were performed to optimize antimicrobial prescribing. These focused on appropriate timing of the initiation of an antimicrobial treatment for presumed infections in the emergency ward and on parenteral to oral conversion of fluoroquinolone antibiotics. We showed that the implementation of merely persuasive interventions such as hospital-wide publication of guidelines in the local drug letter and educational interactive sessions towards nurses and physicians only resulted in limited improvement. However, a pro-active intervention by a clinical pharmacist to stimulate parenteral to oral conversion resulted in a significant reduction of the duration of the intravenous treatment, as well as in treatment cost. Finally we assessed the functioning of a multidisciplinary infectious diseases team (MIT), which is an example of educational outreach intervention. The MIT formulated a daily average of 5 interventions for non-critically ill adult patients in a teaching hospital. Following bedside assessment by junior staff, diagnostic and therapeutic recommendations were communicated by phone and by notes towards prescribers in the electronic patient file resulting in high acceptance rates, in particular for therapeutic recommendations. In general this thesis provides indicators to the AMT’s to evaluate their antimicrobial stewardship activities. Proactive interventions on an individual patient level are needed to optimize antimicrobial prescribing

Clinical decision support systems in the care of hospitalised patients with diabetes

This thesis explored the role of health informatics (decision support systems) in caring for hospitalised patients with diabetes through a systematic review and by analysing data from University Hospital Birmingham, UK. Findings from the thesis: 1) highlight the potential role of computerised physician order entry system in improving guideline based anti-diabetic medication prescription in particular insulin prescription, and their effectiveness in contributing to better glycaemic control; 2) quantify the occurrence of missed discharge diagnostic codes for diabetes using electronic prescription data and suggests 60% of this could be potentially reduced using an algorithm that could be introduced as part of the information system; 3) found that hypoglycaemia and foot disease in hospitalised diabetes patients were independently associated with higher in-hospital mortality rates and longer length of stay; 4) quantify the hypoglycaemia rates in non-diabetic patients and proposes one method of establishing a surveillance system to identify non diabetic hypoglycaemic patients; and 5) introduces a prediction model that may be useful to identify patients with diabetes at risk of poor clinical outcomes during their hospital stay