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Highest Risk Failure Modes and Recommended Strategies to Reduce Risks Modes and Strategies Highest risk failure modes Miscommunication when the clinician instructs family to change the dose Family misunderstands
Source publication
Observational studies describe high rates of errors in home oral chemotherapy use in children. In hospitals, proactive risk assessment methods help front-line health care workers develop error prevention strategies. Our objective was to engage parents of children with cancer in a multisite study using proactive risk assessment methods to identify h...
Contexts in source publication
Context 1
... several of the major steps in the process map, minor steps were identified in a more granular analysis. (Appendix Table A1, online only) For example, for the major step 2, "family receives information," two minor steps were identified: the clinicians pro- vided the information and the family understood the information. Both of these minor steps had different potential errors. ...
Context 2
... to reduce risk at home. Parent recommendations for reducing the risk of highly ranked failure modes fell into three general categories: (1) streamlining processes, (2) eliciting in- formation and support from clinicians, and (3) eliciting infor- mation and support from other parents (Table 1). Parents recommended streamlining processes that were already in place to improve their accuracy or consistency. ...
Citations
... A study on the adherence to label and device recommendations for over-the-counter pediatric liquid medications found that these products generally complied with most recommendations [78]. In the context of home oral chemotherapy use for children, effective communication, clear instructions and support systems are essential for safe medication administration [79]. Proactive risk assessment, involving parents and identifying error-prone areas, is crucial in reducing medication errors. ...
Introduction:
Medication errors during drug manipulations in pediatric care pose significant challenges to patient safety and optimal medication management. Epidemiological studies have revealed a high prevalenceof medication errors throughout the medication process. Due to the lack of age-appropriate dosage forms, medication manipulation is common in pediatric drug administration. The consequences of these manipulations on drug efficacy and safety could be devastating, highlighting the need for evidence-based guidelines and standardized compounding practices.
Areas covered:
This review focuses on examining medication errors in pediatric care and delving into the manipulation of medicinal products.
Expert opinion:
The observed prevalence of medication errors and manipulations underscores the importance of addressing these issues to enhance patient safety and improve medication outcomes in pediatric care. Overall, the development of age-appropriate formulations and the dissemination of comprehensive clinical guidelines are essential steps toward improving medication safety and minimizing manipulations in pediatric healthcare settings.
... To prioritize failure modes, we calculated risk priority numbers by multiplying participant Likert scale ratings of frequency of occurrence, the likelihood of detection, and clinician ratings of severity for each failure mode. 19,20 The group proposed possible interventions for failure modes with the highest risk priority numbers. ...
... We have led previous studies on outpatient and home medication errors among children with cancer, sickle cell anemia, and epilepsy. 2,3,17,20,26 Several common failures emerge from this research, employing chart review, home visits, and failure modes and effects analyses. Errors frequently occurred with dose changes, leading to failures to increase or decrease doses of chemotherapy, insulin, antiepileptic or hydroxyurea medications. ...
Introduction
The limited data indicate that pediatric medical errors in the outpatient setting, including at home, are common. This study is the first step of our Ambulatory Pediatric Patient Safety Learning Lab to address medication errors and treatment delays among children with T1D in the outpatient setting. We aimed to identify failures and potential solutions associated with medication errors and treatment delays among outpatient children with T1D.
Methods
A transdisciplinary team of parents, safety researchers, and clinicians used Systems Engineering Initiative for Patient Safety (SEIPS) based process mapping of data we collected through in-home medication review, observation of administration, chart reviews, parent surveys, and failure modes and effects analysis (FMEA).
Results
Eight (57%) of the 14 children who had home visits experienced 18 errors (31 per 100 medications). Four errors in two children resulted in harm, and 13 had the potential for harm. Two injuries occurred when parents failed to treat severe hypoglycemia and lethargy, and two were due to repeated failures to administer insulin at home properly. In SEIPS-based process maps, high-risk errors occurred during communication between the clinic and home or in management at home. Two FMEAs identified interventions to better communicate with families and support home care, especially during evolving illness.
Conclusion
Using SEIPS-based process maps informed by multimodal methods to identify medication errors and treatment delays, we found errors were common. Better support for managing acute illness at home and improved communication between the clinic and home are potentially high-yield interventions.
... Movie clips can also be used to educate parents on complicated topics. 1,5,23,[25][26][27][28] Parents from non-Swedish-speaking backgrounds expressed their wish to be provided with information in their mother tongue so as to be able to fully understand and process the information. It is well known that parents from different ethical backgrounds are often underinformed by HCPs and that both language ability and culture can be barriers to understanding the provided information. ...
Aim:
The aim of this study was to describe the experiences of parents handling oral anticancer drugs in a home setting.
Methods:
Parents of children with cancer were recruited from a paediatric oncology ward in Sweden to participate in an interview. The interviews were transcribed verbatim and subjected to qualitative content analysis.
Results:
We found the following categories and subcategories: parents' views on the provided information-lack of, too little or contradictory information, and parents' preferences for information delivery; safety over time; correct drug dose; and drug administration. As time passed, most parents adapted to their child's illness, felt safer and found it easier to take in and process any given information. Parents preferred information in different formats (written, movie clips and orally) and in their mother tongue. Many parents were aware of the importance of giving an accurate dose to their child and described the process of drug administration as overwhelming.
Conclusion:
Parents need to be provided with accurate, timely, nonconflicting and repeated information-in different forms and in their mother tongue-on how to handle oral anticancer drugs at home.
... Team member training in the technique prior the PM exercise was reported in only 15% of projects. This was usually delivered throughout meetings and by using examples [44,[64][65][66][67][68][69][70], while in some cases this included intensive QI training [71,72]. ...
... Some studies report that PM supported the effective design of HIT by enhancing the involvement of process stakeholders [88,[111][112][113][114][115]. Studies also describe how greater understanding of different perspectives provided by PM encouraged a culture of ownership and responsibility for improvement work [34,65,66,81,92,118,119]. For example, within ICP projects, PM allowed the clarification and reassessment of the roles and responsibilities within the team [86,87,101]. ...
... Other studies highlight how participation in PM helped to establish sense of urgency in clinicians regarding patient safety issues, thus enhancing their engagement [81,92,157]. Reviewed studies also show that the capacity of PM to facilitate the dialogue between diverse stakeholders helps to smooth barriers and tensions occurring during improvement projects or reach consensus on solutions [65,66,71,73,81,92,103,118,119]. For example, some studies reported how PM helped to promote the integration of health services across different settings by developing clinical evidence-based recommendations agreed among different healthcare professionals [74,86,87,89]. ...
Introduction
Process mapping (PM) supports better understanding of complex systems and adaptation of improvement interventions to their local context. However, there is little research on its use in healthcare. This study (i) proposes a conceptual framework outlining quality criteria to guide the effective implementation, evaluation and reporting of PM in healthcare; (ii) reviews published PM cases to identify context and quality of PM application, and the reported benefits of using PM in healthcare.
Methods
We developed the conceptual framework by reviewing methodological guidance on PM and empirical literature on its use in healthcare improvement interventions. We conducted a systematic review of empirical literature using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology. Inclusion criteria were: full text empirical study; describing the process through which PM has been applied in a healthcare setting; published in English. Databases searched are: Medline, Embase, HMIC–Health Management Information Consortium, CINAHL-Cumulative Index to Nursing and Allied Health Literature, Scopus. Two independent reviewers extracted and analysed data. Each manuscript underwent line by line coding. The conceptual framework was used to evaluate adherence of empirical studies to the identified PM quality criteria. Context in which PM is used and benefits of using PM were coded using an inductive thematic analysis approach.
Results
The framework outlines quality criteria for each PM phase: (i) preparation, planning and process identification, (ii) data and information gathering, (iii) process map generation, (iv) analysis, (v) taking it forward.
PM is used in a variety of settings and approaches to improvement. None of the reviewed studies (N = 105) met all ten quality criteria; 7% were compliant with 8/10 or 9/10 criteria. 45% of studies reported that PM was generated through multi-professional meetings and 15% reported patient involvement. Studies highlighted the value of PM in navigating the complexity characterising healthcare improvement interventions.
Conclusion
The full potential of PM is inhibited by variance in reporting and poor adherence to underpinning principles. Greater rigour in the application of the method is required. We encourage the use and further development of the proposed framework to support training, application and reporting of PM.
Trial Registration
Prospero ID: CRD42017082140
... For example, in ICP projects the use of PM to understand systems helped to improve coordination of care across different settings and networks [79,81,95], while in FMEA projects it helped to identify potential systems failures. [64,94,[96][97][98][98][99][100][101][102][103][104] (ii) Inform scope, design, development and evaluation of interventions ...
... For example, in ICP projects the use of PM to understand systems helped to improve coordination of care across different settings and networks [79,81,95], while in FMEA projects it helped to identify potential systems failures. [64,94,[96][97][98][98][99][100][101][102][103][104] (ii) Inform scope, design, development and evaluation of interventions ...
... [108][109][110][111][112]115] Studies also describe how greater understanding of different perspectives provided by PM encouraged a culture of ownership and responsibility for improvement work. [35,74,80,86,98,116,117] For example, within ICP projects, PM allowed the clari cation and reassessment of the roles and responsibilities within the team. [79,81,95] Other studies highlight how participation in PM helped to establish sense of urgency in clinicians regarding patient safety issues, thus enhancing their engagement. ...
Introduction
Process mapping (PM) supports better understanding of complex systems and adaptation of improvement interventions to their local context. However, there is little research on its use in healthcare. This study (i) proposes a conceptual framework outlining quality criteria to guide the effective implementation, evaluation and reporting of PM in healthcare; (ii) reviews published PM cases to identify context and quality of PM application, and the reported benefits of using PM in healthcare.
Methods
We developed the conceptual framework by reviewing methodological guidance on PM and empirical literature on its use in healthcare improvement interventions. We conducted a systematic review of empirical literature using PRISMA methodology. Inclusion criteria were: full text empirical study; describing the process through which PM has been applied in a healthcare setting; published in English. Databases searched are: Medline, Embase, HMIC–Health Management Information Consortium, CINAHL-Cumulative Index to Nursing and Allied Health Literature, Scopus. Two independent reviewers extracted and analyzed data. Each manuscript underwent line by line coding. The conceptual framework was used to evaluate adherence of empirical studies to the identified PM quality criteria. Context in which PM is used and benefits of using PM were coded using an inductive thematic analysis approach.
Results
The framework outlines quality criteria for each PM phase: (i) preparation, planning and process identification, (ii) data and information gathering, (iii) process map generation, (iv) analysis, (v) taking it forward.
PM is used in a variety of settings and approaches to improvement. None of the reviewed studies (N=105) met all ten quality criteria; 7% were compliant with 8/10 or 9/10 criteria. 45% studies reported that PM was generated through multi-professional meetings and 15% reported patient involvement. Studies highlighted the value of PM in navigating the complexity characterizing healthcare improvement interventions.
Conclusion
The full potential of PM is inhibited by variance in reporting and poor adherence to underpinning principles. Greater rigour in the application of the method is required. We encourage the use and further development of the proposed framework to support training, application and reporting of PM.
Prospero ID : CRD42017082140.
... Incidents related to medication handling can impact patients and families, as well as staff if appropriate cytotoxic protections are not in place. Incidents occurring while medications are managed by patients or families, also highlight difficulties typical for paediatric oncology patients given the close involvement of families in patients' care(Walsh et al., 2013;Walsh, Ryan, Daraiseh, & Pai, 2016). ...
Objective:
To explore medication safety issues related to use of an electronic medication management system (EMM) in paediatric oncology practice, through the analysis of patient safety incident reports.
Methods:
We analysed 827 voluntarily reported incidents relating to oncology patients that occurred over an 18-month period immediately following implementation of an EMM in a paediatric hospital in Australia. We identified medication-related and EMM-related incidents and carried out a content analysis to identify patterns.
Results:
We found ~79% (n = 651) of incidents were medication-related and, of these, ~45% (n = 294) were EMM-related. Medication-related incidents included issues with: prescribing; dispensing; administration; patient transfers; missing chemotherapy protocols and information on current stage of patient treatment; coordination of chemotherapy administration; handling or storing medications; children or families handling medications. EMM-related incidents were classified into four groups: technical issues, issues with the user experience, unanticipated problems in EMM workflow, and missing safety features.
Conclusions:
Incidents reflected difficulties with managing therapies rich in interdependencies. EMM, and especially its 'automaticity', contributed to these incidents. As EMM impacts on safety in such high-risk settings, it is essential that users are aware of and attend to EMM automatic behaviours and are equipped to troubleshoot them.
... This is all in line with results from prior studies addressing medication errors involving oral antineoplastic agents. 23,24 Also, failure to deliver information in small amounts allowing patients time to question information, as well as delivering information in a timely manner to ensure information is understood, was related to similar risks and rated with a high RPN by the patients and HCPs. ...
Objectives:
To identify risks associated with delivery of treatment with oral antineoplastic agents in an outpatient setting and to evaluate additional value and feasibility of engaging patients in a proactive risk analysis.
Methods:
We conducted 2 separate but parallel failure mode and effects analyses (FMEAs) among patients and health care professionals (HCPs) at a clinical oncology department in Denmark. Comparative analyses were performed using the FMEA process maps and risk priority numbers (RPNs) as main outcome measures. The FMEAs were augmented by semistructured interviews with HCPs and patients on acceptability and feasibility of FMEAs analyzed using systematic text condensation.
Results:
Patients and HCPs found failures in information regarding treatment (cause, aim, and plan) to be of high risk. Also, HCPs found failures in checking for potential interactions to be of high risk. HCPs focused on the in-hospitals procedures, whereas patients identified risks related to both the hospital and the home setting. Both HCPs and patients found participation in the FMEA process meaningful but found the use of RPNs difficult.
Conclusions:
Patient engagement in proactive risk analysis using FMEA is acceptable, meaningful, and feasible, with patients providing a different perspective on the risks associated with oral antineoplastic treatment compared with HCPs.
... The anticancer drugs production process carries a particularly high degree of risk and medication error in oncology and can have serious impacts on the health of patients (Butts et al. 2013;Carrez et al. 2014;INCa 2012; Institute for Safe Medication Practices 2017; JORF n°0090 2011). Indeed, many studies confirmed that the risks of errors concern all dispensation stages process (prescription analysis, preparation, control, delivery and patient information) and also prescription and administration stages (Ashley et al. 2011;Bonan et al. 2009;Bonnabry et al. 2006;Cairns et al. 2016;Chia-Hui et al. 2012;Christine et al. 2011;Ciofi et al. 2013;Fyhr and Akslsson 2012;Kathleen et al. 2013;Limat et al. 2001;Mattsson et al. 2015;Pongudom and Chinthammitr 2011;Ranchon et al. 2011;Robinson et al. 2006;Tournel et al. 2006;Ulas et al. 2015;Van Tilburg et al. 2006;Weingart et al. 2010). These studies highlight a complex process which involves several trades: physicians, pharmacists and nurses. ...
... These studies highlight a complex process which involves several trades: physicians, pharmacists and nurses. Many teams mapped the entire process (Chia-Hui et al. 2012;Van Tilburg et al. 2006;Bonan et al. 2009;Robinson et al. 2006;Ciofi et al. 2013), some studies targeted only prescription (Christine et al. 2011) or administration processes (Ashley et al. 2011) and others described the process until patient's home (Kathleen et al. 2013;Bonnabry et al. 2006 ). A recent review compared non analytical and analyt-ical methods but did not consider robotization in its original SWOT analysis . ...
The observed increase in cancer led to a continuous rise in anticancer drug preparations in Hospital Centres. The quality and security of these preparations are essential to ensure the efficacy and to limit the risk of iatrogenic toxicity. Several methods have been described to secure the process of preparation (i.e. non-analytical methods for the control during the fabrication; analytical methods for the final product evaluation). These different methods have been presented in many studies, in particular in descriptive studies, but in practice, selecting a method is difficult and related to needs and hospital priorities. Therefore, we decided to conduct this present review focused on various existing methods allowing enhancement in security of anti-cancer drugs preparation process. A proactive hazard analysis method was applied, considering preparation and control steps, to discuss the choice of a method in terms of quality and security and to identify potential risks of failure. The results show that none method is perfect. Methods with the lowest criticality score are the robotization closely followed by Drugcam® in the case of re-labelling of all containers. According to these elements a University Hospital Centre could consider these risk indexesimplementing control methods. © 2018 Govi-Verlag Pharmazeutischer Verlag GmbH. All Rights Reserved.
... 14 The Failure Mode and Effects Analysis (FMEA) is one of these techniques. 15 FMEA is used to identify potential risks and can be implemented to enhance the patients' safety. 16 This systematic method is based on team work for identification, evaluation, prevention, control or the elimination of the causes and effects of potential risks in a system before a final product is delivered to a final user. ...
... The researchers developed a better understanding of these children's problems and realized the parents' willing to participate in the implementation of the FMEA model. 15 The 15th article, by Mesa et al., was an attempt to improve surgeons' skills and patients' safety in laparoscopy. The FMEA implementation included the following steps: forming a team of 48 surgeons, dividing them into 24 teams of 2, training on laparoscopy by examining laboratory animals in three steps and finally analyzing the results. ...
Background:
Medical errors are one of the greatest problems in any healthcare systems. The best way to prevent such problems is errors identification and their roots. Failure Mode and Effects Analysis (FMEA) technique is a prospective risk analysis method. This study is a review of risk analysis using FMEA technique in different hospital wards and departments.
Methods:
This paper systematically investigated the available databases. After selecting inclusion and exclusion criteria, the related studies were found. This selection was made in two steps. First, the abstracts and titles were investigated by the researchers and, after omitting papers which did not meet the inclusion criteria, 22 papers were finally selected and the text was thoroughly examined. At the end, the results were obtained.
Results:
The examined papers had focused mostly on the process and had been conducted in the pediatric wards and radiology departments, and most participants were nursing staffs. Many of these papers attempted to express almost all the steps of model implementation, and after implementing the strategies and interventions, the Risk Priority Number (RPN) was calculated to determine the degree of the technique's effect. However, these papers have paid less attention to the identification of risk effects.
Conclusions:
The study revealed that a small number of studies had failed to show the FMEA technique effects. In general, however, most of the studies recommended this technique and had considered it a useful and efficient method in reducing the number of risks and improving service quality.
... Rates of medication errors and related injuries among children receiving chemotherapy at home are high. [1][2][3][4] Home medication use in children with cancer is highly complex: doses change from day to day, liquids are difficult to measure, pills must be cut and crushed, and children with cancer take a median of 10 medications daily. 2,4 In a recent editorial, Landrigan et al called for more effective support for parents caring for ill children at home. 5 Our objective was to facilitate the family-centered development of a Web-based intervention, called Home Medication Support (HoMeS), to support home medication use and to assess its the feasibility, acceptability, and usefulness among children with cancer. ...
... [1][2][3][4] Home medication use in children with cancer is highly complex: doses change from day to day, liquids are difficult to measure, pills must be cut and crushed, and children with cancer take a median of 10 medications daily. 2,4 In a recent editorial, Landrigan et al called for more effective support for parents caring for ill children at home. 5 Our objective was to facilitate the family-centered development of a Web-based intervention, called Home Medication Support (HoMeS), to support home medication use and to assess its the feasibility, acceptability, and usefulness among children with cancer. In previous studies, we systematically reviewed the literature on medication errors at home and visited 92 homes to describe mistakes in home medication use. ...
... 2,6 We also worked with parents who identified common failures that led to errors in home chemotherapy use. 4 These parents systematically identified Web-based intervention components that would help prevent these errors. ...
Purpose:
Errors in the use of medications at home by children with cancer are common, and interventions to support correct use are needed. We sought to (1) engage stakeholders in the design and development of an intervention to prevent errors in home medication use, and (2) evaluate the acceptability and usefulness of the intervention.
Methods:
We convened a multidisciplinary team of parents, clinicians, technology experts, and researchers to develop an intervention using a two-step user-centered design process. First, parents and oncologists provided input on the design. Second, a parent panel and two oncology nurses refined draft materials. In a feasibility study, we used questionnaires to assess usefulness and acceptability. Medication error rates were assessed via monthly telephone interviews with parents.
Results:
We successfully partnered with parents, clinicians, and IT experts to develop Home Medication Support (HoMeS), a family-centered Web-based intervention. HoMeS includes a medication calendar with decision support, a communication tool, adverse effect information, a metric conversion chart, and other information. The 15 families in the feasibility study gave HoMeS high ratings for acceptability and usefulness. Half recorded information on the calendar to indicate to other caregivers that doses were given; 34% brought it to the clinic to communicate with their clinician about home medication use. There was no change in the rate of medication errors in this feasibility study.
Conclusion:
We created and tested a stakeholder-designed, Web-based intervention to support home chemotherapy use, which parents rated highly. This tool may prevent serious medication errors in a larger study.
