SIMulation of Medication Error induced by Clinical Trial drug labeling: the SIMME-CT study

Dollinger, Cécile; Schwiertz, Vérane; Sarfati, L.; Gourc-Berthod, Chloé; Guédat, Marie-Gabrielle; Alloux, Céline; Vantard, Nicolas; Gauthier, Noémie; He, Sophie; Kiouris, Eléna; Caffin, Anne-Gaëlle; Bernard, Delphine; Ranchon, Florence; Rioufol, Catherine

doi:10.1093/intqhc/mzw025

Cited by 8 publications

(7 citation statements)

References 25 publications

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“…The twelve articles did not demonstrate the inclusion of patients, they involved the development of some teaching resource or creation of resources to reduce and prevent adverse drug events through simulation methods. Of these articles, 01 involved the creation of a freeze-dried ampoule of Dantrolene (Giraldo-Gutiérrez et al, 2018); 01 identified unreported errors (You et al, 2015); 02 studies developed drug labels for simulations (Dollinger et al, 2016;GARCIA, et al, 2017); 01 alert created in simulations, 2017); 01 created alerts in medication prescription software to avoid errors (RUSS et al, 2014); 01 used simulated software to verify medication orders and reconciliation by pharmacists (Metzger et al, 2015); 01 involved creating software to train on security vulnerabilities in chemotherapy orders (Wyatt et al, 2020); 01 created a gamification simulator for preparing medicines (Booth et al, 2018); 01 creation of a device for the infusion of intravenous medications after checking the barcode (Khan et al, 2016); an integrative review that shows that high and low fidelity simulations contribute to knowledge acquisition (Santana et al, 2020); one study compared the frequency of errors after safety simulation training (JONES et al, 2021); one developed a simulated electronic medication administration system (Booth et al, 2017).…”

Section: Resultsmentioning

confidence: 99%

Realistic simulation in the preparation and administration of medications: a systematic review

Ribeiro,

Balbino,

Oliveira

et al. 2024

Cuad. Ed. Desar.

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Adverse drug events are multi-causal and interrelated, and it is important to know the causes and create prevention strategies. Realistic simulation is one of the methods widely used to discover the cause of these iatrogenies and as an effective method in the training of nursing professionals and students. The aim of this study is to identify and map how realistic simulations in the preparation and administration of medicines are being used in teaching and in the scientific community. This work is a bibliographical survey through a systematic review of online publications between 2012 and 2022. After selecting the articles, they were read and critically analysed. Of the 75 articles found, 52% were carried out in high-fidelity laboratories. As for the professional category, 29% had a multidisciplinary approach; as for the profile of the scenario used in the simulations, 43% involved scenarios for preventing iatrogenic events in adults. As for the aim of each study, 37% centred on simulation as a teaching resource. It was concluded that realistic simulation is an effective pedagogical tool for developing skills in students and professionals, it is a tool widely used to investigate the cause of adverse drug events and also to train professionals and students in the preparation and administration of medicines; it was shown that the lack of material resources is among the main causes for the occurrence of adverse drug events.

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Section: Resultsmentioning

confidence: 99%

Realistic simulation in the preparation and administration of medications: a systematic review

Ribeiro,

Balbino,

Oliveira

et al. 2024

Cuad. Ed. Desar.

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“…IMP container labels are often printed in small fonts that are difficult to read. Aside from the strict regulatory aspects of labeling, information that is readable, useful, understandable, and in the patient’s own language should be placed on container labels in order to encourage the patients to read them, and in order to reduce medication errors [17–21]. As reported in other studies, pictograms on container labels could be useful [22].…”

Section: Discussionmentioning

confidence: 99%

What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France

Fronteau

Paré

Benoit³

et al. 2019

PLoS ONE

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This study aimed to assess patient investigational medication knowledge and to identify factors associated with medication understanding by adult outpatients included in clinical trials. A cross-sectional prospectively designed survey was conducted on consecutive volunteers at 21 university teaching hospitals (in France) from February to December 2014. Investigational medication understanding was assessed at the time of the first dispensing using a structured interviewer-administered questionnaire based on information obtained from the literature that provided an 8-point score. Demographic and other baseline data were collected using structured interviews. Of the 236 participants, 139 (58.9%) of the respondents were male, and the median age was 54.9 years (range: 18–83 years). The mean understanding score was 6.24 and 72.5% of the patients had a score of 6 or higher. In univariate analysis, the medication understanding score was negatively correlated with age (r = -0.15, p = 0.0247) and positively correlated with the level of education (r = 0.25, p = 0.0002). In multivariate analysis, prognostic factors of a higher medication understanding score were: graduation from high school or a higher level of education; HIV infection; phase II/III/IV studies; mention of the drug on the prescription form, and the dispensing of a single investigational medication. Only a quarter of the adult outpatients included in clinical trials had a maximum possible investigational medication understanding score. Being old and having a low level of education were found to be important risk factors for inadequate medication understanding. This and other data suggest that sponsors should encourage initiatives aimed at improving investigational medication understanding in adults enrolled in clinical trials.

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“…They related mostly to dosage identification, trial code identification, drug confusion and expiry date. 18 Most errors were made with products that they characterized as ''high risk labels,'' according to their score of the risk of error with label information and the risk of confusion with another study. Considering that studies may involve high-risk drugs, appropriate warnings and precautions should also be highlighted on labels for these products in addition to the eight required elements.…”

Section: Conformity and Variabilitymentioning

confidence: 99%

Investigational drug labeling variability

et al. 2019

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Background/aims In comparison with commercial drugs, there are few regulations concerning the labeling of investigational drugs. This leads to variability in their content and layout. This increases the risk of errors during storage, validation, compounding, dispensing and administration. The aim of this study was to evaluate the conformity and variability of investigational drug labels. Additional exploratory aims were to evaluate the use of an automated script to describe the labels and to identify the factors associated with the ease of finding a kit number. Methods An 87-criterion list was developed to evaluate content, format and readability. It included eight criteria to evaluate the conformity to the Canadian Food and Drugs Regulation. A systematic cross-sectional evaluation of all investigational drug labels in our 500-bed mother–child center was performed. All active protocols during the period of 14–22 February 2018 were included. Labels from drugs that were sourced locally were excluded. Labels affixed to the outside (external) and inside (internal) containers, as well as labels from American and European sponsors, were compared with the chi-square and Student’s t tests. A script was developed in Python to automatically determine key information (number of words, main colors and their proportion). A short survey was conducted with a convenience sample of pharmacists to rate the ease of finding the kit number on labels. Correlation was evaluated with different factors. Results A total of 27 protocols were included (24 internal and 34 external labels). The majority (33/34) of external labels were compliant with the Regulation. Some internal labels did not state the expiry date (9/13), the sponsor address (2/13) or storing conditions (1/13). A total of 10 criteria were different between internal and external labels, for instance, the number of languages was higher on external labels (median 3 (2–14) vs 10 (2–50); p = 0.013). Five criteria were different depending on the sponsors’ location, for instance, European sponsors were more prone to use bold characters (25% vs 61%, p = 0.034). There was a mean of 146 ± 111 words and 78.3% ± 7.3% empty space per label. These were positively correlated (p < 0.001). The proportion of free space on a label was also correlated with the ease of finding the kit number (p = 0.002). Conclusion We measured a high variability in the labeling of investigational drugs. Key information was missing from labels affixed to internal containers, despite the use of a high number of pages. The automation worked well and further work is needed to identify criteria that may improve readability and reduce error risk. Detailed and harmonized international guidelines are needed.

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SIMulation of Medication Error induced by Clinical Trial drug labeling: the SIMME-CT study

Cited by 8 publications

References 25 publications

Realistic simulation in the preparation and administration of medications: a systematic review

Realistic simulation in the preparation and administration of medications: a systematic review

What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France

Investigational drug labeling variability

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