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Rationale Superabsorbent polymers are marketed as toys, and cases of ingestion in children are increasingly reported. Even if these cases are usually considered benign, bowel obstruction has been reported. Objective To investigate the exposure characteristics, clinical presentation, management, and outcome of patients who developed bowel obstruction following ingestion of superabsorbent polymer-made products. Methods Databases were searched (no start date - 2020/01/31) using the following keywords: ("superabsorbent" OR "polymer" OR "hydrogel" OR "crystal" OR "jelly" OR "Orbeez" OR "beads") AND ("ingestion" OR "obstruction" OR "perforation") AND ("intestinal" OR "bowel"). All cases of bowel obstruction following superabsorbent polymer-made product ingestion were included. Results Report selection: We found 25 reports reporting 43 cases of bowel obstruction following superabsorbent polymer-made product ingestion. All the reports were retrospective, including 20 case reports and 4 case series. Patient characteristics and clinical presentation: Age ranged from 6 to 36 months, and the female/male sex ratio was 1.3. The median delay between the ingestion of the product and the onset of the first symptoms (available in only four reports) was 1.0 [0.7;1.8] day (from 15 h to 2 days). The median delay between the onset of gastrointestinal symptoms and hospital admission, available for all but 15 patients, was 3 [2;4] days (from 15 h to 30 days). The reported symptoms were persistent vomiting in all cases, associated with constipation (11/43), diarrhea (1/43), abdominal pain (1/43), and clinically assessed dehydration (14/43). Abdominal palpation found abdominal tenderness or distension in 11/43 and 28/43 patients, respectively. An abdominal mass was palpated in 3/43 patients. Two patients presented with fever, and three patients developed seizures. Characteristics of exposure: Ingestion of superabsorbent polymer-made products was reported by relatives on hospital admission in only 10/43 cases. Based on imaging and/or surgically/endoscopically removed products, all were bead-shaped objects. The median number of beads removed (available in 27/43) was 1 [1-2] (range from 1 to 6). Their median diameter (available in 21/43 patients) at the time of the diagnosis of bowel obstruction - i.e., at hydrated state - was 30 [30;36] mm (range from 25 to 65 mm). Imaging findings: Abdominal radiography, performed in 31/43 patients, never showed evidence of foreign body ingestion Abdominal computed tomography scanning, performed in 10/43 patients, visualized an intraluminal mass in 5/10 cases. Abdominal ultrasound performed in 34/43 patients allowed visualization of a rounded intraluminal image that corresponded to a bead in 28/34 patients but led to a correct diagnosis of foreign body-induced bowel obstruction in only 15/34 cases. One case reported the contributory use of abdominal MRI. Beads were always located in the small bowel (from the duodenum to the terminal ileum). Removal of beads: Bead removal required endoscopy in 2/43 cases and surgery in 41/43 cases (enterotomy or resection in 36/43 and 5/43 cases, respectively). In 3/36 cases, additional enterotomy was performed to remove beads that had not been found during the first surgery. The delay between the onset of gastrointestinal symptoms and removal procedures ranged from 1 to 7 days. Outcome: Except for two fatal cases, the outcome was favorable. Conclusions Ingestion of superabsorbent polymer-made beads can be responsible for fatal bowel obstruction in children related to the increase in bead size within the intestinal tract. Diagnosis is made difficult by the radiolucent properties of the beads. The management of bowel obstruction probably most often requires endoscopic or surgical procedures. Children under 4 years of age are probably the most at risk of developing bowel obstruction.

Summary Introduction Cases of ingestion of superabsorbent polymers (SAPs) marketed as ornamental products and toys are increasingly reported. Objective The objectives of this study were to describe the trend and outcome of SAPs beads ingestion in France. Methods We conducted a retrospective descriptive study over a 10-year period of all cases of SAPs beads ingestion collected by the French Poison Control Centers. Results In total, 193 cases of SAPs bead ingestion were collected, 90% of whom among children (median 30 months). More than 75% of cases were asymptomatic while the remaining cases exhibited minor/mild gastrointestinal symptoms. The outcome was spontaneously favorable in all cases except for one fatality in a 18-month-old girl who developed bowel obstruction. Conclusions SAPs beads ingestions were mostly asymptomatic but could be responsible for fatal bowel obstruction in children, related to the increase in SAPs beads size within the intestinal tract. The diagnosis was made difficult by SAPs radiolucent properties. SAPs bead ingestion should be considered by practitioners as a possible cause of obstruction with no foreign body found.

Medication errors (ME) are frequently encountered and present at every step of the therapeutic process. This study's aims were to take stock of the ME reported to the region's pharmacovigilance (CRPV) and poison control centers (CAPTV) and to identify potential regional actions. A 2-months (January and February 2017) prospective gathering of the calls to the CAPTV regarding the ME and of the ME declarations to the region's CRPV (Clermont-Ferrand, Grenoble, Lyon, Saint-Etienne) has been carried out. The place of occurrence, the event's description and its consequences and data regarding the patient were collected. In addition to that, the regional drug observatory OMEDIT analysis has allowed to determine the ME's types (REMED characterization, never event?) and to look for the results of a potential thorough analysis. The study reported 580 calls for 590 ME and 583 patients. ME mostly affected the ambulatory/domicile sector (76%), the medico-social sector (14%) and the healthcare facilities sector (7%). It usually was about dose errors, medication errors and patient errors with a different profile in each sector. The majority of errors (85%) occurred at the administration step. Almost all the observed ME were confirmed errors having reached the patient (99.5%) but only a few had serious consequences. One out of 5 ME was eligible for a thorough analysis but even less were subjected to that kind of analysis. The main never event concerned the unidose in the ambulatory sector. The health products involved were mostly a single medication (75%) and then the patient's full treatment (12%). The CRPV/CAPTV/OMEDIT's skills are complementary for the gathering, the analysis and the management of the ME. Training campaigns and support are to be considered for the professionals and especially within the medico-social facilities.

International audience; Introduction The aim was to assess the impact of the COVID-19 pandemic on French Poison Control Centre (PCC) call characteristics. Methods Reported cases of xenobiotic exposures from 1 March to 30 April in 2018, 2019, and 2020 were extracted from the French National Database of Poisonings. The collected data included call, patient, and exposure characteristics for both general calls and for calls involving sentinel xenobiotic categories related to the COVID-19 pandemic. The 2020 exposures were compared to 2018-2019 exposures by using simple logistic models in order to provide effect size with odds ratios. Results From March to April 2020, 32,182 exposures were reported to French PCCs with an overall increase of 5.6% compared to exposures in the same time frame in 2018-2019. A similar increase in calls was observed in non-epidemic and epidemic COVID-19 areas with an increase in calls from the public (+13.6%) while calls from health-professionals decreased (-7.5%). Despite the increase in exposures, the incidence of symptomatic exposures remained stable (-0.4%) with a decrease in severity (moderate/severe -17.2%). A significant increase in exposures to home cleaning products containing biocides, essential oils, and alcohol-based hand sanitizers (odds ratio >1.3, p < .0001) was observed. Discussion and conclusion The COVID-19 pandemic altered calls to French PCCs with a small increase in calls during the study period and changes in the pattern of exposure. These changes possibly reflected the indirect consequences of the COVID-19 pandemic i.e., limited access to primary care, fear of contracting COVID-19 and anxiety related to home isolation.

Summary Introduction To date, few studies have shown a significant association between off-label drug use and adverse drug reactions (ADRs). The main aims of this study is to evaluate the relationship between adverse drug reactions and unlicensed or off-label drugs in hospitalized children and to provide more information on prescribing practice, the amplitude, consequences of unlicensed or off-label drug use in pediatric inpatients. Methods In this multicenter prospective study started from 2013, we use the French summaries of product characteristics in Theriaque (a prescription products guide) as a primary reference source for determining pediatric drug labeling. The detection of ADRs is carried out spontaneously by health professionals and actively by research groups using a trigger tool and patients’ electronic health records. The causality between suspected ADRs and medication is evaluated using the Naranjo and the French methods of imputability independently by pharmacovigilance center. All suspected ADRs are submitted for a second evaluation by an independent pharmacovigilance experts. Strength and limitations of this study For our best knowledge, EREMI is the first large multicenter prospective and objective study in France with an active ADRs monitoring and independent ADRs validation. This study identifies the risk factors that could be used to adjust preventive actions in children's care, guides future research in the field and increases the awareness of physicians in off-label drug use and in detecting and declaring ADRs. As data are obtained through extraction of information from hospital database and medical records, there is likely to be some under-reporting of items or missing data. In this study the field specialists detect all adverse events, experts in pharmacovigilance centers assess them and finally only the ADRs assessed by the independent committee are confirmed. Although we recruit a high number of patients, this observational study is subject to different confounders.

To describe clinical consequences of risperidone medication errors in children of less than 13 years and to estimate a clinically relevant toxic dose.All cases of risperidone medication errors managed by French Poison Centres from 2001 to 2012 were analyzed. Inclusion criteria were a delay of at least 2 hours between ingestion and request to the FPC in asymptomatic children, an ingested dose above two-fold the maximal daily dose for children above 5 years or any symptomatic patient at the time of first contact.One hundred and sixty cases met our criteria. Median age was 8 years (range 0.9-12) and 28.1% were aged 5 years or less. Causes of the error were an incorrect dose in treated children (84.2%) or a dose given to a wrong child (15.8%). The median ingested dose was 0.1 mg/kg or 3.3-fold the maximum recommended dose. Overall, 59 children had no symptoms, 95 experienced minor symptoms and six moderate symptoms. Somnolence/sedation was the most common (73.3%). Of the 17 children who developed extrapyramidal disorders, all had minor or moderate symptoms and only five required a symptomatic treatment.Risperidone medication errors in children cause minimal effects. Somnolence and mild to moderate extrapyramidal reactions were the main features of toxicity, and significant cardiac or other neurological features were not observed. No case with severe toxicity was noted. At home surveillance can be proposed for children exposed to a dose ≤0.15 mg/kg.

Objective Diphoterine® (Prevor Company, France) is an amphoteric hypertonic solution proposed for decontamination in case of cutaneous or ocular corrosive injury. Our Poison Information Center of Lyon (PIC Lyon) is regularly questioned by occupational health professionals about the benefit of diphoterine®. As new studies became available since the last review of Brent [1] , our aim was to assess systematically the available evidence on diphoterine®. Methods Non clinical studies and randomized or non-randomized trials in humans assessing the benefit of diphoterine® after cutaneous or ocular chemical burns were eligible. We searched Medline, Google and the Prevor website. After screening title and abstracts, relevant articles were selected, and the following data were extracted: study characteristics including quality assessment, type of controls and clinical outcomes (such as healing delay, burn severity), presence of potential conflict of interest. Results We identified 37 articles or abstracts of whom 12 original studies (6 sponsored by Prevor company) were included. Five controlled studies were conducted in animals (ocular exposures in three and skin in two). Sample size ranged from 16 to 30 animals. Two studies (one randomized) suggested an effect of diphoterine® use on ocular pH but not on clinical outcomes; one randomized study suggested a decrease of corneal injury; one randomized study observed a complete or almost complete healing of the burn injury in the five rats treated with diphoterine® compared to a detersion of eschar or a wound re-epithelization in the five rats treated with normal saline solution. However, these last studies reported multiple outcomes, without defining a principal, and did not correct for multiple testing. The last study, assessing the safety of diphoterine®, did not detect hypersensitivity reactions after skin exposure. Seven studies were conducted in humans with both eye and skin exposures. Sample size ranged from 5 to 180. Of the 3 retrospectives cases series, one uncontrolled study (24 subjects) did not detect adverse effects attributable to diphoterine® decontamination; one uncontrolled study (34 subjects) suggested a decrease in pain; the controlled study (131 subjects) did not show a decrease in the time to healing as compared to water (9.0 days in the diphoterine® group versus 7.0 in the non-diphoterine® group, P = 0.258). Of the 4 prospective studies, one was uncontrolled (5 subjects) and 3 compared diphoterine® to water and/or saline solution (from 65 to 180 subjects). Regarding the three controlled prospective trials, none of them were randomized; none of them controlled the alpha risk when reporting multiple outcomes; they suggested clinical benefits with less serious burns, decrease in pain or shorter time for recovery. Discussion We did not find acceptable level of evidence suggesting a clinical benefit of diphoterine®. Observations reported in the prospective clinical trials were at high risk of bias and at high risk of false positive results. Our results are consistent with previous systematic review [1] , [2] , [3] . We did not assess the financial cost of diphoterine®. Conclusion Compared to water or saline solution, the benefit of decontamination with diphoterine® is questionable. We believe that the decontamination should be performed as early as possible with the most easily accessible solution, and water should be the first option.