[Medication errors in Auvergne-Rhône-Alpes: A prospective pilot study led in collaboration by regional vigilance and support structures]. / Erreurs médicamenteuses en Auvergne Rhône-Alpes : étude pilote descriptive collaborative entre structures régionales de vigilance et d'appui (SRVA).

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.

Risk of suicide attempt associated with isotretinoin: a nationwide cohort and nested case-time-control study.

BACKGROUND: Isotretinoin is the only effective treatment for severe acne. An isotretinoin-related suicide risk is still debated and under scrutiny by regulatory agencies. Our objectives were: to assess the risk of suicide attempt before, during and after isotretinoin treatment; to detect any potential triggering effect of isotretinoin initiation on suicide attempt. METHODS: We implemented a cohort and nested case-time-control study of subjects treated with oral isotretinoin (course or initiation) aged 10-50 years, using the Nationwide French Health Insurance data (2009-2016). The main outcome was hospitalized suicide attempt. Standardized incidence ratios for hospitalized suicide attempts were calculated before, during and after isotretinoin treatment. The number of isotretinoin initiations was compared in risk and control periods of 2 months using a case-time-control analysis. RESULTS: In all, 443 814 patients (median age 20.0 years; interquartile range 17.0-27.0 years) were exposed to isotretinoin, amounting to 244 154 person-years, with a marked seasonality for treatment initiation. Compared with the French general population, the occurrence of suicide attempts under isotretinoin treatment was markedly lower, with a standardized incidence ratio of 0.6 [95% confidence interval (CI) = 0.53-0.67]; the same applied, to a lesser extent, before and after isotretinoin treatment. In the case-time-control analysis, among cases of suicide attempt, 108 and 127 isotretinoin initiations were observed in the risk and control periods respectively (i.e. 0-2 months and 2-4 months before the date of suicide attempt). The comparison with the 1199 and 1253 initiations observed among matched controls in the same two periods yielded a case-time-control odds ratio of 0.89 (95% CI = 0.68-1.16). A sensitivity analysis using three-month periods and a complementary analysis adding completed suicides for case definition showed consistent results. CONCLUSION: Compared with the general population, a lower risk of suicide attempt was observed among patients exposed to isotretinoin and there was no evidence for a triggering effect of isotretinoin initiation on suicide attempt. A selection of patients at lower risk for suicidal behaviour and appropriate treatment management could explain these findings. Risk management plans should therefore be maintained.

Self-poisoning with baclofen in alcohol-dependent patients: national reports to French Poison Control Centers, 2008-2013.

BACKGROUND: Alcohol use disorders are frequently associated with self-intoxication in attempted suicide. In France since 2008, the off-label use of baclofen for treatment of alcohol dependence has greatly increased, leading to temporary regulation of use of the drug. At the request of the national authorities, the French Poison Control Centers carried out a retrospective survey to give an overview of baclofen exposure in this population. METHODS: A retrospective study was carried out from January 2008 to December 2013, focusing on baclofen exposures in alcohol-dependent patients managed by the nine national French Poison Control Centers. RESULTS: 294 observations of baclofen exposures in alcohol-dependent patients were identified in our database. Of these, 220 were suicide attempts by self-poisoning and 74 were unintentional. The mean age of patients was 41.7 years, with a sex-ratio of 1.6. Patients attempting suicide with baclofen were younger than those with unintentional exposures, and 43.6% of them were women (vs 22.9%, p < 0.01). The mean supposed ingested dose was higher (480.7 mg) in patients who attempted suicide (vs 192.5 mg, p < 0.0001). 21.8% of intentional exposures involved baclofen alone. Psychiatric comorbidity (50.4%) was more frequent in the group of self-poisoning (p < 0.001). 132 patients were coded as severely exposed (60.0%). Nine victims died, but the causal link between self-poisoning with baclofen and fatal outcome should be interpreted with particular caution. CONCLUSIONS: Baclofen self-poisoning by alcohol-dependent patients is a serious concern for the French health authorities. Our results are similar to those previously published, suggesting that most patients with baclofen overdose should be admitted to an intermediate or intensive care unit as the clinical course requires close monitoring. Because suicidal ideation and suicide attempts are more prevalent in people with substance use disorders than in the general population, and because of the lack of recommendations governing baclofen prescription in such a situation, its use needs to be better controlled.

Hospital preparedness and response in CBRN emergencies: TIER assessment tool.

INTRODUCTION: Chemical, biological, radiological, and nuclear (CBRN) emergencies need particular hospital preparedness and resources availability. Also, specific skills and capabilities are required for efficient response to these types of events. The aim of this study was to develop an assessment tool to evaluate hospital preparedness and response performance with respect to CBRN emergencies. METHODS: An evaluation tool was developed using the Delphi technique. A panel of experts from 10 countries, both European and non-European, with more than 5 years of experience in research or practice in CBRN emergency management was involved in this study. The study was run online, and the experts were asked to evaluate a list of items on hospital preparedness and response in CBRN emergencies. A threshold of 85% agreement level was defined as the consensus of experts in this study. RESULTS: The first-round questionnaire was answered by 13 experts. Consensus on the preparedness section was reached for all 29 items during the first round and one item was also added by the experts. Consensus on the response performance indicators were reached in 51 out of the 59 items, during the first round, and eight items were modified and then approved in the second round by the experts. CONCLUSION: Hospitals need a specific level of preparedness to enable an effective response to CBRN emergencies. The assessment tool, developed through experts' consensus in this study, provides a standardized method for the evaluation of hospital preparedness and response performance with respect to CBRN emergencies. The feasibility and reliability of this assessment tool could be evaluated before and during simulated exercises in a standardized manner.

A screening tool to prioritize public health risk associated with accidental or deliberate release of chemicals into the atmosphere.

The Chemical Events Working Group of the Global Health Security Initiative has developed a flexible screening tool for chemicals that present a risk when accidentally or deliberately released into the atmosphere. The tool is generic, semi-quantitative, independent of site, situation and scenario, encompasses all chemical hazards (toxicity, flammability and reactivity), and can be easily and quickly implemented by non-subject matter experts using freely available, authoritative information. Public health practitioners and planners can use the screening tool to assist them in directing their activities in each of the five stages of the disaster management cycle.