Medication error is a global threat to patient safety, particularly in pediatrics. Yet, this issue remains understudied in this population, in both hospital and community settings.
To characterize ...medication errors involving pediatrics reported to the French Medication Error Guichet, and compare them with medication errors in adults, in each of the hospital and community settings.
This was a retrospective secondary data analysis of medication errors reported throughout 2013-2017. Descriptive and multivariate analyses were performed to compare actual and potential medication error reports between pediatrics (aged <18 years) and adults (aged >18 and <60 years). Two subanalyses of actual medication errors with adverse drug reaction (ADR), and serious ADR were conducted.
We analyzed 4,718 medication error reports. In pediatrics, both in hospital (n=791) and community (n=1,541) settings, antibacterials for systemic use (n=121, 15.7%; n=157, 10.4%, respectively) and wrong dose error type (n=391, 49.6%; n=549, 35.7%, respectively) were frequently reported in medication errors. These characteristics were also significantly more likely to be associated with reported errors in pediatrics compared with adults. In the hospital setting, analgesics (adjusted odds ratio (aOR)=1.59; 95% confidence interval (CI) 1.03:2.45), and blood substitutes and perfusion solutions (aOR=3.74; 95%CI 2.24:6.25) were more likely to be associated with reported medication errors in pediatrics; the latter drug class (aOR=3.02; 95%CI 1.59:5.72) along with wrong technique (aOR=2.28; 95%CI 1.01:5.19) and wrong route (aOR=2.74; 95%CI 1.22:6.15) error types related more to reported medication errors with serious ADR in pediatrics. In the community setting, the most frequently reported pediatric medication errors involved vaccines (n=389, 25.7%). Psycholeptics (aOR=2.42; 95%CI 1.36:4.31) were more likely to be associated with reported medication errors with serious ADR in pediatrics. Wrong technique error type (aOR=2.71; 95%CI 1.47:5.00) related more to reported medication errors with ADR in pediatrics.
We identified pediatric-specific medication error patterns in the hospital and community settings. Our findings inform focused error prevention measures, and pave the way for interventional research targeting the needs of this population.
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NUK, OILJ, UL, UM, UPUK, VSZLJ
Therapeutic drug monitoring is already widely used for immunosuppressive drugs due to their narrow therapeutic index. This article summarizes evidence reported in the literature regarding the ...pharmacogenetics of (i) immunosuppressive drugs used in transplantation and (ii) azathioprine used in chronic inflammatory bowel disease. The conditions of use of currently available major pharmacogenetic tests are detailed and recommendations are provided based on a scale established by the RNPGx scoring tests as "essential", "advisable" and "potentially useful". Other applications for which the level of evidence is still debated are also discussed.
BACKGROUND:Dolutegravir, an integrase strand transfer inhibitor (InSTI), is a major antiretroviral agent for HIV infection. Its use is promising, especially in low- and middle-income countries, ...because of a high resistance barrier and a good safety profile. Very recently, a World Health Organization safety signal has been raised regarding neural tube defects after the first-trimester exposure. Furthermore, to date, the experience is limited regarding the use of the other InSTI drugs (raltegravir and elvitegravir) during pregnancy. Our objective is to analyze the safety of InSTI drugs in pregnant women.
SETTING:Nation-wide database cohort analysis.
METHODS:We evaluated the risk of major birth defects according to EUROCAT classification in pregnant women, which had had a first-trimester exposure to dolutegravir, raltegravir, or elvitegravir.
RESULTS:We found a major birth defect rate of 1.9% in the general population between 2012 and 2016. As InSTI drugs are not used as first-line therapy in pregnant women, we found a very low exposure in this population. Among 49, 240, and 70 pregnancy outcomes exposed to dolutegravir, raltegravir, and elvitegravir, respectively, during the first trimester, there were 2, 3, and 1 major birth defects, respectively. There was no case of neural tube defect.
CONCLUSIONS:Drug exposure to InSTI is limited in our nation-wide database. Nevertheless, our data do not support a pharmacovigilance signal on neural tube defects in women exposed to dolutegravir, raltegravir or elvitegravir during pregnancy. Owing to a small number of pregnancy outcomes, these results need to be confirmed with further studies.
COVID-19 is an unprecedented challenge for physicians and scientists. Several publicized drugs are being used with not much evidence of their efficacy such as hydroxychloroquine, azithromycin or ...lopinavir-ritonavir. Yet, the cardiac safety of these drugs in COVID-19 deserves scrutiny as they are known to foster cardiac adverse ADRs, notably QTc interval prolongation on the electrocardiogram and its arrhythmogenic consequences.
Since March 27th, 2020, the French Pharmacovigilance Network directed all cardiac adverse drug reactions associated with "off-label" use of hydroxychloroquine, azithromycin and lopinavir-ritonavir in COVID-19 to the Nice Regional Center of Pharmacovigilance. Each Regional Center of Pharmacovigilance first assessed causality of drugs. We performed a specific analysis of these cardiac adverse drug reactions amidst an array of risk factors, reassessed the electrocardiograms and estimated their incidence in coronavirus disease 2019.
In one month, 120 reports of cardiac adverse drug reactions have been notified, 103 of which associated with hydroxychloroquine alone (86%), or associated with azithromycin (60%). Their estimated incidence is 0.77% to 1.54% of all patients, notwithstanding strong underreporting. Lopinavir-ritonavir came third with 17 reports (14%) and chloroquine fourth with 3 reports (2.5%). There were 8 sudden, unexplained or aborted deaths (7%), 8 ventricular arrhythmias (7%), 90 reports of prolonged QTc (75%) most of them "serious" (64%), 48 of which proved ≥ 500ms, 20 reports of severe conduction disorders (17%) and 5 reports of other cardiac causes (4%). Six reports derived from automedication.
"Off-label" use of treatments in COVID-19 increases the risk of cardiac ADRs, some of them avoidable. Even if these drugs are perceived as familiar, they are used in patients with added risk factors caused by infection. Precautions should be taken to mitigate the risk, even if they will be proven efficacious.
Objective
Even though systemic vasculitides (SVs) affect primarily patients over 50 years of age, they can occur among women of childbearing age. Preterm birth (PTB) and hypertensive disorders are ...frequent complications of pregnancy in SVs. This study aims to evaluate the risk of hypertensive disorders and PTB among pregnant women with SVs, and to identify associated risk factors.
Method
Using the French health insurance data warehouse, we conducted a nationwide cohort study including all pregnancies between 2013 and 2018 in women with SVs. Theses pregnancies were matched to pregnancies among women without SVs. We estimated risk of hypertensive disorders and PTB risk during pregnancy among women with SVs and investigated associated risk factors using a nested case‐control design.
Results
Among 3,155,723 pregnancies, we identified 646 pregnancies in women with SVs, matched to 3,230 controls. SVs were significantly associated with hypertensive disorders (odds ratio OR 1.7, 95% confidence interval 95% CI 1.3–2.2) and PTB (OR 1.8, 95% CI 1.4–2.3). Chronic renal failure before pregnancy, history of or treated arterial hypertension, the occurrence of vasculitides flare during pregnancy, and the subgroup of SVs were independently associated with the occurrence of hypertensive disorders. Maternal age at delivery, chronic renal failure before conception, and the occurrence of vasculitides flare during pregnancy were independently associated with the occurrence of PTB.
Conclusion
About one of seven pregnancies in women with SVs is associated with hypertensive disorders or preterm birth. The occurrence of vasculitides flare was associated with these complications. Our findings support the importance of prepregnancy counseling to ensure disease stability.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
IntroductionWeight gain and obesity are common adverse effects of antipsychotics (APs). We aimed to assess AP-induced weight gain in pediatrics compared to adults.MethodsIn a case-non case study ...using the WHO global database of individual case safety reports (ICSRs), VigiBase®, we evaluated the existence of disproportionality in weight gain reporting under antipsychotic treatment in children and adolescents compared to adults. Disproportionality of weight gain reporting was evaluated using the reporting odds ratio (ROR) with corresponding 95% confidence intervals (95%CI). Analysis was adjusted for sex, reporting country, year of notification, reporter qualification and concomitant use of antidepressants (ADs) and lithium.ResultsA total of 282,224 ICSRs reported with an AP were retrieved: 6,446 (2.3%) in children, 14,112 (5%) in adolescents and 261,666 (92.7%) in adults. In children, 1,544 (24%) of ICSRs reported weight gain, 1,831 (13%) in adolescents and 13,506 (5.6%) in adults. Most weight gain cases concerned male patients (55%) and were reported by health professionals (47%) in North America (54%) and Europe (27%). Concomitant use of ADs and lithium was reported in 36% and 3.5% of weight gain cases overall. Disproportionality of weight gain reporting associated with APs was found in adolescents (adjusted ROR: 2.3 95%CI 2.1–2.4) and in children (aROR: 3.6 95%CI 3.3–3.8) compared to adults. Use of risperidone was associated with the highest increase in weight gain reporting in children (aROR 4.9, 95%CI 3.9–6.1) and adolescents (aROR 3.6, 95%CI 3.1–4.1).ConclusionsChildren and adolescents are at higher risk of reporting weight gain under APs than adults.
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