Psychiatric adverse drug reactions in the paediatric population

Ekhart, Corine; Vries, Tjalling de; Hunsel, Florence van

doi:10.1136/archdischild-2019-317933

Cited by 15 publications

(10 citation statements)

References 33 publications

(33 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We report that the presence of a pharmacovigilance service greatly increased timely documentation of ADRs within the medical record. This is consistent with reports from other centers, after incorporation of a prospective pharmacovigilance service 3,7,8,15‐19 . Although the increased detection of ADRs after incorporation of a prospective pharmacovigilance program is well documented, these programs are unfortunately not the standard in all hospitals.…”

Section: Discussionsupporting

confidence: 89%

“…This is consistent with reports from other centers, after incorporation of a prospective pharmacovigilance service. 3,7,8,[15][16][17][18][19] Although the increased detection of ADRs after incorporation of a prospective pharmacovigilance program is well documented, these programs are unfortunately not the standard in all hospitals. Developing standardized EMR alerts or reports to detect ADRs requires time and infrastructure.…”

Section: Discussionmentioning

confidence: 99%

“…ADRs were excluded for the following reasons: unknown severity (26), ADR was treated at home and not detected until a later date (88), unknown treatment location (42), unknown ADR location (2), mechanism of ADR was precautionary, religious/preference, or unknown (17), missing ADR reaction type (1), and missing data on how ADR was identified (19).…”

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record

Tillman

Suppes

Feldman

et al. 2020

The Journal of Clinical Pharma

View full text Add to dashboard Cite

Adverse drug reactions (ADRs) often go unreported or are inaccurately documented in the electronic medical recorded (EMR), even when they are severe and life‐threatening. Incomplete reporting can lead to future prescribing challenges and ADR reoccurrence. The aim of this study was to evaluate the documentation of ADRs within the EMR and determine specific factors associated with appropriate and timely ADR documentation. Retrospective data were collected from a pediatric hospital system ADR reports from October 2010 to November 2018. Data included implicated medication, type, and severity of reaction, treatment location, the presence or absence of ADR documentation in the EMR alert profile within 24 hours of the ADR hospital or clinic encounter discharge, ADR identification method, and the presence or absence of pharmacovigilance oversight at the facility where the ADR was treated. A linear regression model was applied to identify factors contributing to optimal ADR documentation. A total of 3065 ADRs requiring medical care were identified. Of these, 961 ADRs (31%) did not have appropriate documentation added to the EMR alert profile prior to discharge. ADRs were documented in the EMR 87% of the time with the presence of pharmacovigilance oversight and only 61% without prospective pharmacovigilance (P < .01). Severity of ADR was not a predictor of ADR documentation in the EMR, yet the implicated medication and location of treatment did impact reporting. An active pharmacovigilance service significantly improved pediatric ADR documentation. Further work is needed to assure timely, accurate ADR documentation.

show abstract

Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record

Tillman

Suppes

Feldman

et al. 2020

The Journal of Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…Another database study, performed using VigiBase data, which focused only on neuropsychiatric outcomes after INC administration, also describes that anxiety is commonly reported [ 31 ]. Moreover, behavioural changes are commonly reported in paediatric populations after GC inhalation [ 32 , 33 ]. However, there seems to be no relationship between inhaled GCs and behavioural changes in children [ 34 , 35 ].…”

Section: Discussionmentioning

confidence: 99%

Adverse Drug Reactions of Intranasal Corticosteroids in the Netherlands: An Analysis from the Netherlands Pharmacovigilance Center

Rollema

Roon

Ekhart

et al. 2022

Drugs - Real World Outcomes

Self Cite

View full text Add to dashboard Cite

Background Intranasal corticosteroids are one of the cornerstone treatment options for allergic rhinitis and chronic sinusitis complaints. Safety information in the summary of product characteristics may not be representative for observations in daily clinical practice. The Netherlands Pharmacovigilance Center (Lareb) collects post-marketing safety information, using spontaneous reporting systems. Objective Our objective was to analyse reports of adverse drug reactions associated with intranasal corticosteroids reported in the Dutch spontaneous reporting database of the Netherlands Pharmacovigilance Center Lareb to obtain insight into real-world safety data. Methods We retrospectively examined all adverse drug reactions of intranasal corticosteroids reported to the Netherlands Pharmacovigilance Center Lareb, entered into the database from 1991 until 1 July, 2020. Results In total, 2263 adverse drug reactions after intranasal corticosteroid use were reported in 1258 individuals. Headache ( n = 143), epistaxis ( n = 124) and anosmia ( n = 57) were reported most frequently. Nasal septum perforation (reporting odds ratio 463.2; 95% confidence interval: 186.7–1149.7) had the highest reporting odds ratio, followed by nasal mucosal disorder (reporting odds ratio 104.5; 95% confidence interval 36.3–301.3) and hyposmia (reporting odds ratio 90.8; 95% confidence interval 45.1–182.7). Moreover, 101 (4.5%) reports were classified as serious by Lareb, including reports of Cushing’s syndrome, adrenal cortical hypofunction and growth retardation. Conclusions Many side effects are consistent with the safety information in the summary of product characteristics of intranasal corticosteroids. Several serious (systemic) side effects are reported and it is important to realise that intranasal corticosteroids may contribute to the development. Healthcare providers and patients should be aware of the potential (individual) adverse drug reactions of intranasal corticosteroids. This information could help in discussing treatment options. Supplementary Information The online version contains supplementary material available at 10.1007/s40801-022-00301-x.

show abstract

“…To investigate the possible adverse reactions to atomoxetine, an adapted semi-structured interview was recorded every three weeks by the guardians or parents electronically ( Supplementary File S1: Detailed information on the semi-structured interview ) based on the literature [ 44 , 45 , 46 ]. In this study, we focused on the most common drug adverse reactions, such as severe adverse reactions (headache, insomnia, suicide attempt) and gastrointestinal symptoms (loss of appetite, constipation, vomiting), fatigue, dizziness, and emotional instability) [ 47 , 48 ].…”

Section: Methodsmentioning

confidence: 99%

Effect of Atomoxetine on Behavioral Difficulties and Growth Development of Primary School Children with Attention-Deficit/Hyperactivity Disorder: A Prospective Study

Mei

Xie

et al. 2022

Children

View full text Add to dashboard Cite

(1) Objective: Atomoxetine is a selective norepinephrine reuptake inhibitor used to treat attention-deficit/hyperactivity disorder (ADHD) in children over six years old. Although it is common knowledge that primary school children with ADHD often present with difficulties in the morning prior to school and in the evening, these two periods, and the family interactions they involve, are often neglected in studies of ADHD. Questionnaire–Children with Difficulties (QCD) has been widely used in China to evaluate parents’ perceptions of ADHD and patients’ daily behaviors during different times. In the long term, the efficacy and safety of atomoxetine have been well established in previous studies. Still, the short-term effects of atomoxetine treatment on serum growth parameters, such as IGF-1, IGFBP-3, and thyroid function, are not well documented. Therefore, this study was the first one using the QCD to quantify the efficacy of atomoxetine treatment in the morning prior to school and in the evening, and has investigated the possible influence on the growth parameters of Chinese primary school children with ADHD. (2) Method: This prospective study was conducted at the Department of Pediatrics at the Affiliated Hospital of Jiangnan University from August 2019 to February 2021. Changes in the children’s behavior and core ADHD symptoms following treatment were assessed using three parent-reported questionnaires, including Children with Difficulties (QCD), the Swanson, Nolan, and Pelham IV scale (SNAP-IV), and the Conners’ parents rating scales (CPRS). The height, weight, and body mass index (BMI) were measured and corrected to reflect the standard deviations (SDS) in Chinese children based on age and gender. Serum growth parameters, such as insulin-like growth factor 1 (IGF-1), insulin-like growth factor-binding protein 3 (IGFBP-3), and thyroid function, were also measured to assess the children’s growth development. Any adverse drug reactions were assessed every three weeks. (3) Result: Finally, 149 children were enrolled in this study, and they completed 12 weeks of atomoxetine treatment. The QCD results indicated that the atomoxetine treatment could significantly alleviate behavioral difficulties in primary children with ADHD, especially in the morning prior to school (p < 0.001, r = 0.66) and in the evening (p < 0.001, r = 0.73). A statically significant decrease in weight SDS (p < 0.05) was noted during treatment, but the effect size was slight (r = 0.09). The atomoxetine treatment had no significant impact on height SDS, BMI SDS, and serum growth parameters, such as the levels of IGF-1, IGFBP-3, and thyroid function. The SNAP-IV results showed a significant improvement in the core symptoms of ADHD, while the CPRS results indicated a significant improvement in controlling ADHD symptoms across two different domains, learning problems (r = 0.81) and hyperactivity (r = 0.86). No severe adverse reactions were observed in the course of treatment, and the most common adverse reactions were gastrointestinal symptoms. (4) Conclusions: Atomoxetine is an effective and safe treatment for primary school children with ADHD. In China, it may be an excellent choice to alleviate parenting stress and improve the condition of primary school children with ADHD. Moreover, our study indicated that the serum levels of IGF-1 and IGFBP-3 were within the normal range in newly diagnosed ADHD children, and atomoxetine will not affect the serum concentration of growth parameters, such as IGF-1, IGFBP-3, and thyroid function, in the short term. However, the treatment may reduce appetite, resulting in a reduction in the Children’s weight for a short period. Further observational studies to monitor the long-term effects of atomoxetine on primary school children are recommended.

show abstract

Psychiatric adverse drug reactions in the paediatric population

Cited by 15 publications

References 33 publications

Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record

Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record

Adverse Drug Reactions of Intranasal Corticosteroids in the Netherlands: An Analysis from the Netherlands Pharmacovigilance Center

Effect of Atomoxetine on Behavioral Difficulties and Growth Development of Primary School Children with Attention-Deficit/Hyperactivity Disorder: A Prospective Study

Contact Info

Product

Resources

About