Parents′ Recognition of Side Effects Experienced by Children Taking Intuniv® and Information Sharing with Teachers: A Retrospective Cohort Study

Rie Ito^1* and Fumiko Ohtsu^2
*Correspondence: Rie Ito, Ito Pharmacy Inc., Tsutsujigaoka, Chita City, Aichi, Japan, Tel: 070899770, Email:

Keywords

ADHD • Intuniv® • Information sharing • School children • Side effect

Abbreviations

Attention Deficit Hyperactivity Disorder (ADHD)

Introduction

The 4^th edition of the attention deficit hyperactivity disorder (ADHD)– Diagnosis and Treatment Guideline states that "the association between the parents of children with ADHD and schools is crucial from the perspective of improving the environment for these children and their treatment and support. However, the kind of available information sharing among parents, healthcare professionals, nursery teachers, kindergarten teachers, and school teachers needs to be clear to enable children to offer ADHD therapy while efficiently supporting their daily lives [1].

One therapeutic agent for ADHD is guanfacine hydrochloride extendedrelease tablets (Intuniv®). The typical side effects include hypotension and somnolence. These side effects can have a significant impact on children’s lives. To date, the occurrence of side effects in children is not completely understood. This study aimed to evaluate parents' perceptions of the side effects of Intuniv® at home, nursery schools, kindergartens, and schools. It also aimed to clarify the current state of information sharing between parents and school teachers.

Methods

All parents of children taking Intuniv® who visited Ito Pharmacy between November 28, 2018, and February 4, 2019, were considered eligible for participation in this study. The participants were asked to complete a selfadministered survey. The form contained seven items: children’s age, sex, number of days of the administration, whether their parents informed their teachers about Intuniv® dosing, side effects experienced by children, sharing information when a side effect occurred, and frequency of contact between parents and teachers. The survey items were compared by dividing the participants into two groups: side effect experienced and side effect inexperienced groups. In addition, focusing on the location of the side effects, we compared the two groups according to the presence of side effects at school. The Mann–Whitney U test and Student's t-test were used to compare the two groups. The dependent variables in the study were age, sex, days of administration of Intuniv®, and sharing of information about Intuniv® dosing. Simultaneously, we focused on where the side effects of Intuniv® occurred and divided the participants into two groups: A group that experienced side effects in school and a group that did not experience side effects in school. The effect size was calculated as Cohen’s d for continuous variables and the φ coefficient for categorical variables. The statistical significance level was set at 5%. The statistical software IBM SPSS Statistics (Version 27) was used for statistical analyses.

The rate of parents’ recognition of side effects in their children was defined as the number of people who recognized side effects out of the total number of respondents. This rate was compared with the incidence of adverse drug reactions in a domestic clinical study (combined domestic placebo-controlled study (A3122) and continuous long-term study (A3131)). The study was approved by the Aichi Pharmaceutical Association Ethics Review Committee (approval number: 2018-6).

Results

Participants

The questionnaire was distributed to 66 participants and collected from 40 participants (response rate: 60.6%). All respondents were mothers of children with ADHD. Approximately 90.0% of the children were male, and 10.0% were female. Approximately 5.0% of the children attended nursery schools, 65.0% attended elementary schools, and 27.5% attended junior high schools. The median number of days of Intuniv® administration was 180 (Table 1).

Occurrence of side effects

Approximately 72.5% of participating children experienced adverse effects. Their mean age was 9.8 ± 2.5 years (6–14 years old), while the mean age of participants who did not experience any side effects was 10.8 ± 2.8 years (7–15 years old). No statistically significant difference in the age of the two groups (Mann–Whitney U test) was found.

In contrast, children who did not experience any side effects received Intuniv® for 192.7 ± 127.9 days (30–478 days), while children who did not experience any side effects received Intuniv® for 230 ± 156.5 days (30–525 days; Student's t-test; P = 0.473). Moreover, there was no significant difference in information-sharing between the two groups of children receiving Intuniv^® (Table 2).

A combined domestic clinical study compared the rate of parents’ recognition of the side effects experienced by their children and the incidence of adverse drug reactions (A3122 and A3131). Sedation (sleepiness and drowsiness) was the side effect most recognized by the respondents in this study, and the frequency of its occurrence in their children was higher than that reported in a domestic clinical study (Figure 1). Some children experienced hypotension and bradycardia.

Side effects in schools

Approximately 65.5% of the children experienced side effects in schools (mean age, 9.6 ± 2.5 years; range, 6–14 years old), while the children who did not experience side effects in schools were aged 10.0 ± 2.6 years (6–15 years old; P = 0.717).

Children who experienced side effects were administered Intuniv® for 172.1 ± 128.7 days (30–465 days), and those who did not experience any side effect were administered Intuniv® for 232.0 ± 123.1 days (30–487 days; P = 0.237).

Contact frequency with teachers was considered a surrogate marker for the strength of sharing information about Intuniv® intake between parents and teachers. Parents of children who had experienced side effects in schools had a higher tendency to use frequent contact means, such as contact books and telephone calls (Table 3).

Discussion

The guidelines for the treatment of ADHD by the UK National Institute for Health and Clinical Excellence provide schoolteachers and parents with the following information [2]: (1) the diagnosis of ADHD varies widely, (2) symptoms can easily affect school life, (3) complications, such as learning disabilities, require different environmental adjustments than ADHD, and (4) information received from schools is highly valuable. These guidelines are consistent with the findings of the present study. In this survey, we investigated the provision of information on the use of Intuniv® tablets. The overwhelming majority of respondents informed their schoolteachers about drug use. It was implied that the mothers of the affected children expected the schoolteachers to provide them with information regarding changes in the physical condition of their children.

The incidence of adverse drug reactions (sedation) was higher in this study than that in a domestic clinical trial. This could be explained by the fact that the parents were the only observers of the children in the domestic clinical study, while in the present study, schoolteachers and parents observed side effects in the affected children. In contrast, the awareness of parents and schoolteachers about serious side effects, such as hypotension and bradycardia, was lower in this study than in the domestic clinical trial. This could be attributed to the measurement of blood pressure and pulse rate on a daily basis for safety evaluation in a domestic clinical study but not in this study.

However, the American Academy of Pediatrics guidelines for ADHD treatment list daily report cards and a point system as methods of intervention for the affected children at school; however, they do not indicate the means of communication between the school and family [3]. The Japanese ADHD treatment guidelines also do not specify the means of communication between the school and family to share the condition of the affected children at school. In the current study, parents used visits and contact books as a means of communication between the school and family. Accordingly, parents are more likely to recognize the occurrence of adverse effects at school and other places when information sharing among parents, schoolteachers, and other involved people is efficient. This can be further augmented by using smartphone applications for the management of mental illnesses. Based on these findings, it is necessary to promote information sharing between school teachers and parents and develop tools that enable real-time sharing of observations about side effects and situations in the future.

Conclusion

Sharing information about children with ADHD by teachers is valuable for evaluating the occurrence of side effects of Intuniv® and their impact on the daily lives of children.

Acknowledgments

None.

Conflict of Interest

The authors have no conflicts of interest to declare.

References

1. Kazuhiko S. The 4th edition of the Attention Deficit Hyperactivity Disorder -ADHD- Diagnosis and Treatment Guideline. (2016).
2. Attention Deficit Hyperactivity Disorder: Diagnosis and Management: Guidance. National Institute Health Care Excellence (2019).

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3. Wolraich, Mark L, Joseph F. Hagan, Carla Allan and Eugenia Chan et al. "Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents." Pediatr 144 (2019).

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